Does health-related quality of life improve for advanced pancreatic cancer patients who respond to gemcitabine? Analysis of a randomized phase III trial of the cancer and leukemia group B (CALGB 80303).
Does health-related quality of life improve for advanced pancreatic cancer patients who respond to gemcitabine? Analysis of a randomized phase III trial of the cancer and leukemia group B (CALGB 80303).
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DOI：
10.1016/j.jpainsymman.2011.09.001
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发表时间：
2012-02
影响因子：
4.7
通讯作者：
Schrag, Deborah
中科院分区：
文献类型：
--
作者：
Romanus, Dorothy;Kindler, Hedy L.;Archer, Laura;Basch, Ethan;Niedzwiecki, Donna;Weeks, Jane;Schrag, Deborah
吉西他滨用于晚期胰腺癌（APC）是姑息性的，预后较差，这使得健康相关生活质量（HRQOL）尤为重要。
我们使用欧洲五维健康量表（EuroQol EQ - 5D™）对参与癌症与白血病B组（CALGB）80303研究的APC患者的HRQOL进行了评估。这是一项多中心、双盲、随机试验，比较了两个治疗组（吉西他滨联合贝伐单抗组，或吉西他滨联合安慰剂组）之间的总生存期（OS）。
连续抽取一部分患者样本被邀请完成EQ - 5D调查。由于临床结果和HRQOL结果在不同研究组之间没有差异，因此进行了合并分析。评估了从基线到8周平均得分的变化以及EQ - 5D的预后价值。
平均指数得分保持稳定（基线时为0.78 [n = 267]，8周时为0.79 [n = 186]，P值 = 0.34，威尔科克森符号秩检验），这是由于身体功能领域得分略有下降，同时疼痛和焦虑/抑郁得分略有改善。观察到视觉模拟量表（VAS）得分略有下降（70.7比68.2，P值 = 0.026）。化疗反应分层内的HRQOL变化显示指数得分稳定，但疾病进展患者与疾病稳定或改善患者相比，身体功能有恶化趋势。无论化疗反应状态如何，VAS得分随时间呈下降趋势，疾病进展患者有统计学意义的恶化（68.9比64.4，P值 = 0.029）。在考克斯比例风险模型中，EQ - 5D两个量表的基线得分都是总生存期的重要预测因子。
APC对吉西他滨治疗的反应与整体HRQOL的明显改善无关。尽管功能逐渐下降，但观察到疼痛和情绪有小幅改善。对吉西他滨有反应的患者可能会经历功能恶化的轻微减缓。
Gemcitabine for advanced pancreas cancer (APC) is palliative and prognosis is poor, making health-related quality of life (HRQOL) particularly important. We evaluated HRQOL with the EuroQol EQ-5D™, in patients with APC participating in Cancer and Leukemia Group B (CALGB) 80303, a multicenter, double-blind, randomized trial comparing overall survival (OS) between two treatment arms, gemcitabine with bevacizumab, or gemcitabine with placebo. A consecutive subsample of patients was invited to complete the EQ-5D surveys. Because neither clinical nor HRQOL outcomes differed based on study arm, analyses were pooled. Changes in mean scores from baseline to eight weeks and the prognostic value of the EQ-5D were evaluated. Mean index scores remained stable (0.78 at baseline [n=267], 0.79 at eight weeks [n=186], P-value=0.34, Wilcoxon signed rank test), attributable to a modest deterioration of physical function domain scores coincident with small improvements in pain and anxiety/depression scores. A small decline in visual analogue scale (VAS) scores was observed (70.7 vs. 68.2, P-value=0.026). HRQOL changes within chemotherapy response strata revealed stable index scores, but a trend of worsened physical function among patients with disease progression compared with those with stable or improved disease. VAS scores trended downward over time irrespective of chemotherapy response status, with a statistically meaningful deterioration in patients who progressed (68.9 vs. 64.4, P-value=0.029). Baseline scores from both EQ-5D scales were significant predictors of OS in Cox proportional hazard models. Response to gemcitabine treatment in APC is not associated with appreciable improvement of global HRQOL. Small improvements in pain and mood are observed despite progressive functional decline. Those who respond to gemcitabine may experience a slight slowing of functional deterioration.
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