The proportions of patients with specific cancer types participating in phase I all-comer trials varied over time, with the proportions of patients having colorectal or lung cancer decreasing steadily from 1991 to 2015, according to a study reported at the TAT 2019 – International Congress on Targeted Anticancer Therapies in Paris, France.
Lead author Jun Sato, and colleagues at the Developmental Therapeutics Department of the National Cancer Centre Hospital in Tokyo, Japan evaluated the global trends, among patients participating in all-comer phase I oncology clinical trials. These trends included regional differences between North America, Europe, and Asia over time. They reviewed the PubMed database to identify single-agent phase I trials that enrolled patients with any solid tumour type, which were published from 1991 to 2015. The inclusion and exclusion criteria were predefined for article selection, which excluded trials recruiting from specific patient populations.
The most prevalent cancer types in patients enrolled in phase I trials were colorectal and lung cancer
A total of 866 clinical trials were determined eligible and included in the analysis. These trials included 29,112 patients with advanced solid tumours.
The majority (55.5%) of trials were conducted in North America; 27.8% of the trials were conducted in Europe and 10.5% were carried out in Asia.
The investigators found that the distribution of cancer types in phase I trials differed from reported cancer-related incidence and mortality. The most prevalent types of cancer in patients enrolled in phase I trials were colorectal cancers (7,510 patients, 25.8%), followed by lung cancer (3,212 patients, 11.0%), sarcoma (1,756 patients, 6.0%), breast cancer (1,623 patients, 5.6%), renal cancer (1589 patients, 5.5%), and ovarian cancer (1473 patients, 5.1%).
Patients with colorectal or lung cancer accounted for ≥50% of the total patients population in each trial. However, this proportion decreased over time. The proportions of patients with colorectal or lung cancer in trials decreased from 46.3% in trials conducted from 1991 to 1995, to 40.8% (trials conducted from 1996 to 2000), to 26.5% (trials conducted from 2001 to 2005). Further decreases in these proportions were seen from 2006 to 2010 wherein 20.1 of enrolled patients had colorectal or lung cancer, and finally to 16.7% in trials conducted between 2011 and 2015. These trends remained consistent across the three regions studied together with an observed increase in the proportion of patients with various other types of cancer enrolled in phase I trials.
Conclusions
The investigators summarised that the distribution of cancer types among patients enrolled in all-comer phase I trials has changed dramatically.
They also concluded that patients with common types of cancer that are in poor general condition and have vital organ dysfunction after multiple lines of therapy are unlikely to participate in phase I trials.
Reference
30P –Sato J, Itahashi K, Shimizu T, et al. Dynamic change in the distribution of cancer types in oncology phase I trials.
No external funding was reported for this study.