Phase II Study of Nab-Paclitaxel and Bevacizumab as First-line Therapy for Patients with Unresectable Stage III and IV Melanoma. (February 2015)

• Record Type: Journal Article
• Authors: Spitler, Lynn E.; Boasberg, Peter; Day, Steven O'; Hamid, Omid; Cruickshank, Scott; Mesko, Shane; Weber, Robert W.
• Is Part Of: American journal of clinical oncology. Volume 38:Number 1(2015)
• Publication Date: 2015-02
• Subjects: nab-paclitaxel -- bevacizumab -- melanoma -- therapy -- clinical trial; Cancer -- Treatment -- Periodicals; Oncology -- Periodicals; Tumors -- Periodicals; 616.994005
• DOI: 10.1097/COC.0b013e318287bbae
• Languages: English
• ISSNs: 0277-3732

Abstract

Abstract : 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/m 2 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.