PMID- 15774779
OWN - NLM
STAT- MEDLINE
DCOM- 20050405
LR  - 20181201
IS  - 0732-183X (Print)
IS  - 0732-183X (Linking)
VI  - 23
IP  - 9
DP  - 2005 Mar 20
TI  - Trabectedin for women with ovarian carcinoma after treatment with platinum and 
      taxanes fails.
PG  - 1867-74
AB  - PURPOSE: To assess the efficacy and toxicity of the marine-derived alkaloid 
      trabectedin (ET-743) in patients with advanced ovarian cancer refractory to or 
      experiencing disease relapse after platinum- and taxane-based chemotherapy. 
      PATIENTS AND METHODS: Fifty-nine patients from four institutions either resistant 
      (n = 30) or sensitive (n = 29) to prior platinum and taxanes were treated with a 
      3-hour infusion of trabectedin every 3 weeks. Patients were monitored weekly for 
      toxicity and restaged every two cycles for response. Response was assessed 
      according to Response Evaluation Criteria in Solid Tumors Group. RESULTS: The 
      peer-reviewed objective response rate in platinum-sensitive patients was 43% (95% 
      CI, 23% to 65%) with an estimated median time to progression of 7.9 months (95% 
      CI, 7.5 to 14.1 months); in platinum-resistant patients two partial responses 
      were observed. Responses were durable for up to 12.9 months (median, 5 months). 
      The predominant toxicities at the recommended dose of 1,300 microg/m(2) were 
      neutropenia, asthenia, and self-limited increase of aminotransferases never 
      requiring treatment interruption. CONCLUSION: Trabectedin administered as a 
      3-hour infusion at 1,300 microg/m(2) is a safe new drug with promising activity 
      in relapsed ovarian cancer, showing a 43% objective response rate in patients 
      with platinum-sensitive disease, which favorably compares with other salvage 
      treatments and warrants additional development either alone or in combination.
FAU - Sessa, Cristiana
AU  - Sessa C
AD  - Southern Europe New Drugs Organization Foundation, Via Visconti di Modrone 12, 
      20100 Milano, Italy. marsonis@sendo-org.it
FAU - De Braud, Filippo
AU  - De Braud F
FAU - Perotti, Antonella
AU  - Perotti A
FAU - Bauer, Jean
AU  - Bauer J
FAU - Curigliano, Giuseppe
AU  - Curigliano G
FAU - Noberasco, Cristina
AU  - Noberasco C
FAU - Zanaboni, Flavia
AU  - Zanaboni F
FAU - Gianni, Luca
AU  - Gianni L
FAU - Marsoni, Silvia
AU  - Marsoni S
FAU - Jimeno, Jose
AU  - Jimeno J
FAU - D'Incalci, Maurizio
AU  - D'Incalci M
FAU - Dall'o, Elisa
AU  - Dall'o E
FAU - Colombo, Nicoletta
AU  - Colombo N
LA  - eng
PT  - Clinical Trial
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - J Clin Oncol
JT  - Journal of clinical oncology : official journal of the American Society of 
      Clinical Oncology
JID - 8309333
RN  - 0 (Antineoplastic Agents, Alkylating)
RN  - 0 (Bridged-Ring Compounds)
RN  - 0 (Dioxoles)
RN  - 0 (Isoquinolines)
RN  - 0 (Taxoids)
RN  - 0 (Tetrahydroisoquinolines)
RN  - 1605-68-1 (taxane)
RN  - ID0YZQ2TCP (Trabectedin)
RN  - Q20Q21Q62J (Cisplatin)
SB  - IM
MH  - Adult
MH  - Aftercare
MH  - Aged
MH  - Aged, 80 and over
MH  - Antineoplastic Agents, Alkylating/administration & dosage/adverse 
      effects/*therapeutic use
MH  - Antineoplastic Combined Chemotherapy Protocols/therapeutic use
MH  - Bridged-Ring Compounds/administration & dosage
MH  - Cisplatin/administration & dosage/adverse effects
MH  - Dioxoles/administration & dosage/adverse effects/*therapeutic use
MH  - Drug Administration Schedule
MH  - Female
MH  - Humans
MH  - Infusions, Intravenous
MH  - Isoquinolines/administration & dosage/adverse effects/*therapeutic use
MH  - Middle Aged
MH  - Ovarian Neoplasms/classification/*drug therapy/pathology
MH  - Salvage Therapy
MH  - Taxoids/administration & dosage
MH  - Tetrahydroisoquinolines
MH  - Trabectedin
MH  - Treatment Failure
EDAT- 2005/03/19 09:00
MHDA- 2005/04/06 09:00
CRDT- 2005/03/19 09:00
PHST- 2005/03/19 09:00 [pubmed]
PHST- 2005/04/06 09:00 [medline]
PHST- 2005/03/19 09:00 [entrez]
AID - 23/9/1867 [pii]
AID - 10.1200/JCO.2005.09.032 [doi]
PST - ppublish
SO  - J Clin Oncol. 2005 Mar 20;23(9):1867-74. doi: 10.1200/JCO.2005.09.032.