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

Zhang, Zhonghan; Yang, Yunpeng; Lu, Ping; Li, Xiaoqin; Chang, Jianhua; Ruan, Zheng; Zhou, Lei; Chen, Shaoshui; Xiao-pin, Chen; Ren, Bin; Jiang, Xiaodong; Peng, Jiyong; Huang, Miaolong; Feng, Guosheng; Shen, Peng; Zhang, Qingyuan; Zhang, Baihong; Huang, Yan; He, Jie; Chen, Ying-Lan; Cao, Jingxu; Wang, Hong; Li, Wei; Wan, Huiping; Kang, Nan; Liao, Zhijun; Zhang, Cuiying; Zhong, Diansheng; Xu, Qing; Liu, Hailong; Sun, Tao; Deng, Yanming; Zhang, Li

doi:10.21037/atm.2019.12.158

Cited by 9 publications

(6 citation statements)

References 21 publications

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“…regimen, and the clinical trial met its predefined primary endpoint. The efficacy findings of the current study were consistent with those of previous phase III trials on fosaprepitant regimens in patients treated with cisplatin-based chemotherapy [7,17].…”

Section: Discussionsupporting

confidence: 89%

Validation of different personalized risk models of chemotherapy‐induced nausea and vomiting: results of a randomized, double‐blind, phase III trial of fosaprepitant for cancer patients treated with high‐dose cisplatin

Zhao

Chen

et al. 2022

Cancer Communications

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Background: Highly emetogenic chemotherapy induces emesis in cancer patients without prophylaxis. The purpose of this study was to evaluate the efficacy and safety of a fosaprepitant-based triple antiemetic regimen for the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients with solid malignant tumors, determine risk factors and externally validate different personalized risk models for CINV.Methods: This phase III trial was designed to test the non-inferiority of fosaprepitant toward aprepitant in cancer patients who were to receive the first cycle of single-day cisplatin chemotherapy. The primary endpoint was complete response (CR) during the overall phase (OP) with a non-inferiority margin of 10.0%. Logistic regression models were used to assess the risk factors of CR and no nausea. To validate the personalized risk models, the accuracy of the risk scoring systems was determined by measuring the specificity, sensitivity and area under the receiver operating characteristic (ROC) curve (AUC), while the predictive accuracy of the nomogram was measured using concordance index (C-index).

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Section: Discussionsupporting

confidence: 89%

Validation of different personalized risk models of chemotherapy‐induced nausea and vomiting: results of a randomized, double‐blind, phase III trial of fosaprepitant for cancer patients treated with high‐dose cisplatin

Zhao

Chen

et al. 2022

Cancer Communications

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“…The conventional oral anti-emetic regimen containing aprepitant resulted in no significant nausea in 70-73% of patients, as reported in three randomized controlled trials with cisplatin-based regimens [ 17 - 19 ] and 61% in an anthracycline and cyclophosphamide-based regimen study [ 20 ]. Fosaprepitant, an injectable anti-emetic that is also used as a single antiemetic prophylaxis, reported NSN in 71.65% of patients [ 21 ].…”

Section: Discussionmentioning

confidence: 99%

“…Pain in the leg (n = 3), abdominal pain, dyspepsia, and general weakness (n = 2 each) were the most common AEs reported in our study. Real-world studies and landmark clinical trials conducted in the past reported treatment AEs in the range of 5-12%, with constipation, headache, and fatigue as common AEs [7][8][9][10][11][12][13][14][15][16][17][18][19][20][21][22][23].…”

Section: Discussionmentioning

confidence: 99%

An Open-Label, Single-Arm, Multicenter, Observational Study Evaluating the Safety and Effectiveness of Akynzeo® in the Management of Chemotherapy-Induced Nausea and Vomiting in India

