Newsletter No 1 / 2015 March 30 Some memories of the founding years of SAKK E arly in the 1960s, when the neighboring countries of Switzerland started to recognize Medical Oncology, the start in our country was rather tardy. At first, there were certain isolated actions without prosecution. Then Georg Martz appeared in Zurich, some of us named him the “forefather” of Oncology. He K. Brunner, G. Martz: established a Medical Oncology two of the SAKK founders unit at the University Hospital in Zurich. Among other things, Georg knew of the importance of psychological support for patients and therapists and collaborated in this field with Prof. Fritz Meerwein, a German pioneer in psycho-oncology. These initial movements in Zurich were followed by a fast development in Oncology and lead thereafter to the foundation of SAKK – the unique and dynamic national network of which we are celebrating its anniversary this year. In Brief 50 years ago, visionary leaders in cancer medicine realized that advancement of patient management requires solid understanding of the disease and biology, vigorous testing of novel treatments, and interdisciplinary collaboration and exchange beyond state boundaries. This remains true today. With these thoughts I look forward to a continued and fruitful development of SAKK and wish the group prosperity and success! Contents Prof. Dr. Pierre Alberto Former SAKK president 1975 to 1981 Voting members 2015 In 2014, a total of 707 patients were accrued. SAKK publishes a list of the voting members of each of its project groups at the beginning of the year. PAGE 2 Success story trial SAKK 41/06 Read more about the aim of the trial, its results and the benefit for the scientific community. PAGE 4 Support by ambassadors SAKK is supported in its anniversary year by ambassadors from the worlds of sport, politics, culture and medicine. PAGE 6 SAKK News 2-5 SAKK Anniversary 6-10 Trial News 10-17 Publications, Presentations 17 IBCSG19-21 ETOP22 Cancer League 23 Grants, Events, Education 24-28 Dates, Flag 29 Read more details on the founding years of SAKK on page 7 and join us at the "Active against Cancer Event" on May 20 in Bern. A unique opportunity to enhance our visibility and raise the awareness for cancer treatment and research. You will find a detailed program on page 7 The Swiss Oncology Research Network 2 March 30, 2015 SAKK Newsletter SAKK NEWS Board decisions SAKK Voting Members 2015 At its board meeting on January 27, 2015, in Bern the SAKK board accepted the following trials: In 2014, a total of 707 patients were accrued which is less than in 2013 with a total of 1006 patients. SAKK publishes a list of the voting members of each of its project groups at the beginning of the year. The centers become voting members of the project groups based on the following article in the project group regulations: Voting members shall recruit at least three evaluable patients per year into SAKK trials and/or trials from cooperative groups SAKK collaborates with; provided that sufficient feasible trials are open. Voting members that recruit less than three patients per year for two consecutive years may lose their voting member status and may be downgraded to the nonvoting membership. SAKK 24/14 Anti-EGFR-ILs: clinical investigator C. Rochlitz A phase II study of anti-EGFR-ILs loaded with doxorubicin in patients with advanced triple negative breast cancer. The primary objective of the trial is to determine the efficacy of anti-EGFR immunoliposomes loaded with doxorubicin as first-line therapy in patients with advanced triple negative breast cancer. Anti-EGFR-immunoliposomes are the first targeted nanocontainers to have shown responses in a phase I trial. Investigating the potential of nanocontainer-mediated delivery of cytotoxic compounds to triple negative breast cancer patients could serve as a proof-of-principle trial for other similar approaches. Due to its innovative technology this trial promises a high visibility in the field of breast cancer research and thus excellent chances of future funding and company-driven development of the drug in case of a positive outcome. SAKK 16/14: clinical investigator S. Rothschild Perioperative anti-PD-L1 antibody (MEDI4736) in addition to standard neoadjuvant chemotherapy in non-small cell lung cancer (NSCLC) patients with mediastinal lymph node metastases (stage IIIA, N2). The addition of the anti-PD-L1 antibody MPDL3280A to standard neoadjuvant chemotherapy offers a novel approach in the treatment of locally advanced NSCLC stage IIIA (N2). Despite multimodal therapy the outcome of patients with stage IIIA NSCLC is poor. The task is to substantially decrease the number of patients who die in spite of intensive multimodality treatment. The addition of a novel treatment modality (immunotherapy) has the potential to improve the outcome without adding additional substantial toxicity as MPDL3280A has been generally well tolerated. Encouraging results are available in the palliative setting. Therefore, this trial allows patients to benefit from a novel treatment approach. New employment regulations The employment regulations of the SAKK Coordinating Center were revised and approved by the board. They will enter into force on March 1, 2015. The Swiss Oncology Research Network The voting members for 2015 are as follows: PG Breast Cancer, voting members: 28 (without EORTC 10085 PRO) Avignon (NEW) Kantonsspital St. Gallen Bordeaux (NEW) Kantonsspital Winterthur Brustzentrum Thurgau Lille (NEW) CHCVS Sion Nice (NEW) CHUV Lausanne Oncocare Engeried Hirslanden Brustzentrum Rouen (NEW) Hôpital Fribourgois Saint-Cloud (NEW) HUG Genève Spital Thun Simmental Inselspital Bern Spitalzentrum Biel IOSI Ticino Thommon les Bains (NEW) Kantonsspital Aarau Universitätsspital Basel Kantonsspital Chur USZ Zürich Kantonsspital Liestal (NEW) ZeTup St. Gallen Kantonsspital Luzern Kantonsspital Olten (NEW) PG Gastrointestinal Cancer, voting members: 17 Budapest Laszlo Hospital CHUV Lausanne Hôpital Claude Huriez Lille HUG Genève Inselspital Bern IOSI Ticino Kantonsspital Aarau Kantonsspital Chur Kantonsspital Luzern Kantonsspital Olten Kantonsspital St. Gallen Kantonsspital Winterthur Krankenhaus Linz Krankenhaus Elisabethinen Linz Spitalzentrum Biel USZ Zürich Zürich Triemli March 30, 2015 3 SAKK Newsletter SAKK NEWS PG Leukemia, voting members: 8 CHUV Lausanne HUG Genève Inselspital Bern IOSI Ticino Awards and Promotions Kantonsspital Aarau Kantonsspital St. Gallen Universitätsspital Basel USZ Zürich PG Lung Cancer, voting members: 10 CHUV Lausanne Hôpital Fribourgeois Inselspital Bern IOSI Ticino (NEW) Kantonsspital Chur Kantonsspital Luzern Kantonsspital St. Gallen Kantonsspital Winterthur Spital Thun Simmental USZ Zürich PG Lymphoma, voting members: 26 CHCVS Sion (NEW) Kantonsspital Winterthur CopenhagenOslo Helsinki Ospedale San Raffaele IEO Milano Spital Thun Simmental Inselspital Bern Stockholm Karolinska, Huddinge IOSI Ticino Stockholm Karolinska, Solna Kantonsspital Aarau Triemli Zürich (NEW) Kantonsspital Baden Tromso Kantonsspital Chur Umea Kantonsspital Liestal Universitätsspital Basel Kantonsspital Luzern Uppsala Kantonsspital Olten USZ Zürich Kantonsspital St. Gallen Zürich Hirslandenklinik F. Birkhäuser & C. Rentsch The Pfizer Research Prize Foundation awarded the Pfizer Research Prize to nine researchers from the regions of Basel, Bern and Zurich for their outstanding scientific work on February 5. Recipients of the prize included Cyrill Rentsch from the University Hospital Basel and with Frédéric Birkhäuser from the University Hospital Bern for their work on non-muscle invasive bladder cancer. The publication is based on trial SAKK 06/98, which was carried out from 1998 to 2003 in the framework of the SAKK network. SAKK CC Staff News Hans-Peter Röthlisberger joined the SAKK team as CFO/ Kantonsspital Chur Kantonsspital St. Gallen Head of Services. He replaces Robert Meyer as member of the executive board. Hans-Peter holds a professional bachelor in business administration HFW and has several years of experience in different industry sectors. HansPeter has two children and lives in Rubigen. PG Urogenital Tumors, voting members: 23 Luzia Steiner joined the SAKK team as clinical data as- PG New Drugs, voting members: 4 IOSI Ticino Kantonsspital Basel (NEW) Basel Universitätsspital Charité Berlin CHCVS Sion CHUV Lausanne Düsseldorf Uniklinikum (NEW) Fondazione oncologica (NEW) Inselspital Bern IOSI Ticino Kantonsspital Aarau Kantonsspital Chur Kantonsspital Luzern Kantonsspital Münsterlingen Kantonsspital St. Gallen Kantonsspital Winterthur Spital Thun Simmental Spitalzentrum Biel (NEW) Triemli Zürich Universitätsklinik Dresden Universitätsklinik Rostock Uniklinik Würzburg Uniklinikum Tübingen University of Ghent Zürich Hirslandenklinik sistant in March. Sabine Rion, data manager, found a new challenge within the coordinating center: she takes over the open position as clinical project manager. Farewell Steffi Demmel has worked as clinical project manager for five years. She will leave the SAKK CC end of April. We thank her for her commitment and dedication to SAKK and we wish her all the best for the future. For information on job vacancies at SAKK, please contact us and/ or refer to http://sakk.ch/en/about-sakk/organization/jobs/ The Swiss Oncology Research Network 4 March 30, 2015 SAKK Newsletter SAKK NEWS Lung cancer symposium in Bern Bronchial carcinoma remains the most common cause of death from cancer in the Western world. Each year, around 4000 people in Switzerland are diagnosed with the disease and about 3000 people die of it. On 12 March, experts from home and abroad met in Bern at the 1st Swiss Lung Cancer Symposium. The