The addition of gemcitabine to pazopanib significantly increased the progression-free survival rate (PFSR) in patients with soft tissue sarcoma at 12 weeks compared to pazopanib alone, according to results of a phase 2 clinical trial.
Although the results suggested the combination seems to have clinical activity, the researchers advised phase 3 trials are needed to confirm.
In this multicenter, randomized phase 2 clinical trial, 86 patients were randomized to receive pazopanib with gemcitabine or without gemcitabine.
At a median follow-up of 12.4 months, the primary endpoint of PFSR was met with a PFSR of 74% in patients receiving the combination treatment versus 47% in patients receiving pazopanib alone.
There was a median PFSR of 5.6 months and 2.0 months in the combination group and single-agent group, respectively. Overall survival was 13.1 and 11.2 months, respectively. The objective response rate, which was overall low, was 11% and 5%, respectively.
The authors said that although the toxicity associated with the combination therapy was increased, “it was manageable and mainly hematological.”
Schmoll H, Lindner LH, Reichardt P, et al. Efficacy of pazopanib with or without gemcitabine in patients with anthracycline- and/or ifosfamide-refractory soft tissue sarcoma: Final results of the PAPAGEMO phase 2 randomized clinical trial. JAMA Oncol. 2020;doi:10.1001/jamaoncol.2020.6564