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<p>Venetoclax (VEN), a BCL-2 inhibitor, was approved in Japan in March 2021, for acute myeloid leukemia (AML). We retrospectively analyzed the impact of VEN approval on treatment patterns and outcomes in older AML patients aged 65–74&#xa0;years unfit for intensive chemotherapy in Japan. Using the Hokkaido Leukemia Net database, we categorized 101 patients into pre-VEN (<i>n</i> = 46) and post-VEN (<i>n</i> = 55) cohorts, excluding those who had acute promyelocytic leukemia or received intensive chemotherapy. Following VEN approval, VEN + azacitidine (AZA) became the most frequently used initial regimen (56%). Despite higher rates of <i>TP53</i> mutations and complex karyotypes (35.5%), VEN + AZA achieved comparable response rates (CR + CRi: 64.5%) and overall survival (OS, median 11.7&#xa0;months) to r7 + 3 (CR + CRi: 64.5%, median OS: 13.1&#xa0;months), and superior outcomes to cytarabine + aclarubicin + G-CSF (CAG, CR + CRi 37.5%, median OS 6.8&#xa0;months) or AZA monotherapy (CR + CRi 12.5%, median OS 4.5&#xa0;months). Early mortality at 60&#xa0;days from diagnosis was lower with VEN + AZA (3.2%) than with reduced-dose cytarabine plus anthracycline (r7 + 3) (12.9%), CAG (26.7%), or AZA monotherapy (18.8%). Our findings demonstrate a substantial shift in real-world treatment practices following VEN approval and suggest that VEN + AZA is an effective option for older AML patients with adverse genetic features.</p>

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Real-world treatment patterns and clinical outcomes in patients with AML from 65 to 74 years unfit for first-line intensive chemotherapy in Japan

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  • 发表日期：

    2026年3月19日

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  • Fumiaki Fujii,
  • Masahiro Onozawa,
  • Shota Yoshida,
  • Naoki Miyashita,
  • Daisuke Hidaka,
  • Reiki Ogasawara,
  • Mutsumi Takahata,
  • Junichi Hashiguchi,
  • Shota Yokoyama,
  • Masahiro Chiba,
  • Tomoyuki Saga,
  • Taku Shimizu,
  • Ikumi Kasahara,
  • Akio Shigematsu,
  • Katsuya Fujimoto,
  • Satoshi Iyama,
  • Tetsuyuki Igarashi,
  • Shinichi Ito,
  • Yoshihito Haseyama,
  • Mizuha Kosugi-Kanaya,
  • Takeshi Kondo,
  • Takanori Teshima

摘要

Venetoclax (VEN), a BCL-2 inhibitor, was approved in Japan in March 2021, for acute myeloid leukemia (AML). We retrospectively analyzed the impact of VEN approval on treatment patterns and outcomes in older AML patients aged 65–74 years unfit for intensive chemotherapy in Japan. Using the Hokkaido Leukemia Net database, we categorized 101 patients into pre-VEN (n = 46) and post-VEN (n = 55) cohorts, excluding those who had acute promyelocytic leukemia or received intensive chemotherapy. Following VEN approval, VEN + azacitidine (AZA) became the most frequently used initial regimen (56%). Despite higher rates of TP53 mutations and complex karyotypes (35.5%), VEN + AZA achieved comparable response rates (CR + CRi: 64.5%) and overall survival (OS, median 11.7 months) to r7 + 3 (CR + CRi: 64.5%, median OS: 13.1 months), and superior outcomes to cytarabine + aclarubicin + G-CSF (CAG, CR + CRi 37.5%, median OS 6.8 months) or AZA monotherapy (CR + CRi 12.5%, median OS 4.5 months). Early mortality at 60 days from diagnosis was lower with VEN + AZA (3.2%) than with reduced-dose cytarabine plus anthracycline (r7 + 3) (12.9%), CAG (26.7%), or AZA monotherapy (18.8%). Our findings demonstrate a substantial shift in real-world treatment practices following VEN approval and suggest that VEN + AZA is an effective option for older AML patients with adverse genetic features.