Hyper-CVAD plus ofatumumab versus hyper-CVAD plus rituximab as frontline therapy in adults with Philadelphia chromosome-negative acute lymphoblastic leukemia: A propensity score analysis

Koji Sasaki, Hagop M Kantarjian, Kiyomi Morita, Nicholas J Short, Marina Konopleva, Nitin Jain, Farhad Ravandi, Guillermo Garcia-Manero, Sa Wang, Joseph D Khoury, Jeffrey L Jorgensen, Richard E Champlin, Issa F Khouri, Partow Kebriaei, Heather M Schroeder, Maria Khouri, Rebecca Garris, Koichi Takahashi, Susan M O'Brien, Elias J Jabbour, Koji Sasaki, Hagop M Kantarjian, Kiyomi Morita, Nicholas J Short, Marina Konopleva, Nitin Jain, Farhad Ravandi, Guillermo Garcia-Manero, Sa Wang, Joseph D Khoury, Jeffrey L Jorgensen, Richard E Champlin, Issa F Khouri, Partow Kebriaei, Heather M Schroeder, Maria Khouri, Rebecca Garris, Koichi Takahashi, Susan M O'Brien, Elias J Jabbour

Abstract

Background: The outcome of hyperfractionated cyclophosphamide, vincristine, doxorubicin, and dexamethasone plus ofatumumab hyper-CVAD + ofatumumab (hyper-CVAD + ofatumumab) has not been compared with the outcome of hyperfractionated cyclophosphamide, vincristine, doxorubicin, and dexamethasone plus ofatumumab hyper-CVAD plus rituximab (hyper-CVAD + Rituximab) in Philadelphia chromosome-negative acute lymphoblastic leukemia (ALL) in a randomized clinical trial.

Methods: The authors compared the outcomes of 69 patients treated with hyper-CVAD + ofatumumab and 95 historical-control patients treated with hyper-CVAD + Rituximab. Historical-control patients were treated with hyper-CVAD + Rituximab if they had CD20 expression ≥ 20%. Ofatumumab (day 1 of course 1, 300 mg intravenously; subsequent doses, 2000 mg intravenously) was administered on days 1 and 11 of courses 1 and 3 and on days 1 and 8 of courses 2 and 4 for a total of 8 doses. A propensity score analysis with inverse probability of treatment weighting (IPTW) was performed to adjust for baseline covariates between groups.

Results: The median event-free survival with stem cell transplantation (SCT) censoring was 33 and 65 months with hyper-CVAD + Rituximab and hyper-CVAD + ofatumumab, respectively (crude P = .064; IPTW P = .054). The median overall survival with SCT censoring was 52 months and not reached, respectively (crude P = .087; IPTW P = .097).

Conclusions: Hyper-CVAD + ofatumumab was associated with better outcomes than hyper-CVAD + Rituximab among patients with newly diagnosed Philadelphia chromosome-negative ALL.

Trial registration: ClinicalTrials.gov NCT01363128.

Keywords: Philadelphia chromosome-negative; acute lymphoblastic leukemia; anti-CD20 antibody; ofatumumab.

© 2021 American Cancer Society.

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Source: PubMed

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