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Title: Trabectedin Plus Pegylated Liposomal Doxorubicin in Recurrent Ovarian Cancer
Authors: Monk, Bradley J ×
Herzog, Thomas J
Kaye, Stanley B
Krasner, Carolyn N
Vermorken, Jan B
Muggia, Franco M
Pujade-Lauraine, Eric
Lisyanskaya, Alla S
Makhson, Anatoly N
Rolski, Janusz
Gorbounova, Vera A
Ghatage, Prafull
Bidzinski, Mariusz
Shen, Keng
Ngan, Hextan Yuen-Sheung
Vergote, Ignace
Nam, Joo-Hyun
Park, Youn Choi
Lebedinsky, Claudia A
Poveda, Andrés M #
Issue Date: Jun-2010
Publisher: Grune & Stratton
Series Title: Journal of Clinical Oncology vol:28 issue:19 pages:3107-3114
Abstract: PURPOSE The objective of this study was to compare the efficacy and safety of trabectedin plus pegylated liposomal doxorubicin (PLD) with that of PLD alone in women with recurrent ovarian cancer after failure of first-line, platinum-based chemotherapy. PATIENTS AND METHODS Women >/= 18 years, stratified by performance status (0 to 1 v 2) and platinum sensitivity, were randomly assigned to receive an intravenous infusion of PLD 30 mg/m(2) followed by a 3-hour infusion of trabectedin 1.1 mg/m(2) every 3 weeks or PLD 50 mg/m(2) every 4 weeks. The primary end point was progression-free survival (PFS) by independent radiology assessment. Results Patients (N = 672) were randomly assigned to trabectedin/PLD (n = 337) or PLD (n = 335). Median PFS was 7.3 months with trabectedin/PLD v 5.8 months with PLD (hazard ratio, 0.79; 95% CI, 0.65 to 0.96; P = .0190). For platinum-sensitive patients, median PFS was 9.2 months v 7.5 months, respectively (hazard ratio, 0.73; 95% CI, 0.56 to 0.95; P = .0170). Overall response rate (ORR) was 27.6% for trabectedin/PLD v 18.8% for PLD (P = .0080); for platinum-sensitive patients, it was 35.3% v 22.6% (P = .0042), respectively. ORR, PFS, and overall survival among platinum-resistant patients were not statistically different. Neutropenia was more common with trabectedin/PLD. Grade 3 to 4 transaminase elevations were also more common with the combination but were transient and noncumulative. Hand-foot syndrome and mucositis were less frequent with trabectedin/PLD than with PLD alone. CONCLUSION When combined with PLD, trabectedin improves PFS and ORR over PLD alone with acceptable tolerance in the second-line treatment of recurrent ovarian cancer.
URI: 
ISSN: 0732-183X
Publication status: published
KU Leuven publication type: IT
Appears in Collections:Gynaecological Oncology
× corresponding author
# (joint) last author

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