Ninomiya Kiichiro, Hosokawa Shinobu, Yokoyama Toshihide, Inoue Masaaki, Sugimoto Keisuke, Kudo Kenichiro, Okada Toshiaki, Maeda Tadashi, Kawai Haruyuki, Yasugi Masayuki, Inoue Koji, Kuyama Shoichi, Ninomiya Takashi, Oze Isao, Maeda Yoshinobu, Hotta Katsuyuki
Center for Comprehensive Genomic Medicine, Okayama University Hospital, Okayama, JPN.
Respiratory Medicine, Japanese Red Cross Okayama Hospital, Okayama, JPN.
Cureus. 2025 May 23;17(5):e84709. doi: 10.7759/cureus.84709. eCollection 2025 May.
Platinum compounds represent standard treatments for various cancers. However, the efficacy of re-administrating platinum compounds has been demonstrated only in ovarian cancer and small cell lung cancer (SCLC), with its utility in non-small cell lung cancer (NSCLC) remaining unclear. Given that the prognosis of NSCLC has improved with effective treatments such as immune checkpoint inhibitors (ICIs), we propose a multicenter, single-arm, prospective phase II trial of re-administrating platinum-based combination therapy for NSCLC. Patients with NSCLC who have progressed after chemoimmunotherapy and exhibit a platinum-free interval of 85 days or more will receive carboplatin combination therapy. The drugs combined with carboplatin - pemetrexed, nab-paclitaxel, or gemcitabine - must not have been administered previously. The primary endpoint is progression-free survival (PFS), assessed using the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Assuming a threshold PFS of 4.2 months and an expected hazard ratio of 0.60, the required sample size is calculated as 40 patients to achieve 70% power with a 5% alpha error. Secondary endpoints included objective response rate, toxicity, and overall survival. This study will clarify the efficacy of re-administrating platinum compounds to patients with NSCLC who have developed resistance to chemoimmunotherapy.
铂类化合物是多种癌症的标准治疗药物。然而，再次使用铂类化合物的疗效仅在卵巢癌和小细胞肺癌（SCLC）中得到证实，其在非小细胞肺癌（NSCLC）中的应用尚不清楚。鉴于免疫检查点抑制剂（ICI）等有效治疗方法使NSCLC的预后有所改善，我们提议开展一项多中心、单臂、前瞻性II期试验，对NSCLC患者再次使用铂类联合疗法。经化学免疫治疗后病情进展且铂类无治疗间隔达85天或更长时间的NSCLC患者将接受卡铂联合治疗。与卡铂联合使用的药物——培美曲塞、纳米白蛋白结合型紫杉醇或吉西他滨——此前不得使用过。主要终点是无进展生存期（PFS），采用实体瘤疗效评价标准（RECIST）1.1版进行评估。假设PFS阈值为4.2个月，预期风险比为0.60，计算得出所需样本量为40例患者，以在5%的α错误率下达到70%的检验效能。次要终点包括客观缓解率、毒性和总生存期。本研究将阐明再次使用铂类化合物对已对化学免疫治疗产生耐药性的NSCLC患者的疗效。
