No 3 / 2015 September 21. University Hospitals offer new technologies and future-oriented structures

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1 Newsletter No 3 / 2015 September 21 EDITORIAL University Hospitals offer new technologies and future-oriented structures SAKK was founded by far-sighted cancer doctors from all five Swiss University and one Cantonal Hospital. SAKK trials eventually were run in other Swiss Cantonal Hospitals, more recently in regional hospitals and some private oncology practices. Hence, SAKK increasingly organizes trials targeting cancers typically seen in the "periphery" and less often in academic centres. So what exactly is the remaining role of University centres in SAKK? I do remember the days when young colleagues carved out splendid University careers with the help of SAKK. Whilst in Bern, Thomas Cerny dug up a new purine analogue, 2-CDA, somewhere in Eastern Europe, and the ensuing SAKK trials fostered his own professional success story as well as those of Daniel Betticher and others. Michele Ghielmini became perhaps not rich, but at least famous as the leader of SAKK trials testing lymphoma maintenance therapy with rituximab. Eventually, he was appointed Professor at the University of Bern. Is this type of activity still the cornerstone of SAKK? I have the creeping feeling that the answer is No. The Universitarian SAKK founder baby is at risk of being thrown out by SAKK with their present trial bathwater which chiefly targets "regional hospital" patients. What s more, the SAKK 50 Jubilee brochure portrayed none of the five University Hospitals a regrettable oversight. In this issue the report on the Comprehensive Cancer Centre at the Inselspital in Bern (see p. 4) impressively demonstrates, that University Hospitals do not represent academic dead wood of low SAKK appeal. Rather, they offer new technologies that are not available elsewhere, and future-oriented structures. SAKK would do well to consider this academic potential, to top up their trial selection with studies geared to look at University patients, and to return, as it were, to their University birth place. There s one more point: Albert Einstein who worked in a federal administrative office in Bern, called bureaucracy the death of all sound work. Scientific accomplishment is inversely proportional to the number of office employees and the height of paper piles suffocating young clinical investigators. To help them in their strife for academic degrees, SAKK must start a fight against Swiss anti-research bureaucracy. Sadly, SAKK religiously obeys clinical trial regulations issued by regulatory desk jockeys, and formalist lawyers. Instead of blind obedience we need political activity, if clinical cancer research is to flourish rather than perish. To embark on this campaign, the SAKK Coordinating Centre should start a slimming regime in their own ranks, and next invest into anti-bureaucratic disarmament in Switzerland. I trust this will provide a benefit for young oncologists careers, and for cancer patients. Prof. Dr. Martin Fey Department of Medical Oncology, University and Inselspital Bern martin.fey@insel.ch In Brief Anniversary events Read more on the regional road shows organized by the member centres PAGE 4 New requirements for GCP training An investigator taking over responsibility in clinical trials needs to be qualified according to Good Clinical Practice. Read more on the new requirements PAGE 7 Orphan Malignancies Seminar The meeting showed that interdisciplinary networking beyond specialist boundaries can increase knowledge PAGE 19 Contents SAKK News 2-3 SAKK Anniversary 4-6 SAKK Regulatory Affairs 7-8 Trial News 8-17 Publications, Presentations Congresses, Seminars Grants, Events, Education Dates, Flag 25

2 2 September 21, 2015 SAKK Newsletter SAKK NEWS News from the SAKK board At its board meeting on September 1 in Bern, the SAKK board approved of the following trial proposals: Subproject SAKK 06/14: subproject investigator L. Derré Comprehensive analysis of immune regulatory mechanisms and BCG-specific T cell responses in non-muscle invasive bladder cancer patients receiving recombinant BCG therapy (VPM1002BC). The SAKK 06/14 trial was activated in September The goal of this subproject is to capture the immunological status of NMIBC patients before and during BCG therapy. It is therefore planned to take advantage of the clinical trial SAKK 06/14 to analyze patients receiving recombinant BCG (rbcg; VPM1002BC) therapy. In parallel, in collaboration with Cyrill Rentsch from the university hospital of Basel, matched NMIBC patients undergoing classical BCG treatment will be enrolled and studied as a control arm. Also, samples collected in the trial from other participating sites including foreign sites (if available) will be analyzed. The subproject can only be conducted if the grant application is accepted by the Swiss National Science Foundation. SAKK 41/14 ACTIVE-2: coordinating investigator V. Hess Physical activity program in patients with metastatic colorectal cancer who receive palliative first-line chemotherapy. A multicenter open label randomized controlled phase III trial. The trial wants to establish whether patients with cancer of the colon benefit more from treatment if they are physically active. It is known from large studies that people who exercise are less likely to suffer from cancer of the colon. Physically active patients also suffer less often from relapses. However, it is still not known to this day whether sport during therapy for colon cancer leads to better treatment results. The board members agreed to conduct this trial. SAKK 67/15: coordinating investigator M. Joerger Open label, non-randomized, phase I, oral bioavailability and oral dose-expansion study of BAL in patients with locally advanced or metastatic solid tumors. The primary objectives of this study are to determine the maximum tolerated dose and to characterize dose-limiting toxicities of BAL101553, administered intravenously over 48 hours on study days 1, 8 and 15 of every 28-day treatment cycle, to adults with advanced or recurrent solid tumors who have failed standard therapy, or for whom no effective standard therapy is available. The pharmaceutical company Basilea takes over all responsibilities for the trial and SAKK acts as academic research organization. The board members agreed to participate in this trial by voting on August 25, EORTC-1416-LCG ETOP PEARLS: coordinating investigator A. Curioni A randomized, phase 3 trial with anti-pd-1 monoclonal antibody pembrolizumab (MK-3475) versus placebo for patients with early stage NSCLC after resection and completion of standard adjuvant therapy (PEARLS). Survival of completely resected NSCLC remains poor. Therefore there is a need to identify new treatment strategies that can increase the efficacy of adjuvant treatment. Although first-generation immunotherapies in advanced disease were of limited efficacy, they provided proofof-concept that, in some patients, the immune balance could be shifted in favor of tumor elimination. Expanding knowledge and understanding of the immune system s role in cancer has revealed multiple mechanisms by which tumors evade immune destruction. In particular, negative regulatory pathways involved in the T-cell-mediated response, including interaction of PD-1 and PD-L1, appear to have a role in tumor progression. Checkpoint inhibitors have demonstrated benefits with a reasonable safety profile/tolerability in lung cancer in the advanced setting. Theoretically, immunotherapy should work best in the situation of minimal residual disease. The adjuvant setting is therefore the ideal clinical scenario to test the true place of immunotherapy with these new agents and potentially improve the cure rate after surgery. This study will be a randomized trial in NSCLC patients after surgery and completed adjuvant treatment comparing adjuvant pembrolizumab for 1 year versus placebo. This trial fits well in the SAKK lung cancer group strategy, with multimodality treatment of early stage NSCLC and will be conducted in collaboration with ETOP. The trial is fully funded by MSD Merck-Sharp&Dhome AG.

