Pielichowski W, Barzal J, Gawronski K, Mlot B, Oborska S, Wasko-Grabowska A, Rzepecki P
BMT Unit, Department of Oncology, Military Institute of Medicine, Warsaw, Poland.
Transplant Proc. 2011 Oct;43(8):3107-10. doi: 10.1016/j.transproceed.2011.08.010.
We performed a clinical study of a triple-drug combination to evaluate its efficacy to prevent both acute and delayed emesis after high-dose chemotherapy with BEAM (BCNU [carmustine]+etoposide+ARA-C [cytarabine]+melphalan) before hematopoietic stem cell transplantation (HSCT) by comparison with a historical control group of patients treated with dexamethasone (dex) and ondansetron or palonosetron.
We evaluated 96 patients non-Hodgkin's lymphomas (n=54), and Hodgkin's disease (n=42). Evaluated patients received: aprepitant+palonosetron and dex. The observation period started with the initiation of chemotherapy (0 hours) and continued for 24 hours after the completion of the chemotherapy for the acute phase, and during 5 days after finishing chemotherapy for the delayed phase. The response rate to study drugs was evaluated using a four-grade scale based on the degree of control of nausea and vomiting: high, modrate, slightly effective, or not effective.
Patients treated with the three-drug combination showed a significantly higher response rate than those receiving palonosetron or ondasetron (+dex) during the both the acute and the delayed phases: highly effective early+late phases, 82% versus 70% versus 35%; highly effective early phase, 94% versus 70% versus 35%; highly effective late phase, 85% versus 85% versus 50%; highly+moderately effective early phase, 97% versus 70% versus 40%; highly+moderately effective late phase, 97% versus 90% versus 60%, for triple combination, palonosctron with dexamethasone and ondasetron+dex, respectively. All antiemetic regimens were well tolerated. The three-drug combination showed a similar safety profile; adverse events were generally mild and transient.
The triple-drug combination was more effective than ondansetron or palonosetron (+dex) treatments to prevent acute (especially) and delayed nausea and vomiting following BEAM before HSCT.
我们开展了一项关于三联药物组合的临床研究，通过与接受地塞米松（dex）和昂丹司琼或帕洛诺司琼治疗的历史对照组患者进行比较，评估其在造血干细胞移植（HSCT）前使用BEAM（卡莫司汀[BCNU]+依托泊苷+阿糖胞苷[ARA-C]+美法仑）进行大剂量化疗后预防急性和迟发性呕吐的疗效。
我们评估了96例非霍奇金淋巴瘤患者（n = 54）和霍奇金病患者（n = 42）。评估的患者接受：阿瑞匹坦+帕洛诺司琼和地塞米松。观察期从化疗开始（0小时）开始，急性期在化疗完成后持续24小时，延迟期在化疗结束后持续5天。根据恶心和呕吐的控制程度，使用四级量表评估对研究药物的反应率：高度有效、中度有效、轻度有效或无效。
在急性和延迟期，接受三联药物组合治疗的患者的反应率均显著高于接受帕洛诺司琼或昂丹司琼（+地塞米松）治疗的患者：早期+晚期高度有效，分别为82%、70%和35%；早期高度有效，分别为94%、70%和35%；晚期高度有效，分别为85%、85%和50%；早期高度+中度有效，分别为97%、70%和40%；晚期高度+中度有效，分别为97%、90%和60%，分别对应三联组合、帕洛诺司琼与地塞米松联合以及昂丹司琼+地塞米松。所有止吐方案耐受性良好。三联药物组合显示出相似的安全性；不良事件一般较轻且为短暂性。
在HSCT前使用BEAM化疗后，三联药物组合在预防急性（尤其是）和迟发性恶心和呕吐方面比昂丹司琼或帕洛诺司琼（+地塞米松）治疗更有效。
