PMID- 25752740 OWN - NLM STAT- MEDLINE DCOM- 20150728 LR - 20181202 IS - 1879-0852 (Electronic) IS - 0959-8049 (Linking) VI - 51 IP - 6 DP - 2015 Apr TI - Health related quality of life of women in TEACH, a randomised placebo controlled adjuvant trial of lapatinib in early stage Human Epidermal Growth Factor Receptor (HER2) overexpressing breast cancer. PG - 685-96 LID - S0959-8049(15)00168-9 [pii] LID - 10.1016/j.ejca.2015.02.005 [doi] AB - BACKGROUND: To evaluate health related quality of life (HRQOL) in TEACH, a phase III randomized placebo controlled trial of 12 months of adjuvant lapatinib in HER2 positive (HER2+) early breast cancer which demonstrated marginal benefit in disease-free survival. METHODS: Women on TEACH completed the Short Form 36-item health survey (version2; SF-36v2) at the baseline, six and 12 months after therapy initiation and six monthly thereafter. Mean changes were compared between treatment groups for two summary measures (Physical and Mental Component Summary scores; PCS and MCS) and eight domain measures (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health), and in patients discontinuing therapy. A five-point change was deemed a Minimally Clinically Important Difference (MCID). Response analysis compared the proportion of patients demonstrating a MCID in HRQOL, and a regression analysis identified predictors of worsening HRQOL. FINDINGS: 3074 (97%) subjects completed baseline SF-36v2. During the initial 12 months, summary SF-36v2 scores decreased in both arms but did not reach Minimally Clinically Important Difference (MCID) despite significant incidences of diarrhoea and rash in lapatinib treated patients. At six months, women receiving lapatinib had more significant reductions (p < 0.01 versus placebo) in social functioning. Early treatment discontinuations were more frequent on lapatinib (32% versus 18%), and were associated with more substantial decrements of HRQOL in both arms. For those discontinuing primarily due to adverse events, decrements in HRQOL reached MCID in Mental Summary scores (MCS) only. Lower baseline HRQOL was a significant predictor of worsening HRQOL (p < 0.05). INTERPRETATION: Despite frequent but usually mild toxicities, adjuvant lapatinib is not associated with clinically significant decreases in overall HRQOL. These placebo-controlled results may also help to inform physicians and patients using lapatinib in metastatic HER2 positive breast cancer. FUNDING: GlaxoSmithKline. The AVON Foundation NY supported PEG, DF and BM and The Friends of the Mater Foundation supported FB. CI - Copyright (c) 2015 Elsevier Ltd. All rights reserved. FAU - Boyle, Frances M AU - Boyle FM AD - Mater Hospital, Sydney, Australia. Electronic address: frances.boyle@sydney.edu.au. FAU - Smith, Ian E AU - Smith IE AD - Royal Marsden Hospital, London, UK. FAU - O'Shaughnessy, Joyce AU - O'Shaughnessy J AD - Baylor Sammons Cancer Center, Texas Oncology, US Oncology, Dallas, TX, United States. FAU - Ejlertsen, Bent AU - Ejlertsen B AD - Rigshospitalet, DBCG Secretariat, Copenhagen, Denmark. FAU - Buzdar, Aman U AU - Buzdar AU AD - UT MD Anderson Cancer Center, Houston, TX, United States. FAU - Fumoleau, Pierre AU - Fumoleau P AD - Centre GF Leclerc, Dijon, France. FAU - Gradishar, William AU - Gradishar W AD - Northwestern University, Chicago, IL, United States. FAU - Martin, Miguel AU - Martin M AD - Hospital Universitario Gregorio Maranon, Universidad Complutense, Madrid, Spain. FAU - Moy, Beverly AU - Moy B AD - Massachusetts General Hospital, Boston, MA, United States. FAU - Piccart-Gebhart, Martine AU - Piccart-Gebhart M AD - Institut Jules Bordet, Universite Libre de Bruxelles, Brussels, Belgium. FAU - Pritchard, Kathleen I AU - Pritchard KI AD - Sunnybrook Odette Cancer Centre, University of Toronto, Toronto, Canada. FAU - Lindquist, Deborah AU - Lindquist D AD - Arizona Oncology, US Oncology, Sedona, AZ, United States. FAU - Amonkar, Mayur AU - Amonkar M AD - GlaxoSmithKline, Collegeville, PA, United States; GlaxoSmithKline, Uxbridge, UK. FAU - Huang, Yingjie AU - Huang Y AD - GlaxoSmithKline, Collegeville, PA, United States; GlaxoSmithKline, Uxbridge, UK. FAU - Rappold, Erica AU - Rappold E AD - GlaxoSmithKline, Collegeville, PA, United States; GlaxoSmithKline, Uxbridge, UK. FAU - Williams, Lisa S AU - Williams LS AD - GlaxoSmithKline, Collegeville, PA, United States; GlaxoSmithKline, Uxbridge, UK. FAU - Wang-Silvanto, Jing AU - Wang-Silvanto J AD - GlaxoSmithKline, Collegeville, PA, United States; GlaxoSmithKline, Uxbridge, UK. FAU - Kaneko, Tomomi AU - Kaneko T AD - GlaxoSmithKline, Collegeville, PA, United States; GlaxoSmithKline, Uxbridge, UK. FAU - Finkelstein, Dianne M AU - Finkelstein DM AD - Massachusetts General Hospital, Boston, MA, United States. FAU - Goss, Paul E AU - Goss PE AD - Massachusetts General Hospital, Boston, MA, United States. CN - TEACH Investigators LA - eng SI - ClinicalTrials.gov/NCT00374322 PT - Clinical Trial, Phase III PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20150306 PL - England TA - Eur J Cancer JT - European journal of cancer (Oxford, England : 1990) JID - 9005373 RN - 0 (Antineoplastic Agents) RN - 0 (Quinazolines) RN - 0VUA21238F (Lapatinib) RN - EC 2.7.10.1 (ERBB2 protein, human) RN - EC 2.7.10.1 (Receptor, ErbB-2) SB - IM MH - Antineoplastic Agents/*therapeutic use MH - Breast Neoplasms/*drug therapy/enzymology/pathology MH - Chemotherapy, Adjuvant MH - Disease-Free Survival MH - Female MH - Humans MH - Lapatinib MH - Middle Aged MH - Quality of Life MH - Quinazolines/*therapeutic use MH - Receptor, ErbB-2/*biosynthesis MH - Surveys and Questionnaires OTO - NOTNLM OT - Adjuvant breast cancer OT - Early breast cancer OT - HER2 positive OT - HRQOL OT - Health related quality of life OT - Human Epidermal Growth Factor Receptor (HER2) OT - Lapatinib OT - Placebo OT - SF-36 OT - Tykerb/Tyverb Evaluation After Chemotherapy (TEACH) trial FIR - Blajman IR - Blajman FIR - Fein IR - Fein FIR - Jankilevich IR - Jankilevich FIR - Lacava IR - Lacava FIR - Lerzo IR - Lerzo FIR - Richardet IR - Richardet FIR - Varela IR - Varela FIR - Zarba IR - Zarba FIR - Chan IR - Chan FIR - Boyle IR - Boyle FIR - Chirgwin IR - Chirgwin FIR - Dalley IR - Dalley FIR - Foo IR - Foo FIR - Koczwara IR - Koczwara FIR - Lynch IR - Lynch FIR - McCarthy IR - McCarthy FIR - Nowak IR - Nowak FIR - Patterson IR - Patterson FIR - Shannon IR - Shannon FIR - Snyder IR - Snyder FIR - Underhill IR - Underhill FIR - de Boer IR - de Boer FIR - Awada IR - Awada FIR - barrios IR - barrios FIR - Cortes IR - Cortes FIR - Cruz IR - Cruz FIR - Oliveira IR - Oliveira FIR - Wainstein IR - Wainstein FIR - Zereu IR - Zereu FIR - bin Blondal IR - bin Blondal FIR - Desjardins IR - Desjardins FIR - Goel IR - Goel FIR - Haider IR - Haider FIR - Hag IR - Hag FIR - Krishnan IR - 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Seiler Jr IR - Seiler Jr FIR - Shimkus IR - Shimkus FIR - Silverman IR - Silverman FIR - Sivarajan IR - Sivarajan FIR - Sleckman IR - Sleckman FIR - Smith IR - Smith FIR - Swan Jr IR - Swan Jr FIR - Van Haelst IR - Van Haelst FIR - Vogel IR - Vogel FIR - Vrindavanam IR - Vrindavanam FIR - Weckstein IR - Weckstein FIR - Weisberg IR - Weisberg FIR - White Jr IR - White Jr FIR - Wright IR - Wright FIR - Wu IR - Wu FIR - Yanagihara IR - Yanagihara FIR - Kuebler IR - Kuebler FIR - Letzer IR - Letzer FIR - Lindquist IR - Lindquist EDAT- 2015/03/11 06:00 MHDA- 2015/07/29 06:00 CRDT- 2015/03/11 06:00 PHST- 2014/08/28 00:00 [received] PHST- 2015/02/05 00:00 [revised] PHST- 2015/02/11 00:00 [accepted] PHST- 2015/03/11 06:00 [entrez] PHST- 2015/03/11 06:00 [pubmed] PHST- 2015/07/29 06:00 [medline] AID - S0959-8049(15)00168-9 [pii] AID - 10.1016/j.ejca.2015.02.005 [doi] PST - ppublish SO - Eur J Cancer. 2015 Apr;51(6):685-96. doi: 10.1016/j.ejca.2015.02.005. Epub 2015 Mar 6.