背景:最近,PORT-C和LUNG-ART试验,评估了术后放射治疗(PORT)的作用,显著改变了以前接受手术的NSCLCpN2患者的治疗前景。作为回应,意大利放疗和肿瘤协会胸部肿瘤研究组启动了一项观察性多中心试验,以评估采用现代技术治疗的pN2NSCLC患者中PORT的急性和晚期毒性.
方法:收集了6个意大利中心在2015年至2020年间接受根治性手术后接受PORT治疗的NSCLC患者的数据。心,肺,和食管急性和晚期毒性进行了回顾性分析,并与放射治疗剂量学参数相关。此外,局部区域控制,分析了远处转移和总体生存率。
结果:共有来自6个不同中心的212名中位年龄为68岁的患者被纳入本分析(男性142名,女性70名)。在接受港口之前,96例(45.8%)患者有心脏病史,110例患者(51.9%)有高血压,51例患者(24%)患有COPD。在147例患者中观察到急性毒性(69.3%),93例患者出现肺毒性(70例患者出现G1,G2在17例患者中,和G3在4名患者中),114例患者的食管毒性(89例患者的G1,23例患者中的G2,和G3在1名患者中),和心脏毒性4例(G12例,G32例)。在60例患者中发现了晚期副作用(28.3%),主要累及肺部(51例患者:32G1,11G2和1G3)和食道(11例患者:8G1和3G2),没有报告的晚期心脏副作用。发现各种临床和剂量学参数与急性和慢性毒性相关。在54个月的中位随访期内,48例患者(22.6%)出现局部疾病复发,106例患者(50%)发生远处转移,66例(31.1%)死亡。
结论:RAC-TAC回顾性多中心研究表明,当使用先进技术时,PORT的毒性较低。同时,值得注意的是,50%的患者在随访中出现远处复发。
BACKGROUND: Recently, the PORT-C and LUNG-ART trials, which evaluated the role of postoperative radiation therapy (PORT), have significantly altered the treatment landscape for NSCLC pN2 patients who previously underwent surgery. In response, the Italian Association of Radiotherapy and Oncology Thoracic Oncology study group has initiated an observational multicenter trial to assess both acute and late toxicities of PORT in pN2 NSCLC patients treated with modern techniques.
METHODS: Data on NSCLC patients submitted to PORT after radical surgery treated between 2015 and 2020 in six Italian Centers were collected. Heart, lung, and esophageal acute and late toxicities have been retrospectively analyzed and related to radiation therapy dosimetric parameters. Furthermore, loco-regional control, distant metastasis and overall survival have been analyzed.
RESULTS: A total of 212 patients with a median age of 68 years from six different centers were included in this analysis (142 males and 70 females). Prior to undergoing PORT, 96 patients (45.8%) had a history of heart disease, 110 patients (51.9%) had hypertension, and 51 patients (24%) had COPD. Acute toxicity was observed in 147 patients (69.3%), with lung toxicity occurring in 93 patients (G1 in 70 patients, G2 in 17 patients, and G3 in 4 patients), esophageal toxicity in 114 patients (G1 in 89 patients, G2 in 23 patients, and G3 in 1 patient), and cardiac toxicity in 4 patients (G1 in 2 patients and G3 in 2 patients). Late side effects were found in 60 patients (28.3%), predominantly involving the lungs (51 patients: 32 G1, 11 G2, and 1 G3) and the esophagus (11 patients: 8 G1 and 3 G2), with no reported late cardiac side effects. Various clinical and dosimetric parameters were found to correlate with both acute and chronic toxicities. Over a median follow-up period of 54 months, 48 patients (22.6%) showed locoregional disease relapse, 106 patients (50%) developed distant metastases, and 66 patients (31.1%) died.
CONCLUSIONS: RAC-TAC retrospective multicentric study showed the low toxicity of PORT when advanced technology is used. At the same time, it\'s noteworthy to underline that 50% of the patients develop distant recurrences in the follow up.