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二线治疗转移性胰腺癌的血清白蛋白和 CA19-9 评分模型:NAPOLEON 研究结果。

Scoring model with serum albumin and CA19-9 for metastatic pancreatic cancer in second-line treatment: results from the NAPOLEON study.

机构信息

Department of Medical Oncology and Hematology, Faculty of Medicine, Oita University, 1-1 Idaigaoka, Hasama-Machi, Yufu, Oita, 879-5593, Japan.

Department of Gastrointestinal Medical Oncology, National Hospital Organization Shikoku Cancer Center, 160 Kou, Minamiumemoto-Machi, Matsuyama, Ehime, 791-0280, Japan.

出版信息

Int J Clin Oncol. 2023 Aug;28(8):1073-1081. doi: 10.1007/s10147-023-02354-6. Epub 2023 May 20.

Abstract

BACKGROUND

Patients with metastatic pancreatic cancer refractory to first-line chemotherapy (CTx) have few treatment options. It is unclear what kind of patients could be brought about survival benefit by 2nd-line CTx after refractory to gemcitabine + nab-PTX (GnP) or FOLFIRINOX.

METHODS

This analysis was conducted as part of a multicenter retrospective study of GnP or FOLFIRINOX in patients with metastatic pancreatic cancer. Excluding censored cases, 156 and 77 patients, respectively, received second-line chemotherapy (CTx) and best supportive care (BSC). Using prognostic factors for post-discontinuation survivals (PDSs) at the first-line determination in multivariate analysis, we developed a scoring system to demonstrate the benefit of second-line CTx.

RESULTS

The second-line CTx group had a median PDS of 5.2 months, whereas the BSC group had a median PDS of 2.7 months (hazard ratio 0.42; 95% confidence interval [CI] 0.31-0.57; p < 0.01). According to the Cox regression model, serum albumin levels below 3.5 g/dL, and CA19-9 levels above 1000 U/mL were independent prognostic factors (p < 0.01). Serum albumin (≥ and < 3.5 g/dL allotted to scores 0 and 1) and CA19-9 (< and ≥ 1000 U/mL allotted to scores 0 and 1) at first-line determination were used to develop the scoring system. The PDSs of patients with scores of 0 and 1 were significantly better than those of the BSC group; however, there was no significant difference between the PDSs of patients with score 2 and the BSC group.

CONCLUSION

The survival advantage of second-line CTx, was observed in patients with scores of 0 and 1 but not in those with score 2.

摘要

背景

一线化疗(CTx)耐药的转移性胰腺癌患者治疗选择有限。对于吉西他滨+白蛋白紫杉醇(GnP)或 FOLFIRINOX 耐药的患者,二线 CTx 能给哪种患者带来生存获益尚不清楚。

方法

本分析是 GnP 或 FOLFIRINOX 治疗转移性胰腺癌多中心回顾性研究的一部分。排除删失病例后,分别有 156 例和 77 例患者接受二线化疗(CTx)和最佳支持治疗(BSC)。使用一线治疗时停止治疗后生存(PDS)的预后因素进行多因素分析,建立评分系统来展示二线 CTx 的获益。

结果

二线 CTx 组的中位 PDS 为 5.2 个月,BSC 组的中位 PDS 为 2.7 个月(风险比 0.42;95%置信区间 [CI] 0.31-0.57;p<0.01)。根据 Cox 回归模型,血清白蛋白水平低于 3.5 g/dL 和 CA19-9 水平高于 1000 U/mL 是独立的预后因素(p<0.01)。血清白蛋白(≥和<3.5 g/dL 分别赋值为 0 和 1)和 CA19-9(<和≥1000 U/mL 分别赋值为 0 和 1)在一线评估时用于建立评分系统。评分 0 和 1 的患者的 PDS 明显好于 BSC 组,而评分 2 的患者的 PDS 与 BSC 组无显著差异。

结论

二线 CTx 的生存优势仅在评分 0 和 1 的患者中观察到,而在评分 2 的患者中未观察到。

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