In RIBBON-1, the combination of Bev with Cap as 1st-line therapy for MBC significantly improved progression-free survival (PFS) compared with Cap alone, with limited impact on tolerability. Vin and Cap are active agents with few overlapping toxicities. The combination of both cytotoxic drugs in phase I/II trials showed good tolerability and promising clinical activity. The CARIN trial aims to further improve efficacy by adding Vin to Cap/Bev to establish a less toxic alternative to taxane-based 1st line therapy.
Patients and Methods:
CARIN is a multicenter randomized study comparing the efficacy of Cap plus Bev versus the same regimen combined with Vin. From 04/2009 until 10/2012 598 pts in 61 participating centers were randomized (1:1) to receive Cap 1000 mg/m2 bid days 1–14 + Bev 15 mg/kg q3w (Arm A) or Cap/Bev combined with Vin 25 mg/m2 days 1+8 (Arm B). Randomization was stratified by prior therapy with anthracycline and/or taxane (yes/no) and hormone receptor status (ER/PR +/-). Treatment was continued until progression or unacceptable toxicity. Key eligibility criteria included Her-2 negative metastatic or locally recurrent disease, no prior palliative chemotherapy for MBC, ECOG ≤2, and absence of brain metastases. Primary endpoint was progression-free survival (PFS); secondary endpoints included objective response rate, overall survival, and safety & tolerability. Baseline demographics, prior therapy and disease characteristics were well balanced. 21.5% of pts had triple negative BC, 10.6% had bone metastases only. Progression free survival data for the two treatment arms will be compared using a log-rank test. The influence of pretreatment, hormone receptor status and predictive variables on progression free survival will be analyzed within a cox regression model.
Data Cleaning and analysis will be complete by October 2013 and results for the primary endpoint PFS and secondary endpoints will be presented at the meeting.
Citation Information: Cancer Res 2013;73(24 Suppl): Abstract nr P3-13-01.