目的:局部晚期口咽鳞状细胞癌患者在标准放化疗后的预后欠佳。这里,我们评估了不良口咽鳞状细胞癌患者使用放射外科加强治疗剂量递增的毒性和肿瘤学结局.
方法:在2010-2017年间,34例中危或高危口咽鳞状细胞癌患者被纳入这项前瞻性I期试验。每位患者同时接受顺铂和分割放疗,总计60Gy或66Gy,然后对残留的大体肿瘤区域进行放射外科增强:单个部分为8Gy或10Gy,或每个5Gy的两个部分。主要终点是治疗毒性。次要终点是局部的,区域,和远处的疾病控制。
结果:11,16名和7名患者接受了1分8Gy的放射外科增强治疗,10Gyin1fraction,和10Gy分别在2个部分。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级咽部出血,需要手术干预。治疗后24个月,7%,9%,15%的人患有2级味觉障碍,口干症,和吞咽困难,分别,两名患者仍依赖饲管。没有发生继发于治疗的5级毒性。当地,区域,中位随访4.2年的远端控制为85.3%,85.3%和88.2%,分别。5例患者死亡,总生存率为85.3%。
结论:本研究首次报道了不良口咽鳞状细胞癌患者使用放射外科增强剂量递增。更长时间的随访,更大的队列,在常规临床实践中实施之前,需要进一步完善加强方法。
背景:Northwell健康协议#09-309A(NCT02703493)(https://clinicaltrials.gov/ct2/show/NCT02703493)。
OBJECTIVE: 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.
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.
BACKGROUND: Northwell Health Protocol #09-309A (NCT02703493) ( https://clinicaltrials.gov/ct2/show/NCT02703493 ).