Progression-Free Survival as a Surrogate for Overall Survival in Advanced/Recurrent Gastric Cancer Trials: A Meta-Analysis

被引：72

作者：

Paoletti, Xavier ^{[1
]}

Oba, Koji ^{[2
]}

Bang, Yung-Jue ^{[3
]}

Bleiberg, Harry ^{[4
]}

Boku, Narikazu ^{[5
]}

Bouche, Olivier ^{[6
]}

Catalano, Paul ^{[7
,8
]}

Fuse, Nozomu ^{[9
]}

Michiels, Stefan ^{[10
]}

Moehler, Markus ^{[11
]}

Morita, Satoshi ^{[12
]}

Ohashi, Yasuo ^{[13
]}

Ohtsu, Atsushi ^{[9
]}

Roth, Arnaud ^{[14
]}

Rougier, Philippe ^{[15
]}

Sakamoto, Junichi ^{[16
]}

Sargent, Daniel ^{[17
]}

Sasako, Mitsuru ^{[18
]}

Shitara, Kohei ^{[19
]}

Thuss-Patience, Peter ^{[20
]}

Van Cutsem, Eric ^{[21
]}

Burzykowski, Tomasz ^{[22
]}

Buyse, Marc ^{[22
,23
]}

机构：

[1] Inst Curie, INSERM, U900, Biostat Dept, F-75005 Paris, France

[2] Hokkaido Univ Hosp, Translat Res & Clin Trial Ctr, Sapporo, Hokkaido, Japan

[3] Seoul Natl Univ Coll Med, Div Oncol, Seoul, South Korea

[4] Jules Bordet Hosp, Brussels, Belgium

[5] St Marianna Univ Sch Med, Kawasaki, Kanagawa, Japan

[6] Hop Robert Debre, Dept Clin Oncol, Reims, France

[7] Dana Farber Canc Inst, Boston, MA 02115 USA

[8] Harvard Univ, Sch Publ Hlth, Dept Biostat, Boston, MA 02115 USA

[9] Natl Canc Ctr Hosp East, Dept Gastrointestinal Oncol, Kashiwa, Chiba, Japan

[10] Univ Paris 11, Inst Gustave Roussy, Biostat & Epidemiol Dept, Villejuif, France

[11] Johannes Gutenberg Univ Mainz, Dept Med, D-55122 Mainz, Germany

[12] Yokohama City Univ, Dept Biostat & Epidemiol, Yokohama, Kanagawa, Japan

[13] Univ Tokyo, Tokyo, Japan

[14] Univ Hosp, Dept Surg, Geneva, Switzerland

[15] Univ Hosp Europeen Georges Pompidou, Gastroenterol Dept, Paris, France

[16] Tokai Cent Hosp, Sohara, Japan

[17] Mayo Clin, Div Biomed Stat & Informat, Rochester, MN USA

[18] Natl Canc Ctr Hosp East, Kashiwa, Chiba, Japan

[19] Aichi Canc Ctr Hosp, Dept Gastrointestinal Oncol, Aichi, Japan

[20] Charite, Dept Haematol Oncol & Tumorimmunol, D-13353 Berlin, Germany

[21] Univ Hosp Gasthuisberg, Digest Oncol Unit, B-3000 Louvain, Belgium

[22] Hasselt Univ, Interuniv Inst Biostat & Stat Bioinformat, Diepenbeek, Belgium

[23] Int Inst Drug Dev, Louvain, Belgium

来源：

JNCI-JOURNAL OF THE NATIONAL CANCER INSTITUTE | 2013年 / 105卷 / 21期

关键词：

RANDOMIZED PHASE-III; HIGH-DOSE METHOTREXATE; 1ST-LINE THERAPY; GASTROESOPHAGEAL ADENOCARCINOMA; INFUSION FLUOROURACIL; EUROPEAN-ORGANIZATION; COMPARING MITOMYCIN; PLUS CISPLATIN; FOLINIC ACID; END-POINTS;

D O I：

10.1093/jnci/djt269

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

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 R-2 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.

引用

页码：1667 / 1670

页数：4

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