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Journal of Clinical Oncology, Vol 18, Issue 7 (April), 2000: 1399-1411
© 2000 American Society for Clinical Oncology

Exemestane Is Superior to Megestrol Acetate After Tamoxifen Failure in Postmenopausal Women With Advanced Breast Cancer: Results of a Phase III Randomized Double-Blind Trial

By Manfred Kaufmann, Emilio Bajetta, Luc Yves Dirix, Luis Enrique Fein, Stephen E. Jones, Nicoletta Zilembo, Jean-Louis Dugardyn, Cristina Nasurdi, Robert G. Mennel, Jozica Cervek, Camilla Fowst, Anna Polli, Enrico di Salle, Alexei Arkhipov, Gabriella Piscitelli, Langdon L. Miller, Giorgio Massimini, for the Exemestane Study Group

From the Universitätsklinik, Frankfurt, Germany; Istituto Nazionale Tumori, Milan, Italy; Sint-Augustinus Ziekenhuis, Antwerpen, Belgium; Centro Oncologico de Rosario, Santa Fe, Argentina; Physicians Reliance Network Research, Baylor-Sammons Cancer Center, Dallas, Texas; Institute of Oncology, Ljubljana, Slovenia; and Pharmacia & Upjohn, Italy and United States.

Address reprint requests to Manfred Kaufmann, MD, Department of Gynecology and Oncology, Johann Wolfgang Goeth-Universität Frankfurt, Theodor-Stern-Kai 7, D-60590 Frankfurt, Germany.

PURPOSE: This phase III, double-blind, randomized, multicenter study evaluated the efficacy, pharmacodynamics, and safety of the oral aromatase inactivator exemestane (EXE) versus megestrol acetate (MA) in postmenopausal women with progressive advanced breast cancer who experienced failure of tamoxifen.

PATIENTS AND METHODS: A total of 769 patients were randomized to EXE 25 mg/d (n = 366) or MA (n = 403) 40 mg four times daily. Tumor response, duration of tumor control, tumor-related signs and symptoms (TRSS), quality of life (QOL), survival, and tolerability were evaluated.

RESULTS: Overall objective response (OR) rates were higher in patients treated with EXE than in those treated with MA (15.0% v 12.4%); a similar trend was noted in patients with visceral metastases (13.5% v 10.5%). Median survival time was significantly longer with EXE (median not reached) than with MA (123.4 weeks; P = .039), as were the median duration of overall success (OR or stable disease >= 24 weeks; 60.1 v 49.1 weeks; P = .025), time to tumor progression (20.3 v 16.6 weeks; P = .037), and time to treatment failure (16.3 v 15.7 weeks; P = .042). Compared with MA, there were similar or greater improvements in pain, TRSS, and QOL with EXE. Both drugs were well tolerated. Grade 3 or 4 weight changes were more common with MA (17.1% v 7.6%; P = .001).

CONCLUSION: EXE prolongs survival time, time to tumor progression, and time to treatment failure compared with MA and offers a well-tolerated treatment option for postmenopausal women with progressive advanced breast cancer who experienced failure of tamoxifen.




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