title: Rituximab as adjuvant to high-dose therapy and autologous hematopoietic cell transplantation for aggressive non-Hodgkin lymphoma.
abstract: Based on the favorable safety profile and the 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 patients), mantle cell (3 patients), transformed (3 patients), or other (4 patients) subtypes of B-cell lymphoma received HDT followed by a purged autologous graft. The rituximab schedule was 4 weekly infusions (375 mg/m(2)) starting at day 42 after HCT and, for patients 5 to 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 2-year event-free survival (EFS) rate was 83% and the overall survival (OS) rate was 88%. For 21 patients with relapsed or refractory large cell lymphoma, the EFS rate was 81% and the OS rate was 85%. Grades 3 to 4 neutropenia occurred in 19 (54%) patients. A 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 immunoglobulin G (IgG) levels and low pneumococcus antibody titers in a subset. Rituximab after HDT and HCT is feasible, and these phase 2 data support the current US Intergroup phase 3 trial in recurrent/refractory diffuse large cell lymphoma.
authors.affiliation: Division of Oncology, Stanford University Medical Center, Ste 202, 1000 Welch Rd, Palo Alto, CA 94304, USA.
authors.forename: Steven M
authors.initials: SM
authors.lastname: Horwitz
authors.forename: Robert S
authors.initials: RS
authors.lastname: Negrin
authors.forename: Karl G
authors.initials: KG
authors.lastname: Blume
authors.forename: Sheila
authors.initials: S
authors.lastname: Breslin
authors.forename: Monic J
authors.initials: MJ
authors.lastname: Stuart
authors.forename: Keith E
authors.initials: KE
authors.lastname: Stockerl-Goldstein
authors.forename: Laura J
authors.initials: LJ
authors.lastname: Johnston
authors.forename: Ruby M
authors.initials: RM
authors.lastname: Wong
authors.forename: Judith A
authors.initials: JA
authors.lastname: Shizuru
authors.forename: Sandra J
authors.initials: SJ
authors.lastname: Horning
mesh_terms: D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000627:therapeutic use*; D058846:Antibodies, Monoclonal, Murine-Derived; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D003131:Combined Modality Therapy; D018572:Disease-Free Survival; D005260:Female; D018380:Hematopoietic Stem Cell Transplantation; D006801:Humans; D016393:Lymphoma, B-Cell / Q000188:drug therapy / Q000401:mortality / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D000069283:Rituximab; D015996:Survival Rate; D014182:Transplantation, Autologous
chemical_list: D000911:Antibodies, Monoclonal; D058846:Antibodies, Monoclonal, Murine-Derived; D000069283:Rituximab