A randomized phase II study evaluating the activity of bevacizumab in combination with carboplatin plus paclitaxel in patients with previously untreated advanced mucosal melanoma.

Authors

null

Xi Nan Sheng

Peking University Cancer Hospital & Institute, Beijing, China

Xi Nan Sheng , Lu Si , Zhihong Chi , Chuanliang Cui , Si Ming Li , Li Li Mao , BIN LIAN , Bixia Tang , Xieqiao Yan , Xuan Wang , Yan Kong , Jie Dai , Xiao-Shi Zhang , Song Xin , Jun Guo

Organizations

Peking University Cancer Hospital & Institute, Beijing, China, Cancer Center of Sun Yat-sen University, Guangzhou, China, The Third Affiliated Hosp of Kunming Medcl College, Kunming, Yunnan, China

Research Funding

Pharmaceutical/Biotech Company

Background: Mucosal melanoma is rare in Caucasian but account for 25% in Asian population and usually associated with poor prognosis. No standard treatment for advanced mucosal melanoma has been established. BEAM study has shown 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 advanced mucosal melanoma. Methods: This study is an open-label, multi-center, randomized phase II trial. Eligible patients had metastatic, recurrent or unresectable mucosal melanoma without previous systemic therapy. Additional inclusion criteria included: ≥ 1 measurable disease, ECOG PS 0/1, and adequate organ functions. C-KIT or BRAF mut will be excluded from this study. Patients were randomly allocated in a 1:1 ratio to receive intravenous infusion of bevacizumab (CPB arm, 5mg/kg every two weeks) or placebo (CP arm) in combination with carboplatin (area under the curve, 5) plus paclitaxel (175 mg/m2) until occurrence of disease progression, unacceptable toxicity, death or withdrawal of consent. The primary study endpoint is progress-free survival (PFS). Overall survival, disease control rate, and safety will also be assessed. Results: The first patient visit was on December 1, 2013. Fifty-seven of a planned 182 evaluable pts have been enrolled: 63.2% female, median age 58 (CBP (n = 29) and CP arm (n = 28). The median follow-up time was 11 months, and the median PFS was 6.3 and 3.1 months respectively (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, and neutropenia (7.4%) in the PC arm. Conclusions: The primary data show that bevacizumab combined with carboplatin plus paclitaxel might benefit for patients with advanced mucosal melanoma. Clinical trial information: NCT02023710

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Abstract Details

Meeting

2015 ASCO Annual Meeting

Session Type

Publication Only

Session Title

Publication Only: Melanoma/Skin Cancers

Track

Melanoma/Skin Cancers

Sub Track

Melanoma/Skin Cancers

Clinical Trial Registration Number

NCT02023710

Citation

J Clin Oncol 33, 2015 (suppl; abstr e20076)

DOI

10.1200/jco.2015.33.15_suppl.e20076

Abstract #

e20076

Abstract Disclosures