Xinan Sheng¹,  LuSi²,  Zhihong Chi²,  Chuanliang Cui²,  Siming Li²,  Lili Mao², Bin Lian², Bixia Tang²,  Xieqiao Yan²,  Xuan Wang²,  Yan Kong²,  Jie Dai², XS Zhang³,  X Song⁴,  Jun Guo²

¹Department of Renal cancer and Melanoma, ChinaPeking University Cancer Hospital & Institute, Beijing.

²China Peking University Cancer Hospital& Institute, Beijing

³China Sun Yat-sen University Cancer Center,Guangzhou

⁴China Yunan Tumor Hospital Cancer Center,Shanghai

Objective: Mucosalmelanoma is rare in Caucasian population but account for 25% in Asianpopulation. It is usually associated with extremely poor prognosis. No standardtreatment for advanced mucosal melanoma has been established. BEAM study hasshown the potential effectiveness of bevacizumab combined with carboplatin plus paclitaxel in patients with previously untreated advanced cutaneous melanoma. This study aimed to evaluate the activity of bevacizumab combined with carboplatin plus paclitaxel in patients with previously untreated advancedmucosal melanoma. Method: This study is an open-label, multi-center,randomizedphase II trial. Eligible patients had metastatic,recurrentor unresectable mucosal melanoma without previous systemic therapy. Additionalinclusion criteria included: ≥1 measurable disease, ECOGPS 0/1,and adequate hematological, renal, and hepatic functions. The patient with mutations in C-KIT or BRAF (treated withtargeted therapy) will be excluded from this study. Patients were randomly allocated in a 1: 1 ratio to receive intravenous infusion of bevacizumab (CPBarm,5mg/kg every two weeks) or placebo(CP arm) in combination with carboplatin (area under the curve,5) plus paclitaxel (175 mg/m²). Treatment was continued for both groups until occurrence of disease progression, unacceptable toxicity, death or withdrawal of consent. Theprimary study endpoint is progress-free survival (PFS). Overall survival, diseasecontrol rate, and safety will also be assessed. Result:The first patient visit was on December 1, 2013. Fifty-seven of a planned 182 evaluable pts have been enrolled: 63.2% female, medianage 58. They were randomly assigned to the CBP (n=29) or CP arm (n=28). The median follow-up time was 11 months, and the median progression-free survival was 6.3 months and 3.1 monthsrespectively. There was significant difference in mPFS between CPB and CP arm (P=0.023). The objective response rate was 10.3% and 7.4% respectively. The median overall survival has not been reached. Treatment emergent grade 3 or 4 adverse events were neutropenia (13.8%), hypertension(3.4%), proteinuria (3.4%) in the PCB arm, andneutropenia (7.4%) in the PC arm. Conclusion: The primary data show that bevacizumab combined with carboplatin plus paclitaxel might benefit for patients with advanced mucosal melanoma. More advanced mucosal melanoma patients will be enrolled in this study.

KeyWords: Melanoma