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Please use this identifier to cite or link to this item: http://hdl.handle.net/1942/16080

Title: Disease-Free Survival as a Surrogate for Overall Survival in Adjuvant Trials of Gastric Cancer: A Meta-Analysis
Authors: Oba, Koji
PAOLETTI, Xavier
Alberts, Steven
Bang, Yung-Jue
Benedetti, Jacqueline
Bleiberg, Harry
CATALANO, Paul
Lordick, Florian
Michiels, Stefan
Morita, Satoshi
Ohashi, Yasuo
Pignon, Jean-pierre
Rougier, Philippe
Sasako, Mitsuru
Sakamoto, Junichi
Sargent, Daniel
Shitara, Kohei
Cutsem, Eric Van
BUYSE, Marc
BURZYKOWSKI, Tomasz
Issue Date: 2013
Citation: JNCI-JOURNAL OF THE NATIONAL CANCER INSTITUTE, 105 (21), p. 1600-1607
Abstract: In investigations of the effectiveness of surgery and adjuvant chemotherapy for gastric cancers, overall survival (OS) is considered the gold standard endpoint. However, the disadvantage of using OS as the endpoint is that it requires an extended follow-up period. We sought to investigate whether disease-free survival (DFS) is a valid surrogate for OS in trials of adjuvant chemotherapy for gastric cancer. The GASTRIC group initiated a meta-analysis of individual patient data collected in randomized clinical trials comparing adjuvant chemotherapy vs surgery alone for patients with curatively resected gastric cancer. Surrogacy of DFS was assessed through the correlation between the endpoints as well as through the correlation between the treatment effects on the endpoints. External validation of the prediction based on DFS was also evaluated. Individual patient data from 14 randomized clinical trials that included a total of 3288 patients were analyzed. The rank correlation coefficient between DFS and OS was 0.974 (95% confidence interval [CI] 0.971 to 0.976). The coefficient of determination between the treatment effects on DFS and on OS was as high as 0.964 (95% CI 0.926 to 1.000), and the surrogate threshold effect based on adjusted regression analysis was 0.92. In external validation, the six hazard ratios for OS predicted according to DFS were in very good agreement with those actually observed for OS. DFS is an acceptable surrogate for OS in trials of cytotoxic agents for gastric cancer in the adjuvant setting.
URI: http://hdl.handle.net/1942/16080
DOI: 10.1093/jnci/djt270
ISI #: 000326973900006
ISSN: 0027-8874
Category: A1
Type: Journal Contribution
Validation: ecoom, 2014
Appears in Collections: Research publications

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