Ades Steven, Halyard M, Wilson K, Ashikaga T, Heimann R, Kumar S, Blackstock W
University of Vermont Cancer Center, Given Building, E214C, 89 Beaumont Ave, Burlington, VT, 05405, USA.
Mayo Clinic, Scottsdale, AZ, USA.
Support Care Cancer. 2017 May;25(5):1503-1510. doi: 10.1007/s00520-016-3540-4. Epub 2016 Dec 28.
Despite a lower risk of nausea and vomiting in patients receiving radiotherapy to the upper abdomen (UA-RINV) with prophylactic 5-HT3 antagonist therapy, patients can still experience UA-RINV. The aim of this multicenter phase II study was to assess effectiveness, safety, and tolerability of protracted dual NK1-receptor and 5-HT3 antagonist prophylaxis against UA-RINV.
Patients receiving fractionated radiotherapy with radiosensitizing chemotherapy received oral ondansetron 8 mg po q12 h and aprepitant 125/80/80 mg on a Monday, Wednesday, Friday schedules throughout radiotherapy. The primary outcome was complete response (CR) defined as no vomiting or rescue therapy during the entire observation period of radiotherapy (OP). Nausea, vomiting, and use of rescue medication were recorded in a modified version of the MASCC antiemesis tool completed twice weekly.
Fifty-five patients were enrolled at 5 sites, 52 of whom were evaluable. 57.7% of patients (30/52, 95% CI 43.2-71.3%) achieved CR on study, with 73.1% (38/52, 95% CI 59.0-84.4%) who did not vomit, and 71.2% (37/52, 95% CI 56.9-82.9%) who did not use rescue medication during the OP. Overall, participants vomited or experienced significant nausea (SN) for an average of 6.8% (95% CI 11.4-21.0) and 8.4% (95% CI 4.2-12.7%) of time on study, respectively. Nausea was common with 32 (61.5%) reporting SN at any time during the OP.
UA-RINV remains an important morbidity despite the advent of modern radiotherapy. Aprepitant and ondansetron as dosed in this trial was not superior to standard ondansetron monotherapy.
尽管接受上腹部放疗（UA-RINV）的患者在接受预防性5-HT3拮抗剂治疗时恶心和呕吐风险较低，但患者仍可能出现UA-RINV。这项多中心II期研究的目的是评估延长使用NK1受体拮抗剂和5-HT3拮抗剂联合预防UA-RINV的有效性、安全性和耐受性。
接受分割放疗联合放射增敏化疗的患者在整个放疗期间，于周一、周三、周五口服昂丹司琼8毫克，每日两次，阿瑞匹坦125/80/80毫克。主要结局为完全缓解（CR），定义为在整个放疗观察期（OP）内无呕吐或挽救治疗。恶心、呕吐和挽救药物的使用情况通过改良版的MASCC止吐工具进行记录，每周记录两次。
5个研究点共纳入55例患者，其中52例可评估。57.7%（30/52，95%CI 43.2-71.3%）的患者在研究中达到CR，73.1%（38/52，95%CI 59.0-84.4%）的患者未呕吐，71.2%（37/52，95%CI 56.9-82.9%）的患者在OP期间未使用挽救药物。总体而言，参与者在研究期间呕吐或经历严重恶心（SN）的时间平均分别为6.8%（95%CI 11.4-21.0）和8.4%（95%CI 4.2-12.7%）。恶心很常见，32例（61.5%）患者在OP期间的任何时间报告有SN。
尽管现代放疗技术已经出现，但UA-RINV仍然是一个重要的发病问题。本试验中使用的阿瑞匹坦和昂丹司琼并不优于标准的昂丹司琼单药治疗。
