Steroidal Side Effects of Exemestane

Field: Pharmacology, Toxicology and Pharmaceutics (Life Sciences)

Article Tools SPECIAL DEPARTMENTS Article Tools OPTIONS & TOOLS Export Citation Track Citation Add To Favorites Rights & Permissions COMPANION ARTICLES No companion articles ARTICLE CITATION DOI: 10.1200/JCO.2001.19.7.2107 Journal of Clinical Oncology - published online before print September 21, 2016 PMID: 11283149 Steroidal Side Effects of Exemestane Jean-Marc A. NabholtzxJean-Marc A. NabholtzSearch for articles by this author M. KaufmannxM. KaufmannSearch for articles by this author Show More University of California at Los Angeles, Jonsson Comprehensive Cancer Center, UCLA, Los Angeles, CAKlinik für Gynäkologie und Geburtschilfe, Klinikum der Johann Wolfgang Goethe-Universität, Frankfurt am Main, Germany https://doi.org/10.1200/JCO.2001.19.7.2107 First Page Full Text PDF Figures and Tables © 2001 by American Society of Clinical OncologyjcoJ Clin OncolJournal of Clinical OncologyJCO0732-183X1527-7755American Society of Clinical OncologyResponse01042001In Reply:We thank Dr Nabholtz for his comments on the phase III trial comparing the effect of exemestane versus megestrol acetate in women with metastatic breast cancer progressing on or after tamoxifen. As he points out, we reported only the drug-related adverse events, to isolate the true effect (in this case, negative) of the drugs. The data Nabholtz refers to are available to the oncology community through the Physician Desk Reference,1 where adverse events of all causes are reported.Also, in response to his concerns, androgenic adverse events of all grade and cause were not detailed in our publication because their level was below the threshold of 2% (in fact, it was approximately 1% or lower) chosen for reporting the events in tabular format. Androgenic events reported appeared rather early on in treatment, within the first 8 weeks of therapy, and did not affect more than two or three patients at any given time, with a follow-up period that reached 2 years for some patients. Nabholtz also refers to a potential increase in weight for patients treated with exemestane. To clarify, the analysis refers to any weight change (upward or downward), and to the worst grade observed on treatment.When one considers the weight gain observed in the exemestane arm versus that observed in the megestrol acetate arm, there seems to be no cause for concern with exemestane.When treating breast cancer, especially in the advanced stages, the primary factor governing selection of therapy is survival. Only exemestane has prospectively demonstrated both prolongation of time to progression and improvement in survival compared with megestrol acetate. In addition, reports of androgenic events associated with exemestane are infrequent and usually associated with supratherapeutic doses.Large randomized adjuvant and first-line studies in breast cancer patients in which antiaromatase agents are not used on a background of heavy pretreatment are presently ongoing and should allow us to better assess the merits and pitfalls of long-term exposure to these agents.1. Aromasin tablets, in Physicians Desk Reference. Montvale, NJ, Medical Economics Company, 2000 Google Scholar