Cancer Research and Treatment

Original Articles

Ramosetron versus Palonosetron in Combination with Aprepitant and Dexamethasone for the Control of Highly-Emetogenic Chemotherapy-Induced Nausea and Vomiting: Jin Hyoung Kang, Jung Hye Kwon, Yun-Gyoo Lee, Keon Uk Park, Ho Jung An, Joohyuk Sohn, Young Mi Seol, Hyunwoo Lee, Hwan-Jung Yun, Jin Seok Ahn, Ji Hyun Yang, Hunho Song, Dong-Hoe Koo, Jin Young Kim, Gun Min Kim, Hwa Jung Kim; Cancer Res Treat. 2020;52(3):907-916. Published online March 18, 2020; DOI: https://doi.org/10.4143/crt.2019.713

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Purpose
The purpose of this study was to compare ramosetron (RAM), aprepitant (APR), and dexamethasone (DEX) [RAD] with palonosetron (PAL), APR, and DEX [PAD] in controlling highly-emetogenic chemotherapy (HEC)–induced nausea and vomiting.
Materials and Methods
Patients were randomly assigned (1:1) to receive RAD or PAD:RAM (0.3 mg intravenously) or PAL (0.25 mg intravenously) D1, combined with APR (125 mg orally, D1 and 80 mg orally, D2-3) and DEX (12 mg orally or intravenously, D1 and 8 mg orally, D2-4). Patients were stratified by gender, cisplatin-based chemotherapy, and administration schedule. The primary endpoint was overall complete response (CR), defined as no emesis and no rescue regimen during 5 days of HEC. Secondary endpoints were overall complete protection (CP; CR+nausea score < 25 mm) and total control (TC; CR+nausea score < 5 mm). Quality of life was assessed by Functional Living Index Emesis (FLIE) questionnaire on D0 and D6.
Results
A total of 279 patients receiving RAD (n=137) or PAD (n=142) were evaluated. Overall CR rates in RAD and PAD recipients were 81.8% and 79.6% (risk difference [RD], 2.2%; 95% confidence interval [CI], −7.1 to 11.4), respectively. Overall CP and TC rates for RAD and PAD were 56.2% and 58.5% (RD, −2.3%; 95% CI, −13.9 to 9.4) and 47.5% vs. 43.7% (RD, 3.8%; 95% CI, −7.9 to 15.5), respectively. FLIE total score ≥ 108 (no impact on daily life) was comparable between RAD and PAD (73.9% vs. 73.4%, respectively). Adverse events were similar between the two groups.
Conclusion
In all aspects of efficacy, safety and QOL, RAD is non-inferior to PAD for the control of CINV in cancer patients receiving HEC.

Citations

Citations to this article as recorded by

Impact of body weight-based dosing of palonosetron and ondansetron on postoperative nausea and vomiting following laparoscopic sleeve gastrectomy: a randomized, double-blind study
Büşra Burcu, Nadir Adnan Hacım, Ozan Caliskan, Serdar Demirgan, Talar Vartanoglu Aktokmakyan, Serhat Meric, Tomris Duymaz, Onder Karabay, Ali Solmaz
Acta Chirurgica Belgica.2024; 124(1): 41. CrossRef
2023 updated MASCC/ESMO consensus recommendations: prevention of nausea and vomiting following high-emetic-risk antineoplastic agents
Jørn Herrstedt, L Celio, PJ Hesketh, L Zhang, R Navari, A Chan, M Saito, R Chow, M Aapro
Supportive Care in Cancer.2024;[Epub] CrossRef
2023 MASCC and ESMO guideline update for the prevention of chemotherapy- and radiotherapy-induced nausea and vomiting
J. Herrstedt, R. Clark-Snow, C.H. Ruhlmann, A. Molassiotis, I. Olver, B.L. Rapoport, M. Aapro, K. Dennis, P.J. Hesketh, R.M. Navari, L. Schwartzberg, M.L. Affronti, M.A. Garcia-Del-Barrio, A. Chan, L. Celio, R. Chow, M. Fleury, R.J. Gralla, R. Giusti, F.
ESMO Open.2024; 9(2): 102195. CrossRef
Ramosetron 3.0 μg/mL Combining with Dexamethasone (0.05, 0.1, 0.2 mg/mL) in Infusion Solutions: A Physicochemical Stability Study
Baoxia Fang, Lijun Zhao, Shirong Yu, Fuchao Chen
Dose-Response.2024;[Epub] CrossRef
Efficacy and safety of Antiemetic Regimens for Highly Emetogenic Chemotherapy-Induced Nausea and Vomiting: A Systematic Review and Network Meta-Analysis
Marco Filetti, Pasquale Lombardi, Raffaele Giusti, Rosa Falcone, Florian Scotte, Diana Giannarelli, Antonella Carcagnì, Valeria Altamura, Giovanni Scambia, Gennaro Daniele
Cancer Treatment Reviews.2023; : 102512. CrossRef
Effect of Acupuncture on Delayed Emesis for the Patients Who Received High-Emetogenic Chemotherapy with Standard Antiemetic Prophylaxis (KHMC-HO-01): An Open-Label, Randomized Study
Chi Hoon Maeng, Seunghoon Lee, Jae Joon Han, Hong Jun Kim, Dongwoo Nam, Junhee Lee, Sun Kyung Baek, Maria Grazia Ferraro
Evidence-Based Complementary and Alternative Medicine.2022; 2022: 1. CrossRef
Cardioprotective action of aprepitant in a rat model of ischemia-reperfusioninduced myocardial injury: role of PI3K-AkT-GSK-3β-HIF-1α signaling pathway
Mei Qian, Yang Liu
Acta Cirúrgica Brasileira.2022;[Epub] CrossRef
Comparison of the Effectiveness of Palonosetron and Ramosetron in Preventing Postoperative Nausea and Vomiting: Updated Systematic Review and Meta-Analysis with Trial Sequential Analysis
Hyo Jin Kim, EunJin Ahn, Geun Joo Choi, Hyun Kang
Journal of Personalized Medicine.2022; 13(1): 82. CrossRef
Oliceridine is Associated with Reduced Risk of Vomiting and Need for Rescue Antiemetics Compared to Morphine: Exploratory Analysis from Two Phase 3 Randomized Placebo and Active Controlled Trials
Timothy L. Beard, Cathy Michalsky, Keith A. Candiotti, Paul Rider, Linda Wase, Ashraf S. Habib, Mark A. Demitrack, Michael J. Fossler, Eugene R. Viscusi
Pain and Therapy.2021; 10(1): 401. CrossRef
Forsythiae Fructus aqueous extract attenuates cisplatin-induced kaolin consumption (pica) by inhibiting NLRP3 inflammasome activation in rats
Qi Meng, Pingping Bi, Guanglong Zhang, Yaqi Li, Siqi Chen, Ke Nie
Bioscience, Biotechnology, and Biochemistry.2021; 85(9): 2054. CrossRef
Antiemetics for adults for prevention of nausea and vomiting caused by moderately or highly emetogenic chemotherapy: a network meta-analysis
Vanessa Piechotta, Anne Adams, Madhuri Haque, Benjamin Scheckel, Nina Kreuzberger, Ina Monsef, Karin Jordan, Kathrin Kuhr, Nicole Skoetz
Cochrane Database of Systematic Reviews.2021;[Epub] CrossRef
Duration of dexamethasone administration for the prevention of chemotherapy-induced nausea and vomiting – A systematic review and meta-analysis
Ajay Raghunath, Sahan D. Chandrasekara, Shane N. Anthony, Ben Markman
Critical Reviews in Oncology/Hematology.2020; 152: 103012. CrossRef

