Additionally, pivotal clinical trials have typically under-represented this sub-group. For example, in non-small cell lung cancer (NSCLC) trials, the patients enrolled were almost 10 years younger than the average age of diagnosis in the United Kingdom (UK).
Several pooled analyses from clinical trials and real-world datasets have not shown an increased risk of developing toxicity with such drugs among older patients compared with younger patients. The recent ELDERS study in the UK, primarily designed to investigate prospectively if older patients with advanced/metastatic NSCLC and melanoma had a higher risk of severe toxicity, showed no differences in its interim analysis; the final results are expected to be published soon. More studies in France and others countries are ongoing and results are awaited.
Whilst the current evidence deems these treatments safe for fit older patients, data is still lacking for those more vulnerable and frail. One concern with immunotherapy is the use of high dose steroids to manage its side effects, the long-term use of which may be particularly problematic for older patients.
Finally, immunotherapy with checkpoint inhibitors has revolutionised the treatment of many cancer types and older cancer patients are benefiting from this worldwide. While we further strengthen our knowledge about their effect in this sub-group of patients, research is now moving towards new treatment combination strategies, which are often associated with more toxicity. This highlights the need to understand their impact particularly on vulnerable older patients where appropriate assessments and patient selection is paramount.