Phase II Trial of Induction Chemotherapy for Advanced Sinonasal Squamous Cell Carcinoma

Purpose: Outcomes after primary surgery for advanced sinonasal squamous cell carcinoma (SCC) are poor. We tested whether induction chemotherapy (IC) can improve disease control or organ preservation. Patients and Methods: A phase II trial evaluated previously untreated patients with stage II to IV, M0 sinonasal SCC. Patients received IC with docetaxel, cisplatin, and fluorouracil, followed by chemoradiotherapy (CRT) for responders and surgery with adjuvant radiotherapy or CRT for nonresponders. The primary endpoints were overall response rate and locoregional control. Secondary endpoints included progression-free survival (PFS), overall survival (OS), organ preservation, and treatment toxicity. Results: Of the 31 patients enrolled between 2008 and 2020, 28 were evaluated for efficacy. Disease was T4a, T4b, and N+ in 57%, 21%, and 36% of patients, respectively. The overall response rate was 82.1%; 17.9% of patients had stable disease, and 0% had progressive disease. Grade 3 and 4 adverse events occurred in 54% and 18% of patients, respectively; there were no grade 5 adverse events. The 2-year locoregional control and PFS rates were 64.3% [95% confidence interval (CI), 40.4-77.6) and 52.4% (95% CI, 32.3-69.0), respectively. The median PFS was 25.8 months. The median OS was 47.4 months, with a 2-year OS rate of 69.4% (95% CI, 44.9-80.4). No survival difference was observed between surgery versus CRT (HR, 1.07; 95% CI, 0.9- 3.84). Of patients alive at 2 years, 63% achieved organ preservation, avoiding maxillectomy (38%), craniotomy (13%), or orbital exenteration (38%). Conclusions: IC and response-directed local treatment achieved promising disease control and added organ preservation for patients with advanced sinonasal SCC.