02.06. Área de Salud VI Vega Media

Real-World Outcomes of Midostaurin Plus Intensive Chemotherapy in FLT3-Mutated AML: The PETHRATIFY Study

2026-10-28T08:26:20Z

Real-World Outcomes of Midostaurin Plus Intensive Chemotherapy in FLT3-Mutated AML: The PETHRATIFY Study Romero-Riquelme, Mónica-Alejandra; Aspas-Requena, Gaspar; Lloret-Madrid, Pilar; Gil, Cristina; Aguiar, Eliana; Tormo, Mar; del-Bernal-del-Castillo, Teresa; Rodríguez-Arboli, Eduardo; Serrano, Josefina; Sánchez-García, Joaquin; Rodríguez-Medina, Carlos; Mariz, José-Mario; Ayala, Rosa; Martínez-López, Joaquin; Amigo, María-Luz; Vives, Susana; Algarra-Algarra, Lorenzo; García-Boyero, Raimundo; Brioso, Joana; Castano, Tamara; Bergua-Burgues, Juan-Miguel; Salamero, Olga; Bass-Maturana, María-Francisca; Colorado, Mercedes; García-Fortes, María; Sayas-Lloris, María-José; Vicente, Belén-Vidriales; Chillon, Carmen; Pérez-Santaolalla, Esther; Madrigal, María-Dolores; Labrador-Gómez, Jorge; García-Pérez, María-José; Casado-Calderon, Soledad; Pérez-Encinas, Manuel; Balerdi-Malcorra, Amaia; Rodríguez, María-Sole; Gómez-García, Lara-María; Herrera-Puente, Pilar; Arce-Fernández, Olga; Barrios-García, Manuel; Noriega, Victor; Fernández, Rosa; Mateos, Mamen; Lacalzada, Carolina; Almela-Gallego, Agata; García-Garay, María-Carmen; Couto, Carmen; Pérez-Simon, José-Antonio; Barragan-González, Eva; Montesinos, Pau Mutations in FLT3 are present in approximately 30% of patients with AML. The addition of midostaurin (MIDO) to intensive chemotherapy (IC) became standard of care following the RATIFY trial, but comprehensive real-world data spanning the full adult age spectrum and including both FLT3-ITD and FLT3-TKD mutations remain limited. We retrospectively analyzed 1658 adults aged 14-85 years with newly diagnosed FLT3-mutated AML from 129 PETHEMA registry centers: 469 received IC + MIDO and 1189 IC alone. Composite complete remission was higher with IC + MIDO than IC (81.4% vs. 71.7%; p < 0.001) and Day 30 mortality was substantially lower (2.1% vs. 7.1%; p < 0.001). Median overall survival was 47.2 versus 19.3 months (HR 0.64; 95% CI, 0.53-0.76; p < 0.001), and the benefit was sustained after multivariable adjustment (HR 0.73; p = 0.017). In 261 propensity score-matched pairs, the effect was attenuated, remaining significant for event-free survival (HR 0.77; p = 0.029) and showing a nonsignificant trend for OS (HR 0.77; p = 0.06). Allogeneic hematopoietic stem cell transplantation in first remission was more frequent in the IC + MIDO cohort (48.9% vs. 41.3%; p = 0.023). Time-dependent analyses showed the largest MIDO effect among autologous and non-transplanted patients (OS HR 0.45; p = 0.138, and HR 0.69; p = 0.014, respectively). The benefit of MIDO was consistent irrespective of FLT3 mutation type, FLT3-ITD allelic burden, cytogenetic risk, and gender, while less improvement occurred among NPM1 wild type and secondary AML patients. This large real-world cohort confirms the survival benefit of MIDO plus IC across the full adult age spectrum, supporting its standard-of-care status in FLT3-mutated AML.

Cross-Cultural Adaptation and Psychometric Validation of the Hospital Survey on Patient Safety Culture Version 2 (HSOPSv2) in Spanish Hospitals

