title: Treatment of patients with low-grade B-cell lymphoma with the combination of chimeric anti-CD20 monoclonal antibody and CHOP chemotherapy.
abstract: OBJECTIVE
  To determine the safety and efficacy of the combination of the chimeric anti-CD20 antibody, Rituxan (Rituximab, IDEC-C2B8; IDEC Pharmaceuticals Corporation, San Diego, CA), and cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) chemotherapy.
  
  
  METHODS
  Forty patients with low-grade or follicular B-cell non-Hodgkin's lymphoma received six infusions of Rituxan (375 mg/m2 per dose) in combination with six doses of CHOP chemotherapy.
  
  
  RESULTS
  The overall response rate was 95% (38 of 40 patients). Twenty-two patients experienced a complete response (55%), 16 patients had a partial response (40%), and two patients, who received no treatment, were classified as nonresponders. Medians for duration of response and time to progression had not been reached after a median observation time of 29 + months. Twenty-eight of 38 assessable patients (74%) continued in remission during this median follow-up period. The most frequent adverse events attributable to CHOP were alopecia (38 patients), neutropenia (31 patients), and fever (23 patients). The most frequent events attributed to Rituxan were fever and chills, observed primarily with the first infusion. No quantifiable immune response to the chimeric antibody was detected. In a subset of 18 patients, the bcl-2 [t(14;18)] translocation was positive in eight patients; seven of these patients had complete remissions and converted to polymerase chain reaction (PCR) negativity by completion of therapy.
  
  
  CONCLUSIONS
  This is the first report demonstrating the safety and efficacy of Rituxan anti-CD20 chimeric antibody in combination with standard-dose systemic chemotherapy in the treatment of indolent B-cell lymphoma. The clinical responses suggest an additive therapeutic benefit for the combination with no significant added toxicity. The conversion of bcl-2 from positive to negative by PCR in blood and/or marrow suggests possible clearing of minimal residual disease not previously demonstrated by CHOP chemotherapy alone.
authors.affiliation: Department of Hematologic Oncology and Bone Marrow Transplantation, Roswell Park Cancer Institute, Buffalo, NY 14263, USA.
authors.forename: M S
authors.initials: MS
authors.lastname: Czuczman
authors.forename: A J
authors.initials: AJ
authors.lastname: Grillo-López
authors.forename: C A
authors.initials: CA
authors.lastname: White
authors.forename: M
authors.initials: M
authors.lastname: Saleh
authors.forename: L
authors.initials: L
authors.lastname: Gordon
authors.forename: A F
authors.initials: AF
authors.lastname: LoBuglio
authors.forename: C
authors.initials: C
authors.lastname: Jonas
authors.forename: D
authors.initials: D
authors.lastname: Klippenstein
authors.forename: B
authors.initials: B
authors.lastname: Dallaire
authors.forename: C
authors.initials: C
authors.lastname: Varns
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 / Q000009:adverse effects / Q000627:therapeutic use*; D003520:Cyclophosphamide / Q000008:administration & dosage / Q000009:adverse effects; D004317:Doxorubicin / Q000008:administration & dosage / Q000009:adverse effects; D005260:Female; D006801:Humans; D007136:Immunoglobulins / Q000032:analysis; D016393:Lymphoma, B-Cell / Q000235:genetics / Q000276:immunology / Q000628:therapy*; D008228:Lymphoma, Non-Hodgkin / Q000235:genetics / Q000276:immunology / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D016133:Polymerase Chain Reaction; D011241:Prednisone / Q000008:administration & dosage / Q000009:adverse effects; D019253:Proto-Oncogene Proteins c-bcl-2 / Q000235:genetics; D000069283:Rituximab; D014178:Translocation, Genetic; D014750:Vincristine / Q000008:administration & dosage / Q000009:adverse effects
chemical_list: D000911:Antibodies, Monoclonal; D058846:Antibodies, Monoclonal, Murine-Derived; D007136:Immunoglobulins; D019253:Proto-Oncogene Proteins c-bcl-2; D000069283:Rituximab; D014750:Vincristine; D004317:Doxorubicin; D003520:Cyclophosphamide; D011241:Prednisone