PMID- 22022341
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20211020
IS  - 1753-5174 (Print)
IS  - 1753-5174 (Electronic)
IS  - 1753-5174 (Linking)
VI  - 4
IP  - 3
DP  - 2011 Sep
TI  - Epoetin Theta with a New Dosing Schedule in Anaemic Cancer Patients Receiving 
      Nonplatinum-Based Chemotherapy: A Randomised Controlled Trial.
PG  - 33-41
AB  - INTRODUCTION: Recombinant human erythropoietin (r-HuEPO) is used to treat 
      symptomatic anaemia due to chemotherapy. A new r-HuEPO, Epoetin theta 
      (Eporatio(R)), was investigated and compared to placebo in a randomised, 
      double-blind clinical trial in adult cancer patients receiving nonplatinum-based 
      chemotherapy. The primary efficacy endpoint was the responder rate (complete 
      haemoglobin (Hb) response, i.e., Hb increase >/=2 g/dl) without the benefit of a 
      transfusion within the previous 4 weeks. RESEARCH DESIGN AND METHODS: 186 
      patients were randomised to s.c. treatment for 12 weeks with either Epoetin theta 
      (N = 95) or placebo (N = 91). The starting dose was 20,000 IU once weekly Epoetin 
      theta or placebo. RESULTS: The incidence of complete Hb responders was 
      significantly higher in the Epoetin theta group than in the placebo group (72.6 
      vs. 25.3%, P < 0.0001). More patients in the placebo group than in the Epoetin 
      theta group received blood transfusions after randomisation (23 patients, 25.3% 
      vs. 13 patients, 13.7%, P = 0.0277). The majority of patients with a complete Hb 
      response had 20,000 IU/week as their maximum dose prior to response, indicating 
      that a dose of 20,000 IU is an appropriate starting dose. The overall frequencies 
      of adverse events (AEs) were similar in both treatment groups. Hypertension was 
      the only AE that was more frequent in the Epoetin theta group compared to the 
      placebo group (8.4 vs. 1.1%). CONCLUSIONS: Epoetin theta showed a superior 
      efficacy to placebo in terms of complete Hb response without blood transfusion 
      within the previous 4 weeks. Treatment with Epoetin theta resulted in a 
      statistically significant increase in mean haemoglobin levels compared to 
      placebo. The overall frequencies of adverse events were similar in both treatment 
      groups.
FAU - Tjulandin, Sergei A
AU  - Tjulandin SA
FAU - Bias, Peter
AU  - Bias P
FAU - Elsasser, Reiner
AU  - Elsasser R
FAU - Gertz, Beate
AU  - Gertz B
FAU - Kohler, Erich
AU  - Kohler E
FAU - Buchner, Anton
AU  - Buchner A
LA  - eng
PT  - Journal Article
PL  - United States
TA  - Arch Drug Inf
JT  - Archives of drug information
JID - 101322852
PMC - PMC3193379
EDAT- 2011/10/25 06:00
MHDA- 2011/10/25 06:01
CRDT- 2011/10/25 06:00
PHST- 2011/10/25 06:00 [entrez]
PHST- 2011/10/25 06:00 [pubmed]
PHST- 2011/10/25 06:01 [medline]
AID - 10.1111/j.1753-5174.2011.00035.x [doi]
PST - ppublish
SO  - Arch Drug Inf. 2011 Sep;4(3):33-41. doi: 10.1111/j.1753-5174.2011.00035.x.