Abstract
Introduction: Patients with aggressive NHL may respond to treatment, but 4-year DFS is < 40%. Rituximab has shown activity as monotherapy in patients even in refractory or relapsing post-MOT patients. Besides, preliminary results from maintenance therapy studies are promising.
Objective: To determine if maintenance with Rituximab in first complete remission increases disease-free survival and overall survival compared to observation.
Methods: A clinical trial with post-remission randomization was carried out, including patients with Aggressive Non-Hodgkin Lymphoma, stages IIb- III- IV, with ECOG 0–2, and ≥15 years old. All patients received the Rituximab + CHOP/CHOP-Like regimen during induction to remission (IR), and those with Complete Remission (CR) were randomized to receive rituximab-based maintenance therapy biannually (2 x 375 mg/sc) vs observation.
Results: 217 patients have been enrolled to IR, age 52±14 years old, 114 (52.5%) masculine, 174 of them (80.2%) presented remission; 149 CR, 25 PR. Two (0.9%) patients showed stable disease, 25 (11.5%) developed disease progression, and 16 (7.4%) died. Out of the 174 patients with remission, 96 patients have received maintenance therapy for over 6 months, 45 in the rituximab group, and 51 in the observation group, with a median follow-up of 14.4 months (pt 25– 75, 7.74 – 21.88 months). To date only 1 patient per group had a progress and none has died. During IR -considering the maximum toxicity developed per patient -, acute toxicity was remarkable: fever I, II in 13%, III–IV 1%, and chills I, II 8.2%, III 1%. And not acute: anemia I,II 54%, III 1.9, IV 1.4%, neutropenia I,II 46.1%, III 18.4, IV 2.8% and infection I,II 16.4%, III 1.0%, and IV 1.4%.
Discussion: Overall response to Rituximab + CHOP regimen is very good (80.2%), and to date 96 patients included in maintenance therapy with a median follow-up of 14.4 months, the difference between the groups is not evident yet; therefore, surveillance should be continued.
Author notes
Disclosure: No relevant conflicts of interest to declare.
