title: Randomized phase III trial of ABVD versus Stanford V with or without radiation therapy in locally extensive and advanced-stage Hodgkin lymphoma: an intergroup study coordinated by the Eastern Cooperative Oncology Group (E2496).
abstract: OBJECTIVE
  Although ABVD (doxorubicin, bleomycin, vinblastine, and dacarbazine) has been established as the standard of care in patients with advanced Hodgkin lymphoma, newer regimens have been investigated, which have appeared superior in early phase II studies. Our aim was to determine if failure-free survival was superior in patients treated with the Stanford V regimen compared with ABVD.
  
  
  METHODS
  The Eastern Cooperative Oncology Group, along with the Cancer and Leukemia Group B, the Southwest Oncology Group, and the Canadian NCIC Clinical Trials Group, conducted this randomized phase III trial in patients with advanced Hodgkin lymphoma. Stratification factors included extent of disease (localized v extensive) and International Prognostic Factors Project Score (0 to 2 v 3 to 7). The primary end point was failure-free survival (FFS), defined as the time from random assignment to progression, relapse, or death, whichever occurred first. Overall survival, a secondary end point, was measured from random assignment to death as a result of any cause. This design provided 87% power to detect a 33% reduction in FFS hazard rate, or a difference in 5-year FFS of 64% versus 74% at two-sided .05 significance level.
  
  
  RESULTS
  There was no significant difference in the overall response rate between the two arms, with complete remission and clinical complete remission rates of 73% for ABVD and 69% for Stanford V. At a median follow-up of 6.4 years, there was no difference in FFS: 74% for ABVD and 71% for Stanford V at 5 years (P = .32).
  
  
  CONCLUSIONS
  ABVD remains the standard of care for patients with advanced Hodgkin lymphoma.
authors.affiliation: Northwestern University Feinberg School of Medicine and Robert H. Lurie Comprehensive Cancer Center, Chicago, IL, USA. l-gordon@northwestern.edu
authors.forename: Leo I
authors.initials: LI
authors.lastname: Gordon
authors.forename: Fangxin
authors.initials: F
authors.lastname: Hong
authors.forename: Richard I
authors.initials: RI
authors.lastname: Fisher
authors.forename: Nancy L
authors.initials: NL
authors.lastname: Bartlett
authors.forename: Joseph M
authors.initials: JM
authors.lastname: Connors
authors.forename: Randy D
authors.initials: RD
authors.lastname: Gascoyne
authors.forename: Henry
authors.initials: H
authors.lastname: Wagner
authors.forename: Patrick J
authors.initials: PJ
authors.lastname: Stiff
authors.forename: Bruce D
authors.initials: BD
authors.lastname: Cheson
authors.forename: Mary
authors.initials: M
authors.lastname: Gospodarowicz
authors.forename: Ranjana
authors.initials: R
authors.lastname: Advani
authors.forename: Brad S
authors.initials: BS
authors.lastname: Kahl
authors.forename: Jonathan W
authors.initials: JW
authors.lastname: Friedberg
authors.forename: Kristie A
authors.initials: KA
authors.lastname: Blum
authors.forename: Thomas M
authors.initials: TM
authors.lastname: Habermann
authors.forename: Joseph M
authors.initials: JM
authors.lastname: Tuscano
authors.forename: Richard T
authors.initials: RT
authors.lastname: Hoppe
authors.forename: Sandra J
authors.initials: SJ
authors.lastname: Horning
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001761:Bleomycin / Q000008:administration & dosage / Q000009:adverse effects; D003131:Combined Modality Therapy; D003606:Dacarbazine / Q000008:administration & dosage / Q000009:adverse effects; D004317:Doxorubicin / Q000008:administration & dosage / Q000009:adverse effects; D005047:Etoposide / Q000008:administration & dosage / Q000009:adverse effects; D005260:Female; D006689:Hodgkin Disease / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy; D006801:Humans; D008297:Male; D008466:Mechlorethamine / Q000008:administration & dosage / Q000009:adverse effects; D008875:Middle Aged; D009367:Neoplasm Staging; D009503:Neutropenia / Q000139:chemically induced; D011241:Prednisone / Q000008:administration & dosage / Q000009:adverse effects; D012074:Remission Induction; D016019:Survival Analysis; D016896:Treatment Outcome; D014747:Vinblastine / Q000008:administration & dosage / Q000009:adverse effects; D014750:Vincristine / Q000008:administration & dosage / Q000009:adverse effects; D055815:Young Adult
chemical_list: D001761:Bleomycin; D008466:Mechlorethamine; D014750:Vincristine; D014747:Vinblastine; D005047:Etoposide; D003606:Dacarbazine; D004317:Doxorubicin; D011241:Prednisone