Randomized phase II trial of sorafenib alone or in combination with carboplatin/paclitaxel in women with recurrent platinum sensitive epithelial ovarian, peritoneal, or fallopian tube cancer.

BACKGROUND/PURPOSE: This study was designed to evaluate the response and toxicity of sorafenib alone or when combined with carboplatin and paclitaxel in patients with platinum-sensitive, recurrent ovarian cancer, fallopian tube cancer, or primary peritoneal cancer (EOC). METHODS: Patients with recurrent platinum-sensitive EOC with no more than 2 prior courses of chemotherapy were randomized to single-agent sorafenib 400 mg twice daily or combination sorafenib 400 mg bid (days 2-19) with IV carboplatin (AUC 6) and IV paclitaxel 175 mg/m(2) (S+C/T) every 3 weeks. Single agent sorafenib could cross over to combination upon progression. RESULTS: Patients were initially randomized to either arm, however, due to poor accrual, sorafenib arm was prematurely closed. A total of 13 patients were evaluable for response to sorafenib and 23 patients were evaluable for response to S+C/T. Objective response rate (RR) was 15 % for patients on sorafenib vs. 61 % for patients on S+C/T (p = 0.014); stable disease was seen in 62 % and 35 %, respectively. Clinical benefit rate (CBR) at 4 months (mos.) was 69 % for S and 65 % for S+C/T. The median progression free survival was 5.6 months on sorafenib vs. 16.8 months on S+C/T (p = 0.012) and there was no significant difference of overall survival between two arms (p = 0.974) with median overall survival 25.6 months under sorafenib vs. 25.9 months on S+C/T. Patients remained on trial for a median of 7.8 cycles on sorafenib and 5.4 cycles on S+C/T. CONCLUSION: Sorafenib, alone or in combination with carboplatin and paclitaxel, has activity in patients with platinum-sensitive EOC. Sorafenib in combination with carboplatin and paclitaxel improved RR and PFS; however, there were increased grade and frequencies of toxicities.

Longitudinal assessment of quality of life and lifestyle in newly diagnosed ovarian cancer patients: the roles of surgery and chemotherapy.

OBJECTIVES: To prospectively evaluate quality of life (QoL), use of complementary and alternative medicine (CAM), and diet/exercise changes in ovarian cancer patients during the first 6 months following diagnosis. METHODS: Patients with newly diagnosed ovarian cancer were enrolled pre- or post-operatively and surveyed at 3 and 6 months. The Functional Assessment of Cancer Therapy (FACT-G), Medical Outcomes Survey (SF-36), and CAM/diet/exercise questionnaires were used. Independent samples t test and repeated measures ANOVA were used. RESULTS: Forty-two patients underwent surgical debulking and staging prior to chemotherapy. Patients completing the initial surveys post-operatively had significantly lower physical FACT-G and SF-36 physical scores compared to patients completing the surveys pre-operatively. In patients completing the baseline survey pre-operatively, there was a decrease in physical scores at 3 months (after surgery and during chemotherapy). There was no change observed at 3 months relative to baseline when patients completed the baseline survey post-operatively. Increases in physical and functional well-being were seen at 6 months relative to 3 months. There were no changes in emotional or social scores over time. CAM use increased over time; main reasons were to improve QoL and relieve symptoms. Alterations in diet and exercise were not seen. CONCLUSIONS: These data highlight the need to conduct assessments before and after surgery to identify effects due to surgery and/or chemotherapy. Patients may be using CAM during chemotherapy to deal with symptoms and compensate for decreased QoL. Intervention trials should be implemented to increase QoL following surgery and during adjuvant chemotherapy.