title: Rituximab therapy for patients with newly diagnosed, advanced-stage, follicular grade I non-Hodgkin's lymphoma: a phase II trial in the North Central Cancer Treatment Group.
abstract: OBJECTIVE
  Patients with newly diagnosed, advanced-stage, follicular grade 1 non-Hodgkin's lymphoma (NHL) are often asymptomatic and can be observed without immediate chemotherapy. The goals of this study were to assess the overall response rate (ORR) to rituximab in this patient population and to determine the time-to-progression (TTP) and time-to-subsequent-chemotherapy (TTSC).
  
  
  METHODS
  Eligible patients had untreated follicular grade 1 NHL, and measurable stage III/IV disease. Patients received rituximab 375 mg/m(2) intravenous weekly x 4 doses and were then followed for response and progression; no maintenance therapy was provided.
  
  
  RESULTS
  Thirty-seven patients were accrued; one patient was ineligible. The median age was 59 years (range, 29 to 83 years). Six patients (18%) had elevated lactate dehydrogenase levels. The ORR was 72%, with 36% complete remissions. Fourteen (39%) of 36 patients remain in unmaintained remission, two died without disease progression, and three died with disease progression. Twenty (56%) of 36 patients have disease progression. The median TTP was 2.2 years (95% CI, 1.3 to not yet reached). Eighteen patients have subsequently been treated with chemotherapy, with a median TTSC of 2.3 years (95% CI, 1.6 to not yet reached). Patients with a high lactate dehydrogenase level had a lower ORR of 33% and a short TTP of only 6 months.
  
  
  CONCLUSIONS
  Rituximab can be safely administered to patients with advanced-stage follicular grade 1 NHL with efficacy and minimal toxicity. This therapy is highly active and offers an acceptable alternative to observation in this patient population. Patients with high LDH should not be considered for rituximab monotherapy.
authors.affiliation: Department of Internal Medicine, Division of Hematology, Mayo Clinic 200 First St SW, Rochester, MN 55905, USA. witzig@mayo.edu
authors.forename: Thomas E
authors.initials: TE
authors.lastname: Witzig
authors.forename: Allen M
authors.initials: AM
authors.lastname: Vukov
authors.forename: Thomas M
authors.initials: TM
authors.lastname: Habermann
authors.forename: Susan
authors.initials: S
authors.lastname: Geyer
authors.forename: Paul J
authors.initials: PJ
authors.lastname: Kurtin
authors.forename: William R
authors.initials: WR
authors.lastname: Friedenberg
authors.forename: William L
authors.initials: WL
authors.lastname: White
authors.forename: Haji I
authors.initials: HI
authors.lastname: Chalchal
authors.forename: Patrick J
authors.initials: PJ
authors.lastname: Flynn
authors.forename: Thomas R
authors.initials: TR
authors.lastname: Fitch
authors.forename: Debra A
authors.initials: DA
authors.lastname: Welker
mesh_terms: D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000627:therapeutic use*; D058846:Antibodies, Monoclonal, Murine-Derived; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D018450:Disease Progression; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D016393:Lymphoma, B-Cell / Q000188:drug therapy*; D008224:Lymphoma, Follicular / Q000188:drug therapy*; D008228:Lymphoma, Non-Hodgkin / Q000188:drug therapy; D008297:Male; D008875:Middle Aged; D009503:Neutropenia / Q000139:chemically induced; D000069283:Rituximab; D016019:Survival Analysis
chemical_list: D000911:Antibodies, Monoclonal; D058846:Antibodies, Monoclonal, Murine-Derived; D000970:Antineoplastic Agents; D000069283:Rituximab