{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,1]],"date-time":"2026-08-01T00:01:50Z","timestamp":1785542510922,"version":"3.56.0"},"reference-count":31,"publisher":"Oxford University Press (OUP)","issue":"2","license":[{"start":{"date-parts":[[2021,11,29]],"date-time":"2021-11-29T00:00:00Z","timestamp":1638144000000},"content-version":"vor","delay-in-days":767,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2020,2,1]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>In the phase III MONARCH 2 study (NCT02107703), abemaciclib plus fulvestrant significantly improved progression-free survival (PFS) versus placebo plus fulvestrant in patients with hormone receptor-positive (HR+), HER2-negative advanced breast cancer (ABC). This study assessed patient-reported pain, global health-related quality of life (HRQoL), functioning, and symptoms.<\/jats:p><\/jats:sec><jats:sec><jats:title>Materials and Methods<\/jats:title><jats:p>Abemaciclib or placebo (150 p.o. mg twice daily) plus fulvestrant (500 mg, per label) were randomly assigned (2:1). The modified Brief Pain Inventory, Short Form (mBPI-sf); European Organization for Research and Treatment of Cancer (EORTC) QoL Core 30 (QLQ-C30); and Breast Cancer Questionnaire (QLQ-BR23) assessed outcomes. Data were collected at baseline, cycle 2, every two cycles 3\u201313, thereafter at every three cycles, and 30\u2009days postdiscontinuation. Longitudinal mixed regression and Cox proportional hazards models assessed postbaseline change and time to sustained deterioration (TTSD) by study arm.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>On-treatment HRQoL scores were consistently maintained from baseline and similar between arms. Patients in the abemaciclib arm (n =\u2009446) experienced a 4.9-month delay in pain deterioration (mBPI-sf), compared with the control arm (n =\u2009223), and significantly greater TTSD on the mBPI-sf and analgesic use (hazard ratio, 0.76; 95% CI, 0.59\u20130.98) and QLQ-C30 pain item (hazard ratio, 0.62; 95% CI, 0.48\u20130.79). TTSD for functioning and most symptoms significantly favored the abemaciclib arm, including fatigue, nausea and vomiting, and cognitive and social functioning. Only diarrhea significantly favored the control arm (hazard ratio, 1.60; 95% CI, 1.20\u20132.10).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>HRQoL was maintained on abemaciclib plus fulvestrant. Alongside superior PFS and manageable safety profile, results support treatment with abemaciclib plus fulvestrant in a population of patients with endocrine-resistant HR+, HER2-negative ABC.<\/jats:p><\/jats:sec>","DOI":"10.1634\/theoncologist.2019-0551","type":"journal-article","created":{"date-parts":[[2019,10,24]],"date-time":"2019-10-24T19:35:14Z","timestamp":1571945714000},"page":"e243-e251","source":"Crossref","is-referenced-by-count":69,"title":["Health-Related Quality of Life in MONARCH 2: Abemaciclib plus Fulvestrant in Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer After Endocrine Therapy"],"prefix":"10.1093","volume":"25","author":[{"given":"Peter A.","family":"Kaufman","sequence":"first","affiliation":[{"name":"University of Vermont Cancer Center, University of Vermont Medical Center, Burlington, Vermont, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Masakazu","family":"Toi","sequence":"additional","affiliation":[{"name":"Department of Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Patrick","family":"Neven","sequence":"additional","affiliation":[{"name":"University Hospitals Leuven, Leuven, Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joohyuk","family":"Sohn","sequence":"additional","affiliation":[{"name":"Yonsei Cancer Center, Seoul, Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eva-Maria","family":"Grischke","sequence":"additional","affiliation":[{"name":"Department of Women's Health, University Hospital T\u00fcbingen, T\u00fcbingen, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Valerie","family":"Andre","sequence":"additional","affiliation":[{"name":"Eli Lilly and