last few years have seen crucial advances in the treatment of non-small-cell bronchial carcinoma, which accounts for 85 % of lung tumors. This is especially true for the approximately 15 percent of all patients with specific molecular lesions that can be treated with oral tyrosine kinase inhibitors. The discovery of ever more new potential “driver alterations” in some cases with a low incidence of less than 3 % presents an increasing challenge for clinicians and for collaborative research groups. Improvements in therapeutic results have also been achieved in classical treatment with chemotherapy and with anti-VEGFR and anti-EGFR antibodies, albeit to a lesser extent. A very rapid and interesting development can be observed at present in the field of molecular diagnostics and also in immunotherapy with immune checkpoint inhibitors, which are expected to find their way into clinical use very soon. All these important issues were presented and discussed by experts at the 1st Swiss Lung Cancer Symposium in Bern on 12 March. A success story Trial SAKK 41/06: Bevacizumab maintenance versus no maintenance after stop of first-line chemotherapy in patients with metastatic colorectal cancer. A randomized multicenter phase III non-inferiority trial. Trial chair PD Dr. Dieter Köberle is Head of the Department of Internal Medicine and Head of the Cancer Center in the St. Claraspital in Basel. Köberle studied in Austria and specialized in Internal Medicine and Oncology. He is member of the project group gastrointestinal cancers. In the following interview, he explains why research in cooperative groups like ours is crucial and can help not only patients but also help cost saving. What was the aim of the SAKK 41/06 trial? Why were you interested in developing the trial? The scientific question concerning this trial was based on a dilemma in clinical routine care: it was unclear, whether we should continue or not bevacizumab treatment after stopping chemotherapy for the first-line treatment of metastatic colorectal cancer patients. Discontinuation of bevacizumab was considered a yet unproven treatment strategy, as in the pivotal trials of bevacizumab, the full treatment (including chemotherapy) was continued until disease progression or intractable toxicity. As a result, many trials with uninterrupted polychemotherapy became increasingly obsolete. At the time we discussed this question within SAKK, many Swiss oncologists stopped chemotherapy after 4-6 months, but continued bevacizumab, as it was assumed that bevacizumab monotherapy might be sufficient to prolong disease control achieved with combination therapy. We were interested to investigate the non-inferiority question between bevacizumab continuation versus discontinuation within a phase III trial. How was the trial funded? Roche, the manufacturer of bevacizumab, was not interested to support SAKK with this trial. It was calculated that the drug costs for bevacizumab continuation alone would be above 4 Mio. Swiss Francs in a trial of approximately 140 patients per arm. SAKK, as an independent national network for clinical cancer research, was not able to conduct this trial without a partner. Next, we contacted the Swiss health insurances. From the very beginning they were interested and provided substantial funding for this trial. What were the results? Between October 2007 and May 2012, 265 patients were included at 26 sites in Switzerland and 262 were randomly assigned in equal numbers to bevacizumab continuation or no bevacizumab continua- The Swiss Oncology Research Network SAKK Newsletter March 30, 2015 5 SAKK NEWS tion. The time to progression (TTP; the primary endpoint) was longer in the bevacizumab continuation group (4.1 versus 2.9 months). Non-inferiority could not be demonstrated. The difference in median TTP was however shorter than the 6-weeks boundary, which we assumed to indicate clinical equipotency between bevacizumab continuation and treatment holidays. Based on no impact on overall survival and increased treatment costs, we concluded that bevacizuamb as a single agent is of no meaningful therapeutic value. The full paper, including all additional results, was recently published in the Annals of Oncology. What are the benefits for the scientific community, the patients? The benefits for the patients and for the community are very clear: saving the patients from a noneffective treatment including the inconvenience of a 3-weekly infusional therapy, some minor toxicities and finally reducing treatment costs of approximately 25’000 to 30’000 Swiss Francs per patient. SAKK gained reputation in the scientific community for this trial. Why was the trial difficult to communicate, heavily polarizing and difficult to get published? Reducing therapies for an incurable disease like metastatic colorectal cancer requires sufficient evidence that the patient does not loose a relevant part of a limited lifetime. Scientific advances move in two directions: first and most important – all of us are eager to develop new therapies, which aim to prolong survival time with an incurable disease. On the other hand, we need to validate treatments in the setting of routine care, especially if the registration trials are too selective, or if new findings erode current treatment standards. All these considerations should include the patient´s demand for the best possible balance between treatment burden and recovery time. Obviously, not everybody is interested in a de-escalation trial. In general, this type of trial is less awarding, includes potential of ambiguity and is more difficult to get published. Larger sample sizes are usually needed to demonstrate equivalence or non-inferiority than superiority. For this reason, a lot of non-inferiority trials are rather underpowered and therefore not able to define a new standard of care. The clinicians view can be divergent in determining whether the degree of non-inferiority demonstrated is clinically acceptable and whether the ancillary effects of the treatment justify or discredit its use. General acceptability of our main findings increased when the results of two other trials conducted in Germany and France were presented at major meetings. Both trials confirm our results. Likewise other trials, investigating combined maintenance strategies, opened doors for more efficient treatment options. Today’s preference is to continue with fluoropyrimidines alone or in combination with bevacizumab, or to offer treatment holidays. How many people were involved in the trial, for how many years? Many dedicated people were involved in this trial, which was conducted in multiple sites in Switzerland. Beside from hospitals, private oncologists also recruited patients. SAKK did a tremendous job in the coordination and support of all phases of the trial, between trial conception, which started in 2006 and publication in early 2015. We wish to express our sincere gratitude to all contributors of this trial, the State Secretariat for Education, Research and Innovation (SERI) for financial support and santésuisse (Swiss Association of Health Insurance Companies) for making this trial possible. PD Dr. Dieter Köberle, Claraspital Basel Dieter.Koeberle@claraspital.ch The Swiss Oncology Research Network 6 March 30, 2015 SAKK Newsletter SAKK ANNIVERSARY Support by ambassadors In its research on cancer, SAKK is supported in its jubilee year by ambassadors from the worlds of sport, politics, culture and medicine. One of these ambassadors is skiing legend Bernhard Russi: “Cancer can hit anyone. I support SAKK because it makes an important contribution to cancer research with its work”. Star chef Ivo Adam is also only too aware that, while a healthy diet can help in the prevention of cancer, it unfortunately does not offer a cure. “This is why I support the SAKK, because it tries to improve treatments and gain new insights through clinical studies.” And National Councillor Ruedi Lustenberger underlines why clinical research with and for patients is important: “Science and research must meet the challenge to come up with knowledge for practical use. Clinical cancer research does precisely this and helps future patients to benefit from new findings.” Some of the ambassadors include: • • • • • • • • • • • Ursula Abgottspon, Partner of This Jenny († 15.11.2014) Ivo Adam, star chef and managing director Prof. Dr. med. Thomas Cerny, President of Swiss Cancer Research (KFS) GUSTAV, singer Wendy Holdener, downhill skier Laszlo I. Kish, actor, director and communication trainer Ruedi Lustenberger, National Councilor, President of the National Council in 2014 Gabriela Manetsch, head of research team Cantonal Hospital Graubünden Bernhard Russi, Skiing legend Ted Scapa, cartoonist Mathias Seger, ice hockey player ZSC Lions and captain of the national ice hockey team I. Adam All ambassadors and further information on the jubilee year can be found at http://sakk.ch/en/50-years/ If you wish to plan a local event at your center, contact Sonja Bill, sonja.bill@sakk.ch Active Against Cancer Event Visit us at the “Active Against Cancer” event at the Bundesplatz in Bern on May 20, 2015. In the SAKK information tent you will be guided through the map “cancer research” to get to know how clinical research works. There are children and fitness activities in the afternoon as well as concerts in the evening. Program 15.00 15.00 – 15.30 16.00 – 17.00 17.00 – 17.45 17.45 – 18.15 18.15 – 19.00 19.30 – 20.30 21.00 – 22.00 Opening of SAKK Village SAKK information tent, fitness activities, food & beverage fairy story teller Prisca Saxer (open for everyone) drawing with Ted Scapa (registration necessary) concert for children with the