3 SAKK Newsletter September 21, SAKK NEWS SAKK's high quality confirmed The SAKK network has proven effective in conducting clinical trials that benefit patients. This is the verdict of the Swiss National Science Foundation (SNSF) in a report it has prepared at the request of the State Secretariat for Education, Research and Innovation (SERI). Working with an international expert group, the SNSF has evaluated the way in which SAKK selects and funds trial projects. The resulting report acknowledges SAKK's good international reputation, its contributions to cancer research in Switzerland and the potential of these contributions to bring about change in medical practice. The complete evaluation report and the according press release can be found on news/listview/news/2015/07/08/sakks-high-quality-confirmed/ Awards and promotions K. Hohloch SAKK CC Staff News PD Dr Karin Hohloch, leading physician at the Cantonal Hospital Graubünden in Chur, was nominated as associate professor at the Georg August University of Göttingen. Karin Hohloch is member of the SAKK project groups lymphoma and leukemia. Welcome Sabine Bucher, Politics & Development, August 15 Claudia Gübelin, Head of Safety Office, September 1 Mario Baresic, Clinical Research Associate, September 1 Piera Gargiulo, Internship, September 1, 2015 Vincent Tchang, Clinical Research Associate, September 15 Flurina Hoffmann, Head Fundraising & Communications, October 1 Moritz Jacobshagen, Clinical Research Associate, October 1 Martina Schneider, Clinical Project Manager, November 1, 2015 Celebrations Annik Steiner, communications manager, celebrated her 5-years jubilee at the coordinating center. We thank her for her great contribution over the past years and wish her all the best for the coming ones. Karin Rothgiesser, clinical research associate, gave birth to baby girl Sophia. She is currently on maternity leave and is being replaced by Stavros Milatos. Lukas Stalder became father of baby boy Simon and also Dennis Ammann became father of baby boy Vito Orlando. We wish them all the best and good health for the whole family. Farewell Céline Genton, head monitoring, will leave the coordinating center end of September. Antonia Sigrist, clinical research associate, will leave the coordinating center end of October. And Michael Beyeler, clinical project manager, will leave the coordinating center end of November. We thank them for their commitment and dedication to SAKK and we wish them all the best for their future. For information about job vacancies at SAKK, please contact us and/or refer to www NOTE: The semi-annual meeting had to be rescheduled. The meeting will take place on November 26 & 27, 2015, in Zurich For more information refer to

4 4 September 21, 2015 SAKK Newsletter SAKK ANNIVERSARY Activities of SAKK member centers In the SAKK anniversary brochure ( years/anniversary-brochure/), some of our member centers were portrayed in a brief text. But we would like to take advantage of our anniversary year and present several additional centers and their contribution to SAKK. If you are interested to hand in a portrait, please contact Claudia Herren, claudia.herren@sakk.ch. The center Bern Inselspital one of the top recruiters to SAKK trials The center Bern Inselspital is an active and dedicated member of SAKK since its founding year in In fact, Prof. Kurt Brunner, the former director of the Medical Oncology Department at the Inselspital, was one of the driving forces of the Swiss Chemotherapy Group and later of SAKK. These early activities formed the basis for a long-standing research activity committed to all aspects of clinical cancer research at the Inselspital. Traditionally, the Medical Oncology Department as well as all other departments involved in the treatment of cancer patients at the Inselspital have participated in all working and project groups of SAKK, with a strong commitment to an active interdisciplinary approach. Thus, we are proud of our long-standing record of recruiting patients to SAKK trials. In addition, a considerable number of SAKK trials have also been initiated by researchers working at the Inselspital. M. Fey speaking at the patients'day academic environment. We strongly believe that young fellows at our clinic must be involved in treating cancer patients within clinical trials whenever possible. This also implies that participation in clinical trials is a therapeutic option that must be discussed with cancer patients whenever applicable. In the rapidly evolving landscape of clinical cancer research, SAKK remains one of the important partners and sponsors for cancer trials in Switzerland. The Inselspital is proud of its decade-long record of being one of the top recruiters to SAKK trials. We are convinced that SAKK represents a unique opportunity to conduct clinical cancer research on a national multicenter level, be it for early phase I as well as phase II or III trials. On our patients day on June 4, the medical oncology department organized a public event to celebrate SAKK s anniversary and 50 years of progress in cancer care. The interesting program included talks on the history of clinical cancer research, a day in the life of a study nurse or the hereditary aspects of cancer. The talks were accompanied by the performance of comedian Thomas Leuenberger and the Narrenpack Theater Bern. Prof. Dr. Thomas Pabst thomas.pabst@insel.ch Comedian T. Leuenberger Conducting clinical trials, besides laboratory basic research and translational research, is representing a challenge and responsibility for every physician working in an Corinne Vorburger corinne.vorburger@insel.ch Dr. Manuela Rabaglio manuela.rabaglio@insel.ch

5 SAKK Newsletter September 21, SAKK ANNIVERSARY 50 years SAKK event of the IOSI On June 20, the team of the Oncology institute of Southern Switzerland (IOSI) organized an event with interesting speeches regarding clinical cancer research in the Palazzo dei Congressi in Lugano. Among others, Pierre Alberto, SAKK president from 1975 to 1981, spoke of his memories of the founding years of SAKK. The speeches were followed by an apéro with the performance of guitarist Gianluca Sala. Public presentation in Thun: Cancer research in Switzerland progress improves chances D. Rauch To mark the 50th anniversary of SAKK, the Spital STS AG in Thun organized a public presentation on August 26 in the Burgsaal. Daniel Rauch, deputy head physician in oncology, presented a talk on "Cancer research in Switzerland progress improves chances" together with study coordinator Lilian Mäusli. The presentation introduced clinical research projects to a public audience: what is a clinical trial? What are people's fears and concerns about clinical trials? What does it mean to take part and what does it entail? The Thun-Bernese Oberland Centre for Oncology has been regularly and independently working on clinical research projects since 2002 (20 to 30 open trials) with the aim of giving patients access to the latest therapies while also remaining on top of the newest medical developments as a treatment team. In 2012, the Spital STS AG in Thun was elected as a full member of SAKK. Local campaign in St. Gallen: we are conducting cancer research for you On the occasion of SAKKs anniversary, staff members of the Oncology department of the Cantonal Hospital St.Gallen and the Childrens Hospital of Eastern Switzerland informed passersby in the city centre on August 29 about the importance, the missions and the benefits of modern cancer research but spoke also of concerns and requirements. They were supported by representatives of the Cancer League St.Gallen, the Palliative Center and various research organizations. Information material was distributed and small promotions as well as a generation s course were conducted. Clowns at the campaign

