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Phase II Study of Pegylated Liposomal Doxorubicin in Combination With Gemcitabine in Patients With Metastatic Breast Cancer

Edgardo Rivera, Vicente Valero, Banu Arun, Melanie Royce, Rosni Adinin, Karen Hoelzer, Ronald Walters, James L. Wade, III, Lajos Pusztai, Gabriel N. Hortobagyi

From The Department of Breast Medical Oncology, Division of Cancer Medicine, The University of Texas M.D. Anderson Cancer Center, Houston, TX; M.D. Anderson Community Clinical Oncology Program, Decatur, IL.

Address reprint requests to Edgardo Rivera, MD, Department of Breast Medical Oncology, The University of Texas M.D. Anderson Cancer Center, 1515 Holcombe Blvd, Unit 424, Houston, TX 77030-4009; e-mail: erivera{at}mail.mdanderson.org.

Purpose: We conducted a phase II clinical trial to determine the clinical efficacy and safety of pegylated liposomal doxorubicin in combination with gemcitabine in patients with metastatic breast cancer.

Patients and Methods: Patients were eligible if they had measurable disease, no prior chemotherapy for metastatic disease, and a performance status 2 on the Zubrod scale. Patients received pegylated liposomal doxorubicin 24 mg/m² intravenously on day 1, plus gemcitabine 800 mg/m² intravenously on days 1 and 8 of each 21-day cycle.

Results: Of 49 patients enrolled, 27 had received prior adjuvant chemotherapy (19 with an anthracycline). Prior median cumulative anthracycline dose was 240 mg/m². In total, three complete responses and 21 partial responses were achieved in 46 assessable patients, for an overall response rate of 52% (95% confidence interval, 37% to 67%). Responses were observed in 11 (58%) of 19 patients with previous anthracycline exposure. Median response duration was 5.6 months, time to progression was 4.5 months, and overall survival was 16.1 months. Although the most common grade 3 to 4 toxicities were hematologic, few neutropenic complications resulted. The most frequent nonhematologic toxicities were nausea and vomiting, fatigue, stomatitis, and hand-foot syndrome. One patient previously treated with an anthracycline developed a transient decrease (21%) in the left ventricular ejection fraction, with cardiac function recovering within 2 months.

Conclusion: Pegylated liposomal doxorubicin in combination with gemcitabine is active and well tolerated in patients with metastatic breast cancer. Median overall survival was 16.1 months, and approximately 78% of patients derived clinical benefit from treatment. This regimen represents a therapeutic option for patients receiving front-line therapy for their metastatic breast cancer.

Supported by a research grant from Ortho Biotech Products LP, Bridgewater, NJ, and Eli Lilly and Company, Indianapolis, IN.

Results previously presented at the San Antonio Breast Cancer Symposium, December 11–14, 2002, San Antonio, TX.

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