Due to the complexity of providing care for older adults with cancer, geriatric oncology has emerged as a subspecialty in high-income countries (HICs). In most low and middle-income countries (LMICs), this branch of oncology is still in its infancy—currently there are <10 cancer centres with dedicated geriatric oncology clinics in India.1 The challenges for geriatric cancer care in India reflect such challenges in most LMICs: lack of awareness, experts, and training programme in geriatric oncology. However, the biggest barrier is the huge patient volume a medical oncologist sees in a day. In the context of an oncologist seeing 20 new consults in 1 clinic, incorporating geriatric assessments (GA) can feel frustratingly time consuming. Furthermore, many geriatric assessment tools (GAT) currently recommended in guidelines were derived from studies not tailored to the LMICs’ sociocultural contexts. Thus, most LMIC oncologists depend on clinical judgement rather than a comprehensive GA when deciding fitness for cancer therapies, which can lead to suboptimal outcomes for older patients with cancer.
Noronha et al have published results of a single-centre retrospective audit of cancer clinical trials conducted at Tata Memorial Hospital, Mumbai, India and analysed if older adults are proportionally represented in trials.2 From 2003 to 2023, the proportion of older adults in the hospital registry remained stable at around 30%, while their representation in clinical trials at this academic institution was 23%. The authors conclude that older adults are disproportionately less represented in clinical trials.
The under-representation of older adults in cancer clinical trials is not specific to this centre or India—this has been a global issue, recognised for many years.3 Clinical trials, especially the registration-seeking trials of new therapeutics, often have notoriously stringent eligibility criteria that practically exclude many older adults. However, regulators and cooperative groups in the West have acknowledged this problem and taken some positive steps to improve enrolment of older adults especially in registration trials.4 5 Indeed, some improvements have been documented: >40% of patients included in practice-changing trials of targeted therapy and immunotherapy mostly conducted in HIC were aged ≥65 years.6 Similarly, in their current study, Noronha et al have reported a gradual improvement over time in the proportion of enrolled older adults, from 8% in 2003 to 22% in 2019.2
However, a major limitation of the study remains the definition of what constitutes older adults. In this study, the authors determined 60 years as the cut-off for defining older age consistent with the operational definition used by the Government of India. In comparison, American Society of Clinical Oncology uses 65 years and European Society for Medical Oncology uses 70 years as cut-off for their geriatric oncology guidelines. At face value, the cut-off age in this Indian study seems lower than international standards. However, we don’t believe that the age cut-off should be uniform globally, since life expectancies differ across the globe. Rather, an adaptable definition such as average life expectancy minus 10 years, for example, could be used. Indeed, when we consider the average life expectancy at birth for India, USA and Europe (67, 76 and 80 years, respectively, 2021), these cut-off differences make more sense. Nevertheless, although helpful for such retrospective research, we believe that the chronological age shouldn’t matter for clinical assessment and trial enrolment which should be based on functional status as assessed by validated GAT. As Noronha et al show, even within their single centre, different clinical trials had used different age cut-offs, rather than selecting older patients based on GA. However, the GAT may also need to be tailored to the local contexts—an area that needs further studies from LMICs. Another important limitation of this study is that the trials included in this analysis are a selected cohort of trials and not all trials conducted in the centre.
Almost 10% of India’s population is aged ≥60 years, and this proportion is only going to increase in the future as life expectancy continues to rise.7 According to population-based cancer registries, 44.9% of cancer cases in India occur in adults aged ≥60 years and 24.4% in those aged ≥75 years.8 If we were to offer a comprehensive GA to every patient with cancer over the age of 60, healthcare resources would be quickly overwhelmed. The prevalence of frailty in Indian patients with cancer aged ≥60 is about 60%, but 71% of those aged ≥75 are frail.9 In a country like India where resources for geriatric cancer care are extremely limited, perhaps using a higher age cut-off for GA could be reasonable while capacity is expanded. The use of geriatric screening tools can assist in determining who needs a full GA. In the Indian context, self-administered GATs could be extremely useful as it saves time of healthcare providers.10 Combining these approaches may help to focus highly specialised care in frail, older patients who would be more likely to benefit from GA-guided management.
The financial, time and emotional burden of participating in clinical trials cannot be ignored. Especially for older adults who already have a hard time understanding the complex cancer treatment journey, navigating clinical trials bureaucracy could be frustrating. Dedicated support staff and an easier participation process can somewhat mitigate these challenges. Synchronised efforts at national levels are needed to ensure that older adults are proportionately represented in clinical trials, and barriers to their enrolment are removed. Proportionate representation of older adults in clinical trials is not only an equity or ethics issue, but also a scientific issue because older adults continue to have disproportionately poor outcomes and scientific evidence to guide their treatment remains scanty.11 These lessons are important for many LMICs that are already or soon facing the rise of older population with cancer.
Contributors: The corresponding author is the guarantor. All authors were equally involved in conceptualisation and writing of this manuscript.
Funding: The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.
Competing interests: Haydee Verduzco-Aguirre has received fees as advisor from Asofarma and Bowhead Health, and travel expenses from AstraZeneca. Bishal Gyawali has received consulting fees from Vivio Health and holds stock options in OneCell Diagnostics, Inc.
Patient and public involvement: Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.
Provenance and peer review: Commissioned; internally peer reviewed.
Data availability statement
Data sharing not applicable as no datasets generated and/or analysed for this study.
Ethics statements
Patient consent for publication:
Not applicable.
Ethics approval:
Not applicable.
Acknowledgements
Dr. Gyawali has received salary support from Ontario Institute for Cancer Research funded by the government of Ontario. The opinions expressed herein are authors and do not reflect those of the government.
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