6 6 September 21, 2015 SAKK Newsletter SAKK ANNIVERSARY SAKK Graubünden stages anniversary event in Chur SAKK CC Office Outing 2015 Oncology Team KSGR (photo by S. Haas) While SAKK is celebrating its half-centenary, the SAKK Graubünden association was founded 20 years ago. To mark these anniversaries, SAKK Graubünden is held an information evening in Chur on 22 September. The event gave anyone interested the chance to find out for themselves about cancer research in Switzerland and in the Canton of Graubünden in particular. Physicians and trial specialists together with affected patients provided insight in todays possibilities of cancer treatment. On this occasion, special SAKK shirts were designed for the whole oncology team and worn during one month at work. A great idea to promote SAKK and its goals! The program of the event included interesting speeches as well as a panel discussion and the opportunity for the participants to ask questions. According the motto "going back in time" the SAKK CC staff travelled by bus to the ballenberg open-air museum in Brienz. The guided tour through parts of the museum provided an in-depth insight of the life in the Alps or demonstrated old handcrafts such as cheese making or the workshop of a blacksmith. After lunch, the participants rolled up their sleeves in the active programmes and mixed herb teas, graved small wooden cows or built a log cabin. Although the graving caused some minor injuries, all participants had a lot of fun during the workshops and gathered new insights. The trip ended with an apéro in the bus back to Bern, served by the two co-organizators Sonja Bill and Claudia Herren. R. von Moos and team members with SAKK shirts (photo by S. Haas)

7 SAKK Newsletter September 21, SAKK REGULATORY AFFAIRS New requirements for GCP training for investigators in clinical research An investigator or sub-investigator taking over responsibility in clinical trials needs to be qualified by education, training and experience according to Good Clinical Practice. The human research act specifies this even in more detail (see clinical trials ordinance, Art. 6): "The clinical trial investigator must be adequately trained in Good Clinical Practice and have the professional knowledge and experience required for the clinical trial; and be conversant with the legal requirements for clinical trials or be able to ensure compliance by calling in appropriate expertise". The Ethics committees are responsible to evaluate the suitability of an investigator. They approve for each trial the principle investigator prior to trial conduct. Regarding the medical qualification and experience in clinical research their assessment is based on the documentation in the curriculum vitae of the investigator. For the GCP training and training on legal requirements they approve a principal investigator on the availability of a GCP training certificate of a recognized training course. However, what exactly is meant with a recognized GCP training course? Requirements for recognized GCP trainings Since 2010, there exists a catalogue of increasing training objectives for three training levels, namely: sub-investigator, investigator and sponsor investigator. This catalogue was initially published on the Swissmedic website. Course providers could get an approval of their training courses according to these specifications. For instance, the SAKK investigator s education two day training course, conducted twice a year, is approved by Swissmedic and Swissethics on the levels sub-investigator and principle investigator. The current list of all recognized course providers is published on the Swissethics website ( An overview on the conduct of the single courses during the year is accessible on the website of the Swiss Clinical Trials Organization SCTO ( New requirements for 2016 Due to the implementation of the human research act on January 1st 2014, the Ethics Committees revised the requirements and learning objectives on GCP trainings established in The new requirements were recently published on the Swissethics website and are similar to the existing ones. As a main change, the training levels were reduced from tree to two, consisting on one for investigators (previously sub-investigator and principal investigator) and one for sponsor investigators. All course providers are invited to adapt their training accordingly and to certify their training by Swissethics. As of 2016, Swissethics will only recognize new GCP trainings if the course is Swissethics approved and as a result published on the Swissethics website as a recognized GCP training. SAKK is currently approving its two day investigator s education training course to meet the new requirements and learning objectives of Swissethics for the level "investigators". In 2016, SAKK will offer again a Swissethics recognized investigator s training course twice a year. What are the consequences for the principal and sub-investigators of SAKK clinical trials? Investigators who attended a Swissethics recognized training between 2010 and 2015 possess still a valid GCP certificate after 2016 as it will be recognized by the Ethics Committees. Investigators who did not yet attend a training course or their training was not Swissethics recognized (e.g. training before 2010 or training after 2010, but not Swissethics approved) have to ensure that they attend a Swissethics recognized training in The remaining question, which is not yet answered by Swissethics, is about the need and frequency of GCP refresher trainings. As the expiry dates of the recognized Swissethics GCP trainings are not defined, Swissethics highly recommends refreshing trainings in research ethics and GCP (e.g. every 5 years). However, this and the learning objectives of refresher trainings is not yet specified in detail. Dr. Peter Durrer, Head of QA & RAs, peter.durrer@sakk.ch

