TY - JOUR
T1 - Phase 2 study of rituximab plusABVD in patients with newly diagnosed classical Hodgkin lymphoma
AU - Younes, Anas
AU - Oki, Yasuhiro
AU - McLaughlin, Peter
AU - Copeland, Amanda R.
AU - Goy, Andre
AU - Pro, Barbara
AU - Feng, Lei
AU - Yuan, Ying
AU - Chuang, Hubert H.
AU - Macapinlac, Homer A.
AU - Hagemeister, Fredrick
AU - Romaguera, Jorge
AU - Samaniego, Felipe
AU - Fanale, Michelle A.
AU - Dabaja, Bouthaina Shbib
AU - Rodriguez, Maria A.
AU - Dang, Nam
AU - Kwak, Larry W.
AU - Neelapu, Sattva S.
AU - Fayad, Luis E.
PY - 2012/5/3
Y1 - 2012/5/3
N2 - In the present study, we evaluated the efficacy and safety of rituximab in combination with standard doxorubicin, bleomycin, vinblastine, and dacarbazine (RABVD) in patients with classical Hodgkin lymphoma (cHL). In this phase 2 study, patients with chemotherapy-naive, advanced-stage cHL were treated with rituximab 375 mg/m2 weekly for 6 weeks and standard ABVD for 6 cycles. The primary outcome was event-free survival (EFS) at 5 years. Eighty-five patients were enrolled, of whom 78 were eligible. With a median follow-up duration of 68 months (range, 26-110), and based on an intent-totreat analysis, the 5-year EFS and overall survival rates were 83% and 96%, respectively. The 5-year EFS for patients with stage III/IV cHLwas 82%. Furthermore, the 5-year EFS for patients with an International Prognostic Score of 0-2 was 88% and for those with a score of > 2, it was 73%. The most frequent treatment-related grade 3 or 4 adverse events were neutropenia (23%), fatigue (9%), and nausea (8%). Our results demonstrate that the addition of rituximab to ABVD is safe and has a promising clinical activity in patients with advanced-stage cHL. These data are currently being confirmed in a multicenter randomized trial. This trial has been completed and is registered with www.clinicaltrials. gov as NCT00504504.
AB - In the present study, we evaluated the efficacy and safety of rituximab in combination with standard doxorubicin, bleomycin, vinblastine, and dacarbazine (RABVD) in patients with classical Hodgkin lymphoma (cHL). In this phase 2 study, patients with chemotherapy-naive, advanced-stage cHL were treated with rituximab 375 mg/m2 weekly for 6 weeks and standard ABVD for 6 cycles. The primary outcome was event-free survival (EFS) at 5 years. Eighty-five patients were enrolled, of whom 78 were eligible. With a median follow-up duration of 68 months (range, 26-110), and based on an intent-totreat analysis, the 5-year EFS and overall survival rates were 83% and 96%, respectively. The 5-year EFS for patients with stage III/IV cHLwas 82%. Furthermore, the 5-year EFS for patients with an International Prognostic Score of 0-2 was 88% and for those with a score of > 2, it was 73%. The most frequent treatment-related grade 3 or 4 adverse events were neutropenia (23%), fatigue (9%), and nausea (8%). Our results demonstrate that the addition of rituximab to ABVD is safe and has a promising clinical activity in patients with advanced-stage cHL. These data are currently being confirmed in a multicenter randomized trial. This trial has been completed and is registered with www.clinicaltrials. gov as NCT00504504.
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U2 - 10.1182/blood-2012-01-405456
DO - 10.1182/blood-2012-01-405456
M3 - Article
C2 - 22371887
AN - SCOPUS:84860712523
SN - 0006-4971
VL - 119
SP - 4123
EP - 4128
JO - Blood
JF - Blood
IS - 18
ER -