{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,4]],"date-time":"2026-08-04T12:38:49Z","timestamp":1785847129874,"version":"3.56.0"},"reference-count":38,"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":"CAMS Innovation Fund for Medical Sciences","award":["2021\u20101\u2010I2M\u2010012"],"award-info":[{"award-number":["2021\u20101\u2010I2M\u2010012"]}]},{"name":"CAMS Innovation Fund for Medical Sciences","award":["2022\u2010I2M\u2010C&T\u2010B\u2010078"],"award-info":[{"award-number":["2022\u2010I2M\u2010C&T\u2010B\u2010078"]}]},{"DOI":"10.13039\/501100012166","name":"National Key Research and Development Program of China","doi-asserted-by":"publisher","award":["2022YFC2409902"],"award-info":[{"award-number":["2022YFC2409902"]}],"id":[{"id":"10.13039\/501100012166","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                      Anaplastic lymphoma kinase (\n                      <jats:italic toggle=\"yes\">ALK<\/jats:italic>\n                      ) test in advanced non\u2010small cell lung cancer (NSCLC) can help physicians provide target therapies for patients harboring\n                      <jats:italic toggle=\"yes\">ALK<\/jats:italic>\n                      gene rearrangement. This study aimed to investigate the real\u2010world test patterns and positive rates of\n                      <jats:italic toggle=\"yes\">ALK<\/jats:italic>\n                      gene rearrangements in advanced NSCLC.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec xml:lang=\"en\">\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p xml:lang=\"en\">\n                      In this real\u2010world study (ChiCTR2000030266), patients with advanced NSCLC who underwent an\n                      <jats:italic toggle=\"yes\">ALK<\/jats:italic>\n                      rearrangement test in 30 medical centers in China between October 1, 2018 and December 31, 2019 were retrospectively analyzed. Interpretation training was conducted before the study was initiated. Quality controls were performed at participating centers using immunohistochemistry (IHC)\u2010VENTANA\u2010D5F3. The positive\n                      <jats:italic toggle=\"yes\">ALK<\/jats:italic>\n                      gene rearrangement rate and consistency rate were calculated. The associated clinicopathological characteristics of\n                      <jats:italic toggle=\"yes\">ALK<\/jats:italic>\n                      gene rearrangement were investigated as well.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec xml:lang=\"en\">\n                    <jats:title>Results<\/jats:title>\n                    <jats:p xml:lang=\"en\">\n                      The overall\n                      <jats:italic toggle=\"yes\">ALK<\/jats:italic>\n                      gene rearrangement rate was 6.7% in 23,689 patients with advanced NSCLC and 8.2% in 17,436 patients with advanced lung adenocarcinoma. The quality control analysis of IHC\u2010VENTANA\u2010D5F3 revealed an intra\u2010hospital consistency rate of 98.2% (879\/895) and an inter\u2010hospital consistency rate of 99.2% (646\/651). IHC\u2010VENTANA\u2010D5F3 was used in 53.6%, real\u2010time polymerase chain reaction (RT\u2010PCR) in 25.4%, next\u2010generation sequencing (NGS) in 18.3%, and fluorescence in\u2010situ hybridization (FISH) in 15.9% in the adenocarcinoma subgroup. For specimens tested with multiple methods, the consistency rates confirmed by IHC\u2010VENTANA\u2010D5F3 were 98.0% (822\/839) for FISH, 98.7% (1,222\/1,238) for NGS, and 91.3% (146\/160) for RT\u2010PCR. The overall\n                      <jats:italic toggle=\"yes\">ALK<\/jats:italic>\n                      gene rearrangement rates were higher in females, patients of \u2264 35 years old, never smokers, tumor cellularity of &gt; 50, and metastatic specimens used for testing in the total NSCLC population and adenocarcinoma subgroup (all\n                      <jats:italic toggle=\"yes\">P<\/jats:italic>\n                      &lt; 0.05).\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                      This study highlights the real\u2010world variability and challenges of\n                      <jats:italic toggle=\"yes\">ALK<\/jats:italic>\n                      test in advanced NSCLC, demonstrating a predominant use of IHC\u2010VENTANA\u2010D5F3 with high consistency and distinct clinicopathological features in\n                      <jats:italic toggle=\"yes\">ALK<\/jats:italic>\n                      \u2010positive patients. These findings underscore the need for a consensus on optimal test practices and support the development of refined\n                      <jats:italic toggle=\"yes\">ALK<\/jats:italic>\n                      test strategies to enhance diagnostic accuracy and therapeutic decision\u2010making in NSCLC.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/cac2.12593","type":"journal-article","created":{"date-parts":[[2024,7,17]],"date-time":"2024-07-17T05:41:34Z","timestamp":1721194894000},"page":"992-1004","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":10,"title":["Real\u2010world data on ALK rearrangement test in Chinese advanced non\u2010small cell lung cancer (RATICAL): a nationwide multicenter retrospective study"],"prefix":"10.34133","volume":"44","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-4932-6488","authenticated-orcid":false,"given":"Lin","family":"Li","sequence":"first","affiliation":[{"name":"National Cancer Center\/National Clinical Research Center for Cancer\/Cancer Hospital","place":["Beijing, P. 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