Overall survival no better for those receiving autologous HCT plus maintenance rituximab versus rituximab alone
By Elana Gotkine HealthDay Reporter
FRIDAY, Dec. 6, 2024 (HealthDay News) — Autologous hematopoietic cell transplant (auto-HCT) is not beneficial for patients with mantle cell lymphoma (MCL) in first complete remission (CR) with undetectable minimal residual disease (uMRD), according to a study to be presented at the annual meeting of the American Society of Hematology, held from Dec. 7 to 10 in San Diego.
Timothy S. Fenske, M.D., from the Medical College of Wisconsin in Milwaukee, and colleagues conducted a four-arm trial involving patients with MCL between 18 and 70 years of age and in first remission. Patients in CR with uMRD at 1 in 10-6 sensitivity (uMRD6) were randomly assigned to arm A (auto-HCT + three years of maintenance rituximab [MR]) or arm B (three years of MR alone). Patients with MRD-positive CR or MRD-indeterminate CR both received auto-HCT + three years of MR (arms C and D, respectively). The primary end point was to compare survival in arms A and B.
From August 2017 to July 2024, 257, 259, 49, and 85 patients were enrolled in arms A, B, C, and D, respectively. The researchers found that the estimated overall survival hazard ratios for arms A and B in all randomized and treated-as-assigned patients (516 and 375, respectively) were 1.11 (95 percent confidence interval, 0.71 to 1.74; P = 0.66) and 1.00 (95 percent confidence interval, 0.58 to 1.74; P = 0.99), and crossed the boundary for futility. Three-year overall survival was 82.1 and 82.7 percent, respectively, for arms A and B in all randomly assigned patients, and 86.2 and 84.8 percent, respectively, in those treated as assigned.
“In this interim analysis, in the era of highly effective induction and maintenance regimens, MCL patients in first CR with uMRD6 did not benefit from consolidative auto-HCT,” the authors write.
Several authors disclosed ties to the pharmaceutical and biotechnology industries.
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