Rituximab maintenance therapy after autologous hematopoietic cell transplantation (HCT) significantly prolonged event-free survival, progression-free survival, and overall survival in patients with mantle cell lymphoma, according to a phase III randomized study of 299 patients <66 years old.
Researchers randomly assigned 240 patients to either receive rituximab maintenance therapy (n=120) or to undergo observation (n=120) after autologous HCT. The remaining 59 patients did not undergo randomization.
After four courses of immunochemotherapy induction, the overall response rate was 89% and the complete response rate 77%. HCT was performed in 257 patients, and patients in the maintenance therapy group received rituximab at 375 mg/m2 of body surface area administered every 2 months for 3 years post-HCT.
The table below shows 4-year post-HCT outcomes.
| 4-year outcome | Rituximab n=120 | Observation n=120 | p-value |
| Overall survival | 89% | 80% | 0.04 |
| Event-free survival | 79% | 61% | 0.001 |
| Progression-free survival | 83% | 64% | <0.001 |
A Cox regression unadjusted analysis found that the 4-year rate of overall survival was significantly higher in the rituximab group than in the observation group (hazard ratio for death, 0.50; 95% CI, 0.26 to 0.99; p=0.04).
The researchers concluded that “rituximab maintenance therapy after transplantation prolonged event-free survival, progression-free survival, and overall survival among patients with mantle cell lymphoma who were younger than 66 years of age at diagnosis.”
Le Gouille S, et al. N Engl J Med