Neoadjuvant Anlotinib Plus Paclitaxel-Cisplatin for Technically Resectable Locally Advanced Head and Neck Squamous Cell Carcinoma: A Prospective Single-Arm Phase II Study
In brief
Anlotinib plus chemotherapy shrank tumors in two-thirds of patients
In this single-arm study of 21 patients with resectable, locally advanced head and neck cancer, 14 had an objective tumor response after two cycles of anlotinib plus chemotherapy. Of eight patients who underwent surgery, all had clear margins and four had less extensive surgery than planned; without a comparison group, the regimen's added benefit and effect on function remain unknown.
- Journal
- Head & neck (Q1)
- Published
- 30 September 2026
- Study design
- Non-randomized / quasi-experimental trial
- Evidence level
- Level 2, Moderate (CEBM 2b)
- Authors
- Ran Xu, Meng-Jie Huang, Zhen-Hua Jiang, Lei Liu, Li-Jun Zhang, Shuang Zhang, et al.
- PMID
- 42816421
- DOI
- 10.1002/hed.70501
Why clinicians should know about it
- Picked for Otorhinolaryngology (paper of the day, 2 October 2026): Phase II neoadjuvant trial, informs surgical planning
Abstract
BACKGROUND: Technically resectable locally advanced head and neck squamous cell carcinoma may require highly morbid surgery. We evaluated short-course neoadjuvant anlotinib plus paclitaxel-cisplatin as a signal-generating strategy. METHODS: Twenty-one patients received two 21-day cycles in a prospective, single-arm Phase II study. The primary endpoint was RECIST 1.1 objective response rate; pathological response and surgical extent were exploratory. RESULTS: Objective response rate was 66.7% (14/21; 95% CI, 43.0%-85.4%), meeting the prespecified activity criterion. Eight patients underwent surgery; all achieved R0 resection, 5/8 achieved major pathological response, and 4/8 underwent less extensive resection than initially planned. Documented adverse events were mainly Grade 1, including one Grade 1 hypertension controlled with levamlodipine and one Grade 2 primary-tumor bleeding event; proteinuria was not systematically captured. CONCLUSIONS: The regimen generated antitumor activity and surgical feasibility signals but does not establish anlotinib benefit beyond TP or functional preservation. TRIAL REGISTRATION: Chinese Clinical Trial Registry: ChiCTR2100046440.
Abstract as published, via PubMed.
For healthcare professionals. The summary is generated by AI from the published abstract, and the evidence level is assigned automatically from the study design on the Oxford CEBM hierarchy. Neither is medical advice. Read the full paper before changing practice.