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Rituximab prevented corticosteroid-requiring chronic GVHD
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Rituximab prophylaxis considerably reduced corticosteroid-requiring chronic graft-vs.-host disease in patients who underwent allogeneic peripheral blood stem cell transplantation, according to results of a prospective, open-label, phase 2 study.
The analysis included 65 patients who underwent allogeneic peripheral blood stem cell transplantation between 2006 and 2010.
Corey S. Cutler, MD, MPH, FRCPC, a member of the hematologic malignancies staff at Dana-Farber Cancer Institute and assistant professor of medicine at Harvard Medical School, and colleagues hypothesized that post-transplantation B-cell depletion with 375 mg/m2 rituximab (Rituxan, Genentech/Idec Pharmaceuticals) administered at 3, 6, 9 and 12 months after transplantation would help prevent chronic GVHD.
Corey S. Cutler
Researchers compared the outcomes of the study population with those from patients who underwent transplantation during the same time period but did not receive rituximab prophylaxis. The control patients were randomly selected from a database, and selection criteria matched those used for the clinical trial population.
Patients in the rituximab group received a median three doses, and 32 patients (49.2%) completed the full four-dose regimen. Patient-reported reasons for not receiving all four doses included the development of chronic GVHD, relapse and patient preference.
Overall, rituximab appeared safe and was associated with no severe adverse events.
Although researchers observed no difference in relapse rates between the treatment and control arms, treatment-associated mortality at 4 years from transplantation was significantly lower in treated patients (5% vs. 19%; P=.02). The rate of 4-year OS also was higher in the rituximab arm (71% vs. 56%; P=.05).
The rates of cumulative incidence of chronic GVHD (48% vs. 60%) and incidence of systemic corticosteroid-requiring chronic GVHD (31% vs. 48.5%) were lower among patients treated with rituximab.
Treated patients who developed chronic GVHD had a significantly greater BAFF/B-cell ratio at 2 years after transplantation compared with those who did not develop chronic GVHD (P=.039).
“Rituximab can prevent systemic corticosteroid-requiring chronic GVHD after peripheral blood stem cell transplantation and should be tested in a prospective randomized trial,” the researchers wrote. “A prospective phase 3 trial is being designed to further test this strategy.”
Disclosure: The researchers report no relevant financial disclosures.
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