PMID- 29635145 OWN - NLM STAT- MEDLINE DCOM- 20190111 LR - 20190111 IS - 1879-0852 (Electronic) IS - 0959-8049 (Linking) VI - 95 DP - 2018 May TI - Treatment decisions and the impact of adverse events before and during extended endocrine therapy in postmenopausal early breast cancer. PG - 59-67 LID - S0959-8049(18)30732-9 [pii] LID - 10.1016/j.ejca.2018.03.014 [doi] AB - BACKGROUND: Extended endocrine therapy beyond 5 years for postmenopausal breast cancer has been studied within multiple phase III trials. Treatment compliance in these trials is generally poor. In this analysis, we aimed to determine factors that were associated with participation in the phase III Investigation on the Duration of Extended Adjuvant Letrozole (IDEAL) trial and with early treatment discontinuation, and how this influenced survival outcome. METHODS: In the IDEAL trial, postmenopausal patients were randomised between 2.5 or 5 years of extended letrozole, after completing 5 years of endocrine therapy for hormone receptor-positive early breast cancer. A subgroup of this population participated earlier in the Tamoxifen Exemestane Adjuvant Multinational trial (5 years of exemestane or 2.5 years of tamoxifen followed by exemestane as primary adjuvant therapy) in which we explored which factors were determinative for enrolment in the IDEAL study. In the IDEAL cohort, we evaluated which factors predicted for early treatment discontinuation and the effect of early treatment discontinuation on disease-free survival (DFS). RESULTS: Nodal status, younger age and adjuvant chemotherapy were significantly associated with higher enrolment in the IDEAL trial. In the IDEAL cohort, adverse events (AEs), the type of primary endocrine therapy and the interval between primary and extended therapy were associated with early treatment discontinuation. Among the reported AEs, depressive feelings (56%) were most frequently associated with early treatment discontinuation. Early treatment discontinuation was not associated with worse DFS (hazard ratio [HR] = 1.02, 95% confidence interval = 0.76-1.37). CONCLUSIONS: In this analysis, we found that risk factors were most strongly associated enrolment in the IDEAL trial. In contrast, patient experiences were the most significant factors leading to early treatment discontinuation, with no effect on DFS. CI - Copyright (c) 2018 Elsevier Ltd. All rights reserved. FAU - Blok, Erik J AU - Blok EJ AD - Department of Surgery, Leiden University Medical Center, Leiden, The Netherlands; Department of Medical Oncology, Leiden University Medical Center, Leiden, The Netherlands. FAU - Kroep, Judith R AU - Kroep JR AD - Department of Medical Oncology, Leiden University Medical Center, Leiden, The Netherlands. FAU - Meershoek-Klein Kranenbarg, Elma AU - Meershoek-Klein Kranenbarg E AD - Department of Surgery, Leiden University Medical Center, Leiden, The Netherlands. FAU - Duijm-de Carpentier, Marjolijn AU - Duijm-de Carpentier M AD - Department of Surgery, Leiden University Medical Center, Leiden, The Netherlands. FAU - Putter, Hein AU - Putter H AD - Department of Medical Statistics, Leiden University Medical Center, Leiden, The Netherlands. FAU - Liefers, Gerrit-Jan AU - Liefers GJ AD - Department of Surgery, Leiden University Medical Center, Leiden, The Netherlands. FAU - Nortier, Johan W R AU - Nortier JWR AD - Department of Medical Oncology, Leiden University Medical Center, Leiden, The Netherlands. FAU - Rutgers, Emiel J Th AU - Rutgers EJT AD - Department of Surgery, Netherlands Cancer Institute, Amsterdam, The Netherlands. FAU - Seynaeve, Caroline M AU - Seynaeve CM AD - Department of Medical Oncology, Erasmus MC Cancer Institute, Rotterdam, The Netherlands. FAU - van de Velde, Cornelis J H AU - van de Velde CJH AD - Department of Surgery, Leiden University Medical Center, Leiden, The Netherlands. Electronic address: c.j.h.van_de_velde@lumc.nl. CN - IDEAL and TEAM Study Groups LA - eng SI - EudraCT/2006-003958-16 SI - NTR/NTR3077 PT - Clinical Trial, Phase III PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20180407 PL - England TA - Eur J Cancer JT - European journal of cancer (Oxford, England : 1990) JID - 9005373 RN - 0 (Antineoplastic Agents, Hormonal) RN - 0 (Aromatase Inhibitors) RN - 7LKK855W8I (Letrozole) SB - IM MH - Aged MH - Antineoplastic Agents, Hormonal/*administration & dosage/*adverse effects MH - Aromatase Inhibitors/administration & dosage/adverse effects MH - Breast Neoplasms/*drug therapy/pathology MH - Chemotherapy, Adjuvant/adverse effects/methods MH - Decision Making MH - Drug Administration Schedule MH - Female MH - Humans MH - Letrozole/*administration & dosage/*adverse effects MH - Middle Aged MH - Neoplasm Staging MH - *Postmenopause/drug effects MH - Time Factors MH - Treatment Outcome OTO - NOTNLM OT - Adverse events OT - Aromatase inhibitor OT - Breast cancer OT - Clinical trial OT - Compliance OT - Early treatment discontinuation OT - Extended endocrine therapy OT - Survival OT - Tamoxifen EDAT- 2018/04/11 06:00 MHDA- 2019/01/12 06:00 CRDT- 2018/04/11 06:00 PHST- 2018/01/13 00:00 [received] PHST- 2018/03/12 00:00 [revised] PHST- 2018/03/13 00:00 [accepted] PHST- 2018/04/11 06:00 [pubmed] PHST- 2019/01/12 06:00 [medline] PHST- 2018/04/11 06:00 [entrez] AID - S0959-8049(18)30732-9 [pii] AID - 10.1016/j.ejca.2018.03.014 [doi] PST - ppublish SO - Eur J Cancer. 2018 May;95:59-67. doi: 10.1016/j.ejca.2018.03.014. Epub 2018 Apr 7.