Company, Paris, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Clemens","family":"Stoffregen","sequence":"additional","affiliation":[{"name":"Eli Lilly and Company, Bad Homburg, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sarah","family":"Shekarriz","sequence":"additional","affiliation":[{"name":"Eli Lilly and Company, Bad Homburg, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gregory L.","family":"Price","sequence":"additional","affiliation":[{"name":"Eli Lilly and Company, Indianapolis, Indiana, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gebra Cuyun","family":"Carter","sequence":"additional","affiliation":[{"name":"Eli Lilly and Company, Indianapolis, Indiana, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"suffix":"Jr.","given":"George W.","family":"Sledge","sequence":"additional","affiliation":[{"name":"Stanford University School of Medicine, Stanford, California, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2019,10,24]]},"reference":[{"key":"2021122510121838700_R1","doi-asserted-by":"crossref","first-page":"5218","DOI":"10.1158\/1078-0432.CCR-17-0754","article-title":"Monarch 1, a phase II study of abemaciclib, a CDK4 and CDK6 inhibitor, as a single agent, in patients with refractory HR(+)\/HER2(\u2212) metastatic breast cancer","volume":"23","author":"Dickler","year":"2017","journal-title":"Clin Cancer Res"},{"key":"2021122510121838700_R2","doi-asserted-by":"crossref","first-page":"825","DOI":"10.1007\/s10637-014-0120-7","article-title":"Preclinical characterization of the CDK4\/6 inhibitor ly2835219: In-vivo cell cycle-dependent\/independent anti-tumor activities alone\/in combination with gemcitabine","volume":"32","author":"Gelbert","year":"2014","journal-title":"Invest New Drugs"},{"key":"2021122510121838700_R3","doi-asserted-by":"crossref","first-page":"740","DOI":"10.1158\/2159-8290.CD-16-0095","article-title":"Efficacy and safety of abemaciclib, an inhibitor of CDK4 and CDK6, for patients with breast cancer, non-small cell lung cancer, and other solid tumors","volume":"6","author":"Patnaik","year":"2016","journal-title":"Cancer Discov"},{"key":"2021122510121838700_R4","doi-asserted-by":"crossref","first-page":"2875","DOI":"10.1200\/JCO.2017.73.7585","article-title":"MONARCH2: Abemaciclib in combination with fulvestrant in women with HR+\/HER2- advanced breast cancer who had progressed while receiving endocrine therapy","volume":"35","author":"Sledge","year":"2017","journal-title":"J Clin Oncol"},{"issue":"15 suppl","key":"2021122510121838700_R5","doi-asserted-by":"crossref","first-page":"3101a","DOI":"10.1158\/1538-7445.AM2015-3101","article-title":"In-vitro characterization of abemaciclib pharmacology in ER+ breast cancer cell lines","volume":"75","author":"Lallena","year":"2015","journal-title":"Cancer Res"},{"key":"2021122510121838700_R6","doi-asserted-by":"crossref","first-page":"5","DOI":"10.1038\/s41523-018-0097-z","article-title":"Monarch 3 final PFS: A randomized study of abemaciclib as initial therapy for advanced breast cancer","volume":"17","author":"Johnston","year":"2019","journal-title":"NPJ Breast Cancer"},{"key":"2021122510121838700_R7","doi-asserted-by":"crossref","first-page":"1067","DOI":"10.1016\/j.chembiol.2019.05.005","article-title":"Multiomics profiling establishes the polypharmacology of FDA-approved CDK4\/6 inhibitors and the potential for differential clinical activity","volume":"26","author":"Hafner","year":"2019","journal-title":"Cell Chem Biol"},{"key":"2021122510121838700_R8","doi-asserted-by":"crossref","first-page":"3638","DOI":"10.1200\/JCO.2017.75.6155","article-title":"MONARCH 3: Abemaciclib as initial therapy for advanced breast cancer","volume":"35","author":"Goetz","year":"2017","journal-title":"J Clin Oncol"},{"issue":"5 suppl","key":"2021122510121838700_R9","doi-asserted-by":"crossref","first-page":"641","DOI":"10.6004\/jnccn.2016.0181","article-title":"NCCN guidelines update: Breast cancer","volume":"14","author":"Gradishar","year":"2016","journal-title":"J Natl Compr Canc Netw"},{"key":"2021122510121838700_R10","doi-asserted-by":"crossref","first-page":"16","DOI":"10.1093\/annonc\/mdw544","article-title":"3rd