Rituximab Added to an Intensified Salvage Chemotherapy Program Followed by Autologous Stem Cell Transplantation Improve in Relapsed and Refractory Aggressive Non-Hodgkin-Lymphoma.

Background

We investigated the addition of rituximab to an intensified salvage program followed by a myeloablative course with autologous stem cell transplantation (ASCT) in patients with relapsed or refractory aggressive NHL.

Methods

Patients with relapsed or progressive aggressive NHL were treated with two cycles of conventional salvage chemotherapy followed by high-dose sequential chemotherapy and a final myeloablative course with ASCT. Rituximab (375mg/m2) was administered at each treatment cycle. This cohort was compared with a historical control group of patients treated with the same chemotherapy but without rituximab. Patients from both treatment groups were matched according to age, duration of first remission, lactate dehydrogenase (LDH) serum level and B symptoms at relapse/progress.

Results

22 patients were treated with immunochemotherapy and 57 patients with chemotherapy. The overall response rates (ORR) at the final evaluation were 71% (65% CR and 6% PR) for the immunochemotherapy group compared to 65% (59% CR and 6% PR) for the chemotherapy group. In the historical controlled analysis freedom from second failure (FF2F) at two years in the immunochemotherapy group was 64% and overall survival 77%. Within the chemotherapy group FF2F was 25% (p=0,0185) and OS 44% (p=0,0159). In the matched-pair analysis FF2F was 64% in the immunochemotherapy group, compared to 47% in the chemotherapy group (p=0,7274). OS was 82% vs. 70% respectively (p=0,4854). The toxicity was tolerable and comparable in both groups.

Conclusions

The addition of rituximab to an intensified salvage chemotherapy regimen seems to improve the prognosis. However, only prospective randomized trial can offer sufficient data of the value of rituximab in relapsed and refractory aggressive NHL.