band Leierchischte sport activity part 1 concert with Luca Hänni concert with BAUM concert with GUSTAV Please refer to our website for further information. We are looking forward to welcoming you in Bern! The Swiss Oncology Research Network SAKK Newsletter March 30, 2015 7 SAKK ANNIVERSARY Memories of the founding years 50 years ago, a group of young oncologists founded the Swiss Chemotherapy Group, the forerunner of today’s SAKK. It started with the establishment of a first Medical Oncology unit at the University Hospital in Zurich by Georg Martz. Georg Martz had important fellow campaigners. The first was Kurt Brunner. Brunner was a collaborator of Georg Martz in Zurich, who had met three of the American pioneers of Medical Oncology in New York and Buffalo: Dave Karnofsky, Jo Burchenal and Jim Holland. Among them, he received a rigorous training, particularly the mastering of prospective multicenter clinical trials which were, after his return to Bern, the basis of the newly founded SAKK. In the academic medical setting, the research of Martz and Brunner was well appreciated. However, support was needed also from politics to boost the group’s activities. There, two additional characters played an important role: federal counselor Alfred Schaller and founder of the Swiss National Science Foundation (SNF) Alexander von Muralt. Schaller presented a motion to the National Council in which he demanded the establishment of a national tumor center. The pertinence of the cause was generally accepted but the proposed solution was judged as incompatible with the cantonal structures in Switzerland. The motion had therefore no direct effect but the urgency of the subject was addressed and recognized. Support came from Prof. Alexander von Muralt he suggested a collaboration between five University Hospitals and research in the laboratory. His initiative had a large political support as it was financially feasible and it permitted the involvement of the Swiss Cancer League. This was the birth of a first laboratory group under Silvio Barandun and a chemotherapeutic group lead by Kurt Brunner. The first meetings took place in the Tiefenauhospital in Bern where Brunner had his office. The first proposition for a clinical trial was a multiple myeloma trial. It allowed First page of the "motion Schaller", 1969 a large collection of blood samples for Barandun’s laboratory. The number of participants increased rapidly and also young collaborators from the five member hospitals were regularly present. These meetings were very animated and everyone participated with great enthusiasm. Even with these modest structures, the group acquired international recognition as it was one of the few European members of the American Acute Leukemia Group B besides Nis Nissen in Copenhagen and Jean Bernard in Paris. The name “SAKK” appeared 1971 in a meeting regarding a regular budget of the Federal Office of Public Health (FOPH) for the ISREC (Institut Suisse de Recherche Expérimentale sur le Cancer) which initiated a discussion of the need of finances for the clinical research. Brunner tried to obtain financial support but with a decentralized group without defined structures he did not succeed. However, the FOPH would grant a First SAKK logo yearly allowance if the name of the group included the word “national”. That is when Brunner came up with the name “Swiss Group for Clinical Cancer Research SAKK”. The short form “SAKK” was quickly adopted in French and English. In the development of SAKK, I distinguish between two eras. The first, which I call “prehistoric”, includes the founding years under the presidency of Kurt Brunner and my presidency from 1975 to 1981. The group had no constant office but resided where its president worked and the administrative support was very limited. Brunner had laid the corner stone of the group but there was still a long way to go. SAKK found its first permanent home on the Rue Carouge in Geneva. I managed the group with an assistant, Anne-Lis Clerc, and a statistician, Bernadette Mermillod. My presidency was the end The Swiss Oncology Research Network 8 March 30, 2015 SAKK Newsletter SAKK ANNIVERSARY of this early phase and the group transformed into a real comprehensive group with the establishment of the pediatric, surgical, gynecological, pathological, psycho-oncological and ear- nose and throat sections. This change assigned a more active role to the colleagues of other oncological disciplines than being a simple deliverer of services in the framework of medical oncology. But also the appearance of trials with adjuvant treatments, which required the participation of surgeons and gynecologists, forged the group together. This evolution was similar to other groups in Europe and collaboration with the EORTC (European Organisation for Research and Treatment of Cancer) increased the activity within Europe. At the end of the 1970s, the group had grown considerably. The pioneering years came to an end and the group needed a central office and additional supportive staff to process the workload. With the presidency of Franco Cavalli, the group maintained its first firm seat in Bern and the historic era of SAKK began. P. Alberto Prof. Dr. Pierre Alberto, former SAKK President F. Cavalli Two neighbours united in their success to battle against cancer In the year 2015, there are two great jubilees to celebrate: the 30 year anniversary of the ABCSG and the impressive 50-year anniversary of SAKK. Upon this special occasion, I take the liberty to both personally as well as on behalf of the Austrian Breast & Colorectal Cancer Study Group congratulate our Swiss colleagues to their 50th anniversary! Interdisciplinary study groups have had a long tradition both in Austria and Switzerland. The ABCSG has been actively conducting clinical trials for 30 years now, focussing on the subject of breast and colorectal cancer, and more recently also on pancreatic cancer and liver metastasis. Our colleagues at SAKK, the broad national clinical cancer research network in Switzerland, exhibit an even longer track record of 50 years. Both study groups are leading national cancer research societies and can for sure be considered as „big players“ in the international cancer research and clinical trials community. Cancer research continues to be a dynamic field defined by an ongoing transforming and progressive environment. The staggering increase in molecular and pharmacological knowledge continues to drive both the ABCSG and SAKK to tirelessly adapt and develop in order to meet the high demands set by patients and physicians. New promising cancer drugs and assessment methods, such as molecular screening and testing, provided enormous opportunities, but traps at the same time. This background as well as a challenging regulatory and funding environment requests innovative and specific coping and development strategies of study groups. The improvements in biotechnology and hopefully subsequently in clinical cancer medicine harbour opportunities for major progress in standard cancer treatment and patient outcome. As indicated, these chances also create major challenges for national study groups, particularly in smaller countries: Nowadays, it is not any longer possible/meaningful to conduct clinical trials on a sufficient scale within narrow (country) limits. This evolving challenge arises from the increasing biometric complexity of modern study designs. Within shrinking patient subgroups defined by new biomarkers it has become more difficult for small countries to gather enough patients for randomization on their own in order to obtain a valid result. This is why the vast majority of clinical research is and increasingly will be conducted via cooperation on national but even more important on the international level. ABCSG and SAKK have wisely recognised already at an early stage that a broad view of research is absolutely essential – especially when considering that cancer treatment requires a combination of therapies relying on a multi-disciplinary approach. Therefore both ABCSG and SAKK participate and conduct several international clinical research projects, giving their patients the opportunity to receive state-of-the-art therapies and drugs: treatments The Swiss Oncology Research Network March 30, 2015 9 SAKK Newsletter SAKK ANNIVERSARY that may eventually become the gold standard in cancer treatment. ABCSG: 30 years and more than 25.000 patients Since 1984, ABCSG has conducted numerous clinical trials, with a special focus on breast cancer. After a while, ABCSG decided to broaden its portfolio, leading to the decision on commencing trials aiming to further explore colorectal cancer, liver metastasis, and - since autumn 2013 - also pancreatic cancer. ABCSG is Austria’s biggest and best-established academic research organisation that has over time and dedication achieved a very high public reputation. Also patient commitment is key to ABCSG's success, and high compared to international standards: In some indications, more than 35 % of all patients with a given diagnosis are recruited into ABCSG trials: Overall, more than 25.000 patients have been recruited in ABCSG’s trials during the last 30 years, and over 900 physicians are part of the extensive ABCSG’s network. At ABCSG we are proud that our efforts in research and international networking over the last decades have been this successful – in the global breast cancer world, Austria can today be considered much larger than it actually is geographically. This is also reflected by many international cancer conferences such as EBCC, ESMO, ECCO coming to Vienna, including in 2015 the important "St. Gallen Breast Cancer Conference", which