ESO-ESMO International Consensus Guidelines for advanced breast cancer (ABC 3)","volume":"28","author":"Cardoso","year":"2017","journal-title":"Ann Oncol"},{"key":"2021122510121838700_R11","doi-asserted-by":"crossref","first-page":"289","DOI":"10.1200\/JGO.2016.008318","article-title":"Paloma-3: Phase III trial of fulvestrant with or without palbociclib in premenopausal and postmenopausal women with hormone receptor-positive, human epidermal growth factor receptor 2-negative metastatic breast cancer that progressed on prior endocrine therapy\u2014Safety and efficacy in Asian patients","volume":"3","author":"Iwata","year":"2017","journal-title":"J Glob Oncol"},{"key":"2021122510121838700_R12","doi-asserted-by":"crossref","first-page":"127","DOI":"10.1007\/s10549-017-4518-8","article-title":"Ribociclib plus letrozole versus letrozole alone in pateints with de novo HR+, HER2-advanced breast cancer in the randomized monaleesa-2 trial","volume":"168","author":"O'Shaughnessy","year":"2018","journal-title":"Breast Cancer Res Treat"},{"key":"2021122510121838700_R13","doi-asserted-by":"crossref","first-page":"3","DOI":"10.1016\/S1359-6349(05)82018-X","article-title":"Combination versus sequential single-agent therapy for the treatment of metastatic breast cancer","volume":"3","author":"Modi","year":"2005","journal-title":"EJC Suppl"},{"key":"2021122510121838700_R14","doi-asserted-by":"crossref","first-page":"2286","DOI":"10.1093\/annonc\/mdy481","article-title":"Quality of life assessment using patient-reported outcome (PRO) measures: Still a cinderella outcome?","volume":"29","author":"Fallowfield","year":"2018","journal-title":"Ann Oncol"},{"key":"2021122510121838700_R15","first-page":"85","article-title":"Recurrent breat cancer: Treatment strategies for maintaining and prolonging quality of life","volume":"107","author":"Gerber","year":"2010","journal-title":"Dtsc Arztebl Int"},{"key":"2021122510121838700_R16","doi-asserted-by":"crossref","first-page":"116","DOI":"10.1097\/AJP.0b013e3181f3f667","article-title":"Fear of pain in patients with advanced cancer or in patients with chronic noncancer pain","volume":"27","author":"Lemay","year":"2011","journal-title":"Clin J Pain"},{"key":"2021122510121838700_R17","doi-asserted-by":"crossref","first-page":"2288","DOI":"10.1093\/annonc\/mdy449","article-title":"Deficiencies in health-related quality-of-life assessment and reporting: A systematic review of oncology randomized phase III trials published between 2012 and 2016","volume":"29","author":"Marandino","year":"2018","journal-title":"Ann Oncol"},{"key":"2021122510121838700_R18","volume-title":"Pain Assessment in Cancer","author":"Cleeland","year":"1991"},{"key":"2021122510121838700_R19","doi-asserted-by":"crossref","first-page":"365","DOI":"10.1093\/jnci\/85.5.365","article-title":"The European Organisation for Research and Treatment of Cancer QLQ-c30: A quality-of life instrument for use in international clinical trials in oncology","volume":"85","author":"Aaronson","year":"1993","journal-title":"J Natl Cancer Inst"},{"key":"2021122510121838700_R20","volume-title":"Cancer Pain Relief and Palliative Care: Report of a WHO Expert Committee","author":"World Health Organization","year":"1990"},{"key":"2021122510121838700_R21","doi-asserted-by":"crossref","first-page":"2756","DOI":"10.1200\/JCO.1996.14.10.2756","article-title":"The European Organization for Research and Treatment of Cancer breast cancer-specific quality-of-life questionnaire module: First results from a three-country field study","volume":"14","author":"Sprangers","year":"1996","journal-title":"J Clin Oncol"},{"key":"2021122510121838700_R22","doi-asserted-by":"crossref","first-page":"72","DOI":"10.1016\/j.suponc.2010.12.004","article-title":"Estimating minimally important differences for the worst pain rating of the brief pain inventory-Short Form","volume":"9","author":"Mathias","year":"2011","journal-title":"J Support Oncol"},{"key":"2021122510121838700_R23","doi-asserted-by":"crossref","first-page":"139","DOI":"10.1200\/JCO.1998.16.1.139","article-title":"Interpreting