Erythropoietin to treat head and neck cancer patients with anaemia undergoing radiotherapy: randomised, double-blind, placebo-controlled trial.

Henke M, Laszig R, Rube C, et al.
Lancet 2003;362:1255-1260.
NATA Rating :
Review by :
NATA Review

This study by Henke et al. is certainly provocative. It reports a poor disease free and overall survival in head and neck cancer patients receiving locoregional radiation therapy. What might explain this negative tumor and overall survival effect in this erythropoietin study when virtually every other erythropoietin study has not had such an observation?

First of all, there was a nonrandom dropout (approximately one third) from each of the two treatment arms, which might be the study’s biggest problem.

In addition, this study includes patients with only mild, if any, anemia at the start, gives two different doses of IV iron, and gives a higher dose of erythropoietin than in most other studies.

Nevertheless, the authors should be applauded for reporting a negative study. Given the problems with the study, I do not think we can conclude that erythropoietin is necessarily harmful, rather, we should be reminded that no medication is ever 100% safe and without the potential for adverse effect.

Perhaps we can use this study, and a similar European study in breast cancer patients, to help us carefully define populations and treatment programs in which erythropoietin therapy might be harmful.

– David H. Henry