title: Phase II trial of galiximab (anti-CD80 monoclonal antibody) plus rituximab (CALGB 50402): Follicular Lymphoma International Prognostic Index (FLIPI) score is predictive of upfront immunotherapy responsiveness.
abstract: BACKGROUND
  This phase II CALGB trial evaluated the activity and safety of an extended induction schedule of galiximab (G) plus rituximab (R) in untreated follicular lymphoma (FL).
  
  
  METHODS
  Patients with previously untreated FL (grades 1, 2, 3a) received 4 weekly infusions of G + R, followed by an additional dose every 2 months four times. International Workshop Response Criteria were used to evaluate response.
  
  
  RESULTS
  Sixty-one patients were treated and antibody infusions were well tolerated. The overall response rate (ORR) is 72.1% (95% confidence interval 59.2% to 82.9%): 47.6% complete response (CR)/unconfirmed complete response (CRu) and 24.6% partial response. At a median follow-up time of 4.3 years (range, 0.3-5.3 years) median progression-free survival (PFS) is 2.9 years. Notably, Follicular Lymphoma International Prognostic Index (FLIPI) correlated with ORR, CR rate, and PFS, and the low-risk FLIPI group (n = 12) achieved a 92% ORR, 75% CR/CRu rate, and 75% 3-year PFS.
  
  
  CONCLUSIONS
  An extended induction schedule of G + R in previously untreated FL is well tolerated and appears particularly efficacious in those patients with low-risk FLIPI scores. In addition, this trial served as the initial platform for additional CALGB 'doublet' combination regimes of rituximab plus other novel targeted agents.
authors.affiliation: Roswell Park Cancer Institute, Buffalo. Electronic address: Myron.czuczman@roswellpark.org.
authors.forename: M S
authors.initials: MS
authors.lastname: Czuczman
authors.affiliation: Weill Medical College of Cornell University, New York.
authors.forename: J P
authors.initials: JP
authors.lastname: Leonard
authors.affiliation: CALGB Statistical Office, Duke University Medical Center, Durham.
authors.forename: S
authors.initials: S
authors.lastname: Jung
authors.affiliation: CALGB Statistical Office, Duke University Medical Center, Durham.
authors.forename: J L
authors.initials: JL
authors.lastname: Johnson
authors.affiliation: Cleveland Clinic Foundation, Cleveland.
authors.forename: E D
authors.initials: ED
authors.lastname: Hsi
authors.affiliation: The Ohio State University, Columbus.
authors.forename: J C
authors.initials: JC
authors.lastname: Byrd
authors.affiliation: Lombardi Cancer Center, Georgetown University Hospital, Washington, USA.
authors.forename: B D
authors.initials: BD
authors.lastname: Cheson
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000911:Antibodies, Monoclonal / Q000008:administration & dosage; D058846:Antibodies, Monoclonal, Murine-Derived / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D007116:Immunization, Passive; D060828:Induction Chemotherapy; D053208:Kaplan-Meier Estimate; D008224:Lymphoma, Follicular / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D008875:Middle Aged; D000069283:Rituximab; D012720:Severity of Illness Index; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000911:Antibodies, Monoclonal; D058846:Antibodies, Monoclonal, Murine-Derived; D000069283:Rituximab; C437823:galiximab