INTRODUCTION: Recombinant human
erythropoietin (r-HuEPO) is used to treat symptomatic anaemia due to
chemotherapy. A new r-HuEPO,
Epoetin theta (Eporatio®), was investigated and compared to placebo and
Epoetin beta in a randomised, double-blind clinical trial in adult
cancer patients receiving
platinum-based
chemotherapy, using a fixed weekly starting dose of 20,000 IU
Epoetin theta. The primary efficacy endpoint was the responder rate (complete Hb response, Hb increase ≥ 2 g/dL). RESEARCH DESIGN AND METHODS: 223 patients were randomised to s.c. treatment for 12 weeks with either
Epoetin theta (n = 76) once per week,
Epoetin beta (n = 73) three times per week or placebo (n = 74). The starting dose was 20,000 IU once weekly
Epoetin theta or 450 IU/kg(BW) per week
Epoetin beta administered in 3 equal weekly doses. RESULTS: In the
Epoetin theta group were significantly more responders than in the placebo group (65.8 vs. 20.3%, P < 0.0001).
Epoetin beta was also more effective than placebo (71.2 vs. 20.3%, P < 0.0001). The mean weekly dose at the time of complete Hb response was lower in the
Epoetin theta group (30,000 IU) than in the
Epoetin beta group (42,230 IU).
Epoetin theta was clearly more effective than placebo. CONCLUSION: This small study showed, that
Epoetin theta is a safe and effective treatment of symptomatic anaemia due to
platinum-based
chemotherapy in
cancer patients.