This article, originally published by Undark Magazine, discusses the lack of age-specific data in clinical trials for cancer treatments, particularly for older adults. The article highlights the case of 84-year-old Jim Yeldell, who was diagnosed with Stage 3 lung cancer and experienced severe side effects from the initial drug he tried. Yeldell’s daughter-in-law, Elizabeth Kvale, a palliative-care specialist, had witnessed similar side effects in older adults at her clinic. This lack of age-specific data has significant implications for older cancer patients, who are more likely to be diagnosed with cancer but are underrepresented in clinical trials.
The article points out that older patients are often excluded from clinical trials due to concerns about preexisting conditions, medications, and participants’ ability to travel. As a result, there is uncertainty about how approved cancer drugs will work in older adults. This information gap means that older cancer patients must decide whether to pursue treatments that may have fewer benefits and more side effects than in younger patients.
The article emphasizes that this lack of data extends across various cancer treatments, including chemotherapy, radiation, and immune-checkpoint inhibitors. For example, many forms of chemotherapy have been found to be more toxic in older adults after approval for use. Despite recommendations and media coverage, there has been little improvement in including older adults in clinical trials.
The article discusses research conducted by Cary Gross and his team, which found that older patients were being prescribed immune-checkpoint inhibitors soon after FDA approval. However, these patients were significantly older than those in the clinical trials. Another analysis revealed that these drugs extended the life of younger patients by a median of four and a half months but only by a month in older patients.
The article highlights the connection between the lack of evidence from clinical trials and worse outcomes in the clinic, including severe side effects from chemotherapy in older patients. Understanding where certain treatments work well in older adults is crucial, not just for efficacy but also because these drugs can be expensive.
Efforts have been made to address the problem, such as removing upper age limits in clinical trials and providing guidance for industry-funded trials to include older adults. However, the article states that trials are still not designed with older adults in mind. Clinical trials focus on measuring improvements in health, such as tumor size or increased months of life, which may not be the top priorities for older adults considering treatment. Older adults often have concerns about side effects affecting their cognitive function and ability to live independently, which are not usually captured in clinical trials.
The article mentions the case of Jim Yeldell, who chose a less intensive course of treatment based on discussions with his care team and Elizabeth Kvale. Yeldell’s cancer has remained stable since October 2022, and he continues to live independently and exercise regularly. Tools like geriatric assessments are being developed to provide a more complete picture of a person’s physiological age and help predict their response to treatment.
In conclusion, the article highlights the need for age-specific data in clinical trials for cancer treatments and the impact this lack of data has on older adults. It emphasizes the importance of designing trials that capture the end points that are significant for older adults and mentions ongoing efforts to address the problem.
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