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Randomized Phase III Trial of Gemcitabine Compared With Pegylated Liposomal Doxorubicin in Patients With Platinum-Resistant Ovarian Cancer

David G. Mutch, Mauro Orlando, Tiana Goss, Michael G. Teneriello, Alan N. Gordon, Scott D. McMeekin, Yanping Wang, Dennis R. Scribner, Jr, Martin Marciniack, R. Wendel Naumann, Angeles Alvarez Secord

From the Washington University School of Medicine, St. Louis, MO; Eli Lilly & Co, Indianapolis, IN; Texas Oncology Cancer Center, Austin; Sammons Cancer Center, Baylor University Medical Center, Dallas, TX; University of Oklahoma Health Sciences Center, Oklahoma City, OK; Carilion GYN Oncology Associates, Roanoke, VA; Carolinas Medical Center, Charlotte; and the Duke University Medical Center, Durham, NC

Address reprint requests to David G. Mutch, MD, Washington University School of Medicine, Department of Obstetrics and Gynecology, Division of Gynecologic Oncology, 4911 Barnes Jewish Hospital Plaza, St Louis, MO 63110; e-mail: mutchd{at}msnotes.wustl.edu

Purpose: Ovarian cancer (OC) patients experiencing progressive disease (PD) within 6 months of platinum-based therapy in the primary setting are considered platinum resistant (Pt-R). Currently, pegylated liposomal doxorubicin (PLD) is a standard of care for treatment of recurrent Pt-R disease. On the basis of promising phase II results, gemcitabine was compared with PLD for efficacy and safety in taxane-pretreated Pt-R OC patients.

Patients and Methods: Patients (n = 195) with Pt-R OC were randomly assigned to either gemcitabine 1,000 mg/m² (days 1 and 8; every 21 days) or PLD 50 mg/m² (day 1; every 28 days) until PD or undue toxicity. Optional cross-over therapy was allowed at PD or at withdrawal because of toxicity. Primary end point was progression-free survival (PFS). Additional end points included tumor response, time to treatment failure, survival, and quality of life.

Results: In the gemcitabine and PLD groups, median PFS was 3.6 v 3.1 months; median overall survival was 12.7 v 13.5 months; overall response rate (ORR) was 6.1% v 8.3%; and in the subset of patients with measurable disease, ORR was 9.2% v 11.7%, respectively. None of the efficacy end points showed a statistically significant difference between treatment groups. The PLD group experienced significantly more hand-foot syndrome and mucositis; the gemcitabine group experienced significantly more constipation, nausea/vomiting, fatigue, and neutropenia but not febrile neutropenia.

Conclusion: Although this was not designed as an equivalency study, gemcitabine and PLD seem to have a comparable therapeutic index in this population of Pt-R taxane-pretreated OC patients. Single-agent gemcitabine may be an acceptable alternative to PLD for patients with Pt-R OC.

Supported by Eli Lilly & Co.

Presented in part at the 29th European Congress on Clinical Oncology, October 30-November 3, 2005, Paris, France; and at the 37th Annual Meeting of the Society of Gynecologic Oncologists, March 22-26, 2006, Palm Springs, CA.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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