OBJECTIVE: The combination of GEM/PLD has been tested for its efficacy on survival of recurrent ovarian cancer patients. METHODS: This is a multicenter phase II study of GEM/PLD regimen in recurrent ovarian cancer patients previously treated with at least one platinum/paclitaxel regimen, and with evidence of measurable disease. PLD, 30 mg m(-2), was administered on day 1 followed by GEM, 1000 mg m(-2), on days 1 and 8, every 21 days. RESULTS: 106 patients were available for response evaluation. 9 complete responses (8.5%) and 27 partial responses (25.5%) have been registered. 36 patients (34.0%) experienced stabilization of disease, while 34 (32.1%) cases progressed during treatment. OS was significantly shorter in platinum-resistant (median OS = 50 weeks) than in platinum-sensitive patients (median OS = 92 weeks) (P value = 0.0016). In the group of platinum-sensitive patients, cases responsive to GEM/PLD combination showed a better OS with respect to patients unresponsive to GEM/PLD (median OS = 120 weeks versus median OS = 60 weeks, P value = 0.019). The same trend was observed in platinum-resistant patients. Grade 4 hematological toxicity affected 20 patients (18%). Grade 3 palmar-plantar erythrodysesthesia (PPE) was registered in 16 patients (14.4%). Grades 3 and 4 mucositis was documented in 16 (14.4%) and 2 (1.8%) patients, respectively. CONCLUSIONS: GEM/PLD combination represents a valid approach in recurrent ovarian cancer patients. The hematological toxicity was easily managed, and the incidence and severity of PPE was low.
OBJECTIVE: The combination of GEM/PLD has been tested for its efficacy on survival of recurrent ovarian cancerpatients. METHODS: This is a multicenter phase II study of GEM/PLD regimen in recurrent ovarian cancerpatients previously treated with at least one platinum/paclitaxel regimen, and with evidence of measurable disease. PLD, 30 mg m(-2), was administered on day 1 followed by GEM, 1000 mg m(-2), on days 1 and 8, every 21 days. RESULTS: 106 patients were available for response evaluation. 9 complete responses (8.5%) and 27 partial responses (25.5%) have been registered. 36 patients (34.0%) experienced stabilization of disease, while 34 (32.1%) cases progressed during treatment. OS was significantly shorter in platinum-resistant (median OS = 50 weeks) than in platinum-sensitive patients (median OS = 92 weeks) (P value = 0.0016). In the group of platinum-sensitive patients, cases responsive to GEM/PLD combination showed a better OS with respect to patients unresponsive to GEM/PLD (median OS = 120 weeks versus median OS = 60 weeks, P value = 0.019). The same trend was observed in platinum-resistant patients. Grade 4 hematological toxicity affected 20 patients (18%). Grade 3 palmar-plantar erythrodysesthesia (PPE) was registered in 16 patients (14.4%). Grades 3 and 4 mucositis was documented in 16 (14.4%) and 2 (1.8%) patients, respectively. CONCLUSIONS: GEM/PLD combination represents a valid approach in recurrent ovarian cancerpatients. The hematological toxicity was easily managed, and the incidence and severity of PPE was low.
Authors: Sham S Kakar; Christopher A Worth; Zhenglong Wang; Kelsey Carter; Mariusz Ratajczak; Pranesh Gunjal Journal: J Cancer Stem Cell Res Date: 2016-04-19
Authors: V Adamo; V Lorusso; R Rossello; B Adamo; G Ferraro; D Lorusso; G Condemi; D Priolo; L Di Lullo; A Paglia; S Pisconti; G Scambia; G Ferrandina Journal: Br J Cancer Date: 2008-05-20 Impact factor: 7.640