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Phase II study of rituximab plus ABVD in patients with newly diagnosed classical Hodgkin lymphoma

Anas Younes, Yasuhiro Oki, Peter McLaughlin, Amanda R. Copeland, Andre Goy, Barbara Pro, Lei Feng, Ying Yuan, Hubert H. Chuang, Homer A. Macapinlac, Frederick Hagemeister, Jorge Romaguera, Felipe Samaniego, Michelle A. Fanale, Bouthaina Shabib Dabaja, Maria A. Rodriguez, Nam Dang, Larry W. Kwak, Sattva S. Neelapu and Luis E. Fayad

Abstract

We evaluated the efficacy and safety of rituximab in combination with standard doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) in patients with classical Hodgkin lymphoma (cHL). In this phase II study, patients with chemotherapy naive advanced stage cHL were treated with rituximab 375 mg/m2 weekly for six weeks and standard ABVD for six cycles. The primary outcome is event free survival (EFS) at five years. 85 patients were enrolled, of whom 78 patients were eligible. With a median follow up duration of 68 months (range 26-110), and based on an intent-to-treat analysis, the five-year EFS and overall survival (OS) rates were 83% and 96%, respectively. The five-year EFS for patients with stage III/IV was 82%. Furthermore, the five-year EFS for patients with International Prognostic Score (IPS) of 0 to 2 was 88% and for those with IPS score of > 2 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. This data is currently being confirmed in a multicenter randomized trial. This trial has been completed and is registered with www.ClinicalTrials.gov, number NCT00504504.

  • Submitted January 25, 2012.
  • Accepted January 31, 2012.