Department of Radiation Oncology, University of Pennsylvania, Philadelphia, Pennsylvania.
Department of Medicine, Division of Hematology/Oncology, University of Pennsylvania, Philadelphia, Pennsylvania.
Int J Radiat Oncol Biol Phys. 2020 Mar 15;106(4):725-732. doi: 10.1016/j.ijrobp.2019.11.021. Epub 2019 Nov 27.
This trial tested the safety and efficacy of a novel, deintensified radiation therapy (RT) approach after initial surgical resection for patients with human papilloma virus (HPV)-associated oropharyngeal squamous cell carcinoma (OPSCC).
This single-arm phase 2 prospective clinical trial enrolled 60 patients with stage pT1-pT2 N1-3 HPV-associated OPSCC treated with transoral robotic surgery (TORS) and selective neck dissection at a single institution between May 2014 and September 2017. Patients had favorable features at the primary site (negative surgical margins ≥2 mm, no perineural invasion, and no lymphovascular invasion) but required adjuvant therapy based on lymph node involvement. Surgeries were all performed at a high-volume head and neck cancer center with expertise in TORS. Patients received postoperative RT to at-risk areas in the involved neck (60-66 Gy) and uninvolved neck (54 Gy). The resected primary site was treated as an active avoidance structure in the treatment planning of postoperative RT. Concurrent chemotherapy was administered for patients with extranodal extension.
Median follow-up of the 60 patients enrolled was 2.4 years (range, 8.5-53.8 months). A single patient recurred at the primary site, for 2-year local control of 98.3%. One patient (1.7%) developed a regional neck recurrence, and 2 patients (3.3%) developed distant metastases. Measured 2-year local recurrence-free survival was 97.9% (95% confidence interval, 86.1%-99.7%). Overall survival was 100% at the time of analysis. The mean radiation dose to the primary site was 36.9 Gy (standard deviation, 10.3 Gy). Two patients (3.3%) experienced late soft tissue necrosis in the primary site surgical bed that resolved within 2 months. Feeding tube dependence rates were 0% during RT, 3.3% temporarily during follow-up, and 0% at last follow-up.
Deintensified postoperative RT that avoids the resected primary tumor site and targets only the at-risk neck after TORS for selected patients with HPV-associated OPSCC may be safe and is worthy of further study.
本试验旨在测试新的、减量化放疗（RT）方案在接受经口机器人手术（TORS）和选择性颈部解剖的 HPV 相关口咽鳞状细胞癌（OPSCC）患者初始手术后的安全性和疗效。
这项单臂 2 期前瞻性临床试验纳入了 2014 年 5 月至 2017 年 9 月在一家机构接受 TORS 和选择性颈部解剖的 60 例 pT1-pT2N1-3HPV 相关 OPSCC 患者。这些患者原发部位具有有利特征（切缘阴性≥2mm，无神经周围侵犯，无脉管侵犯），但根据淋巴结受累情况需要辅助治疗。所有手术均在一个具有 TORS 专业知识的大型头颈部癌症中心进行。术后患者接受高危颈部（60-66Gy）和未受累颈部（54Gy）的 RT。切除的原发部位在术后 RT 的治疗计划中被视为主动回避结构。对于有结外延伸的患者给予同期化疗。
纳入的 60 例患者的中位随访时间为 2.4 年（范围 8.5-53.8 个月）。仅有 1 例患者在原发部位复发，2 年局部控制率为 98.3%。1 例（1.7%）患者发生颈部区域复发，2 例（3.3%）患者发生远处转移。测量的 2 年局部无复发生存率为 97.9%（95%置信区间 86.1%-99.7%）。分析时的总生存率为 100%。原发部位的平均放疗剂量为 36.9Gy（标准差 10.3Gy）。2 例（3.3%）患者发生原发性手术床的迟发性软组织坏死，2 个月内得到缓解。放疗期间有 0%的患者需要依赖饲管，随访期间有 3.3%的患者暂时需要依赖饲管，最后随访时无患者需要依赖饲管。
对于接受 HPV 相关 OPSCC 的特定患者，TORS 后的减量化术后 RT 避免照射切除的原发肿瘤部位，仅针对高危颈部，可能是安全的，值得进一步研究。