we are proud to host in Vienna for the first time. We sincerely hope that most of our Swiss friends meanwhile view this as a neighbour's bonding exercise. This success shows that ABCSG manages to present Austria as a research-friendly country (which it not always is in terms of politics!) with several internationally well-respected experts in breast cancer research and treatment. With some individual trials, ABCSG especially received international recognition and reputation within the global breast cancer „scene“, e.g. with trials ABCSG 5, ABCSG 8, and ABCSG 12, which lead to discussions and amend- ments in the global standards of breast cancer treatment. ABCSG 18 and ABCSG 34 are forthcoming and yield similar potential. SAKK: Know-how and success for 50 years SAKK looks back on an even more impressive track record of achievements. Since 2010, Prof. Dr. Beat Thürlimann is SAKK’s acting president, with currently 19 members, 70 employees and 40 research sites. SAKK is involved in the national cancer program in Switzerland and works closely with the most important partners there, such as cancer research Switzerland, the cancer liga, Swiss paediatric oncology group (SPOG) and the national institute for cancer epidemiology and registry (NICER). Collaboration across multiple disciplines is an integral part of modern cancer treatment. At SAKK, physicians work together across a wide range of disciplines. Markedly better than in Austria, Swiss national authorities are recognizing and supporting SAKK's activities. This hand-in-hand cooperation ensures that diagnostic and therapeutic issues are addressed and resolved through clinical trials of the very highest quality. SAKK contains of seven interdisciplinary project groups (breast cancer, gastrointestinal cancer, lung cancer, leukemia, lymphoma, urogenital tumours and new anticancer drugs), which – similar to ABCSG’s task forces – are responsible for inputs, such as proposals for new research projects and innovative study designs. The central body at SAKK acts as unifying service center for all project groups, and fends off some of the regulatory and formalistic challenges scientists today face during the realization of a clinical research idea. Together across the borders It is evident that plenty of resemblances between ABCSG and SAKK exist. The obvious potential for exploiting existing synergies could (and has started to!) inspire closer cooperation. The first step towards this trans-border approximation was to nominate ABCSG’s president Michael Gnant as international advisor for the SAKK Breast Group. Collaborating in organizing and evolving SG-BCC - as envisioned by Hans-Jörg Senn - could also be a next step. Furthermore, deliberations concerning common specific research projects in breast cancer have The Swiss Oncology Research Network 10 March 30, 2015 SAKK Newsletter SAKK ANNIVERSARY already started, recently at the Senology Congress in Lugano last September: The first project ABCSG and SAKK could phase out together may be a registry study about immediate reconstruction of the breast in both countries. Other projects continue to remain in the pipeline, such as a study in breast cancer in elderly patients with focus on adequate locoregional therapy. Also, SAKK’s trial SAKK 96/12 is considered to be expanded into Austria - this project evaluates the prevention of symptomatic skeletal events with the antibody denosumab administered every four weeks versus every twelve weeks. Of course, international cooperations are not particularly easy to manage. The two groups will have to continue talking extensively about all the details including funding and regulatory affairs – but we can be confident that SAKK and ABCSG are capable to overcome all obstacles with commitment and dedication to create a new "alpine" path for cancer research. M. Gnant In the meantime, the ABCSG expresses its gratitude towards SAKK and wholeheartedly congratulates our partner to their 50 years of success and outstanding achievements! We are looking forward towards intensifying our trans-border cooperation, and towards improving the treatment of cancer for our patients: All the best, and ad multos annos! TRIAL NEWS Trials to be activated 2015, effective March 2015 Trial Trial Name SAKK 06/14 A phase I/II open label clinical trial assessing safety and efficacy of intravesical instillation Q2 2015 of the recombinant BCG VPM1002 in patients with recurrent non-muscle invasive bladder cancer after standard BCG therapy SAKK 33/14 Effects of sympathicomimetic agonists on the disease course and mutant allele burden in Q2 2015 patients with Jak2-mutatated myeloproliferative neoplasms Alliance/ Prospect trial A phase II/III trial of neoadjuvant folfox, with selective use of combined modality chemora- Q2 2015* diation vs. preoperative combined modality chemoradiation for locally advanced rectal cancer patients undergoing low anterior resection with total mesorectal excision BIG 6-13 A randomised, double‐blind, parallel group, placebocontrolled multi‐centre Phase III study to Q2 2015* assess the efficacy and safety of olaparib vs placebo as adjuvant treatment in patients with high risk germline BRCA mutated HER2‐negative breast cancer who have completed definitive local and systemic neoadjuvant/adjuvant treatment HOVON 132 SAKK 30/13 Randomized study with a run-in dose-selection phase to assess the added value of lenalido- Q2 2015* mide in combination with standard remission-induction chemotherapy and post-remission treatment in patients aged 18-65 years with previously untreated acute myeloid leukemia (AML) or high risk myelodysplasia (MDS) (according to IPSS-R risk score > 4.5) LungArt (IFCT-EORTC) Phase III study comparing post-operative conformal radiotherapy to no post-operative ra- Q2 2015* diotherapy in patients with completely resected non-small cell lung cancer and mediastinal N2 Involvement *Dependent on the cooperative group, just an estimated opening for accrual The Swiss Oncology Research Network Opening of the first site March 30, 2015 11 SAKK Newsletter TRIAL NEWS Trials to be activated 2015, effective March 2015 SAKK 36/13 Combination of Ibrutinib and Bortezomib to treat mantle cell lymphomas patients – a mul- Q2-3 2015 ticenter phase I/II trial MCL young/ TRIANGLE Efficacy of Ibrutinib during R-CHOP/R-DHAP induction and after or in comparison to au- Q2-3 2015 tologous stem cell trasnaplantation (ASCT) in previously untreated patients with mantle cell lymphoma SAKK 25/14 Eribulin 1st line in elderly (≥ 70years) and old patients (> 80y) with metastatic breast cancer: Q3 2015 a phase II trial GRAALL-2014 Treatment of adult acute lymphoblastic leukemia (ALL), evaluating the addition of a second Q3 2015* late intensification course in B-lineage PH-negative ALL, the addition of Nelarabine in highrisk T-lineage ALL, and the reduction of chemotherapy intensity in Ph+ ALL HOVON 103 SEL SAKK 30/10 A randomized phase II multicenter study with a safety run-in to assess the tolerability and Q3 2015 efficacy of the addition of oral selinexor (KPT-330) to standard induction therapy in AML high risk myelodysplasia (MDS) (IPSS-R risk score >4.5) in patients aged ≥ 66 years IELSG-43 High-dose chemotherapy and autologous stem cell transplant consolidating conventional Q3 2015* chemotherapy in primary CNS lymphoma -randomized phase III trial IELSG-42 An international phase II trial assessing tolerability and efficacy of sequential Methotrexate- Q3 2015* Aracytin-based combination and R-ICE combination followed by high-dose chemotherapy supported by autologous stem cell transplant in patients with systemic DLBCL with CNS involvement at diagnosis or relapse (MARIETTA regimen) SAKK 35/14 Extended Rituximab with or without Ibrutinib. A randomized blinded Phase II trial SAKK 08/14 IMPROVE Enzalutamide in combination with metformin vs. enzalutamide in patients with CRPC pro- Q3-4 2015 gressing on androgen deprivation therapy (ADT) SAKK 16/14 Perioperative anti-PD-L1 antibody MEDI4736 in addition to standard neoadjuvant chemo- Q4 2015 therapy in non-small cell lung cancer (NSCLC) patients with mediastinal lymph node metastases (stage IIIA, N2) SAKK 41/13 Adjuvant aspirin treatment in PIK3CA mutated colon cancer patients. A randomized, double- Q4 2015 blinded, placebo-controlled, phase III trial. SAKK 41/14 Active-2 Physical activity program in patients with metastatic colorectal cancer who receive palliative Q4 2015 first-line chemotherapy. A multicenter open label randomized controlled phase III trial SAKK 21/12 (Phase II part) A Phase I and stratified, multicenter Phase II trial of transdermal CR1447 (4-OH-testosterone) Q1 2016 in endocrine responsive-HER2 negative and triple negative-androgen receptor positive metastatic or locally advanced breast cancer Q3-4 2015 *Dependent on the cooperative group, just an estimated opening for accrual The Swiss Oncology Research Network 12 March 30, 2015 SAKK Newsletter TRIAL NEWS Trials Open for Accrual March 2015 Disease Group Trial Name Trial Description Urogenital Cancers SAKK 01/10 Urogenital Cancers Accrual Target Current Estimated Accrual* Closure for Accrual Trial Coordinator Involved Node Radiotherapy and Car- 115 boplatin Chemotherapy in Stage IIA/B Seminoma 33 stavros.milatos@ sakk.ch SAKK 63/12 Prospective cohort study with collection 1930 of clinical data and serum of patients with prostate disease 75 Urogenital & Breast Cancers SAKK 96/12 Prevention of Symptomatic Skeletal 1380 Events with Denosumab Administered every 4 Weeks versus every 12 Weeks – A Non-Inferiority Phase III Trial 75 Q1 2019 lukas.stalder@sakk. ch Urogenital Cancers STAMPEDE** Systemic Therapy in Advancing or Metastatic Prostate Cancer: Evaluation of Drug Efficacy A 5-stage multi-arm randomised controlled trial 46 31.12.2016 estelle.cassoly @sakk.ch Lung Cancers SAKK 15/12 Early prophylactic cranial irradiation with 42 hippocampal avoidance in patients with limited disease small-cell lung cancer. A multicenter phase II trial 5 11.05.2016 andrea.fuhrer@sakk. ch Lung Cancers SAKK 16/08 Preoperative chemotherapy and radio- 69 therapy with concomitant Cetuximab in non-small cell lung cancer (NSCLC) patients with IIIB disease. A multicenter phase II trial 56 30.12.2015 heike.kenner @sakk.ch Lung Cancers SPLENDOUR A randomised, open-label phase III trial 1000 evaluating the addition of denosumab to standard first-line anticancer treatment in advanced NSCLC 4 30.03.2018 SPLENDOUR@etopeu.org Breast Cancers SAKK 22/10 A randomized phase II trial of pertu- 208 zumab in combination with trastuzumab with or without chemotherapy, both followed by T-DM1 in case of progression, in patients with HER2-positive metastatic breast cancer 125 30.11.2015 marie-aline. gerard@sakk.ch Breast Cancers SAKK 23/13 Randomized Controlled Trial to Evaluate 140 the Impact of a Surgical Sealing Patch on Lymphatic Drainage after Axillary Lymph Node Dissection for Breast Cancer 0 Q1 2017 estelle.cassoly@ sakk.ch Breast Cancers EORTC 10085 EORTC 10085 prospective part, Clinical and bioPRO logical characterization of Male Breast Cancer: an international EORTC, BIG and NABCG intergroup study 13 30.06.2016 estelle.cassoly@ sakk.ch 15.06.2017 vincent.bize@sakk. ch Updated **Trial is temporary closed for accrual *Current accrual as of end of February, 2015. Accrual for non-SAKK trials only includes patients enrolled at SAKK centers. The Swiss Oncology Research Network March 30, 2015 13 SAKK Newsletter TRIAL NEWS Trials Open for Accrual March 2015 Disease Group Trial Name Trial Description Accrual Target Current Estimated Accrual* Closure for Accrual Trial Coordinator Breast Cancers IBCSG 42-12 SNAP A randomized phase II study evaluating 258 different schedules of nab-Paclitaxel in metastatic breast cancer 68 Q2 2015 ibcsg42_SNAP @fstrf.org Breast Cancers IBCSG 43-09 HOHO Prospective observational study of young 300 women (£ 40 years at diagnosis) with breast cancer. Data analyzed will include serial patient surveys and medical record information 67 Q4 2015 Monica.Ruggeri @ibcsg.org Breast Cancers IBCSG 48-14/ A study evaluating the pregnancy out- 500 BIG 8-13 comes and safety of interrupting endocrine therapy for young women with endocrine responsive breast cancer who desire pregnancy 1 Leukemias APL 2006 Randomized phase III trial assessing 800 the role of arsenic trioxide and/or ATRA during consolidation course in newly diagnosed acute promyelocytic leukemia (APL) 63 15.05.2016 fatma.karabulut @sakk.ch Leukemias CML V Treatment optimization of newly diag- 628 nosed Ph/BCR-ABL positive patients with chronic myeloid leukemia (CML) in chronic phase with nilotinib vs. nilotinib plus interferon alpha induction and nilotinib or interferon alpha maintenance therapy 8 23.08.2015 anna.tomaszewska@ sakk.ch Leukemias EBMT HCT vs CT Compare conventinal chemotherapy to 231 low dose total body irradiation-based conditioning and hematopoietic cell transplantation as consolidation therapy 7 31.12.2015 fatma.karabulut @sakk.ch Leukemias HOVON 103TOS A randomized phase II multicenter study 200 with a safety run-in to assess the tolerability and efficacy of the addition of oral tosedostat to standard induction chemotherapy in AML and high risk myelodysplasia (MDS) (IPSS-R > 4.5) in patients aged ≥ 66 0 15.10.2015 andrea.fuhrer@sakk. ch Lymphomas SAKK 39/10 Nelfinavir and lenalidomide/dexametha- 35 sone in patients with progressive multiple myeloma that have failed lenalidomidecontaining therapy. A single arm phase I/ II trial 13 31.03.2016 michael.beyeler @sakk.ch Monica.Ruggeri @ibcsg.org Updated *Current accrual as of end of February, 2015. Accrual for non-SAKK trials only includes patients enrolled at SAKK centers. The Swiss Oncology Research Network 14 March 30, 2015 SAKK Newsletter TRIAL NEWS Trials Open for Accrual March 2015 Disease Group Trial Name Trial Description Lymphomas SAKK 39/13 Lymphomas Accrual Target Current Estimated Accrual* Closure for Accrual Trial Coordinator Nelfinavir and lenalidomide/dexametha- 34 sone in patients with progressive multiple myeloma that have failed lenalidomidecontaining therapy. A single arm phase I/ II trial 4 31.08.2016 catherine.berset@ sakk.ch HD 16 HD16 for early stages: Treatment optimization trial in the first-line treatment of early stage Hodgkin lymphoma; treatment stratification by means of FDG-PET 55 30.09.2015 katrin.eckhardt @sakk.ch Lymphomas HD 17 Therapieoptimierungsstudie in der Primär- 1100 therapie des intermediären Hodgkin Lymphoms: Therapiestratifizierung mittels FDG-PET 42 01.12.2016 katrin.eckhardt @sakk.ch Lymphomas REMoDL-B A randomised evaluation of Molecular 940 guided therapy for Diffuse Large B-Cell Lymphoma with Bortezomib (phase III) 74 30.04.2015 regula.lustenberger@sakk.ch Lymphomas IELSG-37 A randomized, open-label, multicentre, 376 two-arm phase III comparative study assessing the role of involved mediastinal radiotherapy after Rituximab containing chemotherapy regimens to patients with newly diagnosed Primary Mediastinal Large B-Cell Lymphoma (PMLBCL) 6 31.12.2016 simona.berardi @sakk.ch Lymphomas T-cell project Das T-Cell project ist eine Registrierstudie mit Referenzpathologie um Daten zu seltenen malignen Erkrankungen der TZell Linie zu gewinnen 32 31.12.2016 simona.berardi @sakk.ch New Drugs SAKK 65/12 Phase I study of LDE225 in combination 22 with Paclitaxel in patients with advanced solid tumors 18 15.12.2015 milica.enoiu @sakk.ch New Drugs SAKK 66/12 A Phase I, open-label, multi-center, dose escalation study of oral CGM097, a p53/ HDM2-interaction inhibitor, in adult patients with se-lected advanced solid tumors characterized by wild-type TP53 2 30.06.2016 simona.berardi @sakk.ch New Drugs SAKK 66/13 INC280 Combination with BKM120 for 58 glioblastoma patients, Phase I/II trial 1 31.05.2015 simona.berardi @sakk.ch New Drugs SAKK 69/13 Phase IB of oral BGJ398 (pan FGFR inhibitor) and oral BYL719 (a specific PI3K inhibitor) in adult patients with selected solid tumors 0 30.04.2016 simona.berardi @sakk.ch Updated *Current accrual as of end of February 2015. Accrual for non-SAKK trials only includes patients enrolled at SAKK centers. The Swiss Oncology Research Network March 30, 2015 15 SAKK Newsletter TRIAL NEWS Trials Open for Accrual March 2015 Disease Group Trial Name Trial Description Gynaecological Cancers Mito/ Mango 16b Gynaecological Cancers INOVATYON Accrual Target Current Estimated Accrual* Closure for Accrual Trial Coordinator A multicenter phase III randomized study 400 with second line chemotherapy plus or minus bevacizumab in patients with platinum sensitive epithelial ovarian cancer recurrence after a bevacizumab/chemotherapy first line 5 31.12.2015 heidi.baumgartner@ sakk.ch Phase III international, randomized study of tra- 588 bectedin plus Pegylated Liposomal Doxorubicin (PLD) versus Carboplatin plus PLD in patients with ovarian cancer progressing within 6-12 months of last platinum 12 30.06.2017 anna.tomaszewska@ sakk.ch Activated trials SPLENDOUR A randomised, open-label phase III trial evaluating the addition of denosumab to standard first- line anticancer treatment in advanced NSCLC Activated Coordinating investigator Clinical project manager Solange Peters, Lausanne SPLENDOUR@etop-eu.org SAKK 23/13 Activated Coordinating investigator Clinical project manager January 12, 2015 Randomized Controlled Trial to Evaluate the Impact of a Surgical Sealing Patch on Lymphatic Drainage after Axillary Lymph Node Dissection for Breast Cancer March 18, 2015 Walter P. Weber, Basel estelle.cassoly@sakk.ch Authorized trial HOVON 132/SAKK 30/10 Randomized study with a run-in dose-selection phase to assess the added value of lenalidomide in combination with standard remission-induction chemotherapy and post-remission treatment in patients aged 18-65 years with previously untreated acute myeloid leukemia (AML) or high risk myelodysplasia (MDS) (according to IPSS-R risk score > 4.5) Approval Swissmedic Approval ethical committee Coordinating investigator Clinical project manager August 14, 2014 December 23, 2014 Thomas Pabst, Bern andrea.fuhrer@sakk.ch Remark: Based on the HOVON DSMB recommendation, an amendment to the protocol was written and submitted in December 2014 to the competent authorities in the Netherlands. Approval was obtained mid-January 2015. Unfortunately, all the countries that were not activated for the study before December 2014 can only be activated after the amendment is accepted. In Switzerland, the trial was officially authorized at the end of December 2014. The amendment was submitted to the lead EC Bern and Swissmedic at the beginning of March. Activation of the trial is expected for April 2014. The Swiss Oncology Research Network 16 March 30, 2015 SAKK Newsletter TRIAL NEWS Approval pending SAKK 06/14 A phase I/II open label clinical trial assessing safety and efficacy of intravesical instillation of the recombinant BCG VPM1002 in patients with recurrent non-muscle invasive bladder cancer after standard BCG therapy Submitted Coordinating investigator Clinical project manager SAKK 33/14 January 28, 2015 Cyrill Rentsch, Basel milica.enoui@sakk.ch Effects of sympathicomimetic agonists on the disease course and mutant allele burden in patients with Jak2-mutatated myeloproliferative neoplasms. A multicenter phase II trial Submitted Coordinating investigator Clinical project manager January 29, 2015 Jakob Passweg, Basel andrea.fuhrer@sakk.ch