Epoetin Theta in Anaemic Cancer Patients Receiving Platinum-Based Chemotherapy: A Randomised Controlled Trial
| Autor: | Beate Gertz, Reiner Elsässer, Anton Buchner, Peter Bias, Sergei A. Tjulandin, Erich Kohler |
|---|---|
| Rok vydání: | 2010 |
| Předmět: |
medicine.medical_specialty
Epoetin beta Chemotherapy business.industry medicine.medical_treatment Cancer medicine.disease Placebo Gastroenterology law.invention Surgery Clinical trial Complementary and alternative medicine Randomized controlled trial law Erythropoietin Internal medicine medicine Pharmacology (medical) General Pharmacology Toxicology and Pharmaceutics business Epoetin theta medicine.drug |
| Zdroj: | Archives of Drug Information. 3:45-53 |
| ISSN: | 1753-5174 |
| DOI: | 10.1111/j.1753-5174.2010.00030.x |
| Popis: | 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. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|
Plný text