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Phase II trial of carboplatin and distearoylphosphatidylcholine pegylated liposomal doxorubicin (Lipo-Dox®) in recurrent platinum-sensitive ovarian cancer following front-line therapy with paclitaxel and platinum

2008; Elsevier BV; Volume: 112; Issue: 1 Linguagem: Inglês

10.1016/j.ygyno.2008.09.033

1095-6859

Sheng‐Mou Hsiao, Chi‐An Chen, Ho‐Hsiung Lin, Chang‐Yao Hsieh, Lin‐Hung Wei,

Testicular diseases and treatments

Objective To evaluate the effectiveness and toxicity of distearoylphosphatidylcholine pegylated liposomal doxorubicin (DPLD) combined with carboplatin for the treatment of platinum-sensitive, paclitaxel-pretreated, recurrent, epithelial ovarian cancer. Methods A phase II study of carboplatin/DPLD treatment for platinum-sensitive, paclitaxel-pretreated, recurrent, epithelial ovarian cancer was initiated in July 2002. As of March 2008, a total of 32 patients were enrolled. Results Of the 32 patients, one achieved a complete response; 19 (59%) achieved a partial response. The overall objective response rate was 62% (95% confidence interval [CI], 45%–80%). The median progression-free survival and overall survival for all 32 patients was 9.1 months (95% CI, 6.4–10.4 months) and 27.9 months (95% CI, 13.9–38.6 months), respectively. Toxicity was tolerable. The most common grade 3 or 4 toxicities were anemia (n=3) and nausea/vomiting (n=3). Grade 3/4 leukopenia (n=2), grade 3/4 thrombocytopenia (n=2) and grade 4 hepatitis (n=1) occurred in five patients. Conclusion Carboplatin/DPLD appears to be an effective regimen with low toxicity for treatment of patients with platinum-sensitive, paclitaxel-pretreated, recurrent, epithelial ovarian cancer.