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Title of Journal: Cancer Chemother Pharmacol

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Abbravation: Cancer Chemotherapy and Pharmacology

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A phase II study of capecitabine in the treatment of ovarian cancer resistant or refractory to platinum therapy: a multicentre Italian trial in ovarian cancer (MITO-6) trial

Authors: Carmela Pisano, Alessandro Morabito, Roberto Sorio, Enrico Breda, Rossella Lauria, Vittorio Gebbia, Laura Scaltriti, Simona Scalone, Vittorina Zagonel, Stefano Greggi, Gerardo Beneduce, Simona Losito, Ciro Gallo, Massimo Di Maio, Valeria Forestieri, Sandro Pignata,

Publish Date: 2009/03/06
Volume: 64, Issue:5, Pages: 1021-1027
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Capecitabine is an oral chemotherapeutic agent, already used in breast and colon cancer. Previous data showed encouraging results in the treatment of recurrent ovarian cancer. The aim of this study was to describe activity and toxicity of capecitabine in patients with platinum resistant or refractory ovarian cancer.Patients were eligible if they had cytologically or histologically proven epithelial ovarian cancer, refractory or resistant to prior platinum-containing chemotherapy. Capecitabine was administered at the dose of 1,250 mg/m2 twice daily on days 1–14 of a 21-day cycle for a maximum of six cycles. The primary end point of the study was activity in terms of objective response rate in according to RECIST criteria. A two-stage minimax design for phase II studies was used: at least four objective responses had to be reached among 32 evaluable patients to define the treatment active.Between March 2006 and October 2007, 36 patients were enrolled. All patients had ovarian cancer and 83.3% had previously received two or three lines of chemotherapy. Thirty-two patients were evaluable for response and included in the activity analysis. The objective response rate was 3.1% [95% exact confidence interval (CI): 0.08–16.22%], lower than the threshold required to define the treatment as active. The median progression free survival was 68 days (95% CI: 65–120). Haematological toxicity was not frequent. Nausea and fatigue were common, but never severe, and they were observed in 13 (37.1%) and 12 (34.2%) patients, respectively. Diarrhoea occurred in 11 patients (31.5%) and it was of grade 3 in 8.6% of cases. Grade 1–2 stomatitis was observed in seven patients (20%). Cardiovascular toxicity was reported in two cases, including a death for pulmonary embolism.Partially supported by AIRC. The Authors thank Alfonso Savio for informatic assistance. Roche supported the study giving capecitabine at no cost and a research grant, without any right of property of data nor any influence on protocol planning, study conduction, analysis and interpretation.



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