title: Trabectedin as single agent in the salvage treatment of heavily treated ovarian cancer patients: a retrospective, multicenter study.
abstract: OBJECTIVE
  The aim of this multicenter, retrospective study was to evaluate the efficacy and the safety of single agent Trabectedin (ET-743, Yondelis) in very heavily treated, relapsed ovarian cancer (ROC) patients.
  
  
  METHODS
  Response to treatment was classified according to RECIST criteria. Progression-free (PFS), and overall survival (OS) were also assessed.
  
  
  RESULTS
  98 patients were analyzed (originally 67 platinum sensitive, and 31 platinum refractory/resistant). Median number of previous regimens was 4 (range: 1-6). In the whole population, overall response rate (ORR) was 27.5%; stable disease (SD) was observed in 33 patients (33.6%), and clinical benefit was achieved in 60 cases (61.2%). ORR was 38.6% in fully platinum sensitive population, and 26.1% in partially platinum sensitive patients. In platinum refractory/resistant disease, ORR was 12.9%. Overall, median PFS and OS were 5, and 13 months, respectively. Patients responding to Trabectedin showed a more favorable PFS (median = 9 months) than patients with SD (median = 6 months), or progression (median = 2 months). Median OS of responding patients was 18 months compared to 14 months in SD patients, and 9 months in progressing patients. Grade 3-4 neutropenia was observed in 17 (17.3%) patients. Transient and non-cumulative Grade 3-4 AST and ALT level elevation was found in 7 (7.1%), and 13 (13.3%) cases, respectively. There was 1 case of Grade 3, and 1 case of Grade 4 cardiac toxicity.
  
  
  CONCLUSIONS
  Trabectedin, as a single agent, retains its efficacy in terms of rate of ORR and clinical benefit in heavily treated ROC patients, especially in the group of platinum sensitive disease.
authors.affiliation: Gynecologic Oncology Unit, Catholic University of Rome, Italy. gabriella.ferrandina@libero.it
authors.forename: Gabriella
authors.initials: G
authors.lastname: Ferrandina
authors.forename: Vanda
authors.initials: V
authors.lastname: Salutari
authors.forename: Bruno
authors.initials: B
authors.lastname: Vincenzi
authors.forename: Marco
authors.initials: M
authors.lastname: Marinaccio
authors.forename: Emanuele
authors.initials: E
authors.lastname: Naglieri
authors.forename: Vera
authors.initials: V
authors.lastname: Loizzi
authors.forename: Silvia
authors.initials: S
authors.lastname: Carpano
authors.forename: Giulia
authors.initials: G
authors.lastname: Amadio
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Tonini
authors.forename: Giovanni
authors.initials: G
authors.lastname: Scambia
authors.forename: Domenica
authors.initials: D
authors.lastname: Lorusso
mesh_terms: D000328:Adult; D000368:Aged; D000410:Alanine Transaminase / Q000097:blood; D018906:Antineoplastic Agents, Alkylating / Q000009:adverse effects / Q000627:therapeutic use*; D001219:Aspartate Aminotransferases / Q000097:blood; D001247:Asthenia / Q000139:chemically induced; D002277:Carcinoma / Q000628:therapy*; D004149:Dioxoles / Q000009:adverse effects / Q000627:therapeutic use*; D018572:Disease-Free Survival; D019008:Drug Resistance, Neoplasm; D005260:Female; D006801:Humans; D008875:Middle Aged; D009503:Neutropenia / Q000139:chemically induced; D010051:Ovarian Neoplasms / Q000628:therapy*; D017671:Platinum Compounds; D012189:Retrospective Studies; D016879:Salvage Therapy; D044005:Tetrahydroisoquinolines / Q000009:adverse effects / Q000627:therapeutic use*; D000077606:Trabectedin
chemical_list: D018906:Antineoplastic Agents, Alkylating; D004149:Dioxoles; D017671:Platinum Compounds; D044005:Tetrahydroisoquinolines; D001219:Aspartate Aminotransferases; D000410:Alanine Transaminase; D000077606:Trabectedin
keywords: Ovarian cancer; Salvage treatment; Trabectedin