No clinical trials have been conducted before on relapsed ovarian sex cord-stromal tumors. This study aims to evaluate the efficacy of paclitaxel, a chemotherapy medication, with or without bevacizumab for the treatment of relapsed ovarian sex cord-stromal tumors.
This open-label and randomized phase 2 trial included a total of 60 women with sex cord-stromal tumors that had relapsed after one or more platinum-based chemotherapy. The patients were randomly assigned in a 1:1 ratio to receive either paclitaxel alone (n=32) or paclitaxel with bevacizumab (n=28). The primary outcome of the study was a six-month progression-free rate.
The findings suggested that the estimated six-month survival rate was 71% among patients who received paclitaxel only and 72% among those who received paclitaxel with bevacizumab. The Bayesian estimates suggested the probability of six-month progression-free survival was higher with the paclitaxel-bevacizumab combination than with paclitaxel alone. The findings further indicated that the objective response rate increased from 25% to 44% when bevacizumab was added to paclitaxel. No severe adverse events were reported, and only one patient discontinued the treatment because of toxicity.
The research concluded that patients assigned to weekly paclitaxel had a higher rate of six-month progression-free survival, as compared with those who received paclitaxel alone.