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-Patience; Eric Van Cutsem; Tomasz Burzykowski; Marc Buyse

doi:10.1093/jnci/djt269

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

Quantitative Health Sciences

Research output: Contribution to journal › Article › peer-review

55 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 language	English (US)
Pages (from-to)	1667-1670
Number of pages	4
Journal	Journal of the National Cancer Institute
Volume	105
Issue number	21
DOIs	https://doi.org/10.1093/jnci/djt269
State	Published - Nov 6 2013

ASJC Scopus subject areas

Oncology
Cancer Research

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10.1093/jnci/djt269

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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

Paoletti, X, Oba, K, Bang, YJ, 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, Thuss-Patience, P, Van Cutsem, E, Burzykowski, T & 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, vol. 105, no. 21, pp. 1667-1670. https://doi.org/10.1093/jnci/djt269

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

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.",

author = "Xavier Paoletti and Koji Oba and Bang, {Yung Jue} and Harry Bleiberg and Narikazu Boku and Olivier Bouch{\'e} and Paul Catalano and Nozomu Fuse and Stefan Michiels and Markus Moehler and Satoshi Morita and Yasuo Ohashi and Atsushi Ohtsu and Arnaud Roth and Philippe Rougier and Junichi Sakamoto and Daniel Sargent and Mitsuru Sasako and Kohei Shitara and Peter Thuss-Patience and {Van Cutsem}, Eric and Tomasz Burzykowski and Marc Buyse",

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T1 - Progression-free survival as a surrogate for overall survival in advanced/recurrent gastric cancer trials

T2 - A meta-analysis

AU - Paoletti, Xavier

AU - Oba, Koji

AU - Bang, Yung Jue

AU - Bleiberg, Harry

AU - Boku, Narikazu

AU - Bouché, Olivier

AU - Catalano, Paul

AU - Fuse, Nozomu

AU - Michiels, Stefan

AU - Moehler, Markus

AU - Morita, Satoshi

AU - Ohashi, Yasuo

AU - Ohtsu, Atsushi

AU - Roth, Arnaud

AU - Rougier, Philippe

AU - Sakamoto, Junichi

AU - Sargent, Daniel

AU - Sasako, Mitsuru

AU - Shitara, Kohei

AU - Thuss-Patience, Peter

AU - Van Cutsem, Eric

AU - Burzykowski, Tomasz

AU - Buyse, Marc

PY - 2013/11/6

Y1 - 2013/11/6

N2 - 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.

AB - 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.

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

Abstract

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