{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,27]],"date-time":"2026-02-27T16:14:47Z","timestamp":1772208887704,"version":"3.50.1"},"reference-count":16,"publisher":"MDPI AG","issue":"1","license":[{"start":{"date-parts":[[2022,12,23]],"date-time":"2022-12-23T00:00:00Z","timestamp":1671753600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Takeda Development Center Americas, Inc."}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JCM"],"abstract":"<jats:p>Mobocertinib, an oral, first-in-class epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor selective for EGFR exon 20 insertions (ex20ins), achieved durable responses in adults with previously treated EGFR ex20ins+ metastatic non-small cell lung cancer (mNSCLC) in the EXCLAIM extension cohort of a phase 1\/2 study (N = 96; NCT02716116). We assessed patient-reported outcomes (PROs) with mobocertinib 160 mg once daily (28-day cycles) in EXCLAIM (N = 90) with the European Organisation for Research and Treatment of Cancer Core Quality-of-Life Questionnaire (EORTC QLQ-C30) v3.0, lung cancer module (QLQ-LC13), EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) questionnaire, and selected PRO Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) questionnaire. Median treatment duration was 6.8 (range, 0.0\u201318.8) months (median follow-up: 13.0 [0.7\u201318.8] months; data cutoff: 1 November 2020). Clinically meaningful improvements in lung cancer symptoms measured by EORTC QLQ-LC13 were observed for dyspnea (54.4% of patients), cough (46.7%), and chest pain (38.9%), evident at cycle 2 and throughout treatment (least-squares mean [LSM] changes from baseline: dyspnea, \u22123.2 [p = 0.019]; cough, \u22129.3 [p &lt; 0.001]; chest pain, \u22128.2 [p &lt; 0.001]). EORTC QLQ-C30 results indicated no statistically significant changes in global health status\/quality of life (LSM change from baseline: \u22121.8 [p = 0.235]). On symptom scores, significant worsening from baseline was observed for diarrhea (LSM change from baseline: +34.1; p &lt; 0.001) and appetite loss (+6.6; p = 0.004), while improvements were observed for dyspnea (LSM change from baseline: \u22125.1 [p = 0.002]), insomnia (\u22126.5 [p = 0.001]), and constipation (\u22125.7 [p &lt; 0.001]). EQ-5D-5L health status was maintained. Common PRO-CTCAE symptoms were diarrhea, dry skin, rash, and decreased appetite (mostly low grade); in the first 24 weeks of treatment, 64.4% of patients had worsening diarrhea frequency and 67.8% had worsening dry skin severity. Overall, PROs with mobocertinib showed clinically meaningful improvement in lung cancer\u2013related symptoms, with health-related quality of life maintained despite changes in some adverse event symptom scales.<\/jats:p>","DOI":"10.3390\/jcm12010112","type":"journal-article","created":{"date-parts":[[2022,12,27]],"date-time":"2022-12-27T02:50:01Z","timestamp":1672109401000},"page":"112","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":10,"title":["Mobocertinib (TAK-788) in EGFR Exon 20 Insertion+ Metastatic NSCLC: Patient-Reported Outcomes from EXCLAIM Extension Cohort"],"prefix":"10.3390","volume":"12","author":[{"given":"Maria","family":"Garcia Campelo","sequence":"first","affiliation":[{"name":"Department of Medical Oncology, University Hospital Complex A Coru\u00f1a, 15006 A Coru\u00f1a, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Caicun","family":"Zhou","sequence":"additional","affiliation":[{"name":"Department of Oncology, Shanghai Pulmonary Hospital, Shanghai 200433, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Suresh","family":"Ramalingam","sequence":"additional","affiliation":[{"name":"Winship Cancer Institute, Emory University, Atlanta, GA 30322, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Huamao","family":"Lin","sequence":"additional","affiliation":[{"name":"Takeda Development Center Americas, Inc., Lexington, MA 02421, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6145-4426","authenticated-orcid":false,"given":"Tae","family":"Kim","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine, Seoul National University Hospital, Seoul 03080, Republic of Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gregory","family":"Riely","sequence":"additional","affiliation":[{"name":"Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY 10065, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tarek","family":"Mekhail","sequence":"additional","affiliation":[{"name":"Advent Health Orlando, Orlando, FL 32803, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2479-2271","authenticated-orcid":false,"given":"Danny","family":"Nguyen","sequence":"additional","affiliation":[{"name":"Pacific Shores Medical Group, Long Beach, CA 90813, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Erin","family":"Goodman","sequence":"additional","affiliation":[{"name":"Takeda Development Center Americas, Inc., Lexington, MA 02421, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Minal","family":"Mehta","sequence":"additional","affiliation":[{"name":"Takeda Development Center Americas, Inc., Lexington, MA 02421, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2087-4963","authenticated-orcid":false,"given":"Sanjay","family":"Popat","sequence":"additional","affiliation":[{"name":"Lung Unit, The Royal Marsden Hospital, London SW3 6JJ, UK"},{"name":"The Institute of Cancer Research, University of London, London SM2 5NG, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Pasi","family":"J\u00e4nne","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA 02215, USA"},{"name":"Harvard Medical School, Boston, MA 02215, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"1968","published-online":{"date-parts":[[2022,12,23]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"1243","DOI":"10.1097\/JTO.0000000000000244","article-title":"An Evidence-Based Determination of Issues Affecting Quality of Life and Patient-Reported Outcomes in Lung Cancer: Results of a Survey of 660 Patients","volume":"9","author":"Gralla","year":"2014","journal-title":"J. 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