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  3. ESMO 2016

Metastasis free survival (MFS) is a surrogate for overall survival (OS) in localized prostate cancer (CaP)

Date

07 Oct 2016

Session

Genitourinary tumours, prostate

Presenters

Wanling Xie

Citation

Annals of Oncology (2016) 27 (6): 243-265. 10.1093/annonc/mdw372

Authors

W. Xie1, C. Sweeney2, M. Regan1, M. Nakabayashi2, M. Buyse3, N. Clarke4, L. Collette5, J. Dignam6, K. Fizazi7, M. Habibian8, S. Halabi9, P. Kantoff10, W. Parulekar11, H.M. Sandler12, O. Sartor13, H. Soule14, M. Sydes15, B.F. Tombal16, S. Williams17

Author affiliations

  • 1 Department Of Biostatistics And Computational Biology, Dana-Farber Cancer Institute, 02215 - Boston/US
  • 2 Lank Center For Genitourinary Oncology, Dana Farber Cancer Institute, 02115 - Boston/US
  • 3 Iddi, IDDI International Drug Development Institute, 1340 - Louvain-la-Neuve/BE
  • 4 Urological Oncology, The Christie NHS Foundation Trust, Manchester/GB
  • 5 Headquarters, EORTC, Brussels/BE
  • 6 Dept. Of Public Health Science, University of Illlinois at Chicago, Chicago/US
  • 7 Department Of Cancer Medicine, Institut Gustave Roussy, 94805 - Villejuif/FR
  • 8 R & D, UNICANCER, Paris/FR
  • 9 Biostatistics And Bioinformatics, Duke University, 27710 - Durham/US
  • 10 Department Of Medicine, Memorial Sloan Kettering Cancer Center, New York/US
  • 11 Ncic Clinical Trials Group, Cancer Research Institute, Queen's University, Kinston/CA
  • 12 Radiation Oncology, Cedars-Sinai Medical Center, Los Angeles/US
  • 13 Dept. Of Medicine & Urology, Tulane University, 70112 - New Orleans/US
  • 14 Pcf, Prostate Cancer Foundation, Santa Monica/US
  • 15 Mrc Clinical Trials Unit, Institute of Clinical Trials and Methodology-UCL, WC2B6NH - London/GB
  • 16 Institut De Recherche Clinique,, Université Catholique de Louvain, Brussels,/BE
  • 17 Urological Cancer Research, Peter MacCallum Cancer Centre, East Melbourne/AU
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Abstract 2636

Background

Advances in the treatment of localized CaP have led to decreased recurrences and improved OS. The Intermediate Clinical Endpoints in CaP (ICECaP) Working Group is conducting meta-analysis of potential surrogate endpoints for localized CaP trials. We hypothesized that MFS is a surrogate for OS.

Methods

By June 2013, we systematically identified 102 eligible randomized trials (completed or ongoing) comparing treatments in localized CaP and collected individual patient data (IPD) from trialists. MFS was defined from randomization to the first evidence of distant metastatic disease (excluding pelvic lymph nodes), or death from any cause; or was censored at the date of last follow-up. OS was defined from randomization to death from any cause. We evaluated the surrogacy of MFS with OS using a 2-stage meta-analytic validation model where 2 conditions must hold to claim MFS is a surrogate for OS (Buyse et al, 2000 & 2011 - table). The secondary objective evaluated surrogacy of time to metastasis (TTM) with disease specific survival (DSS), defined analogously to MFS and OS but with non-CaP deaths censored.

Results

By May 2016, IPD from 12,712 men randomized in 19 mature trials between 1987 and 2010 were available for analysis. 90% of the men were from radiation based trials, 30% had intermediate and 57% high-risk disease (NCCN criteria) and 83% were

Conclusions

MFS can be used as a surrogate of OS and TTM as a surrogate of DSS.

Clinical trial identification

Legal entity responsible for the study

Dana Farber Cancer Institution, Boston, MA, United States

Funding

Prostate Cancer Foundation, CA, United States

Disclosure

C. Sweeney: consultant with compensation - Sanofi, BIND, Janssen, Astellas, Genentech, Bayer, AZ.

H.M. Sandler: Financial: Consulting: Janssen, Sanofi, Clovis Oncology, Ferring, Eviti Non-financial: Chairman, GU Cancer Committee, NRG Oncology.

All other authors have declared no conflicts of interest.

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