Lingyun Zhang, Xiujuan Qu, Yuee Teng, Jing Shi, Ping Yu, Mingfang Zhao, Jing Liu, Bo Jin, Ying Luo, Zan Teng, Ying Chen, Jinglei Qu, Feng Jin, Lingyu Fu, and Yunpeng Liu, First Hospital of China Medical University, Shenyang; Tao Sun and Jingdong Zhang, Cancer Hospital of China Medical University; Xiaodong Xie, General Hospital of Shenyang Military Region, Shenyang; Jingyan Wang, Liaoyang Petrochemical General Hospital; Jian Zhang, Liaoyang Central Hospital; Jun Wang, The Third People's Hospital of Liaoyang City, Liaoyang; Zhitu Zhu, Yuzhi An, Caijun Yuan, Lizhong Zhou, and Zhenghua Wang, The First Affiliated Hospital of Jinzhou Medical University, Jinzhou; Xiuna Zhang, Yuyang Dong, Fugang Wen, Xiuhua Jin, and Li Man, Anshan Cancer Hospital, Anshan; and Tiejun Chen, Benxi Central Hospital, Benxi, People's Republic of China.
J Clin Oncol. 2017 Nov 1;35(31):3558-3565. doi: 10.1200/JCO.2017.72.2538. Epub 2017 Aug 30.
Purpose We examined the efficacy and safety of thalidomide (THD) for the prevention of delayed nausea and vomiting in patients who received highly emetogenic chemotherapy (HEC). Patients and Methods In a randomized, double-blind, active-controlled, phase III trial, chemotherapy-naive patients with cancer who were scheduled to receive HEC that contained cisplatin or cyclophosphamide-doxorubicin/epirubincin ≥ 50 mg/m regimens were randomly assigned to a THD group (100 mg twice daily on days 1 to 5) or placebo group, both with palonosetron (0.25 mg on day 1) and dexamethasone (12 mg on day 1; 8 mg on days 2 to 4). Primary end point was complete response to vomiting-no emesis or use of rescue medication-in the delayed phase (25 to 120 h). Nausea and anorexia on days 1 to 5 were evaluated by the 4-point Likert scale (0, no symptoms; 3, severe). Quality of life was assessed by the European Organization for Research and Treatment of Cancer QLQ-C30 version 3 questionnaire on days -1 and 6. Results Of 656 patients, 638 were evaluable: 317 in the THD group and 321 in the control group. Compared with placebo, delayed and overall (0 to 120 h) complete response rates to vomiting were significantly higher with THD: 76.9% versus 61.7% ( P < .001) and 66.1% versus 53.3% ( P = .001), respectively. Rates of no nausea were also higher in the THD group (delayed: 47.3% v 33.3%; P < .001; overall: 41% v 29.6%; P = .003), and mean scores of anorexia were lower overall (0.44 ± 0.717 v 0.64 ± 0.844; P = .003). Adverse effects were mild to moderate. The THD group had increased sedation, dizziness, constipation, and dry mouth, but experienced better quality of life after chemotherapy. Conclusion Thalidomide combined with palonosetron and dexamethasone significantly improved HEC-induced delayed nausea and vomiting prevention in chemotherapy-naive patients.
我们研究了沙利度胺（THD）预防接受高致吐性化疗（HEC）的患者延迟性恶心和呕吐的疗效和安全性。
在一项随机、双盲、阳性对照、III 期试验中，计划接受包含顺铂或环磷酰胺-多柔比星/表柔比星≥50mg/m2 方案的化疗初治癌症患者被随机分配至 THD 组（100mg，每日 2 次，第 1 至 5 天）或安慰剂组，两组均给予帕洛诺司琼（第 1 天 0.25mg）和地塞米松（第 1 天 12mg；第 2 至 4 天 8mg）。主要终点是延迟期（25 至 120 小时）呕吐完全缓解（无呕吐或使用解救药物）。第 1 至 5 天的恶心和厌食通过 4 分李克特量表（0，无症状；3，严重）进行评估。通过欧洲癌症研究与治疗组织生活质量问卷 EORTC QLQ-C30 版本 3 于-1 天和 6 天评估生活质量。
在 656 例患者中，638 例可评估：THD 组 317 例，对照组 321 例。与安慰剂相比，THD 组延迟和总体（0 至 120 小时）呕吐完全缓解率显著更高：76.9%比 61.7%（P<0.001）和 66.1%比 53.3%（P=0.001）。THD 组无恶心发生率也更高（延迟：47.3%比 33.3%；P<0.001；总体：41%比 29.6%；P=0.003），总体上厌食评分较低（0.44±0.717 比 0.64±0.844；P=0.003）。不良反应为轻度至中度。THD 组镇静、头晕、便秘和口干发生率增加，但化疗后生活质量更好。
沙利度胺联合帕洛诺司琼和地塞米松可显著改善化疗初治患者接受 HEC 诱导的延迟性恶心和呕吐的预防。
