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Peer-reviewedCC BY-NC-ND 4.0Nature Communications

Response-Adapted Postoperative Therapy Following Neoadjuvant Chemoimmunotherapy in Locally Advanced Head and Neck Squamous Cell Carcinoma: a phase II trial

  • Yu Qian1
  • Liu Hu2
  • Liang Jiang3
  • Manxiang Wang4
  • Xin Jin5
  • Wenyou Deng6
  • Kun Wu2
  • Shuang Qin2
  • Desheng Hu2
  • Jian Chen3
  • Yuan Wu2
6 affiliations
  1. 1Department of Medical Oncology, Hubei Cancer Hospital, Tongji Medical College, Huazhong University of Science and Technology, 430071 Wuhan, P.R. China
  2. 2Department of Radiation Oncology, Hubei Cancer Hospital, Tongji Medical College, Huazhong University of Science and Technology, 430071 Wuhan, P.R. China
  3. 3Department of Head and Neck Surgery, Hubei Cancer Hospital, Tongji Medical College, Huazhong University of Science and Technology, 430071 Wuhan, P.R. China
  4. 4Department of Pathology, Hubei Cancer Hospital, Tongji Medical College, Huazhong University of Science and Technology, 430071 Wuhan, P.R. China
  5. 5Department of Nutrition, Hubei Cancer Hospital, Tongji Medical College, Huazhong University of Science and Technology, 430071 Wuhan, P.R. China
  6. 6Department of Radiology, Hubei Cancer Hospital, Tongji Medical College, Huazhong University of Science and Technology, 430071 Wuhan, P.R. China
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Abstract

Neoadjuvant chemo-immunotherapy (NACI) demonstrates promising efficacy in locally advanced head and neck squamous cell carcinoma (LA-HNSCC), yet its effect on postoperative radiotherapy/chemoradiotherapy (PORT/POCRT) remains undefined. This open-label phase 2 study (NCT05476965) assessed NACI efficacy and its role in guiding adaptive PORT/POCRT. Primary endpoint was major pathologic response (MPR) rate (0-10% residual tumor). Secondary endpoints are overall survival (OS), disease-free survival (DFS), objective response rate (ORR), and adverse events. Thirty resectable stage III–IVB HNSCC patients received sintilimab plus chemotherapy, followed by surgery and response-adapted PORT/POCRT. Patients with MPR received low-dose PORT (0–54 Gy), while patients without MPR received standard PORT/POCRT. The MPR rate was 59.1% (38.7%-76.7%). The MPR with low-dose group showed higher 2-year OS (100% vs. 77.8%) and DFS (100% vs. 55.6%) with fewer radiotherapy-related adverse events than non-MPR with standard-dose group (all P < 0.05). Adaptive radiation de-escalation maintains survival while reducing toxicity, representing a new strategy for LA-HNSCC.

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Cite

BibTeXRIS
BibTeX
@article{qian2026responseadapted,
  title = {{Response-Adapted Postoperative Therapy Following Neoadjuvant Chemoimmunotherapy in Locally Advanced Head and Neck Squamous Cell Carcinoma: a phase II trial}},
  author = {Yu Qian and Liu Hu and Liang Jiang and Manxiang Wang and Xin Jin and Wenyou Deng and Kun Wu and Shuang Qin and Desheng Hu and Jian Chen and Yuan Wu},
  journal = {Nature Communications},
  year = {2026},
  month = sep,
  doi = {10.1038/s41467-026-77698-4},
  url = {https://doi.org/10.1038/s41467-026-77698-4},
  note = {CC BY-NC-ND 4.0},
}
RIS
TY  - JOUR
TI  - Response-Adapted Postoperative Therapy Following Neoadjuvant Chemoimmunotherapy in Locally Advanced Head and Neck Squamous Cell Carcinoma: a phase II trial
AU  - Yu Qian
AU  - Liu Hu
AU  - Liang Jiang
AU  - Manxiang Wang
AU  - Xin Jin
AU  - Wenyou Deng
AU  - Kun Wu
AU  - Shuang Qin
AU  - Desheng Hu
AU  - Jian Chen
AU  - Yuan Wu
PY  - 2026
DA  - 2026/09/28
JO  - Nature Communications
DO  - 10.1038/s41467-026-77698-4
UR  - https://doi.org/10.1038/s41467-026-77698-4
AB  - Neoadjuvant chemo-immunotherapy (NACI) demonstrates promising efficacy in locally advanced head and neck squamous cell carcinoma (LA-HNSCC), yet its effect on postoperative radiotherapy/chemoradiotherapy (PORT/POCRT) remains undefined. This open-label phase 2 study (NCT05476965) assessed NACI efficacy and its role in guiding adaptive PORT/POCRT. Primary endpoint was major pathologic response (MPR) rate (0-10% residual tumor). Secondary endpoints are overall survival (OS), disease-free survival (DFS), objective response rate (ORR), and adverse events. Thirty resectable stage III–IVB HNSCC patients received sintilimab plus chemotherapy, followed by surgery and response-adapted PORT/POCRT. Patients with MPR received low-dose PORT (0–54 Gy), while patients without MPR received standard PORT/POCRT. The MPR rate was 59.1% (38.7%-76.7%). The MPR with low-dose group showed higher 2-year OS (100% vs. 77.8%) and DFS (100% vs. 55.6%) with fewer radiotherapy-related adverse events than non-MPR with standard-dose group (all P < 0.05). Adaptive radiation de-escalation maintains survival while reducing toxicity, representing a new strategy for LA-HNSCC.
SN  - 2041-1723
ER  -