title: Randomized, open-label, phase III study comparing patupilone (EPO906) with pegylated liposomal doxorubicin in platinum-refractory or -resistant patients with recurrent epithelial ovarian, primary fallopian tube, or primary peritoneal cancer.
abstract: OBJECTIVE
  This study compared the efficacy and safety of patupilone with those of pegylated liposomal doxorubicin (PLD) in patients with platinum-refractory or -resistant epithelial ovarian, primary fallopian tube, or primary peritoneal cancer.
  
  
  METHODS
  Patients with three or fewer prior regimens were eligible if they had received first-line taxane/platinum-based combination chemotherapy and were platinum refractory or resistant. Patients were randomly assigned to receive patupilone (10 mg/m(2) intravenously every 3 weeks) or PLD (50 mg/m(2) intravenously every 4 weeks).
  
  
  RESULTS
  A total of 829 patients were randomly assigned (patupilone, n = 412; PLD, n = 417). There was no statistically significant difference in overall survival (OS), the primary end point, between the patupilone and PLD arms (P = .195; hazard ratio, 0.93; 95% CI, 0.79 to 1.09), with median OS rates of 13.2 and 12.7 months, respectively. Median progression-free survival was 3.7 months for both arms. The overall response rate (all partial responses) was higher in the patupilone arm than in the PLD arm (15.5% v 7.9%; odds ratio, 2.11; 95% CI, 1.36 to 3.29), although disease control rates were similar (59.5% v 56.3%, respectively). Frequently observed adverse events (AEs) of any grade included diarrhea (85.3%) and peripheral neuropathy (39.3%) in the patupilone arm and mucositis/stomatitis (43%) and hand-foot syndrome (41.8%) in the PLD arm.
  
  
  CONCLUSIONS
  Patupilone did not demonstrate significant improvement in OS compared with the active control, PLD. No new or unexpected serious AEs were identified.
authors.affiliation: Dipartimento di Scienze Chirurgiche, Università Milano-Bicocca, Medico Direttore, Unità Ginecologia Oncologica Medica, Divisione di Ginecologia, Via Ripamonti, 435-20141 Milano, Italy. nicoletta.colombo@ieo.it
authors.forename: Nicoletta
authors.initials: N
authors.lastname: Colombo
authors.forename: Elzbieta
authors.initials: E
authors.lastname: Kutarska
authors.forename: Meletios
authors.initials: M
authors.lastname: Dimopoulos
authors.forename: Duk-Soo
authors.initials: DS
authors.lastname: Bae
authors.forename: Izabella
authors.initials: I
authors.lastname: Rzepka-Gorska
authors.forename: Mariusz
authors.initials: M
authors.lastname: Bidzinski
authors.forename: Giovanni
authors.initials: G
authors.lastname: Scambia
authors.forename: Svend Aage
authors.initials: SA
authors.lastname: Engelholm
authors.forename: Florence
authors.initials: F
authors.lastname: Joly
authors.forename: Dirk
authors.initials: D
authors.lastname: Weber
authors.forename: Mona
authors.initials: M
authors.lastname: El-Hashimy
authors.forename: Jingjin
authors.initials: J
authors.lastname: Li
authors.forename: Farida
authors.initials: F
authors.lastname: Souami
authors.forename: Patricia
authors.initials: P
authors.lastname: Wing
authors.forename: Silke
authors.initials: S
authors.lastname: Engelholm
authors.forename: Aristotelis
authors.initials: A
authors.lastname: Bamias
authors.forename: Peter
authors.initials: P
authors.lastname: Schwartz
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000903:Antibiotics, Antineoplastic / Q000009:adverse effects / Q000627:therapeutic use; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use; D000077216:Carcinoma, Ovarian Epithelial; D004317:Doxorubicin / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D019008:Drug Resistance, Neoplasm; D034261:Epothilones / Q000009:adverse effects / Q000627:therapeutic use*; D005185:Fallopian Tube Neoplasms / Q000188:drug therapy*; D005260:Female; D006801:Humans; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy* / Q000473:pathology; D009375:Neoplasms, Glandular and Epithelial / Q000188:drug therapy* / Q000473:pathology; D009944:Organoplatinum Compounds / Q000627:therapeutic use; D010051:Ovarian Neoplasms / Q000188:drug therapy* / Q000473:pathology; D010534:Peritoneal Neoplasms / Q000188:drug therapy* / Q000473:pathology; D011092:Polyethylene Glycols / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D000903:Antibiotics, Antineoplastic; D000970:Antineoplastic Agents; D034261:Epothilones; D009944:Organoplatinum Compounds; C506643:liposomal doxorubicin; D011092:Polyethylene Glycols; D004317:Doxorubicin; C093788:epothilone B