title: Comparing long-term toxicity and efficacy of combined modality treatment including extended- or involved-field radiotherapy in early-stage Hodgkin's lymphoma.
abstract: BACKGROUND
  To evaluate long-term toxicity and efficacy of a combined modality strategy including extended-field radiotherapy (EF-RT) or involved-field radiotherapy (IF-RT), the German Hodgkin Study Group carried out a follow-up analysis in patients with early unfavorable Hodgkin's lymphoma (HL).
  
  
  METHODS
  One thousand two hundred and four patients were randomized to four cycles of chemotherapy followed by either 30 Gy EF- or 30 Gy IF-RT (HD8 trial); 532 patients in each treatment arm were eligible.
  
  
  RESULTS
  At 10 years, no arm differences were revealed with respect to freedom from treatment failure (FFTF) (79.8% versus 79.7%), progression-free survival (79.8% versus 80.0%), and overall survival (86.4% versus 87.3%). Non-inferiority of IF-RT was demonstrated for the primary end point FFTF (95% confidence interval for hazard ratio 0.72-1.25). Elderly patients had a poorer outcome when treated with EF-RT. So far, 15.0% of patients in arm A and 12.2% in arm B died, mostly due to secondary malignancies (5.3% versus 3.4%) or HL (3.2% versus 3.4%). After EF-RT, there were more secondary malignancies overall (58 versus 45), especially acute myeloid leukemias (11 versus 4).
  
  
  CONCLUSIONS
  Radiotherapy intensity reduction to IF-RT does not result in poorer long-term outcome but is associated with less acute toxicity and might be associated with less secondary malignancies.
authors: First Department of Internal Medicine, University Hospital Cologne, Cologne; German Hodgkin Study Group, Cologne, Germany.
authors: S
authors: S
authors: Sasse
authors: First Department of Internal Medicine, University Hospital Cologne, Cologne; German Hodgkin Study Group, Cologne, Germany.
authors: B
authors: B
authors: Klimm
authors: German Hodgkin Study Group, Cologne, Germany.
authors: H
authors: H
authors: Görgen
authors: German Hodgkin Study Group, Cologne, Germany.
authors: M
authors: M
authors: Fuchs
authors: German Hodgkin Study Group, Cologne, Germany.
authors: A
authors: A
authors: Heyden-Honerkamp
authors: Department of Internal Medicine, Kantonsspital Liestal, Liestal, Switzerland.
authors: A
authors: A
authors: Lohri
authors: Third Department of Internal Medicine, Klinikum Osnabrück, Osnabrück.
authors: O
authors: O
authors: Koch
authors: Fifth Department of Internal Medicine, Klinikum Nuernberg, Nuernberg.
authors: M
authors: M
authors: Wilhelm
authors: Department of Internal Medicine, Knappschaftskrankenhaus Bottrop, Bottrop.
authors: G
authors: G
authors: Trenn
authors: First Department of Internal Medicine, University Hospital Freiburg, Freiburg.
authors: J
authors: J
authors: Finke
authors: Department of Radiotherapy, University Hospital Cologne, Cologne.
authors: R P
authors: RP
authors: Müller
authors: German Hodgkin Study Group, Cologne, Germany.
authors: V
authors: V
authors: Diehl
authors: Department of Radiotherapy, University Hospital Muenster, Muenster, Germany.
authors: H T
authors: HT
authors: Eich
authors: German Hodgkin Study Group, Cologne, Germany.
authors: P
authors: P
authors: Borchmann
authors: First Department of Internal Medicine, University Hospital Cologne, Cologne; German Hodgkin Study Group, Cologne, Germany. Electronic address: a.engert@uni-koeln.de.
authors: A
authors: A
authors: Engert
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use; D003131:Combined Modality Therapy / Q000009:adverse effects; D003520:Cyclophosphamide / Q000009:adverse effects / Q000627:therapeutic use; D018572:Disease-Free Survival; D005260:Female; D006689:Hodgkin Disease / Q000188:drug therapy / Q000401:mortality / Q000532:radiotherapy / Q000628:therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011241:Prednisone / Q000009:adverse effects / Q000627:therapeutic use; D011344:Procarbazine / Q000009:adverse effects / Q000627:therapeutic use; D011878:Radiotherapy / Q000009:adverse effects; D014750:Vincristine / Q000009:adverse effects / Q000627:therapeutic use; D055815:Young Adult
chemical_list: D011344:Procarbazine; D014750:Vincristine; D003520:Cyclophosphamide; D011241:Prednisone