French Phase II Trial Suggests No Benefit of Adding Bevacizumab to Paclitaxel in Advanced Angiosarcoma
In a French phase II trial reported in the Journal of Clinical Oncology, Ray-Coquard et al found no apparent benefit of paclitaxel plus bevacizumab (Avastin) compared with weekly paclitaxel in patients with inoperable locally advanced or metastatic angiosarcoma.
Study Details
In this noncomparative open-label study, 49 evaluable patients from 14 centers were randomly assigned to receive paclitaxel alone at 90 mg/m2 per week for six 28-day cycles (n = 24) or in combination with bevacizumab at 10 mg/kg every 2 weeks and as maintenance at 15 mg/kg every 3 weeks after completion of paclitaxel treatment. The primary endpoint was 6-month progression-free survival, with a rate of 40% defined as indicating a promising treatment.
The most common primary disease sites were breast (49%) and skin (12%); 34% of patients had visceral disease, 49% had radiation-induced disease, and all had Eastern Cooperative Oncology Group performance status of 0 (49%) or 1.
Efficacy Outcomes
Median follow-up was 14.5 months. Progression-free survival at 6 months was 54% in the paclitaxel group and 57% in the paclitaxel/bevacizumab group, with both groups thus meeting the primary endpoint. The objective response rates at 3 months were 45.8% and 28.0%. Median progression-free survival was 6.6 months in both groups, and median overall survival was 19.5 months and 15.9 months.
Adverse Events
Toxicity was greater in the combination group. Grade 3 or 4 treatment-related toxicities occurred in 21.7% of patients in the paclitaxel group and 44.0% of the combination group. Drug-related serious adverse events occurred in 0% and 32% and consisted of hematoma, anemia (n = 2), dyspnea of unknown cause, heart failure, pulmonary embolism, peritonitis, diarrhea (n = 2), and intestinal occlusion, with the latter resulting in death.
The investigators concluded: “The primary objective was met in both treatment arms. However, the present data do not support additional clinical investigation of combined paclitaxel/bevacizumab for the treatment of advanced [angiosarcoma].”
Nicolas Penel, MD, PhD, of Centre Oscar Lambret and Lille-Nord-de-France Medical School, is the corresponding author for the Journal of Clinical Oncology article.
The study was supported by grants from the French Cancer Institute and Roche. For full disclosures of the study authors, visit jco.ascopubs.org.
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