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

共 50 条

[1] Progression-free survival as a surrogate endpoint for overall survival in modern ovarian cancer trials: a meta-analysis
Sjoquist, Katrin M.
Lord, Sarah J.
Friedlander, Michael L.
Simes, Robert John
Marschner, Ian C.
Lee, Chee Khoon
[J]. THERAPEUTIC ADVANCES IN MEDICAL ONCOLOGY, 2018, 10 : 1 - 16
[2] META-ANALYSIS OF THE VALIDITY OF PROGRESSION-FREE SURVIVAL AS A SURROGATE ENDPOINT FOR OVERALL SURVIVAL IN METASTATIC COLORECTAL CANCER TRIALS
Chirila, C.
Odom, D. M.
Devercelli, G.
Khan, S.
Sherif, B. N.
Kaye, J. A.
Molnar, I.
Sherrill, B. H.
[J]. ANNALS OF ONCOLOGY, 2010, 21 : 202 - 202
[3] Progression-Free Survival and Time to Progression as Real Surrogate End Points for Overall Survival in Advanced Breast Cancer: A Meta-Analysis of 37 Trials
Li, Ling
Pan, Zhanyu
[J]. CLINICAL BREAST CANCER, 2018, 18 (01) : 63 - 70
[4] Progression-free survival and time to progression as surrogate markers of overall survival in patients with advanced gastric cancer: analysis of 36 randomized trials
Shitara, Kohei
Ikeda, Junko
Yokota, Tomoya
Takahari, Daisuke
Ura, Takashi
Muro, Kei
Matsuo, Keitaro
[J]. INVESTIGATIONAL NEW DRUGS, 2012, 30 (03) : 1224 - 1231
[5] Progression-free survival and time to progression as surrogate markers of overall survival in patients with advanced gastric cancer: analysis of 36 randomized trials
Kohei Shitara
Junko Ikeda
Tomoya Yokota
Daisuke Takahari
Takashi Ura
Kei Muro
Keitaro Matsuo
[J]. Investigational New Drugs, 2012, 30 : 1224 - 1231
[6] Progression-free survival as a surrogate for overall survival in advanced cancer.
Gillies, Eric
Holdai, Veera
Cowall, David Eric
[J]. JOURNAL OF CLINICAL ONCOLOGY, 2015, 33 (15)
[7] A meta-analysis of randomized, controlled trials in metastatic melanoma establishes progression-free survival as a surrogate for overall survival
Flaherty, K. T.
Lee, S. J.
Dummer, R.
Hauschild, A.
Hennig, M.
Long, G. V.
Lorigan, P.
Robert, C.
Schadendorf, D.
[J]. EUROPEAN JOURNAL OF CANCER, 2013, 49 : S856 - S856
[8] Disease-Free Survival as a Surrogate for Overall Survival in Adjuvant Trials of Gastric Cancer: A Meta-Analysis
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
[J]. JNCI-JOURNAL OF THE NATIONAL CANCER INSTITUTE, 2013, 105 (21) : 1600 - 1607
[9] Interpretation of meta-analysis evaluating progression-free survival as a surrogate endpoint for overall survival in glioblastoma
Han, Kelong
Ren, Melanie
Wick, Wolfgang
Abrey, Lauren
Das, Asha
Jin, Jin
Reardon, David A.
[J]. NEURO-ONCOLOGY, 2015, 17 (05) : 764 - 765
[10] Progression-free survival as a surrogate endpoint of overall survival in advanced biliary tract cancer: A meta-analysis of randomized trials and individual-patient level correlation
Fabregat Franco, Carles
Castet, Florian
La Casta, Adelaida
Adeva, Jorge
Castillo, Alfredo
Munoz, Andres
Peinado, Paloma
Martinez de Castro, Eva
Lobo, Miriam
Granja, Monica
Maria Rodriguez-Alonso, Rosa
Fernandez Montes, Ana
Vera, Ruth
Gallego, Javier
Grana, Begona
Ghanem, Ismael
Ales, Inmaculada
Molina, Raquel
Macarulla, Teresa
Aranda, Enrique
[J]. JOURNAL OF CLINICAL ONCOLOGY, 2023, 41 (16)

← 1 2 3 4 5 →