Title
Trabectedin plus pegylated liposomal doxorubicin (PLD) versus PLD in recurrent ovarian cancer : overall survival analysis Trabectedin plus pegylated liposomal doxorubicin (PLD) versus PLD in recurrent ovarian cancer : overall survival analysis
Author
Faculty/Department
Faculty of Medicine and Health Sciences
Publication type
article
Publication
Oxford ,
Subject
Human medicine
Source (journal)
European journal of cancer. - Oxford, 1990, currens
Volume/pages
48(2012) :15 , p. 2361-2368
ISSN
0959-8049
ISI
000309265400009
Carrier
E
Target language
English (eng)
Full text (Publishers DOI)
Affiliation
University of Antwerp
Abstract
Aim: Trabectedin in combination with pegylated liposomal doxorubicin (PLD) improves progression-free survival (PFS) compared to PLD alone in recurrent ovarian cancer (J Clin Oncol 2010; 28: 3107-14). Methods: Women, stratified by performance status (0-1 versus 2) and platinum sensitivity (platinum-free interval [PFI] < 6 versus >= 6 months), were randomly assigned to receive PLD 30 mg/m(2) IV followed by a 3-h infusion of trabectedin 1.1 mg/m(2) every 3 weeks or PLD 50 mg/m(2) every 4 weeks. The study was powered to show a 33% increase in overall survival (OS) after 520 deaths had occurred. Results: After a median follow-up of 47.4 months, there were 522 deaths among 672 subjects. The median OS for trabectedin + PLD and PLD arms was 22.2 and 18.9 months, respectively (hazard ratio [HR] = 0.86; 95% confidence interval [CI]: 0.72-1.02; p = 0.0835). An unexpected but significant imbalance in the PFI favouring the PLD arm (mean PFI: PLD = 13.3 months, trabectedin + PLD = 10.6 months) was identified. On the basis of this finding, an unplanned hypothesis generating analysis adjusting for the PFI imbalance and other prognostic factors suggested an improvement in OS associated with the trabectedin + PLD arm (HR = 0.82; 95% CI: 0.69-0.98; p = 0.0285). In another unplanned exploratory analysis, the subset of patients with a PFI of 6-12 months had the largest difference in OS (HR = 0.64; 95% CI: 0.47-0.86; p = 0.0027). Conclusions: The final OS analysis did not meet the protocol-defined criterion for statistical significance. Despite stratification on platinum sensitivity, there was an imbalance in mean platinum free interval that had an effect on OS. (C) 2012 Elsevier Ltd. All rights reserved.
E-info
https://repository.uantwerpen.be/docman/iruaauth/595e93/58b2773.pdf
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