Department of Radiation Oncology, Cedars-Sinai Medical Center, Los Angeles, California.
Samuel Oschin Comprehensive Cancer Institute, Cedars-Sinai Medical Center, Los Angeles, California.
JAMA Oncol. 2020 Oct 1;6(10):1555-1562. doi: 10.1001/jamaoncol.2020.3172.
Transoral robotic surgery has been widely adopted since approval by the US Food and Drug Administration in December 2009, despite limited comparative data.
To compare the long-term outcomes of transoral robotic surgery with those of nonrobotic surgery for patients with early-stage oropharyngeal cancer.
DESIGN, SETTING, AND PARTICIPANTS: A retrospective cohort comparative effectiveness analysis was performed of patients in the National Cancer Database with clinical T1 and T2 oropharyngeal squamous cell carcinoma diagnosed between January 1, 2010, and December 31, 2015, who underwent definitive robotic and nonrobotic surgery. Multivariable Cox proportional hazards regression analysis and propensity score matching were performed in patients with known human papillomavirus status to adjust for patient- and disease-related covariates. Survival after robotic and nonrobotic surgery was also compared in 3 unrelated cancers: prostate, endometrial, and cervical cancer. Statistical analysis was performed from April 10, 2019, to May 21, 2020.
Overall survival.
Of 9745 patients (7652 men [78.5%]; mean [SD] age, 58.8 [9.6] years) who met inclusion criteria, 2694 (27.6%) underwent transoral robotic surgery. There was a significant increase in the use of robotic surgery from 18.3% (240 of 1309) to 35.5% (654 of 1841) of all surgical procedures for T1 and T2 oropharyngeal cancers from 2010 to 2015 (P = .003). Robotic surgery was associated with lower rates of positive surgical margins (12.5% [218 of 1746] vs 20.3% [471 of 2325]; P < .001) and lower use of adjuvant chemoradiotherapy (28.6% [500 of 1746] vs 35.7% [831 of 2325]; P < .001). Among 4071 patients with known human papillomavirus status, robotic surgery was associated with improved overall survival compared with nonrobotic surgery in multivariable Cox proportional hazards regression (hazard ratio [HR], 0.74; 95 CI, 0.61-0.90; P = .002). Similar results were seen when analyzing only the subset of facilities offering both robotic and nonrobotic surgery. The 5-year overall survival was 84.8% vs 80.3% among patients undergoing robotic vs nonrobotic surgery in propensity score-matched cohorts (P = .001). By contrast, there was no evidence that robotic surgery was associated with improved survival in other cancers, such as prostate cancer (HR, 0.92; 95% CI, 0.79-1.07; P = .26), endometrial cancer (HR, 0.97; 95% CI, 0.90-1.04; P = .36), and cervical cancer (HR, 1.27; 95% CI, 0.96-1.69; P = .10).
This study suggests that transoral robotic surgery was associated with improved surgical outcomes and survival compared with nonrobotic surgery in patients with early-stage oropharyngeal cancer. Evaluation in comparative randomized trials is warranted.
自 2009 年 12 月美国食品和药物管理局批准以来,尽管比较数据有限,经口机器人手术已经被广泛采用。
比较早期口咽癌患者经口机器人手术与非机器人手术的长期结果。
设计、地点和参与者:对 2010 年 1 月 1 日至 2015 年 12 月 31 日期间在国家癌症数据库中诊断为临床 T1 和 T2 口咽鳞状细胞癌的患者进行了回顾性队列比较有效性分析,这些患者接受了明确的机器人和非机器人手术。对已知人乳头瘤病毒状态的患者进行多变量 Cox 比例风险回归分析和倾向评分匹配,以调整患者和疾病相关的协变量。还在 3 种无关癌症(前列腺癌、子宫内膜癌和宫颈癌)中比较了机器人和非机器人手术后的生存情况。统计分析于 2019 年 4 月 10 日至 2020 年 5 月 21 日进行。
总生存率。
在符合纳入标准的 9745 名患者(7652 名男性[78.5%];平均[标准差]年龄为 58.8[9.6]岁)中,2694 名(27.6%)接受了经口机器人手术。从 2010 年到 2015 年,T1 和 T2 口咽癌的所有手术中,机器人手术的使用率从 18.3%(1309 例中的 240 例)显著增加到 35.5%(1841 例中的 654 例)(P = .003)。机器人手术与较低的阳性切缘率(12.5%[1746 例中的 218 例]与 20.3%[2325 例中的 471 例];P < .001)和较低的辅助放化疗使用率(28.6%[1746 例中的 500 例]与 35.7%[2325 例中的 831 例];P < .001)相关。在 4071 名已知人乳头瘤病毒状态的患者中,与非机器人手术相比,多变量 Cox 比例风险回归分析显示机器人手术与总生存率提高相关(风险比[HR],0.74;95%置信区间,0.61-0.90;P = .002)。当仅分析提供机器人和非机器人手术的设施子集时,也得到了类似的结果。在倾向评分匹配队列中,接受机器人手术和非机器人手术的患者的 5 年总生存率分别为 84.8%和 80.3%(P = .001)。相比之下,没有证据表明机器人手术与其他癌症(如前列腺癌[HR,0.92;95%置信区间,0.79-1.07;P = .26]、子宫内膜癌[HR,0.97;95%置信区间,0.90-1.04;P = .36]和宫颈癌[HR,1.27;95%置信区间,0.96-1.69;P = .10])的生存改善相关。
本研究表明,与非机器人手术相比,经口机器人手术与早期口咽癌患者的手术结果和生存改善相关。需要进行比较随机试验评估。