A placebo-controlled, double-blind trial of infliximab for cancer-associated weight loss in elderly and/or poor performance non-small cell lung cancer patients (N01C9).
A placebo-controlled, double-blind trial of infliximab for cancer-associated weight loss in elderly and/or poor performance non-small cell lung cancer patients (N01C9).
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DOI：
10.1016/j.lungcan.2009.06.020
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发表时间：
2010-05
期刊：
影响因子：
--
通讯作者：
Loprinzi CL
中科院分区：
文献类型：
--
作者：
Jatoi A;Ritter HL;Dueck A;Nguyen PL;Nikcevich DA;Luyun RF;Mattar BI;Loprinzi CL
这项研究测试了英夫利昔单抗，一种嵌合IgG1kappa单克隆抗体，阻断肿瘤坏死因子(TNF) α，是否改善/稳定老年和/或转移性非小细胞肺癌（NSCLC）患者的体重减轻。这项双盲试验将患者随机分配到英夫利昔单抗/多西他赛组（n=32）和安慰剂/多西他赛组（n=29）。主要终点为体重增加10%。各组在年龄、先前化疗方案的数量、基线体重减轻和运动状态方面是平衡的。没有患者体重增加至基线体重的10%，缺乏疗效的早期证据促使试验提前结束。两组的食欲改善都微不足道。然而，英夫利昔单抗/多西他赛治疗的患者出现更大的疲劳和更差的总体生活质量评分。其他结果，如肿瘤缓解率（两组均<10%）和总生存率，两组间无统计学差异。尽管有一例死亡归因于英夫利昔单抗，但在不良事件方面没有统计学上的显著差异。TNF α - 238和- 308多态性的基因分型显示，这些基因型与体重或食欲下降有关，没有临床意义。该试验提前结束，因为英夫利昔单抗不能预防或缓解癌症相关的体重减轻。英夫利昔单抗与疲劳增加和整体生活质量下降有关。
This study tested whether infliximab, a chimeric IgG1kappa monoclonal antibody that blocks tumor necrosis factor (TNF) alpha, improves/stabilizes weight loss in elderly and/or poor performance status patients with metastatic non-small cell lung cancer (NSCLC). This double-blind trial randomly assigned patients to infliximab/docetaxel (n=32) versus placebo/docetaxel (n=29). The primary endpoint was a >/=10% weight gain. Groups were balanced with respect to age, number of prior chemotherapy regimens, baseline weight loss, and performance status. No patient gained >/= 10% baseline weight, and early evidence of lack of efficacy prompted early trial closure. Appetite improvement was negligible in both arms. However, infliximab/docetaxel-treated patients developed greater fatigue and worse global quality of life scores. Other outcomes, such as tumor response rate (<10% in both groups) and overall survival, were not statistically different between groups. There were no statistically significant differences in adverse events, although one death was attributed to infliximab. Genotyping for the TNF alpha −238 and −308 polymorphisms revealed no clinical significance of these genotypes, as relevant to loss of weight or appetite. This trial closed early because infliximab did not prevent or palliate cancer-associated weight loss. Infliximab was associated with increased fatigue and inferior global quality of life.
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DOI：
10.1097/01.mco.0000078983.18774.cc
发表时间：
2003-07-01
影响因子：
3.1
作者：
Argilés, JM;Busquets, S;López-Soriano, FJ
通讯作者：
López-Soriano, FJ
影响因子：
6.2
作者：
Jatoi, Aminah;Dakhil, Shaker R.;Loprinzi, Charles L.
通讯作者：
Loprinzi, Charles L.
影响因子：
5.9
作者：
Libby, Peter
通讯作者：
Libby, Peter
影响因子：
3.1
作者：
Jatoi, A;Jett, JR;Loprinzi, CL
通讯作者：
Loprinzi, CL
影响因子：
5.8
作者：
Rolland, Y.;Czerwinski, S.;van Kan, G. Abellan;Morley, J. E.;Cesari, M.;Onder, G.;Woo, J.;Baumgartner, R.;Pillard, F.;Boirie, Y.;Chumlea, W. M. C.;Vellas, B.
通讯作者：
Vellas, B.