e14037 Background: Detailed information on cancer types of enrolled patients in phase I oncology trials is scarce. Global distribution, time-dependent change, and regional differences were evaluated. Methods: A systematic search of the PubMed database was performed and all single-agent phase I clinical trials permitting enrollment of all-comer patients (i.e. patients with any type of solid tumor) published between Jan 1991 and Dec 2015 were included. The trials expected to enroll specific patient populations were excluded per the criteria developed for this study. Results: A total of 10,596 articles were reviewed by three researchers. We identified 866 eligible clinical trials, which enrolled a total of 28,751 patients with advanced solid tumors. The extracted trials were performed mainly in North America (55.5%), Europe (27.8%), and Asia (10.5%). Colorectal (n = 7,483; 26.0%) and lung (n = 3,211; 11.2%) cancers were the most prevalent solid tumors, followed by sarcoma (n = 1,739, 6.0%), breast cancer (n = 1,625, 5.7%), and renal cancer (n = 1,547, 5.4%). The proportion of patients with either colorectal or lung cancer tended to decrease with time: 28.0% and 16.3% in 1991-1995; 31.9% and 12.4% in 1996-2000; 27.1% and 10.8% in 2001-2005; 23.9% and 10.7% in 2006-2010; and 23.4% and 9.9% in 2011-2015. In the same years, the proportion of trials, in which patients with either of these two cancers accounted for ≥50% of the total number of patients in each trial, also decreased: 33 of 67 trials (33/67) (49.3%), 59/142 (41.5%), 62/223 (27.8%), 38/189 (20.1%), and 40/245 (16.3%), respectively. This tendency was consistent in the three main regions. Instead, the proportion of patients with various types of cancer increased, leading to diversification of enrolled patients in phase I trials. Conclusions: The distribution of cancer types among enrolled patients in all-comer phase I trials has changed. Patients with common forms of cancer, whose general condition is likely to be deteriorated after many lines of standard chemotherapy or other approved drugs, tend to not participate in these trials. Diversification of enrolled patients will increase the chances of assessing the preliminary efficacy of new treatments against various types of cancer.
Abstract CT161: Phase I clinical trials of SLC-0111, a novel inhibitor of carbonic anhydrase IX, in patients with advanced solid tumors
