TY - JOUR
T1 - Hyper-CVAD plus ofatumumab versus hyper-CVAD plus rituximab as frontline therapy in adults with Philadelphia chromosome–negative acute lymphoblastic leukemia
T2 - A propensity score analysis
AU - Sasaki, Koji
AU - Kantarjian, Hagop M.
AU - Morita, Kiyomi
AU - Short, Nicholas J.
AU - Konopleva, Marina
AU - Jain, Nitin
AU - Ravandi, Farhad
AU - Garcia-Manero, Guillermo
AU - Wang, Sa
AU - Khoury, Joseph D.
AU - Jorgensen, Jeffrey L.
AU - Champlin, Richard E.
AU - Khouri, Issa F.
AU - Kebriaei, Partow
AU - Schroeder, Heather M.
AU - Khouri, Maria
AU - Garris, Rebecca
AU - Takahashi, Koichi
AU - O’Brien, Susan M.
AU - Jabbour, Elias J.
N1 - Publisher Copyright:
© 2021 American Cancer Society
PY - 2021/9/15
Y1 - 2021/9/15
N2 - 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.
AB - 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.
KW - Philadelphia chromosome–negative
KW - acute lymphoblastic leukemia
KW - anti-CD20 antibody
KW - ofatumumab
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U2 - 10.1002/cncr.33655
DO - 10.1002/cncr.33655
M3 - Article
C2 - 34138471
AN - SCOPUS:85108174855
SN - 0008-543X
VL - 127
SP - 3381
EP - 3389
JO - Cancer
JF - Cancer
IS - 18
ER -