Schweizerische Arbeitsgemeinschaft für Klinische Krebsforschung Groupe Suisse de Recherche Clinique sur le Cancer
BOARD DECISIONS
At its regular board meeting on May 8, 2012, the SAKK Board accepted to conduct the following trials:
NCI: Advanced Rectal Cancer, N.N A phase II/III trial of neoadjuvant folfox, with selective use of combined modality chemoradiation vs. preoperative combined modality chemoradi-ation for locally advanced rectal cancer patients undergoing low anterior resection with total mesorectal excision.
This phase II/III trial by the US National cancer insti-tute (NCI) investigates whether six cycles of neoadjuvant folfox (oxaliplatin, leucovorin calcium, and fluorouracil) followed by comprehensive restaging with selective use of radiation therapy (5FUCMT) followed by total mesorectal excision achieves favorable outcomes for patients with lo-cally advanced rectal cancer. The current standard of care for locally advanced rectal cancer involves use of 5FUCMT for all patients.
Biobank, D. Engeler Biomarkers in localized prostate cancer (A large serum biobank, prospective trial).
One of the big issues with prostate cancer diagnosis and scree-ning is the risk of overtreatment. The effectiveness of syste-matic (mass) screening for prostate
cancer with prostate-specific antigen (PSA)-testing remains controversial because it has no or limited benefi-cial effects on overall survival. Ad-ditional markers for improving spe-cificity of testing for prostate cancer are urgently needed. In this project, biobanking of sera of five patient groups with different and specific indications for PSA-testing of their sera is planned.
Guidelines for expenses revised The SAKK Board approved the revised guidelines for expenses (Spesenreglement). The guidelines can be found on the SAKK website
SAKK News
Annik Steiner, SAKK Coordinating Center, Bern
in the members’ section under Guidelines & Documents (http://sakk.ch/en/download/29).
PROMOTIONS
Yves Chalandon was appointed professor, head of the Hemato-Oncology Unit and director of the BMT program, Hematology Division, University Hospital of Geneva as of July 1, 2012.
Yves Chalandon is member of the SAKK Board and president of the SAKK Project Group Leu-kemias.
NEW STRUCTURE OF THE SAKK COORDINATING CENTER
Since the beginning of June, the SAKK Coordinating Center has a new organizational structure. It consists now of five units: Clinical Trial Management, Statistics, Qua-lity Assurance & Regulatory Affairs, Information Tech-nology & Clinical Data Management and Services. The heads of these units together with the director constitute the executive board of the Coordinating Center. New head of the Clinical Trial Management is Christoph Kolb. His unit is subdivided into four teams headed by Christine Biaggi, Christiane Pilop, Simona Berardi and Céline Genton.
The organigram further shows the four staff positions at the SAKK Coordinating Center reporting directly to the director: Outcomes Research Management, Medical Ad-visor, Public Affairs Management as well as Relationship Management.
Yves Chalandon
* MEMBERS OF THE EXECUTIVE BOARD
CEO Dr. Peter Brauchli*
STATISTICS Dr. Dirk Klingbiel*
PUBLIC AFFAIRS MGMT Andy Marthaler
SERVICES Robert Meyer*
QUALITY ASSURANCE &
REGULATORY AFFAIRS Dr. Peter Durrer*
INFORMATION TECHNOLOGY &
CLINICAL DATA MANAGEMENT a.i. Dr. Peter Durrer*
CLINICAL TRIAL MANAGEMENT Christoph Kolb*
TRIAL COORDINATION Dr. Christiane Pilop
TRIAL COORDINATION Christine Biaggi
MONITORING Dr. Céline Genton
TRIAL COORDINATION Dr. Simona Berardi
MEDICAL ADVISOR Dr. Hanne Hawle
RELATIONSHIP MGMT Severin Strasky OUTCOMES RESEARCH MGMT Dr. Klazien Matter-Walstra
GENERAL ASSEMBLY
During the General Assembly, which took place on June 20, the participants were informed about the following ongoing processes that will influence the work of SAKK in the coming years:
Law on research involving humans (Humanfor-schungsgesetz): The ordinance is in public consultation from August to November 2012; additionally, risk-based approaches are pilot-tested.
Guideline for the collaboration of physicians and industry by the Swiss Academy of Medical Sciences (SAMS): The draft of the revised guideline from May 30, 2012, is open for consultation until August 31, 2012. In-terested persons are invited to give their input.
