title: Pegylated liposomal doxorubicin (Lipo-Dox) for platinum-resistant or refractory epithelial ovarian carcinoma: a Taiwanese gynecologic oncology group study with long-term follow-up.
abstract: OBJECTIVE
  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 naïve 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.
  
  
  CONCLUSIONS
  Lipo-Dox, the third liposome encapsulated doxorubicin, at 45 mg/m2 every 4 weeks, is effective against recurrent, platinum-resistant epithelial ovarian cancers.
authors.affiliation: Gynecologic Oncology Service, Department of Obstetrics and Gynecology, Chang Gung Memorial Hospital, Taipei, Taiwan.
authors.forename: Hung-Hsueh
authors.initials: HH
authors.lastname: Chou
authors.forename: Kung-Liahng
authors.initials: KL
authors.lastname: Wang
authors.forename: Chi-An
authors.initials: CA
authors.lastname: Chen
authors.forename: Lin-Hung
authors.initials: LH
authors.lastname: Wei
authors.forename: Chyong-Huey
authors.initials: CH
authors.lastname: Lai
authors.forename: Chang-Yao
authors.initials: CY
authors.lastname: Hsieh
authors.forename: Yuh-Cheng
authors.initials: YC
authors.lastname: Yang
authors.forename: Nae-Fang
authors.initials: NF
authors.lastname: Twu
authors.forename: Ting-Chang
authors.initials: TC
authors.lastname: Chang
authors.forename: Ming-Shyen
authors.initials: MS
authors.lastname: Yen
mesh_terms: D000328:Adult; D000368:Aged; D000903:Antibiotics, Antineoplastic / Q000009:adverse effects / Q000627:therapeutic use; D004317:Doxorubicin / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D019008:Drug Resistance, Neoplasm; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008875:Middle Aged; D009944:Organoplatinum Compounds / Q000494:pharmacology; D010051:Ovarian Neoplasms / Q000188:drug therapy*; D011092:Polyethylene Glycols / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D000903:Antibiotics, Antineoplastic; D009944:Organoplatinum Compounds; C506643:liposomal doxorubicin; D011092:Polyethylene Glycols; D004317:Doxorubicin