Rituximab therapy for patients with newly diagnosed, advanced-stage, follicular grade I non-Hodgkin's lymphoma: a phase II trial in the North Central Cancer Treatment Group.

Abstract

PURPOSE:

Patients with newly diagnosed, advanced-stage, follicular grade 1 non-Hodgkin's lymphoma (NHL) are often asymptomatic and can be observed without immediate chemotherapy. The goals of this study were to assess the overall response rate (ORR) to rituximab in this patient population and to determine the time-to-progression (TTP) and time-to-subsequent-chemotherapy (TTSC).

PATIENTS AND METHODS:

Eligible patients had untreated follicular grade 1 NHL, and measurable stage III/IV disease. Patients received rituximab 375 mg/m(2) intravenous weekly x 4 doses and were then followed for response and progression; no maintenance therapy was provided.

RESULTS:

Thirty-seven patients were accrued; one patient was ineligible. The median age was 59 years (range, 29 to 83 years). Six patients (18%) had elevated lactate dehydrogenase levels. The ORR was 72%, with 36% complete remissions. Fourteen (39%) of 36 patients remain in unmaintained remission, two died without disease progression, and three died with disease progression. Twenty (56%) of 36 patients have disease progression. The median TTP was 2.2 years (95% CI, 1.3 to not yet reached). Eighteen patients have subsequently been treated with chemotherapy, with a median TTSC of 2.3 years (95% CI, 1.6 to not yet reached). Patients with a high lactate dehydrogenase level had a lower ORR of 33% and a short TTP of only 6 months.

CONCLUSION:

Rituximab can be safely administered to patients with advanced-stage follicular grade 1 NHL with efficacy and minimal toxicity. This therapy is highly active and offers an acceptable alternative to observation in this patient population. Patients with high LDH should not be considered for rituximab monotherapy.

• Authors: Thomas E Witzig, Allen M Vukov, Thomas M Habermann, Susan Geyer, Paul J Kurtin, William R Friedenberg, William L White, Haji I Chalchal, Patrick J Flynn, Thomas R Fitch, Debra A Welker
• Journal: Journal of clinical oncology : official journal of the American Society of Clinical Oncology (J Clin Oncol) Vol. 23 Issue 6 Pg. 1103-8 (Feb 20 2005) ISSN: 0732-183X [Print] United States
• PMID: 15657404 (Publication Type: Clinical Trial, Clinical Trial, Phase II, Journal Article)

Chemical References

• Antibodies, Monoclonal
• Antibodies, Monoclonal, Murine-Derived
• Antineoplastic Agents
• Rituximab

Topics

• Adult
• Aged
• Antibodies, Monoclonal (adverse effects, therapeutic use)
• Antibodies, Monoclonal, Murine-Derived
• Antineoplastic Agents (adverse effects, therapeutic use)
• Disease Progression
• Disease-Free Survival
• Female
• Humans
• Lymphoma, B-Cell (drug therapy)
• Lymphoma, Follicular (drug therapy)
• Lymphoma, Non-Hodgkin (drug therapy)
• Male
• Middle Aged
• Neutropenia (chemically induced)
• Rituximab
• Survival Analysis