Assessment of doxorubicin and pembrolizumab in patients with advanced anthracycline-naive sarcoma
JAMA Sep 18, 2020
Pollack SM, Redman MW, Baker KK, et al. - Researchers performed this nonrandomized clinical trial using a 2-stage phase 2 design, to test doxorubicin plus pembrolizumab in patients with advanced, anthracycline-naive sarcomas, focusing on the safety and efficacy of this combination. This inquiry was conducted at a single, academic sarcoma specialty center. Cases of osteosarcoma, Ewing sarcoma, and alveolar and embryonal rhabdomyosarcoma were not included. Two dose levels of doxorubicin (45 and 75 mg/m2) in combination with pembrolizumab were evaluated for safety. The estimated objective response rate (ORR) for phase 2 patients was 13% and was 19% overall. A median progression-free survival (PFS) of 8.1 months was reported. At the time of this analysis, the estimated median overall survival (OS) was 27.6 months. There were no dose-limiting toxic impacts. Findings demonstrated the good tolerability of doxorubicin plus pembrolizumab. The PFS and OS noted compared favorably with earlier published investigations, although the primary endpoint for ORR was not reached in this study.
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