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.