Trabectedin plus pegylated liposomal doxorubicin in recurrent ovarian cancer
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.
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- Authors
- Monk, B. J., Herzog, T. J., Kaye, S. B., Krasner, C. N., Vermorken, J. B., Muggia, F. M., Pujade-Lauraine, E., Lisyanskaya, A. S., Makhson, A. N., Rolski, J., Gorbounova, V. A., Ghatage, P., Bidzinski, M., Shen, K., Ngan, H. Y.-S., Vergote, I. B., Nam, J.-H., Park, Y. C., Lebedinsky, C. A., & Poveda, A. M.
- Affiliations
- University of California, Irvine (US)
- From the University of California at Irvine (UCI) and UCI Medical Center, Orange, CA; Columbia University College of Physicians and Surgeons; New York University Hospital, New York, NY; the Royal Marsden Hospital, Surrey, United Kingdom; Gillette Center for Women's Studies, Massachusetts General Hospital, Boston, MA; Antwerp University Hospital, Edegem; University Hospital, Leuven, Belgium; Université Paris Descartes, Assistance Publique Hôpitaux de Paris, Hôpital Hôtel-Dieu, Paris, France; SPBSIH City...
- ORCID
- Venue
- Journal of Clinical Oncology
- Published
- 2010-07-01
- Volume
- 28
- Issue
- 19
- Pages
- 3107-3114
- ISSN
- 0732-183X (ISSN-L)
- 1527-7755
- OpenAlex
- W2125064537
- Cited by
- 395
- References
- 30
- Citations by year
- 2026: 2 · 2025: 4 · 2024: 9 · 2023: 10 · 2022: 17 · 2021: 25 · 2020: 18 · 2019: 13 · 2018: 25 · 2017: 41 · 2016: 26 · 2015: 32 · 2014: 37 · 2013: 40 · 2012: 37
- FWCI
- 51.61
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Journal of Clinical Oncology (publishedVersion)
- PubMed (publishedVersion)
- The HKU Scholars Hub (University of Hong Kong) (submittedVersion)
- Topics
- Health Sciences › Medicine › Reproductive Medicine › Ovarian cancer diagnosis and treatment
- Health Sciences › Medicine › Oncology › PARP inhibition in cancer therapy
- Health Sciences › Medicine › Oncology › Cancer Treatment and Pharmacology
- Keywords
- trabectedin, pegylated liposomal doxorubicin, recurrent ovarian cancer, second-line chemotherapy, platinum-resistant ovarian cancer, platinum-sensitive ovarian cancer, progression-free survival, overall response rate, neutropenia, transaminase elevation, hand-foot syndrome, mucositis
- MeSH terms
- Trabectedin, Adult, Aged, Aged, 80 and over, Antineoplastic Combined Chemotherapy Protocols, Dioxoles, Doxorubicin, Drug Administration Schedule, Female, Humans, Leukopenia, Middle Aged, Neoplasm Recurrence, Local, Neutropenia, Ovarian Neoplasms, Polyethylene Glycols, Stomatitis, Multivariate Analysis, Treatment Outcome, Tetrahydroisoquinolines, Kaplan-Meier Estimate
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