Literature DB >> 24108811

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

Xavier Paoletti1, 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.   

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 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.

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Year:  2013        PMID: 24108811      PMCID: PMC4994928          DOI: 10.1093/jnci/djt269

Source DB:  PubMed          Journal:  J Natl Cancer Inst        ISSN: 0027-8874            Impact factor:   13.506


  34 in total

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2.  Practical methodology of meta-analyses (overviews) using updated individual patient data. Cochrane Working Group.

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4.  Phase III study of docetaxel and cisplatin plus fluorouracil compared with cisplatin and fluorouracil as first-line therapy for advanced gastric cancer: a report of the V325 Study Group.

Authors:  Eric Van Cutsem; Vladimir M Moiseyenko; Sergei Tjulandin; Alejandro Majlis; Manuel Constenla; Corrado Boni; Adriano Rodrigues; Miguel Fodor; Yee Chao; Edouard Voznyi; Marie-Laure Risse; Jaffer A Ajani
Journal:  J Clin Oncol       Date:  2006-11-01       Impact factor: 44.544

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Review 6.  Role of chemotherapy for advanced/recurrent gastric cancer: an individual-patient-data meta-analysis.

Authors:  Koji Oba; Xavier Paoletti; Yung-Jue Bang; Harry Bleiberg; Tomasz Burzykowski; Nozomu Fuse; Stefan Michiels; Satoshi Morita; Yasuo Ohashi; Jean-Pierre Pignon; Philippe Rougier; Junichi Sakamoto; Daniel Sargent; Mitsuru Sasako; Kohei Shitara; Akira Tsuburaya; Eric Van Cutsem; Marc Buyse
Journal:  Eur J Cancer       Date:  2013-01-24       Impact factor: 9.162

7.  Capecitabine and oxaliplatin for advanced esophagogastric cancer.

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8.  Docetaxel, cisplatin, and fluorouracil; docetaxel and cisplatin; and epirubicin, cisplatin, and fluorouracil as systemic treatment for advanced gastric carcinoma: a randomized phase II trial of the Swiss Group for Clinical Cancer Research.

Authors:  Arnaud D Roth; Nicola Fazio; Roger Stupp; Stephen Falk; Jürg Bernhard; Piercarlo Saletti; Dieter Köberle; Markus M Borner; Kaspar Rufibach; Rudolf Maibach; Martin Wernli; Martin Leslie; Robert Glynne-Jones; Lukas Widmer; Matthew Seymour; Filippo de Braud
Journal:  J Clin Oncol       Date:  2007-08-01       Impact factor: 44.544

9.  Randomized phase III study comparing irinotecan combined with 5-fluorouracil and folinic acid to cisplatin combined with 5-fluorouracil in chemotherapy naive patients with advanced adenocarcinoma of the stomach or esophagogastric junction.

Authors:  M Dank; J Zaluski; C Barone; V Valvere; S Yalcin; C Peschel; M Wenczl; E Goker; L Cisar; K Wang; R Bugat
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10.  Randomized phase III trial of fluorouracil alone versus fluorouracil plus cisplatin versus uracil and tegafur plus mitomycin in patients with unresectable, advanced gastric cancer: The Japan Clinical Oncology Group Study (JCOG9205).

Authors:  Atsushi Ohtsu; Yasuhiro Shimada; Kuniaki Shirao; Narikazu Boku; Ichinosuke Hyodo; Hiroshi Saito; Noboru Yamamichi; Yoshinori Miyata; Nobumasa Ikeda; Seiichiro Yamamoto; Haruhiko Fukuda; Shigeaki Yoshida
Journal:  J Clin Oncol       Date:  2003-01-01       Impact factor: 44.544

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  27 in total

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2.  Surrogate endpoints in immunotherapy trials for solid tumors.

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3.  Variations in outcome for advanced gastric cancer between Japanese and Western patients: a subgroup analysis of the RAINBOW trial.

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4.  Surrogate End Points for Overall Survival in Loco-Regionally Advanced Nasopharyngeal Carcinoma: An Individual Patient Data Meta-analysis.

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Journal:  J Natl Cancer Inst       Date:  2017-04       Impact factor: 13.506

5.  Surrogate markers of overall survival in metastatic colorectal cancer: an evolving challenge still more complex with repeat surgery.

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6.  Impact of progression type on overall survival in patients with advanced gastric cancer based on randomized phase III study of S-1 plus oxaliplatin versus S-1 plus cisplatin.

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Journal:  Gastric Cancer       Date:  2016-11-07       Impact factor: 7.370

7.  Progression-Free Survival as a Surrogate for Overall Survival in Clinical Trials of Targeted Therapy in Advanced Solid Tumors.

Authors:  Stefan Michiels; Everardo D Saad; Marc Buyse
Journal:  Drugs       Date:  2017-05       Impact factor: 9.546

Review 8.  Microarray analysis in gastric cancer: a review.

Authors:  Giovanna D'Angelo; Teresa Di Rienzo; Veronica Ojetti
Journal:  World J Gastroenterol       Date:  2014-09-14       Impact factor: 5.742

9.  Multitrial Evaluation of Progression-Free Survival as a Surrogate End Point for Overall Survival in First-Line Extensive-Stage Small-Cell Lung Cancer.

Authors:  Nathan R Foster; Lindsay A Renfro; Steven E Schild; Mary W Redman; Xiaofei F Wang; Suzanne E Dahlberg; Keyue Ding; Penelope A Bradbury; Suresh S Ramalingam; David R Gandara; Taro Shibata; Nagahiro Saijo; Everett E Vokes; Alex A Adjei; Sumithra J Mandrekar
Journal:  J Thorac Oncol       Date:  2015-07       Impact factor: 15.609

Review 10.  Chemotherapy for advanced gastric cancer.

Authors:  Anna Dorothea Wagner; Nicholas Lx Syn; Markus Moehler; Wilfried Grothe; Wei Peng Yong; Bee-Choo Tai; Jingshan Ho; Susanne Unverzagt
Journal:  Cochrane Database Syst Rev       Date:  2017-08-29
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