8 8 September 21, 2015 SAKK Newsletter SAKK REGULATORY AFFAIRS Insourcing of SAKK Safety Office For many years SAKK sourced out the safety office activities to IBCSG. A few years ago the medical expertise at the SAKK Coordinating Center was increased by the employment of a medical advisor, working in close collaboration with the IBCSG safety office for all medical and safety related questions. Additional changes in the regulatory environment during the last years triggered to consider the insourcing of the safety office as an option. The main reasons are: 1. The trials of SAKK demand more and more pharmacovigilance services and resources due to increasing regulatory requirements (e.g. development of safety update reports (DSUR), 24h/7d availability for phase I trials) 2. Higher Phase I trial activity. This requires special knowledge and a dedicated know-how which we further have to build up in house. 3. The option and opportunity to build up a national safety office for the SCTO network (starting 2017) which requires establishing in house a strong pharmacovigilance team. As a consequence, it was decided to establish an own safety office as of January 1st A head of the SAKK safety office could be appointed by the employment of Claudia Gübelin, a medical doctor with a huge experience in clinical research in different positions and disease areas. She is the right person to drive this change process together with Hanne Hawle, the medical advisor of SAKK and the head of QA & RA which will be mainly responsible for the insourcing of the SAKK safety office by the end of We are all looking forward to this change and are confident that it will increase our performance as we will soon have all required pharmacovigilance resources and expertise in-house available. Dr. Peter Durrer, Head of QA & RAs, peter.durrer@sakk.ch TRIAL NEWS SAKK 36/13 patients needed I am happy to inform you about the recent activation of the trial SAKK 36/13 for patients with relapsed or refractory mantle cell lymphoma. The attractiveness of the trial treatment is based on the non-overlapping toxicities and the in vitro synergy of ibrutinib and bortezomib. Bortezomib inhibits, among others, the NF-KB pathway. MCL patients with moderate or no response to ibrutinib have mutations in various genes of this pathway. Janssen-Cilag AG supports the trial by providing both drugs free of charge. The phase I of the trial will be offered at the University Hospitals of Geneva and Bern, the Cantonal Hospitals in Bellinzona, Luzern, Liestal, Aarau, Chur and St. Gallen as well as at the Hirslanden in Zurich. In the phase II part of the trial, further centers in Switzerland and large centers in Italy will join. We would appreciate if we could collaborate with you on a new treatment option for relapsed/refractory mantle cell lymphoma patients in Switzerland. If you have any questions on this trial, I would be pleased to be at your disposal. Urban Novak, coordinating investigator SAKK 36/13 urban.novak@insel.ch

9 SAKK Newsletter September 21, TRIAL NEWS

10 10 September 21, 2015 SAKK Newsletter TRIAL NEWS Trials to be activated 2015/2016, effective September 2015 Trial Trial Name Opening of the first site SAKK 35/14 Extended Rituximab with or without Ibrutinib. A randomized blinded Phase II trial Q (October) SAKK 41/14 Active-2 Physical activity program in patients with metastatic colorectal cancer who receive palliative first-line chemotherapy. A multicenter open label randomized controlled phase III trial Q BIG 6-13 IELSG-42 IELSG-43 SAKK 08/14 IMPROVE SAKK 41/13 SAKK 16/14 SAKK 21/12 (Phase II part) GRAALL-2014 HOVON 103 SEL SAKK 30/10 PRODIGE 32 HD21 MCL young/ TRIANGLE A randomised, double blind, parallel group, placebocontrolled multi centre Phase III study to 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 An international phase II trial assessing tolerability and efficacy of sequential Methotrexate- 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) High-dose chemotherapy and autologous stem cell transplant consolidating conventional chemotherapy in primary CNS lymphoma -randomized phase III trial Enzalutamide in combination with metformin vs. enzalutamide in patients with CRPC progressing on androgen deprivation therapy (ADT) Adjuvant aspirin treatment in PIK3CA mutated colon cancer patients. A randomized, doubleblinded, placebo-controlled, phase III trial. 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) A Phase I and stratified, multicenter Phase II trial of transdermal CR1447 (4-OH-tes tosterone) in endocrine responsive-her2 negative and triple negative-androgen receptor positive metastatic or locally ad vanced breast cancer Treatment of adult acute lymphoblastic leukemia (ALL), evaluating the addition of a second late intensification course in B-lineage PH-negative ALL, the addition of Nelara-bine in highrisk T-lineage ALL, and the reduction of chemotherapy intensity in Ph+ ALL A randomized phase II multicenter study with a safety run-in to assess the tolerability and 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 Randomised phase II-III strategic trial in operable oesophageal cancer in case of clinical complete response after chemoradiation: systematic surgery vs surveillance with selective salvage surgery in case of operable recurrence Treatment optimization trial in the first-line treatment of advanced stage Hodgkin Lymphoma: comparision of 6 cycles of escaleted BEACOPP with 6 cycles of BrECADD Efficacy of Ibrutinib during R-CHOP/R-DHAP induction and after or in comparison to autologous stem cell transaplantation (ASCT) in previously untreated patients with mantle cell lymphoma Q4 2015* Q4 2015* Q4 2015* Q Q Q Q Q Q Q1 2016* Q1 2016* Q1 2016* Q2 2016* Q * SAKK 06/13 BOOST: A prospective placebo controlled randomized study comparing intradermal BCG immunization before intravesical BCG to standard intravesical BCG therapy alone in patients with non-muscle invasive bladder cancer on hold due to financial reasons *Dependent on the cooperative group, just an estimated opening for accrual

11 SAKK Newsletter September 21, TRIAL NEWS Trials to be activated 2015/2016, effective September 2015 SAKK 08/15 ProMET Multicenter, Randomized, Double Blind, Placebo Controlled Phase II Trial of Salvage Radiotherapy +/- Metformin HCL after Prostatectomy Failure on hold due to financial reasons SAKK 09/15 Extended pelvic lymph node dissection vs. no pelvic lymph node dissection at radical prostatectomy for intermediate- and high-risk prostate cancer: A randomized multicenter international trial on hold due to financial reasons Trials Open for Accrual September 2015 Disease Group Urogenital Urogenital Urogenital Urogenital Urogenital Lung Trial Name Trial Description Accrual Target SAKK 01/10 SAKK 06/14 SAKK 63/12 Involved Node Radiotherapy and Carboplatin Chemotherapy in Stage IIA/B Seminoma A phase I/II open label clinical trial assessing safety and efficacy of intravesical instillation of VPM1002BC in patients with recurrent non-muscle invasive bladder cancer after standard BCG therapy Prospective cohort study with collection of clinical data and serum of patients with prostate disease SAKK 96/12 Prevention of Symptomatic Skeletal Events with Denosumab Administered every 4 Weeks versus every 12 Weeks A Non-Inferiority Phase III Trial STAMPEDE SAKK 15/12 Systemic Therapy in Advancing or Metastatic Prostate Cancer: Evaluation of Drug Efficacy A 5-stage multi-arm randomised controlled trial Early prophylactic cranial irradiation with hippocampal avoidance in patients with limited disease small-cell lung cancer. A multicenter phase II trial Current Accrual* Estimated Closure for Accrual Trial Coordinator stavros.milatos@sakk. ch milica.enoiu@sakk.ch vincent.bize@sakk.ch (total 156) lukas.stalder@sakk.ch andrea.fuhrer@sakk.ch Lung SAKK 16/08 Preoperative chemotherapy and radiotherapy with concomitant Cetuximab in non-small cell lung cancer (NSCLC) patients with IIIB disease. A multicenter phase II trial Updated *Current accrual as of end of August, Accrual for non-sakk trials only includes patients enrolled at SAKK centers.

