title: Phase 2 study of rituximab plus ABVD in patients with newly diagnosed classical Hodgkin lymphoma.
abstract: 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/m(2) 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-to-treat analysis, the 5-year EFS and overall survival rates were 83% and 96%, respectively. The 5-year EFS for patients with stage III/IV cHL was 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.
authors.affiliation: Departments of Lymphoma and Myeloma, University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd, Houston, TX 77030, USA. ayounes@mdanderson.org
authors.forename: Anas
authors.initials: A
authors.lastname: Younes
authors.forename: Yasuhiro
authors.initials: Y
authors.lastname: Oki
authors.forename: Peter
authors.initials: P
authors.lastname: McLaughlin
authors.forename: Amanda R
authors.initials: AR
authors.lastname: Copeland
authors.forename: Andre
authors.initials: A
authors.lastname: Goy
authors.forename: Barbara
authors.initials: B
authors.lastname: Pro
authors.forename: Lei
authors.initials: L
authors.lastname: Feng
authors.forename: Ying
authors.initials: Y
authors.lastname: Yuan
authors.forename: Hubert H
authors.initials: HH
authors.lastname: Chuang
authors.forename: Homer A
authors.initials: HA
authors.lastname: Macapinlac
authors.forename: Fredrick
authors.initials: F
authors.lastname: Hagemeister
authors.forename: Jorge
authors.initials: J
authors.lastname: Romaguera
authors.forename: Felipe
authors.initials: F
authors.lastname: Samaniego
authors.forename: Michelle A
authors.initials: MA
authors.lastname: Fanale
authors.forename: Bouthaina Shbib
authors.initials: BS
authors.lastname: Dabaja
authors.forename: Maria A
authors.initials: MA
authors.lastname: Rodriguez
authors.forename: Nam
authors.initials: N
authors.lastname: Dang
authors.forename: Larry W
authors.initials: LW
authors.lastname: Kwak
authors.forename: Sattva S
authors.initials: SS
authors.lastname: Neelapu
authors.forename: Luis E
authors.initials: LE
authors.lastname: Fayad
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000505:Alopecia / Q000139:chemically induced; D058846:Antibodies, Monoclonal, Murine-Derived / Q000008:administration & dosage / Q000009:adverse effects; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001761:Bleomycin / Q000008:administration & dosage / Q000009:adverse effects; D003606:Dacarbazine / Q000008:administration & dosage / Q000009:adverse effects; D018572:Disease-Free Survival; D004317:Doxorubicin / Q000008:administration & dosage / Q000009:adverse effects; D005221:Fatigue / Q000139:chemically induced; D005260:Female; D005767:Gastrointestinal Diseases / Q000139:chemically induced; D006689:Hodgkin Disease / Q000175:diagnosis / Q000188:drug therapy*; D006801:Humans; D053208:Kaplan-Meier Estimate; D008171:Lung Diseases / Q000139:chemically induced; D008297:Male; D008875:Middle Aged; D009503:Neutropenia / Q000139:chemically induced; D012074:Remission Induction; D000069283:Rituximab; D015996:Survival Rate; D014747:Vinblastine / Q000008:administration & dosage / Q000009:adverse effects; D055815:Young Adult
chemical_list: D058846:Antibodies, Monoclonal, Murine-Derived; D001761:Bleomycin; D000069283:Rituximab; D014747:Vinblastine; D003606:Dacarbazine; D004317:Doxorubicin