Gemcitabine plus best supportive care (BSC) vs BSC in inoperable non-small cell lung cancer--a randomized trial with quality of life as the primary outcome. UK NSCLC Gemcitabine Group. Non-Small Cell Lung Cancer.
Gemcitabine plus best supportive care (BSC) vs BSC in inoperable non-small cell lung cancer--a randomized trial with quality of life as the primary outcome. UK NSCLC Gemcitabine Group. Non-Small Cell Lung Cancer.
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吉西他滨加上最佳支持护理（BSC）vs BSC在无法手术的非小细胞肺癌中 - 一项随机试验，其生活质量是主要结果。英国NSCLC吉西他滨集团。非小细胞肺癌。
DOI：
10.1054/bjoc.2000.1307
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发表时间：
2000-08
影响因子：
8.8
通讯作者：
Carmichael, J.
中科院分区：
文献类型：
--
作者：
Anderson, H.;Hopwood, P.;Stephens, R. J.;Thatcher, N.;Cottier, B.;Nicholson, M.;Milroy, R.;Maughan, T. S.;Falk, S. J.;Bond, M. G.;Burt, P. A.;Connolly, C. K.;McIllmurray, M. B.;Carmichael, J.
300例不需要立即放疗的症状性、局部晚期或转移性NSCLC患者入组了这项比较吉西他滨+ BSC与BSC单药治疗的随机多中心试验。分配吉西他滨的患者在28天周期的第1、8和15天接受1000 mg/m2，最多6个周期。本试验的主要目的是比较EORTC QLQ-C30和LC 13量表中常见报告症状（SS 14）预定义子集的患者评估。主要终点定义为（1）基线和2个月之间平均SS 14评分的百分比变化和（2）基线和2个月之间SS 14评分显著改善（≥ 25%）并持续≥4周的患者比例。次要目的是比较治疗组的总生存率和多维QL参数，治疗组在年龄、性别、Karnofsky体能状态（KPS）和疾病分期（40%有转移性疾病）方面平衡。吉西他滨+BSC组平均SS 14评分从基线至2个月的百分比变化为降低10%（即改善），BSC单药组增加1%（即恶化）（P = 0.113，双样本t检验）。吉西他滨+ BSC患者（22%）中记录的SS 14持续（≥ 4周）改善（≥25%）的比例显著高于BSC单药治疗患者（9%）（P = 0.0014，Pearson卡方检验）。QLQ-C30和L13子量表显示吉西他滨+BSC组（11个领域）的改善大于BSC组（1个症状项目）。BSC单药治疗组（6个领域/项目）的恶化程度大于吉西他滨+ BSC治疗组（3个QL领域）。19%（95% CI 13-27）的吉西他滨患者发生肿瘤缓解。总生存期无差异：吉西他滨+ BSC患者的中位生存期为5.7个月（95% CI 4.6-7.6），BSC患者为5.9个月（95% CI 5.0-7.9）（对数秩，P = 0.84），吉西他滨+ BSC和BSC的1年生存期分别为25%和22%。总体而言，74例（49%）吉西他滨+ BSC患者和119例（79%）BSC患者接受了姑息性放疗。吉西他滨+ BSC患者的中位放疗时间为29周，BSC为3.8周。与单独接受BSC的患者相比，接受吉西他滨+ BSC治疗的患者报告了更好的QL和减少的疾病相关症状。患者评估的QL的这些改善在幅度上是显著的，并且是持续的。2000癌症研究运动
Three hundred patients with symptomatic, locally advanced or metastatic NSCLC not requiring immediate radiotherapy were enrolled into this randomized multicentre trial comparing gemcitabine + BSC vs BSC alone. Patients allocated gemcitabine received 1000 mg/m2on days 1, 8 and 15 of a 28-day cycle, for a maximum of six cycles. The main aim of this trial was to compare patient assessment of a predefined subset of commonly reported symptoms (SS14) from the EORTC QLQ-C30 and LC13 scales. The primary end-points were defined as (1) the percentage change in mean SS14 score between baseline and 2 months and (2) the proportion of patients with a marked (≥ 25%) improvement in SS14 score between baseline and 2 months sustained for ≥4 weeks. The secondary objectives were to compare treatments with respect to overall survival, and multidimensional QL parameters.The treatment groups were balanced with regard to age, gender, Karnofsky performance status (KPS) and disease stage (40% had metastatic disease). The percentage change in mean SS14 score from baseline to 2 months was a 10% decrease (i.e. improvement) for gemcitabine plus BSC and a 1% increase (i.e. deterioration) for BSC alone (P = 0.113, two-sample t -test). A sustained (≥ 4 weeks) improvement (≥25%) on SS14 was recorded in a significantly higher proportion of gemcitabine + BSC patients (22%) than in BSC alone patients (9%) (P = 0.0014, Pearson’s chi-squared test). The QLQ-C30 and L13 subscales showed greater improvement in the gemcitabine plus BSC arm (in 11 domains) than in the BSC arm (one symptom item). There was greater deterioration in the BSC alone arm (six domains/items) than in the gemcitabine + BSC arm (three QL domains). Tumour response occurred in 19% (95% CI 13–27) of gemcitabine patients. There was no difference in overall survival: median 5.7 months (95% CI 4.6–7.6) for gemcitabine + BSC patients and 5.9 months (95% CI 5.0–7.9) (log-rank, P = 0.84) for BSC patients, and 1-year survival was 25% for gemcitabine + BSC and 22% for BSC. Overall, 74 (49%) gemcitabine + BSC patients and 119 (79%) BSC patients received palliative radiotherapy. The median time to radiotherapy was 29 weeks for gemcitabine + BSC patients and 3.8 weeks for BSC. Patients treated with gemcitabine + BSC reported better QL and reduced disease-related symptoms compared with those receiving BSC alone. These improvements in patient-assessed QL were significant in magnitude and were sustained. © 2000 Cancer Research Campaign
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影响因子：
8.4
作者：
BERGMAN, B;AARONSON, NK;SULLIVAN, M
通讯作者：
SULLIVAN, M
影响因子：
8.8
作者：
HOPWOOD, P;STEPHENS, RJ
通讯作者：
STEPHENS, RJ
影响因子：
3.5
作者：
HOPWOOD, P;STEPHENS, RJ;MACHIN, D
通讯作者：
MACHIN, D
影响因子：
8.8
作者：
通讯作者：
--
影响因子：
8.8
作者：
Bleehen, NM;Girling, DJ;Hopwood, P;Lallemand, G;Machin, D;Stephens, RJ;Bailey, AJ
通讯作者：
Bailey, AJ