Scholarlink

Introduction <p>Venetoclax has demonstrated clinical benefit for newly-diagnosed acute myeloid leukemia (AML), but significant neutropenia is a concern. Data on the time course of neutrophil counts for across treatment cycles in real-world settings remain limited. We report an interim analysis of the VENUS study, which examined neutropenia management in patients with AML receiving venetoclax with azacitidine (VEN/AZA) in Japan.</p> Methods <p>This multicenter (10 sites), retrospective, observational study included adults with newly-diagnosed AML ineligible for intensive chemotherapy and initiating venetoclax treatment. Treatment patterns, granulocyte colony-stimulating factor (G-CSF) use, antifungal prophylaxis, and time course of neutrophil counts were analyzed for patients who received &gt; 1 cycle of venetoclax.</p> Results <p>Venetoclax was administered for a median 27.0 days in Cycle 1 and then a median 21.0 (range 14.0–22.0) days for subsequent cycles, with median dose holds at the end of each cycle of 8.5–15.0 days. Patients (<i>n</i> = 81) receiving G-CSF were treated with VEN/AZA for a median of 6.0 cycles versus 3.0 in those who did not receive G-CSF (<i>n</i> = 39). In Cycle 1, median neutrophil counts decreased to &lt; 500/µl during Days 8–28 but recovered to &gt; 500/µl by Days 29–35. Median nadir neutrophil count was reached during Days 22–28 in almost all subsequent cycles until Cycle 10. Neutrophil counts decreased to &lt; 500/µl in some cycles but improved to &gt; 500/µl by the next week, suggesting neutrophil levels without higher risk of infection in most patients after Cycle 2 with venetoclax dosing schedule modifications and G-CSF administration. Eighty-eight (73.3%) patients received antifungal prophylaxis, but risk-based antifungal prophylaxis may be considered.</p> Conclusion <p>This real-world analysis provides insight into the timing of neutrophil count recovery with dosing schedule modification of venetoclax and G-CSF use in patients with newly-diagnosed AML receiving VEN/AZA, informing timing of the use of antifungal prophylaxis for patients at higher risk.</p>

错误：搜索内容不能为空，请输入英文关键词
错误：关键词超出字数限制，请精简
高级检索

Real-World Experience with Venetoclax Treatment for Newly-Diagnosed Acute Myeloid Leukemia in Japan (VENUS Study): An Interim Analysis Focusing on Neutropenia Management

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2025年3月7日

查看全文
  • Tatsunori Goto,
  • Hiroki Numata,
  • Yuna Katsuoka,
  • Nobuhiko Uoshima,
  • Satoru Hara,
  • Jun Ando,
  • Shuichi Ota,
  • Goichi Yoshimoto,
  • Akihito Matsuoka,
  • Hideyuki Hashiba,
  • Tetsuo Morita,
  • Atsuko Tsutsui,
  • Ryota Imanaka

摘要

Introduction

Venetoclax has demonstrated clinical benefit for newly-diagnosed acute myeloid leukemia (AML), but significant neutropenia is a concern. Data on the time course of neutrophil counts for across treatment cycles in real-world settings remain limited. We report an interim analysis of the VENUS study, which examined neutropenia management in patients with AML receiving venetoclax with azacitidine (VEN/AZA) in Japan.

Methods

This multicenter (10 sites), retrospective, observational study included adults with newly-diagnosed AML ineligible for intensive chemotherapy and initiating venetoclax treatment. Treatment patterns, granulocyte colony-stimulating factor (G-CSF) use, antifungal prophylaxis, and time course of neutrophil counts were analyzed for patients who received > 1 cycle of venetoclax.

Results

Venetoclax was administered for a median 27.0 days in Cycle 1 and then a median 21.0 (range 14.0–22.0) days for subsequent cycles, with median dose holds at the end of each cycle of 8.5–15.0 days. Patients (n = 81) receiving G-CSF were treated with VEN/AZA for a median of 6.0 cycles versus 3.0 in those who did not receive G-CSF (n = 39). In Cycle 1, median neutrophil counts decreased to < 500/µl during Days 8–28 but recovered to > 500/µl by Days 29–35. Median nadir neutrophil count was reached during Days 22–28 in almost all subsequent cycles until Cycle 10. Neutrophil counts decreased to < 500/µl in some cycles but improved to > 500/µl by the next week, suggesting neutrophil levels without higher risk of infection in most patients after Cycle 2 with venetoclax dosing schedule modifications and G-CSF administration. Eighty-eight (73.3%) patients received antifungal prophylaxis, but risk-based antifungal prophylaxis may be considered.

Conclusion

This real-world analysis provides insight into the timing of neutrophil count recovery with dosing schedule modification of venetoclax and G-CSF use in patients with newly-diagnosed AML receiving VEN/AZA, informing timing of the use of antifungal prophylaxis for patients at higher risk.