RESUMO
BACKGROUND: Available treatments for older patients with primary diffuse large B-cell CNS lymphoma (PCNSL) offer progression-free survival of up to 16 months. We aimed to investigate an intensified treatment of high-dose chemotherapy and autologous haematopoietic stem-cell transplantation (HSCT) in older patients with PCNSL. METHODS: MARTA was a prospective, single-arm, phase 2 study done at 15 research hospitals in Germany. Patients aged 65 years or older with newly diagnosed, untreated PCNSL were enrolled if they had an Eastern Cooperative Oncology Group performance status of 0-2 and were fit for high-dose chemotherapy and autologous HSCT. Induction treatment consisted of two 21-day cycles of high-dose intravenous methotrexate 3·5 g/m2 (day 1), intravenous cytarabine 2 g/m2 twice daily (days 2 and 3), and intravenous rituximab 375 mg/m2 (days 0 and 4) followed by high-dose chemotherapy with intravenous rituximab 375 mg/m2 (day -8), intravenous busulfan 3·2 mg/kg (days -7 and -6), and intravenous thiotepa 5 mg/kg (days -5 and -4) plus autologous HSCT. The primary endpoint was progression-free survival at 12 months in all patients who met eligibility criteria and started treatment. The study was registered with the German clinical trial registry, DRKS00011932, and recruitment is complete. FINDINGS: Between Nov 28, 2017, and Sept 16, 2020, 54 patients started induction treatment and 51 were included in the full analysis set. Median age was 71 years (IQR 68-75); 27 (53%) patients were female and 24 (47%) were male. At a median follow-up of 23·0 months (IQR 16·8-37·4), 23 (45%) of 51 patients progressed, relapsed, or died. 12-month progression-free survival was 58·8% (80% CI 48·9-68·2; 95% CI 44·1-70·9). During induction treatment, the most common grade 3-5 toxicities were thrombocytopenia and leukopenia (each in 52 [96%] of 54 patients). During high-dose chemotherapy and autologous HSCT, the most common grade 3-5 toxicity was leukopenia (37 [100%] of 37 patients). Treatment-related deaths were reported in three (6%) of 54 patients, all due to infectious complications. INTERPRETATION: Although the primary efficacy threshold was not met, short induction followed by high-dose chemotherapy and autologous HSCT is active in selected older patients with PCNSL and could serve as a benchmark for comparative trials. FUNDING: Else Kröner-Fresenius Foundation, Riemser Pharma, and Medical Center-University of Freiburg.
Assuntos
Transplante de Células-Tronco Hematopoéticas , Leucopenia , Linfoma Difuso de Grandes Células B , Humanos , Feminino , Masculino , Idoso , Estudos Prospectivos , Rituximab , Linfoma Difuso de Grandes Células B/tratamento farmacológicoRESUMO
OBJECTIVE: This article introduces a Spanish version of the Generalized Expectancies for Negative Mood Regulation Scale (NMR-S) and tests the reliability and the validity of the new questionnaire. METHODS: A sample of 360 students from Chile completed the NMR-S along with instruments measuring depressive symptoms, social desirability, coping, and emotion regulation. RESULTS: A factor analysis indicated that the NMR-S has a one-dimensional structure. The reliability of the new instrument was α = 0.89. The concurrent validity of the NMR-S was supported by correlations with measures of coping, emotion regulation, and depressive symptoms. Furthermore, the NMR-S predicted depressive symptoms when controlling for emotion regulation and coping. CONCLUSIONS: The findings are the first evidence to support the reliability and validity of the NMR-S.
OBJETIVO: En este artículo se presenta la versión en español de la Escala de Expectativas Generalizadas para la Regulación del Animo Negativo (NMR-S) y se evalúa la confiabilidad y la validez del nuevo cuestionario. MÉTODOS: Una muestra de 360 estudiantes de Chile completó la NMR-S junto con instrumentos dirigidos a medir síntomas depresivos, deseabilidad social, afrontamiento y regulación emocional. RESULTADOS: Un análisis factorial indicó que la NMR-S tiene una estructura unidimensional. La confiabilidad del nuevo instrumento fue de α = 0,89. La validez concurrente de la NMR-S fue avalada a través de su correlación con las mediciones de afrontamiento, regulación emocional y síntomas depresivos. Asimismo, la NMR-S predijo los síntomas depresivos cuando se controló por la regulación emocional y el afrontamiento. CONCLUSIONES: Los datos presentados son la primera evidencia para avalar la confiabilidad y la validez de la NMR-S.