Anamorelin (ONO-7643) for the treatment of patients with non-small cell lung cancer and cachexia: Results from a randomized, double-blind, placebo-controlled, multicenter study of Japanese patients (ONO-7643-04).
Anamorelin (ONO-7643) for the treatment of patients with non-small cell lung cancer and cachexia: Results from a randomized, double-blind, placebo-controlled, multicenter study of Japanese patients (ONO-7643-04).
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DOI：
10.1002/cncr.31128
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发表时间：
2018-02-01
期刊：
影响因子：
6.2
通讯作者：
Eguchi K
中科院分区：
文献类型：
--
作者：
Katakami N;Uchino J;Yokoyama T;Naito T;Kondo M;Yamada K;Kitajima H;Yoshimori K;Sato K;Saito H;Aoe K;Tsuji T;Takiguchi Y;Takayama K;Komura N;Takiguchi T;Eguchi K
恶病质，被描述为体重减轻（主要是瘦体重[LBM]）和厌食，在晚期癌症患者中很常见。本研究检查了anamorelin（ONO-7643）（一种新型选择性ghrelin受体激动剂）在日本恶病质癌症患者中的疗效和安全性。这项双盲临床试验（ONO-7643 - 04）在日本入组了174例患有不可切除的III/IV期非小细胞肺癌（NSCLC）和恶病质的患者。患者被随机分配到每日口服阿拉莫林（100毫克）或安慰剂12周。主要终点是12周内LBM（采用双能X线吸收法测量）较基线的变化。次要终点为食欲、体重、生活质量、握力（HGS）和6分钟步行试验（6 MWT）结果的变化。12周内，阿拉莫林组和安慰剂组LBM相对于基线的最小二乘平均变化（±标准误差）分别为1.38 ± 0.18和-0.17 ± 0.17 kg（P < .0001）。在所有时间点，两个治疗组之间LBM、体重和厌食症状较基线的变化均显示出显著差异。阿拉莫林在第3周和第9周增加前白蛋白。两组之间未检测到HGS或6 MWT的变化。阿那莫林治疗NSCLC患者12周安全且耐受性良好。阿拉莫林显著增加LBM和改善厌食症状和营养状态，但不运动功能，在日本晚期NSCLC患者。由于目前没有有效的治疗癌症恶病质，阿拉莫林可以是一个有益的治疗选择。癌症2018;124：606 - 16。© 2017作者。出版社：Wiley Periodicals，Inc.代表美国癌症协会这是一个开放获取的条款下的知识共享署名-非商业性-非衍生许可证，允许使用和分发在任何媒体，只要原作品是正确引用，使用是非商业性的，没有修改或改编。阿拉莫林导致瘦体重和体重的显著增加以及厌食症状和营养状态的改善。阿拉莫林可以是恶病质患者的有益治疗选择。第456 - 8页
Cachexia, described as weight loss (mainly in lean body mass [LBM]) and anorexia, is common in patients with advanced cancer. This study examined the efficacy and safety of anamorelin (ONO‐7643), a novel selective ghrelin receptor agonist, in Japanese cancer patients with cachexia. This double‐blind clinical trial (ONO‐7643‐04) enrolled 174 patients with unresectable stage III/IV non–small cell lung cancer (NSCLC) and cachexia in Japan. Patients were randomized to daily oral anamorelin (100 mg) or a placebo for 12 weeks. The primary endpoint was the change from the baseline LBM (measured with dual‐energy x‐ray absorptiometry) over 12 weeks. The secondary endpoints were changes in appetite, body weight, quality of life, handgrip strength (HGS), and 6‐minute walk test (6MWT) results. The least squares mean change (plus or minus the standard error) in LBM from the baseline over 12 weeks was 1.38 ± 0.18 and −0.17 ± 0.17 kg in the anamorelin and placebo groups, respectively (P < .0001). Changes from the baseline in LBM, body weight, and anorexia symptoms showed significant differences between the 2 treatment groups at all time points. Anamorelin increased prealbumin at weeks 3 and 9. No changes in HGS or 6MWT were detected between the groups. Twelve weeks' treatment with anamorelin was safe and well tolerated in NSCLC patients. Anamorelin significantly increased LBM and improved anorexia symptoms and the nutritional state, but not motor function, in Japanese patients with advanced NSCLC. Because no effective treatment for cancer cachexia is currently available, anamorelin can be a beneficial treatment option. Cancer 2018;124:606‐16. © 2017 The Authors. Cancer published by Wiley Periodicals, Inc. on behalf of American Cancer Society. This is an open access article under the terms of the Creative Commons Attribution‐NonCommercial‐NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made. Anamorelin leads to significant increases in lean body mass and body weight as well as improvements in anorexia symptoms and the nutritional state. Anamorelin can be a beneficial treatment option for cachexia patients. See also pages 456‐8.
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