title: Treatment of patients with ovarian carcinoma with pegylated liposomal doxorubicin: analysis of toxicities and predictors of outcome.
abstract: BACKGROUND
  Pegylated liposomal doxorubicin is a new formulation with activity against epithelial ovarian carcinoma (EOC). The authors sought to determine patient characteristics that may predict for response to this treatment and favorable time to failure as well as survival.
  
  
  METHODS
  Eight patients in a Phase I study and 44 patients in two consecutive Phase II studies who were treated with pegylated liposomal doxorubicin (40-60 mg/m2 every 3 weeks for the first two cycles and 40 mg/m2 every 4 weeks thereafter) after failing initial platinum-based chemotherapies for ovarian carcinoma were analyzed. Associations were sought for response, time to failure (TTF), and survival after the treatment and various pretreatment characteristics.
  
  
  RESULTS
  Treatment with pegylated liposomal doxorubicin yielded 23% objective responses in measurable disease and 31% overall responses, including serum CA 125-defined responses. The median TTF was 5.2 months (95% confidence interval, 4.1-6.9 months) in all patients, and the median response duration in all responders was 13.2 months (95% confidence interval, 11.9-18.5 months). The overall median survival was 15 months (95% confidence interval, 11-40 months). The main predictive factors were tumor size and baseline hemoglobin level for TTF, and these plus Karnofsky performance status were the main predictive factors for survival.
  
  
  CONCLUSIONS
  Pegylated liposomal doxorubicin is an effective drug when it is given as secondary therapy to patients with EOC. Lack of bulky disease is the major predictor for a favorable response, TTF, and survival. The role of this treatment in combination with other effective drugs should be explored in both previously treated and untreated patients with ovarian carcinoma.
authors.affiliation: Department of Medical Oncology, Kenneth Norris Jr. Comprehensive Cancer Center, University of Southern California, Los Angeles, California, USA.
authors.forename: T
authors.initials: T
authors.lastname: Safra
authors.forename: S
authors.initials: S
authors.lastname: Groshen
authors.forename: S
authors.initials: S
authors.lastname: Jeffers
authors.forename: D D
authors.initials: DD
authors.lastname: Tsao-Wei
authors.forename: L
authors.initials: L
authors.lastname: Zhou
authors.forename: L
authors.initials: L
authors.lastname: Muderspach
authors.forename: L
authors.initials: L
authors.lastname: Roman
authors.forename: C P
authors.initials: CP
authors.lastname: Morrow
authors.forename: A
authors.initials: A
authors.lastname: Burnett
authors.forename: F M
authors.initials: FM
authors.lastname: Muggia
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000494:pharmacology*; D002277:Carcinoma / Q000188:drug therapy* / Q000473:pathology; D004317:Doxorubicin / Q000008:administration & dosage* / Q000494:pharmacology*; D005260:Female; D006304:Health Status; D006454:Hemoglobins / Q000032:analysis; D006801:Humans; D008081:Liposomes; D008875:Middle Aged; D009367:Neoplasm Staging; D010051:Ovarian Neoplasms / Q000188:drug therapy* / Q000473:pathology; D011237:Predictive Value of Tests; D011379:Prognosis; D016019:Survival Analysis; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D006454:Hemoglobins; D008081:Liposomes; D004317:Doxorubicin