Despite advancements in diagnosing and treating non-small cell lung cancer (NSCLC), the prognosis remains poor. Immune checkpoint inhibitors have shown promise in enhancing survival rates. Therefore, this study aimed to investigate the safety of nivolumab administration with concurrent chemoradiation therapy (CCRT) in patients with unresectable locally advanced NSCLC. Twelve patients with unresectable locally advanced NSCLC at Kansai Medical University Hospital and Izumi City General Medical Center were enrolled from May 2018 to September 2020. They received nivolumab (360 mg) tri-weekly twice, weekly carboplatin (AUC 2 min × mg/mL) and paclitaxel (40 mg/m2) for 6 weeks, and thoracic radiotherapy (60 Gy/30 fractions), followed by maintenance nivolumab therapy (360 mg, tri-weekly) for 6 months. The primary endpoint was incidence of dose-limiting toxicities (DLTs), and the secondary endpoints included safety, response rate, progression-free survival (PFS), overall survival (OS), 2-year survival rate, and treatment completion rate. Three patients completed the protocol. Nine discontinued due directly to interstitial pneumonia (three) and pneumonia (one). Ten patients (83.3%) experienced a grade 3 or higher event, of which three (25%) experienced a grade 4 or higher event, and of these, one (8.3%) experienced a grade 5 event. Three patients experienced DLTs. Concurrent nivolumab with CCRT was tolerated in unresectable locally advanced NSCLC, which offers potential treatment benefits.
尽管非小细胞肺癌（NSCLC）的诊断和治疗已取得进展，但其预后仍然较差。免疫检查点抑制剂在提高生存率方面显示出潜力。因此，本研究旨在探讨纳武利尤单抗联合同步放化疗（CCRT）在不可切除局部晚期NSCLC患者中的安全性。2018年5月至2020年9月，关西医科大学医院和泉市综合医疗中心共纳入12例不可切除局部晚期NSCLC患者。治疗方案包括：纳武利尤单抗（360 mg）每三周一次，共两次；每周卡铂（AUC 2 min × mg/mL）和紫杉醇（40 mg/m²），持续6周；胸部放疗（60 Gy/30次）；随后进行为期6个月的纳武利尤单抗维持治疗（360 mg，每三周一次）。主要终点为剂量限制性毒性（DLTs）发生率，次要终点包括安全性、缓解率、无进展生存期（PFS）、总生存期（OS）、2年生存率及治疗完成率。3例患者完成全部治疗方案。9例患者因间质性肺炎（3例）和肺炎（1例）直接中断治疗。10例患者（83.3%）出现3级或以上不良事件，其中3例（25%）出现4级或以上事件，1例（8.3%）出现5级事件。3例患者出现DLTs。纳武利尤单抗联合CCRT在不可切除局部晚期NSCLC患者中耐受性良好，具有潜在治疗获益。
肿瘤(癌症)患者之家