melanoma

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

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

In the March 10, 2021 edition of Journal of Clinical Oncology, Xieqiao Yan and colleagues report on the results of a randomized phase II trial of bevacizumab plus carboplatin plus paclitaxel in patients with untreated advanced mucosal melanoma.

PURPOSE

Because mucosal melanoma has such a poor prognosis, investigators developed a randomized, open-label, phase II study, where the efficacy and safety of bevacizumab in combination with carboplatin and paclitaxel in patients with untreated advanced MM was tested.

METHODS

Patients were randomized in a 2:1 fashion to either carboplatin (AUC = 5) and paclitaxel (175 mg/m2) intravenously every 4 weeks with or without bevacizumab (5 mg/kg) every 2 weeks. PFS was a primary endpoint with OS, ORR, and DOR as secondary endpoints.

RESULTS

114 patients were involved in the study, with a median progression free survival that was significantly longer in the treatment arm (4.8 months; 95% CI, 3.6 – 6.0 months) than in the doublet arm (3.0 months; 95% CI, 1.7 – 4.3 months) (HR, 0.461; 95% CI, 0.306 to 0.695; P < .001). The ORR rates were 19.7% and 13.2%, respectively (P = .384). The median overall survival was lengthened in triplet versus doublet arm (13.6 versus 9.0 months; hazard ratio, 0.611; 95% CI, 0.407 to 0.917; P = .017). The authors did not report any safety concerns.

The authors concluded “PFS and OS were significantly better in patients with metastatic MM who received bevacizumab in addition to CPB than in those who received CPB alone. A phase III study should be performed to confirm these benefits.”

https://ascopubs.org/doi/full/10.1200/JCO.20.00902

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