Neoadjuvant Anlotinib Plus Paclitaxel-Cisplatin for Technically Resectable Locally Advanced Head and Neck Squamous Cell Carcinoma: A Prospective Single-Arm Phase II Study.

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.