A Phase II study of trabectedin single agent in patients with recurrent ovarian cancer previously treated with platinum-based regimens.

A Phase II study of trabectedin single agent in patients with recurrent ovarian cancer previously treated with platinum-based regimens. Research Abstract Details 

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A Phase II study of trabectedin single agent in patients with recurrent ovarian cancer previously treated with platinum-based regimens. Abstract Text:

C N Krasner,D S McMeekin,S Chan,P S Braly,F G Renshaw,S Kaye,D M Provencher,S Campos,M E Gore,C N Krasner,D S McMeekin,S Chan,P S Braly,F G Renshaw,S Kaye,D M Provencher,S Campos,M E Gore,C N Krasner,D S McMeekin,S Chan,P S Braly,F G Renshaw,S Kaye,D M Provencher,S Campos,M E Gore,

The objective of this study was to determine the objective response rate in patients with platinum-sensitive and platinum-resistant recurrent ovarian cancer to treatment with trabectedin (Yondelis((R))) administered as a 3-h infusion weekly for 3 weeks of a 4-week cycle. We carried out a multicentre Phase II trial of trabectedin in patients with advanced recurrent ovarian cancer. Trabectedin (0.58 mg m(-2)) was administered via a central line, after premedication with dexamethasone, to 147 patients as a 3-h infusion weekly for 3 weeks followed by 1-week rest. Major eligibility criteria included measurable relapsed advanced ovarian cancer and not more than two prior platinum-containing regimens. Patients were stratified according to the treatment-free interval (TFI) between having either platinum-sensitive (>/=6 months TFI) or platinum-resistant disease (<6 months TFI)/platinum-refractory disease (progression during first line therapy). In the platinum-sensitive cohort, 62 evaluable patients with measurable disease had an overall response rate (ORR) of 29.0% (95% CI: 18.2-41.9%) and median progression-free survival (PFS) was 5.1 months (95% CI: 2.8-6.2). Four patients with measurable disease per Response Evaluation Criteria in Solid Tumours (RECIST) criteria had no follow-up scans at the end of treatment. In the platinum-resistant/refractory cohort, 79 patients were evaluable with an ORR of 6.3% (95% CI: 2.1-14.2%). Median PFS was 2.0 months (95% CI: 1.7-3.5 months). Two patients with measurable disease per RECIST criteria had no follow-up scans at the end of treatment. The most frequent (>/=2% of patients) drug-related treatment-emergent grade 3/4 adverse events were reversible liver alanine transferase elevation (10%), neutropaenia (8%), nausea, vomiting, and fatigue (5% each). Trabectedin is an active treatment, with documented responses in patients with platinum sensitive advanced relapsed ovarian cancer, and has a manageable toxicity profile.British Journal of Cancer (2007) 97, 1618-1624. doi:10.1038/sj.bjc.6604088 www.bjcancer.com Published online 13 November 2007.

A Phase II study of trabectedin single agent in patients with recurrent ovarian cancer previously treated with platinum-based regimens. Publishing Authors By Initials

CN Krasner,DS McMeekin,S Chan,PS Braly,FG Renshaw,S Kaye,DM Provencher,S Campos,ME Gore,CN Krasner,DS McMeekin,S Chan,PS Braly,FG Renshaw,S Kaye,DM Provencher,S Campos,ME Gore,CN Krasner,DS McMeekin,S Chan,PS Braly,FG Renshaw,S Kaye,DM Provencher,S Campos,ME Gore,

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A Phase II study of trabectedin single agent in patients with recurrent ovarian cancer previously treated with platinum-based regimens. Journal Published:

PUBLICATION TYPE: Journal Article

Journal: British journal of cancer

VOLUME: 97

Page Numbers: 1618-24

Journal Abbreviation: Br. J. Cancer

ISSN: 0007-0920

DAY: 13

MONTH: 11

YEAR: 2007

A Phase II study of trabectedin single agent in patients with recurrent ovarian cancer previously treated with platinum-based regimens. Information

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LANGUAGE: eng

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AFFILIATION: 1Department of Medical Oncology, Massachusetts General Hospital, Boston, MA, USA.

Country: England

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MEDLINETA: Br J Cancer

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