title: Results of a trial of PET-directed therapy for early-stage Hodgkin's lymphoma.
abstract: BACKGROUND
  It is unclear whether patients with early-stage Hodgkin's lymphoma and negative findings on positron-emission tomography (PET) after three cycles of chemotherapy with doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) require radiotherapy.
  
  
  METHODS
  Patients with newly diagnosed stage IA or stage IIA Hodgkin's lymphoma received three cycles of ABVD and then underwent PET scanning. Patients with negative PET findings were randomly assigned to receive involved-field radiotherapy or no further treatment; patients with positive PET findings received a fourth cycle of ABVD and radiotherapy. This trial assessing the noninferiority of no further treatment was designed to exclude a difference in the 3-year progression-free survival rate of 7 or more percentage points from the assumed 95% progression-free survival rate in the radiotherapy group.
  
  
  RESULTS
  A total of 602 patients (53.3% male; median age, 34 years) were recruited, and 571 patients underwent PET scanning. The PET findings were negative in 426 of these patients (74.6%), 420 of whom were randomly assigned to a study group (209 to the radiotherapy group and 211 to no further therapy). At a median of 60 months of follow-up, there had been 8 instances of disease progression in the radiotherapy group, and 8 patients had died (3 with disease progression, 1 of whom died from Hodgkin's lymphoma); there had been 20 instances of disease progression in the group with no further therapy, and 4 patients had died (2 with disease progression and none from Hodgkin's lymphoma). In the radiotherapy group, 5 of the deaths occurred in patients who received no radiotherapy. The 3-year progression-free survival rate was 94.6% (95% confidence interval [CI], 91.5 to 97.7) in the radiotherapy group and 90.8% (95% CI, 86.9 to 94.8) in the group that received no further therapy, with an absolute risk difference of -3.8 percentage points (95% CI, -8.8 to 1.3).
  
  
  CONCLUSIONS
  The results of this study did not show the noninferiority of the strategy of no further treatment after chemotherapy with regard to progression-free survival. Nevertheless, patients in this study with early-stage Hodgkin's lymphoma and negative PET findings after three cycles of ABVD had a very good prognosis either with or without consolidation radiotherapy. (Funded by Leukaemia and Lymphoma Research and others; RAPID ClinicalTrials.gov number, NCT00943423.).
authors.affiliation: From the Institute of Cancer Sciences, University of Manchester, and the Christie NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester (J.R., T.I.), Cancer Research UK and University College London Cancer Trials Centre, Cancer Institute, University College London (N.C., B.P., P.S.), St. Georges Hospital, University of London (R.P.), St. Bartholomew's Hospital (A.L.), and the PET Imaging Centre, Division of Imaging Sciences and Biomedical Engineering, King's College London, King's Health Partners, St. Thomas' Hospital (M.O., S.B.), London, the University of Sheffield and Weston Park Hospital, Sheffield (B.H.), Cancer Research UK Centre, Southampton (P.J.), Norfolk and Norwich University Hospital, Norwich (J.W.), Aberdeen Royal Infirmary, Aberdeen (D.C.), Nottingham City Hospital, Nottingham (A.M.), Queen's Hospital, Romford (A.B.), Royal Cornwall Hospital NHS Trust, Truro (A.K.), and the Cancer Centre, Mount Vernon Hospital, Northwood (P.H.) - all in the United Kingdom.
authors.forename: John
authors.initials: J
authors.lastname: Radford
authors.forename: Tim
authors.initials: T
authors.lastname: Illidge
authors.forename: Nicholas
authors.initials: N
authors.lastname: Counsell
authors.forename: Barry
authors.initials: B
authors.lastname: Hancock
authors.forename: Ruth
authors.initials: R
authors.lastname: Pettengell
authors.forename: Peter
authors.initials: P
authors.lastname: Johnson
authors.forename: Jennie
authors.initials: J
authors.lastname: Wimperis
authors.forename: Dominic
authors.initials: D
authors.lastname: Culligan
authors.forename: Bilyana
authors.initials: B
authors.lastname: Popova
authors.forename: Paul
authors.initials: P
authors.lastname: Smith
authors.forename: Andrew
authors.initials: A
authors.lastname: McMillan
authors.forename: Alison
authors.initials: A
authors.lastname: Brownell
authors.forename: Anton
authors.initials: A
authors.lastname: Kruger
authors.forename: Andrew
authors.initials: A
authors.lastname: Lister
authors.forename: Peter
authors.initials: P
authors.lastname: Hoskin
authors.forename: Michael
authors.initials: M
authors.lastname: O'Doherty
authors.forename: Sally
authors.initials: S
authors.lastname: Barrington
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001761:Bleomycin / Q000627:therapeutic use; D003131:Combined Modality Therapy; D003606:Dacarbazine / Q000627:therapeutic use; D018450:Disease Progression; D004317:Doxorubicin / Q000627:therapeutic use; D005260:Female; D005500:Follow-Up Studies; D006689:Hodgkin Disease / Q000188:drug therapy* / Q000401:mortality / Q000532:radiotherapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D049268:Positron-Emission Tomography; D016016:Proportional Hazards Models; D012008:Recurrence; D016019:Survival Analysis; D014747:Vinblastine / Q000627:therapeutic use; D055815:Young Adult
chemical_list: D001761:Bleomycin; D014747:Vinblastine; D003606:Dacarbazine; D004317:Doxorubicin