title: Rituximab in combination with fludarabine chemotherapy in low-grade or follicular lymphoma.
abstract: OBJECTIVE
  To evaluate the safety and efficacy of fludarabine plus rituximab in treatment-naive or relapsed patients with low-grade and/or follicular non-Hodgkin's lymphoma.
  
  
  METHODS
  This was an open-label, single-arm, single-center phase II study enrolling 40 patients. During the first week of the study, patients received two infusions of rituximab 375 mg/m2 administered 4 days apart. Seventy-two hours after the second infusion of rituximab, patients received the first of six cycles of fludarabine chemotherapy (25 mg/m2/d for 5 days on a 28-day cycle). Single infusions of rituximab were administered 72 hours before the second, fourth, and sixth cycles of fludarabine, and two infusions of rituximab were given 4 weeks after the last cycle of fludarabine. Treatment duration was 26 weeks.
  
  
  RESULTS
  An overall response rate of 90% (80% complete response rate) was achieved in the intent-to-treat population. Similar response rates were seen in treatment-naive and previously treated patients. The median duration of response has not been reached at 40+ months. The median follow-up time in this study is 44 months (range, 15 to 66 months). In patients positive for the 14;18 translocation in blood and/or marrow at enrollment, molecular remission was achieved in 88% of cases, with patients remaining negative for up to 4 years to date. Hematologic toxicity was manageable, and except for a 15% incidence of herpes simplex/zoster infections, infectious complications were rare. Nonhematologic toxicities were minimal.
  
  
  CONCLUSIONS
  Rituximab plus fludarabine was well tolerated and associated with an excellent complete response rate, including molecular remissions, in patients with low-grade or follicular lymphoma.
authors.affiliation: Roswell Park Cancer Institute, Buffalo, NY 14263, USA. myron.czuczman@roswellpark.org
authors.forename: M S
authors.initials: MS
authors.lastname: Czuczman
authors.forename: A
authors.initials: A
authors.lastname: Koryzna
authors.forename: A
authors.initials: A
authors.lastname: Mohr
authors.forename: C
authors.initials: C
authors.lastname: Stewart
authors.forename: K
authors.initials: K
authors.lastname: Donohue
authors.forename: L
authors.initials: L
authors.lastname: Blumenson
authors.forename: Z P
authors.initials: ZP
authors.lastname: Bernstein
authors.forename: P
authors.initials: P
authors.lastname: McCarthy
authors.forename: A
authors.initials: A
authors.lastname: Alam
authors.forename: F
authors.initials: F
authors.lastname: Hernandez-Ilizaliturri
authors.forename: M
authors.initials: M
authors.lastname: Skipper
authors.forename: K
authors.initials: K
authors.lastname: Brown
authors.forename: A
authors.initials: A
authors.lastname: Chanan-Khan
authors.forename: D
authors.initials: D
authors.lastname: Klippenstein
authors.forename: P
authors.initials: P
authors.lastname: Loud
authors.forename: M K
authors.initials: MK
authors.lastname: Rock
authors.forename: M
authors.initials: M
authors.lastname: Benyunes
authors.forename: A
authors.initials: A
authors.lastname: Grillo-Lopez
authors.forename: S H
authors.initials: SH
authors.lastname: Bernstein
mesh_terms: D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000008:administration & dosage* / Q000009:adverse effects; D058846:Antibodies, Monoclonal, Murine-Derived; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D005260:Female; D005434:Flow Cytometry; D019254:Genes, bcl-2; D006801:Humans; D008224:Lymphoma, Follicular / Q000188:drug therapy* / Q000276:immunology / Q000401:mortality; D008228:Lymphoma, Non-Hodgkin / Q000188:drug therapy* / Q000276:immunology / Q000401:mortality; D008297:Male; D008875:Middle Aged; D000069283:Rituximab; D016176:T-Lymphocyte Subsets / Q000276:immunology; D014740:Vidarabine / Q000008:administration & dosage* / Q000009:adverse effects / Q000031:analogs & derivatives*
chemical_list: D000911:Antibodies, Monoclonal; D058846:Antibodies, Monoclonal, Murine-Derived; D000069283:Rituximab; D014740:Vidarabine; C024352:fludarabine