PMID- 22865782 OWN - NLM STAT- MEDLINE DCOM- 20130619 LR - 20240229 IS - 1569-8041 (Electronic) IS - 0923-7534 (Linking) VI - 23 IP - 12 DP - 2012 Dec TI - Relationship between specific adverse events and efficacy of exemestane therapy in early postmenopausal breast cancer patients. PG - 3091-3097 LID - S0923-7534(19)37489-7 [pii] LID - 10.1093/annonc/mds204 [doi] AB - BACKGROUND: Many adverse events (AEs) associated with aromatase inhibitors (AIs) involve symptoms related to the depletion of circulating estrogens, and may be related to efficacy. We assessed the relationship between specific AEs [hot flashes (HF) and musculoskeletal AEs (MSAE)] and survival outcomes in Dutch and Belgian patients treated with exemestane (EXE) in the Tamoxifen Exemestane Adjuvant Multinational (TEAM) trial. Additionally, the relationship between hormone receptor expression and AEs was assessed. METHODS: Efficacy end points were relapse-free survival (RFS), overall survival (OS) and breast cancer-specific mortality (BCSM), starting at 6 months after starting EXE treatment. AEs reported in the first 6 months of treatment were included. Specific AEs comprised HF and/or MSAE. Landmark analyses and Cox proportional hazards models assessed survival differences up to 5 years. RESULTS: A total of 1485 EXE patients were included. Patients with HF had a better RFS than patients without HF [multivariate hazard ratio (HR) 0.393, 95% confidence interval (CI) 0.19-0.813; P = 0.012]. The occurrence of MSAE versus no MSAE did not relate to better RFS (multivariate HR 0.677, 95% CI 0.392-1.169; P = 0.162). Trends were maintained for OS and BCSM. Quantitative hormone receptor expression was not associated with specific AEs. CONCLUSIONS: Some AEs associated with estrogen depletion are related to better outcomes and may be valuable biomarkers in AI treatment. FAU - Fontein, D B Y AU - Fontein DBY AD - Department of Surgery, Leiden University Medical Center, Leiden. FAU - Houtsma, D AU - Houtsma D AD - Department of Medical Oncology, Leiden University Medical Center, Leiden. FAU - Hille, E T M AU - Hille ETM AD - Department of Surgery, Leiden University Medical Center, Leiden. FAU - Seynaeve, C AU - Seynaeve C AD - Department of Medical Oncology, Erasmus MC-Daniel den Hoed Cancer Center, Rotterdam. FAU - Putter, H AU - Putter H AD - Department of Medical Statistics, Leiden University Medical Center, Leiden. FAU - Meershoek-Klein Kranenbarg, E AU - Meershoek-Klein Kranenbarg E AD - Department of Surgery, Leiden University Medical Center, Leiden. FAU - Guchelaar, H J AU - Guchelaar HJ AD - Department of Clinical Pharmacy & Toxicology, Leiden University Medical Center, Leiden, The Netherlands. FAU - Gelderblom, H AU - Gelderblom H AD - Department of Medical Oncology, Leiden University Medical Center, Leiden. FAU - Dirix, L Y AU - Dirix LY AD - St Augustinus Hospital, Wilrijk. FAU - Paridaens, R AU - Paridaens R AD - UZ Gasthuisberg, Leuven, Belgium. FAU - Bartlett, J M S AU - Bartlett JMS AD - Ontario Institute for Cancer Research, Toronto, Canada; Department of Pathology, University of Edinburgh, Edinburgh, UK. FAU - Nortier, J W R AU - Nortier JWR AD - Department of Medical Oncology, Leiden University Medical Center, Leiden. FAU - van de Velde, C J H AU - van de Velde CJH AD - Department of Surgery, Leiden University Medical Center, Leiden. Electronic address: c.j.h.van_de_velde@lumc.nl. CN - Dutch TEAM Steering Committee LA - eng PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20120802 PL - England TA - Ann Oncol JT - Annals of oncology : official journal of the European Society for Medical Oncology JID - 9007735 RN - 0 (Androstadienes) RN - 0 (Antineoplastic Agents) RN - 0 (Aromatase Inhibitors) RN - NY22HMQ4BX (exemestane) SB - IM MH - Adult MH - Aged MH - Aged, 80 and over MH - Androstadienes/*adverse effects/*therapeutic use MH - Antineoplastic Agents/adverse effects/therapeutic use MH - Aromatase Inhibitors/*adverse effects/*therapeutic use MH - *Breast Neoplasms/drug therapy/mortality/pathology MH - Chemotherapy, Adjuvant MH - Disease-Free Survival MH - Female MH - Humans MH - Middle Aged MH - Neoplasm Recurrence, Local MH - Postmenopause MH - Treatment Outcome EDAT- 2012/08/07 06:00 MHDA- 2013/06/20 06:00 CRDT- 2012/08/07 06:00 PHST- 2012/08/07 06:00 [entrez] PHST- 2012/08/07 06:00 [pubmed] PHST- 2013/06/20 06:00 [medline] AID - S0923-7534(19)37489-7 [pii] AID - 10.1093/annonc/mds204 [doi] PST - ppublish SO - Ann Oncol. 2012 Dec;23(12):3091-3097. doi: 10.1093/annonc/mds204. Epub 2012 Aug 2.