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Phase II randomized...
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
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- M Del Campo, J (författare)
- Vall Hebron University Hospital
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- Roszak, A (författare)
- Wielkopolska Oncol Centre
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- Bidzinski, M (författare)
- Maria Sklodowska Curie Mem Canc Centre
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- Ciuleanu, T E (författare)
- Ion Chiricuta Canc Institute
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- Högberg, Thomas (författare)
- Östergötlands Läns Landsting,Linköpings universitet,Onkologi,Hälsouniversitetet,Onkologiska kliniken US
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- Wojtukiewicz, M Z (författare)
- Med University, Comprehens Canc Centre Bialystok
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- Poveda, A (författare)
- Valencian Institute Oncol
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- Boman, Karin, 1946- (författare)
- Umeå universitet,Onkologi,Umeå University Hospital
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- Westermann, A M (författare)
- University of Amsterdam
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- Lebedinsky, C (författare)
- PharmaMar Clin R&D
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(creator_code:org_t)
- Elsevier BV, 2009
- 2009
- Engelska.
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Ingår i: ANNALS OF ONCOLOGY. - : Elsevier BV. - 0923-7534. ; 20:11, s. 1794-802
- Relaterad länk:
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https://doi.org/10.1...
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https://urn.kb.se/re...
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https://doi.org/10.1...
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https://urn.kb.se/re...
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Abstract
Ämnesord
Stäng
- 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.
Nyckelord
- ovarian cancer
- phase II
- RECIST
- response rate
- trabectedin
- MEDICINE
- MEDICIN
Publikations- och innehållstyp
- ref (ämneskategori)
- art (ämneskategori)
Hitta via bibliotek
Till lärosätets databas
- Av författaren/redakt...
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M Del Campo, J
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Roszak, A
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Bidzinski, M
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Ciuleanu, T E
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Högberg, Thomas
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Wojtukiewicz, M ...
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visa fler...
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Poveda, A
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Boman, Karin, 19 ...
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Westermann, A M
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Lebedinsky, C
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- Artiklar i publikationen
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ANNALS OF ONCOLO ...
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Annals of oncolo ...
- Av lärosätet
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Linköpings universitet
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Umeå universitet