Department of Otolaryngology-Head and Neck Surgery, Western University, London, Ontario, Canada.
School of Communication Sciences and Disorders, Western University, London, Ontario, Canada.
J Clin Oncol. 2022 Mar 10;40(8):866-875. doi: 10.1200/JCO.21.01961. Epub 2022 Jan 7.
The incidence of oropharyngeal squamous cell carcinoma (OPSCC) has risen rapidly, because of an epidemic of human papillomavirus infection. The optimal management of early-stage OPSCC with surgery or radiation continues to be a clinical controversy. Long-term randomized data comparing these paradigms are lacking.
We randomly assigned patients with T1-T2, N0-2 (≤ 4 cm) OPSCC to radiotherapy (RT) (with chemotherapy if N1-2) versus transoral robotic surgery plus neck dissection (TORS + ND) (with or without adjuvant therapy). The primary end point was swallowing quality of life (QOL) at 1-year using the MD Anderson Dysphagia Inventory. Secondary end points included adverse events, other QOL outcomes, overall survival, and progression-free survival. All analyses were intention-to-treat. Herein, we present long-term outcomes from the trial.
Sixty-eight patients were randomly assigned (n = 34 per arm) between August 10, 2012, and June 9, 2017. Median follow-up was 45 months. Longitudinal MD Anderson Dysphagia Inventory analyses demonstrated statistical superiority of RT arm over time ( = .049), although the differences beyond 1 year were of smaller magnitude than at the 1-year timepoint (year 2: 86.0 ± 13.5 in the RT arm 84.8 ± 12.5 in the TORS + ND arm, = .74; year 3: 88.9 ± 11.3 83.3 ± 13.9, = .12). These differences did not meet the threshold to qualify as a clinically meaningful change at any timepoint. Certain differences in QOL concerns including more pain and dental concerns in the TORS + ND arm seen at 1 year resolved at 2 and 3 years; however, TORS patients started to use more nutritional supplements at 3 years ( = .015). Dry mouth scores were higher in RT patients over time ( = .041).
On longitudinal analysis, the swallowing QOL difference between primary RT and TORS + ND approaches persists but decreases over time. Patients with OPSCC should be informed about the pros and cons of both treatment options (ClinicalTrials.gov identifier: NCT01590355).
由于人乳头瘤病毒感染的流行，口咽鳞状细胞癌（OPSCC）的发病率迅速上升。手术或放疗治疗早期 OPSCC 的最佳方法仍然是临床争议。缺乏比较这些模式的长期随机数据。
我们将 T1-T2、N0-2（≤4cm）OPSCC 患者随机分配接受放疗（RT）（如果 N1-2 则接受化疗）或经口机器人手术加颈部清扫术（TORS+ND）（是否有辅助治疗）。主要终点是使用 MD 安德森吞咽障碍量表在 1 年时评估吞咽质量（QOL）。次要终点包括不良事件、其他 QOL 结果、总生存和无进展生存。所有分析均为意向治疗。在此，我们介绍了该试验的长期结果。
2012 年 8 月 10 日至 2017 年 6 月 9 日期间，68 例患者随机分配（每组 34 例）。中位随访时间为 45 个月。MD 安德森吞咽障碍量表的纵向分析表明，RT 组随时间推移具有统计学优势（=0.049），尽管 1 年以上的差异比 1 年时的差异要小（第 2 年：RT 组为 86.0±13.5，TORS+ND 组为 84.8±12.5，=0.74；第 3 年：88.9±11.3，83.3±13.9，=0.12）。这些差异在任何时间点都没有达到有临床意义变化的阈值。在 1 年时，TORS+ND 组的某些 QOL 问题（包括更多疼痛和牙齿问题）在 2 年和 3 年时得到解决；然而，TORS 患者在 3 年时开始使用更多的营养补充剂（=0.015）。RT 组的口干评分随时间升高（=0.041）。
在纵向分析中，原发 RT 和 TORS+ND 之间的吞咽 QOL 差异持续存在，但随时间推移而减小。OPSCC 患者应了解两种治疗选择的优缺点（临床试验.gov 标识符：NCT01590355）。
