Wiedenmann Bertram, Malfertheiner Peter, Friess Helmut, Ritch Paul, Arseneau James, Mantovani Giovanni, Caprioni Francesco, Van Cutsem Eric, Richel Dirk, DeWitte Mark, Qi Ming, Robinson Don, Zhong Bob, De Boer Carla, Lu J D, Prabhakar Uma, Corringham Robert, Von Hoff Daniel
Department of Internal Medicine, Charité, Humboldt University, Berlin, Germany.
J Support Oncol. 2008 Jan;6(1):18-25.
To evaluate the safety and efficacy of infliximab administered with gemcitabine to treat cancer cachexia and to explore a functional measure of clinical benefit, investigators involved in this multicenter, phase II, placebo-controlled study randomized 89 patients with stage II-IV pancreatic cancer and cachexia to receive either placebo or 3 mg/ kg or 5 mg/kg of infliximab at weeks 0, 2, and 4 and then every 4 weeks to week 24; patients also received 1,000 mg/m2 of gemcitabine weekly from weeks 0-6 and then for 3 of every 4 weeks until their disease progressed. The primary endpoint was change in lean body mass (LBM) at 8 weeks from baseline; major secondary endpoints included overall survival, progression-free survival, Karnofsky performance status, and 6-minute walk test distance. In addition, quality of life was measured. The mean change in LBM at 8 weeks was +0.4 kg for patients receiving placebo, +0.3 kg for those receiving 3 mg/kg of infliximab, and +1.7 kg for those receiving 5 mg/kg of infliximab. No statistically significant differences in LBM or secondary endpoints were observed among the groups. Safety findings were similar in all groups. Adding infliximab to gemcitabine to treat cachexia in advanced pancreatic cancer patients was not associated with statistically significant differences in safety or efficacy when compared with placebo.
为评估英夫利昔单抗联合吉西他滨治疗癌症恶病质的安全性和有效性，并探索一种衡量临床获益的功能指标，参与这项多中心、II期、安慰剂对照研究的研究人员将89例II-IV期胰腺癌合并恶病质患者随机分组，在第0、2和4周接受安慰剂或3mg/kg或5mg/kg的英夫利昔单抗治疗，随后每4周一次，直至第24周；患者在第0-6周每周还接受1000mg/m²的吉西他滨治疗，然后每4周中的3周接受该治疗，直至疾病进展。主要终点是第8周时瘦体重（LBM）相对于基线的变化；主要次要终点包括总生存期、无进展生存期、卡诺夫斯基体能状态和6分钟步行试验距离。此外，还对生活质量进行了测量。接受安慰剂的患者在第8周时LBM的平均变化为+0.4kg，接受3mg/kg英夫利昔单抗的患者为+0.3kg，接受5mg/kg英夫利昔单抗的患者为+1.7kg。各组之间在LBM或次要终点方面未观察到统计学上的显著差异。所有组的安全性结果相似。与安慰剂相比，在晚期胰腺癌患者中，将英夫利昔单抗添加到吉西他滨中治疗恶病质在安全性或有效性方面未显示出统计学上的显著差异。