SAKK 36/13 Combination of Ibrutinib and Bortezomib to treat mantle cell lymphomas patients – a multi center phase I/II tria Submitted Coordinating investigator Clinical project manager Alliance/PROSPECT trial Submitted Coordinating investigator Clinical project manager February 27, 2015 Urban Novak, Bern katrin.eckhardt@sakk.ch A phase II/III trial of neoadjuvant folfox, with selective use of combined modality chemoradiation vs. preoperative combined modality chemoradiation for locally advanced rectal cancer patients undergoing low anterior resection with total mesorectal excision December 19, 2014 Michael Montemurro, Bellinzona anna.tomaszewska@sakk.ch Trial closed for accrual SAKK 21/12 Phase I A Phase I and stratified, multicenter Phase II trial of transdermal CR1447 (4-OH-testosterone) in endocrine responsive-HER2 negative and triple negative-androgen receptor positive metastatic or locally advanced breast cancer Closed for accrual Coordinating investigator Clinical project manager Martin Zweifel, Bern March 10, 2015 SAKK 41/10 Closed for accrual Coordinating investigator Clinical project manager Cetuximab Monotherapy versus Cetuximab plus Capecitabine as first-line treatment in elderly patients with KRAS wild-type metastatic colorectal cancer January 15, 2015 Dirk Kienle, Zurich daniela.baertschi@sakk.ch SAKK 67/13 Phase I study of oral PQR309 in Patients with Advanced Solid Tumors Closed for accrual Coordinating investigator Clinical project manager Andreas Wicki, Basel karin.rothgiesser@sakk.ch March 17, 2015 vincent.bize@sakk.ch The Swiss Oncology Research Network March 30, 2015 17 SAKK Newsletter TRIAL NEWS Trial terminated SAKK 19/05 Bevacizumab and erlotinib first-line therapy in advanced non-squamous non-small- cell lung cancer (stage lllB/lV) followed by platinum-based chemotherapy at disease progression Terminated February 10, 2015 |www| All information on SAKK trials can also be found under www.sakk.ch in the members’ section. PUBLICATIONS Q1 2015 Publications Urogenital Cancers SAKK 08/09 Joerger M, van Schaik RH, Becker ML, Hayoz S, Pollak M, Cathomas R, Winterhalder R, Gillessen S, Rothermundt C. Multidrug and toxin extrusion 1 and human organic cation transporter 1 polymorphisms in patients with castration-resistant prostate cancer receiving metformin (SAKK 08/09). Prostate Cancer Prostatic Dis. 2015 Mar 10. Lung Cancers SAKK 17/04 Rusch A, Ziltener G, Nackaerts K, Weder W, Stahel RA, Felley-Bosco E. Prevalence of BRCA-1 associated protein 1 germline mutation in sporadic malignant pleural mesothelioma cases. Lung Cancer. 2015 Jan 8. Leukemia GRAALL-2003/2005 Dhédin N, Huynh A, Maury S, Tabrizi R, Beldjord K, Asnafi V, Thomas X, Chevallier P, Nguyen S, Coiteux V, Bourhis JH, Hichri Y, Escoffre-Barbe M, Reman O, Graux C, Chalandon Y, Blaise D, Schanz U, Lhéritier V, Cahn JY, Dombret H, Ifrah N. Role of allogeneic stem cell transplantation in adult patients with Ph-negative acute lymphoblastic leukemia. Blood. 2015 Jan 13. HOVON Walter RB, Othus M, Burnett AK, Löwenberg B, Kantarjian HM, Ossenkoppele GJ, Hills RK, Ravandi F, Pabst T, Evans A, Pierce SR, Vekemans MC, Appelbaum FR, Estey EH. Resistance prediction in AML: analysis of 4601 patients from MRC/NCRI, HOVON/SAKK, SWOG and MD Anderson Cancer Center. Leukemia. 2015 Feb 29. Gastrointestinal Cancer SAKK 41/06 Koeberle D, Betticher DC, von Moos R, Dietrich D, Brauchli P, Baertschi D, Matter K, Winterhalder R, Borner M, Anchisi S, Moosmann P, Kollar A, Saletti P, Roth A, Frueh M, Kueng M, Popescu RA, Schacher S, Hess V, Herrmann R. Bevacizumab continuation versus no continuation after first-line chemotherapy plus bevacizumab in patients with metastatic colorectal cancer: a randomized phase III non-inferiority trial (SAKK 41/06). Ann Oncol. 2015 Jan 20. The Swiss Oncology Research Network 18 March 30, 2015 SAKK Newsletter PUBLICATIONS & PRESENTATIONS Q1 2015 Head and Neck cancer SAKK 10/94 Ghadjar P, Hayoz S, Zimmermann F, Bodis S, Kaul D, Badakhshi H, Bernier J, Studer G, Plasswilm L, Budach V, Aebersold DM; For the Swiss Group for Clinical Cancer Research (SAKK). Impact of weight loss on survival after chemoradiation for locally advanced head and neck Cancer: secondary results of a randomized phase III trial (SAKK 10/94). Radiat Oncol. 2015 Jan 17. Abstracts Gastrointestinal Cancers Symposium Poster Helbling D. et al. Neoadjuvant chemoradiation (CRT) with or without panitumumab (Pan) in patients with K-ras unmutated, locally advanced rectal cancer (LARC): Final results of a randomized multicenter phase II trial (SAKK 41/07). |www| All SAKK publications can also be found under http://sakk.ch/en/sakk-provides/for-research/scientific-publications/ MISCELLANEOUS FAceS-project University of Munich Im Rahmen des FAceS-Projekts (www.faces.wi.tum.de/) führt der Lehrstuhl für Strategie und Organisation an der Technischen Universität München derzeit eine Befragung zu Publikationspraktiken und zur Leistungsbewertung in der Wissenschaft durch. Um repräsentatives Wissen zu den Publikationspraktiken und zur Leistungsbewertung in der Wissenschaft über verschiedene Länder und Disziplinen (z.B. Medizin) hinweg zu gewinnen, sind wir an Ihren Einschätzungen und Meinungsäußerungen zu diesem Thema interessiert. Personen, die an der Befragung teilnehmen, wird die Möglichkeit gegeben, an der Verlosung eines iPad mini teilzuhaben. Zur Befragung gelangen Sie, indem Sie auf den folgenden Link klicken: http://ww3.unipark.de/uc/OA/. Wir würden uns sehr freuen, wenn Sie an unserer Befragung teilnehmen. Wir danken Ihnen im Voraus herzlich für Ihre Unterstützung. Technische Universität München Lehrstuhl für Strategie und Organisation Prof. Dr. Isabell M. Welpe Arcisstraße 21 D-80333 München Tel.: +49-(0)89-289-24800 Fax: +49-(0)89-289-24805 The Swiss Oncology Research Network SAKK Newsletter March 30, 2015 19 IBCSG St.Gallen International Breast Cancer Award 2015 During the opening ceremony of the St.Gallen International Breast Cancer Conference, Alan Coates received this prestigious award in consideration of his strong commitment to international scientific trial cooperation, especially in breast cancer research, with a strong focus on tolerability of treatment and quality of life, and his indispensable contributions in the writing committee of the St.Gallen Consensus. IBCSG expresses its heartfelt congratulation to Alan for this well-deserved recognition. Alan has been one of the leaders of IBCSG for the past decades, and served for many years as scientific co-chair of our group, a position from which he only just resigned last year. In this function, Alan has been essential in helping to guide the group in a continuously evolving context of the polarity between academic and pharma-sponsored clinical research. We are all fortuA. Coates nate to have him with us, and look forward to many more stimulating discussions and continuous mentorship. Angelo DiLeo contributes, Rich Gelber takes notes cal trials. Giuseppe Curigliano from the European Institute of Oncology in Milan, Italy, sketched the future of IBCSG with trials in the phase I-II setting which becomes a key focus in the era of ever increasing numbers of new targeted agents with a need for rapid evaluation. The newly founded Executive of the Scientific Committee will consider the proposals over the next weeks and months and come back to the Foundation Council with a development strategy. IBCSG Annual Meeting On March 21 and 22, right after the St.Gallen Breast Cancer Conference, the IBCSG community met for our Annual Meeting. Since “St.Gallen” took place in Vienna, IBCSG had the opportunity to gather in this unique city with its thrilling history, world class cultural heritage and friendly inhabitants. The meeting was organized to perfection by Marianne Peer from the IBCSG Coordinating Center, and was held in Parkhotel Schönbrunn, next to the Schönbrunn Palace where Franz Joseph, the last emperor of the Habsburgian Empire, lived and died. The Data Managers’ Workshop is one of the pillars of the Annual Meeting. This year, Karen Price, Director of Scientific Administration, gave the key note address about “Managing the Dynamics of a Protocol – How You and the Protocol are Essential to the Study’s Success”. Several other presentations addressed the complex issues around all aspects of conducting and documenting clinical trials. During the PI meeting, principal investigators from several IBCSG institutions proposed new initiatives for clini- Critical questions from the audience The Swiss Oncology Research Network 20 March 30, 2015 SAKK Newsletter IBCSG In the Scientific Session, the newly elected Scientific Committee Chair, Marco Colleoni, from the European Institute of Oncology, presented the new structure of the Scientific Committee. Anita Hiltbrunner, IBCSG Director, summarized the decisions made by the Foundation Council and presented the members of the new Executive to Scientific Committee (members: Fran Boyle, Angelo Di Leo, Guy Jerusalem, Karen Price, Meredith Regan, Giuseppe Viale). Karen Price gave an overview of the 2014 publications of the group. The respective trial chairs took turn to recall all currently open trials to the attendees. These presentations were interspersed with research intermezzi on recent results of trial 22-00 (to be published soon), QoL findings in SOFT and TEXT, and an overview of Quality Assurance in Academic Research by Petra Sicher, Head of QA at the Coordinating Center. The social part of an Annual Meeting is always a highlight; this year, delegates convened and dined at the beautiful renaissance Palais Niederösterreich, where Rolf Stahel, IBCSG President, addressed the crowd and expressed his gratitude to Aron Goldhirsch and