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durvalumab 在同步放化疗后用于局部晚期非小细胞肺癌黑人患者的安全性和有效性。

Safety and efficacy of durvalumab after concurrent chemoradiation in Black patients with locally advanced non-small cell lung cancer.

机构信息

Department of Radiation Oncology, Winship Cancer Institute of Emory University, Atlanta, Georgia, USA.

Department of Hematology and Medical Oncology, Winship Cancer Institute of Emory University, Atlanta, Georgia, USA.

出版信息

Cancer. 2023 Dec 1;129(23):3713-3723. doi: 10.1002/cncr.34915. Epub 2023 Jun 24.

Abstract

BACKGROUND

The PACIFIC trial established consolidative durvalumab after concurrent chemoradiation as standard-of-care in patients with stage III or unresectable non-small cell lung cancer (NSCLC). Black patients, however, comprised just 2% (n = 14) of randomized patients in this trial, warranting real-world evaluation of the PACIFIC regimen in these patients.

METHODS

This single-institution, multi-site study included 105 patients with unresectable stage II/III NSCLC treated with concurrent chemoradiation followed by durvalumab between 2017 and 2021. Overall survival (OS), progression-free survival (PFS), and grade ≥3 pneumonitis-free survival (PNFS) were compared between Black and non-Black patients using Kaplan-Meier and Cox regression analyses.

RESULTS

A total of 105 patients with a median follow-up of 22.8 months (interquartile range, 11.3-37.3 months) were identified for analysis, including 57 Black (54.3%) and 48 (45.7%) non-Black patients. The mean radiation prescription dose was higher among Black patients (61.5 ± 2.9 Gy vs. 60.5 ± 1.9 Gy; p = .031), but other treatment characteristics were balanced between groups. The median OS (not-reached vs. 39.7 months; p = .379) and PFS (31.6 months vs. 19.3 months; p = .332) were not statistically different between groups. Eight (14.0%) Black patients discontinued durvalumab due to toxicity compared to 13 (27.1%) non-Black patients (p = .096). The grade ≥3 pneumonitis rate was similar between Black and non-Black patients (12.3% vs. 12.5%; p = .973), and there was no significant difference in time to grade ≥3 PNFS (p = .904). Three (5.3%) Black patients and one (2.1%) non-Black patient developed grade 5 pneumonitis.

CONCLUSIONS

The efficacy and tolerability of consolidative durvalumab after chemoradiation appears to be comparable between Black and non-Black patients.

摘要

背景

PACIFIC 试验确立了在同步放化疗后巩固性 durvalumab 治疗不可切除的 III 期或不可切除的非小细胞肺癌(NSCLC)患者的标准治疗方案。然而,在这项试验中,黑人患者仅占随机患者的 2%(n=14),需要对 PACIFIC 方案在这些患者中的应用进行真实世界的评估。

方法

本研究为单机构、多中心研究,纳入了 2017 年至 2021 年间接受同步放化疗后 durvalumab 巩固治疗的 105 例不可切除的 II/III 期 NSCLC 患者。采用 Kaplan-Meier 法和 Cox 回归分析比较黑人和非黑人患者的总生存期(OS)、无进展生存期(PFS)和≥3 级肺炎无进展生存期(PNFS)。

结果

共纳入 105 例患者进行分析,中位随访时间为 22.8 个月(四分位距,11.3-37.3 个月),包括 57 例黑人(54.3%)和 48 例非黑人(45.7%)患者。黑人患者的平均放疗处方剂量较高(61.5±2.9 Gy 比 60.5±1.9 Gy;p=0.031),但两组的其他治疗特征较为均衡。两组的中位 OS(未达到 vs. 39.7 个月;p=0.379)和 PFS(31.6 个月 vs. 19.3 个月;p=0.332)均无统计学差异。8 例(14.0%)黑人患者因毒性而停用 durvalumab,13 例(27.1%)非黑人患者因毒性而停用 durvalumab(p=0.096)。黑人患者与非黑人患者的≥3 级肺炎发生率相似(12.3% vs. 12.5%;p=0.973),≥3 级 PNFS 时间也无显著差异(p=0.904)。3 例(5.3%)黑人患者和 1 例(2.1%)非黑人患者发生 5 级肺炎。

结论

在放化疗后巩固性 durvalumab 的疗效和耐受性似乎在黑人和非黑人患者中相当。

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