Real-world clinical utility and challenges of comprehensive genomic profiling for advanced solid tumors in a community health institution.
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BACKGROUND: Comprehensive genomic profiling (CGP) tests were approved, and opportunities to consider tissue-agnostic targeted therapies based on molecular tumor profiling have increased even in the community-based medicine practice. However, low treatment success rates and regional disparities in access to investigational drugs remain significant challenges. This retrospective study aimed to evaluate the drug accessibility rate and prognostic impact of CGP testing for advanced or metastatic solid tumors at Hiroshima Prefectural Hospital, a facility located far from clinical trial sites. METHODS: We analyzed data from 378 patients who underwent CGP testing between June 2019 and June 2024. Patient characteristics, specimen details, molecular tumor board (MTB) assessments of CGP results, and clinical courses were collected. Overall survival (OS) after MTB assessment was evaluated using the Kaplan-Meier method and log-rank test. RESULTS: The median patient age was 69 (range: 10-92) years. Lung cancer was the most common cancer type, affecting 105 patients (27.8%). CGP testing identified one or more gene mutations in 356 patients (94.2%), of whom 248 (65.6%) harbored druggable genomic alterations, and 37 (9.8%) received genomically matched therapy. Among them, 27 (73%) received approved drugs. The OS advantage observed in patients who received genomically matched therapy was statistically significant. Among patients who did not receive genomically matched therapy, approximately 20% expressed willingness to participate in clinical trials. CONCLUSIONS: These findings demonstrate the clinical utility of CGP testing in local medical facilities; however, the high proportion of approved drugs among genomically matched treatments highlights significant barriers to clinical trial participation.