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Phase II Study of Nab-Paclitaxel and Bevacizumab as First-line Therapy for Patients with Unresectable Stage III and IV Melanoma

Spitler, Lynn E. MD*; Boasberg, Peter MD; Day, Steven O’ MD; Hamid, Omid MD; Cruickshank, Scott MS; Mesko, Shane BS; Weber, Robert W. MD*

American Journal of Clinical Oncology: February 2015 - Volume 38 - Issue 1 - p 61–67
doi: 10.1097/COC.0b013e318287bbae
Original Articles: Cutaneous
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Objectives: This study was an open-label multicenter phase II trial to investigate the efficacy and safety of nab-paclitaxel and bevacizumab as first-line therapy in patients with histologically confirmed unresectable metastatic melanoma.

Methods: The treatment regimen consisted of a 28-day cycle in which patients received nab-paclitaxel, 150 mg/m2 through intravenous (IV) infusion weekly for 3 weeks and bevacizumab, 10 mg/kg IV every 2 weeks without a rest period. The 28-day cycle was repeated until there was unacceptable toxicity or disease progression. If 1 drug had to be stopped because of toxicity, treatment was continued with the other drug until disease progression or unacceptable toxicity. The primary endpoint was the progression-free survival rate (PFS) at 4 months.

Results: Fifty patients were enrolled. The PFS rate at 4 months was 75%. The median PFS was 7.6 months and the median overall survival was 16.8 months with a median duration follow-up of 41.6 months. The overall survival rate was 64% at 1 year and 30% at 2 years. Ten patients (20%) remain alive. The objective response rate was 36%. Common adverse events associated with this regimen were peripheral neuropathy, fatigue, alopecia, and gastrointestinal disorders.

Conclusions: In this phase II multicenter study, this doublet had significant activity in patients with metastatic melanoma, and was well tolerated. These results are promising and follow-up trials to further explore this regimen are warranted.

*Northern California Melanoma Center, St. Mary’s Medical Center, San Francisco

The Angeles Clinic and Research Institute, Santa Monica

Scott Cruickshank and Associates, Santa Barbara, CA

Supported by the Melanoma Research Institute, Joyce N Furman Memorial Trust, Abraxis Biosciences, LLC, a wholly owned subsidiary of Celgene Corporation, and Genentech/Roche. No NIH Grants supported this work. Presented, in part, at Perspectives in Melanoma XII, The Hague, The Netherlands 2008 and at the Annual Meeting of the American Society of Clinical Oncology, Chicago, IL, 2009 and 2011.

L.E.S. has received research funding and honoraria from, and is a consultant and advisor to Abraxis/Celgene and Genentech/Roche, received payment for writing this manuscript from Abraxis/Celgene, and is on the Speaker’s Bureau for Genentech/Roche; P.B. is on the Speaker’s Bureau for Bristol-Myers Squibb; S.O.D. has received research funding from, has been a consultant and advisor to, is on the Speakers bureau of and has received honoraria and meeting travel and accommodations from Abraxis/Celgene and Genentech/Roche, and has had clinical trial medication supplied by Genentech/Roche; O.H. has grants pending for research funding from and is a consultant to Abraxis/Celgene and Genentech/Roche, and receives payment for lectures from Genentech/Roche; S.C. received payment for data analysis for this manuscript from Abraxis/Celgene and Genentech/Roche; R.W.W. is on the Speaker’s Bureau for Bristol-Myers Squibb. The remaining authors declare no conflicts of interest.

Reprints: Lynn E. Spitler, MD, Northern California Medical Center, St. Mary’s Medical Center, 450 Stanyan St, San Francisco, CA 94117. E-mail: ls@drspitler.com.

© 2015 by Lippincott Williams & Wilkins, Inc