20 abstracts submitted
In 2012, 20 abstracts were submitted by SAKK until mid-year. The SAKK Coordinating Center has a prospec-tive planning list for the submission of abstracts available.
Stefan Aebi new board member
Stefan Aebi from the Luzerner Kantonsspital was elected as board member. Aebi has ac-tively participated in diffe-rent SAKK project groups for several years and is a member of the foundation council of IBCSG. He replaces Mar-kus Borner from the Spital-zentrum Biel and Inselspital Bern, who stepped back as a board member.
SAKK SEMI-ANNUAL MEETING
On June 21, SAKK held its summer semi-annual meeting in Bern, which was attended by more than 250 specialists.
Award for Dirk Kienle
Dirk Kienle from the Kantonsspital Graubünden obtained the SAKK/Dr. Paul Janssen Fellowship, which is joint-ly awarded by SAKK and Janssen-Cilag AG. The educa-tional grant is endowed with CHF 50 000.- and is aimed at offering young doctors the opportunity to spend four months at a renowned research center abroad to gain ex-perience and acquire the necessary know-how and tools to develop and conduct top-quality clinical trials. Kienle has been working in Switzerland for four years and is an active member of the Project Group Gastro-Intestinal Cancers.
He is trial chair of the trial SAKK 41/10, «Cetuximab Monotherapy versus Cetuximab plus Capecitabine as first-line treatment in elderly patients with KRAS wild-type
metastatic colorectal cancer» that is likely to be activated in autumn 2012. Kienle hopes that he can further improve his clinical trial knowledge by the fellowship, as he said at the award ceremony.
Gateway/RTF-CCR/SAKK Research Grant: Call for proposals launched
Eveline Mumenthaler, Direc-tor of Research and Grants at Gateway, presented the Gateway/RTF-CCR/SAKK Research Grant, and there-by launched the call for pro-posals. This grant is endo-wed for a maximum of up to US$ 450 000 and is joint-ly awarded by SAKK, The Gateway for Cancer Research (Gateway), a U.S.-based non-profit organization and the Rising Tide Foundation for Clinical Cancer Research (RTF-CCR), a Swiss-based non-profit organization. All in-vestigators are called upon now to submit clinical research proposals. For more information about the grant contact the SAKK website: http://sakk.ch/en/download/367/.
ASCO ABSTRACTS General poster session Abstract No: 9059
T. Ruhstaller Prevention of palmoplantar erythro-dysesthesia (PPE) with an antiperspirant in breast cancer patients treated with pegylated liposomal do-xorubicin (PLD), a placebo-controlled, double blin-ded, phase lll trial (SAKK 92/08).
Stefan Aebi
SAKK President Beat Thürlimann, Dirk Kienle, winner of the Janssen Fellowship and Reza Safaei from Janssen-Cilag AG
SAKK
Eveline Mumenthaler
Schweizer Krebsbulletin Nr. 3/2012 233 Abstract No: 3595
R. von Moos Neoadjuvant radiotherapy (RT) com-bined with capecitabine (Cape) and sorafenib (Sor) in patients with locally advanced, K-ras-mutated rectal cancer (LARC): A phase I/II trial (SAKK 41/08).
Abstract No: 9045
F. Hitz Predictors of satisfaction with decision in pa-tients with advanced cancer.
Poster discussion session Abstract No: 10033
M. Montemurro Dasatinib first-line treatment in gas-trointestinal stromal tumors: A multicenter phase II trial of the SAKK (SAKK 56/07).
International trials with participation of SAKK General poster session
Abstract No: 3575
V. C. Popovici Molecular and clinicopathologic evi-dence of heterogeneity in KRAS-mutant colon can-cers.
Poster discussion session Abstract No: 3509
A. Roth Validation of two gene-expression risk scores in a large colon cancer cohort and contribution to an improved prognostic method.
Abstract No: 3511
E. Budinska Identification and validation of gene ex-pression subtypes in a large set of colorectal cancer samples.
Abstract No: 6510
R. Hehlmann The prognostic significance of early mo-lecular and cytogenetic response for long-term pro-gression-free and overall survival in imatinib-treated chronic myeloid leukemia (CML).
