Summarising the therapeutic and adverse effects of anticancer medicines according to race and sex: pooled analysis of clinical trials of contemporary treatments for solid tumours

Over the last decade there has been substantial advancement in the treatment of solid tumours (e.g., lung, breast, colorectal, prostate cancer), including the introduction of immune checkpoint inhibitors (a type of anticancer medicines), targeted therapies, and novel chemotherapies. However, response and toxicity to many of these medicines remains highly unpredictable. Two factors urgently requiring investigation are potential differences in therapeutic and adverse effects of contemporary anticancer medicines according to race and sex [1, 2].

Race differences are associated with a significant health disparity gap. For many common malignancies there are substantial differences in incidences according to race, while race is a phenotype for differences in genetic and tumour biology factors. Further there are inequities in drug development processes (e.g., in reporting and representation) and it is unclear if this is resulting in systematic disparities in anticancer treatment therapeutic and adverse effects [1, 3-10]. Science is also becoming increasingly aware that sex is an important modifier of health, disease and medicine efficacy [11]; however, the availability of quality information to inform sex (or gender) differences in outcomes from anticancer medicines are currently limited [2, 12]. This project will bring together individual participant data from key clinical trials to summarise the therapeutic and adverse effects of contemporary anticancer medicines according to race and sex. Being able to appraise the expected response and adverse effect profile of anticancer treatments according to racial and sex differences will enable patients and clinicians to make better patient-centred decisions.

Specifically, this project will endeavour to gather and then utilise data available via AstraZeneca, Bayer, Boehringer Ingelheim, Daiichi Sankyo, Eisai, Eli Lilly, Roche, Janssen, EMD Serono, Merck Sharp & Dohme, Novartis, Pfizer, Puma Biotechnology, Regeneron, Sanofi and Takeda’s data sharing policies to summarise the therapeutic and adverse effects of contemporary anticancer medicines according to race and sex.