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However, real-world evidence on dosing, scheduling, and outcomes is lacking, particularly for patients with prior myelodysplastic syndrome (MDS) or AZA treatment, who have been excluded from clinical trials. This was a multicenter retrospective study of VEN\u2009+\u2009AZA in 120 patients newly diagnosed with AML between June 2021 and September 2022. The cohort had a median age of 77\u00a0years, 52% had secondary AML, 74% had previously been diagnosed with MDS, and 39% had previously received AZA. During cycle 1, half of the patients received 400\u00a0mg of VEN for a median of 27\u00a0days, with a median holding period of 12\u00a0days. With a median follow-up of 13.6\u00a0months, the rate of complete remission (CR) or CR with incomplete blood count recovery was 56.7% in VEN\u2009+\u2009AZA-treated patients in the overall cohort and 56.5% in patients with prior MDS. Median overall survival was 14.8\u00a0months for the overall cohort and 15.4\u00a0months for those with prior MDS. The real-world outcomes were comparable to those of clinical trials.<\/jats:p>","DOI":"10.1007\/s12185-025-04093-y","type":"journal-article","created":{"date-parts":[[2025,11,7]],"date-time":"2025-11-07T07:29:42Z","timestamp":1762500582000},"page":"178-188","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["Real-world outcomes of venetoclax and azacitidine in Japanese patients with newly diagnosed acute myeloid leukemia (VENUS study)"],"prefix":"10.1007","volume":"123","author":[{"given":"Ryota","family":"Imanaka","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hiroki","family":"Numata","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yuna","family":"Katsuoka","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nobuhiko","family":"Uoshima","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Satoru","family":"Hara","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jun","family":"Ando","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shuichi","family":"Ota","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Goichi","family":"Yoshimoto","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Akihito","family":"Matsuoka","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tetsuo","family":"Morita","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Atsuko","family":"Tsutsui","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mizuha","family":"Kosugi-Kanaya","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0314-9498","authenticated-orcid":false,"given":"Tatsunori","family":"Goto","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2025,11,7]]},"reference":[{"key":"4093_CR1","doi-asserted-by":"publisher","first-page":"1136","DOI":"10.1056\/NEJMra1406184","volume":"373","author":"H D\u00f6hner","year":"2015","unstructured":"D\u00f6hner H, Weisdorf DJ, Bloomfield CD. 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Nobuhiko Uoshima has received payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from AbbVie, Bristol Myers Squibb, and Janssen. Jun Ando has received payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from AbbVie. Shuichi Ota has received payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Novartis, Takeda, AstraZeneca, AbbVie, PharmaEssentia, Bristol Myers Squibb, Janssen, Amgen, and Sanofi. Goichi Yoshimoto has received honoraria from AbbVie. Tetsuo Morita, Atsuko Tsutsui, and Mizuha Kosugi-Kanaya are employees of AbbVie. Tetsuo Morita and Atsuko Tsutsui hold stock and\/or stock options in AbbVie. Tatsunori Goto has received payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from AbbVie and Nippon Shinyaku. The other authors declare no conflicts of interest.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}}]}}