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Abstract
Purpose. To evaluate progression-free survival (PFS), overall response rate (ORR) and disease control rate (DCR) as potential surrogate endpoints (SEP) for overall survival (OS) in second-line treatment for metastatic colorectal cancer (mCRC).
Methods. A systematic literature search of randomised trials of second-line chemotherapy for mCRC reported from January 2000 to July 2013 was performed. Correlation coefficients weighted by number of patients in the treatment arms between median PFS, ORR and DCR with median OS were estimated.
Results. Twenty-three trials reflecting 10 800 patients met the inclusion criteria. Median PFS and OS across all trials were 4.5 months and 11.5 months and median ORR and DCR were 11.4% and 65%, respectively. PFS showed moderate correlation with OS [RPFS = 0.73; 95% confidence interval (CI) 0.61–0.82]. In contrast, ORR only weakly correlated with OS (RORR = 0.58; 95% CI 0.38–0.72, n = 22). Despite a small number of studies (n = 10) reporting on DCR, moderate correlation with OS was observed (RDCR = 0.74; 95% CI 0.56–0.86).
Conclusion. Based on the available trial-level data, PFS may serve as an appropriate SEP in second-line chemotherapy for mCRC. A small number of studies revealed moderate correlation of DCR with OS that justifies further investigation.
Acknowledgements
No direct or indirect funding was received for this study. No funding bodies had any role in the study design, data collection, analysis, decision to publish or preparation of the manuscript. The authors were personally salaried by their institutions during the period of writing (though no specific salary was set aside or given for the writing of this paper).
Declaration of interest: Clemens Giessen has received travel support form Roche. Ruediger Paul Laubender has received honoraria, research and travel support from Merck. Sebastian Stintzing has received honoraria and travel support from Merck and Roche. Dominik Paul Modest has received travel support from Amgen and Roche and received honoraria from Amgen, Merck and Roche. Volker Heinemann has received honoraria, is member at advisory boards and received financial support for research from Amgen, Merck, Sanofi-Aventis and Roche. All remaining authors have declared no conflicts of interest.