Identification of adverse events that have a negative impact on quality of life in a clinical trial comparing docetaxel versus S-1 with cisplatin in lung cancer
Identification of adverse events that have a negative impact on quality of life in a clinical trial comparing docetaxel versus S-1 with cisplatin in lung cancer
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DOI：
10.1007/s10147-016-0960-6
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发表时间：
2016-10-01
影响因子：
3.3
通讯作者：
Kobayashi, Kunihiko
中科院分区：
文献类型：
--
作者：
Aotani, Eriko;Hamano, Tetsutaro;Kobayashi, Kunihiko
在CATS(顺铂和TS-1)随机试验中，比较顺铂和多西紫杉醇(DP组)或TS-1(SP组)治疗肺癌的疗效相同，但SP组的总体生活质量(QOL)评分更高。本研究的目的是确定哪些不良事件(AEs)导致了QOL的恶化。使用来自CATS试验的QOL和AEs数据来定量分析QOL评分恶化与AEs发生之间的关系。两组患者化疗后至化疗前的生活质量减去值进行充分比较(t检验，显著性水平=0.001)。并进行多元线性回归分析。经单因素和多因素分析(P<；0.001和P<；0.0001)，胃肠道(GI)毒性与两个试验组的多个生活质量项目的恶化有关。多变量分析不可预测地表明，血清胆红素水平的升高是唯一与DP组的身体功能恶化(p=0.0002)、认知功能(p<；0.0001)和经济问题(p=0.0005)相关的唯一的AE，尽管在SP组中没有。在猫的试验中，胃肠道毒性在SP组有延长的趋势，血清胆红素水平的增加可能导致DP组受试者整体生活质量的下降。我们在这里使用的方法可能是一种独特的方法来识别导致化疗患者生活质量恶化的不可预测的AE(S)。
In the CATS (Cisplatin And TS-1) randomized trial comparing cisplatin plus either docetaxel (DP arm) or TS-1 (SP arm) in lung cancer, efficacy was found to be equivalent but the global quality of life (QOL) score was higher in the SP arm. The purpose of the current study was to identify which of the adverse events (AEs) contributed to the deterioration of QOL.QOL and AE data from the CATS trial were used to quantitatively analyze the relationship between deterioration of QOL score and occurrence of AEs. Subtracted values of the QOL score from post-chemotherapy to pre-chemotherapy were fully compared between patients with or without each AE (Student's t test, significance level = 0.001). Multivariate linear regression analysis was also performed. Analysis of variance was performed to identify whether grade of AE(s) might be significantly correlated with the deterioration of the QOL score (significance level of 0.05).As expected, gastrointestinal (GI) toxicities were associated with worsening of a variety of QOL items in both trial arms, detected by both univariate and multivariate analysis (p < 0.001 and p < 0.0001, respectively). Multivariate analysis unpredictably indicated that an increase in serum bilirubin level was the only AE that was uniquely associated with worsening of physical functioning (p = 0.0002), cognitive functioning (p < 0.0001), and financial problems (p = 0.0005) in the DP arm, although not in the SP arm. GI toxicities tended to be prolonged in the SP arm.An increase in serum bilirubin level may contribute to the worse global QOL of subjects in the DP arm in the CATS trial. The method we used here may be a unique approach to identify unpredictable AE(s) that worsen the QOL of patients treated by chemotherapy.