Image: PD AML
1. Rituximab use is linked with a reduction in chronic graft-vs-host disease following peripheral blood stem cell transplantation.
2. Rituximab is also linked with improved survival following transplantation compared to controls.
Evidence Rating Level: 2 (Good)
Study rundown: Following peripheral blood stem cell transplantation, chronic GVHD (graft-vs-host disease) is a major cause of morbidity and reduced quality of life. While treatments involving T-cell depletion have helped prevent this complication, they have not been successful at improving overall survival. As B-cell-dependent processes have been implicated in the occurrence of chronic GVHD, the authors of this study investigated whether B-cell depletion therapy with rituximab can prevent CVHD, and if this treatment is associated with improvements in mortality. They found that their treatment group had significantly reduced rates of steroid-requiring chronic GVHD, though overall rate of chronic disease was only slightly affected. Furthermore, the rates of transplant-related mortality dropped significantly in this group. Based on these results, the study authors recommend that future prospective studies be done to further investigate potential uses of rituximab as prophylactic therapy following blood stem cell transplantation.
These findings are supported by the controlled design of this prospective study. However, it should be noted that the control population came from patients who had refused to participate in treatment, thus introducing potential variation between the control and treatment arms. As the study authors point out, a phase three randomized, controlled trial will be necessary to further investigate their findings before drawing more concrete conclusions.
In-depth [prospective cohort study]: The study authors enrolled a total of 65 subjects for treatment in this trial, and concluded data collection with a median follow-up of 48 months. At the conclusion of the trial, 65 contemporaneous control subjects were randomly selected from a database of stem cell transplant patients who had refused treatment with rituximab. All patients had received peripheral blood stem cell transplants, with AML, CLL/SLL/PLL being the most common diagnoses in both groups. In the treatment arm, rituximab was administered at 100 days, then again at 6, 9, and 12 months following transplantation. The primary outcomes measured included clinician-diagnosed chronic GVHD, whether this complication required systemic corticosteroid therapy, and treatment-related mortality at 2 and 4 years following transplantation.
The study authors found that the incidence of chronic GVHD was 48% and 60% (P = 0.1) in the treatment and control arms, respectively. Furthermore, the 2-year cumulative incidence of systemic steroid-requiring chronic GVHD was 31& and 48.5& (P = 0.015), respectively. The 4-year cumulative incidence of relapse did not differ significantly between the two groups, however, treatment-related survival was 71% in the treatment group vs 56% in the control group at 4 years (P = 0.05).
By Monica Parks and Andrew Bishara
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