重新审视放射治疗肿瘤学组 1221 假设：HPV 阴性口咽癌 III/IV 期的治疗。

Revisiting the Radiation Therapy Oncology Group 1221 Hypothesis: Treatment for Stage III/IV HPV-Negative Oropharyngeal Cancer.

机构信息

Yale University School of Medicine, New Haven, Connecticut, USA.

Department of Therapeutic Radiology, Yale University School of Medicine, New Haven, Connecticut, USA.

出版信息

Otolaryngol Head Neck Surg. 2021 Jun;164(6):1240-1248. doi: 10.1177/0194599820969613. Epub 2020 Nov 17.

DOI:10.1177/0194599820969613

PMID:33198564

Abstract

OBJECTIVE

In 2014, the Radiation Therapy Oncology Group 1221 trial was initiated to analyze whether surgery with risk-based radiation therapy or chemoradiation therapy was superior to chemoradiation therapy alone in patients with clinically staged T1-2N1-2bM0 HPV-negative oropharyngeal squamous cell carcinoma. However, the study was prematurely terminated. Given the lack of a randomized controlled trial, we retrospectively approached the same question using large national cancer databases.

STUDY DESIGN

Retrospective cohort study.

SETTING

The National Cancer Database and Surveillance, Epidemiology, and End Results (SEER) program from 2010 to 2016.

METHODS

We identified 3004 patients in the National Cancer Database and 670 patients in the SEER database. Statistical techniques included Kaplan-Meier survival analysis, binary and multinomial logistic regressions, Cox proportional hazard regressions, and inverse propensity score weighting.

RESULTS

On weighted multivariable Cox regression, patients recommended to receive frontline surgery had improved overall survival as compared with those recommended to receive chemoradiation therapy alone (hazard ratio [HR], 0.77; 95% CI, 0.68-0.86). On post hoc multivariable analysis based on therapy actually received, frontline surgery with adjuvant chemoradiation therapy was associated with improved overall survival (HR, 0.59; 95% CI, 0.50-0.71) as compared with chemoradiation therapy without surgery. Analysis of the SEER cohort revealed improved overall survival (HR, 0.69; 95% CI, 0.54-0.87) and head and neck cancer-specific survival (HR, 0.59; 95% CI, 0.41-0.84) in patients recommended to receive frontline surgery over chemoradiation therapy alone.

CONCLUSION

Our findings support the use of surgery with risk-based addition of adjuvant therapy in patients with cT1-2N1-2bM0 HPV-negative oropharyngeal cancer.

摘要

目的

2014 年，启动了放射治疗肿瘤学组 1221 试验，旨在分析对于临床分期为 T1-2N1-2bM0HPV 阴性口咽鳞状细胞癌患者，手术联合基于风险的放疗或放化疗是否优于单纯放化疗。然而，该研究提前终止。鉴于缺乏随机对照试验，我们使用大型国家癌症数据库回顾性地探讨了同样的问题。

研究设计

回顾性队列研究。

设置

国家癌症数据库和监测、流行病学和最终结果（SEER）计划，时间范围为 2010 年至 2016 年。

方法

我们在国家癌症数据库中确定了 3004 例患者，在 SEER 数据库中确定了 670 例患者。统计技术包括 Kaplan-Meier 生存分析、二项和多项逻辑回归、Cox 比例风险回归和逆倾向评分加权。

结果

在加权多变量 Cox 回归中，与推荐接受单纯放化疗的患者相比，建议接受一线手术的患者总生存得到改善（风险比 [HR]，0.77；95%置信区间，0.68-0.86）。根据实际接受的治疗进行事后多变量分析，与单纯放化疗相比，一线手术联合辅助放化疗与总生存改善相关（HR，0.59；95%置信区间，0.50-0.71）。对 SEER 队列的分析显示，与单纯放化疗相比，建议接受一线手术的患者总生存（HR，0.69；95%置信区间，0.54-0.87）和头颈部癌症特异性生存（HR，0.59；95%置信区间，0.41-0.84）得到改善。