{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,9]],"date-time":"2026-10-09T17:23:24Z","timestamp":1791566604225,"version":"4.3.4"},"reference-count":19,"publisher":"American Association for the Advancement of Science (AAAS)","issue":"9","license":[{"start":{"date-parts":[[2024,7,17]],"date-time":"2024-07-17T00:00:00Z","timestamp":1721174400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"name":"Hansoh Pharmaceutical Group Co. Ltd"},{"DOI":"10.13039\/501100001809","name":"National Natural Science Foundation of China","doi-asserted-by":"publisher","award":["82030045"],"award-info":[{"award-number":["82030045"]}],"id":[{"id":"10.13039\/501100001809","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100001809","name":"National Natural Science Foundation of China","doi-asserted-by":"publisher","award":["82241227"],"award-info":[{"award-number":["82241227"]}],"id":[{"id":"10.13039\/501100001809","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Cancer Commun"],"published-print":{"date-parts":[[2024,9]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec xml:lang=\"en\">\n                    <jats:title>Background<\/jats:title>\n                    <jats:p xml:lang=\"en\">\n                      The initial randomized, double\u2010blinded, actively controlled, phase III ANEAS study (NCT03849768) demonstrated that aumolertinib showed superior efficacy relative to gefitinib as first\u2010line therapy in epidermal growth factor receptor (\n                      <jats:italic toggle=\"yes\">EGFR<\/jats:italic>\n                      )\u2010mutated advanced non\u2010small cell lung cancer (NSCLC). Metastatic disease in the central nervous system (CNS) remains a challenge in the management of NSCLC. This study aimed to compare the efficacy of aumolertinib versus gefitinib among patients with baseline CNS metastases in the ANEAS study.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec xml:lang=\"en\">\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p xml:lang=\"en\">Eligible patients were enrolled and randomly assigned in a 1:1 ratio to orally receive either aumolertinib or gefitinib in a double\u2010blinded fashion. Patients with asymptomatic, stable CNS metastases were included. Follow\u2010up imaging of the same modality as the initial CNS imaging was performed every 6 weeks for 15 months, then every 12 weeks. CNS response was assessed by a neuroradiological blinded, independent central review (neuroradiological\u2010BICR). The primary endpoint for this subgroup analysis was CNS progression\u2010free survival (PFS).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec xml:lang=\"en\">\n                    <jats:title>Results<\/jats:title>\n                    <jats:p xml:lang=\"en\">\n                      Of the 429 patients enrolled and randomized in the ANEAS study, 106 patients were found to have CNS metastases (CNS Full Analysis Set, cFAS) at baseline by neuroradiological\u2010BICR, and 60 of them had CNS target lesions (CNS Evaluable for Response, cEFR). Treatment with aumolertinib significantly prolonged median CNS PFS compared with gefitinib in both cFAS (29.0 vs. 8.3 months; hazard ratio [HR] = 0.31; 95% confidence interval [CI], 0.17\u20100.56;\n                      <jats:italic toggle=\"yes\">P<\/jats:italic>\n                      &lt; 0.001) and cEFR (29.0 vs. 8.3 months; HR = 0.26; 95% CI, 0.11\u20100.57;\n                      <jats:italic toggle=\"yes\">P<\/jats:italic>\n                      &lt; 0.001). The confirmed CNS overall response rate in cEFR was 85.7% and 75.0% in patients treated with aumolertinib and gefitinib, respectively. Competing risk analysis showed that the estimated probability of CNS progression without prior non\u2010CNS progression or death was consistently lower with aumolertinib than with gefitinib in patients with and without CNS metastases at baseline. No new safety findings were observed.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec xml:lang=\"en\">\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p xml:lang=\"en\">\n                      These results indicate a potential advantage of aumolertinib over gefitinib in terms of CNS PFS and the risk of CNS progression in patients with\n                      <jats:italic toggle=\"yes\">EGFR<\/jats:italic>\n                      \u2010mutated advanced NSCLC with baseline CNS metastases.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec xml:lang=\"en\">\n                    <jats:title>Trial registration<\/jats:title>\n                    <jats:p xml:lang=\"en\">ClinicalTrials.gov number, NCT03849768<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/cac2.12594","type":"journal-article","created":{"date-parts":[[2024,7,17]],"date-time":"2024-07-17T05:36:14Z","timestamp":1721194574000},"page":"1005-1017","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":30,"title":["Central nervous system efficacy of aumolertinib versus gefitinib in patients with untreated,\n                    <i>EGFR<\/i>\n                    \u2010mutated, advanced non\u2010small cell lung cancer: data from a randomized phase III trial (AENEAS)"],"prefix":"10.34133","volume":"44","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-8833-7262","authenticated-orcid":false,"given":"Shun","family":"Lu","sequence":"first","affiliation":[{"name":"Shanghai Chest Hospital Shanghai JiaoTong University","place":["Shanghai, P. 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