Progression-free survival as a surrogate for overall survival in advanced/recurrent gastric cancer trials: A meta-analysis

Xavier Paoletti, Koji Oba, Yung Jue Bang, Harry Bleiberg, Narikazu Boku, Olivier Bouché, Paul Catalano, Nozomu Fuse, Stefan Michiels, Markus Moehler, Satoshi Morita, Yasuo Ohashi, Atsushi Ohtsu, Arnaud Roth, Philippe Rougier, Junichi Sakamoto, Daniel Sargent, Mitsuru Sasako, Kohei Shitara, Peter Thuss-PatienceEric Van Cutsem, Tomasz Burzykowski, Marc Buyse

Research output: Contribution to journalArticle

50 Scopus citations

Abstract

The traditional endpoint for assessing efficacy of chemotherapies for advanced/ recurrent gastric cancer is overall survival (OS), but OS requires prolonged follow-up. We investigated whether progression-free survival (PFS) is a valid surrogate for OS. Using individual patient data from the GASTRIC meta-analysis, surrogacy of PFS was assessed through the correlation between the endpoints and through the correlation between the treatment effects on the endpoints. External validation of the prediction based on PFS was also evaluated. Individual data from 4069 patients in 20 randomized trials were analyzed. The rank correlation coefficient between PFS and OS was 0.853 (95% confidence interval [CI] = 0.852 to 0.854). The R2 between treatment effects on PFS and on OS was 0.61 (95% CI = 0.04 to 1.00). Treatment effects on PFS and on OS were only moderately correlated, and we could not confirm the validity of PFS as a surrogate endpoint for OS in advanced/recurrent gastric cancer.

Original languageEnglish (US)
Pages (from-to)1667-1670
Number of pages4
JournalJournal of the National Cancer Institute
Volume105
Issue number21
DOIs
StatePublished - Nov 6 2013

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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    Paoletti, X., Oba, K., Bang, Y. J., Bleiberg, H., Boku, N., Bouché, O., Catalano, P., Fuse, N., Michiels, S., Moehler, M., Morita, S., Ohashi, Y., Ohtsu, A., Roth, A., Rougier, P., Sakamoto, J., Sargent, D., Sasako, M., Shitara, K., ... Buyse, M. (2013). Progression-free survival as a surrogate for overall survival in advanced/recurrent gastric cancer trials: A meta-analysis. Journal of the National Cancer Institute, 105(21), 1667-1670. https://doi.org/10.1093/jnci/djt269