Marziyeh Ghorbani1, Mehdi Dehghani2, Noushin Fahimfar3, Soha Namazi4, Ali Dehshahri5. 1. Department of Pharmaceutical Biotechnology, School of Pharmacy, Shiraz University of Medical Sciences, Shiraz, Iran. 2. Hematology Research Center, Department of Hematology and Medical Oncology, Shiraz University of Medical Sciences, Shiraz, Iran. 3. Osteoporosis Research Center, Endocrinology and Metabolism Clinical Sciences Institute, Tehran University of Medical Sciences, Tehran, Iran. 4. Research Center for Rational Use of Drugs, Tehran University of Medical Sciences (TUMS), Tehran, Iran. 5. Department of Pharmaceutical Biotechnology, School of Pharmacy, Shiraz University of Medical Sciences, Shiraz, Iran. A.Dehshahri@gmail.com.
Abstract
PURPOSE: The current study aimed at investigating the efficacy of aprepitant-containing triple antiemetic regimen in FLOT (fluorouracil + leucovorin + oxaliplatin + docetaxel) recipients as well as the emetogenic potential of FLOT regimen, through comparison of nausea and vomiting rates in a moderately emetogenic chemotherapy, FLOT, and a highly emetogenic chemotherapy recipients. STUDY: Patients planned to receive one of FLOT, FOLFOX (fluorouracil + leucovorin + oxaliplatin/moderate-emetic risk), or TAC (docetaxel + doxorubicin + cyclophosphamide/high-emetic risk) regimens were recruited. All patients were treated with the same triple antiemetic regimen containing aprepitant. RESULTS: A total of 165 chemotherapy-naïve patients (52 FLOT recipients) were eligible to enter the study. At the end of day 5, "complete response" (primary efficacy endpoint) was achieved by 84.6%, 63.5%, and 61.5% of the FLOT-receiving patients in acute, delayed, and overall phases, respectively. A significant difference was seen among the odds of FLOT recipients and FOLFOX recipients concerning "complete response" achievement in delayed (p = 0.014) and overall (p = 0.017) phases, "no emesis" in delayed (p = 0.018) and overall (p = 0.010) phases, and also "complete protection" in acute (p = 0.023), delayed (p = 0.009), and overall (p = 0.006) phases; however, the difference between the odds of FLOT recipients and TAC recipients, in relation to achieving these endpoints, was insignificant. FLOT group showed significantly faster time-to-antiemetic regimen failure and time-to-first emetic episode in comparison with the FOLFOX group, which was insignificant in comparison with the TAC group. CONCLUSION: According to the findings, FLOT has to be considered as a high-emetic-risk regimen; provided that, as recommended by the antiemetic guidelines towards better management of delayed nausea and vomiting induced by highly emetogenic regimens, executing clinical trials concerning the efficacy of continuing dexamethasone on days 2-4 in aprepitant-containing triple antiemetic regimen schedule is required.
PURPOSE: The current study aimed at investigating the efficacy of aprepitant-containing triple antiemetic regimen in FLOT (fluorouracil + leucovorin + oxaliplatin + docetaxel) recipients as well as the emetogenic potential of FLOT regimen, through comparison of nausea and vomiting rates in a moderately emetogenic chemotherapy, FLOT, and a highly emetogenic chemotherapy recipients. STUDY: Patients planned to receive one of FLOT, FOLFOX (fluorouracil + leucovorin + oxaliplatin/moderate-emetic risk), or TAC (docetaxel + doxorubicin + cyclophosphamide/high-emetic risk) regimens were recruited. All patients were treated with the same triple antiemetic regimen containing aprepitant. RESULTS: A total of 165 chemotherapy-naïve patients (52 FLOT recipients) were eligible to enter the study. At the end of day 5, "complete response" (primary efficacy endpoint) was achieved by 84.6%, 63.5%, and 61.5% of the FLOT-receiving patients in acute, delayed, and overall phases, respectively. A significant difference was seen among the odds of FLOT recipients and FOLFOX recipients concerning "complete response" achievement in delayed (p = 0.014) and overall (p = 0.017) phases, "no emesis" in delayed (p = 0.018) and overall (p = 0.010) phases, and also "complete protection" in acute (p = 0.023), delayed (p = 0.009), and overall (p = 0.006) phases; however, the difference between the odds of FLOT recipients and TAC recipients, in relation to achieving these endpoints, was insignificant. FLOT group showed significantly faster time-to-antiemetic regimen failure and time-to-first emetic episode in comparison with the FOLFOX group, which was insignificant in comparison with the TAC group. CONCLUSION: According to the findings, FLOT has to be considered as a high-emetic-risk regimen; provided that, as recommended by the antiemetic guidelines towards better management of delayed nausea and vomiting induced by highly emetogenic regimens, executing clinical trials concerning the efficacy of continuing dexamethasone on days 2-4 in aprepitant-containing triple antiemetic regimen schedule is required.
