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.

中文翻译：

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晚期鼻窦鳞状细胞癌诱导化疗的 II 期试验


目的： 晚期鼻窦鳞状细胞癌 （SCC） 初次手术后预后较差。我们测试了诱导化疗 （IC） 是否可以改善疾病控制或器官保存。患者和方法： 一项 II 期试验评估了先前未治疗的 II-IV 期、M0 鼻窦 SCC 患者。患者接受多西他赛、顺铂和氟尿嘧啶的 IC，然后对反应者进行放化疗 （CRT），对无反应者接受辅助放疗或 CRT 手术。主要终点是总缓解率 （ORR） 和局部区域对照 （LRC）。次要终点包括无进展生存期 （PFS） 、总生存期 （OS） 、器官保存和治疗毒性。结果： 在 2008 年至 2020 年间入组的 31 例患者中，有 28 例接受了疗效评估。疾病分别为 57% 、 21% 和 36% 的患者 T4a 、 T4b 和 N+。ORR 为 82.1%;17.9% 的患者病情稳定，0% 的患者病情进展。3 级和 4 级不良事件 （AE） 分别发生在 54% 和 18% 的患者身上;没有 5 级 AE。2 年 LRC 和 PFS 率分别为 64.3% （95% CI 40.4-77.6） 和 52.4% （95% CI 32.3-69.0）。中位 PFS 为 25.8 个月。中位 OS 为 47.4 个月，2 年 OS 率为 69.4% （95% CI 44.9-80.4）。手术与 CRT 之间未观察到生存差异 （风险比 1.07,95% CI 0.9-3.84）。在 2 年存活的患者中，63% 实现了器官保留，避免了上颌骨切除术 （38%） 、开颅手术 （13%） 或眼眶切除术 （38%）。结论： IC 和反应导向治疗为晚期鼻窦鼻 SCC 患者实现了有希望的疾病控制并增加了器官保留。