{"id":7314,"date":"2018-06-04T12:19:27","date_gmt":"2018-06-04T20:19:27","guid":{"rendered":"https:\/\/www.sfj-pharma.com\/?p=7314"},"modified":"2021-05-13T14:31:29","modified_gmt":"2021-05-13T22:31:29","slug":"improvement-in-overall-survival-in-a-randomized-study-that-compared-dacomitinib-with-gefitinib-in-patients-with-advanced-non-small-cell-lung-cancer-and-egfr-activating-mutations","status":"publish","type":"post","link":"https:\/\/www.sfj-pharma.com\/improvement-in-overall-survival-in-a-randomized-study-that-compared-dacomitinib-with-gefitinib-in-patients-with-advanced-non-small-cell-lung-cancer-and-egfr-activating-mutations\/","title":{"rendered":"Improvement in Overall Survival in a Randomized Study That Compared Dacomitinib With Gefitinib in Patients With Advanced Non\u2013Small-Cell Lung Cancer and EGFR-Activating Mutations"},"content":{"rendered":"\r\n<p><strong>Purpose<\/strong><\/p>\r\n\r\n\r\n\r\n<p>ARCHER 1050, a randomized, open-label, phase III study of dacomitinib versus gefitinib in treatment-na\u00efve patients with advanced non\u2013small-cell lung cancer (NSCLC) and activating mutations in\u00a0<em>EGFR<\/em>, reported significant improvement in progression-free survival with dacomitinib. The mature overall survival (OS) analysis for the intention-to-treat population is presented here.<\/p>\r\n\r\n\r\n\r\n<p>&nbsp;<\/p>\r\n\r\n\r\n\r\n<p><strong>Patients and Methods<\/strong><\/p>\r\n\r\n\r\n\r\n<p>In this multinational, multicenter study, patients age 18 years or older (\u2265 20 years in Japan and Korea) who had an Eastern Cooperative Oncology Group performance status of 0 or 1 and newly diagnosed NSCLC with activating mutations in\u00a0<em>EGFR<\/em>\u00a0(exon 19 deletion or exon 21 L858R) were enrolled and randomly assigned in a 1:1 manner to dacomitinib (n = 227) or gefitinib (n = 225). Random assignment was stratified by race (Japanese, Chinese, other East Asian, or non-Asian) and\u00a0<em>EGFR<\/em>\u00a0mutation type. The final OS analysis was conducted with a data cutoff date of February 17, 2017; at that time 220 deaths (48.7%) were observed.<\/p>\r\n\r\n\r\n\r\n<p><strong>Results<\/strong><\/p>\r\n\r\n\r\n\r\n<p>During a median follow-up time of 31.3 months, 103 (45.4%) and 117 (52.0%) deaths occurred in the dacomitinib and gefitinib arms, respectively. The estimated hazard ratio for OS was 0.760 (95% CI, 0.582 to 0.993; two-sided\u00a0<em>P<\/em>\u00a0= .044). The median OS was 34.1 months with dacomitinib versus 26.8 months with gefitinib. The OS probabilities at 30 months were 56.2% and 46.3% with dacomitinib and gefitinib, respectively. Preliminary subgroup analyses for OS that are based on baseline characteristics were consistent with the primary OS analysis.<\/p>\r\n\r\n\r\n\r\n<p><strong>Conclusion<\/strong><\/p>\r\n\r\n\r\n\r\n<p>In patients with advanced NSCLC and\u00a0<em>EGFR<\/em>\u00a0activating mutations, dacomitinib is the first second-generation epidermal growth factor receptor tyrosine kinase inhibitor (TKI) to show significant improvement in OS in a phase III randomized study compared with a standard-of-care TKI. Dacomitinib should be considered one of the standard treatment options for these patients.<\/p>\r\n\r\n\r\n\r\n<p>&nbsp;<\/p>\r\n\r\n\r\n\r\n<p><a href=\"https:\/\/ascopubs.org\/doi\/full\/10.1200\/jco.2018.78.7994\" target=\"_blank\" rel=\"noreferrer noopener\">Read full article on Journal of Clinical Oncology.<\/a><\/p>\r\n","protected":false},"excerpt":{"rendered":"<p>Purpose ARCHER 1050, a randomized, open-label, phase III study of dacomitinib versus gefitinib in treatment-na\u00efve patients with advanced non\u2013small-cell lung cancer (NSCLC) and activating mutations in\u00a0EGFR, reported significant improvement in progression-free survival with dacomitinib. The mature overall survival (OS) analysis for the intention-to-treat population is&#8230;<\/p>\n","protected":false},"author":8,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v22.5 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Improvement in Overall Survival in a Randomized Study That Compared