Health-related quality of life in a randomised phase III study of gemcitabine plus S-1, S-1 alone and gemcitabine alone for locally advanced or metastatic pancreatic cancer: GEST study
Health-related quality of life in a randomised phase III study of gemcitabine plus S-1, S-1 alone and gemcitabine alone for locally advanced or metastatic pancreatic cancer: GEST study
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DOI：
10.1136/esmoopen-2016-000151
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发表时间：
2017-03-01
期刊：
影响因子：
7.3
通讯作者：
Tanaka, Masao
中科院分区：
文献类型：
--
作者：
Hagiwara, Yasuhiro;Ohashi, Yasuo;Tanaka, Masao
目的：本研究旨在比较吉西他滨+S-1（GS）、S-1单药和吉西他滨单药作为GEST中局部晚期或转移性胰腺癌一线化疗的健康相关生活质量（HRQOL）。（吉西他滨和TS-1试验）研究，并评估不良事件和肿瘤反应对HRQOL的影响。患者被随机分配接受吉西他滨单药治疗（1000 mg/m（2）每周一次，持续3/4周），S-1单药（80、100或120 mg/天，每日两次，持续4/6周）或GS（吉西他滨1000 mg/m2，每周一次+S-1 60、80或100 mg/天，每日两次，持续2/3周）。在基线和第6、12、24、48和72周使用EuroQoL-5D（EQ-5D）问卷评估HRQOL。比较三组之间的EQ-5D评分、质量调整生命月数（QALM）、质量调整无进展月数（QAPFM）和至明确HRQOL恶化的时间（TUDD）。结果：包括死亡后的EQ-5D评分为0，GS组的平均情况明显优于吉西他滨组（差异，0.069; p=0.003），但S-1组则不然（差异，-0.011; p=0.613）。三组中直至死亡的平均曲线相似。GS组的QALM、QAPFM和TUDD显著长于吉西他滨组（p
Objective: This study was performed to compare health-related quality of life (HRQOL) of gemcitabine plus S-1 (GS), S-1 alone and gemcitabine alone as first-line chemotherapy for locally advanced or metastatic pancreatic cancer in the GEST(Gemcitabine and TS-1 Trial) study and to assess the impacts of adverse events and tumour response on HRQOL.Methods: Patients were randomly assigned to receive gemcitabine alone (1000 mg/m(2) weekly for 3 of 4 weeks), S-1 alone (80, 100 or 120 mg/day twice daily for 4 of 6 weeks) or GS (gemcitabine at 1000 mg/m(2) weekly plus S-1 at 60, 80 or 100 mg/day twice daily for 2 of 3 weeks). HRQOL was assessed using the EuroQoL-5D (EQ-5D) questionnaire at baseline and weeks 6, 12, 24, 48 and 72. EQ-5D scores, quality- adjusted life months (QALMs), quality- adjusted progression-free months (QAPFMs) and time until definitive HRQOL deterioration (TUDD) were compared among the three groups. The impacts of adverse events and tumour response on EQ-5D scores were analysed.Results: Including EQ-5D scores after death as 0, the mean profile was significantly better in the GS than gemcitabine group (difference, 0.069; p=0.003), but not the S-1 group (difference, -0.011; p=0.613). The mean profiles until death were similar in the three groups. QALMs, QAPFMs and TUDD were significantly longer in the GS than gemcitabine group (p