Multicenter phase II study of second-line bevacizumab plus doublet combination chemotherapy in patients with metastatic colorectal cancer progressed after upfront bevacizumab plus doublet combination chemotherapy Full Text
Investigational New Drugs, 07/17/2012
Hong YS et al. – Bevacizumab beyond first progression could be considered a treatment strategy even in patients progressed after first–line bevacizumab plus doublet chemotherapy. Second–line efficacy outcomes did not differ according to the first–line responses.Methods
- This multicenter phase II study included 76 patients with metastatic colorectal cancer progressed after first-line bevacizumab plus doublet chemotherapy.
- Study treatment consisted of second-line continuation of bevacizumab plus crossover standard doublet chemotherapy, consisting of FOLFOX, CapeOX, or FOLFIRI.
- Bevacizumab was administered in doses of 5mg/kg/2-week or 7.5mg/kg/3-week according to the schedules of the combined regimen.
- Median progression-free survival (PFS) and overall survival (OS) was 6.5months (95 % CI, 5.2–7.8) and 12.8months (95 % CI, 8.8–16.9), respectively, with no significant differences according to combined doublet chemotherapy.
- The response rate (RR) was 17.1 % (95 % CI, 8.6–5.6) with no statistical significance between regimens (p=0.053).
- The first-line RR and PFS did not affect the second-line efficacy outcomes; RR (14.0 % vs 21.2 %, p=0.405), median PFS (5.6 vs 6.7months, p=0.335), and OS (15.4 vs 11.0months, p=0.383) were not different between previous responders and non-responders, and the median PFS (p=0.186) and OS (p=0.495) were not different either according to the length of first-line PFS; however, OS from the first-line chemotherapy was longer in patients with longer first-line PFS (26.4 vs 14.8months, p=0.010).
- Bevacizumab-related significant adverse events included proteinuria (1.3 %) and thromboembolism (1.3 %).