Comparison in safety of chemotherapy protocols for blood cancers: toxicity of H-CVAD versus GELA/BURKIMAB/PETHEMA LAL.

BACKGROUND AND OBJECTIVE: The Hyper-CVAD/Methotrexate-Cytarabine (H-CVAD/MTX-AraC) chemotherapy protocol has been one of the standard treatments for blood cancers, such as Mantle cell lymphoma (MCL), Burkitt's lymphoma (BL) and B-cell and T-cell acute lymphoblastic leukaemia (ALL). Due to high toxicity, it has been progressively replaced with new specific regimens with a better safety profile (GELA protocol for MCL, BURKIMAB for BL and PETHEMA for B-cell and T-cell ALL). The objective of this study is to analyse the toxicity and infectious complications of these therapeutic regimens, as well as the event free survival (EFS). PATIENTS AND METHODS: This is a retrospective and descriptive observational study of 81 patients, comparing 42 patients treated with H-CVAD/MTX-AraC (group A) versus 39 patients treated with GELA/BURKIMAB/PETHEMA (group B). RESULTS: All patients in group A developed pancytopenia, but in group B 74.4% neutropenia, 51.3% thrombocytopenia and 69.2% anaemia. The total number of infections in group A was higher than in group B: 154 versus 48, 3.67 versus 1.23 per patient and 0.59 versus 0.25 per cycle. Likewise, febrile neutropenia happened: 106 versus 21 cases, 2.52 versus 0.52 per patient and 0.41 versus 0.11 per cycle. EVS is higher in group B: 33% versus 79% (2-year), and 24% versus 69% (5-year). CONCLUSIONS: Current therapeutic protocols have shown higher EFS due to better safety profile, with less haematological, neurological and haemorrhagic toxicity, as well as lower rates of infectious complications.

Efficacy of chemotherapy protocols for hematological malignancies: H-CVAD versus GELA/BURKIMAB/PETHEMA LAL.

The hyper-CVAD/methotrexate-cytarabine (H-CVAD/ MTX-AraC) chemotherapy protocol has been one of the standard treatments for hematological malignancies, such as mantle cell lymphoma (MCL), Burkitt lymphoma (BL), and B-cell and T-cell acute lymphoblastic leukemia. Because results of this therapy are poor, it has been progressively replaced with new specific regimens with better efficacy profiles (GELA protocol for MCL, BURKIMAB for BL, and PETHEMA for B-cell and T-cell acute lymphoblastic leukemia [ALL]). The objective of this study was to analyze the response rates and survival of these therapeutic regimens. This retrospective and descriptive observational study of 81 patients compared 42 patients treated with hyper-CVAD/methotrexate-cytarabine (group A) with 39 patients treated with GELA/BURKIMAB/PETHEMA (group B). More patients in group B than in group A completed the treatment (89.7% vs. 47.6%, p < 0.001). In group A, 14.3% did not complete treatment because of death compared with 7.7% in group B, and 29% in group A had cycle delays versus 6.7% in group B (p < 0.001). In group A, 78.6% of group A achieved a complete response (CR) compared with 94.9% of group B (p = 0.050). Disease-free survival (DFS) and overall survival (OS) were significantly higher in group B (p < 0.001 in both cases). Data for current therapeutic protocols have indicated superior efficacy, with higher complete response rates, as well as better disease-free survival and overall survival results. This article provides the best results in terms of the efficacy of treatment of four hematological malignancies (MCL, BL, B-cell ALL, and T-cell ALL) with the most current specific therapeutic regimens (GELA for MCL, BURKIMAB for BL, and PETHEMA for B-cell ALL and T-cell ALL) with respect to a classic general protocol (H-CVAD/MTX-AraC for all four). These results may represent a great advance in the treatment of these blood cancers, achieving an important long-term benefit for these hematological patients.

Risk factors and outcome of COVID-19 in patients with hematological malignancies.

BACKGROUND: Prognostic factors of poor outcome in patients with hematological malignancies and COVID-19 are poorly defined. PATIENTS AND METHODS: This was a Spanish transplant group and cell therapy (GETH) multicenter retrospective observational study, which included a large cohort of blood cancer patients with laboratory-confirmed SARS-CoV-2 infection through PCR assays from March 1st 2020 to May 15th 2020. RESULTS: We included 367 pediatric and adult patients with hematological malignancies, including recipients of autologous (ASCT) (n = 58) or allogeneic stem cell transplantation (allo-SCT) (n = 65) from 41 hospitals in Spain. Median age of patients was 64 years (range 1-93.8). Recipients of ASCT and allo-SCT showed lower mortality rates (17% and 18%, respectively) compared to non-SCT patients (31%) (p = 0.02). Prognostic factors identified for day 45 overall mortality (OM) by logistic regression multivariate analysis included age > 70 years [odds ratio (OR) 2.1, 95% confidence interval (CI) 1.2-3.8, p = 0.011]; uncontrolled hematological malignancy (OR 2.9, 95% CI 1.6-5.2, p < 0.0001); ECOG 3-4 (OR, 2.56, 95% CI 1.4-4.7, p = 0.003); neutropenia (< 0.5 × 109/L) (OR 2.8, 95% CI 1.3-6.1, p = 0.01); and a C-reactive protein (CRP) > 20 mg/dL (OR 3.3, 95% CI 1.7-6.4, p < 0.0001). In multivariate analysis of 216 patients with very severe COVID-19, treatment with azithromycin or low dose corticosteroids was associated with lower OM (OR 0.42, 95% CI 0.2-0.89 and OR 0.31, 95% CI 0.11-0.87, respectively, p = 0.02) whereas the use of hidroxycloroquine did not show significant improvement in OM (OR 0.64, 95% CI 0.37-1.1, P = 0.1). CONCLUSIONS: In most patients with hematological malignancies COVID-19 mortality was directly driven by older age, disease status, performance status, as well as by immune (neutropenia) parameters and level of inflammation (high CRP). Use of azithromycin and low dose corticosteroids may be of value in very severe COVID-19.