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Clinical Trial
. 2015 May;4(5):673-81.
doi: 10.1002/cam4.376. Epub 2014 Dec 31.

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

John D Hainsworth  1   2 , Dana S Thompson  1   2 , John A Bismayer  1   3 , Victor G Gian  1   2 , William M Merritt  1   4 , Robert C Whorf  1   5 , Lindsey H Finney  1 , B Stephens Dudley  1   2
Affiliations
Clinical Trial

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

John D Hainsworth et al. Cancer Med. 2015 May.

Abstract

This trial compared the efficacy and toxicity of standard first-line treatment with paclitaxel/carboplatin versus paclitaxel/carboplatin plus sorafenib in patients with advanced ovarian carcinoma. Patients with stage 3 or 4 epithelial ovarian cancer with residual measurable disease or elevated CA-125 levels after maximal surgical cytoreduction were randomized (1:1) to receive treatment with paclitaxel (175 mg/m(2) , 3 h infusion, day 1) and carboplatin (AUC 6.0, IV, day 1) with or without sorafenib 400 mg orally twice daily (PO BID). Patients were reevaluated for response after completing 6 weeks of treatment (two cycles); responding or stable patients received six cycles of paclitaxel/carboplatin. Patients receiving the sorafenib-containing regimen continued sorafenib (400 PO BID) for a total of 52 weeks. Eighty-five patients were randomized and received treatment.Efficacy was similar for patients receiving paclitaxel/carboplatin/sorafenib versus paclitaxel/carboplatin: overall response rates 69% versus 74%; median progression-free survival 15.4 versus 16.3 months; 2 year survival 76% versus 81%. The addition of sorafenib added substantially to the toxicity of the regimen; rash, hand-foot syndrome, mucositis, and hypertension were significantly more common in patients treated with sorafenib. The addition of sorafenib to standard paclitaxel/carboplatin did not improve efficacy and substantially increased toxicity in the first-line treatment of advanced epithelial ovarian cancer. Based on evidence from this study and other completed trials, sorafenib is unlikely to have a role in the treatment of ovarian cancer.

Keywords: Carboplatin; first-line therapy; ovarian cancer; paclitaxel; sorafenib.

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Figures

Figure 1
Figure 1
Patient flow diagram.
Figure 2
Figure 2
Estimated progression-free survival of patients receiving paclitaxel/carboplatin/sorafenib (Arm A) versus paclitaxel/carboplatin (Arm B).
Figure 3
Figure 3
Estimated overall survival of patients receiving paclitaxel/carboplatin/sorafenib (Arm A) versus paclitaxel/carboplatin (Arm B).
See this image and copyright information in PMC

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