the significnace of changes in health-related quality of life scores","volume":"16","author":"Osoba","year":"1998","journal-title":"J Clin Oncol"},{"key":"2021122510121838700_R24","doi-asserted-by":"crossref","first-page":"535","DOI":"10.1007\/s10549-018-4769-z","article-title":"Health-related quality of life of postmenopausal women with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer treated with ribociclib + letrozole: Results from MONALEESA-2","volume":"170","author":"Verma","year":"2018","journal-title":"Breast Cancer Res Treat"},{"issue":"15 suppl","key":"2021122510121838700_R25","doi-asserted-by":"crossref","first-page":"1049a","DOI":"10.1200\/JCO.2018.36.15_suppl.1049","article-title":"Health-related quality of life (HRQOL) in MONARCH 2: Abemaciclib plus fulvestrant in women with HR+, HER2- advanced breast cancer (ABC) who progressed on endocrine therapy","volume":"36","author":"Kaufman","year":"2018","journal-title":"J Clin Oncol"},{"key":"2021122510121838700_R26","doi-asserted-by":"crossref","first-page":"1709","DOI":"10.1007\/s00520-013-1717-7","article-title":"Predictive factors for overall quality of life in patients with advanced cancer","volume":"21","author":"Cramarossa","year":"2013","journal-title":"Support Care Cancer"},{"key":"2021122510121838700_R27","doi-asserted-by":"crossref","first-page":"679","DOI":"10.1007\/s10549-015-3420-5","article-title":"Determining issues of importance for the evaluation of quality of life and patient-reported outcomes in breast cancer: Results of a survey of 1072 patients","volume":"151","author":"Hollen","year":"2015","journal-title":"Breast Cancer Res Treat"},{"key":"2021122510121838700_R28","article-title":"Patient preferences for palliative treatment of locally advanced or metastatic breast cancer: An adaptive choice-based conjoint analysis study from germany. Paper presented at: BMC Congress; January 2019; Berlin","author":"Weidling","journal-title":"Germany."},{"key":"2021122510121838700_R29","doi-asserted-by":"crossref","first-page":"1159","DOI":"10.1007\/s11136-011-0031-4","article-title":"Reliability of adverse symptom event reporting by clinicians","volume":"21","author":"Atkinson","year":"2012","journal-title":"Qual Lif Res"},{"key":"2021122510121838700_R30","doi-asserted-by":"crossref","first-page":"1047","DOI":"10.1093\/annonc\/mdw139","article-title":"Quality of life with plabociclib plus fulvestrant in previously treated hormone receptor-positive, HER2-negative metastatic breast cancer: Patient-reported outcomes from the PALOMA-3 trial","volume":"27","author":"Harbeck","year":"2016","journal-title":"Ann Oncol"},{"key":"2021122510121838700_R31","article-title":"EORTC QLQ-c30 Reference Values. Brussels, Belgium: EORTC Quality of Life","author":"Scott","year":"2008","journal-title":"Group"}],"container-title":["The Oncologist"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1634\/theoncologist.2019-0551","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1634\/theoncologist.2019-0551","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/academic.oup.com\/oncolo\/article-pdf\/25\/2\/e243\/41921137\/oncolo_25_2_e243.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"https:\/\/academic.oup.com\/oncolo\/article-pdf\/25\/2\/e243\/41921137\/oncolo_25_2_e243.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2022,10,2]],"date-time":"2022-10-02T14:55:19Z","timestamp":1664722519000},"score":1,"resource":{"primary":{"URL":"https:\/\/academic.oup.com\/oncolo\/article\/25\/2\/e243\/6443368"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2019,10,24]]},"references-count":31,"journal-issue":{"issue":"2","published-online":{"date-parts":[[2019,10,24]]},"published-print":{"date-parts":[[2020,2,1]]}},"URL":"https:\/\/doi.org\/10.1634\/theoncologist.2019-0551","relation":{},"ISSN":["1083-7159","1549-490X"],"issn-type":[{"value":"1083-7159","type":"print"},{"value":"1549-490X","type":"electronic"}],"subject":[],"published-other":{"date-parts":[[2020,2,1]]},"published":{"date-parts":[[2019,10,24]]}}}