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Clinical Trial
. 2012 May 3;119(18):4123-8.
doi: 10.1182/blood-2012-01-405456. Epub 2012 Feb 27.

Phase 2 study of rituximab plus ABVD in patients with newly diagnosed classical Hodgkin lymphoma

Anas Younes  1 , 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
Affiliations
Clinical Trial

Phase 2 study of rituximab plus ABVD in patients with newly diagnosed classical Hodgkin lymphoma

Anas Younes et al. Blood. .

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.

Trial registration: ClinicalTrials.gov NCT00504504.

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Figures

Figure 1
Figure 1
Study profile.
Figure 2
Figure 2
Kaplan-Meier curves showing the survival of patients. (A) EFS and OS in all patients. (B) EFS by Ann Arbor stage. (C) EFS by IPS grouping.
Figure 3
Figure 3
Kaplan-Meier curves showing the survival of patients. (A) EFS by CD20 status on malignant cells. (B) EFS by interim PET result.
See this image and copyright information in PMC

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References

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