{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,14]],"date-time":"2026-07-14T11:03:47Z","timestamp":1784027027427,"version":"3.55.0"},"reference-count":37,"publisher":"Wiley","issue":"13","license":[{"start":{"date-parts":[[2026,6,30]],"date-time":"2026-06-30T00:00:00Z","timestamp":1782777600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2026,6,30]],"date-time":"2026-06-30T00:00:00Z","timestamp":1782777600000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"funder":[{"DOI":"10.13039\/100001003","name":"Boehringer Ingelheim","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100001003","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Thoracic Cancer"],"published-print":{"date-parts":[[2026,7]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Afatinib is an approved first\u2010line treatment for advanced non\u2010small\u2010cell lung cancer (NSCLC) harboring sensitizing EGFR mutations. At the standard 40\u2009mg dose, 28%\u201353% of patients in randomized trials required dose reductions due to adverse events (AEs), predominantly cutaneous and gastrointestinal. This study evaluated whether a 30\u2009mg starting dose could improve tolerability without compromising efficacy.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      This multicenter, single\u2010arm phase 2 study enrolled treatment\u2010naive patients with advanced EGFR\u2010mutant NSCLC. Patients received afatinib 30\u2009mg daily until progression or unacceptable toxicity. The primary endpoint was 6\u2010month progression\u2010free survival (PFS) rate. Secondary endpoints included median PFS, time\u2010to\u2010treatment failure (TTF), objective response rate (ORR), disease control rate (DCR), and safety. Using A'Hern's single\u2010stage design (one\u2010sided\n                      <jats:italic>\u03b1<\/jats:italic>\n                      \u2009=\u20090.1, 80% power), 62 patients were required to distinguish a target 6\u2010month of PFS\u2009\u2265\u200975% from \u2264\u200962%.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>The study was terminated early due to slow accrual; 30 patients were enrolled between May 2023 and May 2024. Median follow\u2010up was 11.3\u2009months (IQR 9.6\u201315.5). The 6\u2010month PFS rate was 93.2% (95% CI 75.5\u201398.3), median PFS of 15.8\u2009months (95% CI 13.4\u2013not reached) and median TTF of 17.0\u2009months. ORR was 80% and DCR 96.7%. Common treatment\u2010related AEs included diarrhea (83.3%), mucositis (60.0%), paronychia (60.0%), and acneiform rash (46.7%). Grade\u2009\u2265\u20093 AEs occurred in 10.0% of patients, with no Grade 4\u20135 events. Dose modification was required in 13.3% of patients.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>Afatinib 30\u2009mg daily was well tolerated and demonstrated encouraging efficacy, with a 6\u2010month PFS of 93.2%, suggesting outcomes comparable to standard dosing.<\/jats:p>\n                    <jats:p>\n                      <jats:bold>Trial Registration:<\/jats:bold>\n                      Registration number: NCT04909073;\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"https:\/\/clinicaltrials.gov\">https:\/\/clinicaltrials.gov<\/jats:ext-link>\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/1759-7714.70331","type":"journal-article","created":{"date-parts":[[2026,7,1]],"date-time":"2026-07-01T09:42:52Z","timestamp":1782898972000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["An Observational Study of Afatinib 30\u2009mg Daily in Patients With Advanced Non\u2010Small\u2010Cell Lung Cancer Harboring Common\n                    <scp>EGFR<\/scp>\n                    Mutations Treated With Afatinib"],"prefix":"10.1111","volume":"17","author":[{"given":"Kenneth","family":"Sooi","sequence":"first","affiliation":[{"name":"Department of Haematology\u2010Oncology National University Hospital  Singapore Singapore"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8230-5232","authenticated-orcid":false,"given":"Pongwut","family":"Danchaivijtr","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, Department of Medicine, Faculty of Medicine Siriraj Hospital Mahidol University  Bangkok Thailand"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"C. K.","family":"Wong","sequence":"additional","affiliation":[{"name":"Department of Medicine, Faculty of Medicine Universiti Malaya  Kuala Lumpur Malaysia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"V. D.","family":"Tu","sequence":"additional","affiliation":[{"name":"Cancer Research and Clinical Trials Center Vietnam National Cancer Hospital  Hanoi Vietnam"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Manavi","family":"Sachdeva","sequence":"additional","affiliation":[{"name":"Department of Haematology\u2010Oncology National University Hospital  Singapore Singapore"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"B. C.","family":"Tai","sequence":"additional","affiliation":[{"name":"Saw Swee Hock School of Public Health National University Hospital  Singapore Singapore"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ross A.","family":"Soo","sequence":"additional","affiliation":[{"name":"Department of Haematology\u2010Oncology National University Hospital  Singapore 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