[Erythropoietin in patients with head and neck carcinomas?].
BACKGROUND
Various studies have demonstrated the prognostic significance of the pretherapeutic blood hemoglobin concentration for patients with head and neck cancer following surgery or primary definitive or adjuvant radio- or radiochemotherapy. It was the aim of this study to evaluate whether the prognosis of these patients might be improved when correcting decreased pretherapeutic hemoglobin values by administering erythropoietin.


METHODS
In a prospective placebo-controlled double-blind study (Cochrane "evidence-based medicine" level Ib) the effect of erythropoietin was analyzed in patients with locally advanced head or neck tumours with low blood hemoglobin values (women: < 12 g/dL; men: < 13 dL) and a Karnofski value of > 60 following primary definite or adjuvant radiotherapy (up to 70 Gy). The time to local tumour progression and survival was evaluated. Kaplan-Maier estimates were applied and, the relative risk of well-known prognostic factors tested for with a Cox Proportional Hazards model.


RESULTS
157 patients of the Freiburg University ENT-clinic were recruited from 1997 to 2001. Study conduct was performed according to the GCP guidelines. A rapid increase of the blood hemoglobin value happened during the first five weeks of treatment under epoetin beta. Placebo patients experienced only minor changes of the hemoglobin value. Following adjuvant radiotherapy local tumour control probability at two years was 68 % +/- 7 % and 72 +/- 7 % for placebo and epoetin beta patients, respectively (p = 0.64). Patients who had undergone primary definite radiation experienced a local control probability of 36 % +/- 11 % in the placebo arm after two years, compared to epoetin beta with 23 % +/- 11 % (p = 0.05).


CONCLUSIONS
Epoetin beta resulted in prompt and stable correction of blood hemoglobin values in anemic patients with advanced head or neck tumours, but tumour control and survival was impaired particularly in patients with a high tumour burden.
Schipper
J
J
Universitätsklinik für Hals-, Nasen- und Ohrenheilkunde und Poliklinik, Universitätsklinikum Freiburg.
Henke
M
M
D000740:Anemia / Q000097:blood / Q000188:drug therapy*; D003131:Combined Modality Therapy; D018450:Disease Progression; D004311:Double-Blind Method; D004921:Erythropoietin / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D005500:Follow-Up Studies; D006452:Hemoglobinometry; D006801:Humans; D008207:Lymphatic Metastasis; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D010039:Otorhinolaryngologic Neoplasms / Q000097:blood / Q000473:pathology / Q000532:radiotherapy* / Q000601:surgery; D011292:Premedication; D011446:Prospective Studies; D018714:Radiotherapy, Adjuvant; D011994:Recombinant Proteins
D011994:Recombinant Proteins; C103998:epoetin beta; D004921:Erythropoietin