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<p>In DESTINY-Breast04 (<a href="https://clinicaltrials.gov/study/NCT03734029?term=DESTINY-Breast04&amp;rank=1">NCT03734029</a>), trastuzumab deruxtecan (T-DXd) significantly improved overall survival (OS) and progression-free survival compared with treatment of physician’s choice of chemotherapy (TPC) for patients with human epidermal growth factor receptor 2-low (HER2-low) (immunohistochemistry (IHC) 1+ or IHC 2+/in situ hybridization-negative) metastatic breast cancer. After an extended median follow-up of 32.0 months, median OS in the overall cohort was 22.9 months for T-DXd and 16.8 months for TPC (hazard ratio 0.69; 95% confidence interval 0.55–0.86). For the hormone receptor-positive cohort, median OS was 23.9 and 17.6 months for T-DXd and TPC, respectively (hazard ratio 0.69; 95% confidence interval 0.55–0.87). Median OS also favored T-DXd in exploratory analyses of hormone receptor-negative, estrogen receptor IHC 1%–10% and estrogen receptor IHC &gt;10% cohorts. The overall safety profile of T-DXd was acceptable and generally manageable. Results confirm T-DXd as standard of care after prior chemotherapy in patients with HER2-low metastatic breast cancer. ClinicalTrials.gov identifier: <a href="https://clinicaltrials.gov/study/NCT03734029?term=DESTINY-Breast04&amp;rank=1">NCT03734029</a>.</p>

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Trastuzumab deruxtecan in HER2-low metastatic breast cancer: long-term survival analysis of the randomized, phase 3 DESTINY-Breast04 trial

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年10月8日

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  • Shanu Modi,
  • William Jacot,
  • Hiroji Iwata,
  • Yeon Hee Park,
  • Maria Vidal Losada,
  • Wei Li,
  • Junji Tsurutani,
  • Naoto T. Ueno,
  • Khalil Zaman,
  • Aleix Prat,
  • Konstantinos Papazisis,
  • Hope S. Rugo,
  • Toshinari Yamashita,
  • Nadia Harbeck,
  • Seock-Ah Im,
  • Michelino De Laurentiis,
  • Jean-Yves Pierga,
  • Xiaojia Wang,
  • Andrea Gombos,
  • Eriko Tokunaga,
  • Cecilia Orbegoso Aguilar,
  • Lotus Yung,
  • Feng Xiao,
  • Yingkai Cheng,
  • David Cameron

摘要

In DESTINY-Breast04 (NCT03734029), trastuzumab deruxtecan (T-DXd) significantly improved overall survival (OS) and progression-free survival compared with treatment of physician’s choice of chemotherapy (TPC) for patients with human epidermal growth factor receptor 2-low (HER2-low) (immunohistochemistry (IHC) 1+ or IHC 2+/in situ hybridization-negative) metastatic breast cancer. After an extended median follow-up of 32.0 months, median OS in the overall cohort was 22.9 months for T-DXd and 16.8 months for TPC (hazard ratio 0.69; 95% confidence interval 0.55–0.86). For the hormone receptor-positive cohort, median OS was 23.9 and 17.6 months for T-DXd and TPC, respectively (hazard ratio 0.69; 95% confidence interval 0.55–0.87). Median OS also favored T-DXd in exploratory analyses of hormone receptor-negative, estrogen receptor IHC 1%–10% and estrogen receptor IHC >10% cohorts. The overall safety profile of T-DXd was acceptable and generally manageable. Results confirm T-DXd as standard of care after prior chemotherapy in patients with HER2-low metastatic breast cancer. ClinicalTrials.gov identifier: NCT03734029.