Rituximab consolidation after high-dose chemotherapy and autologous blood stem cell transplantation in follicular and mantle cell lymphoma: a prospective, multicenter phase II study.
BACKGROUND
Patients with follicular (FL) or mantle cell lymphoma (MCL) are incurable with conventional therapy. We investigated the safety and efficacy of rituximab consolidation after autologous stem cell transplantation (ASCT) in order to prevent relapse by clearance of minimal residual disease (MRD).


METHODS
Rituximab was given approximately 8 weeks after CD34+ cell enriched ASCT at 375 mg/m2, weekly for 4 weeks. Monitoring of MRD was performed by repetitive PCR analyses.


RESULTS
Thirty-one patients were included; one died early after ASCT before rituximab administration. Thirty patients (20 FL, 10 MCL) were evaluable after rituximab consolidation, and 27 of these were assessable for MRD detection. Rituximab consolidation post-ASCT was safe, the most common toxicity being infection. At a median follow-up of 42 months (range 13-96) after ASCT, 25 patients were censored with an actuarial event-free survival (EFS) of 81% at 4 and 5 years. Four patients (two FL, two MCL) relapsed, and one additional MCL patient died unexpectedly in complete remission. PCR-negativity was observed in 22% of the patients before ASCT, 53% post-ASCT (P=0.0547), 72% after rituximab (P=0.0018) and 100% at 6 months post-transplant (P < 0.001).


CONCLUSIONS
One single course of rituximab consolidation given after ASCT is safe, may help to eliminate MRD and may translate into improved EFS in both FL and MCL patients.
Brugger
W
W
Department of Hematology, University of Tübingen, Tübingen, Germany. imo.wolfram.brugger@klinikumvs.de
Hirsch
J
J
Grünebach
F
F
Repp
R
R
Brossart
P
P
Vogel
W
W
Kopp
H-G
HG
Manz
M G
MG
Bitzer
M
M
Schlimok
G
G
Kaufmann
M
M
Ganser
A
A
Fehnle
K
K
Gramatzki
M
M
Kanz
L
L
D000328:Adult; D000911:Antibodies, Monoclonal / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D058846:Antibodies, Monoclonal, Murine-Derived; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D007239:Infections / Q000139:chemically induced; D007970:Leukopenia / Q000139:chemically induced; D008224:Lymphoma, Follicular / Q000188:drug therapy* / Q000628:therapy; D020522:Lymphoma, Mantle-Cell / Q000188:drug therapy* / Q000628:therapy; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D036102:Peripheral Blood Stem Cell Transplantation; D011182:Postoperative Care; D000069283:Rituximab; D016019:Survival Analysis; D014182:Transplantation, Autologous; D016896:Treatment Outcome
D000911:Antibodies, Monoclonal; D058846:Antibodies, Monoclonal, Murine-Derived; D000970:Antineoplastic Agents; D000069283:Rituximab