Abstract C065: Research biopsy participation and safety in cancer therapeutic trials

作者：Taiwo Adesoye, Michelle L. Elders, Hung Le, David S. Hong, Sheferaw Y. Belay, Jordi Rodón, Ecaterina E. Dumbrava, Aung Naing, Sarina A. Piha‐Paul, Siqing Fu, Tin‐Yun Tang, Apostolia M. Tsimberidou, Alda L. Tam, Ravi Murthy, Lorna H. McNeill, Funda Meric‐Bernstam · 发表于：Molecular Cancer Therapeutics · 年份：2025 · DOI：10.1158/1535-7163.targ-25-c065 · 研究领域：Cancer Genomics and Diagnostics、Biomedical Ethics and Regulation、Ethics in Clinical Research

Abstract Background: Tumor biopsies are essential for biomarker discovery and validation of mechanism of action in early phase clinical trials, however, patients may be unwilling to participate. We examined biopsy safety and factors influencing biopsy participation in clinical trials. Methods: We analyzed active clinical trials that incorporated biopsies from at our Phase I program from January 1, 2023 to February 28, 2025. Patient demographics, disease characteristics and trial-specific factors were extracted from a prospectively maintained database. Biopsy characteristics were analyzed by mandatory or optional requirement status. Procedural-related complications were reported. Results: Among 91 trials, 60 (65.9%) were phase 1 studies and 80 (87.9%) were industry sponsored. Biopsy was required in 50 trials (54.9%), of which 10 permitted archival tissue. In 27 trials (29.7%) biopsy was optional, and in 13 trials (14.3%) both mandatory and optional biopsies were included. 648 patients were enrolled. Median age of patients was 61 years (IQR 51-69), and majority were female (n=346, 53.4%), white (n=491, 75.8%), and with in-state (Texas) location (n=331, 51.1%). The most common primary cancers were colorectal (n=121, 18.7%), pancreatic (n=103, 15.9%), and breast (n=79, 12.2%) cancers. Of 203 patients treated in cohorts requiring biopsy, 142 (70%) underwent biopsy. Of 216 patients treated in cohorts with optional biopsy requirement, 58 (26.9%) underwent biopsy. Among patients enro...