2026-10-28T08:26:25Z

Cross-Cultural Adaptation and Psychometric Validation of the Hospital Survey on Patient Safety Culture Version 2 (HSOPSv2) in Spanish Hospitals López-Picazo-Ferrer, Julio-J; Torres-Ramírez, Juan; Gascón-Cánovas, Juan-J; Alcaraz-Martínez, Julián; Seva, Ana-M; Soria-Aledo, Víctor; Escolar, Pilar INTRODUCTION: Patient safety culture is a key component of healthcare quality. The Hospital Survey on Patient Safety Culture (HSOPS), developed by AHRQ in 2004, has been widely used internationally to assess healthcare professionals' perceptions of safety. In 2019, version 2 (HSOPSv2) was released, with improvements in structure and item clarity. Although a Spanish version for North America exists, it has not yet been validated in the Spanish hospital context. OBJECTIVES: To adapt and validate HSOPSv2 for the Spanish hospital context, ensuring its cultural, linguistic, and psychometric equivalence with the original version, and to assess its suitability for use in Spanish hospitals. METHODS: A cross-cultural adaptation process was conducted, including translation, back-translation, and expert consensus, followed by a cognitive pretest with 20 healthcare professionals. A pilot study was then carried out in four hospitals in Murcia and Alicante, with 369 participants. Internal consistency (Cronbach's ? and composite reliability), convergent validity (AVE, factor loadings), and discriminant validity (Fornell-Larcker criterion and HTMT) were assessed through confirmatory factor analysis using the WLSMV estimator. RESULTS: The 10-factor model showed satisfactory fit indices (CFI and TLI > 0.90; RMSEA < 0.06; SRMR < 0.08). Most dimensions presented acceptable reliability (? and CR > 0.70), except for "Staffing and Work Pace" and "Handoffs and Information Exchange." Convergent validity was adequate in seven of the ten dimensions (AVE ? 0.50), with some weaker loadings in negatively worded items. The Fornell-Larcker criterion indicated overlap in some communication-related constructs, although HTMT results supported overall discriminant validity. CONCLUSIONS: The Spanish version of HSOPSv2 shows satisfactory psychometric properties, comparable to other international adaptations. Its availability provides Spanish hospitals with a robust tool to assess patient safety culture, identify areas for improvement, and design interventions aimed at reducing adverse events and strengthening patient safety.

Multilineage lymphoid clonal hematopoiesis: a cross-sectional, correlative analysis of plasma cell dyscrasias and large granular lymphocytic leukemia

2026-10-28T08:26:24Z

Multilineage lymphoid clonal hematopoiesis: a cross-sectional, correlative analysis of plasma cell dyscrasias and large granular lymphocytic leukemia Bravo-Pérez, Carlos; Gurnari, Carmelo; Durmaz, Arda; Ruiz, Miguel; Braunstein, Zachary; Kawashima, Naomi; Jiang, Justin; Brady, Zachary; Marumo, Atsushi; Ahmed, Arooj; Orland, Mark; Mandala, Aashray; Guarnera, Luca; D'Addona, Matteo; Unlu, Serhan; Haddad, Christopher; Lakhotiya, Kartik; Thiagarajan, Praveena; Nakashima, Megan; Rogers, Heesun-J; Brammer, Jonathan-E; Visconte, Valeria; Maciejewski, Jaroslaw-P Clonal expansions in large granular lymphocytic leukemia (LGLL) may arise in response to immune dysregulation in the context of other hematologic malignancies. This study aimed to investigate the co-occurrence of LGLL and plasma cell dyscrasias (PCDs) to assess its prevalence, features, and potential underlying mechanisms. We conducted a cross-sectional study involving 2064 PCD cases and 534 LGLL cases. Of the 534 LGLL cases, 20% co-occurred with PCD, while LGLL was present in 2% of the 2064 PCD cases. Among 117 patients with both conditions, PCDs were predominantly associated with IgM M-protein, while LGLL patients had increased NK-cell proliferation and fewer mutations in STAT3/5B. The co-occurrence was linked to a higher incidence of autoimmune conditions, B-cell neoplasms, and more severe immune-mediated cytopenias. In symptomatic PCD/LGLL patients with low plasma-cell infiltration, B-cell-targeted therapies outperformed immunosuppression, suggesting humoral involvement. Correlation with biological parameters revealed elevated interleukin-6 and inhibitory effects of sera of symptomatic PCD/LGLL patients on hematopoietic cells. Our findings suggest an association between PCD and LGLL, characterized by distinct features that may have significant implications for clinical management. These results highlight the importance of considering hematologic co-occurrences in clinical practice and warrant further investigation into the molecular mechanisms linking these conditions.

Hair bulb and oral mucosa DNA for prompt germline testing in hematologic neoplasms

2026-10-28T08:26:24Z

Hair bulb and oral mucosa DNA for prompt germline testing in hematologic neoplasms Balbastre-Ubeda, Ferran; Torres-Esquius, Sara; Gabarros-Subira, María; Beas, Francisco; Leno-Colorado, Jordi; Sánchez-Morales, Cristina; Chen-Liang, Tzu-Hua; Urban-Giral, Susana; Tena-Alegre, Meritxell; Hurtado-López, Ana-María; Casas-Tio, María-Jesús; Garrido, Ana-María; Acha, Pamela; Blanco, Adoracion; Sole, Francesc; Del-Rey, Monica; Diez-Campelo, María; Valcarcel, David; Montoro, María-Julia; Jerez, Andres