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ABSOLUTE 试验中二线化疗晚期胃癌患者早期肿瘤应答对健康相关生活质量的影响。

Effect of early tumor response on the health-related quality of life among patients on second-line chemotherapy for advanced gastric cancer in the ABSOLUTE trial.

机构信息

Department of Surgery, Osaka General Medical Center, 3-1-56, Bandaihigashi, Sumiyoshi-ku, Osaka, 558-0056, Japan.

Department of Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa, Japan.

出版信息

Gastric Cancer. 2021 Mar;24(2):467-476. doi: 10.1007/s10120-020-01131-y. Epub 2020 Nov 2.

DOI:10.1007/s10120-020-01131-y
PMID:33136231
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7902565/
Abstract

BACKGROUND

This study evaluated the association between early tumor response at 8 weeks, previously reported as a positive outcome prognosticator, and health-related quality of life (HRQOL) in advanced gastric cancer (AGC) patients enrolled in the ABSOLUTE trial.

METHODS

HRQOL was assessed using the EuroQol-5 Dimension (EQ-5D) utility index score in patients with complete response (CR) + partial response (PR) and progressive disease (PD) at 8 weeks, and time-to-deterioration (TtD) of the EQ-5D score, with the preset minimally important difference (MID) of 0.05, was compared between these populations. Among the enrolled patients, 143 and 160 patients were assessable in weekly solvent-based paclitaxel (Sb-PTX) arm and weekly nanoparticle albumin-bound paclitaxel (nab-PTX) arm, respectively.

RESULTS

Changes of the EQ-5D score from baseline to 8 weeks in the nab-PTX arm were 0.0009 and - 0.1229 in CR + PR and PD patients, respectively; the corresponding values for the Sb-PTX arm were - 0.0019 and - 0.1549. For both treatments, changes of the EQ-5D score from baseline at 8 weeks were significantly larger in patients with PD than in those with CR + PR. The median TtD was 3.9 and 2.2 months in patients with CR + PR and PD, respectively, for nab-PTX [hazard ratio (HR) = 0.595, 95% confidence interval (CI) 0.358-0.989]. For Sb-PTX, the corresponding values were 4.7 and 2.0 months (HR = 0.494, 95% CI 0.291-0.841).

CONCLUSIONS

Early tumor shrinkage was associated with maintained HRQOL in AGC patients on the second-line chemotherapy with taxanes.

摘要

背景

本研究评估了在 ABSOLUTE 试验中,8 周时的早期肿瘤应答(先前报道为阳性预后预测因子)与晚期胃癌(AGC)患者的健康相关生活质量(HRQOL)之间的关联。

方法

使用 EuroQol-5 维度(EQ-5D)效用指数评分评估具有完全缓解(CR)+部分缓解(PR)和 8 周时进展性疾病(PD)的患者的 HRQOL,以及 EQ-5D 评分的恶化时间(TtD),并与 0.05 的预设最小重要差异(MID)进行比较。在纳入的患者中,每周溶剂型紫杉醇(Sb-PTX)组和每周纳米白蛋白结合紫杉醇(nab-PTX)组分别有 143 例和 160 例可评估。

结果

nab-PTX 组 CR+PR 和 PD 患者的 EQ-5D 评分从基线到 8 周的变化分别为 0.0009 和-0.1229,Sb-PTX 组的相应值分别为-0.0019 和-0.1549。对于两种治疗方法,从基线开始,8 周时 PD 患者的 EQ-5D 评分变化明显大于 CR+PR 患者。nab-PTX 治疗组 CR+PR 和 PD 患者的中位 TtD 分别为 3.9 和 2.2 个月(nab-PTX 风险比(HR)=0.595,95%置信区间(CI)0.358-0.989)。对于 Sb-PTX,相应的值分别为 4.7 和 2.0 个月(HR=0.494,95%CI 0.291-0.841)。

结论

在接受紫杉醇二线化疗的 AGC 患者中,早期肿瘤缩小与 HRQOL 保持相关。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9fd1/7902565/5fc7d18e809d/10120_2020_1131_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9fd1/7902565/7eba6bc57d5c/10120_2020_1131_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9fd1/7902565/5fc7d18e809d/10120_2020_1131_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9fd1/7902565/7eba6bc57d5c/10120_2020_1131_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9fd1/7902565/5fc7d18e809d/10120_2020_1131_Fig2_HTML.jpg

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