Rituximab and chemotherapy in primary gastric lymphoma.
OBJECTIVE
We performed a phase II clinical trial to assess the efficacy and toxicity of the addition of rituximab and conventional chemotherapy in primary gastric lymphoma (PGL).


METHODS
Forty-two (42) patients with PGL, stage IE and IIE, and with low- or low-intermediate clinical risk were treated in a prospective longitudinal study with standard CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) chemotherapy and rituximab (375 mg/m2, intravenously) on day 1 of each cycle administered every 21 days, for 6 cycles. The endpoint was to assess improvement in outcome measured by prolongation in event-free survival (EFS) and overall survival (OS). Complete response was achieved in 40 cases (95%) (95% confidence interval [CI]: 88%-102%). Relapse was observed in 2 cases. Two (2) patients died secondary to tumor progression. Thus, actuarial 5-year EFS was 95% (95 % CI: 87%-104%) and OS was 95% (95% CI: 88%-101%), which was not statistically different to historic controls. Acute toxicity was minimal and well tolerated, 4 cases developed late toxicity, 2 cases of herpes zoster infection, and 2 cases with granulocytopenia; in 1 case, the patient continued with mild granulocytopenia 3 years after treatment.


CONCLUSIONS
The addition of rituximab to CHOP chemotherapy did not improve outcome in early-stage PGL.
Avilés
Agustin
A
Oncology Research Unit, Oncology Hospital, National Medical Center, Plaza Luis Cabrera 5-502, Colonia Roma, Mexico. agustin.aviles@imss.gob.mx
Castañeda
Claudia
C
Cleto
Sergio
S
Neri
Natividad
N
Huerta-Guzmán
Judith
J
Gonzalez
Martha
M
Nambo
Maria-Jesús
MJ
D000328:Adult; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D058846:Antibodies, Monoclonal, Murine-Derived; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D003520:Cyclophosphamide; D004317:Doxorubicin; D005260:Female; D006801:Humans; D007167:Immunotherapy / Q000379:methods; D008137:Longitudinal Studies; D008223:Lymphoma / Q000188:drug therapy / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D011239:Prednisolone; D011446:Prospective Studies; D012306:Risk; D000069283:Rituximab; D013274:Stomach Neoplasms / Q000188:drug therapy / Q000628:therapy*; D014750:Vincristine
D000911:Antibodies, Monoclonal; D058846:Antibodies, Monoclonal, Murine-Derived; D000970:Antineoplastic Agents; D000069283:Rituximab; D014750:Vincristine; D004317:Doxorubicin; D003520:Cyclophosphamide; D011239:Prednisolone