Scholarlink

Background <p>Retrospective studies suggested that autologous stem cell transplantation (auto-SCT) might achieve comparable or even better outcomes compared with allogeneic SCT for patients with genetic intermediate-risk acute myeloid leukemia (IR-AML) and no detectable measurable residual disease (MRD-). However, prospective studies are lacking comparing auto-SCT and matched sibling donor SCT (MSD-SCT).</p> Patient and methods <p>We initiated a biological assignment comparative study at fourteen institutions in China. Patients with newly diagnosed de novo IR-AML and MRD- within 3 cycles of intensive chemotherapy were eligible for the study if they were 14 to 60 years old and received auto-SCT or MSD-SCT. Patients were assigned to auto-SCT or MSD-SCT based on donor availability. The primary endpoint was the 3-year disease-free survival (DFS). The trial was registered with Clinicaltrials.gov, NCT03620955 and completed.</p> Results <p>Between November 15, 2018, and March 31, 2022, 708 patients were screened and 518 eligible for analysis, including 259 in the auto-SCT and 259 in the MSD-SCT groups. With a median follow-up time of 55.2 (IQR 47.4–65.2) months, the 3-year DFS was 82.2% (95% CI 77.0-86.4) and 85.7% (95% CI 80.8–89.4) in auto-SCT and MSD-SCT respectively (HR, 1.24 [95% CI, 0.81–1.91]; <i>p</i>=.32). The treatment-adjusted difference was 3.2% (95% CI, − 3.1 to 9.4; <i>p</i>&lt;.001). Because the upper bound of the 95% CI (9.4) did not exceed 10%, noninferiority was shown. The 3-year overall survival (OS) was 90.7% (95% CI 86.5–93.7) and 87.6% (95% CI 83.0-91.1) respectively (HR, 0.78 [95% CI, 0.47–1.30]; <i>p</i>=.34). In subgroup analyses, auto-SCT achieved similar DFS and OS to MSD-SCT among patients who reached MRD- in the first 2 cycles of chemotherapy, while auto-SCT had inferior DFS but similar OS for patients who achieved MRD- after 3 cycles.</p> Conclusions <p>Auto-SCT achieved non-inferior DFS and similar OS compared with MSD-SCT, suggesting that auto-SCT is a viable and preferable first-line choice for IR-AML patients achieving MRD- within 3 cycles of chemotherapy, particularly those who reached MRD- in the first 2 cycles.</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

Autologous transplant versus matched sibling donor transplant in intermediate-risk AML in CR1 with no detectable MRD: a biological assignment comparative study

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2026年7月6日

查看全文
  • Sijian Yu,
  • Hui Liu,
  • Weihua Zhao,
  • Guopan Yu,
  • Pengcheng Shi,
  • Danian Nie,
  • Zhiqiang Sun,
  • Qianwei Liu,
  • Ruoyang Shao,
  • Zinan Feng,
  • Xinquan Liang,
  • Xiong Zhang,
  • Xin Du,
  • Xiaojun Xu,
  • Shunqing Wang,
  • Qing Zhang,
  • Yirong Jiang,
  • Hongyu Zhang,
  • Ziwen Guo,
  • Min Dai,
  • Xuejie Jiang,
  • Dan Xu,
  • Fen Huang,
  • Zhiping Fan,
  • Na Xu,
  • Qiong Liu,
  • Qianyi Liang,
  • Can Liu,
  • Meiqing Wu,
  • Guangyang Wen,
  • Ren Lin,
  • Hua Jin,
  • Jing Sun,
  • Yu Wang,
  • Li Xuan,
  • Yu Zhang,
  • Qifa Liu

摘要

Background

Retrospective studies suggested that autologous stem cell transplantation (auto-SCT) might achieve comparable or even better outcomes compared with allogeneic SCT for patients with genetic intermediate-risk acute myeloid leukemia (IR-AML) and no detectable measurable residual disease (MRD-). However, prospective studies are lacking comparing auto-SCT and matched sibling donor SCT (MSD-SCT).

Patient and methods

We initiated a biological assignment comparative study at fourteen institutions in China. Patients with newly diagnosed de novo IR-AML and MRD- within 3 cycles of intensive chemotherapy were eligible for the study if they were 14 to 60 years old and received auto-SCT or MSD-SCT. Patients were assigned to auto-SCT or MSD-SCT based on donor availability. The primary endpoint was the 3-year disease-free survival (DFS). The trial was registered with Clinicaltrials.gov, NCT03620955 and completed.

Results

Between November 15, 2018, and March 31, 2022, 708 patients were screened and 518 eligible for analysis, including 259 in the auto-SCT and 259 in the MSD-SCT groups. With a median follow-up time of 55.2 (IQR 47.4–65.2) months, the 3-year DFS was 82.2% (95% CI 77.0-86.4) and 85.7% (95% CI 80.8–89.4) in auto-SCT and MSD-SCT respectively (HR, 1.24 [95% CI, 0.81–1.91]; p=.32). The treatment-adjusted difference was 3.2% (95% CI, − 3.1 to 9.4; p<.001). Because the upper bound of the 95% CI (9.4) did not exceed 10%, noninferiority was shown. The 3-year overall survival (OS) was 90.7% (95% CI 86.5–93.7) and 87.6% (95% CI 83.0-91.1) respectively (HR, 0.78 [95% CI, 0.47–1.30]; p=.34). In subgroup analyses, auto-SCT achieved similar DFS and OS to MSD-SCT among patients who reached MRD- in the first 2 cycles of chemotherapy, while auto-SCT had inferior DFS but similar OS for patients who achieved MRD- after 3 cycles.

Conclusions

Auto-SCT achieved non-inferior DFS and similar OS compared with MSD-SCT, suggesting that auto-SCT is a viable and preferable first-line choice for IR-AML patients achieving MRD- within 3 cycles of chemotherapy, particularly those who reached MRD- in the first 2 cycles.