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Correlation between overall survival and other endpoints in clinical trials of second-line chemotherapy for patients with advanced gastric cancer

Gastric Cancer, 2014, Vol.17(2), pp.362-370 [Peer Reviewed Journal]

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  • Title:
    Correlation between overall survival and other endpoints in clinical trials of second-line chemotherapy for patients with advanced gastric cancer
  • Author: Shitara, Kohei ; Matsuo, Keitaro ; Muro, Kei ; Doi, Toshihiko ; Ohtsu, Atsushi
  • Found In: Gastric Cancer, 2014, Vol.17(2), pp.362-370 [Peer Reviewed Journal]
  • Subjects: Chemotherapy ; Gastric cancer ; Second-line chemotherapy ; Surrogate endpoint ; Progression-free survival ; Time-to-progression
  • Language: English
  • Description: Byline: Kohei Shitara (1,2), Keitaro Matsuo (3), Kei Muro (2), Toshihiko Doi (1), Atsushi Ohtsu (1) Keywords: Chemotherapy; Gastric cancer; Second-line chemotherapy; Surrogate endpoint; Progression-free survival; Time-to-progression Abstract: Background The correlation between progression-free survival (PFS) or time to progression (TTP) and overall survival (OS) has been evaluated in patients with advanced gastric cancer (AGC) who received first-line chemotherapy. No corresponding analysis has been done in patients who have undergone second-line chemotherapy. Methods We evaluated the correlation between PFS, TTP, objective response rate (ORR), disease control rate (DCR), and OS in patients with AGC who underwent second-line chemotherapy. Correlations were evaluated by Spearman rank correlation coefficient ([rho]). Results Sixty-four trials, including 10 randomized studies, were selected for analysis. Median PFS/TTP moderately correlated with OS ([rho] = 0.56). The correlation tended to be stronger in non-Asian trials ([rho] = 0.74) than in Asian trials ([rho] = 0.37). ORR and DCR did not strongly correlate with OS ([rho] = 0.38 for ORR [rho] = 0.54 for DCR). The hazard ratio of PFS and OS in each of the arms of the 10 randomized studies also showed a low correlation ([rho] = 0.36). Conclusions PFS/TTP, ORR, and DCR did not correlate sufficiently with OS to be used as surrogate endpoints in patients with AGC who have undergone second-line chemotherapy. Further research is needed based on individual patient data from ongoing randomized trials. Author Affiliation: (1) Department of Gastrointestinal Oncology, National Cancer Center Hospital East, Chiba, Japan (2) Department of Clinical Oncology, Aichi Cancer Center Hospital, 1-1 Kanokoden, Chikusa-ku, Nagoya, Aichi, 464-8681, Japan (3) Division of Epidemiology and Prevention, Aichi Cancer Center Research Institute, Nagoya, Japan Article History: Registration Date: 17/05/2013 Received Date: 23/03/2013 Accepted Date: 15/05/2013 Online Date: 05/06/2013 Article note: Electronic supplementary material The online version of this article (doi: 10.1007/s10120-013-0274-6) contains supplementary material, which is available to authorized users.
  • Identifier: ISSN: 1436-3291 ; E-ISSN: 1436-3305 ; DOI: 10.1007/s10120-013-0274-6

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