Abstract
5555 Background: To assess the anti-tumor effect and safety of carboplatin and PLD administration in pts with relapsed, platinum sensitive and platinum semi-sensitive ovarian cancer. Methods: The objective of this phase II second line study is to determine efficacy and toxicity of PLD at a dose of 50mg/m2 in combination with carboplatin (AUC = 5) q 28days, in pts with recurrent ovarian cancer with a disease free interval (DFI) greater than 6 months. Pts were divided into 2 groups: Group 1 (G1) with a DFI of 6 months to 1 year (semisensitive disease), and group 2 (G2) with DFI longer than 1 year (sensitive disease). Fourty pts were enrolled (G1 = 19 pts and G2 = 21pts). Median age was 58 years (range 34–75), 21 pts had an ECOG PS of 1 and 19 had PS of 0. Median CA 125 at presentation is 129 U/ml (range 3–8,894). A total of 227 cycles have been administered, median 6 cycles (range 1–8). Results: Response: A total of 27 pts responded to treatment (67.5%) (95% confidence interval 50.8% - 81.4%). There were 14 CR and 13 PR. In the G1 10/19 pts responded (52.6%) (6 pts (38.1%) attained a CR). Among the G2 pts, 17/21 responded to treatment 80.95% (8 pts (38.1%) attained a CR). The median response duration among the 27 responders was 373 days (53–1856 days). The median response duration for pts attaining a CR was 462 days (94- 1856).The median survival was 911 days (range 129–2037) with 10 pts alive.Toxicity: No toxic related deaths were documented. Grade III and IV haematological toxicity includes anaemia (grade III: 4 pts), neutropenia (grade III: 15 pts; grade IV: 5 pts) and thrombocytopenia (grade III: 12 pts; grade IV: 1 pt). Febrile neutropenia: Six pts. No active bleeding was documented.Grade III and IV non haematological toxicity included nausea and vomiting (grade III in 3 pts). Other relevant toxicities included PPE (grade I: 5 pts; grade II: 12 pts; grade III: 3 pts). Stomatitis (grade I: 6 pts; grade II: 14 pts; grade III: 2 pts) and aesthenia (grade I-III: 28 pts). No renal toxicity has been observed. Conclusions: The combination of PLD 50mg/m2 with carboplatin AUC = 5, is a safe and active second line chemotherapy regime for advanced platinum sensitive and semi-sensitive ovarian cancer. No significant financial relationships to disclose.
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