XM01-22
XM01-22 showed that a weekly injection of epoetin theta, a made-to-order copy of the hormone that tells the marrow to make red blood cells, lifted haemoglobin by a clear margin without a transfusion in almost three quarters of people on nonplatinum chemotherapy, against one quarter on placebo, which helped support its European approval for the anaemia of chemotherapy.
Overview
XM01-22 was a multinational, multicentre, randomised, double-blind, placebo-controlled phase 3 trial of epoetin theta in anaemic adults with solid tumours or non-myeloid haematological malignancies receiving nonplatinum chemotherapy. Patients were randomised to subcutaneous epoetin theta starting at 20,000 IU once weekly or matching placebo for 12 weeks. The primary endpoint was complete haemoglobin response, defined as a haemoglobin increase of at least 2 g/dL without a transfusion in the previous four weeks.
In the Archives of Drug Information 2011 report, 72.6 percent of patients on epoetin theta and 25.3 percent on placebo had a complete response (P less than 0.0001). Fewer patients on epoetin theta received transfusions after randomisation (13.7 percent versus 25.3 percent, P = 0.0277). Most responders reached their response at the 20,000 IU starting dose. Overall adverse-event frequencies were similar; hypertension was the only adverse event more frequent with epoetin theta (8.4 percent versus 1.1 percent).
The ISRCTN08063129 record carries the protocol serial number XM01-22, names BioGeneriX AG as sponsor and gives an overall end date of 11 May 2007. The Eporatio product information describes this 186-patient nonplatinum study as the first of the two cancer chemotherapy trials behind the anaemia indication. The programme treats chemotherapy-induced anaemia across mixed tumour types rather than a single corpus cancer, so the record carries no cancer ids.
- 72.6 vs 25.3 out of 100 had no sign of cancer on scans or tests with Epoetin theta 20,000 IU weekly compared with Placebo; 47.3 more per 100.
- Roughly one extra person helped for every 2 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.
- The p-value (<0.0001) says a difference this large would rarely happen by chance; it does not say how large or how useful the difference is.
- 13.7 vs 25.3 out of 100 reached this endpoint with Epoetin theta 20,000 IU weekly compared with Placebo; 11.6 fewer per 100.
- On this measure the first group did worse, not better.
- The p-value (0.0277) says a difference this large would rarely happen by chance; it does not say how large or how useful the difference is.
- This endpoint is not one of the standard survival or response measures; read it alongside the trial's primary result.
- These results apply to the people the trial enrolled: Anaemic adults with solid tumours or non-myeloid haematological malignancies receiving nonplatinum chemotherapy: epoetin theta 20,000 IU subcutaneously once weekly versus placebo for 12 weeks. People in a different situation may not see the same effect.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
186 randomised.
13 patients · 23 patients
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Complete haemoglobin response (increase of at least 2 g/dL without transfusion in the previous 4 weeks)primary | Epoetin theta 20,000 IU weekly | 95 | 72.6% | - | <0.0001 | link |
| Placebo | 91 | 25.3% | ||||
| Patients transfused after randomisation | Epoetin theta 20,000 IU weekly | 95 | 13.7% | - | 0.0277 | link |
| Placebo | 91 | 25.3% |