Naoto Furukawa1, Seiji Kanayama2, Yasuhito Tanase2, Fuminori Ito2. 1. Department of Obstetrics and Gynecology, Nara Prefecture Western Medical Center, 1-14-16 Mimuro, Sango-cho, Ikoma-gun, Nara, 636-0802, Japan. furunao0813@gmail.com. 2. Department of Obstetrics and Gynecology, Nara Medical University, 840 Shijo-cho, Kashihara, Nara, 634-8522, Japan.
Abstract
PURPOSE: The aim of the present study was to evaluate the efficacy and toxicity of palonosetron (PAL) and dexamethasone (DEX) on day 1 only in patients with gynecologic cancer receivingpaclitaxel combined with carboplatin (TC). The primary endpoint was to evaluate the complete response (CR) rate in the delayed phase. METHODS: This study was a randomized phase 2. Regardless of assignment to either study arm, all patients received an intravenous prophylactic regimen of DEX (20 mg) within 15 min and then an intravenous dose of PAL (0.75 mg) as a bolus given 30 min before initiation of TC on day 1. Patients in the DEX 1-day group received no additional DEX on days 2 and 3. Patients in the DEX 3-day group received DEX (8 mg) orally on days 2 and 3. RESULTS: Eighty-two patients had evaluable data on the primary outcome. The CR rates in the delayed phase between the two groups were not statistically significantly different (3-day group, 76.9 % [30/39]; 1-day group 69.8 % [30/43]; p = 0.4652). The frequency of constipation and insomnia which were antiemetic treatment-related adverse events was similar between two groups, and no serious adverse events occurred. CONCLUSIONS: Administration of a combination of PAL and DEX 1 day may prevent chemotherapy-induced nausea and vomiting (CINV) in the delayed phase for TC as well as administration of DEX 3 days. Further evaluation of the antiemetic regimen of combination of PAL and DEX 1 day for TC is warranted in future phase 3 trials.
RCT Entities:
PURPOSE: The aim of the present study was to evaluate the efficacy and toxicity of palonosetron (PAL) and dexamethasone (DEX) on day 1 only in patients with gynecologic cancer receiving paclitaxel combined with carboplatin (TC). The primary endpoint was to evaluate the complete response (CR) rate in the delayed phase. METHODS: This study was a randomized phase 2. Regardless of assignment to either study arm, all patients received an intravenous prophylactic regimen of DEX (20 mg) within 15 min and then an intravenous dose of PAL (0.75 mg) as a bolus given 30 min before initiation of TC on day 1. Patients in the DEX 1-day group received no additional DEX on days 2 and 3. Patients in the DEX 3-day group received DEX (8 mg) orally on days 2 and 3. RESULTS: Eighty-two patients had evaluable data on the primary outcome. The CR rates in the delayed phase between the two groups were not statistically significantly different (3-day group, 76.9 % [30/39]; 1-day group 69.8 % [30/43]; p = 0.4652). The frequency of constipation and insomnia which were antiemetic treatment-related adverse events was similar between two groups, and no serious adverse events occurred. CONCLUSIONS: Administration of a combination of PAL and DEX 1 day may prevent chemotherapy-induced nausea and vomiting (CINV) in the delayed phase for TC as well as administration of DEX 3 days. Further evaluation of the antiemetic regimen of combination of PAL and DEX 1 day for TC is warranted in future phase 3 trials.
Entities:
Keywords:
Chemotherapy-induced nausea and vomiting; Dexamethasone; Paclitaxel and carboplatin; Palonosetron
Authors: Ethan Basch; Ann Alexis Prestrud; Paul J Hesketh; Mark G Kris; Petra C Feyer; Mark R Somerfield; Maurice Chesney; Rebecca Anne Clark-Snow; Anne Marie Flaherty; Barbara Freundlich; Gary Morrow; Kamakshi V Rao; Rowena N Schwartz; Gary H Lyman Journal: J Clin Oncol Date: 2011-09-26 Impact factor: 44.544
Authors: Dyah Aryani Perwitasari; Jarir Atthobari; Mustofa Mustofa; Iwan Dwiprahasto; Mohammad Hakimi; Hans Gelderblom; Hein Putter; Johan W R Nortier; Henk-Jan Guchelaar; Ad A Kaptein Journal: Int J Gynecol Cancer Date: 2012-01 Impact factor: 3.437
Authors: Silvia Damian; Luigi Celio; Elena De Benedictis; Paola Mariani; Francesco Agustoni; Francesca Ricchini; Filippo De Braud Journal: Oncology Date: 2013-05-22 Impact factor: 2.935
Authors: Paul A Vasey; Gordon C Jayson; Alan Gordon; Hani Gabra; Rob Coleman; Ronnie Atkinson; David Parkin; James Paul; Andrea Hay; Stan B Kaye Journal: J Natl Cancer Inst Date: 2004-11-17 Impact factor: 13.506
Authors: Robert C Grant; Coleman Rotstein; Geoffrey Liu; Leta Forbes; Kathy Vu; Roy Lee; Pamela Ng; Monika Krzyzanowska; David Warr; Jennifer Knox Journal: Support Care Cancer Date: 2020-06-30 Impact factor: 3.603
Authors: Luigi Celio; Erminio Bonizzoni; Emma Zattarin; Paolo Codega; Filippo de Braud; Matti Aapro Journal: BMC Cancer Date: 2019-12-30 Impact factor: 4.430