title: Is it equivalent? Evaluation of the clinical activity of single agent Lipodox® compared to single agent Doxil® in ovarian cancer treatment.
abstract: BACKGROUND
  In response to the critical shortage of liposomal doxorubicin (Doxil®) in the United States, the Food and Drug Administration (FDA) approved temporary importation of doxorubicin hydrochloride liposome (Lipodox®). The objective was to compare toxicity and clinical activity of Lipodox® with Doxil®.
  
  
  METHODS
  Recurrent ovarian cancer patients who received Lipodox® were compared 3:1 to matched control Doxil® patients who had received Doxil®. Patients were matched based on age, stage, dose, platinum sensitivity, and prior treatments from an existing de-identified database. Patients receiving combination regimens were excluded.
  
  
  RESULTS
  The data from 40 Lipodox® patients was compared to 120 matched control Doxil® patients. In this study, 17 (42.5%) of the Lipodox® patients were switched to Doxil®. The overall response rate Lipodox® was 4.3% (1/23) compared to 18% (20/111) in matched control Doxil® patients. In the platinum-sensitive patients, 100% progressed in the Lipodox® group compared to 78.4% in matched control Doxil® patients. The mean time to progression was 4.1 ± 2.8 months for Lipodox® and 6.2 ± 7.2 months in control Doxil®s (p = 0·25). Toxicity was similar in the Lipodox® group and control Doxil® group.
  
  
  CONCLUSIONS
  Lipodox® for treatment of recurrent ovarian cancer did not appear to have equivalent efficacy compared to Doxil®. A prospective clinical study is warranted before Lipodox® can be deemed equivalent substitution for Doxil®.
authors.affiliation: Department of Obstetrics, Gynecology & Reproductive Sciences, UTHealth Medical School, Houston, TX, USA Judith.Ann.Smith@uth.tmc.edu.
authors.forename: Judith A
authors.initials: JA
authors.lastname: Smith
authors.affiliation: Department of Obstetrics, Gynecology & Reproductive Sciences, UTHealth Medical School, Houston, TX, USA.
authors.forename: Anthony B
authors.initials: AB
authors.lastname: Costales
authors.affiliation: Division of Pharmacy, M.D. Anderson Cancer Center, Houston, TX, USA.
authors.forename: Mona
authors.initials: M
authors.lastname: Jaffari
authors.affiliation: Department of Biostatistics, UT M.D. Anderson Cancer Center.
authors.forename: Diana L
authors.initials: DL
authors.lastname: Urbauer
authors.affiliation: Department of Gynecologic Oncology, Division of Surgery, UT M.D. Anderson Cancer Center.
authors.forename: Michael
authors.initials: M
authors.lastname: Frumovitz
authors.affiliation: Division of Pharmacy, M.D. Anderson Cancer Center, Houston, TX, USA.
authors.forename: Christine K
authors.initials: CK
authors.lastname: Kutac
authors.affiliation: Division of Pharmacy, M.D. Anderson Cancer Center, Houston, TX, USA.
authors.forename: Huyentran
authors.initials: H
authors.lastname: Tran
authors.affiliation: Department of Gynecologic Oncology, Division of Surgery, UT M.D. Anderson Cancer Center.
authors.forename: Robert L
authors.initials: RL
authors.lastname: Coleman
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000903:Antibiotics, Antineoplastic / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000077216:Carcinoma, Ovarian Epithelial; D018450:Disease Progression; D018572:Disease-Free Survival; D004305:Dose-Response Relationship, Drug; D004317:Doxorubicin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D019008:Drug Resistance, Neoplasm; D005260:Female; D006801:Humans; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy; D009367:Neoplasm Staging; D009375:Neoplasms, Glandular and Epithelial / Q000188:drug therapy*; D010051:Ovarian Neoplasms / Q000188:drug therapy*; D011092:Polyethylene Glycols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D012189:Retrospective Studies
chemical_list: D000903:Antibiotics, Antineoplastic; C506643:liposomal doxorubicin; D011092:Polyethylene Glycols; D004317:Doxorubicin
keywords: Doxil®; Lipodox®; bioequivalence; liposomal doxorubicin; ovarian cancer