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Phase II randomized study of trabectedin given as two different every 3 weeks dose schedules (1.5 mg/m(2) 24 h or 1.3 mg/m(2) 3 h) to patients with relapsed, platinum-sensitive, advanced ovarian cancer
Vall Hebron University Hospital.
Wielkopolska Oncol Centre.
Maria Sklodowska Curie Mem Canc Centre.
Ion Chiricuta Canc Institute.
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2009 (English)In: ANNALS OF ONCOLOGY, ISSN 0923-7534, Vol. 20, no 11, 1794-1802 p.Article in journal (Refereed) Published
Abstract [en]

Patients and methods: Patients previously treated with less than two or two previous chemotherapy lines were randomized to receive trabectedin 1.5 mg/m(2) 24 h (arm A, n = 54) or 1.3 mg/m(2) 3 h (arm B, n = 53). Objective response rate (ORR) per RECIST was the primary efficacy end point. Toxic effects were graded according to the National Cancer Institute-Common Toxicity Criteria v. 2.0. Results: ORR was 38.9% [95% confidence interval (CI) 25.9% to 53.1%; arm A] and 35.8% (95% CI 23.1% to 50.2%; arm B) (intention-to-treat primary analysis). Median time to progression was 6.2 months (95% CI 5.3-8.6 months; arm A) and 6.8 months (95% CI 4.6-7.4 months; arm B). Frequent severe adverse events were nausea/vomiting (24%, arm A; 15%, arm B) and fatigue (15%, arm A; 10%, arm B). Common severe laboratory abnormalities were transient, noncumulative neutropenia (55%, arm A; 37%, arm B) and transaminase increases (alanine aminotransferase, 55%, arm A; 59%, arm B). Conclusions: Both every-3-weeks trabectedin regimes, 1.5 mg/m(2) 24 h and 1.3 mg/m(2) 3 h, were active and reasonably well tolerated in AOC platinum-sensitive patients. Trabectedin every-3-weeks has promising activity and deserves to be further evaluated in relapsed AOC.

Place, publisher, year, edition, pages
2009. Vol. 20, no 11, 1794-1802 p.
Keyword [en]
ovarian cancer, phase II, RECIST, response rate, trabectedin
National Category
Medical and Health Sciences
URN: urn:nbn:se:liu:diva-51784DOI: 10.1093/annonc/mdp198OAI: diva2:277390
Available from: 2009-11-18 Created: 2009-11-17 Last updated: 2009-11-18

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Högberg, Thomas
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Oncology Faculty of Health SciencesDepartment of Oncology UHL
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