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Background: The global population aged 80 years or older is expected to triple by 2050, leading to an increased cancer burden in the oldest population. This study describes the estimated cancer incidence and mortality in 2022 and projections for 2050 in the oldest old, analyzed globally and by world regions and World Bank income levels, for all sexes combined, as well as separately for males and females., Methods: Using GLOBOCAN 2022 estimates, we reported the estimated number of new cancer cases (excluding non-melanoma skin cancers), deaths, and truncated age-standardized incidence (ASIR) and mortality rates (ASMR) (per 100,000 individuals aged 80 years or older). We also presented the top five cancers by cases and deaths. Additionally, we projected the number of new cancer cases and deaths for each region in 2050, assuming no change in cancer incidence and death rates., Result: In 2022, an estimated 2.6 million new cancer cases (14 % of all cancer cases) and 2.1 million cancer deaths (22 % of all cancer deaths) occurred in the oldest old, with regional variations. Globally, lung, colorectal, and prostate cancers were the most common cancers diagnosed and leading causes of cancer death. ASIR ranged from 987 in Africa to 2044 per 100,000 in Northern America while ASMR ranged from 981 in Africa to 1769 per 100,000 in Oceania. In 2050, an estimated 7.4 million new cancer cases and 6 million cancer deaths are expected. The greatest increases are anticipated in China, India, and Africa, with increases exceeding 200 % compared to 2022 estimates., Conclusion: The growing cancer burden among the oldest old poses significant challenges to global healthcare systems, necessitating resource-tailored adaptations. These findings call for the inclusion of the oldest old in the development and implementation of cancer control policies and a better representation in cancer research., Competing Interests: Declaration of Competing Interest NMLB: Advisory board: Pfizer, Abbott, Sanofi, Astellas. Travel grants: Exact Sciences, Pfizer, Lilly, Novartis. Speaker fees: Pfizer, AbbVie, Roche, Sanofi, Novartis, Servier, Gilead, AstraZeneca, Lilly, Exact Sciences. VN has received institutional research funding from Astra Zeneca Pharma India Ltd, Glenmark, Nanobiotix SA, Novartis, and Roche Products (India) Pvt. Ltd. All research grants have been paid to the institution. EB: honoraria: AstraZeneca, Daiichi, Eli Lilly, Incyte, Pfizer, Seagen, Takeda; consultation fees: Daiichi, Menarini, Pfizer, Sandoz; travel supports: AstraZeneca, Daiichi, Gilead, Novartis, Pfizer. Other authors have no conflict to declare., (Copyright © 2024. Published by Elsevier Ltd.)

Immune checkpoint inhibitors (ICI) have transformed the management of cancer, particularly for older adults, who constitute a majority of the global cancer patient population. This study aimed to assess the inclusion, characteristics, and reporting of older adults enrolled in Food and Drug Administration (FDA) registration clinical trials of ICI between 2018 and 2022. Clinical trials of ICI leading to an FDA approval in solid tumor oncology between 2018 and 2022 were included. Primary study reports and all available secondary publications were assessed. The availability and completeness of older subgroup data for protocol-defined clinical efficacy endpoints, health-related quality of life (HRQOL) and toxicity outcomes, and baseline characteristics were assessed according to predefined criteria which categorized reporting completeness hierarchically in relation to the availability of published data, including effect size, sample size, and measures of precision. 53 registration trials were included, involving a total of 37,094 participants. Most trials (64.2%) were of ICI combination therapy. 42.3% of patients were aged≥65 years; 11.1% were aged≥75. No trials specified an upper age limit for eligibility. 98.1% of trials excluded patients with European Cooperative Oncology Group performance status>1. 87.2% of primary efficacy endpoints and 17.9% of secondary efficacy endpoints were reported completely for older adults. Five studies (9.4%) reported baseline characteristics, three (6.1%) reported HRQOL assessments, and four (7.5%) reported toxicity outcomes completely among older subgroups. No trials conducted baseline geriatric assessments or reported geriatric-specific symptoms or quality of life scales. This analysis highlights significant deficits in the enrollment and reporting of older subgroups in pivotal trials of ICI therapy. The findings highlight an urgent need for improved reporting and inclusion standards in clinical trials of ICI to better inform treatment decisions for older adults., Competing Interests: Competing interests: CME: None. RP: None. CS: None. MR: None. NMG-S: None. DW: None. NMLB: Advisory board: Pfizer, Abbott, Sanofi, Astellas; Travel grants: Exact Sciences, Pfizer, Lilly, Novartis; Speaker fees: Pfizer, AbbVie, Roche, Sanofi, Novartis, Servier, Gilead, AstraZeneca, Lilly., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)