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Building the evidence for clinical practice: ROMANA trials (part 1)
Presentation by Dr. Kenneth Fearon, recorded at the Int. SCWD Conference on Cachexia on 05 December 2015
This video has been recorded at the 8th Int. Conference on Cachexia, Sarcopenia and Muscle Wasting on the 5th of December 2015 in Paris, France.
Dr. Kenneth Fearon (Edinburgh, Scotland) opened by describing unmet needs in cancer cachexia. Unfortunately, few treatment options exist for patients with cancer cachexia. Hydrazine sulfate is currently the only drug licensed for its treatment. While hydrazine sulfate stimulates appetite, it does not stimulate increases in lean tissue and is associated with a small but significant increase in mortality due to thromboembolic events. Because of these risks, the use of hydrazine sulfate is restricted to patients who are nearing end of life.
Next, Dr. Fearon described phase 3 trials using the oral ghrelin-receptor agonist anamorelin for the treatment of cancer cachexia. ROMANA 1 and 2 were international, double-blind phase 3 trials in which patients with unresectable stage III or IV non-small cell lung cancer were randomized to receive anamorelin or placebo for 12 weeks. Patients in ROMANA 1 gained an average of 1.2 kg of lean body mass, and patients in ROMANA 2 gained just under 1 kg. However, the investigators were unable to show a significant benefit in the functional indices evaluated. Anamorelin was associated with significant benefits in quality of life regarding anorexia and cachexia symptom burden.
In the safety extension study, no serious or grade 3 treatment-related adverse events and no drug-related deaths were reported. Dr. Fearon noted that even at the end of the 12-week safety extension study, patients receiving anamorelin continued to gain weight.
In summary, anamorelin treatment resulted in significantly increased lean body mass and improvement in quality of life measures and was generally well tolerated.
The symposium on Cachexia at the Int. SCWD Conference 2015 was sponsored by Helsinn SA.