A randomized, open-label, phase 2, multicenter trial of gemcitabine with pazopanib or gemcitabine with docetaxel in patients with advanced soft-tissue sarcoma.

摘要: Background Therapeutic options for patients with advanced soft-tissue sarcoma (STS) are limited. The goal of the current phase 2 study was to examine clinical activity and safety combination gemcitabine plus pazopanib, a multityrosine kinase inhibitor in STS. Methods randomized, trial enrolled nonadipocytic STS who had received prior anthracycline-based therapy. Patients were assigned 1:1 receive at dose 1000 mg/m2 on days 1 8 pazopanib 800 mg daily (G+P) or 900 docetaxel 100 day (G+T) every 3 weeks. Crossover allowed time disease progression. used noncomparative statistical design based precision 95% confidence intervals reporting primary endpoints median progression-free survival (PFS) rate grade ≥3 adverse events (AEs) these regimens intent-to-treat patient population (AEs graded using version 4.0 National Cancer Institute Common Terminology Criteria Adverse Events). Results A total 90 enrolled: 45 each treatment arm. PFS 4.1 months arm (P = .3, log-rank test). best overall response stable better (complete + partial disease) same both arms (64% G+T G+P arms). related AEs 82% 78% Related occurring ≥10% anemia (36% 20%, respectively), fatigue (29% 13%, thrombocytopenia (53% 49%, neutropenia (20% lymphopenia (13% 11%, hypertension (2% respectively). Conclusions data from have demonstrated efficacy as an alternative