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在小细胞肺癌化疗随机试验中使用每日日记卡评估“生活质量”

Assessment of 'quality of life' using a daily diary card in a randomised trial of chemotherapy in small-cell lung cancer.

作者信息

Gower N H, Rudd R M, Ruiz de Elvira M C, Spiro S G, James L E, Harper P G, Souhami R L

机构信息

Department of Respiratory Oncology, London Chest Hospital, U.K.

出版信息

Ann Oncol. 1995 Jul;6(6):575-80. doi: 10.1093/oxfordjournals.annonc.a059247.

DOI:10.1093/oxfordjournals.annonc.a059247
PMID:8573537
Abstract

BACKGROUND

Quality of life (QOL) was assessed using a daily diary-card within a multicentre randomised trial of treatment of small-cell lung cancer. The trial compared a weekly dose-intensive regimen with a 3-weekly conventional treatment in good prognosis patients, that is patients with limited disease or extensive disease with a good performance status (ECOG 0or 1) and alkaline phosphatase of less than one and a half times the upper limit of normal. The trial which has been previously reported detected no difference in response or survival.

PATIENTS AND METHODS

Daily diary cards (DDCs) were collected for up to eight months from the first day of chemotherapy in a cohort of 75 patients at one centre. Percentages of scores over a specified level were calculated for each of the eight diary card questions and comparisons were made between treatment arms.

RESULTS

During the period of chemotherapy compliance in completing DDCs was 72.5% in the weekly arm and 77.2% in the 3 weekly. Significantly worse scores were reported with weekly chemotherapy during this period for six of the eight parameters, namely: ;nausea, vomiting, happiness, appetite, general well-being and sleep. Recognised problems of QOL data collection, in particular, compliance, attrition and generalisability are highlighted by this study and are discussed in the paper.

CONCLUSIONS

The QOL measurements indicate that 3 weekly chemotherapy is the preferred treatment. This study demonstrates that QOL measurements may be helpful in choosing between treatment alternatives where no difference in outcome is observed.

摘要

背景

在一项小细胞肺癌治疗的多中心随机试验中,使用每日日记卡评估生活质量(QOL)。该试验在预后良好的患者中比较了每周剂量密集方案与每三周一次的传统治疗,即疾病局限或广泛但体能状态良好(东部肿瘤协作组0或1)且碱性磷酸酶低于正常上限1.5倍的患者。先前报道的该试验未发现反应或生存方面的差异。

患者与方法

在一个中心的75名患者队列中,从化疗第一天起收集长达八个月的每日日记卡(DDC)。针对八张日记卡问题中的每一个,计算超过特定水平的分数百分比,并在各治疗组之间进行比较。

结果

在化疗期间,每周治疗组完成DDC的依从率为72.5%,每三周治疗组为77.2%。在此期间,每周化疗组在八个参数中的六个参数上报告的分数明显更差,即恶心、呕吐、幸福感、食欲、总体健康状况和睡眠。本研究突出了生活质量数据收集公认的问题,特别是依从性、损耗和普遍性,并在文中进行了讨论。

结论

生活质量测量表明每三周一次化疗是首选治疗方法。本研究表明,在未观察到结果差异的治疗选择之间,生活质量测量可能有助于做出选择。

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