Authors: P J Hesketh; M G Kris; S M Grunberg; T Beck; J D Hainsworth; G Harker; M S Aapro; D Gandara; C M Lindley Journal: J Clin Oncol Date: 1997-01 Impact factor: 44.544
Authors: Paul J Hesketh; Mark G Kris; Ethan Basch; Kari Bohlke; Sally Y Barbour; Rebecca Anne Clark-Snow; Michael A Danso; Kristopher Dennis; L Lee Dupuis; Stacie B Dusetzina; Cathy Eng; Petra C Feyer; Karin Jordan; Kimberly Noonan; Dee Sparacio; Mark R Somerfield; Gary H Lyman Journal: J Clin Oncol Date: 2017-07-31 Impact factor: 44.544
Authors: Joseph S Bubalo; Jon D Herrington; Marc Takemoto; Patricia Willman; Michael S Edwards; Casey Williams; Alan Fisher; Alison Palumbo; Eric Chen; Charles Blanke; Charles D Lopez Journal: Support Care Cancer Date: 2017-10-31 Impact factor: 3.603
Authors: Salah-Eddin Al-Batran; Nils Homann; Claudia Pauligk; Thorsten O Goetze; Johannes Meiler; Stefan Kasper; Hans-Georg Kopp; Frank Mayer; Georg Martin Haag; Kim Luley; Udo Lindig; Wolff Schmiegel; Michael Pohl; Jan Stoehlmacher; Gunnar Folprecht; Stephan Probst; Nicole Prasnikar; Wolfgang Fischbach; Rolf Mahlberg; Jörg Trojan; Michael Koenigsmann; Uwe M Martens; Peter Thuss-Patience; Matthias Egger; Andreas Block; Volker Heinemann; Gerald Illerhaus; Markus Moehler; Michael Schenk; Frank Kullmann; Dirk M Behringer; Michael Heike; Daniel Pink; Christian Teschendorf; Carmen Löhr; Helga Bernhard; Gunter Schuch; Volker Rethwisch; Ludwig Fischer von Weikersthal; Jörg T Hartmann; Michael Kneba; Severin Daum; Karsten Schulmann; Jörg Weniger; Sebastian Belle; Timo Gaiser; Fuat S Oduncu; Martina Güntner; Wael Hozaeel; Alexander Reichart; Elke Jäger; Thomas Kraus; Stefan Mönig; Wolf O Bechstein; Martin Schuler; Harald Schmalenberg; Ralf D Hofheinz Journal: Lancet Date: 2019-04-11 Impact factor: 79.321
Authors: Gábor Kovács; Antonio E Wachtel; Elena V Basharova; Tulla Spinelli; Pierre Nicolas; Edita Kabickova Journal: Lancet Oncol Date: 2016-01-19 Impact factor: 41.316
Authors: Alessandro Parisi; Riccardo Giampieri; Alex Mammarella; Cristiano Felicetti; Lisa Salvatore; Maria Bensi; Maria Grazia Maratta; Antonia Strippoli; Roberto Filippi; Maria Antonietta Satolli; Angelica Petrillo; Bruno Daniele; Michele De Tursi; Pietro Di Marino; Guido Giordano; Matteo Landriscina; Pasquale Vitale; Ina Valeria Zurlo; Emanuela Dell'Aquila; Silverio Tomao; Ilaria Depetris; Francesca Romana Di Pietro; Federica Zoratto; Davide Ciardiello; Maria Vittoria Pensieri; Ornella Garrone; Barbara Galassi; Claudio Ferri; Rossana Berardi; Michele Ghidini Journal: Front Oncol Date: 2022-08-12 Impact factor: 5.738