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Gemcitabine Plus Paclitaxel Versus Paclitaxel Monotherapy in Patients With Metastatic Breast Cancer and Prior Anthracycline Treatment

Kathy S. Albain, Shona M. Nag, German Calderillo-Ruiz, Johann P. Jordaan, Antonio C. Llombart, Anna Pluzanska, Janusz Rolski, Allen S. Melemed, Jose M. Reyes-Vidal, Jagdev S. Sekhon, Lorinda Simms, Joyce O'Shaughnessy

From the Loyola University Chicago Stritch School of Medicine, Cardinal Bernardin Cancer Center, Maywood, IL; Lilly Oncology and Department of Biostatistics, Eli Lilly & Company, Indianapolis, IN; Baylor-Sammons Cancer Center, TX Oncology, PA, US Oncology, Dallas, TX; Jehangir Hospital, Pune; Dayanand Medical College and Hospital, Ludhiana, Punjab, India; Instituto Nacional de Cancerologia, Mexico City, Mexico; Addington Hospital, Durban, South Africa; Instituto Valenciano de Oncologia, Valencia, Spain; Klinika Chemioterapii, Lodz, Poland; Centrum Onkologii, Krakow, Poland; and the Clinica Las Condes, Santiago, Chile

Corresponding author: Kathy S. Albain, MD, Loyola University Chicago Stritch School of Medicine, Cardinal Bernardin Cancer Center, 2160 S First Ave, Maywood, IL 60153; e-mail: kalbain{at}lumc.edu

Purpose The objective of this phase III global study was to compare the efficacy of gemcitabine plus paclitaxel (GT) versus paclitaxel in patients with advanced breast cancer. It was designed as a pivotal study for the approval of G for a breast cancer treatment indication.

Patients and Methods Patients who relapsed after adjuvant anthracyclines were randomly assigned to gemcitabine,1,250 mg/m² days 1 and 8 plus paclitaxel, 175 mg/m² on day 1; or, to paclitaxel at same dose on day 1 (both arms administered every 21 days, unblinded). The primary end point was overall survival (OS) and secondary end points were time to progression (TTP), response rate (RR), progression-free survival, response duration, and toxicity. This final OS analysis was planned at 380 deaths.

Results A total of 266 patients were randomly assigned to GT and 263 to paclitaxel. Median survival on GT was 18.6 months versus 15.8 months on paclitaxel (log-rank P = . 0489), with an adjusted Cox hazard ratio of 0.78 (95% CI, 0.64 to 0.96; P = .0187). The TTP was longer (6.14 v 3.98 months; log-rank P = .0002) and the RR was better (41.4% v 26.2%; P = .0002) on GT. There was more grade 3 to 4 neutropenia on GT and grade 2 to 4 fatigue and neuropathy were slightly more prevalent on GT.

Conclusion This phase III study documents a role for gemcitabine in advanced breast cancer after anthracycline-based adjuvant therapy. The results establish GT as a reasonable choice for women who require cytoreduction with manageable toxicities and validate ongoing testing of GT in the adjuvant setting.

Supported by Eli Lilly and Company (drug supply, data management and analysis, site audits, funding for independent radiology review, institutional review board fees and clinical research associate support).

Presented in part at the 39th Annual Meeting of the American Society of Clinical Oncology, Chicago, IL, May 31-June 3, 2003, and the 40th Annual Meeting of the American Society of Clinical Oncology, New Orleans, LA, June 5-8, 2004.

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

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