When bevacizumab was added to standard chemotherapy, the patients with a poor prognosis of ovarian cancer had an overall survival benefit, according to the ICON7 study published online this week in journal The Lancet Oncology.
An international, phase 3, two-arm, open-label study included 1,528 women with newly diagnosed ovarian cancer, high-risk early-stage disease or more advanced disease, and an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. The patients were randomly assigned to arm A with standard chemotherapy (carboplatin and paclitaxel) and arm B with standard chemotherapy plus bevacizumab.
The primary endpoint was progression-free survival (PFS), and the secondary endpoint was restricted mean survival time (RMST).
After a median follow-up of 48.9 months, there was no difference in PFS between the treatment arms. Moreover, RMST was no different in the overall study population with 44.6 months (95% CI: 43.2, 45.9) in arm A and 45.5 months (95% CI: 44.2, 46.7) in arm B (P=0.85). The patients in non-high-risk group had a similar outcome with no difference in RMST with 49.7 months (95% CI: 48.3, 51.1) in arm A and 48.4 months (95% CI: 47.0, 49.9) in arm B (P=0.20).
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However, in patients with poor prognosis disease, a significant difference in RMST was found where arm A had 34.5 months (95% CI: 32.0, 37.0) and arm B had 39.9 months (95% CI: 37.0, 41.7) (P=0.03).
The findings suggest that standard chemotherapy with bevacizumab shows benefit in patients with poor prognosis disease although no improvement in the overall study population.
- Oza AM, Cook AD, Pfisterer J, et al. Standard chemotherapy with or without bevacizumab for women with newly diagnosed ovarian cancer (ICON7): overall survival results of a phase 3 randomised trial. Lancet Oncol. 2015. [epub ahead of print]. doi: 10.1016/S1470-2045(15)00086-8.