title: Does transfusion improve the outcome for HNSCC patients treated with radiotherapy? - results from the randomized DAHANCA 5 and 7 trials.
abstract: BACKGROUND
  Patients with head and neck squamous cell carcinoma (HNSCC) and a low level of hemoglobin often have a poor response to radiation that may be related to hypoxia-induced radioresistance. We have previously published the importance of hemoglobin level and the effect of transfusion by the results from the randomized DAHANCA 5 trial, including 414 patients in the analysis. Aim of the current analysis was to gain additional power by adding patients from the continued subrandomization in the DAHANCA 7 trial, now including a total of almost 1200 patients.
  
  
  METHODS
  Patients were randomized to treatment in the DAHANCA 5 and 7 study (nimorazole vs. placebo and five fx/week vs. six fx/week), and in addition, patients with "low" pre-irradiation hemoglobin values (females <13 g/dl; males <14.5 g/dl) were subrandomized to plus or minus transfusion. Transfusion was given with packed red blood cells with the aim to achieve a hemoglobin level in the "high" value range.
  
  
  RESULTS
  A total of 1166 patients were included, 701 patients had high hemoglobin levels and 465 had low hemoglobin levels. Among the low hemoglobin patients, 235 were randomized to receive transfusion. Patient characteristics and treatment arms were well balanced. In the majority of patients, transfusion resulted in increased hemoglobin levels although this decreased slightly throughout treatment as in the non-transfused patients. Overall, the patients with low hemoglobin level had a significant reduced probability of locoregional control, disease-specific and overall survival. In the low hemoglobin group, transfusion did not improve the outcome in locoregional control, disease-specific or overall survival. In multivariate analyses, HPV/p16 status, T and N classification were significant factors for all outcome measures, whereas there was no significant influence of transfusion or hemoglobin level on endpoints.
  
  
  CONCLUSIONS
  Transfusion prior to and during radiation treatment did not improve the outcome in patients with HNSCC and low hemoglobin values, but may have a negative impact on survival.
authors.affiliation: Department of Experimental Clinical Oncology, Aarhus University Hospital, Denmark. camilla@oncology.dk
authors.forename: Camilla Molich
authors.initials: CM
authors.lastname: Hoff
authors.forename: Pernille
authors.initials: P
authors.lastname: Lassen
authors.forename: Jesper Grau
authors.initials: JG
authors.lastname: Eriksen
authors.forename: Hanne Sand
authors.initials: HS
authors.lastname: Hansen
authors.forename: Lena
authors.initials: L
authors.lastname: Specht
authors.forename: Marie
authors.initials: M
authors.lastname: Overgaard
authors.forename: Cai
authors.initials: C
authors.lastname: Grau
authors.forename: Jørgen
authors.initials: J
authors.lastname: Johansen
authors.forename: Jens
authors.initials: J
authors.lastname: Bentzen
authors.forename: Lisbeth
authors.initials: L
authors.lastname: Andersen
authors.forename: Jan F
authors.initials: JF
authors.lastname: Evensen
authors.forename: Jens
authors.initials: J
authors.lastname: Overgaard
mesh_terms: D000328:Adult; D000368:Aged; D002294:Carcinoma, Squamous Cell / Q000097:blood / Q000188:drug therapy / Q000401:mortality / Q000532:radiotherapy*; D003131:Combined Modality Therapy / Q000009:adverse effects; D017707:Erythrocyte Transfusion / Q000009:adverse effects; D005260:Female; D006258:Head and Neck Neoplasms / Q000097:blood / Q000188:drug therapy / Q000401:mortality / Q000532:radiotherapy*; D006454:Hemoglobins / Q000032:analysis*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009554:Nimorazole / Q000627:therapeutic use; D011878:Radiotherapy / Q000009:adverse effects; D016019:Survival Analysis
chemical_list: D006454:Hemoglobins; D009554:Nimorazole