Comparison of two dosing schedules of palonosetron for the prevention of nausea and vomiting due to interleukin-2-based biochemotherapy
Comparison of two dosing schedules of palonosetron for the prevention of nausea and vomiting due to interleukin-2-based biochemotherapy
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DOI：
10.1007/s00520-011-1359-6
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发表时间：
2012-10-01
影响因子：
3.1
通讯作者：
Homsi, Jade
中科院分区：
文献类型：
--
作者：
Noor, Rahat;Bedikian, Agop Y.;Homsi, Jade
以白介素2为基础的生物化疗治疗转移性黑色素瘤包括在5天内给予中度和高度催吐化疗的组合。用于预防生物化疗引起的恶心和呕吐(CINV)的皮质类固醇是禁忌的，因为它们能引起对白细胞介素2的反应而产生的LAK细胞的溶解。帕洛诺司琼是一种长效、高效的第二代5-羟色胺受体拮抗剂。在II期试验中，接受第一周期生物化疗的转移性黑色素瘤患者随机接受帕洛诺司琼0.25 mg静脉注射预防CINV(计划1)或第1、3、5天(计划2)。所有患者在第1天接受达卡巴津治疗，在第1-4天接受顺铂、长春花碱和白介素2治疗，在第1-5天接受干扰素α-2b治疗。我们通过帕洛诺司琼给药计划，评估和比较治疗前7天CINV的类型和严重程度，以及21天周期的持续时间，以及对日常功能的影响。30例患者入选，中位年龄53岁。其中18人(60%)为男性。在头7天和整个周期中，观察到了有利于附表2的恶心和呕吐得到更好控制的一致趋势。在附表1的前7天内的任何一天发生恶心的患者(平均发作次数8.1+/-1.5)显著多于附表2(平均发作次数5.6+/-2.3，p=0.028)。两组患者对日常生活功能的影响相似，帕洛诺司琼的给药方案耐受性良好。隔天服用帕洛诺司琼在控制CINV方面更有效。
Treatment of metastatic melanoma with interleukin-2-based biochemotherapy involves administration of a combination of moderately and highly emetogenic chemotherapies over 5 days. Corticosteroids for the prevention of biochemotherapy-induced nausea and vomiting (CINV) are contraindicated because they cause lysis of LAK cells produced in response to interleukin-2. Palonosetron is a long-acting, highly potent, second-generation serotonin receptor antagonist. The recommended dosing schedule of palonosetron for the control of CINV due to biochemotherapy is not known.In a phase II design, treatment-na < ve patients with metastatic melanoma undergoing the first cycle of biochemotherapy were randomized to receive palonosetron 0.25 mg intravenously for CINV prophylaxis on either days 1 and 4 (schedule 1) or days 1, 3, and 5 (schedule 2). All patients received dacarbazine on day 1, cisplatin, vinblastine, and interleukin-2 on days 1-4, and interferon alpha-2b on days 1-5. We evaluated and compared, by palonosetron dosing schedule, the pattern and the severity of CINV during the first 7 days of treatment and the duration of the 21-day cycle as well as the impact on daily function with the Functional Living Index-Emesis.Thirty patients (median age 53 years) were enrolled. Eighteen (60%) were men. A consistent trend of a better control of both nausea and vomiting favoring schedule 2 was observed during the first 7 days and throughout the cycle. Significantly more patients experienced nausea on any day during the first 7 days on schedule 1 (mean number of episodes 8.1 +/- 1.5) than on schedule 2 (mean number of episodes 5.6 +/- 2.3, p = 0.028). The impact on daily function was similar between the two groups.Both dosing schedules of palonosetron were tolerated well. Alternate day dosing of palonosetron was more effective in controlling CINV in this patient population.