Pegylated liposomal doxorubicin (Lipo-Dox®) for platinum-resistant or refractory epithelial ovarian carcinoma: A Taiwanese gynecologic oncology group study with long-term follow-up
Journal
Gynecologic Oncology
Journal Volume
101
Journal Issue
3
Pages
423-428
Date Issued
2006
Author(s)
Chou H.-H
Wang K.-L
Lai C.-H
Yang Y.-C
Twu N.-F
Chang T.-C
Yen M.-S.
Abstract
Objectives.: To evaluate the efficacy and safety of a distearoylphosphatidylcholine pegylated liposomal doxorubicin, Lipo-Dox?, in platinum-resistant or refractory epithelial ovarian cancer. Methods.: A multicenter phase II trial enrolled women with platinum-resistant or refractory epithelial ovarian carcinoma and na?ve to anthracycline. Eligible patients had either measurable tumor(s) or elevated serum CA 125 titer. Lipodox was initiated with a dose of 45 mg/m2 at a 4-week interval with subsequent escalation or reduction. A total of six cycles were scheduled. Results.: 29 patients, 20 with platinum-resistant and 9 with platinum refractory tumors, were enrolled. Lipo-Dox was given for an average of 4.6 cycles per patient with a total of 134 cycles. Among the 26 evaluable patients, one achieved CR, 5 PR and 9 SD. The overall response rate was 23.1% (95% CI, 6.8%-39.3%) with a median response duration of 11.6 weeks. 5 of the 6 responses were in patients with resistant disease. The median progression-free duration in the SD patients was 25.7 weeks. With a median follow-up of 13.8 months, the median progression-free and median overall survivals in the 26 patients were 5.4 months and 13.8 months, respectively. Hand-foot skin reaction occurred in 4.5% and skin pigmentation in 11.2% of all treatment cycles, all were Grade 1/2. Nausea and vomiting occurred in 14.2%, while anemia, leukopenia and thrombocytopenia occurred in 20.9%, 32.8% and 9% of cycle, respectively, and were mostly Grade 1 or 2. Conclusion.: Lipo-Dox, the third liposome encapsulated doxorubicin, at 45 mg/m2 every 4 weeks, is effective against recurrent, platinum-resistant epithelial ovarian cancers. ? 2005 Elsevier Inc. All rights reserved.
SDGs
Other Subjects
CA 125 antigen; doxorubicin; platinum; adult; aged; anemia; article; cancer grading; cancer growth; cancer resistance; cancer survival; clinical article; clinical trial; controlled clinical trial; controlled study; drug efficacy; drug safety; female; follow up; gynecology; human; leukopenia; long term care; multicenter study; nausea and vomiting; oncology; ovary carcinoma; priority journal; skin manifestation; skin pigmentation; Taiwan; thrombocytopenia; time; Adult; Aged; Antibiotics, Antineoplastic; Doxorubicin; Drug Resistance, Neoplasm; Female; Follow-Up Studies; Humans; Middle Aged; Organoplatinum Compounds; Ovarian Neoplasms; Polyethylene Glycols
Type
journal article