12 12 September 21, 2015 SAKK Newsletter TRIAL NEWS Trials Open for Accrual September 2015 Disease Group Trial Name Trial Description Accrual Target Current Accrual* Estimated Closure for Accrual Trial Coordinator Lung SPLENDOUR A randomised, open-label phase III trial evaluating the addition of denosumab to standard first-line anticancer treatment in advanced NSCLC SPLENDOUR@etop-eu. org Lung Breast Breast Breast Breast Breast Breast EORTC LungArt SAKK 22/10 SAKK 23/13 SAKK 25/14 Phase III study comparing post-operative conformal radiotherapy to no post-operative radiotherapy in patients with completely resected non-small cell lung cancer and mediastinal N2 involvement A randomized phase II trial of pertuzumab 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 Randomized Controlled Trial to Evaluate the Impact of a Surgical Sealing Patch on Lymphatic Drainage after Axillary Lymph Node Dissection for Breast Cancer Eribulin as 1st line treatment in elderly patients (>= 70 years) with advanced breast cancer: a multicenter phase II trial SAKK 96/12 Prevention of Symptomatic Skeletal Events with Denosumab Administered every 4 Weeks versus every 12 Weeks A Non-Inferiority Phase III Trial EORTC PRO IBCSG HOHO EORTC prospective part, Clinical and biological characterization of Male Breast Cancer: an international EORTC, BIG and NABCG intergroup study Prospective observational study of young women ( 40 years at diagnosis) with breast cancer. Data analyzed will include serial patient surveys and medical record information oussama.karroum@ eortc.be marie-aline. gerard@sakk.ch estelle.cassoly@sakk. ch stavros.milatos@sakk. ch (total 156) lukas.stalder@sakk.ch estelle.cassoly@sakk. ch Q Updated *Current accrual as of end of August, Accrual for non-sakk trials only includes patients enrolled at SAKK centers.

13 SAKK Newsletter September 21, TRIAL NEWS Trials Open for Accrual September 2015 Disease Group Trial Name Trial Description Accrual Target Current Accrual* Estimated Closure for Accrual Trial Coordinator Breast IBCSG 48-14/ BIG 8-13 A study evaluating the pregnancy outcomes and safety of interrupting endocrine therapy for young women with endocrine responsive breast cancer who desire pregnancy Leukemias SAKK 33/14 Effects of sympathicomimetic agonists on the disease course and mutant allele burden in patients with JAK2-mutated myeloproliferative neoplasms A multicenter phase II trial Leukemias APL 2006 Randomized phase III trial assessing the role of arsenic trioxide and/or ATRA during consolidation course in newly diagnosed acute promyelocytic leukemia (APL) Leukemias CML V Treatment optimization of newly diagnosed 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 andrea.fuhrer@sakk.ch Q anna.tomaszewska@ sakk.ch Leukemias EBMT HCT vs CT Compare conventinal chemotherapy to low dose total body irradiation-based conditioning and hematopoietic cell transplantation as consolidation therapy joerg.brechbuehl@ sakk.ch Leukemias HOVON 103- TOS A randomized phase II multicenter study 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 andrea.fuhrer@sakk.ch Updated *Current accrual as of end of August, Accrual for non-sakk trials only includes patients enrolled at SAKK centers.

14 14 September 21, 2015 SAKK Newsletter TRIAL NEWS Trials Open for Accrual September 2015 Disease Group Trial Name Trial Description Accrual Target Current Accrual* Estimated Closure for Accrual Trial Coordinator Leukemias HOVON 132 Randomized study with a run-in doseselection phase to assess the added value of lenalidomide in combination with standard remission-induction chemotherapy and post-remission treatment in patients aged years with previously untreated acute myeloid leukemia (AML) or high risk myelodysplasia (MDS) (IPSS-R risk score > 4.5) Lymphomas SAKK 36/13 Combination of ibrutinib and Bortezomib followed by ibrutinib maintenance to treat patients with relapsed and refractory mantle cell lymphoma. A multicenter Phase I/II trial Lymphomas SAKK 39/10 Nelfinavir and lenalidomide/dexamethasone in patients with progressive multiple myeloma that have failed lenalidomidecontaining therapy. A single arm phase I/ II trial Lymphomas SAKK 39/13 Nelfinavir as Bortezomib-sensitizing drug in patients with proteasome inhibitornonresponsive myeloma Lymphomas HD 17 Therapieoptimierungsstudie in der Primärtherapie des intermediären Hodgkin Lymphoms: Therapiestratifizierung mittels FDG-PET Lymphomas IELSG-37 A randomized, open-label, multicentre, 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) Lymphomas T-cell project Das T-Cell project ist eine Registrierstudie mit Referenzpathologie um Daten zu seltenen malignen Erkrankungen der T- Zell Linie zu gewinnen andrea.fuhrer@sakk.ch katrin.eckhardt@sakk. ch catherine.berset@ sakk.ch Updated *Current accrual as of end of August Accrual for non-sakk trials only includes patients enrolled at SAKK centers.

15 SAKK Newsletter September 21, TRIAL NEWS Trials Open for Accrual September 2015 Disease Group Gastrointestinal Updated Trial Name Trial Description Accrual Target Alliance/ PROSPECT A phase II/III trial of neoadjuvant folfox, with selective use of combined modality chemora-diation vs. preoperative combined modality chemoradiation for locally advanced rectal cancer patients undergoing low anterior resec-tion with total mesorectal excision. 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 New Drugs SAKK 66/13 INC280 Combination with BKM120 for glioblastoma patients, Phase I/II trial 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 Gynaecological Gynaecological Mito/ Mango 16b INOVATYON A multicenter phase III randomized study with second line chemotherapy plus or minus bevacizumab in patients with platinum sensitive epithelial ovarian cancer recurrence after a bevacizumab/chemotherapy first line Phase III international, randomized study of trabectedin plus Pegylated Liposomal Doxorubicin (PLD) versus Carboplatin plus PLD in patients with ovarian cancer progressing within 6-12 months of last platinum Current Accrual* Estimated Closure for Accrual Trial Coordinator anna.tomaszewska@ sakk.ch heidi.baumgartner@ sakk.ch anna.tomaszewska@ sakk.ch *Current accrual as of end of August Accrual for non-sakk trials only includes patients enrolled at SAKK centers.