Alan Coates for their longstanding leadership of the group. CLINICAL TRIALS IBCSG 42-12 SNAP The trial evaluates in a randomized phase II fashion three different schedules of nab-Paclitaxel in patients with histologically or cytologically confirmed HER2-negative metastatic (stage IV) breast cancer who have not received any prior chemotherapy. Based on recommendations from the IBCSG Data and Safety Monitoring Committee (DSMC), IBCSG issued an amendment to adapt the dose of nab-Paclitaxel in the induction phase. It was decided to decrease the dose in the induction phase to 125 mg/ m² while keeping the current doses in the maintenance phase. The amendment has to be activated by end of the year 2014. The accrual has increased recently and the accrual goal will be reached at the beginning of 2015. Based on a recommendation from the DSMC, IBCSG has decided to increase the total sample size from 240 to 258, which will extend the recruitment period to Q2, 2015. The statistical plan in the protocol requires 76 evaluable patients per arm in order to have, within a reasonable follow-up time, the 63 progression-free survival (PFS) events per arm needed to provide the planned power. The The Swiss Oncology Research Network “drop-out” rate of patients who will not contribute to the determination of the primary endpoint PFS has proved to be higher than the originally expected 5%. The rate of non-evaluability, especially for the maintenance phase of the treatment, is anticipated to rise to as much as 12%. To retain the originally planned power, the accrual goal per arm has therefore been increased to 86. The corresponding amendment has been issued and is in the approval process. IBCSG’s Program for Young Patients IBCSG 43-09 HOHO IBCSG 43-09 is the Young Women’s Breast Cancer Study, and HOHO stands for “Helping Ourselves Helping Others”. It is a longitudinal cohort study of 300 young women with breast cancer (early or advanced) in selected institutions in Europe. All eligible patients treated at each center are invited to join the cohort. Patient surveys and medical record review are utilized. Women are surveyed every 6 months for the first 3 years after diagnosis, then yearly thereafter for an additional 7 years (for a total follow-up of 10 years following diagnosis). The study has two main objectives: 1. To identify in selected institutions in Europe a cohort of young women (age 18-40) newly diagnosed with breast cancer (early or advanced) to assess a broad range of variables at baseline and over the course of the ensuing 10 years. 2. To characterize this population at diagnosis and in follow-up regarding disease and psychosocial outcomes (e.g., presentation and disease characteristics, fertility and menopausal issues, and long term outcome). At present 17 centers in Italy and 5 centers in Switzerland are participating in the trial and have accrued 249 patients up to end of February 2015, 67 of them by Swiss sites. IBCSG 48-14/BIG 8-13 POSITIVE The best available evidence suggests that pregnancy after breast cancer does not negatively impact disease outcome and is safe for the offspring but no definitive information is available to recommend a safe interval from BC diagnosis to pregnancy. The POSITIVE trial will investigate endocrine therapy (ET) interruption to enable conception for young women between 18 and 42 years of age with endocrine responsive early breast cancer who received adjuvant ET for 18 to 30 months and wish to attempt March 30, 2015 21 SAKK Newsletter IBCSG pregnancy. The main objectives are: 1. To assess the risk of breast cancer relapse associated with temporary interruption of endocrine therapy to permit pregnancy 2. To evaluate factors associated with pregnancy success after interruption of endocrine therapy. The trial will also allow for the testing of biologic correlates of pregnancy and disease outcome. E, Bellet M, Bonnefoi HR, Climent MA, Da Prada GA, Burstein HJ, Martino S, Davidson NE, Geyer Jr CE, Walley BA, Coleman RC, Kerbrat P, Buchholz S, Ingle JN, Winer EP, Rabaglio-Poretti M, Maibach R, Ruepp B, Giobbie-Hurder A, Price KN, Colleoni M, Viale G, Coates AS, Goldhirsch A, Gelber RD for the SOFT investigators and the International Breast Cancer Study Group. Adjuvant ovarian suppression in premenopausal breast cancer. *Co-first authors. N Engl J Med 372:436-446, 2015 (IBCSG 24-02). A psycho-oncological companion study evaluating psychological distress, fertility concerns and decisional conflict in young women who participate in POSITIVE has been developed and will be activated in sites interested and capable to conduct it. The participation of the USAmerican Alliance Group is anticipated and will be negotiated in the months to come. The other countries currently scheduled for activation are Belgium, Italy, Greece, Spain, Denmark, Hungary and Australia. Stearns V, Chapman JA, Ma CX, Ellis MJ, Ingle JN, Pritchard KI, Budd GT, Rabaglio M, Sledge GW, Le Maitre A, Kundapur J, Liedke PER, Shepherd LE, Goss PE. Treatmentassociated musculoskeletal and vasomotor symptoms and relapse-free survival in the NCIC CTG MA.27 adjuvant breast cancer aromatase inhibitor trial. J Clin Oncol 33:265-271, 2015 (IBCSG 30-04). Sieuwerts AM, Willis S, Burns MB, Look MP, Gelder ME, Schlicker A, Heideman MR, Jacobs H, Wessels L, LeylandJones B, Gray KP, Foekens JA, Harris RS, Martens JW. Elevated APOBEC3B Correlates with Poor Outcomes for Estrogen-Receptor-Positive Breast Cancers. Horm Cancer 5:405-413, 2014. (BIG 1-98). A total of 500 patients are planned to be recruited into the trial from centers worldwide in approximately 4 years. The trial is currently being activated in Switzerland, 2 out of 13 planned sites are open. The Institute of Oncology of Southern Switzerland is the first site which has opened the trial worldwide, and has accrued the first patient in December. The complete IBCSG publication list can be downloaded from http://www.ibcsg.org/Member/Publi/IBCSG_Publi/ Pages/default.aspx Latest IBCSG publication Moore HC, Unger JM, Phillips KA, Boyle F, Hitre E, Porter D, Francis PA, Goldstein LJ, Gomez HL, Vallejos CS, Partridge AH, Dakhil SR, Garcia AA, Gralow J, Lombard JM, Forbes JF, Martino S, Barlow WE, Fabian CJ, Minasian L, Meyskens FL Jr, Gelber RD, Hortobagyi GN, Albain KS; the POEMS/S0230 Investigators. Goserelin for ovarian protection during breast-cancer adjuvant chemotherapy. N Engl J Med 5:372:923-932, 2015. (IBCSG 34-05). Francis PA, Regan MM, Fleming GF, Láng I, Ciruelos Rudolf Maibach IBCSG Coordinating Center (www.ibcsg.org) Accrual of open clinical trials (As of February 28, 2015) Trials Current accrual Current accrual SAKK Total target accrual 42-12 SNAP 237 68 258 43-09 HOHO 249 67 300 48-14 POSITIVE 1 1 500 The Swiss Oncology Research Network 22 March 30, 2015 SAKK Newsletter ETOP Clinical trials ETOP 2-11 BELIEF BELIEF, a phase II prospective trial sponsored by ETOP and coordinated together with the Spanish Lung Cancer Group (SLCG), is the first therapeutic ETOP trial. BELIEF will determine the long-term outcome of patients with advanced nonsquamous NSCLC with activating EGFR mutations (L858R and exon 19 deletion) with or without T790M resistance mutation at diagnosis and treated with the combination of erlotinib and bevacizumab. The accrual goal of 102 patients was reached in October 2014. Treatment and follow-up continue as planned. ETOP 3-12 EMPHASIS-lung In this trial, the predictive value of Veristrat, a serum proteomic test, is being assessed regarding the efficacy of erlotinib in pretreated patients with advanced squamous cell lung carcinoma. Over 50 centers from several European countries were activated. By the end of January 2013, 81 patients were randomized, 14 from SAKK sites. Recruitment was terminated prematurely due to an accrual rate that was deemed insufficient and publication of controversial new data from another study. No safety concerns led to the decision to close accrual. Treatment and follow-up of all included patients continue as specified in the protocol. An abstract has been submitted to ASCO. Additionally, a pooled analysis with a similar trial conducted in all advanced NSCLC subtypes is planned. ETOP 4-12 STIMULI The combination of chemotherapy and thoracic radiotherapy is currently the standard treatment approach in limited stage SCLC. Several studies now showed that stimulation of immune cells may stop tumor growth. Ipilimumab, a humanized monoclonal antibody, activates the immune system by targeting CTLA-4, a protein receptor that down-regulates anticancer immune response. This randomized multicenter open-label trial tests the efficacy and tolerability of the standard treatment alone or with subsequent consolidation with ipilimumab in patients with limited disease SCLC, with overall survival as primary endpoint. ETOP conducts the trial in collaboration with the Intergroupe Francophone de Cancérologie Thoracique (IFCT). Centre activation is progressively ongoing and the accrual just started with to date 9 patients enrolled. From Switzerland, the university hospitals Zürich and Lausanne are participating in this trial. ETOP 5-12 SPLENDOUR Denosumab is a monoclonal antibody targeting and inhibiting RANKL, a protein that acts as the primary signal for bone resorption. The purpose of this study is to investigate the potential of the combination of standard treatment (chemotherapy) with denosumab as compared to the standard treatment alone to increase survival of patients with advanced NSCLC with or without bone metastasis in advanced unselected treatment-naïve patients. ETOP is the sponsor of this trial that will be conducted in collaboration with EORTC as coordinating group, as well as CECOG. The 1000 patients will be enrolled within approximately 3 years. 