Paclitaxel/carboplatin with or without sorafenib in the first-line treatment of patients with stage III/IV epithelial ovarian cancerry

open access: Paclitaxel/carboplatin with or without sorafenib in the first-line treatment of patients with stage III/IV epithelial ovarian cancer: a randomized phase II study of the Sarah Cannon Research Institute

".....Unfortunately, interpretation of the results is hindered since the trial accrued slowly and was closed after 85 of a planned 120 patients had been randomized. However, comparisons of the efficacy of the two regimens showed no differences in overall response rates, PFS, or overall survival. The PFSs for both groups of  patients (paclitaxel/carboplatin/sorafenib, 15.4 months; paclitaxel/carboplatin, 16.3 months) were similar to those previously reported using standard therapy for advanced ovarian cancer. As anticipated, the patients who received sorafenib had more toxicity. The additional toxicity consisted primarily of well described sorafenib-related toxicity including skin toxicity, hand–foot syndrome, mucositis, and hypertension. The difficulty in tolerating the sorafenib-containing regimen resulted in a high rate of sorafenib dose reductions and discontinuations, and may have had an adverse impact on the efficacy of the regimen..........

 As more evidence accumulates, it is evident that sorafenib is not the angiogenesis inhibitor-of-choice in the treatment of patients with advanced ovarian cancer.
Sorafenib has modest activity as a single-agent in relapsed ovarian cancer, and although not studied in phase III trials, the addition of sorafenib to effective combination chemotherapy regimens has not suggested increased efficacy in any trial. In addition, sorafenib (at the standard dose of 400 mg BID) is tolerated poorly by ovarian cancer patients, even when used as a single agent; difficulties in adding sorafenib to combination chemotherapy have also been demonstrated in other diseases [22, 23]. It appears unlikely that sorafenib has a role in the treatment of ovarian cancer, and future clinical trials should focus on agents with new targets.