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/m2 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.

中文翻译：

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沙利度胺预防高致吐化疗引起的延迟性恶心和呕吐的功效：一项随机、多中心、双盲、安慰剂对照的 III 期试验（CLOG1302 研究）

目的 我们研究了沙利度胺 (THD) 在预防接受高致吐性化疗 (HEC) 患者延迟性恶心和呕吐方面的有效性和安全性。患者和方法 在一项随机、双盲、活性对照、III 期试验中，计划接受含有顺铂或环磷酰胺-多柔比星/表柔比星 ≥ 50 mg/m2 方案的 HEC 的未接受化疗的癌症患者被随机分配到THD 组（第 1 天至第 5 天每天两次 100 毫克）或安慰剂组，均使用帕洛诺司琼（第 1 天 0.25 毫克）和地塞米松（第 1 天 12 毫克；第 2 天至第 4 天 8 毫克）。主要终点是延迟阶段（25 至 120 小时）对呕吐的完全反应——无呕吐或使用急救药物。第 1 天至第 5 天的恶心和厌食通过 4 点李克特量表进行评估（0，无症状；3，严重）。在第 -1 天和第 6 天，通过欧洲癌症研究和治疗组织 QLQ-C30 第 3 版问卷评估生活质量。结果 656 名患者中，638 名可评估：THD 组 317 名，对照组 321 名。与安慰剂相比，THD 对呕吐的延迟和总体（0 至 120 小时）完全缓解率显着更高：分别为 76.9% 与 61.7% ( P < .001) 和 66.1% 与 53.3% ( P = .001)。THD 组的无恶心率也较高（延迟：47.3% 对 33.3%；P < .001；总体：41% 对 29.6%；P = .003），厌食症的平均得分总体较低（0.44 ± 0.717 v 0.64 ± 0.844；P = .003）。不良反应为轻度至中度。THD 组的镇静、头晕、便秘和口干增加，但化疗后生活质量更好。