早期肿瘤缩小作为广泛期小细胞肺癌患者接受程序性细胞死亡配体1抑制剂联合铂类-依托泊苷化疗后良好治疗结局的预测指标：一项前瞻性观察研究
Early Tumor Shrinkage as a Predictor of Favorable Treatment Outcomes in Patients With Extensive-Stage SCLC Who Received Programmed Cell Death-Ligand 1 Inhibitor Plus Platinum-Etoposide Chemotherapy: A Prospective Observational Study.
作者信息
Ishida Masaki, Morimoto Kenji, Yamada Tadaaki, Takeda Takayuki, Shiotsu Shinsuke, Date Koji, Harada Taishi, Tamiya Nobuyo, Chihara Yusuke, Takemura Yoshizumi, Yamada Takahiro, Kanda Hibiki, Iwasaku Masahiro, Tokuda Shinsaku, Kim Young Hak, Takayama Koichi
机构信息
Department of Pulmonary Medicine, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto, Japan.
Department of Respiratory Medicine, Japanese Red Cross Kyoto Daini Hospital, Kyoto, Japan.
出版信息
JTO Clin Res Rep. 2023 Feb 28;4(4):100493. doi: 10.1016/j.jtocrr.2023.100493. eCollection 2023 Apr.
INTRODUCTION
In recent years, programmed cell death-ligand 1 (PD-L1) inhibitor plus platinum-etoposide chemotherapy was found to have favorable clinical outcomes in patients with extensive-stage SCLC (ES-SCLC). The usefulness of early tumor shrinkage (ETS) has been reported in various types of cancers. Nevertheless, there have been few reports evaluating ETS in ES-SCLC. Therefore, this study aimed to evaluate the role of ETS in the clinical outcomes of patients with ES-SCLC receiving chemoimmunotherapy.
METHODS
We prospectively identified 46 patients with ES-SCLC who received PD-L1 inhibitor plus platinum-etoposide chemotherapy at 10 institutions in Japan between September 2019 and October 2021. Of them, 35 patients were selected for analyses.
RESULTS
The responders (progression-free survival [PFS] ≥ 6.0 mo) had significantly greater tumor shrinkage at the first evaluation than the nonresponders (PFS < 6.0 mo) (65.0% versus 53.7%, = 0.03). We defined the cutoff value for ETS as a 57% change from the baseline on the basis of the receiver operating characteristic results to determine the optimal tumor shrinkage rate at the first evaluation for identifying responders. The patients with ES-SCLC who achieved ETS had longer PFS and overall survival than those who did not achieve ETS (5.6 versus 4.0 mo, log-rank test = 0.001 and 15.0 versus 8.3 mo, log-rank test = 0.02). In the multivariate analyses, ETS was significantly associated with PFS and overall survival (hazard ratio = 0.27, 95% confidence interval: 0.12-0.63, = 0.002 and hazard ratio = 0.34, 95% confidence interval: 0.13-0.85, = 0.02).
CONCLUSIONS
Our prospective observational study indicated that ETS was related to favorable clinical outcomes for patients with ES-SCLC receiving PD-L1 inhibitor plus platinum-etoposide chemotherapy.
引言
近年来，程序性细胞死亡配体1（PD-L1）抑制剂联合铂类-依托泊苷化疗在广泛期小细胞肺癌（ES-SCLC）患者中显示出良好的临床疗效。早期肿瘤缩小（ETS）在各类癌症中的作用已有报道。然而，关于ES-SCLC中ETS的评估报道较少。因此，本研究旨在评估ETS在接受化疗免疫治疗的ES-SCLC患者临床结局中的作用。
方法
我们前瞻性地纳入了2019年9月至2021年10月期间在日本10家机构接受PD-L1抑制剂联合铂类-依托泊苷化疗的46例ES-SCLC患者。其中，35例患者被选入分析。
结果
缓解者（无进展生存期[PFS]≥6.0个月）在首次评估时的肿瘤缩小程度显著大于未缓解者（PFS<6.0个月）（65.0%对53.7%，P = 0.03）。根据受试者工作特征曲线结果，我们将ETS的临界值定义为与基线相比变化57%，以确定首次评估时识别缓解者的最佳肿瘤缩小率。实现ETS的ES-SCLC患者的PFS和总生存期长于未实现ETS的患者（5.6个月对4.0个月，对数秩检验P = 0.001；15.0个月对8.3个月，对数秩检验P = 0.02）。在多因素分析中，ETS与PFS和总生存期显著相关（风险比=0.27，95%置信区间：0.12 - 0.63，P = 0.002；风险比=0.34，95%置信区间：0.13 - 0.85，P = 0.02）。
结论
我们的前瞻性观察研究表明，ETS与接受PD-L1抑制剂联合铂类-依托泊苷化疗的ES-SCLC患者的良好临床结局相关。
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