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<p>Relapse remains the leading cause of treatment failure in pediatric and young adult patients with relapsed/refractory B-cell acute lymphoblastic leukemia (r/r B-ALL) undergoing chimeric antigen receptor T-cell (CAR-T) therapy. While prognostic factors for relapse have been identified, further refinement is needed. We conducted a single-center retrospective study of 69 patients treated with Tisagenlecleucel, to evaluate the prognostic impact of <i>TP53</i> alterations (<i>TP53</i><sup><i>Alt</i></sup>), including mutations and/or deletions. Among 49 patients with available samples, 17 (34.7%) had <i>TP53</i><sup><i>Alt</i></sup>. These patients showed significantly lower remission rates (68.8% vs. 93.8%, <i>p</i> = 0.033) and worse event-free survival (EFS) and overall survival (OS), independent of genetic risk group. Median EFS was 3.8 months (95% CI: 1.2–NE) for <i>TP53</i><sup><i>Alt</i></sup> versus 50.9 months (95% CI: 23.9–NE) for <i>TP53</i> wild-type (<i>TP53</i><sup><i>wt</i></sup>). Three-year EFS and OS were 33.1% (95% CI: 16.4%–66.6%) and 37.2% (95% CI: 19.4%–71.4%) for <i>TP53</i><sup><i>Alt</i></sup>, compared to 56.2% and 81.2% for <i>TP53</i><sup><i>wt</i></sup> (<i>p</i> = 0.0069 and <i>p</i> = 0.0010, respectively). These findings identify <i>TP53</i> alterations as a strong adverse prognostic factor in patients with r/r B-ALL treated with CAR-T therapy. Screening for <i>TP53</i><sup><i>Alt</i></sup> may guide risk-adapted strategies, including early consolidation with hematopoietic stem cell transplantation or alternative therapies.</p><p></p>

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Impact of TP53 alterations on outcomes in pediatric and young adult patients with relapsed / refractory B-cell acute lymphoblastic leukemia after CD19-CAR T-Cell therapy

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年4月4日

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  • Anna Alonso-Saladrigues,
  • Elena Esperanza-Cebollada,
  • Clara Vicente-Garcés,
  • Sara Perez-Jaume,
  • Nazaret Sánchez-Sierra,
  • Mercè Richarte-Franqués,
  • Albert Català,
  • Alba Crespo-Carrasco,
  • José-Luis Dapena,
  • Esther Cuatrecasas Capdevila,
  • Anna Faura Morros,
  • Maria A. Ruiz-Cobo,
  • Laura Arqués,
  • Nuria Conde Cuevas,
  • Sandra Andreu,
  • Ignacio Isola,
  • Iolanda Jordan,
  • Enric García-Rey,
  • Cristina Llanos,
  • Júlia Marsal,
  • Verónica Celis,
  • Mireia Camós,
  • Montserrat Torrebadell,
  • Nerea Vega-García,
  • Susana Rives

摘要

Relapse remains the leading cause of treatment failure in pediatric and young adult patients with relapsed/refractory B-cell acute lymphoblastic leukemia (r/r B-ALL) undergoing chimeric antigen receptor T-cell (CAR-T) therapy. While prognostic factors for relapse have been identified, further refinement is needed. We conducted a single-center retrospective study of 69 patients treated with Tisagenlecleucel, to evaluate the prognostic impact of TP53 alterations (TP53Alt), including mutations and/or deletions. Among 49 patients with available samples, 17 (34.7%) had TP53Alt. These patients showed significantly lower remission rates (68.8% vs. 93.8%, p = 0.033) and worse event-free survival (EFS) and overall survival (OS), independent of genetic risk group. Median EFS was 3.8 months (95% CI: 1.2–NE) for TP53Alt versus 50.9 months (95% CI: 23.9–NE) for TP53 wild-type (TP53wt). Three-year EFS and OS were 33.1% (95% CI: 16.4%–66.6%) and 37.2% (95% CI: 19.4%–71.4%) for TP53Alt, compared to 56.2% and 81.2% for TP53wt (p = 0.0069 and p = 0.0010, respectively). These findings identify TP53 alterations as a strong adverse prognostic factor in patients with r/r B-ALL treated with CAR-T therapy. Screening for TP53Alt may guide risk-adapted strategies, including early consolidation with hematopoietic stem cell transplantation or alternative therapies.