Results from expanded access programs: a review of academic literature 149 7♦ fact that the expanded access program population included patients with a worse performance status and more prior treatment lines: 15% of the patients in the expanded access program had ECOG PS 2 compared with 5% in the SELECT trial, and 64% of patients in the expanded access program had already received at least one systemic treatment versus 25.3% in the SELECT trial. The authors compare their expanded access program also to other real-world experience from a French expanded access program and a Swiss named patient program. In Italian, French, and Swiss experiences, lenvatinib was started in more heavily pre-treated patients, with worse performance status and more advanced disease compared with patients in the pivotal trial. The authors conclude that: Interestingly, general patients’ characteristics and clinical outcomes were consistent to those reported in a real-life experience carried out in France. Conclusion The authors conclude that: ‘Lenvatinib is active and safe in unselected, RAI-refractory, progressive DTC patients in real-life setting. The activity of lenvatinib could be improved if the drug administration started in the early phase of RAI refractory disease.’ No recommendations for future studies are given.
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