剂量递增立体定向放射外科（SRS）治疗局部晚期或口咽癌的 I 期试验。
Phase I trial of dose-escalated stereotactic radiosurgery (SRS) boost for unfavorable locally advanced oropharyngeal cancer.
机构信息
Department of Radiation Medicine, Northwell Health, Zucker School of Medicine at Hofstra/Northwell, 450 Lakeville Road, Lake Success, NY, 11040, USA.
Hofstra Northwell School of Medicine, Hempstead, NY, USA.
出版信息
Radiat Oncol. 2020 Dec 11;15(1):278. doi: 10.1186/s13014-020-01718-w.
BACKGROUND AND PURPOSE
Patients with locally advanced oropharynx squamous cell carcinoma have suboptimal outcomes with standard chemoradiation. Here, we evaluated toxicity and oncologic outcomes of dose escalation using radiosurgical boost for patients with unfavorable oropharynx squamous cell carcinoma.
MATERIALS AND METHODS
Between 2010-2017, Thirty four patients with intermediate- or high-risk oropharynx squamous cell carcinoma were enrolled onto this prospective phase I trial. Each patient received concurrent cisplatin and fractionated radiotherapy totaling 60 Gy or 66 Gy followed by radiosurgery boost to areas of residual gross tumor: single fraction of 8 Gy or 10 Gy, or two fractions of 5 Gy each. Primary endpoint was treatment toxicity. Secondary endpoints were local, regional, and distant disease control.
RESULTS
Eleven, sixteen and seven patients received radiosurgery boost with 8 Gy in 1 fraction, 10 Gy in 1 fraction, and 10 Gy in 2 fractions respectively. Acute toxicities include 4 patients with tumor necrosis causing grade 3 dysphagia, of which 3 developed grade 4 pharyngeal hemorrhage requiring surgical intervention. At 24 months after treatment, 7%, 9%, and 15% had grade 2 dysgeusia, xerostomia, and dysphagia, respectively, and two patients remained feeding tube dependent. No grade 5 toxicities occurred secondary to treatment. Local, regional, and distant control at a median follow up of 4.2 years were 85.3%, 85.3% and 88.2%, respectively. Five patients died resulting in overall survival of 85.3%.
CONCLUSIONS
This study is the first to report the use of radiosurgery boost dose escalation in patients with unfavorable oropharynx squamous cell carcinoma. Longer follow-up, larger cohorts, and further refinement of boost methodology are needed prior to implementation in routine clinical practice.
TRIAL REGISTRATION
Northwell Health Protocol #09-309A (NCT02703493) ( https://clinicaltrials.gov/ct2/show/NCT02703493 ).
背景与目的
局部晚期或口咽鳞状细胞癌患者采用标准放化疗效果不佳。在此，我们评估了对不适合口咽鳞状细胞癌患者使用放射外科推量来提高剂量的毒性和肿瘤学结果。
材料与方法
在 2010-2017 年期间，有 34 例中高危口咽鳞状细胞癌患者参与了这项前瞻性 I 期试验。每位患者接受顺铂联合分割放疗，总剂量为 60Gy 或 66Gy，然后对残留的大体肿瘤区域进行放射外科推量：单次 8Gy 或 10Gy，或两次 5Gy 各一次。主要终点是治疗毒性。次要终点是局部、区域和远处疾病控制。
结果
分别有 11、16 和 7 例患者接受了 8Gy 单次、10Gy 单次和 10Gy 2 次的放射外科推量。急性毒性包括 4 例肿瘤坏死导致 3 级吞咽困难，其中 3 例发生 4 级咽出血需要手术干预。治疗后 24 个月，分别有 7%、9%和 15%的患者出现 2 级味觉障碍、口干和吞咽困难，有 2 例仍依赖于喂养管。没有因治疗而发生 5 级毒性。中位随访 4.2 年后，局部、区域和远处控制率分别为 85.3%、85.3%和 88.2%。5 例患者死亡，总生存率为 85.3%。
结论
本研究首次报告了在不适合口咽鳞状细胞癌患者中使用放射外科推量剂量递增。在常规临床实践中实施之前，需要进行更长时间的随访、更大的队列研究，并进一步完善推量方法。
试验注册
Northwell Health 方案 #09-309A（NCT02703493）（临床试验.gov）。
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