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
Journal
Gynecologic Oncology
Journal Volume
112
Journal Issue
1
Pages
35-39
Date Issued
2009
Author(s)
Abstract
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. ? 2008 Elsevier Inc. All rights reserved.
SDGs
Other Subjects
carboplatin; cisplatin; cyclophosphamide; doxorubicin; gemcitabine; paclitaxel; platinum; topotecan; adult; aged; anemia; article; bloodstream infection; cancer chemotherapy; clinical trial; controlled study; diarrhea; disease free survival; drug efficacy; drug tolerability; female; hand foot syndrome; hepatitis; human; leukopenia; liver toxicity; major clinical study; multiple cycle treatment; nausea and vomiting; nephrotoxicity; neurotoxicity; ovary cancer; overall survival; phase 2 clinical trial; priority journal; stomatitis; thrombocytopenia; treatment response; Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Disease-Free Survival; Doxorubicin; Female; Humans; Middle Aged; Neoplasm Recurrence, Local; Ovarian Neoplasms; Paclitaxel; Phosphatidylcholines; Polyethylene Glycols
Type
journal article