{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,19]],"date-time":"2026-06-19T11:14:28Z","timestamp":1781867668676,"version":"3.54.5"},"reference-count":34,"publisher":"Oxford University Press (OUP)","issue":"1","license":[{"start":{"date-parts":[[2021,11,5]],"date-time":"2021-11-05T00:00:00Z","timestamp":1636070400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100004328","name":"Genentech","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004328","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100006483","name":"AbbVie","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100006483","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2022,1,3]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>The phase 3 VIALE-A trial (NCT02993523) reported that venetoclax-azacitidine significantly prolonged overall survival compared with placebo-azacitidine in patients with newly diagnosed acute myeloid leukemia ineligible for intensive chemotherapy. Herein, efficacy and safety of venetoclax-azacitidine are analyzed in the Japanese subgroup of VIALE-A patients.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>Eligible Japanese patients were randomized 2:1 to venetoclax-azacitidine (N\u00a0=\u00a024) or placebo-azacitidine (N\u00a0=\u00a013). Primary endpoints for Japan were overall survival and complete response (CR)\u00a0+\u00a0CR with incomplete hematologic recovery (CRi). Venetoclax (target dose 400\u00a0mg) was given orally once daily. Azacitidine (75\u00a0mg\/m2) was administered subcutaneously or intravenously on Days 1\u20137 of each 28-day cycle.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>Median follow-up was 16.3\u00a0months (range, 1.0\u201320.3). Median overall survival was not reached with venetoclax-azacitidine (hazard ratio 0.409 and 95% confidence interval: 0.151, 1.109); overall survival estimate was higher with venetoclax-azacitidine than placebo-azacitidine at 12 (67 and 46%) and 18\u00a0months (57 and 31%), respectively. CR and CRi rates were 67% with venetoclax-azacitidine and 15% with placebo-azacitidine. Most common any-grade adverse events were febrile neutropenia (79 and 39%), thrombocytopenia (54 and 77%), constipation (54 and 54%) and decreased appetite (54 and 38%) in the venetoclax-azacitidine and placebo-azacitidine arms, respectively. Only 1 patient in the venetoclax-azacitidine arm, and no patients in the placebo-azacitidine arm, had grade 4 febrile neutropenia that led to treatment discontinuation.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>This Japanese subgroup analysis of VIALE-A demonstrates comparable safety and efficacy outcomes compared with the global study and supports venetoclax-azacitidine as first-line standard-of-care for Japanese treatment-naive patients with acute myeloid leukemia who are ineligible for intensive chemotherapy.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/jjco\/hyab170","type":"journal-article","created":{"date-parts":[[2021,10,27]],"date-time":"2021-10-27T19:12:59Z","timestamp":1635361979000},"page":"29-38","source":"Crossref","is-referenced-by-count":29,"title":["Venetoclax plus azacitidine in Japanese patients with untreated acute myeloid leukemia ineligible for intensive chemotherapy"],"prefix":"10.1093","volume":"52","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-8588-8955","authenticated-orcid":false,"given":"Kazuhito","family":"Yamamoto","sequence":"first","affiliation":[{"name":"Department of Hematology and Cell Therapy , Aichi Cancer Center, Nagoya, Aichi, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Atsushi","family":"Shinagawa","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine , Hitachi General Hospital, Hitachi, Ibaraki, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Courtney D","family":"DiNardo","sequence":"additional","affiliation":[{"name":"Department of Leukemia , Division of Cancer Medicine, University of Texas MD Anderson Cancer Center, Houston, TX, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Keith W","family":"Pratz","sequence":"additional","affiliation":[{"name":"Leukemia Program , Division of Medicine, University of Pennsylvania, Philadelphia, PA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kenichi","family":"Ishizawa","sequence":"additional","affiliation":[{"name":"Department of Third Internal Medicine , Yamagata University Hospital, Yamagata, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Toshihiro","family":"Miyamoto","sequence":"additional","affiliation":[{"name":"Department of Medicine and Biosystemic Science , Kyushu University Graduate School of Medical Sciences, Fukuoka, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Norio","family":"Komatsu","sequence":"additional","affiliation":[{"name":"Department of Hematology , Juntendo University School of Medicine, Tokyo, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yasuhiro","family":"Nakashima","sequence":"additional","affiliation":[{"name":"Department of Hematology , Graduate School of Medicine, Osaka City University, Osaka, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chikashi","family":"Yoshida","sequence":"additional","affiliation":[{"name":"Department of Hematology , National Hospital Organization, Mito Medical Center, Ibaraki, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Noriko","family":"Fukuhara","sequence":"additional","affiliation":[{"name":"Department of Hematology , Tohoku University Graduate School of Medicine, Sendai, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kensuke","family":"Usuki","sequence":"additional","affiliation":[{"name":"Department of Hematology , NTT Medical Center Tokyo, Tokyo, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takahiro","family":"Yamauchi","sequence":"additional","affiliation":[{"name":"Department of Hematology and Oncology , University of Fukui Hospital, Fukui, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Noboru","family":"Asada","sequence":"additional","affiliation":[{"name":"Department of Hematology and Oncology , Okayama University Hospital, Okayama, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Norio","family":"Asou","sequence":"additional","affiliation":[{"name":"Department of Hematology , Saitama Medical University International Medical Center, Hidaka, Saitama, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ilseung","family":"Choi","sequence":"additional","affiliation":[{"name":"Department of Hematology , National Hospital Organization, Kyushu Cancer Center, Fukuoka, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yasushi","family":"Miyazaki","sequence":"additional","affiliation":[{"name":"Department of Hematology , Atomic Bomb Disease Institute, Nagasaki University, Nagasaki, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hideyuki","family":"Honda","sequence":"additional","affiliation":[{"name":"AbbVie GK , Tokyo, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sumiko","family":"Okubo","sequence":"additional","affiliation":[{"name":"AbbVie GK , Osaka, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Misaki","family":"Kurokawa","sequence":"additional","affiliation":[{"name":"AbbVie GK , Tokyo, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ying","family":"Zhou","sequence":"additional","affiliation":[{"name":"AbbVie , Inc., North Chicago, IL, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jiuhong","family":"Zha","sequence":"additional","affiliation":[{"name":"AbbVie , Inc., North Chicago, IL, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jalaja","family":"Potluri","sequence":"additional","affiliation":[{"name":"AbbVie , Inc., North Chicago, IL, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Itaru","family":"Matsumura","sequence":"additional","affiliation":[{"name":"Department of Hematology and Rheumatology , Kindai University Hospital, Osaka, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2021,11,5]]},"reference":[{"key":"2022062915332455800_ref1","doi-asserted-by":"crossref","first-page":"2099","DOI":"10.1002\/cncr.22233","article-title":"Acute myeloid leukemia: epidemiology and etiology","volume":"107","author":"Deschler","year":"2006","journal-title":"Cancer"},{"key":"2022062915332455800_ref2","doi-asserted-by":"crossref","first-page":"171","DOI":"10.1007\/s12185-012-1150-6","article-title":"Clinical studies of acute myeloid leukemia in the Japan Adult Leukemia Study Group","volume":"96","author":"Miyawaki","year":"2012","journal-title":"Int J 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