{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,3]],"date-time":"2026-03-03T15:47:49Z","timestamp":1772552869827,"version":"3.50.1"},"reference-count":35,"publisher":"Oxford University Press (OUP)","issue":"9","license":[{"start":{"date-parts":[[2021,7,29]],"date-time":"2021-07-29T00:00:00Z","timestamp":1627516800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"AbbVie and Genentech"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2021,8,30]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>In a multinational phase 3 trial (VIALE-C), venetoclax plus low-dose cytarabine prolonged overall survival vs placebo plus low-dose cytarabine in patients with newly diagnosed acute myeloid leukaemia ineligible for intensive chemotherapy, although it was not statistically significant. Herein, we assess the benefit of venetoclax plus low-dose cytarabine in the Japanese subgroup of VIALE-C patients (n = 27).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>VIALE-C, a randomized (2:1), double-blind study (NCT03069352), enrolled untreated patients (\u226518 years) with acute myeloid leukaemia. Patients received venetoclax (600 mg days 1\u201328, 4-day ramp-up in cycle 1) or placebo in 28-day cycles with low-dose cytarabine (20 mg\/m2 days 1\u201310). The primary endpoint was median overall survival.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>In the Japanese subgroup, at a 6-month follow-up from the primary analysis, median overall survival for venetoclax (n = 18) and placebo (n = 9), plus low-dose cytarabine, was 4.7 and 8.1 months, respectively (hazard ratio, 0.928, 95% confidence intervals : 0.399, 2.156). The rate of complete remission plus complete remission with incomplete blood count recovery was higher with venetoclax plus low-dose cytarabine (44.4%) vs placebo plus low-dose cytarabine (11.1%). All patients experienced at least 1 adverse event. The most common grade \u22653 adverse events with venetoclax or placebo, plus low-dose cytarabine, were febrile neutropenia (50.0% vs 44.4%, respectively) and thrombocytopenia (27.8% vs 44.4%, respectively). Serious adverse events were reported in 50.0 and 33.3% of patients in the venetoclax and placebo, plus low-dose cytarabine arms, respectively; pneumonia was the most common (22.2% each).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>Limited survival benefit in the Japanese subgroup can be attributed to small patient numbers and to baseline imbalances observed between treatment arms, with more patients in the venetoclax plus low-dose cytarabine arm presenting poor prognostic factors. Venetoclax plus low-dose cytarabine was well tolerated in Japanese patients with acute myeloid leukaemia ineligible for intensive chemotherapy.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/jjco\/hyab112","type":"journal-article","created":{"date-parts":[[2021,6,29]],"date-time":"2021-06-29T19:08:24Z","timestamp":1624993704000},"page":"1372-1382","source":"Crossref","is-referenced-by-count":6,"title":["Venetoclax plus low-dose cytarabine in Japanese patients with untreated acute myeloid leukaemia ineligible for intensive chemotherapy"],"prefix":"10.1093","volume":"51","author":[{"given":"Takahiro","family":"Yamauchi","sequence":"first","affiliation":[{"name":"Department of Hematology and Oncology, University of Fukui Hospital, Fukui, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Chikashi","family":"Yoshida","sequence":"additional","affiliation":[{"name":"Department of Hematology, National Hospital Organization, Mito Medical Center, Ibaraki, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kensuke","family":"Usuki","sequence":"additional","affiliation":[{"name":"Department of Hematology, NTT Medical Center Tokyo, Tokyo, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Satoru","family":"Takada","sequence":"additional","affiliation":[{"name":"Leukemia Research Center, Saiseikai Maebashi Hospital, Maebashi, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Itaru","family":"Matsumura","sequence":"additional","affiliation":[{"name":"Department of Hematology and Rheumatology, Kindai University Hospital, Osaka, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nobuaki","family":"Dobashi","sequence":"additional","affiliation":[{"name":"Division of Clinical Oncology\/Hematology, The Jikei University Daisan Hospital, Tokyo, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yasushi","family":"Miyazaki","sequence":"additional","affiliation":[{"name":"Department of Hematology, Atomic Bomb Disease Institute, Nagasaki University, Nagasaki, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Toshihiro","family":"Miyamoto","sequence":"additional","affiliation":[{"name":"Medicine and Biosystemic Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hiroatsu","family":"Iida","sequence":"additional","affiliation":[{"name":"Department of Hematology, National Hospital Organization Nagoya Medical Center, Nagoya, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Norio","family":"Asou","sequence":"additional","affiliation":[{"name":"Department of Hematology, Saitama Medical University International Medical Center, Hidaka, 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USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hideyuki","family":"Honda","sequence":"additional","affiliation":[{"name":"AbbVie GK, Tokyo, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sumiko","family":"Okubo","sequence":"additional","affiliation":[{"name":"AbbVie GK, Osaka, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Misaki","family":"Kurokawa","sequence":"additional","affiliation":[{"name":"AbbVie GK, Tokyo, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Qi","family":"Jiang","sequence":"additional","affiliation":[{"name":"AbbVie Inc., North Chicago, IL, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Andrew","family":"Wei","sequence":"additional","affiliation":[{"name":"Department of Clinical Haematology, The Alfred Hospital and Monash University, Melbourne, VIC, 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