16 16 September 21, 2015 SAKK Newsletter TRIAL NEWS Activated trials Alliance/PROSPECT 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 Activated July 2, 2015 Coordinating investigator Michael Montemurro, Bellinzona Clinical project manager anna.tomaszewska@sakk.ch STAMPEDE Systemic Therapy in Advancing or Metastatic Prostate Cancer: Evaluation of Drug Efficacy. A multi-arm multi-stage randomised controlled trial. ARM ENZALUTAMIDE Activated July 16, 2015 Coordinating investigator George Thalmann, Bern Clinical project manager estelle.cassoly@sakk.ch SAKK 25/14 Eribulin as 1st line treatment in elderly patients (>= 70 years) with advanced breast cancer: a multicenter phase II trial Activated August 11, 2015 Coordinating investigator Ursula Hasler-Strub, St.Gallen Clinical project manager stavros.milatos@sakk.ch SAKK 36/13 Combination of Ibrutinib and Bortezomib to treat mantle cell lymphomas patients a multicenter phase I/II trial Activated August 11, 2015 Coordinating investigator Urban Novak, Bern Clinical project manager katrin.eckhardt@sakk.ch 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 Activated September 7, 2015 Coordinating investigator Cyrill Rentsch, Basel Clinical project manager milica.enoui@sakk.ch Authorized trials SAKK 35/14 Rituximab with or without ibrutinib for untreated patients with advanced follicular lymphoma in need of therapy. A randomized, double-blinded, SAKK and NLG collaborative Phase II trial Approval Swissmedic August 6, 2015 Approval ethical committee July 27, 2015 Coordinating investigator Emanuele Zucca, Bellinzona Clinical project manager sabine.rion@sakk.ch www All information on SAKK trials can also be found under in the members section

17 SAKK Newsletter September 21, TRIAL NEWS Approval pending SAKK 41/13 Adjuvant aspirin treatment in PIK3CA mutated colon cancer patients. A randomized, double-blinded, placebo-controlled, phase III trial Approved by EC August 31, 2015 Submitted to Swissmedic August 12, 2015 Coordinating investigator Ulrich Güller, Basel Clinical project manager daniela.baertschi@sakk.ch HOVON SEL A randomized phase II multicenter study with a safety run-in to assess the tolerability and efficacy of the addition of oral selinexor (KPT-330) to standard induction chemotherapy in AML and high risk myelodysplasia (MDS) (IPSS-R > 4.5) in patients aged 66 years Submitted to EC August 14, 2015 Submitted to Swissmedic August 14, 2015 Coordinating investigator Georg Stüssi, Bellinzona Clinical project manager andrea.fuhrer@sakk.ch Trial closed for accrual IBCSG A randomized phase II study evaluating different schedules of nab-paclitaxel in metastatic breast cancer Closed for accrual August 7, 2015 Coordinating investigator ibcsg42_snap@fstrf.org 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 Closed for accrual August 13, 2015 Coordinating investigator Andreas Lohri, Liestal Clinical project manager katrin.eckhardt@sakk.ch PUBLICATIONS Q Lung Cancer SAKK 16/00 Pless M, Stupp R, Ris HB, Stahel RA, Weder W, Thierstein S, Gerard MA, Xyrafas A, Früh M, Cathomas R, Zippelius A, Roth A, Bijelovic M, Ochsenbein A, Meier UR, Mamot C, Rauch D, Gautschi O, Betticher DC, Mirimanoff RO, Peters S; SAKK Lung Cancer Project Group. Induction chemoradiation in stage IIIA/N2 non-small-cell lung cancer: a phase 3 randomised trial. Lancet Aug 11. Breast Cancer BIG 1-98 Metzger Filho O, Giobbie-Hurder A, Mallon E, Gusterson B, Viale G, Winer EP, Thürlimann B, Gelber RD, Colleoni M, Ejlertsen B, Debled M, Price KN, Regan MM, Coates AS, Goldhirsch A. Relative Effectiveness of Letrozole Compared With Tamoxifen for Patients With Lobular Carcinoma in the BIG 1-98 Trial. J Clin Oncol Jul 27.

18 18 September 21, 2015 SAKK Newsletter PUBLICATIONS & PRESENTATIONS Q BIG 2-98 Sonnenblick A, Francis PA, Azim HA Jr, de Azambuja E, Nordenskjöld B, Gutiérez J, Quinaux E, Mastropasqua MG, Ameye L, Anderson M, Lluch A, Gnant M, Goldhirsch A, Di Leo A, Barnadas A, Cortes-Funes H, Piccart M, Crown J. Final 10-year results of the Breast International Group 2-98 phase III trial and the role of Ki67 in predicting benefit of adjuvant docetaxel in patients with oestrogen receptor positive breast cancer. Eur J Cancer Jun 11. IBCSG Munzone E, Colleoni M. Clinical overview of metronomic chemotherapy in breast cancer. Nat Rev Clin Oncol Aug 4. Leukemia Walter RB, Othus M, Löwenberg B, Ossenkoppele GJ, Petersdorf SH, Pabst T, Vekemans MC, Appelbaum FR, Erba HP, Estey EH. Empiric Definition of Eligibility Criteria for Clinical Trials in Relapsed/Refractory Acute Myeloid Leukemia: Analysis of 1,892 Patients from HOVON/ SAKK and SWOG. Haematologica Jul 9. Lymphomas SAKK 38/07 Tzankov A, Leu N, Muenst S, Juskevicius D, Klingbiel D, Mamot C, Dirnhofer S. Multiparameter analysis of homogeneously R-CHOP-treated diffuse large B cell lymphomas identifies CD5 and FOXP1 as relevant prognostic biomarkers: report of the prospective SAKK 38/07 study. J Hematol Oncol Jun 14. Gastrointestinal Cancer Declercq J, Jacobs B, Biesmans B, Roth A, Klingbiel D, Tejpar S, Creemers JW. Single Nucleotide Polymorphism (rs ) in the P1 Promoter of FURIN Is Not Prognostic to Colon Cancer. Biomed Res Int Jun 7. Melanoma Matter-Walstra K, Braun R, Kolb C, Ademi Z, Dummer R, Pestalozzi BC, Schwenkglenks M. A cost-effectiveness analysis of trametinib plus dabrafenib as first-line therapy for metastatic BRAF V600-positive melanoma in the Swiss setting. Br J Dermatol Sep 2. Presentations Q3 World Congress of Surgery WCS 2015 in Bangkok Oral presentation Curti G. et al. Complication pattern according to hospital size in a prospective randomized trial SAKK 40/04 comparing colon-j-pouch, side-to-end anastomosis, and straight coloanal anastomosis after TME. European Cancer Congress 2015 in Vienna Mamot C, Klingbiel D, Hitz F, Renner C, Pabst T, Driessen C, Mey U, Pless M, Bargetzi M, Krasniqi F, Gigli F, Hany T, Samarin A, Biaggi C, Rusterholz C, Dirnhofer S, Zucca E, Martinelli G. Final Results of a Prospective Evaluation of the Predictive Value of Interim Positron Emission Tomography in Patients With Diffuse Large B-Cell Lymphoma Treated With R-CHOP-14 (SAKK 38/07). J Clin Oncol Jul 6. HD12/15 Haverkamp H, Böll B, Eichenauer DA, Sasse S, Fuchs M, Borchmann P, Diehl V, Engert A, von Tresckow B. Impact of Bleomycin and Vincristine Dose Reductions in Patients With Advanced Hodgkin Lymphoma Treated With BEACOPP: An Analysis of the German Hodgkin Study Group HD12 and HD15 Trials. J Clin Onco Jun 22.

