O'Hara James T, Hurt Christopher N, Ingarfield Kate, Patterson Joanne M, Hutcheson Katherine, Canham Joanna E, Nixon Lisette S, Heiberg Christie D, Johson Sean, Evans Mererid, Jones Terry M
Population Health Sciences Institute, Newcastle University, Newcastle, United Kingdom.
Department of Otolaryngology-Head and Neck Surgery, Newcastle-upon-Tyne Hospitals NHS (National Health Service) Foundation Trust, Newcastle, United Kingdom.
JAMA Otolaryngol Head Neck Surg. 2024 Oct 10;150(11):1002-11. doi: 10.1001/jamaoto.2024.3371.
Transoral robotic surgery (TORS) or transoral laser microsurgery (TLM) offer excellent oncological outcomes for oropharyngeal squamous cell carcinoma caused by human papillomavirus (HPV) infection. TORS may offer greater margin clearance around tumors than TLM.
To determine whether the differing energy sources used and surgical technique of TORS or TLM is associated with postoperative early swallowing function, feeding tube use, and specific factors related to quality of life.
DESIGN, SETTING, AND PARTICIPANTS: This prespecified cohort study was performed within the Postoperative Adjuvant Treatment for HPV-Positive Tumours (PATHOS) randomized clinical trial at 40 centers in the UK, Germany, France, the US, and Australia between November 1, 2015, and August 31, 2023. PATHOS trial participants with HPV-positive oropharyngeal carcinoma of stages T1 to T3 and N0 to N2b M0 (TNM7) who underwent TLM or TORS were eligible. Of 989 consecutively recruited patients on the PATHOS trial, 508 were eligible for this substudy.
The exposure of interest was TORS or TLM.
Preplanned outcome measures included nasogastric tube insertion rates within 4 weeks after surgery, length of in-hospital stay following surgery, specific scales from the MD Anderson Dysphagia Inventory (MDADI), 35-item European Organization for Research and Treatment of Cancer Head and Neck Questionnaire (H&N35), and 30-item Quality of Life Questionnaire (QLQ C30), water swallow test results, and videofluoroscopy scores.
Of the 508 patients included in the analysis (390 [76.8%] male; median age, 58.3 [IQR, 52.8-63.6] years), 195 had TLM and 313 had TORS. Nasogastric tube insertion rates were higher after TORS than TLM (85 of 189 [45.0%] vs 10 of 126 [7.9%]; adjusted odds ratio [OR], 4.41 [95% CI, 1.01-19.32]). Mean scores favored TLM with small effect sizes in all MDADI domains and the H&N35 swallowing item at 4 weeks after surgery; between-group difference for the MDADI composite score was -4.89 (95% CI, -8.27 to -1.50); for the MDADI physical functioning score, -6.37 (95% CI, -10.15 to -2.59); for the MDADI global score, -10.02 (95% CI, -16.50 to -3.54); and for H&N35 swallowing score, 7.24 (95% CI, 2.17-12.30). No other measures showed evidence of clinically meaningful differences.
In this cohort study, functional outcomes were moderately less impaired 4 weeks following TLM compared with TORS. Once the longer-term outcomes for these patients are known, these findings could aid the design and use of future head and neck-specific surgical robots.
ClinicalTrials.gov Identifier: NCT02215265.
经口机器人手术(TORS)或经口激光显微手术(TLM)为人乳头瘤病毒(HPV)感染所致口咽鳞状细胞癌提供了良好的肿瘤学治疗效果。TORS在肿瘤周围可能比TLM有更大的切缘。
确定TORS或TLM所使用的不同能量来源和手术技术是否与术后早期吞咽功能、鼻饲管使用情况以及与生活质量相关的特定因素有关。
设计、地点和参与者:这项预先设定的队列研究在2015年11月1日至2023年8月31日期间于英国、德国、法国、美国和澳大利亚的40个中心开展的HPV阳性肿瘤术后辅助治疗(PATHOS)随机临床试验中进行。PATHOS试验中接受TLM或TORS治疗的T1至T3期、N0至N2b期、M0(TNM7)的HPV阳性口咽癌患者符合条件。在PATHOS试验中连续招募的989例患者中,508例符合本亚组研究的条件。
感兴趣的暴露因素是TORS或TLM。
预先计划的结局指标包括术后4周内鼻胃管插入率、术后住院时间、MD安德森吞咽障碍量表(MDADI)的特定量表、35项欧洲癌症研究与治疗组织头颈问卷(H&N35)以及30项生活质量问卷(QLQ C30)、饮水吞咽试验结果和电视荧光吞咽功能造影评分。
纳入分析的508例患者(390例[76.8%]为男性;中位年龄58.3岁[四分位间距,52.8 - 63.6岁])中,195例行TLM,313例行TORS。TORS术后鼻胃管插入率高于TLM(189例中的85例[45.0%]对126例中的10例[7.9%];调整后的优势比[OR]为4.41[95%置信区间,1.01 - 19.32])。术后4周,在所有MDADI领域和H&N35吞咽项目中,平均评分更有利于TLM,效应量较小;MDADI综合评分的组间差异为 - 4.89(95%置信区间: - 8.27至 - 1.50);MDADI身体功能评分差异为 - 6.37(95%置信区间: - 10.15至 - 2.59);MDADI总体评分差异为 - 10.02(95%置信区间: - 16.50至 - 3.54);H&N35吞咽评分差异为7.24(95%置信区间:2.17 - 12.30)。没有其他指标显示出具有临床意义的差异。
在这项队列研究中,与TORS相比,TLM术后4周功能结局的受损程度略轻。一旦了解这些患者的长期结局,这些发现可能有助于未来头颈专用手术机器人的设计和使用。
ClinicalTrials.gov标识符:NCT02215265。