Combined immuno-chemotherapy (R-FCM) results in superior remission rates and overall survival in recurrent follicular and mantle cell lymphoma: Follow-up of a prospective randomized trial of the German Low Grade Lymphoma Study Group (GLSG)

Abstract

6528 Background: Rituximab monotherapy has shown a high activity in relapsed follicular lymphomas. Recently, phase III studies indicated that its addition to chemotherapy may further improve the progression-free survival substantially. Methods: In 1998 the GLSG embarked on a multicenter national trial in patients with relapsed or refractory follicular and mantle cell lymphoma. As most patients had received CHOP for first line treatment, a fludarabine-containing regimen (FCM) was chosen for salvage therapy followed by an optional Rituximab maintenance. A total of 4 courses were given. After the statistical analysis confirmed the significantly improved response rate of the combined study arm (R-FCM), 111 subsequent patients were designated to immuno-chemotherapy. Results: 122 of 244 currently evaluable patients (50%) had follicular, 95 patients (39%) mantle cell and 24 patients (10%) other indolent lymphomas. In 67 randomized patients with follicular lymphoma, complete (39% vs. 23%, p=0.013) as well as overall response rate (96% vs. 71%, p=0.011), progression-free survival (median: 3.9 vs. 1.7 years, p=0,029) and overall survival (74% at 4 years vs. median of 3.8 years, p=0,033) was significantly improved after combined immuno-chemotherapy. 55 patients subsequently designated to the combined study arm (R-FCM) confirmed the superior remission rates (36%/96%), progression-free and overall survival. Similarly, in 50 randomized MCL patients, R-FCM achieved higher complete (29% vs. 0%, p0.004) and overall response (58% vs. 46%, p= 282) as well as overall survival (median: 2.5 vs 0.9 years, p=0,031). Again, the improved remission rates (20%/75%) and overall survival was confirmed by 45 patients subsequently designated to combined immunotherapy. Conclusions: In summary, this is the first prospective randomized trial which demonstrates the superiority of a combined immuno-chemotherapy in patients with relapsed follicular and mantle cell lymphoma, both in terms of response rates but most importantly also in terms of overall survival. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Roche Roche Roche