title: A phase II multicenter trial of hyperCVAD MTX/Ara-C and rituximab in patients with previously untreated mantle cell lymphoma; SWOG 0213.
abstract: BACKGROUND
  Rituximab-hyper-CVAD alternating with rituximab-high-dose methotrexate and cytarabine is a commonly utilized regimen in the United States for mantle cell lymphoma (MCL) based on phase II single institutional data. To confirm the clinical efficacy of this regimen and determine its feasibility in a multicenter study that includes both academic and community-based practices, a phase II study of this regimen was conducted by SWOG.
  
  
  METHODS
  Forty-nine patients with advanced stage, previously untreated MCL were eligible. The median age was 57.4 years (35-69.8 years).
  
  
  RESULTS
  Nineteen patients (39%) did not complete the full scheduled course of treatment due to toxicity. There was one treatment-related death and two cases of secondary myelodysplastic syndrome (MDS). There were 10 episodes of grade 3 febrile neutropenia, 19 episodes of grade 3 and 1 episode of grade 4 infection. With a median follow-up of 4.8 years, the median progression-free survival was 4.8 years (5.5 years for those ≤ 65 years) and the median overall survival (OS) was 6.8 years.
  
  
  CONCLUSIONS
  Although this regimen is toxic, it is active for patients ≤ 65 years of age and can be given both at academic centers and in experienced community centers.
authors.affiliation: James P Wilmot Cancer Center, University of Rochester School of Medicine and Dentistry, Rochester, NY 14642, USA. meduni-kkh@rub.de
authors.forename: S H
authors.initials: SH
authors.lastname: Bernstein
authors.forename: E
authors.initials: E
authors.lastname: Epner
authors.forename: J M
authors.initials: JM
authors.lastname: Unger
authors.forename: M
authors.initials: M
authors.lastname: Leblanc
authors.forename: E
authors.initials: E
authors.lastname: Cebula
authors.forename: R
authors.initials: R
authors.lastname: Burack
authors.forename: L
authors.initials: L
authors.lastname: Rimsza
authors.forename: T P
authors.initials: TP
authors.lastname: Miller
authors.forename: R I
authors.initials: RI
authors.lastname: Fisher
mesh_terms: D000328:Adult; D000368:Aged; D058846:Antibodies, Monoclonal, Murine-Derived / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage*; D003520:Cyclophosphamide / Q000008:administration & dosage; D003561:Cytarabine / Q000008:administration & dosage; D003907:Dexamethasone / Q000008:administration & dosage; D004317:Doxorubicin / Q000008:administration & dosage; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D020522:Lymphoma, Mantle-Cell / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology*; D008297:Male; D008727:Methotrexate / Q000008:administration & dosage; D008875:Middle Aged; D000069283:Rituximab; D015996:Survival Rate / Q000639:trends; D016896:Treatment Outcome; D014750:Vincristine / Q000008:administration & dosage
chemical_list: D058846:Antibodies, Monoclonal, Murine-Derived; D003561:Cytarabine; D000069283:Rituximab; D014750:Vincristine; D003907:Dexamethasone; D004317:Doxorubicin; D003520:Cyclophosphamide; D008727:Methotrexate
keywords: dose-intensive; mantle cell; rituximab