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A Phase II Study to Evaluate the Efficacy of Ramosetron, Aprepitant, and Dexamethasone in Preventing Cisplatin-Induced Nausea and Vomiting in Chemotherapy-Naive Cancer Patients: Geundoo Jang, Hun Ho Song, Keon Uk Park, Hyeong Su Kim, Dae Ro Choi, Jung Hye Kwon, Ho Young Kim, Boram Han, Jung Han Kim, Joo Young Jung, Hyo Jung Kim, Dae Young Zang; Cancer Res Treat. 2013;45(3):172-177. Published online September 30, 2013; DOI: https://doi.org/10.4143/crt.2013.45.3.172

Abstract PDF PubReader ePub

PURPOSE
Combination therapy with aprepitant, serotonin receptor antagonist, and steroids improves the complete response rate of both acute and delayed chemotherapy-induced nausea and vomiting (CINV). However, it is not known whether ramosetron is suitable for administration in combination with aprepitant. Therefore, we conducted a multicenter, open-label, prospective, phase II study in order to assess the efficacy and tolerability of combination therapy with ramosetron, aprepitant, and dexamethasone (RAD) for prevention of cisplatin-based CINV in chemotherapy-naive patients with solid cancers.
MATERIALS AND METHODS
Forty-one patients with various solid cancers (31 male and 10 female; median age, 59 years) who received treatment with highly emetogenic chemotherapy (median cisplatin dose, 70 mg/m2; range 50 to 75 mg/m2) were enrolled in this study. Oral aprepitant (125 mg on day 1; 80 mg on days 2 and 3), intravenous ramosetron (0.6 mg on day 1), and oral dexamethasone (12 mg on day 1; 8 mg on days 2-4) were administered for prevention of CINV.
RESULTS
The complete response (no emesisand retching and no rescue medication) rate was 94.9% in the acute period (24 hours post-chemotherapy), 92.3% in the delayed period (24-120 hours post-chemotherapy), and 92.3% in the overall period (0-120 hours). The absolute complete response (complete response plus no nausea) rate was 74.4% in the acute period, 51.3% in the delayed period, and 46.2% in the overall period. There were no grade 3 or 4 toxicities related to these antiemetic combinations.
CONCLUSION
RAD regimen is a safe and effective antiemetic treatment for prevention of CINV in patients receiving highly emetogenic chemotherapy.

Citations

Citations to this article as recorded by

Ramosetron Versus Ondansetron in Combination With Aprepitant and Dexamethasone for the Prevention of Highly Emetogenic Chemotherapy-Induced Nausea and Vomiting: A Multicenter, Randomized Phase III Trial, KCSG PC10-21
Hyo Jung Kim, Sang Won Shin, Eun-Kee Song, Na-Ri Lee, Jun Suk Kim, Jin Seok Ahn, Hwan-Jung Yun, Yo-Han Cho, Keon Uk Park, Si-Young Kim, Joung Soon Jang, Sang-We Kim, Hyun Woo Lee, Se Ryeon Lee, Yang Soo Kim, Soon Nam Lee, Yoon Ho Ko, Hwa Jung Kim, Jin-Hyo
The Oncologist.2015; 20(12): 1440. CrossRef
Assessment of low-dose cisplatin as a model of nausea and emesis in beagle dogs, potential for repeated administration
Hannah Kenward, Ludovic Pelligand, Jonathan Elliott
Experimental Brain Research.2014; 232(8): 2685. CrossRef
Anticipatory nausea in animal models: a review of potential novel therapeutic treatments
Erin M. Rock, Cheryl L. Limebeer, Linda A. Parker
Experimental Brain Research.2014; 232(8): 2511. CrossRef

13,570 View
73 Download
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