Title
Patient-reported outcomes in relapsed ovarian cancer : results from a randomized Phase III study of trabectedin with pegylated liposomal doxorubicin (PLD) versus PLD alone Patient-reported outcomes in relapsed ovarian cancer : results from a randomized Phase III study of trabectedin with pegylated liposomal doxorubicin (PLD) versus PLD alone
Author
Faculty/Department
Faculty of Medicine and Health Sciences
Publication type
article
Publication
New York ,
Subject
Human medicine
Source (journal)
Gynecologic oncology. - New York
Volume/pages
127(2012) :1 , p. 161-167
ISSN
0090-8258
ISI
000308783800030
Carrier
E
Target language
English (eng)
Full text (Publishers DOI)
Affiliation
University of Antwerp
Abstract
Objective. Trabectedin in combination with PLD improves progression-free suivival (PFS) and overall response rate (ORR) in comparison to PLD alone in patients with relapsed ovarian cancer (J Clin Oncol; 2010 28:3107-14). Here we report the impact of the treatment combination on patient-reported functional status and symptoms. Methods. Patient-reported outcome (PRO) questionnaires, EORTC-QLQ C30, OV28, and EQ-5D were completed by patients at screening and on Day 1 of every other treatment cycle starting with Cycle 1, and at the end-of-treatment visit. Results. Of the 672 patients randomized in this study, 663 treated patients completed at least one of the baseline questionnaires. Median cycles of treatment was 6 (131 days) for the combination arm and 5 (143 days) for the monotherapy arm. Longitudinal data analyses showed no significant differences between the treatment arms for any of the pre-specified scales. Similar analyses of other scales, including Health Index scores and Health State on the Visual Analog Scale, support these findings. Start of subsequent therapy was significantly delayed in the combination arm compared with the monotherapy arm (p = 0.0032). Conclusions. The addition of trabectedin to PLD led to little or no decrement in patient-reported functional status and symptoms in patients with relapsed ovarian cancer, as compared to treatment with PLD alone. The combination led to manageable and non-cumulative overall toxicity with a fewer PLD-associated adverse events, and a significant improvement in PFS and ORR compared to single agent. (C) 2012 Elsevier Inc. All rights reserved.
E-info
https://repository.uantwerpen.be/docman/iruaauth/60f314/b0a2778.pdf
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