Efficacy and safety of fosaprepitant in the prevention of nausea and vomiting following highly emetogenic chemotherapy in Chinese people: A randomized, double-blind, phase III study

Yang, Lei; Sun, Xiaoxuan; Qin, Shu Kui; Cheng, Yin; Shi, Jianfei; Chen, Z.D.; Wang, Q.M.; Zhang, H.L.; Hu, Bing; Liu, B.; Zhang, Q.Y.; Wu, Qiong; Wang, D.; Shu, Yongqian; Dong, Juan; Han, Baohui; Wang, K.M.; Dang, Chengxue; Li, J.L.; Wang, H.B.; Li, B.L.; Lu, Jianhua; Zhang, Z.H.; Chen, Y.X.

doi:10.1111/ecc.12668

Cited by 10 publications

(10 citation statements)

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“…Accordingly, these results were also well consistent with the data from Asian population from Japan with CR rates of 64.2%, 93.6% and 64.7% in OP, AP and DP (7). However, another study investigating fosaprepitant-base (Chia Tai Tianqing Pharmaceutical Group Co., Ltd) triple antiemetic regimen in Chinese patients shown that a higher CR rates during the OP (89.33%), as well as the AP (95.73%) and DP (91.16%) was achieved (23). The differences among these studies suggested that more data of fosaprepitant from Chinese patients were required to better evaluate and verify the efficacy and safety of various generic fosaprepitant in terms of CINV.…”

Section: Discussionmentioning

confidence: 99%

Fosaprepitant versus aprepitant in the prevention of chemotherapy-induced nausea and vomiting in patients receiving cisplatin-based chemotherapy: a multicenter, randomized, double-blind, double-simulated, positive-controlled phase III trial

Zhang¹,

Yang²,

Lu³

et al. 2020

Ann Transl Med

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Section: Discussionmentioning

confidence: 99%

Fosaprepitant versus aprepitant in the prevention of chemotherapy-induced nausea and vomiting in patients receiving cisplatin-based chemotherapy: a multicenter, randomized, double-blind, double-simulated, positive-controlled phase III trial

Zhang¹,

Yang²,

Lu³

et al. 2020

Ann Transl Med

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“…Multiple studies have shown that the overall response rates of acute and delayed CINV in HEC patients treated with the triple regimen are 75% to 80% and 57% to 70%, respectively, and the incidence of nausea is more than 50%. This still falls short of the expected goal of 100% mitigation of CINV (43)(44)(45). The mechanism of action of olanzapine is that it binds to the dopamine receptor, cholinergic receptor, and histamine H1 receptor and plays an antagonistic role.…”

Section: Discussionmentioning

confidence: 93%

The Balance Between the Effectiveness and Safety for Chemotherapy-Induced Nausea and Vomiting of Different Doses of Olanzapine (10 mg Versus 5 mg): A Systematic Review and Meta-Analysis

et al. 2021

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IntroductionThe aim of this study is to rigorously review the efficacy and safety of olanzapine in chemotherapy-induced nausea and vomiting (CINV) settings including (1) at 5- and 10-mg doses, and (2) the setting of highly emetogenic chemotherapy (HEC) and moderately emetogenic chemotherapy (MEC).MethodsEmbase, Pubmed, and Cochrane Library were searched from the establishment of the database through April 18, 2021. The primary efficacy endpoints were the rate of complete response (CR; no emesis and no rescue), in the acute (0–24 h post-chemotherapy), delayed (24–120 h post-chemotherapy), and overall (0–120 h post-chemotherapy) phases. The secondary efficacy endpoints were the rates of complete control (CC, no nausea, and no emesis), for each phase. Safety endpoints were the rate of somnolence, as assessed by Common Terminology Criteria for Adverse Events (CTCAE) criteria. The Mantel–Haenszel, random, or fixed-effect analysis model was used to compute risk ratios and accompanying 95% confidence intervals for each endpoint. For endpoints that statistically favored one arm, absolute risk differences were computed to assess whether there is a 10% or greater difference, used as the threshold for clinical significance by MASCC/ESMO.ResultNine studies reported the use of 10 mg olanzapine to prevent CINV; three studies reported the use of 5 mg olanzapine to prevent CINV. When olanzapine was administered at 10 mg for HEC patients, the six endpoints were statistically and clinically better than the control group. For MEC patients, four out of six endpoints were better than the control group. When olanzapine is administered at 5 mg for MEC patients, four endpoints have statistical and clinical advantages. The sedative effects of 10 and 5 mg olanzapine were statistically more significant than those of the control group. The sedative effect of the 10-mg olanzapine group was more significant than that of the 5-mg olanzapine group, both statistically and clinically.Conclusion5 mg olanzapine may be as effective as 10 mg olanzapine for patients with HEC and MEC, and its sedative effect is lower than 10 mg olanzapine. Fewer studies on 5 mg olanzapine have led to uncertain data. In the future, more randomized controlled trials of 5 mg olanzapine are needed to study the balance between the effectiveness and safety of olanzapine.

