Multicenter phase IV study of palonosetron in the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients with non-Hodgkin lymphomas undergoing repeated cycles of moderately emetogenic chemotherapy.
Multicenter phase IV study of palonosetron in the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients with non-Hodgkin lymphomas undergoing repeated cycles of moderately emetogenic chemotherapy.
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DOI：
10.3109/10428194.2013.813498
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发表时间：
2014-03
影响因子：
2.6
通讯作者：
Di Renzo N
中科院分区：
文献类型：
--
作者：
Choi BS;Borsaru GP;Ballinari G;Voisin D;Di Renzo N
对于接受中度催吐化疗(MEC)的非霍奇金淋巴瘤(NHL)患者化疗引起的恶心和呕吐，止吐治疗通常包括5-羟色胺3型(5-HT3)受体拮抗剂(RA)。第二代5-HT3RA帕洛诺司琼在接受MEC治疗的NHL患者中的有效性和安全性进行了评估。患者在第一个化疗周期的第一天接受单次静脉注射0.25 mg帕洛诺司琼和化疗，并在随后的三个连续周期中接受最多三个周期。88名患者的疗效和安全性可进行评估。主要终点是在整个周期(每个周期化疗后0-120h)完全缓解的患者的百分比从68.2%(周期1)增加到80.5%(周期2)，并在接下来的周期中保持较高水平，90%的患者在治疗过程中没有使用新的治疗方案而呕吐消失。在所有周期中，78.4%的患者经历了与治疗相关的不良事件，但只有8%与研究药物有关，这证实了帕洛诺司琼良好的安全性(EudraCT编号：2008-007827-14)。
Antiemetic therapy for chemotherapy-induced nausea and vomiting in patients with non-Hodgkin lymphoma (NHL) receiving moderately emetogenic chemotherapy (MEC) generally includes a serotonin-type 3 (5-HT3) receptor antagonist (RA). The efficacy and safety of the second-generation 5-HT3 RA, palonosetron, in patients with NHL receiving MEC was assessed. Patients received a single iv bolus injection of 0.25 mg palonosetron and chemotherapy on day 1 of the first chemotherapy cycle, and up to three further consecutive cycles. Eighty-eight patients were evaluable for efficacy and safety. The primary endpoint, the percentage of patients with a complete response in the overall phase (0–120 h after chemotherapy in each cycle), increased from 68.2% (cycle 1) to 80.5% (cycle 2), remaining high for the following cycles, and > 90% patients were emesis-free without using aprepitant during therapy. Across all cycles, 78.4% of patients experienced treatment-emergent adverse events, but only 8% related to study drug, confirming palonosetron's good safety profile (EudraCT Number: 2008-007827-14).
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影响因子：
50.5
作者：
Aapro, M. S.;Grunberg, S. M.;Macciocchi, A.
通讯作者：
Macciocchi, A.
影响因子：
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作者：
Brugnatelli, Silvia;Gattoni, Elisabetta;Danova, Marco
通讯作者：
Danova, Marco
影响因子：
3.1
作者：
Gonullu, Guzin;Demircan, Sabri;Yucel, Idris
通讯作者：
Yucel, Idris
影响因子：
3.1
作者：
Noor, Rahat;Bedikian, Agop Y.;Homsi, Jade
通讯作者：
Homsi, Jade
影响因子：
2.3
作者：
Schwartzberg, Lee;Morrow, Gary;Cox, David
通讯作者：
Cox, David