Phase 2 study of rituximab plusABVD 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, Fredrick Hagemeister, Jorge Romaguera, Felipe Samaniego, Michelle A. Fanale, Bouthaina Shbib Dabaja, Maria A. Rodriguez, Nam Dang, Larry W. Kwak, Sattva S. Neelapu, Luis E. Fayad

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

62 Scopus citations

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/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.

Original languageEnglish (US)
Pages (from-to)4123-4128
Number of pages6
JournalBlood
Volume119
Issue number18
DOIs
StatePublished - May 3 2012

ASJC Scopus subject areas

  • Biochemistry
  • Immunology
  • Hematology
  • Cell Biology

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