Erythropoietin bei Karzinomen im Kopf-/Halsbereich?

Zusammenfassung

Hintergrund: Die prognostische Bedeutung des prätherapeutischen Hämoglobinwertes sowohl bei alleiniger chirurgischer Therapie als auch bei primärer oder adjuvanter Radio- oder Radiochemotherapie von Patienten mit fortgeschrittenen Kopf-/Halskarzinomen wurde vielfach belegt.

Methode: In einer prospektiven Plazebo kontrollierten Doppelblindstudie (Cochrane „Evidence-based-medicine” Level Ib) wurde der Effekt von Erythropoietin auf den Verlauf bei Patienten mit lokal fortgeschrittenen Kopf-/Halskarzinomen mit erniedrigtem Bluthämoglobinwert nach primärer definitiver oder adjuvanter Strahlentherapie analysiert. Untersucht wurde die Zeit bis zum lokalen Tumorprogress und das Überleben nach Kaplan-Maier.

Ergebnisse: Eingeschlossen wurden 140 Patienten. Nach adjuvanter Bestrahlung betrug die 2-Jahres lokale Tumorkontrollwahrscheinlichkeit 68 % ± 7 % und 72 ± 7 % für Plazebo und Epoetin beta-behandelte Patienten (p = 0,64). Primär definitiv bestrahlte Patienten hingegen erreichten nach zwei Jahren im Plazeboarm eine lokale Tumorkontrollwahrscheinlichkeit von 36 % ± 11 % im Vergleich zu Epoetin beta mit 23 % ± 11 % (p = 0,05).

Schlussfolgerungen: Die Gabe von Epoetin beta führte bei anämischen Patienten mit fortgeschrittenen Kopf-/Halskarzinomen zu einer raschen und stabilen Korrektur der Bluthämoglobinwerte. Die Tumorkontrolle von Patienten mit hoher Tumorlast (nach primär definitiver Bestrahlung) verschlechterte sich unter Epoetin beta.

Abstract

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.

Method: 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).

Conclusion: 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.

Schlüsselwörter

Prätherapeutischer Hämoglobinwert - Prognose - Verlauf - prospektive Plazebo kontrollierte Doppelblindstudie

Key words

Pretherapeutical hemoglobin value - prognosis - progression - prospective placebo-controlled double-blind study

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