Neoadjuvant Chemotherapy and Surgery versus Surgery for Organ Preservation of T3 and T4a Nasal and Paranasal Sinus Squamous Cell Carcinoma: ECOG-ACRIN EA3163.

EA3163 was a randomized study investigating whether cytoreductive neoadjuvant chemotherapy would improve SP or overall survival(OS).

EA3163 是一项随机研究，旨在调查细胞减少性新辅助化疗是否能改善结构保留（SP）或总生存（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).

需要进行眼眶或颅底(BOS)切除术的T3/T4a和选择性T4b非小细胞头颈部鳞状细胞癌(NSPCC)患者被随机分配到手术组(组A)与手术前接受三个周期的多西他赛/顺铂治疗组(组B)。

The degree of anticipated SP (orbit and BOS) was required preoperatively and after chemotherapy.

术前和化疗后均需评估预期的软组织侵犯(眼眶和BOS)程度。

SP was noted at surgery.

手术中观察到SP（手术部位/呼吸器官系统）状况。

Co-primary objectives were the SP rate (orbit/BOS) and OS.

共同主要目标是手术部位/呼吸器官系统的SP率和总生存期。

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.

需要招募82名患者以达到81%的功效，使用Fisher精确检验对SP率进行单侧α=0.1的检验，以及使用Log-rank检验对总生存期进行单侧α=0.1的检验，功效达到83%。

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).

在23名可评估患者中，总体SP率为30%：A组为15%（N=2/13；95%置信区间（CI），1.9%-45.4%），B组为50%（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).

在18名病理分期为T3/T4a的患者中，总体SP率为39%：A组为18%（N=2/11；95%置信区间，2.3%-51.8%），B组为71%（N=5/7；95%置信区间，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.

眼眶和BOS特异性保存率分别为A组38%（95%置信区间，8.5%-75.5%）与B组83%（95%置信区间，35.9%-99.6%），以及A组33%（95%置信区间，9.9%-65.1%）与B组67%（95%置信区间，29.9%-92.5%）。

The most common grade ≥3 toxicities included mucositis, anemia, nausea and lymphopenia (all >10%).

最常见的3级或更高级别的毒性反应包括粘膜炎、贫血、恶心和淋巴细胞减少症（均>10%）。

No grade 5 events were reported.

未报告任何5级事件。

Conclusions

These results support neoadjuvant chemotherapy as an effective intervention for SP in T3/T4a NPNSCC and deserve further evaluation.

这些结果支持新辅助化疗作为T3/T4a NPNSCC中SP的有效干预手段，并值得进一步评估。