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Prepublished online as a Blood First Edition Paper on August 7, 2003; DOI 10.1182/blood-2003-04-1257.
Submitted April 23, 2003
Accepted July 28, 2003
Rituximab as adjuvant to high-dose therapy and autologous hematopoietic cell transplantation for aggressive non-Hodgkin's lymphoma
Steven M Horwitz, Robert S Negrin, Karl G Blume, Sheila Breslin, Monic J Stuart, Keith E Stockerl-Goldstein, Laura J Johnston, Ruby M Wong, Judith A Shizuru, and Sandra J Horning*
Division of Oncology, Department of Medicine, Stanford University, Stanford, CA, USA
Division of Bone Marrow Transplantation, Department of Medicine, Stanford University, Stanford, CA, USA
Department of Health Research and Policy, Stanford University, Stanford, CA, USA
* Corresponding author; email: horning{at}stanford.edu.
Based upon the favorable safety profile and independent activity of rituximab in B-cell lymphoma, we evaluated its efficacy and toxicity after high dose therapy (HDT) and autologous hematopoietic cell transplantation (HCT). Thirty-five patients with diffuse large cell (25), mantle cell (3), transformed (3) or other (4) B-cell lymphoma subtypes received HDT followed by a purged autologous graft. The rituximab schedule was 4 weekly infusions (375mg/m2) starting at day +42 after HCT and, for patients 5-35, a second 4-week course 6 months after HCT. All planned therapy was completed in 29 patients. With 30 months median follow-up, the two-year event-free survival (EFS) was 83% and overall survival (OS) was 88%. EFS was 81% and OS was 85% for 21 patients with relapsed or refractory large cell lymphoma. Grade 3-4 neutropenia occurred in 19 (54%) patients. Prospective study of immune reconstitution included measurements of lymphocyte subsets, immunoglobulins and response to vaccination. Serious infections were not observed despite delayed B-cell recovery in all patients and suppressed IgG levels and low pneumococcus antibody titers in a subset. Rituximab after HDT and HCT is feasible and these phase II data support the current U.S. Intergroup phase III trial in recurrent /refractory diffuse large cell lymphoma.
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