19 SAKK Newsletter September 21, PRESENTATIONS Q Oral presentation Cathomas R. et al. Orteronel (Ort) maintenance therapy in patients (pts) with metastatic castration resistant prostate cancer (mcrpc) and non-progressive disease after first-line docetaxel (Doc) therapy: results of a multicenter randomized double-blind placebo-controlled phase III trial (SAKK 08/11). Poster discussion Fischer S. et al. Outcome of relapses after adjuvant carboplatin in clinical stage I seminoma. Pestalozzi B. et al. Adjuvant treatment recommendations for ER+ early breast cancer patients by Swiss tumor boards (SAKK 26/10). Kienle D. et al. Cetuximab monotherapy and cetuximab plus capecitabine as first-line treatment in elderly patients with RAS- and BRAF wild-type metastatic colorectal cancer. Results of the multicenter phase II trial SAKK 41/10. Stathis A. et al. A phase I study of the smoothened (SMO) antagonist LDE225 in combination with paclitaxel in patients with advanced solid tumors. Posters Jaggi R. et al. A correlative study of Ki67 and two multigene RNA expression signatures in operable ER-positive postmenopausal breast cancer (SAKK 26/10). CONGRESSES & SEMINARS Orphan Malignancies Seminar on thyroid and Merkel cell carcinomas The management of thyroid and Merkel cell carcinomas was the subject of this year's Orphan Malignancies Seminar held in Zurich on September 10. The objective of this event is to discuss rare and largely overlooked malignant diseases from an interdisciplinary perspective. Experts from the F. Stenner fields of radio-oncology, nuclear medicine, endocrinology, dermatology, pathology and oncology attended the event, which was chaired by Dr. Richard Cathomas (Department of Oncology, Graubünden Cantonal Hospital) and Dr. Frank Stenner (Department of Oncology, University Hospital R. Cathomas Basel). With an incidence of 13/100,000 inhabitants, thyroid cancer is not, strictly speaking, a rare disease (definition in the EU: incidence of <5 cases/100,000 inhabitants, in the US <7.5/100,000). As a result of the increased use of imaging techniques, the incidence has even been rising over the last few decades. However, most thyroid malignancies involve painless or curable carcinomas. The mortality rate is only 0.5/100,000. In his impressive presentation, Professor Christoph Meier, endocrinologist and chief physician at the Triemlispital in Zurich, described the risks of overdiagnosis and consequent overtreatment. Thyroid nodules are very common and increase by about 10% per decade of life in absolute terms. Thus, almost half of all 50-year-olds have thyroid nodules. However, only around 10% of palpable nodules are malignant, and many of these are painless. As a general rule of thumb, nodules smaller than 1cm do not require any further investigation. Professor Alex Soltermann, chief pathologist at University Hospital Zurich, explained the difficulties associated with the cytological diagnosis of thyroid nodules based on fineneedle aspiration biopsy. Around 60-70% of findings are benign (Thy 2 according to the British classification scale Thy 1-5) and only 5% show a definitely malignant result. Classification is difficult in approx. 20% of cases (Thy 3), which are designated as "follicular neoplasm". Resection

