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Among people whose chemotherapy had left them anaemic, a weekly epoetin theta injection restored haemoglobin without a transfusion in 73 percent, against 25 percent on placebo, and roughly halved the share who needed a transfusion.
Primary publication of XM01-22 (ISRCTN08063129), a randomised, double-blind, placebo-controlled trial of the recombinant erythropoietin epoetin theta (Eporatio) in adult cancer patients receiving nonplatinum-based chemotherapy. The primary efficacy endpoint was the responder rate: a complete haemoglobin response, defined as a haemoglobin increase of at least 2 g/dL without a transfusion within the previous four weeks. 186 patients were randomised to 12 weeks of subcutaneous epoetin theta (n = 95) or placebo (n = 91), starting at 20,000 IU once weekly.
Complete haemoglobin response was 72.6 percent with epoetin theta versus 25.3 percent with placebo (P less than 0.0001). More placebo patients received transfusions after randomisation (23 patients, 25.3 percent, versus 13 patients, 13.7 percent; P = 0.0277). Most responders had 20,000 IU per week as their maximum dose before response, supporting it as the starting dose. Adverse-event frequencies were similar overall; hypertension was the only event more frequent with epoetin theta (8.4 percent versus 1.1 percent).
This is the nonplatinum chemotherapy pivotal behind the 2009 EU authorisation of epoetin theta (Eporatio and Biopoin) for the anaemia of chemotherapy in non-myeloid cancers. It supports the 20,000 IU weekly starting dose that the product information uses.