title: [Everolimus plus exemestane in postmenopausal patients with estrogen-receptor-positive advanced breast cancer - Japanese subgroup analysis of BOLERO -2].
abstract: In a phase 3, double-blind, randomized, international study (the BOLERO-2), the addition of mTOR inhibitor everolimus to exemestane was evaluated in postmenopausal women with estrogen-receptor-positive (ER⁺) advanced/recurrent breast cancer that was refractory to any nonsteroidal aromatase inhibitor (NSAI). This report presents the safety and updated (18- month) efficacy results from the Japanese subset (n=106) of BOLERO-2. After a median follow-up of 18 months, the median progression-free survival time was 8.5 months with everolimus plus exemestane compared to 4.2 months with placebo plus exemestane. The most common adverse events (AEs) with everolimus plus exemestane were stomatitis, rash, dysgeusia, and non-infectious lung disease. The AEs reported with the combination therapy were mostly of grade 1 or 2 and manageable with appropriate intervention. In conclusion, this combination could be a useful addition to the armamentarium of treatments for Japanese postmenopausal women with ER⁺ advanced/recurrent breast cancer progressing on NSAIs.
authors.affiliation: Breast Medical Oncology, Breast Oncology Center, Cancer Institute Hospital of JFCR.
authors.forename: Yoshinori
authors.initials: Y
authors.lastname: Ito
authors.forename: Norikazu
authors.initials: N
authors.lastname: Masuda
authors.forename: Hiroji
authors.initials: H
authors.lastname: Iwata
authors.forename: Hirofumi
authors.initials: H
authors.lastname: Mukai
authors.forename: Jun
authors.initials: J
authors.lastname: Horiguchi
authors.forename: Yutaka
authors.initials: Y
authors.lastname: Tokuda
authors.forename: Katsumasa
authors.initials: K
authors.lastname: Kuroi
authors.forename: Asuka
authors.initials: A
authors.lastname: Mori
authors.forename: Nobutsugu
authors.initials: N
authors.lastname: Ohno
authors.forename: Shinzaburo
authors.initials: S
authors.lastname: Noguchi
mesh_terms: D000328:Adult; D000368:Aged; D000730:Androstadienes / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000378:metabolism / Q000473:pathology; D004311:Double-Blind Method; D000068338:Everolimus; D005260:Female; D006801:Humans; D008875:Middle Aged; D017698:Postmenopause; D011960:Receptors, Estrogen / Q000378:metabolism; D020123:Sirolimus / Q000008:administration & dosage / Q000031:analogs & derivatives
chemical_list: D000730:Androstadienes; D011960:Receptors, Estrogen; D000068338:Everolimus; C056516:exemestane; D020123:Sirolimus