{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,11,18]],"date-time":"2025-11-18T13:29:38Z","timestamp":1763472578492,"version":"3.45.0"},"reference-count":14,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2025,11,17]],"date-time":"2025-11-17T00:00:00Z","timestamp":1763337600000},"content-version":"vor","delay-in-days":16,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Pharmaceutical Statistics"],"published-print":{"date-parts":[[2025,11]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:p>In many acute myeloid leukemia (AML) studies, event\u2010free survival (EFS) has been accepted as a primary efficacy endpoint. In those studies, the patients who do not achieve complete remission (CR) in the induction period are regarded as induction treatment failure (ITF). The recent FDA guidance on AML (2022) has clearly specified ITF as the event at Day 1 of randomization, considering the variability of length of individual induction treatment periods among studies. Xu et\u00a0al. (2021) suggested decomposing the log\u2010rank test statistic into the ITF portion, and the Non\u2010ITF portion that is defined as the patients who achieved CR, and assumed proportional hazards for the Non\u2010ITF portion. However, especially in the newly diagnosed AML study, there is some indication of the cured patients who achieve CR during the induction period. As a result, Non\u2010zero ITF rates and cured patients invalidate the proportional hazards assumption and therefore, the conventional power calculation based on the number of events may be problematic in this setting. Our research follows the same decomposition of the log\u2010rank test statistic as Xu et\u00a0al. (2021) and suggests a new sample size calculation method accounting for the presence of both ITF and cured patients. The result shows that the analytically calculated power of log\u2010rank test based on our proposal was very similar to the empirical power based on simulations in various finite sample settings and was also useful to protect from overestimation and underestimation of the required sample size in the presence of cure fraction.<\/jats:p>","DOI":"10.1002\/pst.70052","type":"journal-article","created":{"date-parts":[[2025,11,17]],"date-time":"2025-11-17T09:28:41Z","timestamp":1763371721000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Statistical Consideration for Event\u2010Free Survival With Cure Rate in Acute Myeloid Leukemia Studies"],"prefix":"10.1002","volume":"24","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-6369-1115","authenticated-orcid":false,"given":"Yuichiro","family":"Kaneko","sequence":"first","affiliation":[{"name":"Clinical Operations, Quantitative Sciences and China Development Astellas Pharma Global Development Inc.  Northbrook Illinois USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8584-0521","authenticated-orcid":false,"given":"Kentaro","family":"Takeda","sequence":"additional","affiliation":[{"name":"Clinical Operations, Quantitative Sciences and China Development Astellas Pharma Global Development Inc.  Northbrook Illinois USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shufang","family":"Liu","sequence":"additional","affiliation":[{"name":"Oncology Biostatistics, Gilead Sciences, Inc.  California USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5893-0169","authenticated-orcid":false,"given":"Lu","family":"Tian","sequence":"additional","affiliation":[{"name":"Department of Biomedical Data Science Stanford University  California USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2025,11,17]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1186\/s13045\u2010019\u20100774\u2010x"},{"volume-title":"Canadian Cancer Statistics Advisory Committee in Collaboration With the Canadian Cancer Society, Statistics Canada and the Public Health Agency of Canada","year":"2023","author":"Brenner D.","key":"e_1_2_10_3_1"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41408\u2010021\u201000425\u20103"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41408\u2010021\u201000425\u20103"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1186\/s13045\u2010017\u20100543\u20107"},{"key":"e_1_2_10_7_1","unstructured":"\u201cAcute Myeloid Leukemia: Developing Drugs and Biological Products for Treatment Guidance for Industry \u201d(2022) http:\/\/www.fda.gov\/media\/134937\/download."},{"key":"e_1_2_10_8_1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.21.01548"},{"key":"e_1_2_10_9_1","doi-asserted-by":"publisher","DOI":"10.1002\/pst.2107"},{"key":"e_1_2_10_10_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1614359"},{"key":"e_1_2_10_11_1","doi-asserted-by":"publisher","DOI":"10.1186\/1471\u20102288\u201012\u20109"},{"key":"e_1_2_10_12_1","doi-asserted-by":"publisher","DOI":"10.1002\/pst.1878"},{"key":"e_1_2_10_13_1","doi-asserted-by":"publisher","DOI":"10.1002\/pst.2060"},{"key":"e_1_2_10_14_1","doi-asserted-by":"publisher","DOI":"10.1002\/sim.5465"},{"key":"e_1_2_10_15_1","doi-asserted-by":"publisher","DOI":"10.1093\/biomet\/68.1.316"}],"container-title":["Pharmaceutical Statistics"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/pst.70052","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,11,18]],"date-time":"2025-11-18T13:23:38Z","timestamp":1763472218000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/pst.70052"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,11]]},"references-count":14,"journal-issue":{"issue":"6","published-print":{"date-parts":[[2025,11]]}},"alternative-id":["10.1002\/pst.70052"],"URL":"https:\/\/doi.org\/10.1002\/pst.70052","archive":["Portico"],"relation":{},"ISSN":["1539-1604","1539-1612"],"issn-type":[{"type":"print","value":"1539-1604"},{"type":"electronic","value":"1539-1612"}],"subject":[],"published":{"date-parts":[[2025,11]]},"assertion":[{"value":"2025-02-05","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-10-17","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-11-17","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e70052"}}