title: Trabectedin plus pegylated liposomal doxorubicin: retrospective analysis in heavily pretreated platinum-sensitive ovarian cancer.
abstract: OBJECTIVE
  This retrospective analysis evaluated treatment with trabectedin plus pegylated liposomal doxorubicin (PLD) in 34 heavily pretreated patients (median number of previous lines, 3; range, 2-10) with platinum-sensitive relapsed ovarian cancer (ROC) at a single center in Italy.
  
  
  METHODS
  Trabectedin/PLD treatment consisted of trabectedin administered every 3 weeks as a 3-hour intravenous (i.v.) infusion at a dose of 1.1 mg/m2, immediately after PLD 30 mg/m2 i.v. infusion. Study objectives were the evaluation of the objective response rate (ORR), progression-free survival (PFS) and overall survival (OS).
  
  
  RESULTS
  Three complete responses and 8 partial responses were observed, with an ORR of 32.4% (95% CI, 17.4-50.5%). Median PFS was 6.1 months (95% CI, 4.4-8.9 months). Median OS was 16.3 months (95% CI, 6.8-23.5). Most responses (9 of 11) were found in patients with partially platinum-sensitive disease (ORR 40.9% in this subset; median PFS 6.8 months and median OS 20.8 months). Grade 3 treatment-related adverse events consisted of nausea/vomiting (n = 5; 14.7%), mucositis (n = 2; 5.9%), alanine aminotransferase increase, anemia and neutropenia (n = 1 each; 2.9%).
  
  
  CONCLUSIONS
  The overall findings appear consistent with those previously observed in a randomized controlled clinical trial, and support the use of trabectedin/PLD in heavily pretreated patients with platinum-sensitive ROC, especially those with partially platinum-sensitive disease.
authors.affiliation: Medical Oncology Unit, Istituto Oncologico Veneto IOV-IRCCS, Padua - Italy.
authors.forename: Maria Ornella
authors.initials: MO
authors.lastname: Nicoletto
authors.forename: Alessandra
authors.initials: A
authors.lastname: Baldoni
authors.forename: Alessandra
authors.initials: A
authors.lastname: Casarin
authors.forename: Giovanni
authors.initials: G
authors.lastname: Randon
authors.forename: Margherita
authors.initials: M
authors.lastname: Nardin
authors.forename: Zora
authors.initials: Z
authors.lastname: Baretta
authors.forename: Pilar
authors.initials: P
authors.lastname: Lardelli
authors.forename: Antonio
authors.initials: A
authors.lastname: Nieto
authors.forename: Vicente
authors.initials: V
authors.lastname: Alfaro
authors.forename: Claudia
authors.initials: C
authors.lastname: Rigamonti
authors.forename: Pier Franco
authors.initials: PF
authors.lastname: Conte
mesh_terms: D000328:Adult; D000368:Aged; D000903:Antibiotics, Antineoplastic / Q000008:administration & dosage; D018906:Antineoplastic Agents, Alkylating / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D004149:Dioxoles / Q000008:administration & dosage; D018572:Disease-Free Survival; D004317:Doxorubicin / Q000008:administration & dosage / Q000031:analogs & derivatives; D005260:Female; D006801:Humans; D008875:Middle Aged; D010051:Ovarian Neoplasms / Q000188:drug therapy*; D017671:Platinum Compounds / Q000008:administration & dosage; D011092:Polyethylene Glycols / Q000008:administration & dosage; D012189:Retrospective Studies; D044005:Tetrahydroisoquinolines / Q000008:administration & dosage; D000077606:Trabectedin; D016896:Treatment Outcome
chemical_list: D000903:Antibiotics, Antineoplastic; D018906:Antineoplastic Agents, Alkylating; D004149:Dioxoles; D017671:Platinum Compounds; D044005:Tetrahydroisoquinolines; C506643:liposomal doxorubicin; D011092:Polyethylene Glycols; D004317:Doxorubicin; D000077606:Trabectedin