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Treatment of Advanced Hormone-Sensitive Breast Cancer in Postmenopausal Women With Exemestane Alone or in Combination With Celecoxib

Luc Yves Dirix, Jorge Ignacio, Shona Nag, Poonamally Bapsy, Henry Gomez, Digumarti Raghunadharao, Robert Paridaens, Stephen Jones, Silvia Falcon, Marina Carpentieri, Antonello Abbattista, Jean-Pierre Lobelle

From the Medical Oncology Unit, Oncologisch Centrum Sint-Augustinus, Wilrijk, Belgium; Philippine General Hospital, Manilla, Philippines; Jehangi Hospital, Pune, India; Kidwa Memorial Institute of Oncology, Bangalore, India; Instituto Nacional de Enfermedades Neoplasicas, Lima, Peru; Department of Medical Oncology, Nizam's Institute of Medical Sciences, Hyderabad, India; University Hospital Gasthuisberg, Leuven, Belgium; US Oncology, Dallas, TX; Es Salud, Lima, Peru; Pfizer Oncology, New York, NY

Corresponding author: Luc Y. Dirix, MD, Oncologisch Centrum Sint-Augustinus, Oosterveldlaan 24, 2610 Wilrijk, Belgium; e-mail: luc.dirix{at}gvagroup.be

Purpose: Preclinical data showed that the combination of exemestane and celecoxib has synergistic effects. Therefore, a study was undertaken to explore the efficacy and tolerability of this combination in postmenopausal patients with advanced, hormone-sensitive breast cancer.

Patients and Methods: A randomized phase II study was conducted in postmenopausal patients with hormone-sensitive breast cancer and measurable disease who had progressive disease after treatment with tamoxifen. Patients were randomly assigned to either exemestane 25 mg daily or the combination of exemestane 25 mg daily with celecoxib 400 mg twice daily. Response Evaluation Criteria in Solid Tumors Group criteria were used to determine antitumor efficacy. Primary end point was the rate of clinical benefit. Secondary end points were tolerability, objective response rate, time to progression (TTP), and duration of clinical benefit. A pharmacodynamic and a pharmacokinetic study were conducted in parallel.

Results: One hundred eleven patients (exemestane, n = 55; combination, n = 56) were enrolled in 2002. The demographic characteristics and prognostic factors were similar in both arms. In the assessable population, 24 of 51 patients in the combination arm and 24 of 49 patients in the exemestane arm achieved clinical benefit. TTP was similar in both groups. Duration of clinical benefit was longer in the combination group (median, 96.6 v 49.1 weeks). The addition of celecoxib did not change the tolerability profile of exemestane alone.

Conclusion: Similar rates of clinical benefit were achieved in both groups.

Supported by Pfizer Inc.

Presented in part at the 39th Annual Meeting of the American Society of Clinical Oncology, May 31-June 3, 2003, Chicago, IL (abstr 77).

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