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Published on: April 22, 2019
Response-Adapted Surgery after Neoadjuvant Immunochemotherapy in Locally Advanced Head and Neck Squamous Cell
Xiaomeng Zhang1, Yan Zhou1, Jing Huang2,3,4
1Department of Otorhinolaryngology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
Purpose:
We assessed the feasibility and efficacy of a response-adapted surgical strategy in patients with locally advanced head and neck squamous cell carcinoma (LA-HNSCC) achieving major tumor regression after neoadjuvant immunochemotherapy (NAICT).
Patients And Methods:
This phase II, single-arm, prospective trial enrolled patients with resectable, human papillomavirus-negative stage III to IVA LA-HNSCC. All received three cycles of NAICT (penpulimab, nab-paclitaxel, and cisplatin). Pre-cycle 3 imaging and laryngoscopy guided surgery: Patients with ≥50% primary tumor regression underwent reduced-volume surgery (RVS); those with <50% regression received standard-volume surgery (SVS). All received risk-adapted adjuvant radiotherapy. The primary endpoint was 2-year disease-free survival (DFS).
Results:
Fifty patients completed NAICT, with an objective response rate of 94% [95% confidence interval (CI), 84%-99%]. At a median follow-up of 34.0 months (IQR, 30.1-39.5), the 2-year DFS for the per-protocol cohort was 83% (95% CI, 69%-91%). The RVS group (n = 42) achieved a 2-year DFS of 90% (95% CI, 77%-96%) with 100% laryngeal preservation in laryngeal/hypopharyngeal cancers, whereas the SVS group (n = 5) had a 2-year DFS of 20% (95% CI, 0.8%-58%). Grade 3 adverse events (AE) occurred in 16% of patients related to NAICT and in 15% related to surgery; there were no grade 4 or 5 AEs. At 9 months after radiotherapy, most quality-of-life scores improved or stabilized compared with baseline.
Conclusions:
The REMATCH trial provides the first prospective evidence that a response-adapted surgical strategy after NAICT is feasible. Patients achieving ≥50% primary tumor regression derived promising survival and universal laryngeal preservation. These findings support the initiation of phase III randomized trials to validate this de-escalation strategy.