PUBLICATIONS Lung Cancer
Antonio Rossi, Massimo Di Maio, Paolo Chiodini, Robin Michael Rudd, Hiroaki Okamoto, Dimosthenis Vasilios Skarlos, Martin Früh, Wendi Qian, Tomohide Tamura, Epaminondas Samantas, Taro Shibata, Francesco Perro-ne, Ciro Gallo, Cesare Gridelli, Olga Martelli, and Siow-Ming Lee. Carboplatin- or Cisplatin-Based Chemo-therapy in First-Line Treatment of Small-Cell Lung
Cancer: The COCIS Meta-Analysis of Individual Pa-tient Data. JCO April 2
Früh M, Cathomas R, Siano M, Tscherry G, Zippelius A, Mamot C, Erdmann A, Krasniqi F, Rauch D, Simcock M, Küttel E, Fustier P, Pless M; Swiss Group for Clinical Can-cer Research. Carboplatin and Paclitaxel Plus ASA404 as First-Line Chemotherapy for Extensive-Stage Small-Cell Lung Cancer: A Multicenter Single Arm Phase II Trial (SAKK 15/08). Clin Lung Cancer May 23
Breast Cancer
Regan MM, Leyland-Jones B, Bouzyk M, Pagani O, Tang W, Kammler R, Dell‘orto P, Biasi MO, Thürlimann B, Lyng MB, Ditzel HJ, Neven P, Debled M, Maibach R, Price KN, Gelber RD, Coates AS, Goldhirsch A, Rae JM, Viale G; Breast International Group (BIG) 1-98 Col-laborative Group. CYP2D6 genotype and tamoxifen response in postmenopausal women with endocrine-responsive breast cancer: the breast international group 1-98 trial J Natl Cancer Inst Mar 21
Regan MM, Price KN, Giobbie-Hurder A, Thürlimann B, Gelber RD; International Breast Cancer Study Group and BIG 1-98 Collaborative Group. Interpreting Bre-ast International Group (BIG) 1-98: a randomized, double-blind, phase III trial comparing letrozole and tamoxifen as adjuvant endocrine therapy for postme-nopausal women with hormone receptor-positive, early breast cancer. Breast Cancer Res. May 26
Lymphoma
Cuccuini W, Briere J, Mounier N, Voelker HU, Rosen-wald A, Sundstrom C, Cogliatti S, Hirchaud E, Ysebaert L, Bron D, Soulier J, Gaulard P, Houlgatte R, Gisselbrecht C, Thieblemont C. MYC+ diffuse large B-cell lympho-ma is not salvaged by classical R-ICE or R-DHAP followed by HDT/ASCT. A bio-CORAL report. Blood.
2012 Mar 9
Engert A, Haverkamp H, Kobe C, Markova J, Renner C, Ho A, Zijlstra J, Král Z, Fuchs M, Hallek M, Kanz L, Döhner H, Dörken B, Engel N, Topp M, Klutmann S, Amthauer H, Bockisch A, Kluge R, Kratochwil C, Scho-ber O, Greil R, Andreesen R, Kneba M, Pfreundschuh M, Stein H, Eich HT, Müller RP, Dietlein M, Borchmann P, Diehl V; on behalf of the German Hodgkin Study Group, the Swiss Group for Clinical Cancer Research, and the Österreichische Arbeitsgemeinschaft für Klinische Phar-makologie und Therapie. Reduced-intensity chemothe-rapy and PET-guided radiothechemothe-rapy in patients with advanced stage Hodgkin’s lymphoma (HD15 trial): a randomised, open-label, phase 3 non-inferiority trial.
Lancet Apr 3
SAKK
Attal M, Lauwers-Cances V, Marit G, Caillot D, Moreau P, Facon T, Stoppa AM, Hulin C, Benboubker L, Garderet L, Decaux O, Leyvraz S, Vekemans MC, Voillat L, Michallet M, Pegourie B, Dumontet C, Roussel M, Leleu X, Mathi-ot C, Payen C, Avet-Loiseau H, Harousseau JL; IFM In-vestigators. Lenalidomide maintenance after stem-cell transplantation for multiple myeloma. N Engl J Med.
