Personalised antiemetic prophylaxis with NEPA for patients at high risk of chemotherapy-induced nausea and vomiting receiving moderately emetogenic chemotherapy: results from the randomised, multinational MyRisk trial.

However, in patients with an elevated risk of chemotherapy-induced nausea and vomiting (CINV) due to individual risk factors, prophylaxis with an neurokinin-1 (NK1) RA-containing regimen may optimise their antiemetic prevention.

然而，在因个体风险因素而有较高化疗相关恶心和呕吐（CINV）风险的患者中，使用含有神经激肽1（NK1）RA的方案进行预防可能会优化他们的抗呕吐预防。

To address this unmet need for a more personalised antiemetic strategy, the MyRisk trial incorporated a predictive risk factor algorithm to select patients at increased risk of CINV who may benefit from enhanced antiemetic prophylaxis.

为了满足更加个性化的抗呕吐策略需求，MyRisk试验纳入了一种预测性风险因素算法，以选择那些可能因CINV风险增加而受益于加强抗呕吐预防的患者。

patients_and_methods

MyRisk was a phase IV, randomised, open-label, multicentre, multinational trial. Adult patients scheduled to receive three cycles of MEC with a high-risk CINV score were randomly assigned to NEPA (a fixed combination of an NK1 RA, netupitant, and 5-HT3 RA, palonosetron) + DEX or SOC.

MyRisk是一项IV期、随机、开放标签、多中心、多国的试验。成年患者计划接受三个周期的MEC治疗，并具有高风险CINV评分，被随机分配至NEPA（一种固定组合的NK1受体拮抗剂，netupitant和5-HT3受体拮抗剂，palonosetron）+ DEX或SOC。

The CINV risk score was calculated based on an algorithm that considered seven risk factors.

化疗相关恶心呕吐（CINV）风险评分是根据一个考虑了七个风险因素的算法计算得出的。

The primary endpoint was complete response (CR: no emesis/no rescue medication) during the overall phase (0-120 h) across three consecutive cycles.

主要终点是在三个连续周期的整个阶段（0-120小时）内完全缓解（CR：无呕吐/无急救药物）。

Results

Of 401 randomly allocated patients, 388 were included in the efficacy analysis.

在随机分配的401名患者中，有388名患者被纳入疗效分析。

The most common cancers were colorectal and lung; oxaliplatin and carboplatin were the most common MECs.

最常见的癌症类型是结直肠癌和肺癌；奥沙利铂和卡铂是最常用的化疗药物。

Patients randomly assigned to NEPA were significantly more likely to experience a CR compared with SOC (odds ratio 1.67, 95% confidence interval1.12-2.49, P = 0.012).

随机分配至NEPA组的患者相比标准治疗(SOC)组更有可能实现完全缓解(CR)，其比值比为1.67，95%置信区间为1.12-2.49，P值为0.012。

The NEPA group had a significantly higher probability of CR, no nausea, no emesis, and complete protection (81.0%, 63.7%, 95.4%, and 71.8%, respectively) compared with the SOC arm (71.8%, 54.9%, 86.7%, and 62.4%, respectively) across three cycles of chemotherapy.

在三个化疗周期中，NEPA组实现完全缓解(CR)、无恶心、无呕吐和完全保护的概率显著高于SOC组，分别为81.0%、63.7%、95.4%和71.8%，而SOC组则分别为71.8%、54.9%、86.7%和62.4%。

Conclusions

When individual risk factors are considered before MEC, a three-drug regimen including NEPA provides superior CINV prevention across multiple cycles compared with the standard two-drug approach.

在多模式预防恶心呕吐（MEC）之前考虑个体风险因素时，包含NEPA的三药方案在多个周期中提供了优于标准两药方法的CINV预防效果。

These findings underscore the value of personalised risk-adapted antiemetic strategies and have practice-changing potential for optimising antiemetic control.

这些发现强调了个性化风险适应性止吐策略的价值，并有可能改变实践，以优化止吐控制。