Reduced-Frequency Endocrine Therapy and Challenges of Noninferiority Study Designs
Mené sur 180 patientes atteintes d'un cancer du sein ER+ après la ménopause, cet essai randomisé de phase IIB compare l'intérêt, du point de vue du niveau sérique d'estradiol avant le traitement chirurgical, de deux schémas posologiques d'exémestane en traitement adjuvant
In this issue of JAMA Oncology, Serrano et al present results of a phase 2b trial of postmenopausal women with early-stage breast cancer assessing change in serum estradiol levels and breast tumor Ki-67 after 4 to 6 weeks of 3-times-weekly or once-weekly exemestane reduced-frequency regimens vs the standard 25 mg daily. The primary end point was the noninferiority of change in serum estradiol between the reduced-frequency and standard-frequency arms when estradiol was measured by solid-phase extraction followed by liquid chromatography–tandem mass spectrometry. The 3-times-weekly and once-weekly dosing regimens were selected based on prior observations of exemestane’s long half-life (27 hours) and at least partial suppression of aromatase activity 9 days after a single 25-mg dose.
JAMA Oncology , commentaire, 2022