APF530 versus ondansetron, each in a guideline-recommended three-drug regimen, for the prevention of chemotherapy-induced nausea and vomiting due to anthracycline plus cyclophosphamide–based highly emetogenic chemotherapy regimens: a post hoc subgroup analysis of the Phase III randomized MAGIC trial
| Autor: | Robert B. Geller, Sharon Wilks, Christopher Dakhil, Lee S. Schwartzberg, Jeffrey L. Vacirca, Nicholas J. Vogelzang, Ian D. Schnadig, Eduardo Braun, Nashat Y. Gabrail, Charles J. Taylor, Richy Agajanian, Michael Mosier |
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| Jazyk: | angličtina |
| Rok vydání: | 2017 |
| Předmět: |
Nausea
Population highly emetogenic chemotherapy (HEC) Granisetron anthracycline Fosaprepitant APF530 Ondansetron 03 medical and health sciences 0302 clinical medicine medicine extended release granisetron 030212 general & internal medicine education Dexamethasone Original Research education.field_of_study business.industry chemotherapy-induced nausea and vomiting (CINV) Regimen Oncology Cancer Management and Research 030220 oncology & carcinogenesis Anesthesia cyclophosphamide medicine.symptom business medicine.drug Chemotherapy-induced nausea and vomiting |
| Zdroj: | Cancer Management and Research |
| ISSN: | 1179-1322 |
| Popis: | Ian D Schnadig1, Richy Agajanian2, Christopher Dakhil3, Nashat Gabrail4, Jeffrey Vacirca5, Charles Taylor6, Sharon Wilks7, Eduardo Braun8, Michael C Mosier9, Robert B Geller10, Lee Schwartzberg11, NicholasVogelzang12 1Compass Oncology, US Oncology Research, Tualatin, OR, 2The Oncology Institute of Hope and Innovation, Whittier, CA, 3Cancer Center of Kansas, Wichita, KS, 4Gabrail Cancer Center, Canton, OH, 5North Shore Hematology Oncology, East Setauket, NY, 6Tulsa Cancer Institute, Tulsa, OK, 7Cancer Care Centers of South Texas, San Antonio, TX, 8Michiana Hematology Oncology, Westville, IN, 9Biostatistics, EMB Statistical Solutions, LLC, Overland Park, KS, 10Medical Affairs, Heron Therapeutics, Inc., San Diego, CA, 11West Cancer Center, Germantown, TN, 12Comprehensive Cancer Centers of Nevada, Las Vegas, NV, USA Background: APF530, a novel extended-release granisetron injection, was superior to ondansetron in a guideline-recommended three-drug regimen in preventing delayed-phase chemotherapy-induced nausea and vomiting (CINV) among patients receiving highly emetogenic chemotherapy (HEC) in the double-blind Phase III Modified Absorption of Granisetron In the prevention of CINV (MAGIC) trial.Patients and methods: This MAGIC post hoc analysis evaluated CINV prevention efficacy and safety of APF530 versus ondansetron, each with fosaprepitant and dexamethasone, in patient subgroup receiving an anthracycline plus cyclophosphamide (AC) regimen. Patients were randomized 1:1 to APF530 500mg subcutaneously (granisetron 10mg) or ondansetron 0.15mg/kg intravenously (IV) (≤16mg); stratification was by planned cisplatin ≥50mg/m2 (yes/no). Patients were to receive fosaprepitant 150mg IV and dexamethasone 12mg IV on day1, then dexamethasone 8mg orally once daily on day 2 and twice daily on days 3 and 4. Patients were mostly younger females (APF530 arm, mean age 54.1years, female, 99.3%; ondansetron arm, 53.8years, female 98.3%). The primary end point was delayed-phase (>24–120 hours) complete response (CR). Results: APF530 versus ondansetron regimens achieved numerically better CINV control in delayed and overall (0–120 hours) phases for CR, complete control, total response, rescue medication use, and proportion with no nausea. APF530 trends are consistent with the overall population, although not statistically superior given the underpowered AC subgroup analysis. The APF530 regimen in this population was generally well tolerated, with safety comparable to that of the overall population.Conclusion: APF530 plus fosaprepitant and dexamethasone effectively prevented CINV among patients receiving AC-based HEC, a large subgroup in whom CINV control has traditionally been challenging. Keywords: APF530, extended release granisetron, chemotherapy-induced nausea and vomiting (CINV), highly emetogenic chemotherapy (HEC), anthracycline, cyclophosphamide |
| Databáze: | OpenAIRE |
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