Shi Yangyang, Xu Hailing, Raynor William Y, Ding Jiapei, Lin Ling, Zhou Chao, Wang Wei, Meng Yinnan, Wu Xiaomai, Chen Xiaofeng, Lv Dongqing, Yang Haihua
Key Laboratory of Radiation Oncology of Taizhou, Radiation Oncology Institute of Enze Medical Health Academy, Affiliated Taizhou Hospital of Wenzhou Medical University, Taizhou 317000, China.
Department of Radiation Oncology, University of Arizona, Tucson, AZ 86721, USA.
Life (Basel). 2022 Nov 22;12(12):1954. doi: 10.3390/life12121954.
Early stereotactic body radiation therapy (SBRT) to the primary tumor combined with epidermal growth factor receptor tyrosine kinase inhibitor (EFGR-TKI) treatment may increase progression-free survival (PFS) by delaying resistance in patients with advanced EGFR-mutant non-small cell lung cancer (NSCLC). In this prospective, single arm, phase II study, patients with advanced NSCLC were treated with EGFR-TKI (icotinib 125 mg tid or gefitinib 250 mg qd) for one month followed by SBRT (40-60 Gy/5-8 F/5-10 d) to the primary tumor with concurrent EGFR-TKI until disease progression. The primary endpoint was PFS and the patterns of failure. Overall survival (OS) and adverse effects (AEs) were secondary endpoints. Overall, 41 advanced NSCLC patients with EGFR mutations received treatment with 24.42 months of median follow-up time. On average, SBRT was initiated 1.49 months after EGFR-TKI administration. Tumors were found to have an average shrinkage rate of 42.50%. Median PFS was 15.23 months (95% CI 13.10-17.36), while median OS was 27.57 months (95% CI 23.05-32.09). Thirty-three patients were found to have disease progression, of which new site failure (NF) (22 patients, 66.66%) was the most common pattern, followed by original site failure (OF) (7 patients, 21.21%) and simultaneous OF/NF (ONF) (4 patients, 12.12%). There were no Aes equal to or greater than grade 3, with the most frequent AE being radiation pneumonitis. Therefore, administering therapy targeted at the primary tumor using early SBRT after EGFR-TKI initiation is a new potentially safe and effective approach to treat EGFR-mutant advanced NSCLC.
对原发性肿瘤进行早期立体定向体部放射治疗（SBRT）联合表皮生长因子受体酪氨酸激酶抑制剂（EFGR-TKI）治疗，可能通过延缓晚期表皮生长因子受体（EGFR）突变的非小细胞肺癌（NSCLC）患者的耐药性来提高无进展生存期（PFS）。在这项前瞻性、单臂、II期研究中，晚期NSCLC患者接受EGFR-TKI（埃克替尼125毫克，每日三次或吉非替尼250毫克，每日一次）治疗1个月，随后对原发性肿瘤进行SBRT（40-60 Gy/5-8次/5-10天），同时使用EGFR-TKI，直至疾病进展。主要终点是PFS和失败模式。总生存期（OS）和不良反应（AE）为次要终点。总体而言，41例EGFR突变的晚期NSCLC患者接受了治疗，中位随访时间为24.42个月。平均而言，SBRT在EGFR-TKI给药后1.49个月开始。发现肿瘤的平均缩小率为42.50%。中位PFS为15.23个月（95%CI 13.10-17.36），而中位OS为27.57个月（95%CI 23.05-32.09）。发现33例患者疾病进展，其中新部位失败（NF）（22例患者，66.66%）是最常见的模式，其次是原部位失败（OF）（7例患者；21.21%）和同时发生的OF/NF（ONF）（4例患者，12.12%）。没有3级或以上的AE，最常见的AE是放射性肺炎。因此，在启动EGFR-TKI后使用早期SBRT对原发性肿瘤进行治疗是一种治疗EGFR突变晚期NSCLC的新的潜在安全有效的方法。
