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肿瘤基线大小是非小细胞肺癌 PD-L1≥50%患者一线接受帕博利珠单抗治疗的独立预后因素。

Baseline tumour size is an independent prognostic factor for overall survival in PD-L1 ≥ 50% non-small cell lung cancer patients treated with first-line pembrolizumab.

机构信息

Medical Oncology Unit, Hôpital Laennec, CHU de Nantes, University Hospital of Nantes, Boulevard Professeur Jacques Monod, Saint Herblain, 44800, Nantes, France.

Medical Oncology Unit, Clinique Mutualiste de l'Estuaire, Saint-Nazaire, France.

出版信息

Cancer Immunol Immunother. 2022 Jul;71(7):1747-1756. doi: 10.1007/s00262-021-03108-x. Epub 2021 Nov 28.

Abstract

BACKGROUND

Advanced non-small cell lung cancer (NSCLC) with a PD-L1 tumour proportion score ≥ 50% can be treated with pembrolizumab alone. Our aim was to assess the impact of baseline tumour size (BTS) on overall survival (OS) in NSCLC patients treated with pembrolizumab versus chemotherapy.

METHODS

This retrospective, multicentre study included all patients with untreated advanced NSCLC receiving either pembrolizumab (PD-L1 ≥ 50%) or platinum-based chemotherapy (any PD-L1). The primary endpoint was the impact of BTS (defined as the sum of the dimensions of baseline target lesions according to RECIST v1.1 criteria) on OS.

RESULTS

Between 09-2016 and 06-2020, 188 patients were included, 96 in the pembrolizumab (P-group) and 92 in the chemotherapy group (CT-group). The median follow-up was 26.9 months (range 0.13-37.91) and 44.4 months (range 0.23-48.62), respectively, while the median BTS was similar, 85.5 mm (IQR 57.2-113.2) and 86.0 mm (IQR 53.0-108.5), respectively (p = 0.42). The median P-group OS was 18.2 months [95% CI 12.2-not reached (NR)] for BTS > 86 mm versus NR (95% CI 27.2-NR) for BTS ≤ 86 mm (p = 0.0026). A high BTS was associated with a shorter OS in univariate analyses (p = 0.009) as well as after adjustment on confounding factors (HR 2.16, [95% CI 1.01-4.65], p = 0.048). The CT-group OS was not statistically different between low and high BTS patients, in univariate and multivariate analyses (p = 0.411).

CONCLUSIONS

After adjustment on major baseline clinical prognostic factors, BTS was an independent prognostic factor for OS in PD-L1 ≥ 50% advanced NSCLC patients treated first-line with pembrolizumab.

摘要

背景

PD-L1 肿瘤比例评分≥50%的晚期非小细胞肺癌(NSCLC)可单独使用帕博利珠单抗治疗。我们的目的是评估基线肿瘤大小(BTS)对接受帕博利珠单抗与化疗治疗的 NSCLC 患者总生存期(OS)的影响。

方法

这是一项回顾性、多中心研究,纳入了所有接受治疗的未经治疗的晚期 NSCLC 患者,这些患者接受了帕博利珠单抗(PD-L1≥50%)或铂类化疗(任何 PD-L1)治疗。主要终点是 BTS(根据 RECIST v1.1 标准定义为基线靶病灶的各维度之和)对 OS 的影响。

结果

在 2016 年 9 月至 2020 年 6 月期间,共纳入了 188 名患者,其中 96 名患者接受了帕博利珠单抗(P 组)治疗,92 名患者接受了化疗(CT 组)。中位随访时间分别为 26.9 个月(范围 0.13-37.91)和 44.4 个月(范围 0.23-48.62),而中位 BTS 相似,分别为 85.5 毫米(IQR 57.2-113.2)和 86.0 毫米(IQR 53.0-108.5)(p=0.42)。对于 BTS>86 毫米的患者,P 组的中位 OS 为 18.2 个月[95%CI 12.2-NR],而 BTS≤86 毫米的患者中位 OS 为 NR(95%CI 27.2-NR)(p=0.0026)。在单变量分析中,高 BTS 与较短的 OS 相关(p=0.009),在调整混杂因素后也是如此(HR 2.16,95%CI 1.01-4.65,p=0.048)。在单变量和多变量分析中,CT 组的 OS 在低 BTS 和高 BTS 患者之间没有统计学差异(p=0.411)。

结论

在调整主要基线临床预后因素后,BTS 是 PD-L1≥50%的晚期 NSCLC 患者一线接受帕博利珠单抗治疗后 OS 的独立预后因素。

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