Rituximab Active in Nodular Lymphocyte–Predominant Hodgkin Lymphoma
Mature results of a phase II study reported in the Journal of Clinical Oncology by Advani et al indicate that rituximab (Rituxan) is active in nodular lymphocyte–predominant Hodgkin lymphoma, which is characterized by expression of CD20 by malignant cells. Most patients relapsed, but durable response was observed in a substantial minority.
Study Details
In the study, 39 patients with previously treated or newly diagnosed nodular lymphocyte–predominant Hodgkin lymphoma received rituximab 375 mg/m2 once weekly for 4 weeks (n = 23, 11 previously treated) or, after a protocol amendment, rituximab plus rituximab maintenance once every 6 months for 2 years (n = 16, 7 previously treated). Progression-free survival was the primary endpoint. Among all patients, 69% were male, median age was 44 years, and 44% had stage II and 30% stage III disease.
Progression-Free and Overall Survival
After four once-weekly treatments, the objective response rate was 100% (complete response in 67%). At median follow-up of 9.8 years in the no maintenance group and 5 years in the maintenance group, progression-free survival was 3.0 and 5.6 years, respectively (P = .26). Median overall survival was not reached in either group. Five-year progression-free survival was 39.1% and 58.9%, and 5-year overall survival was 95.7% and 85.7%.
Newly Diagnosed Patients
Among previously untreated patients, median progression-free survival for the no maintenance group and the maintenance group was 1.9 and 5.6 years (P = .37); 5-year progression-free survival was 41.7% and 51.9%, and 5-year overall survival was 100% and 100%. Progression occurred in 8 of 12 patients in the no maintenance group and 5 of 9 in the maintenance group, with median time to progression of 2.3 years. Six patients (29%) had transformation to aggressive B-cell lymphoma at a median of 4.4 years; five of these patients had abdominal involvement at study entry.
Previously Treated Patients
Among previously treated patients, median progression-free survival for the no maintenance group and the maintenance group was 3.4 and 6.35 years; 5-year progression-free survival was 36.4% and 71.4%, and 5-year overall survival was 90.9% and 71.4%. Progression occurred in 7 of 11 patients in the no maintenance group and in 3 of 7 patients in the maintenance group at a median of 3.25 years. Three patients had transformation to aggressive B-cell lymphoma at a median of 7 years; two of these patients had abdominal involvement at study entry.
Treatment-related adverse events for both groups of patients were minimal, with no grade 3 or 4 toxicities observed.
The investigators concluded: [Rituximab] is an active agent in [nodular lymphocyte–predominant Hodgkin lymphoma]. Although responses are not durable in most patients, a significant minority experience remissions lasting > 5 years. [Rituximab with maintenance rituximab] results in a nonsignificant increase in [progression-free survival] compared with rituximab [without maintenance]. [Rituximab] may be considered in the relapsed setting for [nodular lymphocyte–predominant Hodgkin lymphoma.] The potential for transformation of [nodular lymphocyte–predominant Hodgkin lymphoma] to aggressive B-cell lymphoma underscores the importance of rebiopsy and long-term follow-up.”
Ranjana Advani, MD, of Stanford University Medical Center, is the corresponding author for the Journal of Clinical Oncology article.
The study was supported by Genentech. For full disclosures of the study authors, visit jco.ascopubs.org.
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