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“…In Kashiwa's study, the economic results compared the addition of APR or FosAPR relatively with the standard regimen, forming an indirect comparison between APR and FosAPR. However, the clinical trial incorporated in this study was a randomized, parallel-group study in the Chinese population ( 27 ). Based on the trial, the conclusion of the cost-effectiveness of the FosAPR-containing regimen took the APR-containing regimen as the control group.…”

Section: Discussionmentioning

confidence: 99%

“…The clinical data were stemmed from a randomized, double-blind phase 3 clinical trial, a multicentre study that compared the safety and efficacy of FosAPR with APR in Chinese cancer patients ( 27 ). Cancer patients to be enrolled were required to be between 18 and 75 years old receiving high-risk emetic chemotherapy and had a good physical condition, with an Eastern Cooperative Oncology Group (ECOG) performance status score between 0 and 2.…”

Section: Methodsmentioning

confidence: 99%

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Economic Value of Fosaprepitant-Containing Regimen in the Prevention of Chemotherapy-Induced Nausea and Vomiting in China: Cost-Effectiveness and Budget Impact Analysis

Bao

et al. 2022

Front. Public Health

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ObjectiveThe purpose of this study was to evaluate the cost-effectiveness and budget impact of fosaprepitant (FosAPR)-containing regimen for the prevention of chemotherapy-induced nausea and vomiting (CINV) among patients receiving high emetogenic chemotherapy (HEC) from the Chinese payer's perspective.MethodsA decision tree model was established to measure the 5-day costs and health outcomes between the APR-containing regimen (aprepitant, granisetron, and dexamethasone) and FosAPR-containing regimen (fosaprepitant, granisetron, and dexamethasone). Clinical data were derived from a randomized, double-blind controlled trial on Chinese inpatients who received HEC. Quality-adjusted life-years (QALYs) were used to estimate the utility outcomes and the incremental cost-effectiveness ratio (ICER) was calculated to assess the economics of FosAPR. A static budget impact model was developed to assess the impact of FosAPR as a new addition to the National Reimbursement Drug List (NRDL) on the medical insurance fund within 3 years in Nanjing, China.ResultsCompared with APR, FosAPR had a mean health-care savings of ¥121.56 but got a reduction of 0.0001815 QALY, resulting in an ICER of ¥669926.19 per QALY. Deterministic sensitivity analysis revealed that the cost of APR was the most influential factor to the ICER. The cost of FosAPR and the complete control rate of the delayed period also had a high impact on the results. According to the probabilistic analysis, the acceptability of FosAPR was more than 80% when the Chinese willingness-to-pay (WTP) was ¥215,999. FosAPR would lead to a 3-year medical insurance payment increase of ¥1.84 million compared with ¥1.49 million before FosAPR entered NRDL in Nanjing. The total budget increased with a cumulative cost of ¥694,829 and covered an additional 341 patients who benefited from FosAPR in Nanjing. Deterministic sensitivity analysis showed that the model of budget impact analysis was stable.ConclusionFosAPR had a similar treatment effect to APR but was cost-effective in China at the current WTP threshold. The total budget of medical insurance payments of Nanjing slightly increased year by year after the inclusion of FosAPR. Its inclusion in the NRDL would be acceptable and also expand the coverage of patients who benefited from FosAPR.

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Efficacy and safety of fosaprepitant in the prevention of nausea and vomiting following highly emetogenic chemotherapy in Chinese people: A randomized, double-blind, phase III study

Cited by 10 publications

References 14 publications

Fosaprepitant versus aprepitant in the prevention of chemotherapy-induced nausea and vomiting in patients receiving cisplatin-based chemotherapy: a multicenter, randomized, double-blind, double-simulated, positive-controlled phase III trial

Fosaprepitant versus aprepitant in the prevention of chemotherapy-induced nausea and vomiting in patients receiving cisplatin-based chemotherapy: a multicenter, randomized, double-blind, double-simulated, positive-controlled phase III trial

The Balance Between the Effectiveness and Safety for Chemotherapy-Induced Nausea and Vomiting of Different Doses of Olanzapine (10 mg Versus 5 mg): A Systematic Review and Meta-Analysis

Economic Value of Fosaprepitant-Containing Regimen in the Prevention of Chemotherapy-Induced Nausea and Vomiting in China: Cost-Effectiveness and Budget Impact Analysis

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