The impact of clinical studies in adult oncology performed within the US National Cancer Institute (NCI) National Cancer Clinical Trials Network (NCTN) groups has never been systematically examined. It prompted Prof. Joseph M. Unger of the Public Health Sciences Division, Fred Hutchinson Cancer Research Center in Seattle, WA, US and colleagues to analyze the randomised studies conducted within the network. Those studies have generated substantial gains in life years for patients with cancer and have enormous influence in the cancer field as reflected by how often they inform clinical care guidelines and are cited in the scientific literature. Prof. Unger reported the findings during the proffered papers session on public policy at ESMO Congress 2021 (16-21 September).
Prof. Unger described to the audience how NCTN groups have conducted publicly funded cancer research in the US for more than 50 years. The primary mission of the groups within the network is to identify effective new treatments for patients with cancer. For this analysis, Prof. Unger and colleagues from the SWOG Cancer Research Network identified randomised, phase III studies performed by the adult NCTN groups, in particular those conducted by SWOG, the Alliance, NRG, and ECOG-ACRIN. Studies beginning in 1980 onward were included, and must have demonstrated a statistically significant findings for at least one clinical, time-dependent outcome.
Prof. Unger and colleagues calculated gains in population life-years attributable to the network-group studies by deriving study-specific survival function parameters depicting the difference in survival between standard and experimental treatments, and mapping the benefit of the experimental treatment onto the US cancer population using national cancer registry and life table data.
Life-years were estimated from studies for which overall survival favoured the experimental treatment arm. Clinical impact was defined by influencing practice, and was determined by whether the study findings were explicitly included as evidence in favour of a recommended treatment in a major clinical guideline. Scientific impact was assessed according to citation data from Google Scholar. Results were estimated through 1 January 2020.
A total of 163 clinical studies were analyzed with 108,102 included patients with cancer. This figure represents 30.9% (163 of 528 clinical studies) of estimated number of clinical studies conducted within the network.
The most common cancer types included in the analysis were breast cancer, gynaecologic cancers, lung cancer and prostate cancer. Overall, these studies were estimated to have generated gains of 14.0 million life-years to patients with cancer. The federal investment per life year gained, as previously estimated in a subset of the studies, was 125 USD. Further, more than 80% of the studies influenced guideline care recommendations, and the studies were cited 166,771 times (mean, 64 citations/year/study).
Prof. Unger concluded that the studies conducted by the NCI NCTN groups have demonstrated the critical role of government-sponsored cancer research in prolonging the lives of patients with cancer.
The study was funded by the US NCI, National Institutes of Health.
1503O – Unger JM, LeBlanc M, Bertagnoli M, et al. Clinical and scientific impact of National Cancer Institute: Sponsored clinical trial network group treatment trials. ESMO Congress 2021 (16-21 September).