Phase II Trial of Gemcitabine and Docetaxel with Bevacizumab in Soft Tissue Sarcoma.

ABSTRACT: Gemcitabine (G) and docetaxel (D) are commonly used to treat recurrent/metastatic soft tissue sarcoma. This study tested the hypothesis that outcomes would be improved by addition of bevacizumab (B). The initial design was randomized double-blind trial of G + D + B versus G + D + placebo. Due to slow accrual this was modified to single-arm open-label G + D + B. Eligible patients had diagnosis of leiomyosarcoma, pleomorphic undifferentiated sarcoma, pleomorphic liposarcoma, or angiosarcoma. Treatment was B 15?mg/kg on d1, G 900?mg/m(2) on d1 and d8, and D 75?mg/m(2) on d8, q21d. Primary endpoint was progression-free survival (PFS) at 6 months and would be met if ?17 patients were progression-free at 6?m. Secondary endpoints are response rate, PFS at 3?m, overall survival, and toxicity. Of 44 patients enrolled, 35 were treated with GDB and evaluable for safety and efficacy. Median age was 55, 50% male, most ECOG 0. Toxicity is mostly myelosuppression with one deep vein thrombosis and one small bowel perforation possibly related to B. There were 17 partial responses (49%) by RECIST 1.1. Among 35 patients, the number who remained on study and progression-free was 24 at 3?m and 15 at 6?m. 9 withdrew prior to 6?m for reasons other than toxicity or progression. PFS at 6?m was 65% (95% CI: 51-85%). The primary endpoint of 6?m PFS was not met due to censoring of patients who withdrew. However PFS at 3?m (76%) was promising and response rate was higher than expected from G + D.

SUBMITTER: Dickson MA 

PROVIDER: S-EPMC4446476 | biostudies-literature | 2015

REPOSITORIES: biostudies-literature