11 SAKK sites will participate in this trial. The first sites have been activated in December 2014 and the current accrual is 11 patients, 4 from SAKK sites. Solange Peters Scientific Coordinator Heidi Roschitzki ETOP Coordinating Office (www.etop-eu.org) The Swiss Oncology Research Network March 30, 2015 23 SAKK Newsletter SWISS CANCER LEAGUE Half of the women newly diagnosed with breast cancer are treated in a certified breast cancer centre The quality label of the Swiss Cancer League (SCL) and the Swiss Society of Senology (SSS) is meeting with increasing interest. The label certifies breast centres, which fulfil the quality criteria for treatment and care of women with breast cancer. It therefore provides general guidance to affected women. Since its launch the Swiss quality label has been awarded to 12 breast centres. Together with three more centres, which are certified by the German Cancer Society (DKG) or the European Society of Breast Cancer Specialists (EUSOMA), more than half of all the new breast cancer cases in Switzerland are treated in certified centres. This means that 3000 out of 5500 women newly diagnosed with breast cancer are receiving the best possible care. The aim is that all breast cancer patients will have access to certified centres. This aim will soon be reached if all the parties continue to show great commitment. For further information in German and French visit www.krebsliga.ch/q-label www.liguecancer.ch/q-label Contact Mark Witschi, MD Head Q-Label Office q-label@krebsliga.ch 2nd Swiss Cancer Congress “Quality in oncology” 27th August 2015, University of Fribourg We invite you to sign up for the 2nd Swiss Cancer Congress which will take place on 27th August 2015 at the University of Fribourg. The central topic of the congress is quality. Can quality be quantified? And if yes, how? What importance does quality have in the overall social context, and, more specifically, in oncology? These questions will be addressed in a plenary session and subsequent workshops focusing on specific aspects of quality. The congress offers a unique platform for doctors, nurses and all professionals involved in the treatment and care of cancer patients to engage in a multidisciplinary and inter-professional exchange. For more information and online registration please refer to the congress website www.swisscancercongress.ch. Congress organiser: Pro Medicus GmbH, scc@promedicus.ch, phone 041 266 99 17 The Swiss Oncology Research Network 24 March 30, 2015 SAKK Newsletter GRANT Rising Tide Foundation for Clinical Cancer Research® (RTF-CCR) is proud to enter into its third year of Clinical Cancer Research Grant partnership with the Swiss Group for Clinical Cancer Research (SAKK) and Gateway for Cancer ResearchSM (Gateway). This grant is focused on addressing five critical challenges in clinical cancer research and is endowed with a total of USD 1'500'000. In our quest to support cancer patients to feel better, live longer or be cured TODAY, we are calling all investigators to submit research proposals for innovative, patient-centered clinical cancer trials that: • • • • • Increase the efficacy of cancer diagnostics and therapeutics through targeted and personalized medicine Develop approaches for metastatic disease with broad applicability to multiple cancers Develop technologies or therapeutic approaches to overcoming drug resistance of refractory cancers Improve quality of life: address late effects and long-term outcomes of cancer therapies Use of repurposed durgs and devices to quickly find safe and affordable treatments for both common and rare cancers Research proposals must be submitted in MS Word format with an abbreviated CV and examples of published work. The winning proposal will be announced in November 2015. To download an application form: http://sakk.ch/en/sakk-provides/for-research/research-grants/ For application information, contact: Eveline Mumenthaler, Director Rising Tide Foundation Eveline.mumenthaler@risingtide.ch www.risingtide-ccr.com Prof. Dr. Beat Thürlimann, President SAKK sakkcc@sakk.ch The Swiss Oncology Research Network March 30, 2015 25 SAKK Newsletter GRANTS SAKK / Dr. Paul Janssen Fellowship SAKK and Janssen-Cilag AG have decided to jointly award a fellowship endowed with CHF 30 000.-. The educational grant is aimed at offering young doctors the opportunity to spend three to four months at a renowned research center abroad to gain experience and acquire the necessary know-how and tools to develop and conduct top-quality clinical trials in oncology / hematology . Doctors who train as oncologists / hematologists at Swiss hospitals and are associated with SAKK are herewith invited to apply for the educational grant. The research grant will be awarded at the SAKK semi-annual meeting on June 25, 2015. Submission deadline: April 30, 2015 submission to sakkcc@sakk.ch The SAKK / Dr. Paul Janssen Fellowship regulations can be obtained at http://sakk.ch/en/sakk-provides/for-research/research-grants/. Contact: Dennis Ammann, Marketing Manager, dennis.ammann@sakk.ch SAKK / Pfizer Award 2015 SAKK and Pfizer AG (Switzerland) jointly award the SAKK / Pfizer Award endowed with CHF 20'000.- every two years. The award honors patient-oriented, practice-relevant research in clinical oncology. Medical professionals below the age of 45 are welcome to apply for the SAKK / Pfizer Award by submitting their research work in the form of a scientific publication. The manuscript must be either published within the last year or be submitted for publication in a peer-reviewed journal. The publication must directly contribute to the improvement of cancer treatment and patient outcome. Submission deadline: May 1, 2015 submission to sakkcc@sakk.ch The SAKK / Pfizer Award regulations can be obtained at http://sakk.ch/en/sakk-provides/for-research/researchgrants/. Contact: Dennis Ammann, Marketing Manager, dennis.ammann@sakk.ch The Swiss Oncology Research Network 26 March 30, 2015 SAKK Newsletter EVENTS Join us and celebrate our 50th anniversary at the ACTIVE AGAINST CANCER public event on May 20, 2015 opening at 15h00 Bundesplatz Bern http://sakk.ch/en/calendar/sakk-50-years/ SAKK Semi-Annual Meeting June 25/26, 2015, Zurich It is our pleasure to invite you to our semi-annual meeting which will be held in Zurich on June 25/26, 2015. Please visit http://sakk.ch/en/sakk-provides/for-research/semi-annual-meeting for a detailed program and registration form, as well as a floor plan of the premises. Venue: Zurich Marriott Hotel Information: SAKK Coordinating Center Neumuehlequai 42Effingerstrasse 40 8006 Zürich3008 Bern Phone: +41 44 360 70 70 Phone: +41 31 389 91 91 Fax: +41 31 389 92 00 E-mail: events@sakk.ch Web: www.sakk.ch The Swiss Oncology Research Network March 30, 2015 27 SAKK Newsletter EVENTS Fortbildung Weichteilsarkome - Dreiländer Treffen April 23, 2015, 14h00-18h20 Restaurant “Au Premier”, Bahnhofplatz 15, 8001 Zurich Information and registration: http://sakk.ch/en/calendar/ 9th Swiss PostASCO June 11, 2015, 09h45-17h00 Event & Kongresszentrum, Stade de Suisse Champions Lounge, Bern Information and registration: www.swisspostasco.ch Orphan Malignancies Seminar Management des Schilddrüsen und Merkelzellkarzinoms September 10, 2015, 15h00-19h20 The Central Plaza Hotel Central 1, 8001 Zurich Information and registration: http://sakk.ch/en/calendar/ The Swiss Oncology Research Network 28 March 30, 2015 SAKK Newsletter EDUCATION, EVENTS SAKK Training course for CRCs and CTNs SAKK Investigators'education October 22 & 29, 2015 SAKK, Bern August 28, 2015, Bern For members of the SAKK network and SPOG the course is free of charge. For members of the SAKK network and SPOG the course is free of charge. More information: http://sakk.ch/en/calendar/education/ More information: http://sakk.ch/en/calendar/education/ Supported by Supported by Planned in between meetings of project groups and working groups 2015 Group Next meetings Urogenital Tumors September 18, 2015, 14h15-16h45 Breast Cancers to be confirmed Leukemia September 10, 2015, 13h30-17h00 Lung Cancer to be confirmed Lymphoma to be confirmed New Anticancer Drugs to be confirmed Gynecological Cancer April 17, 2015, 16h15-18h15 Gastrointestinal Cancer September 17, 2015, 13h15-16h15 Detailed information regarding time, place and agenda of the meetings can be found on the members'section on our website www.sakk.ch The Swiss Oncology Research Network 29 March 30, 2015 SAKK Newsletter SAKK ANNIVERSARY EVENTS • • • • • • • • May 20, ACTIVE AGAINST CANCER, public event, Bern June 25, Plenary Lecture @ Semi-Annual Meeting, Zurich July 2, EHA/post-ICML educational event, Zurich August 26, Lecture, Thun August 29, Public event City of St.Gallen October 9, Scientific Symposium @ DGHO, Basel October 29, Symposium @ Cantonal Hospital St.Gallen November 19, Symposium @ Semi-Annual Meeting, Zurich SAKK DATES 2015 • • • • • • • • • • • April 23, 2015, Weichteilsarkome-Dreiländer Treffen Zurich May 5 & 6, 2015, Board Meeting and Retreat June 11, 9th Swiss PostASCO Bern June 24, 2015, General Assembly June 25 & 26, 2015 Semi-Annual Meeting Zurich August 27, 2nd Swiss Cancer Congress Fribourg September 1, 2015, Board Meeting September 10, 2015, Orphan Malignancies Seminar Zurich November 3, 2015, Board Meeting November 18, 2015, General Assembly November 19 & 20, 2015, Semi-Annual Meeting Zurich Flag Swiss Group for Clinical Cancer Research Coordinating Center Effingerstrasse 40 3008 Bern Tel. +41 31 389 91 91 Fax +41 31 389 92 00 E-mail: sakkcc@sakk.ch www.sakk.ch Claudia Herren claudia.herren@sakk.ch Peter Brauchli
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