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<p>Patients with metastatic breast cancer and tumor mutational burden (TMB) ≥10 mutations/megabase are eligible for immunotherapy, but clinical and genomic characteristics and outcomes of patients with ultra-high TMB (UHTMB) ≥20 mutations/megabase remain under-characterized. In this retrospective cohort and comparative effectiveness study we examined comprehensive genomic profiling assessed on tumors as part of routine care. Real-world time to next treatment (TTNT), and overall survival (rwOS) data were collected from the Flatiron Database. 45/2049 (2.2%) patients had UHTMB; patients with UHTMB were more likely to have estrogen receptor-positive disease (86.6% vs. 70.0%), lobular histology (40.0% vs. 14.5%), and PIK3CA mutation (81.8% vs. 37.9%) vs. patients with TMB ≤ 20. Patients with UHTMB who received immunotherapy had longer TTNT (4.9 vs. 2.6 months, hazard ratio (HR) = 0.49, 95% confidence interval (CI):0.26–0.91,<i>p</i> = 0.025) and longer rwOS (14.1 vs. 3.2 months, HR = 0.37, 95%CI:0.18–0.76,<i>p</i> = 0.007) than patients with TMB &lt;10. Single agent immunotherapy is an important treatment option for patients with UHTMB.</p>

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Ultra-high tumor mutation burden breast cancer: genomic profiling and real-world immunotherapy results

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年5月20日

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  • Kristina Fanucci,
  • Mariya Rozenblit,
  • Julia C. F. Quintanilha,
  • Ryon P. Graf,
  • Neal Fischbach,
  • Maureen Pelletier,
  • Abirami Sivapiragasam,
  • Prashanth Ashok Kumar,
  • Mansi Kallem,
  • Ethan S. Sokol,
  • Smruthy Sivakumar,
  • Dean C. Pavlick,
  • Jeffrey S. Ross,
  • Maryam Lustberg,
  • Lajos Pusztai

摘要

Patients with metastatic breast cancer and tumor mutational burden (TMB) ≥10 mutations/megabase are eligible for immunotherapy, but clinical and genomic characteristics and outcomes of patients with ultra-high TMB (UHTMB) ≥20 mutations/megabase remain under-characterized. In this retrospective cohort and comparative effectiveness study we examined comprehensive genomic profiling assessed on tumors as part of routine care. Real-world time to next treatment (TTNT), and overall survival (rwOS) data were collected from the Flatiron Database. 45/2049 (2.2%) patients had UHTMB; patients with UHTMB were more likely to have estrogen receptor-positive disease (86.6% vs. 70.0%), lobular histology (40.0% vs. 14.5%), and PIK3CA mutation (81.8% vs. 37.9%) vs. patients with TMB ≤ 20. Patients with UHTMB who received immunotherapy had longer TTNT (4.9 vs. 2.6 months, hazard ratio (HR) = 0.49, 95% confidence interval (CI):0.26–0.91,p = 0.025) and longer rwOS (14.1 vs. 3.2 months, HR = 0.37, 95%CI:0.18–0.76,p = 0.007) than patients with TMB <10. Single agent immunotherapy is an important treatment option for patients with UHTMB.