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> (2005-2009) >
Phase II randomized...
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M Del Campo, JVall Hebron University Hospital
(författare)
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
- Artikel/kapitelEngelska2009
Förlag, utgivningsår, omfång ...
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Elsevier BV,2009
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printrdacarrier
Nummerbeteckningar
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LIBRIS-ID:oai:DiVA.org:liu-51784
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https://urn.kb.se/resolve?urn=urn:nbn:se:liu:diva-51784URI
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https://doi.org/10.1093/annonc/mdp198DOI
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https://urn.kb.se/resolve?urn=urn:nbn:se:umu:diva-30046URI
Kompletterande språkuppgifter
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Språk:engelska
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Sammanfattning på:engelska
Ingår i deldatabas
Klassifikation
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Ämneskategori:ref swepub-contenttype
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Ämneskategori:art swepub-publicationtype
Anmärkningar
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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.
Ämnesord och genrebeteckningar
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ovarian cancer
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phase II
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RECIST
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response rate
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trabectedin
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MEDICINE
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MEDICIN
Biuppslag (personer, institutioner, konferenser, titlar ...)
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Roszak, AWielkopolska Oncol Centre
(författare)
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Bidzinski, MMaria Sklodowska Curie Mem Canc Centre
(författare)
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Ciuleanu, T EIon Chiricuta Canc Institute
(författare)
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Högberg, ThomasÖstergötlands Läns Landsting,Linköpings universitet,Onkologi,Hälsouniversitetet,Onkologiska kliniken US(Swepub:liu)thoho49
(författare)
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Wojtukiewicz, M ZMed University, Comprehens Canc Centre Bialystok
(författare)
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Poveda, AValencian Institute Oncol
(författare)
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Boman, Karin,1946-Umeå universitet,Onkologi,Umeå University Hospital(Swepub:umu)kabo0010
(författare)
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Westermann, A MUniversity of Amsterdam
(författare)
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Lebedinsky, CPharmaMar Clin R&D
(författare)
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Vall Hebron University HospitalWielkopolska Oncol Centre
(creator_code:org_t)
Sammanhörande titlar
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Ingår i:ANNALS OF ONCOLOGY: Elsevier BV20:11, s. 1794-8020923-7534
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Ingår i:Annals of oncology : official journal of the European Society for Medical Oncology / ESMO: Elsevier BV20:11, s. 1794-8021569-8041
Internetlänk
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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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visa färre...
- 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