20 20 September 21, 2015 SAKK Newsletter CONGRESSES & SEMINARS by hemithyroidectomy is required in these cases for further clarification. Unnecessary surgery should be avoided at all costs. If a well differentiated thyroid carcinoma is diagnosed, the issue of post-surgery adjuvant radioiodine therapy. New guidelines defining the circumstances in which radioiodine therapy is indicated were issued in The scenarios are classified into low risk, intermediate and high risk. Dr. Sabine Weidner, senior physician in nuclear medicine at Bern University Hospital, explained that radioiodine therapy was not necessary in a low-risk situation. A differentiated approach is required in intermediate-risk patients, as radioiodine therapy is not indicated in every case. In S. Weidner view of the possibility of secondary tumour induction, the indication is decided more cautiously nowadays. Radioiodine therapy is always indicated in high-risk situations. Ideally, this should be administered in combination with recombinant TSH (rtsh) and previously initiated thyroxine replacement in order to minimize the side effects. Radioiodine therapy is also the treatment of choice for advanced and metastatic thyroid cancer. Many patients can be cured permanently by this treatment alone. In certain cases however, increasing dedifferentiation and, ultimately, a radioiodine-refractory situation can develop. Dr. Marco Siano, senior oncologist at St. Gallen Cantonal Hospital, explained that several effective systemic treatments have now become available in this situation. This is a crucial advance since chemotherapy is not an appropriate option for these patients. In patients with medullary thyroid cancer, the tyrosine kinase inhibitors (TKI) vandetanib and cabozantinib have produced a good response and an improvement in terms of progression-free survival (PFS). This applies particularly in cases of confirmed RET mutation. In a phase 3 study, sorafenib showed statistically significant advantages over placebo in patients with differentiated, metastatic radioiodine-refractory thyroid cancer. The TKI lenvatinib likewise produced a very good response and prolongation of PFS in treatment-naive and TKI-pretreated patients. However, since all TKIs are associated with restricting side effects, and metastatic thyroid cancers often remain painless for a long time, treatment should not be started until clear progression or symptoms have occurred. Merkel cell carcinoma was discussed in the second part of the seminar. This is a very rare, usually aggressively developing malignancy of the skin, of neuroendocrine origin, with an incidence of /100,000. Dr. Antonio Curzio, chief dermatologist at University Hospital Zurich, talked about its clinical manifestation and pathogenesis. Recent investigations have shown that Merkel cell carcinoma is usually caused by a virus. The Merkel cell polyomavirus (MCV) has been identified as the pathogen. If the condition is localized, local resection (if possible with a 2cm margin of healthy tissue) should be accompanied by excision of the sentinel lymph node (SLN). Dr. Alexandros Papachristofilou, senior physician in radio-oncology at the University of Basel, explained that all patients actually benefit from local radiotherapy, regardless of the size or resection result of the primary tumour. More complex is the decision concerning regional irradiation of the draining lymph nodes. If the SLN biopsy result is negative, no further radiotherapy is needed. If the SLN biopsy result is positive, either regional radiotherapy, resection or a combination of the two is indicated. The decision will depend on the expected morbidity and should be discussed on an interdisciplinary basis. Advanced and metastatic Merkel cell carcinoma is often highly aggressive, and its clinical progression can, as yet, only be influenced to a limited extent. The chemotherapies are borrowed from those for small-cell carcinoma (platinum /etoposide; ACO), but despite their potency, are usually effective only for a short period. Histological staining of somatostatin receptor 2 (SSR2) and somatostatin receptor PET/CT (gallium DOTATATE PET/CT) are recommended. If the imaging result is positive, metabolic treatment with lutetium-dotatoc may prove promising and should be attempted. In view of the viral pathogenesis, current clinical research is focusing on the use of immunooncology treatments with anti-pd 1/PD-L1 drugs. A study with atezolizumab (anti-pd-l1 antibodies) will commence shortly at the Dermatology Unit at University Hospital Zurich. Once again, the meeting showed that interdisciplinary networking beyond specialist boundaries can increase knowledge by means of active discussion and talking about specific cases. The series of seminars is to be continued in 2016 with the aim of reaching an even wider interdisciplinary audience. Dr. Richard Cathomas, Graubünden Cantonal Hospital, richard.cathomas@ksgr.ch

21 SAKK Newsletter September 21, CONGRESSES & SEMINARS 2nd Swiss Cancer Congress "Quality in oncology" On August 27, 2015, the 2nd Swiss Cancer Congress took place at the University in Fribourg. Over 200 participants engaged themselves in the topic "Quality in Oncology". At the beginning, Irène Bachmann-Mettler from Oncology Care Switzerland stated: Quality concerns us all. We strive each day to develop quality but it is impossible to prescribe it. I. Bachmann Quality is an elusive term. In the morning, Georg Kohler, professor emeritus of the philosophy department of the University Zurich, and Hans Stalder, former director of the medical polyclinic of the University Hospitals Geneva, raised some fundamental questions. Philosophically speaking, supposed Kohler, is quality in contrast to quantity generally not measurable. Stalder remarked that medical guidelines are limited even if they are often used to define the quality of good medical practice. Not before quality is stimulated with monetary incentives it is spreading, as the Pay for Performance (P4P) -System of the British National Health Service showed. In ten parallel workshops aligned to the National Strategy Against Cancer (NSK), questions regarding quality in early detection, prevention, health promotion, rehabilitation and in social counselling were discussed. In the afternoon, the speakers of the workshops presented the results of the discussions in the plenum followed by a presentation of the current status of the implementation of the NSK. At the end of the congress, Thomas Cerny, head physician of hematology/oncology at the Cantonal Hospital in St.Gallen, observed that high quality in one field is often transmitted to others, quality is reproduced. It seems that if a culture of quality is installed it can spread manifold. G. Kohler For more information please refer to the congress website Ori Schipper, Communications Manager ori.schipper@krebsliga.ch

22 22 September 21, 2015 SAKK Newsletter EVENTS SAKK SYMPOSIUM AT THE DGHO ANNUAL MEETING years SAKK clinical research and cooperative groups Monday, October 12, 2015, 2 pm to 5.15 pm, in Basel It is our pleasure to invite you to the SAKK symposium on the occasion of the DGHO congress 2015 with the following main topics: The future of cooperative groups in cancer research Clinical Research 50 years SAKK Apéro/Snack 2 pm to 3.30 pm 3.45 pm to 5.15 pm 5.15 pm We invite you discuss these questions with us, and you are welcome to bring in your ideas, answers and recommendations. You can find a detailed program on Venue: Congress Center Basel, Messeplatz 21, 4058 Basel, Room Helvetia 1+2 Registration and tickets: We have a limited number of tickets available, please contact natascha.backes@sakk.ch or register directly on Sponsored by

23 SAKK Newsletter September 21, EVENTS SAKK Semi-Annual Meeting November 26 & 27, 2015, Zurich It is our pleasure to invite you to our semi-annual meeting which will be held in Zurich on November 26 & 27, Please visit for a detailed program and registration form, as well as a floor plan of the premises. Venue: Zurich Marriott Hotel Information: SAKK Coordinating Center Neumühlequai 42 Effingerstrasse Zürich 3008 Bern Phone: Phone: Web: Fax: Web: events@sakk.ch INVITATION TO THE SAKK JUBILEE APÉRO following the semi-annual meeting on November 26, 2015, 7.00 pm, Zurich Marriott Hotel We are looking forward to celebrate with all of you the 50th anniversary of SAKK! A personal invitation will follow soon.

24 24 September 21, 2015 SAKK Newsletter EDUCATION, EVENTS SAKK Investigators'education October 22 & 29, 2015 SAKK, Bern For members of the SAKK network and SPOG the course is free of charge. More information: Supported by Planned in between meetings of project groups and working groups 2015 Group New Anticancer Drugs Lung Cancer Next meeting October 1, 2015, 11h30-14h30 October 8, 2015, 14h15-16h45 Detailed information regarding time, place and agenda of the meetings can be found on the members'section on our website