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

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.

Roszak, AWielkopolska Oncol Centre (author)
Bidzinski, MMaria Sklodowska Curie Mem Canc Centre (author)
Ciuleanu, T EIon Chiricuta Canc Institute (author)
Högberg, ThomasÖstergötlands Läns Landsting,Linköpings universitet,Onkologi,Hälsouniversitetet,Onkologiska kliniken US(Swepub:liu)thoho49 (author)
Wojtukiewicz, M ZMed University, Comprehens Canc Centre Bialystok (author)
Poveda, AValencian Institute Oncol (author)
Boman, Karin,1946-Umeå universitet,Onkologi,Umeå University Hospital(Swepub:umu)kabo0010 (author)
Westermann, A MUniversity of Amsterdam (author)
Lebedinsky, CPharmaMar Clin R&D (author)
Vall Hebron University HospitalWielkopolska Oncol Centre (creator_code:org_t)

In:ANNALS OF ONCOLOGY: Elsevier BV20:11, s. 1794-8020923-7534
In:Annals of oncology : official journal of the European Society for Medical Oncology / ESMO: Elsevier BV20:11, s. 1794-8021569-8041

By the author/editor: M Del Campo, J; Roszak, A; Bidzinski, M; Ciuleanu, T E; Högberg, Thomas; Wojtukiewicz, M ...; show more...; Poveda, A; Boman, Karin, 19 ...; Westermann, A M; Lebedinsky, C; show less...

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