Dacomitinib With Gefitinib in Patients With Advanced Non\u2013Small-Cell Lung Cancer and EGFR-Activating Mutations - SFJ Pharmaceuticals<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.sfj-pharma.com\/improvement-in-overall-survival-in-a-randomized-study-that-compared-dacomitinib-with-gefitinib-in-patients-with-advanced-non-small-cell-lung-cancer-and-egfr-activating-mutations\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Improvement in Overall Survival in a Randomized Study That Compared Dacomitinib With Gefitinib in Patients With Advanced Non\u2013Small-Cell Lung Cancer and EGFR-Activating Mutations - SFJ Pharmaceuticals\" \/>\n<meta property=\"og:description\" content=\"Purpose ARCHER 1050, a randomized, open-label, phase III study of dacomitinib versus gefitinib in treatment-na\u00efve patients with advanced non\u2013small-cell lung cancer (NSCLC) and activating mutations in\u00a0EGFR, reported significant improvement in progression-free survival with dacomitinib. The mature overall survival (OS) analysis for the intention-to-treat population is...\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.sfj-pharma.com\/improvement-in-overall-survival-in-a-randomized-study-that-compared-dacomitinib-with-gefitinib-in-patients-with-advanced-non-small-cell-lung-cancer-and-egfr-activating-mutations\/\" \/>\n<meta property=\"og:site_name\" content=\"SFJ Pharmaceuticals\" \/>\n<meta property=\"article:published_time\" content=\"2018-06-04T20:19:27+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2021-05-13T22:31:29+00:00\" \/>\n<meta name=\"author\" content=\"Lily Xu\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Lily Xu\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"1 minute\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\/\/www.sfj-pharma.com\/improvement-in-overall-survival-in-a-randomized-study-that-compared-dacomitinib-with-gefitinib-in-patients-with-advanced-non-small-cell-lung-cancer-and-egfr-activating-mutations\/#article\",\"isPartOf\":{\"@id\":\"https:\/\/www.sfj-pharma.com\/improvement-in-overall-survival-in-a-randomized-study-that-compared-dacomitinib-with-gefitinib-in-patients-with-advanced-non-small-cell-lung-cancer-and-egfr-activating-mutations\/\"},\"author\":{\"name\":\"Lily Xu\",\"@id\":\"https:\/\/www.sfj-pharma.com\/#\/schema\/person\/770e5cbce35f5f0f90d2218806ceba11\"},\"headline\":\"Improvement in Overall Survival in a Randomized Study That Compared Dacomitinib With Gefitinib in Patients With Advanced Non\u2013Small-Cell Lung Cancer and EGFR-Activating Mutations\",\"datePublished\":\"2018-06-04T20:19:27+00:00\",\"dateModified\":\"2021-05-13T22:31:29+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\/\/www.sfj-pharma.com\/improvement-in-overall-survival-in-a-randomized-study-that-compared-dacomitinib-with-gefitinib-in-patients-with-advanced-non-small-cell-lung-cancer-and-egfr-activating-mutations\/\"},\"wordCount\":300,\"commentCount\":0,\"publisher\":{\"@id\":\"https:\/\/www.sfj-pharma.com\/#organization\"},\"articleSection\":[\"Scientific Publications\"],\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"CommentAction\",\"name\":\"Comment\",\"target\":[\"https:\/\/www.sfj-pharma.com\/improvement-in-overall-survival-in-a-randomized-study-that-compared-dacomitinib-with-gefitinib-in-patients-with-advanced-non-small-cell-lung-cancer-and-egfr-activating-mutations\/#respond\"]}]},{\"@type\":\"WebPage\",\"@id\":\"https:\/\/www.sfj-pharma.com\/improvement-in-overall-survival-in-a-randomized-study-that-compared-dacomitinib-with-gefitinib-in-patients-with-advanced-non-small-cell-lung-cancer-and-egfr-activating-mutations\/\",\"url\":\"https:\/\/www.sfj-pharma.com\/improvement-in-overall-survival-in-a-randomized-study-that-compared-dacomitinib-with-gefitinib-in-patients-with-advanced-non-small-cell-lung-cancer-and-egfr-activating-mutations\/\",\"name\":\"Improvement in Overall Survival in a Randomized Study That Compared Dacomitinib With Gefitinib in Patients With Advanced Non\u2013Small-Cell Lung Cancer and EGFR-Activating Mutations - 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