2012 May 10;366(19):1782-91
Garderet L, Iacobelli S, Moreau P, Dib M, Lafon I, Nie-derwieser D, Masszi T, Fontan J, Michallet M, Gratwohl A, Milone G, Doyen C, Pegourie B, Hajek R, Casassus P, Kolb B, Chaleteix C, Hertenstein B, Onida F, Ludwig H, Ketterer N, Koenecke C, van Os M, Mohty M, Caka-na A, Gorin NC, de Witte T, Harousseau JL, Morris C, Gahrton G. Superiority of the Triple Combination of Bortezomib-Thalidomide-Dexamethasone Over the Dual Combination of Thalidomide-Dexamethasone in Patients With Multiple Myeloma Progressing or Relapsing After Autologous Transplantation: The MMVAR/IFM 2005-04 Randomized Phase III Trial From the Chronic Leukemia Working Party of the European Group for Blood and Marrow Transplanta-tion. J Clin Oncol May 14
Leukemia
Pabst T, Vellenga E, van Putten W, Schouten HC, Graux C, Vekemans MC, Biemond B, Sonneveld P, Passweg J, Verdonck L, Legdeur MC, Theobald M, Jacky E, Bargetzi M, Maertens J, Ossenkoppele GJ, Löwenberg B. Favora-ble effect of priming with granulocyte colony-stimu-lating factor in remission induction of acute myeloid leukemia restricted to dose-escalation of cytarabine Blood Mar 15
Hanfstein B, Müller MC, Hehlmann R, Erben P, Lause-ker M, Fabarius A, Schnittger S, Haferlach C, Göhring G, Proetel U, Kolb HJ, Krause SW, Hofmann WK, Schu-bert J, Einsele H, Dengler J, Hänel M, Falge C, Kanz L, Neubauer A, Kneba M, Stegelmann F, Pfreundschuh M, Waller CF, Branford S, Hughes TP, Spiekermann K, Bae-rlocher GM, Pfirrmann M, Hasford J, Saußele S, Hoch-haus A. Early molecular and cytogenetic response is predictive for long-term progression-free and overall survival in chronic myeloid leukemia (CML). Leukemia Mar 26
Bally C, Fadlallah J, Leverger G, Bertrand Y, Robert A, Baruchel A, Guerci A, Recher C, Raffoux E, Thomas X, Leblanc T, Idres N, Cassinat B, Vey N, Chomienne C, Dombret H, Sanz M, Fenaux P, Adès L. Outcome of Acute Promyelocytic Leukemia (APL) in Children and Adolescents: An Analysis in Two Consecutive Trials of the European APL Group JCO Apr 2
Melanoma
Schraml P, von Teichman A, Mihic-Probst D, Simcock M, Ochsenbein A, Dummer R, Michielin O, Seifert B, Schläppi M, Moch H, von Moos R. Predictive value of the MGMT promoter methylation status in metasta-tic melanoma patients receiving first-line temozo-lomide plus bevacizumab in the trial SAKK 50/07.
Oncol Rep May 18
NEW SMW PUBLICATION SERIES – CALL FOR AUTHORS
SAKK and the National Institute for Cancer Epidemio-logy and Registration (NICER) start collaboration for the regular publication of data of the cancer registries in the journal Swiss Medical Weekly (SMW). NICER will provi-de data about current and interesting topics in the field of cancer. SAKK authors will comment on the data in a publi-cation together with authors from NICER. The first topic is «breast cancer in younger women in Switzerland», for which the publication is already in preparation. The next topic will be «prevalence of screenable (breast, colorectal, prostate) cancers». SAKK is looking for authors from the SAKK network, interested in commenting on that topic or future topics from a clinical point of view. We would like to especially give young oncologists from the SAKK network the opportunity to participate in these publications.
For more information please contact:
Annik Steiner Communications annik.steiner@sakk.ch
PILOT STUDY SHOWS GOOD DATA QUALITY OF SAKK CENTERS
In 2011, the SAKK Coordinating Center conducted a pi-lot study on behalf of the SAKK Board with the aim to develop an adequate tool for evaluating the data quality of the SAKK centers. Now, the results of this study are available.
As the SAKK Coordinating Center conducts hundreds of monitoring visits per year, it decided to use the existing monitoring process for the evaluation. Hence, a questi-onnaire of two pages was established, which could be fil-led in by the monitors after each monitoring visit. The questionnaire covered the following main topics: General GCP compliance, protocol adherence, personnel at the trial site, source data verification and data quality in the case report forms. Each topic was subdivided in several questions, for which the following scores were possible:
Score 3: Good (no findings)
Score 2: Satisfactory (minor findings)
Score 1: Requires improvement (several minor findings, major or critical findings)
SAKK
Schweizer Krebsbulletin Nr. 3/2012 235