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<p>Circulating tumor DNA (ctDNA) has an expanding role in oncology. It is unknown whether on-treatment ctDNA can be used to personalize radiation dose. This phase 2 exploratory clinical trial enrolled 102 patients with human papillomavirus (HPV)-positive oropharyngeal carcinoma (OPC). Intermediate-risk patients (T4 disease or &gt;10 pack-year smokers with pre-treatment HPV ctDNA scores &gt;200) were reclassified as low-risk if HPV ctDNA cleared by &gt;95% mid-treatment. All clinically low-risk and reclassified patients received de-intensified (chemo)radiation. The primary outcome was progression-free survival (PFS) among de-escalated patients; secondary outcomes included tolerability, distant metastatic-free, and overall survival. Eighty-nine patients received de-escalated treatment (60 low-risk, 29 reclassified). Two-year PFS among de-escalated patients was 93% (95%CI, 87-99). Post-hoc analyses suggested that intermediate-risk patients reclassified as low-risk and treated with de-escalation had distinct HPV ctDNA dynamics and favorable outcomes. HPV ctDNA is an emerging biomarker that might improve risk stratification for patients with intermediate-risk HPV-positive OPC. Registration number: NCT04900623.</p>

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Risk-adapted therapy guided by human papillomavirus (HPV) circulating tumor DNA in HPV-positive oropharyngeal cancer (ReACT 1.0): an exploratory phase II trial

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年5月7日

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  • Glenn J. Hanna,
  • Tulika R. Gupta,
  • Lorenzo Trippa,
  • Eleni M. Rettig,
  • Danielle N. Margalit,
  • Roy B. Tishler,
  • Itai Pashtan,
  • Emily Kim,
  • Alexander Droznin,
  • Lauren Gunasti,
  • Riley Maddox,
  • Jacqueline Minken,
  • Dev Mukundan,
  • Kartik Sehgal,
  • Michael J. Dennis,
  • Thomas O’Connor,
  • Jack M. Qian,
  • Graham H. Boyd,
  • Anurag Saraf,
  • Daribelle Massiel Gil,
  • Rosh K. Sethi,
  • Donald J. Annino,
  • Lauren A. Goguen,
  • Jeffrey P. Guenette,
  • Mina Bakhtiar,
  • Vickie Y. Jo,
  • Kristine Wong,
  • Ravindra Uppaluri,
  • Robert I. Haddad,
  • Jonathan D. Schoenfeld

摘要

Circulating tumor DNA (ctDNA) has an expanding role in oncology. It is unknown whether on-treatment ctDNA can be used to personalize radiation dose. This phase 2 exploratory clinical trial enrolled 102 patients with human papillomavirus (HPV)-positive oropharyngeal carcinoma (OPC). Intermediate-risk patients (T4 disease or >10 pack-year smokers with pre-treatment HPV ctDNA scores >200) were reclassified as low-risk if HPV ctDNA cleared by >95% mid-treatment. All clinically low-risk and reclassified patients received de-intensified (chemo)radiation. The primary outcome was progression-free survival (PFS) among de-escalated patients; secondary outcomes included tolerability, distant metastatic-free, and overall survival. Eighty-nine patients received de-escalated treatment (60 low-risk, 29 reclassified). Two-year PFS among de-escalated patients was 93% (95%CI, 87-99). Post-hoc analyses suggested that intermediate-risk patients reclassified as low-risk and treated with de-escalation had distinct HPV ctDNA dynamics and favorable outcomes. HPV ctDNA is an emerging biomarker that might improve risk stratification for patients with intermediate-risk HPV-positive OPC. Registration number: NCT04900623.