title: Phase III randomized intergroup trial of CHOP plus rituximab compared with CHOP chemotherapy plus (131)iodine-tositumomab for previously untreated follicular non-Hodgkin lymphoma: SWOG S0016.
abstract: OBJECTIVE
  Advanced follicular lymphomas (FL) are considered incurable with conventional chemotherapy and there is no consensus on the best treatment approach. Southwest Oncology Group (SWOG) and Cancer and Leukemia Group B compared the safety and efficacy of two immunochemotherapy regimens for FL in a phase III randomized intergroup protocol (SWOG S0016) that enrolled 554 patients with previously untreated, advanced-stage FL between March 1, 2001, and September 15, 2008.
  
  
  METHODS
  Patients were eligible for the study if they had advanced-stage (bulky stage II, III, or IV) evaluable FL of any grade (1, 2, or 3) and had not received previous therapy. In one arm of the study, patients received six cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) chemotherapy at 3-week intervals with six doses of rituximab (CHOP-R). In another arm of the study, patients received six cycles of CHOP followed by consolidation with tositumomab/iodine I-131 tositumomab radioimmunotherapy (RIT).
  
  
  RESULTS
  After a median follow-up period of 4.9 years, the 2-year estimate of progression-free survival (PFS) was 76% on the CHOP-R arm and 80% on the CHOP-RIT arm (P = .11). The 2-year estimate of overall survival (OS) was 97% on the CHOP-R arm and 93% on the CHOP-RIT arm (P = .08).
  
  
  CONCLUSIONS
  There was no evidence of a significant improvement in PFS comparing CHOP-RIT with CHOP-R. However, PFS and OS were outstanding on both arms of the study. Future studies are needed to determine the potential benefits of combining CHOP-R induction chemotherapy with RIT consolidation and/or extended rituximab maintenance therapy.
authors.affiliation: Fred Hutchinson Cancer Research Center, D3-190, 1100 Fairview Ave, Seattle, WA 98109, USA. press@u.washington.edu
authors.forename: Oliver W
authors.initials: OW
authors.lastname: Press
authors.forename: Joseph M
authors.initials: JM
authors.lastname: Unger
authors.forename: Lisa M
authors.initials: LM
authors.lastname: Rimsza
authors.forename: Jonathan W
authors.initials: JW
authors.lastname: Friedberg
authors.forename: Michael
authors.initials: M
authors.lastname: LeBlanc
authors.forename: Myron S
authors.initials: MS
authors.lastname: Czuczman
authors.forename: Mark
authors.initials: M
authors.lastname: Kaminski
authors.forename: Rita M
authors.initials: RM
authors.lastname: Braziel
authors.forename: Catherine
authors.initials: C
authors.lastname: Spier
authors.forename: Ajay K
authors.initials: AK
authors.lastname: Gopal
authors.forename: David G
authors.initials: DG
authors.lastname: Maloney
authors.forename: Bruce D
authors.initials: BD
authors.lastname: Cheson
authors.forename: Shaker R
authors.initials: SR
authors.lastname: Dakhil
authors.forename: Thomas P
authors.initials: TP
authors.lastname: Miller
authors.forename: Richard I
authors.initials: RI
authors.lastname: Fisher
mesh_terms: D000911:Antibodies, Monoclonal / Q000008:administration & dosage* / Q000009:adverse effects; D058846:Antibodies, Monoclonal, Murine-Derived / Q000008:administration & dosage / Q000009:adverse effects; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D060830:Consolidation Chemotherapy; D003520:Cyclophosphamide / Q000008:administration & dosage / Q000009:adverse effects; D018572:Disease-Free Survival; D004317:Doxorubicin / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D053208:Kaplan-Meier Estimate; D008224:Lymphoma, Follicular / Q000188:drug therapy* / Q000401:mortality; D009367:Neoplasm Staging; D011241:Prednisone / Q000008:administration & dosage / Q000009:adverse effects; D016016:Proportional Hazards Models; D016499:Radioimmunotherapy / Q000379:methods*; D000069283:Rituximab; D014750:Vincristine / Q000008:administration & dosage / Q000009:adverse effects
chemical_list: D000911:Antibodies, Monoclonal; D058846:Antibodies, Monoclonal, Murine-Derived; D000069283:Rituximab; D014750:Vincristine; D004317:Doxorubicin; D003520:Cyclophosphamide; C119496:tositumomab I-131; D011241:Prednisone