Real-world clinical utility and challenges of comprehensive genomic profiling for advanced solid tumors in a

Mihoko Doi1,2, Nobuhisa Ishikawa3, Katsunori Shinozaki4

  • 1Department of Genomic Medicine, Hiroshima Prefectural Hospital, 1-5-54 Ujina-kanda, Minami-ku, Hiroshima, 734-8530, Japan. mihoko_doi@yahoo.co.jp.

Abstract

Insights

Comprehensive genomic profiling (CGP) improves outcomes for advanced cancers by identifying targetable mutations. However, access to matched therapies and clinical trials remains a challenge in community settings.

Area of Science:

  • Oncology
  • Genomics
  • Clinical Trials

Background:

  • The increasing availability of comprehensive genomic profiling (CGP) offers opportunities for targeted therapies in advanced cancers.
  • Challenges persist regarding low treatment success rates and disparities in accessing investigational drugs, particularly in community-based practices distant from major research centers.

Purpose of the Study:

  • To evaluate the accessibility of targeted therapies and the prognostic impact of CGP testing for patients with advanced or metastatic solid tumors at a regional hospital.
  • To assess the rate of genomically matched therapy and identify barriers to clinical trial participation.

Main Methods:

  • A retrospective analysis of 378 patients who underwent CGP testing between June 2019 and June 2024.
  • Collection and analysis of patient demographics, specimen details, molecular tumor board (MTB) assessments, and clinical outcomes, including overall survival (OS).
  • OS was evaluated using Kaplan-Meier analysis and log-rank tests.

Main Results:

  • CGP identified mutations in 94.2% of patients, with 65.6% harboring druggable alterations.
  • Genomically matched therapy was administered to 9.8% of patients, with 73% receiving approved drugs.
  • A statistically significant overall survival advantage was observed in patients receiving genomically matched therapy. Approximately 20% of patients not receiving matched therapy expressed interest in clinical trials.

Conclusions:

  • Comprehensive genomic profiling (CGP) demonstrates clinical utility in community hospitals, facilitating targeted treatment selection.
  • The high utilization of approved drugs among genomically matched therapies suggests significant barriers to clinical trial enrollment and access to novel agents.

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