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<p>The comparative value of liposomal cytarabine/daunorubicin (CPX-351) versus venetoclax plus a hypomethylating agent (Ven-HMA) in the frontline treatment of older adults with primary (de novo) or secondary acute myeloid leukemia (AML) remains uncertain. In the current study, we retrospectively examined outcomes of 600 patients with newly diagnosed AML treated with CPX-351 (<i>N</i> = 112) or Ven-HMA (<i>N</i> = 488). AML subtypes included de novo (<i>N</i> = 277, 46%), post-myelodysplastic syndrome (post-MDS, <i>N</i> = 114,19%), post-myeloproliferative neoplasm (post-MPN, <i>N</i> = 70, 12%), post-MDS/MPN (<i>N</i> = 36, 6%), and t-AML (<i>N</i> = 103, 17%). Patients receiving CPX-351 were younger (median 65 vs. 73 years; <i>p</i> &lt; 0.01), predominantly female (50% vs. 38%; <i>p</i> = 0.02), more likely to have secondary AML (68% vs. 51%; <i>p</i> &lt; 0.01), and less likely to harbor <i>NPM1</i><sup>MUT</sup> (5% vs. 12%; <i>p</i> = 0.02). Rates of complete response with or without count recovery (CR/CRi) were comparable between CPX-351 and Ven-HMA (55% vs. 60%; <i>p</i> = 0.30), including AML with myelodysplasia-related gene mutations or cytogenetic abnormalities (AML-MR 60% vs. 63%; <i>p</i> = 0.70). Ven-HMA use was associated with fewer infectious complications (62% vs. 83%; p &lt; 0.01) and yielded higher CR/CRi rates in males (60% vs. 45%; <i>p</i> = 0.04), de novo AML (68% vs. 50%; <i>p</i> = 0.03), and in the presence of <i>STAG2</i><sup>MUT</sup> (86% vs. 44%; <i>p</i> = 0.02), or <i>CEBPA</i><sup>MUT</sup> (88% vs. 50%; <i>p</i> = 0.03). Overall survival censored for transplant, was similar (median 10 vs. 13 months; <i>p</i> = 0.90), with Ven-HMA being superior in post-MDS AML (median 12 vs. 7 months; <i>p</i> = 0.02) and CPX-351 in the presence of <i>SF3B1</i><sup>MUT</sup> (median not reached vs. 14 months; <i>p</i> &lt; 0.01). Our findings suggest that Ven-HMA is as effective and less toxic than CPX-351 in newly diagnosed AML, including AML-MR, despite selection of younger, fitter patients for CPX-351.</p><p></p>

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CPX-351 (Liposomal Cytarabine and Daunorubicin) versus venetoclax plus hypomethylating agent therapy in newly diagnosed acute myeloid leukemia: a retrospective comparison involving 600 Mayo Clinic patients

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  • 发表日期：

    2026年4月6日

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  • Saubia Fathima,
  • Lior Rokach,
  • Nour Ghosoun,
  • Mahsa Rezasoltani,
  • Rimal Ilyas,
  • Ali Alsugair,
  • Kristen McCullough,
  • Maymona Abdelmagid,
  • Aref Al-Kali,
  • Hassan B. Alkhateeb,
  • Kebede H. Begna,
  • Abhishek A. Mangaonkar,
  • Aasiya Matin,
  • Antoine N. Saliba,
  • Mehrdad Hefazi Torghabeh,
  • Mark R. Litzow,
  • William Hogan,
  • Mithun Shah,
  • Mrinal M. Patnaik,
  • Animesh Pardanani,
  • Talha Badar,
  • Hemant Murthy,
  • James Foran,
  • Jeanne Palmer,
  • Nathan Punwani,
  • Lisa Sproat,
  • Nandita Khera,
  • Cecilia Arana Yi,
  • Ayalew Tefferi,
  • Naseema Gangat

摘要

The comparative value of liposomal cytarabine/daunorubicin (CPX-351) versus venetoclax plus a hypomethylating agent (Ven-HMA) in the frontline treatment of older adults with primary (de novo) or secondary acute myeloid leukemia (AML) remains uncertain. In the current study, we retrospectively examined outcomes of 600 patients with newly diagnosed AML treated with CPX-351 (N = 112) or Ven-HMA (N = 488). AML subtypes included de novo (N = 277, 46%), post-myelodysplastic syndrome (post-MDS, N = 114,19%), post-myeloproliferative neoplasm (post-MPN, N = 70, 12%), post-MDS/MPN (N = 36, 6%), and t-AML (N = 103, 17%). Patients receiving CPX-351 were younger (median 65 vs. 73 years; p < 0.01), predominantly female (50% vs. 38%; p = 0.02), more likely to have secondary AML (68% vs. 51%; p < 0.01), and less likely to harbor NPM1MUT (5% vs. 12%; p = 0.02). Rates of complete response with or without count recovery (CR/CRi) were comparable between CPX-351 and Ven-HMA (55% vs. 60%; p = 0.30), including AML with myelodysplasia-related gene mutations or cytogenetic abnormalities (AML-MR 60% vs. 63%; p = 0.70). Ven-HMA use was associated with fewer infectious complications (62% vs. 83%; p < 0.01) and yielded higher CR/CRi rates in males (60% vs. 45%; p = 0.04), de novo AML (68% vs. 50%; p = 0.03), and in the presence of STAG2MUT (86% vs. 44%; p = 0.02), or CEBPAMUT (88% vs. 50%; p = 0.03). Overall survival censored for transplant, was similar (median 10 vs. 13 months; p = 0.90), with Ven-HMA being superior in post-MDS AML (median 12 vs. 7 months; p = 0.02) and CPX-351 in the presence of SF3B1MUT (median not reached vs. 14 months; p < 0.01). Our findings suggest that Ven-HMA is as effective and less toxic than CPX-351 in newly diagnosed AML, including AML-MR, despite selection of younger, fitter patients for CPX-351.