Clinical cancer research : an official journal of the American Association for Cancer Research · 2025
Neoadjuvant Chemotherapy and Surgery versus Surgery for Organ Preservation of T3 and T4a Nasal and Paranasal Sinus Squamous Cell Carcinoma: ECOG-ACRIN EA3163.
СтатьяРандомизированное исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Saba Nabil F, Flamand Yael, Lin Derrick T, Chung Christine H, McDonald Mark W, Flampouri Styliani, Khan Saad A, Snyderman Carl H, Hanna Ehab Y, El-Sayed Ivan H, Solares Clementino A, Le Christopher H, Ghaly Maged, Hwang Peter H, Shin Dong M, Axelrod Rita S, Ikpeazu Chukwuemeka V, Adkins Douglas R, Duan Fenghai, Cohen Marc, Samuels Michael A, Swiecicki Paul L, Subramaniam Rathan M, Chakravarthy A Bapsi, Burtness Barbara A
Аннотация
PURPOSE: Neoadjuvant chemotherapy for structure preservation (SP) in nasal and paranasal sinus squamous cell carcinoma (NPNSCC) has been described in single-institution studies but not in 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 for three cycles (arm B). The degree of anticipated SP (orbit and BOS) was required preoperatively and after chemotherapy. SP was noted at surgery. Co-primary objectives were the SP rate (orbit/BOS) and OS. Eighty-two patients needed to be accrued for 81% power with a 0.1 one-sided alpha using Fisher's exact test for SP rate and 83% with a 0.1 one-sided alpha using the log-rank test for OS.
RESULTS: Among 23 evaluable patients, the overall SP rate was 30%: 15% in arm A (N = 2/13; 95% confidence interval (CI), 1.9%-45.4%) and 50% in arm B (N = 5/10; 95% CI, 18.7%-81.3%; P = 0.17). Among 18 patients with pathologic T3/T4a disease, the overall SP rate was 39%: 18% in arm A (N = 2/11; 95% CI, 2.3%-51.8%) and 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%) versus 83% (95% CI, 35.9%-99.6%) and 33% (95% CI, 9.9%-65.1%) versus 67% (95% CI, 29.9%-92.5%) in arm A versus 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.
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 for three cycles (arm B). The degree of anticipated SP (orbit and BOS) was required preoperatively and after chemotherapy. SP was noted at surgery. Co-primary objectives were the SP rate (orbit/BOS) and OS. Eighty-two patients needed to be accrued for 81% power with a 0.1 one-sided alpha using Fisher's exact test for SP rate and 83% with a 0.1 one-sided alpha using the log-rank test for OS.
RESULTS: Among 23 evaluable patients, the overall SP rate was 30%: 15% in arm A (N = 2/13; 95% confidence interval (CI), 1.9%-45.4%) and 50% in arm B (N = 5/10; 95% CI, 18.7%-81.3%; P = 0.17). Among 18 patients with pathologic T3/T4a disease, the overall SP rate was 39%: 18% in arm A (N = 2/11; 95% CI, 2.3%-51.8%) and 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%) versus 83% (95% CI, 35.9%-99.6%) and 33% (95% CI, 9.9%-65.1%) versus 67% (95% CI, 29.9%-92.5%) in arm A versus 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.