PMID- 25596682 OWN - NLM STAT- MEDLINE DCOM- 20150430 LR - 20161125 IS - 0385-0684 (Print) IS - 0385-0684 (Linking) VI - 42 IP - 1 DP - 2015 Jan TI - [Everolimus plus exemestane in postmenopausal patients with estrogen-receptor-positive advanced breast cancer - Japanese subgroup analysis of BOLERO -2]. PG - 67-75 AB - 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. FAU - Ito, Yoshinori AU - Ito Y AD - Breast Medical Oncology, Breast Oncology Center, Cancer Institute Hospital of JFCR. FAU - Masuda, Norikazu AU - Masuda N FAU - Iwata, Hiroji AU - Iwata H FAU - Mukai, Hirofumi AU - Mukai H FAU - Horiguchi, Jun AU - Horiguchi J FAU - Tokuda, Yutaka AU - Tokuda Y FAU - Kuroi, Katsumasa AU - Kuroi K FAU - Mori, Asuka AU - Mori A FAU - Ohno, Nobutsugu AU - Ohno N FAU - Noguchi, Shinzaburo AU - Noguchi S LA - jpn PT - Clinical Trial, Phase III PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PL - Japan TA - Gan To Kagaku Ryoho JT - Gan to kagaku ryoho. Cancer & chemotherapy JID - 7810034 RN - 0 (Androstadienes) RN - 0 (Receptors, Estrogen) RN - 9HW64Q8G6G (Everolimus) RN - NY22HMQ4BX (exemestane) RN - W36ZG6FT64 (Sirolimus) SB - IM MH - Adult MH - Aged MH - Androstadienes/administration & dosage MH - Antineoplastic Combined Chemotherapy Protocols/*therapeutic use MH - Breast Neoplasms/*drug therapy/metabolism/pathology MH - Double-Blind Method MH - Everolimus MH - Female MH - Humans MH - Middle Aged MH - Postmenopause MH - Receptors, Estrogen/metabolism MH - Sirolimus/administration & dosage/analogs & derivatives EDAT- 2015/01/19 06:00 MHDA- 2015/05/01 06:00 CRDT- 2015/01/19 06:00 PHST- 2015/01/19 06:00 [entrez] PHST- 2015/01/19 06:00 [pubmed] PHST- 2015/05/01 06:00 [medline] PST - ppublish SO - Gan To Kagaku Ryoho. 2015 Jan;42(1):67-75.