Division of Medical Oncology, Department of Medicine, The Ottawa Hospital, Ottawa, Ontario, Canada2Ottawa Hospital Research Institute, Department of Medicine, University of Ottawa, Ottawa, Ontario, Canada.
Division of Medical Oncology, Department of Medicine, The Ottawa Hospital, Ottawa, Ontario, Canada.
JAMA Oncol. 2016 Feb;2(2):225-31. doi: 10.1001/jamaoncol.2015.3730.
Despite multiple patient-centered factors being associated with the risk of chemotherapy-induced nausea and vomiting (CINV), these factors are rarely considered when making antiemetic recommendations.
To compare risk model-guided (RMG) antiemetic prophylaxis with physician's choice (PC) in patients receiving chemotherapy for early-stage breast cancer.
DESIGN, SETTING, AND PARTICIPANTS: A randomized clinical trial of 324 patients with early-stage breast cancer undergoing chemotherapy (cyclophosphamide and an anthracycline) for the first time at 2 specialty cancer care centers in Ottawa from April 10, 2012, to September 2, 2014. Patients were randomized to either the RMG arm (n = 154) or the PC control arm (n = 170). Prior to each cycle of chemotherapy patients in the RMG group were categorized as low or high risk for CINV, and their antiemetic treatments were adjusted accordingly.
Patients considered to be at low risk received standard dexamethasone and a 5-HT3 antagonist, while those at high risk also received aprepitant with or without olanzapine, based on their risk level. The PC control group received antiemetic agents according to the treating physician's discretion.
The primary end points were control of both nausea and vomiting in the acute posttreatment period (first 24 hours after therapy) and in the delayed posttreatment period (days 2-5 after therapy).
The total numbers of chemotherapy cycles delivered in the RMG and PC control groups were 497 and 551 respectively. In the acute period, significantly more patients in the RMG group reported no nausea (53.7% [95% CI, 49.2%-58.1%] vs 41.6% [95% CI, 37.4%-45.3%]; P < .001) and no vomiting (91.8% [95% CI, 89.0%-94.0%] vs 82.2% [95% CI, 78.8%-85.3%]; P < .001) compared with the PC control group. Similarly, significantly more patients in the RMG group reported no nausea (39.6% [95% CI, 35.3%-44.1%] vs 30.7% [95% CI, 26.8%-34.7%]; P = .01) and no vomiting (87.1% [95% CI, 83.8%-90.0%) vs 78.0% [95% CI, 74.3%-81.4%]; P < .001) in the delayed period respectively.
In this trial, the RMG antiemetic prophylaxis led to improved control of acute and delayed CINV compared with physician's choice of therapy.
clinicaltrials.gov Identifier: NCT01913990.
尽管有多项以患者为中心的因素与化疗引起的恶心和呕吐（CINV）的风险相关，但在制定止吐建议时很少考虑这些因素。
比较风险模型指导（RMG）止吐预防与医师选择（PC）在接受早期乳腺癌化疗的患者中的效果。
设计、地点和参与者：这是一项在渥太华的 2 家专业癌症护理中心进行的 324 例早期乳腺癌患者的随机临床试验，这些患者于 2012 年 4 月 10 日至 2014 年 9 月 2 日首次接受环磷酰胺和蒽环类药物化疗。患者被随机分配到 RMG 组（n = 154）或 PC 对照组（n = 170）。在每个化疗周期之前，RMG 组的患者被归类为 CINV 的低风险或高风险，并且根据他们的风险水平相应地调整他们的止吐治疗。
被认为低风险的患者接受标准地塞米松和 5-HT3 拮抗剂治疗，而高风险的患者则根据风险水平接受阿瑞匹坦加或不加奥氮平治疗。PC 对照组根据治疗医生的判断接受止吐药物治疗。
主要终点是在急性治疗后期间（治疗后 24 小时内）和延迟治疗后期间（治疗后第 2-5 天）控制恶心和呕吐。
RMG 组和 PC 对照组分别接受了 497 个和 551 个化疗周期。在急性期，RMG 组报告无恶心的患者明显更多（53.7%[95%CI，49.2%-58.1%] vs 41.6%[95%CI，37.4%-45.3%]；P<0.001）和无呕吐的患者明显更多（91.8%[95%CI，89.0%-94.0%] vs 82.2%[95%CI，78.8%-85.3%]；P<0.001）与 PC 对照组相比。同样，RMG 组报告无恶心的患者明显更多（39.6%[95%CI，35.3%-44.1%] vs 30.7%[95%CI，26.8%-34.7%]；P=0.01）和无呕吐的患者明显更多（87.1%[95%CI，83.8%-90.0%] vs 78.0%[95%CI，74.3%-81.4%]；P<0.001）在延迟期间分别。
在这项试验中，与医师选择的治疗相比，RMG 止吐预防可改善急性和延迟性 CINV 的控制。
clinicaltrials.gov 标识符：NCT01913990。
