title: A Contribution to solve the problem of the need for consolidative radiotherapy after intensive chemotherapy in advanced stages of Hodgkin's lymphoma--analysis of a quality control program initiated by the radiotherapy reference center of the German Hodgkin Study Group (GHSG).
abstract: OBJECTIVE
  The role of radiotherapy (RT) after intensive chemotherapy in patients with advanced stage Hodgkin's lymphoma (HL) is still unclear. The German Hodgkin Study Group (GHSG) randomized HD12 trial was designed to test whether consolidative RT in the region of initial bulky disease and of residual disease is necessary after effective chemotherapy. A quality control program based on a multidisciplinary panel of radiation oncologists, radiologists, and medical oncologists who reviewed all patients' staging and restaging imaging was initiated.
  
  
  METHODS
  A total of 1661 patients aged 16 to 65 years with HL in Stage IIB (large mediastinal mass and/or E-lesions) or Stage III to IV were randomized from January 1999 to January 2003 according to a factorial design between: 8 esc.BEACOPP + RT (arm A), 8 esc.BEACOPP non-RT (arm B), 4+4BEACOPP + RT (arm C), 4+4BEACOPP non-RT (arm D).
  
  
  RESULTS
  In the fifth interim analysis, 1449 patients were eligible for the arm comparison with regard to RT. After a median observation time of 48 months the FFTF rate was 86% and the OS 92%. The FFTF was 95% in the RT arms A+C and 88% in the non-RT arms B+D: no sequential significant difference. One thousand and eighty four patients were evaluated by the panel. The panel defined initial bulky disease in 800 patients and residual disease in 600 patients. The panel recommended continuation of therapy according to the randomization for 934 of 1084 patients and additive RT independently from the randomization arm for 145 of 1084 patients.
  
  
  CONCLUSIONS
  The study showed that RT can be reduced substantially after effective chemotherapy. However, because of the irradiation of 10% of patients in the non-RT arms, equivalent effectiveness of a non-RT strategy cannot be proved. A substantial limitation of consolidative RT according to expert panel recommendations appears to be possible without reducing effectiveness.
authors: Department of Radiation Oncology, University of Cologne, Cologne, Germany. Hans-Theodor.Eich@medizin.uni-Koeln.de
authors: Hans Theodor
authors: HT
authors: Eich
authors: Axel
authors: A
authors: Gossmann
authors: Andreas
authors: A
authors: Engert
authors: Jan
authors: J
authors: Kriz
authors: Henning
authors: H
authors: Bredenfeld
authors: Katja
authors: K
authors: Hansemann
authors: Roman
authors: R
authors: Skripnitchenko
authors: Corinne
authors: C
authors: Brillant
authors: Beate
authors: B
authors: Pfistner
authors: Susanne
authors: S
authors: Staar
authors: Volker
authors: V
authors: Diehl
authors: Rolf-Peter
authors: RP
authors: Müller
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000627:therapeutic use; D001761:Bleomycin / Q000008:administration & dosage; D003131:Combined Modality Therapy / Q000379:methods; D003520:Cyclophosphamide / Q000008:administration & dosage; D004317:Doxorubicin / Q000008:administration & dosage; D005047:Etoposide / Q000008:administration & dosage; D006689:Hodgkin Disease / Q000000981:diagnostic imaging / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy*; D006801:Humans; D008479:Mediastinal Neoplasms / Q000000981:diagnostic imaging / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy*; D008875:Middle Aged; D018365:Neoplasm, Residual; D011241:Prednisone / Q000008:administration & dosage; D011344:Procarbazine / Q000008:administration & dosage; D011785:Quality Assurance, Health Care; D011878:Radiotherapy / Q000592:standards; D014057:Tomography, X-Ray Computed; D014750:Vincristine / Q000008:administration & dosage
chemical_list: D001761:Bleomycin; D011344:Procarbazine; D014750:Vincristine; D005047:Etoposide; D004317:Doxorubicin; D003520:Cyclophosphamide; D011241:Prednisone