High Efficacy and Low Toxicity of the Modified Docetaxel and Carboplatin Protocol in Patients with Recurrent Ovarian Cancer—A Phase 2 Cohort Study. Issue 4 (1st May 2016)

• Record Type: Journal Article
• Authors: Bruchim, Ilan; Weeg, Natalie; Alpert, Yoav; Sade, Dana; Piura, Ettie; Fishman, Ami
• Is Part Of: International journal of gynecological cancer. Volume 26:Issue 4(2016)
• Page Start: 640
• Page End: 647
• Publication Date: 2016-05-01
• Subjects: Recurrent ovarian cancer -- Docetaxel; Generative organs, Female -- Cancer -- Periodicals; 616.99465
• DOI: 10.1097/IGC.0000000000000666
• Languages: English
• ISSNs: 1048-891X

Abstract

Abstract : Objective: Most patients with epithelial ovarian cancer will experience a recurrence; currently, there is no cure. In patients with platinum-sensitive disease (platinum-free interval >6 months), a combination similar to that used as frontline therapy (carboplatin and paclitaxel) is recommended. However, it is associated with a high incidence (20%) of neurotoxicity. This study evaluated the efficacy and toxicity of combination docetaxel/carboplatin therapy in patients with platinum-sensitive recurrent ovarian cancer. Methods: Forty patients with recurrent, histologically proven ovarian, fallopian tube, or primary peritoneal cancer were enrolled in this phase 2 trial. The study protocol included combination therapy with docetaxel, 30 mg/m 2, on days 1 and 8, and carboplatin, area under the curve 5, on day 1, every 21 days. Twenty received the classical paclitaxel/carboplatin regimen (control group), and another 20 received the modified docetaxel/carboplatin protocol (study group). Results: Median follow-up was 78 months for the study group and 62 months for the control group. The study group had a higher overall response rate compared to controls: 80% and 30%, respectively ( P = 0.004; relative risk, 9.3; 95% confidence interval, 2.18–39.96). Complete response was achieved in 60% and 25%, respectively ( P = 0.054). The study group patients showed a superior 2-year survival rate of 75% compared with the 35% of the controls ( P = 0.011; relative risk, 5.57; 95% confidence interval, 1.47–21.56). Hematological and neurological toxicity rates did not differ between the groups ( P = 0.451 and P = 0.605, respectively). Conclusions: Patients with recurrent ovarian cancer who received the modified docetaxel/carboplatin regimen had higher overall response and survival rates compared to those who had the paclitaxel/carboplatin regimen, with no difference in toxicity. Future larger studies should focus on strategies to compare this regimen to the current standard, with an emphasis on quality of life.