Pre-Treatment Tumor Growth Rate Predicts Clinical Outcomes of Patients With Advanced Non-Small Cell Lung Cancer Undergoing Anti-PD-1/PD-L1 Therapy.

Pre-Treatment Tumor Growth Rate Predicts Clinical Outcomes of Patients With Advanced Non-Small Cell Lung Cancer Undergoing Anti-PD-1/PD-L1 Therapy.
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治疗前肿瘤生长率可预测接受抗 PD-1/PD-L1 治疗的晚期非小细胞肺癌患者的临床结果

DOI:
10.3389/fonc.2020.621329
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发表时间:
2020
影响因子:
4.7
通讯作者:
Zhang L
Zhang L
中科院分区:
医学3区
文献类型:
--
作者:
He LN;Zhang X;Li H;Chen T;Chen C;Zhou Y;Lin Z;Du W;Fang W;Yang Y;Huang Y;Zhao H;Hong S;Zhang L

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肿瘤生长率(TGR;每月大小变化百分比[%/m])被假定为抗癌治疗反应的早期影像学预测因子,以克服 RECIST 的局限性。我们的目的是评估治疗前 TGR (TGR0) 对接受抗 PD-1/PD-L1 单药治疗的晚期非小细胞肺癌 (aNSCLC) 患者预后的预测价值。我们回顾性筛选了2016年8月至2018年6月期间在中山大学肿瘤医院接受PD-1轴抑制剂的所有aNSCLC患者。TGR0计算为在开始PD-1轴抑制之前的“清洗”期内两次计算机断层扫描(CT)得出的每月肿瘤大小的百分比变化(%/m)。最终随访日期为2019年8月28日。X-tile程序用于根据最大无进展生存期(PFS)分层确定TGR0的截止值。根据选定的 TGR0 截止值将患者分为两组。主要结局是两组之间 PFS 的差异。采用 Kaplan-Meier 方法和 Cox 回归模型进行生存分析。总共纳入了 80 名符合条件的患者(54 名 [67.5%] 男性;中位年龄 [范围] 55 [30-74] 岁)。中位(范围)TGR0 为 21.1 (-33.7-246.0)%/m。 TGR0的最佳截断值为25.3%/m。高 TGR0 患者的中位 PFS(1.8 个月;95% CI,1.6 - 2.1 个月)比低 TGR0 患者(2.7 个月;95% CI,0.5 - 4.9 个月)短(P = 0.005)。多变量 Cox 回归分析显示,较高的 TGR0 独立预测较差的 PFS(风险比 [HR] 1.97;95% CI,1.08-3.60;P = 0.026)。较高的 TGR0 也与较低的持久临床获益率显着相关(34.8% vs. 8.8%,P = 0.007)。治疗前高 TGR 是接受抗 PD-1/PD-L1 单药治疗的 aNSCLC 患者 PFS 较差和临床获益的可靠预测因子。研究结果强调了 TGR0 作为预测免疫治疗获益的早期生物标志物的作用,并且可以允许调整患者的随访。
Tumor growth rate (TGR; percent size change per month [%/m]) is postulated as an early radio-graphic predictor of response to anti-cancer treatment to overcome limitations of RECIST. We aimed to evaluate the predictive value of pre-treatment TGR (TGR0) for outcomes of advanced non-small cell lung cancer (aNSCLC) patients treated with anti-PD-1/PD-L1 monotherapy. We retrospectively screened all aNSCLC patients who received PD-1 axis inhibitors in Sun Yat-Sen University Cancer Center between August 2016 and June 2018. TGR0 was calculated as the percentage change in tumor size per month (%/m) derived from two computed tomography (CT) scans during a “wash-out” period before the initiation of PD-1 axis inhibition. Final follow-up date was August 28, 2019. The X-tile program was used to identify the cut-off value of TGR0 based on maximum progression-free survival (PFS) stratification. Patients were divided into two groups per the selected TGR0 cut-off. The primary outcome was the difference of PFS between the two groups. The Kaplan-Meier methods and Cox regression models were performed for survival analysis. A total of 80 eligible patients were included (54 [67.5%] male; median [range] age, 55 [30-74] years). Median (range) TGR0 was 21.1 (-33.7-246.0)%/m. The optimal cut-off value of TGR0 was 25.3%/m. Patients with high TGR0 had shorter median PFS (1.8 months; 95% CI, 1.6 - 2.1 months) than those with low TGR0 (2.7 months; 95% CI, 0.5 - 4.9 months) (P = 0.005). Multivariate Cox regression analysis revealed that higher TGR0 independently predicted inferior PFS (hazard ratio [HR] 1.97; 95% CI, 1.08-3.60; P = 0.026). Higher TGR0 was also significantly associated with less durable clinical benefit rate (34.8% vs. 8.8%, P = 0.007). High pre-treatment TGR was a reliable predictor of inferior PFS and clinical benefit in aNSCLC patients undergoing anti-PD-1/PD-L1 monotherapy. The findings highlight the role of TGR0 as an early biomarker to predict benefit from immunotherapy and could allow tailoring patient’s follow-up.
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发表时间: 2009-01-01
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