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

• Published in: Clinical cancer research
• Main Authors: Contrera, Kevin J., Ferrarotto, Renata, Gunn, Brandon, Su, Shirley Y., Kies, Merrill S., Glisson, Bonnie S., Garden, Adam S., Roberts, Dianna, Hanba, Curtis, Hoff, Camilla O., El-Naggar, Adel, Williams, Michelle D., Raza, Shaan M., DeMonte, Franco, Chen, Melissa M., Chambers, Mark S., Hanna, Ehab Y.
• Format: Journal Article
• Language: English
• Published: 12.11.2024
• ISSN: 1078-0432; 1557-3265; 1557-3265
• DOI: 10.1158/1078-0432.CCR-24-1416

Abstract 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-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 non-responders. The primary endpoints were overall response rate (ORR) and locoregional control (LRC). 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 ORR was 82.1%; 17.9% of patients had stable disease, and 0% had progressive disease. Grade 3 and 4 adverse events (AE) occurred in 54% and 18% of patients, respectively; there were no Grade 5 AEs. The 2-year LRC and PFS rates were 64.3% (95% 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 (hazard ratio 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 treatment achieved promising disease control and added organ preservation for patients with advanced sinonasal SCC.