Shandong Cancer Hospital and Institute, Shandong First Medical University, and Shandong Academy of Medical Sciences, Jinan, China.
J Cancer Res Clin Oncol. 2023 Apr;149(4):1443-1451. doi: 10.1007/s00432-022-04023-z. Epub 2022 Apr 28.
Although immune checkpoint inhibitor monotherapy has been used as a second-line treatment in advanced non-small cell lung cancer (NSCLC), the improvement in progression-free survival (PFS) remains unsatisfactory. We investigated the feasibility of sintilimab plus chemotherapy as a second-line treatment in advanced NSCLC.
This was a phase II, single-arm, prospective study in advanced NSCLC patients who had failed standard platinum-based chemotherapy (ChiCTR1900027634, Registered 22 November 2019). Eligible patients received docetaxel 75 mg/m (day 1) plus sintilimab 200 mg (day 3) Q3W. Those did not progress after 4-6 cycles received sintilimab 200 mg Q3W as maintenance treatment. The primary endpoint was PFS.
Forty patients were enrolled between October 2019 and October 2020. With a median follow-up of 12.2 months, the median PFS was 5.8 months, and the PFS rates at 6 and 12 months were 48% and 30%, respectively. The median overall survival (OS) was 12.6 months, with a 12-month OS rate of 62.0%. The overall response rate was 32.4%, and the disease control rate was 89.2%. The incidence of all and ≥ grade 3 treatment-related adverse events (TRAEs) were 65% (26/40) and 17.5% (7/40), respectively. No TRAEs-related permanent treatment discontinuation or death occurred. bTMB reduction at 6 weeks was associated with a longer PFS (NR vs 3.0 months, P < 0.0001).
This prospective phase II study in China suggested that sintilimab plus docetaxel might improve PFS and tumor response with good tolerability for Chinese patients with previously treated advanced NSCLC. bTMB reduction at 6 weeks could serve as a potential predictive biomarker for this regimen.
尽管免疫检查点抑制剂单药治疗已被用作晚期非小细胞肺癌（NSCLC）的二线治疗，但无进展生存期（PFS）的改善仍不理想。我们研究了信迪利单抗联合化疗作为晚期 NSCLC 的二线治疗的可行性。
这是一项在二线治疗失败的晚期 NSCLC 患者中进行的 II 期、单臂、前瞻性研究，这些患者接受了标准铂类化疗（ChiCTR1900027634，2019 年 11 月 22 日注册）。符合条件的患者接受多西他赛 75mg/m（第 1 天）联合信迪利单抗 200mg（第 3 天）Q3W。对于在 4-6 个周期后没有进展的患者，接受信迪利单抗 200mg Q3W 作为维持治疗。主要终点是 PFS。
2019 年 10 月至 2020 年 10 月期间，共纳入 40 例患者。中位随访时间为 12.2 个月，中位 PFS 为 5.8 个月，6 个月和 12 个月的 PFS 率分别为 48%和 30%。中位总生存期（OS）为 12.6 个月，12 个月 OS 率为 62.0%。总缓解率为 32.4%，疾病控制率为 89.2%。所有治疗相关不良事件（TRAEs）和≥3 级 TRAEs 的发生率分别为 65%（26/40）和 17.5%（7/40）。没有 TRAEs 相关的永久性治疗中止或死亡。6 周时 bTMB 降低与更长的 PFS 相关（NR 与 3.0 个月，P<0.0001）。
这项在中国进行的前瞻性 II 期研究表明，信迪利单抗联合多西他赛可能改善中国晚期 NSCLC 患者的 PFS 和肿瘤反应，且耐受性良好。6 周时 bTMB 降低可作为该方案的潜在预测生物标志物。