Gupta,

MV,

Thomas

et al. 2024

Cureus

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Background Chemotherapy-induced nausea and vomiting is a common and unpleasant treatment-related side effect reported by cancer patients receiving chemotherapy. Akynzeo® or NEPA (NEtupitant + PAlonosetron) is the first fixed combination of netupitant and palonosetron that targets both critical pathways involved in emesis while providing a convenient, single oral dose therapy. The current study aimed to assess the effectiveness and safety of NEPA in a real-world setting in India. Methodology This was an open-label, multicenter, prospective, single-arm study conducted at six different locations across India. The study included patients of either gender, aged ≥18 years, naive to chemotherapy, scheduled to receive highly or moderately emetogenic chemotherapy (HEC/MEC), and scheduled to receive oral NEPA, as determined by the investigator. Results A total of 360 people were screened and enrolled in the study. HEC was prescribed to 289 (81.64%) patients, while MEC was prescribed to 65 (18.36%) patients. Complete response was achieved in 94.92% of patients during the acute phase, 95.20% during the delayed phase, and 93.22% during the overall phase. During the overall phase, 92.73% and 95.38% of patients on the HEC and MEC regimens, respectively, achieved complete response. Adverse events were reported in 3.88% of patients. Conclusions Oral NEPA was found to be effective in the Indian real-world setting, eliciting a >90% complete response with HEC and MEC regimens across the acute, delayed, and overall phases.

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“…Further examples of the great potential of NADESs for biocatalysis are shown in Scheme 8. All of these examples are bioreductions of acetophenone derivatives, which have provided key enantiopure intermediates to important bioactive compounds, such as AD101 (SCH-350581) [33,34], Ticagrelor [35] and Aprepitant [36,37]. Xia et al reported the preparation of (R)-1-[4-(trifluoromethyl)phenyl]ethanol through the bioreduction of 4-(trifluoromethyl)acetophenone biocatalyzed by recombinant E. coli LXCAR-S154Y and Geotrichum ZJPH1810, using 3% NADES/DES as co-solvents in a buffer (Scheme 8).…”

Section: Biocatalysis In Dessmentioning

confidence: 99%

Stereoselective Catalytic Synthesis of Bioactive Compounds in Natural Deep Eutectic Solvents (NADESs): A Survey across the Catalytic Spectrum

Carreiro,

Federsel,

Hermann

et al. 2024

Catalysts

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Deep eutectic solvents (DESs) are a mixture of two or more components, and at a particular composition, they become liquids at room temperature. When the compounds that constitute the DESs are primary metabolites namely, amino acids, organic acids, sugars, or choline derivatives, the DESs are called natural deep eutectic solvents (NADESs). NADESs fully represent green chemistry principles. These solvents are highly welcome, as they are obtained from renewable resources, and gratifyingly are biodegradable and biocompatible. They are an alternative to room-temperature ionic liquids (RTILs). From the pharmaceutical industry’s point of view, they are highly desirable, but they unfortunately have been rarely used despite their enormous potential. In this review, we look at their impact on the asymmetric catalytic synthesis of key target molecules via metal-based catalysis, biocatalysis, and organocatalysis. In many cases, the NADESs that have been used are chiral and can even promote enantioselective reactions; this crucial and very exciting aspect is also discussed and analyzed.

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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

Cited by 9 publications

References 21 publications

Validation of different personalized risk models of chemotherapy‐induced nausea and vomiting: results of a randomized, double‐blind, phase III trial of fosaprepitant for cancer patients treated with high‐dose cisplatin

Validation of different personalized risk models of chemotherapy‐induced nausea and vomiting: results of a randomized, double‐blind, phase III trial of fosaprepitant for cancer patients treated with high‐dose cisplatin

An Open-Label, Single-Arm, Multicenter, Observational Study Evaluating the Safety and Effectiveness of Akynzeo® in the Management of Chemotherapy-Induced Nausea and Vomiting in India

Stereoselective Catalytic Synthesis of Bioactive Compounds in Natural Deep Eutectic Solvents (NADESs): A Survey across the Catalytic Spectrum

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