Final Report of Reduced Anthracycline Dose Intensity with the Addition of Dose Dense Rituximab in Children, Adolescents and Young Adults with De Novo Good Risk Mature B-Cell Non Hodgkin Lymphoma (B-NHL)

Background: Previous studies have demonstrated excellent results with FAB/LMB86 chemotherapy alone and in combination with rituximab in children, adolescents and young adults with mature B-NHL. (Cairo et al, JCO 2012, Goldman et al, Leukemia, 2013, Goldman et al, BJH 2014) The intermediate risk FAB/...

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Published in:Blood 2020-11, Vol.136 (Supplement 1), p.3-4
Main Authors: Hochberg, Jessica C., Goldman, Stanton, Barth, Matthew J., Shi, Qiuhu, Klejmont, Liana, Harrison, Lauren, Basso, Jackie, Chu, Yaya, Islam, Humayun, Gerard, Perry, Oesterheld, Javier, Heym, Kenneth Matthew, Kirov, Ivan I., Drachtman, Richard A., Harker-Murray, Paul, Perkins, Sherrie L., Miles, Rodney R., Shiramizu, Bruce, Cairo, Mitchell S
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Language:English
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Summary:Background: Previous studies have demonstrated excellent results with FAB/LMB86 chemotherapy alone and in combination with rituximab in children, adolescents and young adults with mature B-NHL. (Cairo et al, JCO 2012, Goldman et al, Leukemia, 2013, Goldman et al, BJH 2014) The intermediate risk FAB/LMB Group B arm consists of 180mg/m2 of doxorubicin. This was reduced to 120mg/m2 with the addition of dose-dense rituximab. Other standard NHL regimens more commonly used in young adults with advanced stage mature B-NHL, such as R-CHOP, have a total dose doxorubicin of 360mg/m2. These approaches are associated with short term morbidities and long-term health conditions, including anthracycline induced cardiac toxicities.Dose-dense rituximab containing chemoimmunotherapy in high risk mature B-NHL has shown significant improvements in outcomes. We tested the hypothesis that rituximab can be used to even further reduce the burden of anthracycline from 120mg/m2 to 50mg/m2 in patients with good risk B-NHL. Objective: To safely reduce the burden of therapy by reducing the number of IT injections and reducing the total dose of doxorubicin from 120mg/m2 to 50mg/m2 with the addition of liposomal cytarabine and dose-dense rituximab to our prior chemotherapy backbone in children with good risk mature B-NHL. Design/Methods: Multi-institutional Phase II study (NCT01859819). Patients (3-31 years) with CD20+ B-NHL with good risk (FAB Group B GR=Stage I/II, Stage III with any LDH and Stage IV {BM tumor < 25%)}) were eligible. Staging was defined per the IPNHLSS as previously described. (Roselen et al, JCO 2015) All patients received FAB backbone chemotherapy with the addition of six rituximab (375mg/m2) doses; two doses prior to each of two induction courses and one dose prior to each of two consolidation courses. Cumulative doxorubicin was reduced from 120 to 50 mg/m2 (25mg/m2 per dose) total. After systemic methotrexate clearance, patients received age-based dosing of IT liposomal cytarabine resulting in a reduction of IT injections from nine to five. The primary outcome was safety and toxic deaths with an estimated 3-year survival above 90%, monitored by an independent DSMB. Response was defined per the IPNHLRC as previously described. (Sandlund et al, JCO 2015) Results: Twenty-five FAB Group B patients were enrolled at 5 treatment centers in the United States. Histology included DLBCL in 13 patients and Burkitt in 12 patients. Table 1. All patients had at least a 20% tumor
ISSN:0006-4971
1528-0020
DOI:10.1182/blood-2020-139464