Randomized Phase II Study of Bevacizumab in Combination With Carboplatin Plus Paclitaxel in Patients With Previously Untreated Advanced Mucosal Melanoma

• DOI: 10.1200/jco.20.00902
• Publication Date: 2021-01-14T21:16:33Z
• Authors: Xieqiao Yan; Xinan Sheng; Zhihong Chi; Lu Si; Chuanliang Cui; Yan Kong; Bixia Tang; Lili Mao; Xuan Wang; Bin Lian; Siming Li; Xue Bai; Li Zhou; Jie Dai; Hong Yao; Jun Guo
• Keywords: Carboplatin; Clinical endpoint; Progression-free survival

Mucosal melanoma (MM) is a highly vascularized tumor with an extremely poor prognosis. In this randomized, open-label, phase II study, we characterized the efficacy and safety of bevacizumab in combination carboplatin plus paclitaxel (CPB) patients previously untreated advanced MM.Patients were randomly assigned 2:1 ratio to receive (area under curve, 5) (175 mg/m2) once every 4 weeks (CPB arm, 5 mg/kg) or without (CP arm) 2 weeks. Progression-free survival (PFS) was primary end point. Secondary points included overall (OS), objective response rate, adverse events.We recruited 114 our study. The median PFS significantly longer CPB arm (4.8 months; 95% CI, 3.6 6.0 months) than CP (3.0 1.7 4.3 (hazard ratio, 0.461; 0.306 0.695; P < .001). Objective rates 19.7% 13.2%, respectively (P = .384). OS also (13.6 v 9.0 hazard 0.611; 0.407 0.917; .017). No new signals observed.PFS better metastatic MM who received addition those alone. A III study should be performed confirm these benefits (ClinicalTrials.gov identifier: NCT02023710).