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Neoadjuvant chemotherapy and surgery versus surgery for organ preservation of T3 and T4a nasal and paranasal sinus squamous cell carcinoma (NPNSCC) ECOG-ACRIN EA3163.

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Neoadjuvant chemotherapy and surgery versus surgery for organ preservation of T3 and T4a nasal and paranasal sinus squamous cell carcinoma (NPNSCC) ECOG-ACRIN EA3163. Clinical cancer À¶Ý®ÊÓƵ : an official journal of the American Association for Cancer Research Saba, N. F., Flamand, Y., Lin, D. T., Chung, C. H., McDonald, M. W., Flampouri, S., Khan, S. A., Snyderman, C. H., Hanna, E. Y., El-Sayed, I. H., Solares, C. A., Le, C. H., Ghaly, M., Hwang, P. H., Shin, D. M., Axelrod, R. S., Ikpeazu, C. V., Adkins, D. R., Duan, F., Cohen, M., Samuels, M. A., Swiecicki, P. L., Subramaniam, R. M., Chakravarthy, A. B., Burtness, B. A. 2025

Abstract

PURPOSE: Neoadjuvant chemotherapy for structure preservation (SP) in nasal and paranasal sinus squamous cell carcinoma (NPNSCC) has been described in single-institution but not randomized studies. EA3163 was a randomized study investigating whether cytoreductive neoadjuvant chemotherapy would improve SP or overall survival (OS).PATIENTS AND METHODS: Patients with T3/T4a and select T4b NPNSCC requiring orbital or base of skull (BOS) resection were randomized to surgery (Arm A), versus surgery preceded by docetaxel/cisplatin x3 cycles (Arm B). Degree of anticipated SP (orbit and BOS) was required preoperatively and post-chemotherapy. SP was noted at surgery. Co-primary objectives were SP rate (orbit/BOS) and OS. 82 patients needed to be accrued for 81% power with 0.1 one-sided alpha using Fisher's exact test for SP rate and 83% with 0.1 one-sided alpha using log-rank test for OS.RESULTS: Among 23 evaluable patients, overall SP rate was 30%: 15% in Arm A (N=2/13, 95%CI: 1.9-45.4%), 50% in Arm B (N=5/10, 95%CI: 18.7-81.3%) (p=0.17). Among 18 patients with pathologic T3/T4a disease, overall SP rate was 39%: 18% in Arm A (N=2/11, 95%CI: 2.3-51.8%), 71% in Arm B (N=5/7, 95%CI: 29.0-96.3%) (p=0.049). Orbit and BOS-specific preservation rates were 38% (95%CI: 8.5-75.5%) vs 83% (95%CI: 35.9-99.6%), and 33% (95%CI: 9.9-65.1%) vs 67% (95%CI: 29.9-92.5%) in Arm A vs B, respectively. The most common grade =3 toxicities included mucositis, anemia, nausea and lymphopenia (all >10%). No grade 5 events were reported.CONCLUSIONS: These results support neoadjuvant chemotherapy as an effective intervention for SP in T3/T4a NPNSCC and deserve further evaluation.

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