Session: 624. Hodgkin Lymphoma and T/NK Cell Lymphoma—Clinical Studies: Poster III
Hematology Disease Topics & Pathways:
Biological, antibodies, Non-Biological, Combinations, Therapies, chemotherapy, Pediatric, Young Adult, Study Population, Clinically relevant
Patients and Methods: We performed a multi-institution retrospective review of pediatric patients with R/R HL <21 years of age treated with BV/bendamustine. Patients received BV (1.8mg/kg) on Day 1 with bendamustine (90mg/m2) on Days 1 and 2 of 3-week cycles. Response was assessed utilizing Lugano criteria. Twenty-nine patients with a median age of 16 years (range 10 to 20 years) were identified across 3 institutions. Ten patients were classified as having refractory disease and 19 with relapsed disease, with 14/19 patients having relapsed less than a year from the completion of initial therapy. Twenty-one patients received BV/bendamustine as first line salvage therapy. Eight patients (28%) previously received radiation therapy (RT), 4 patients (14%) received prior BV and 4 patients (14%) had ASCT as part of prior therapy.
Results: Patients received a median of 3 cycles of BV/bendamustine (range 2-7). Overall, 18 (62%) patients achieved a CR (95%CI: 42 to 79%). An objective response (OR) was observed in 23 patients (ORR 79%) (95%CI: 60 to 92%). Notably, response rates were comparable among patients with relapsed (CR/ORR: 63/79%) or refractory (CR/ORR: 60/80%) disease. Among responders, 15 (65%) achieved best response within 2 cycles. CR and OR rates in patients receiving BV/bendamustine as first-line salvage therapy versus second-line salvage or greater was 67/81% and 50/75%, respectively. The most common grade 3 or 4 toxicities were hematologic (neutropenia (n=13), anemia (n=4), thrombocytopenia (n=4)). Three patients experienced grade 3 infusion reactions. Two patients proceeded with BV/bendamustine following desensitization protocols and 1 patient continued therapy with single-agent bendamustine. Sixteen patients received a consolidative transplant following BV/bendamustine (13 autologous, 3 allogeneic), 5 patients received consolidative RT, and 10 patients received post-transplant consolidation with BV. For the entire cohort, the 3-year post-BV/bendamustine event-free and overall survival was 65% (95%CI: 46 to 85%) and 89% (95%CI: 74 to 100), respectively.
Conclusions: Combination therapy with BV/bendamustine for pediatric patients with R/R HL compares favorably with currently accepted salvage regimens in terms of response and tolerability. These results support evaluation of this regimen in a multi-center prospective clinical trial.
Disclosures: Absalon: Jazz Pharmaceuticals: Research Funding. Shukla: Syndax Pharmaceuticals, Inc.: Membership on an entity's Board of Directors or advisory committees.
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