Hiromitsu Kitayama1, Yasushi Tsuji2, Junko Sugiyama2, Ayako Doi2, Tomohiro Kondo2, Michiaki Hirayama3. 1. Department of Medical Oncology, Tonan Hospital, Kita 1 Jo Nishi 6 Chome, Chuo-ku, Sapporo, Hokkaido, 060-0001, Japan. m02032hk@jichi.ac.jp. 2. Department of Medical Oncology, Tonan Hospital, Kita 1 Jo Nishi 6 Chome, Chuo-ku, Sapporo, Hokkaido, 060-0001, Japan. 3. Department of Gastroenterological Medicine, Tonan Hospital, Hokkaido, Japan.
Abstract
BACKGROUND: Although palonosetron (PALO) and NK1 receptor antagonist both reduce chemotherapy-induced nausea and vomiting, no comparison trial in moderately emetogenic chemotherapy (MEC) had been reported. The purpose of this study was to find out which drug combinations are preferable for patients receiving MEC. METHODS:Chemotherapy-naive patients receiving MEC were randomized to two groups; group A first received PALO therapy [PALO plus 1-day dexamethasone (DEX)], and group B first received fosaprepitant (FAPR) therapy [FAPR, granisetron (GRAN), and DEX]. Patients were re-allocated to the other therapy, respectively, for the second cycle of chemotherapy. We administered intravenous PALO (0.75 mg) and DEX (9.9 mg) to the PALO therapy group, and FAPR (150 mg), DEX (4.95 mg), and GRAN (3 mg) to the FAPR therapy group, on Day 1. Complete response (CR) was the primary endpoint; complete control (CC), total control (CT), and the therapy chosen by the patients for their third and following cycles of antiemetic therapy were the secondary endpoints. We evaluated CR, CC, and TC in the acute phase, in the delayed phase, and over the whole period. RESULTS: A total of 35 patients and 70 cycles of therapy was evaluable for analysis. No significant difference was found at all evaluation points. Overall CR rates for PALO and FAPR therapy were 74 vs 69 % (P = 0.567), CC rates 66 vs 69 % (P = 0.521), and TC rates 46 vs 60 % (P = 0.235), respectively. Patients also showed no clear preference for their third and following cycles of chemotherapy, choosing both regimens almost equally often (PALO 10 vs FAPR 13). CONCLUSIONS:PALO and 1-day DEX is almost equivalent to FAPR, GRAN, and DEX for MEC.
RCT Entities:
BACKGROUND: Although palonosetron (PALO) and NK1 receptor antagonist both reduce chemotherapy-induced nausea and vomiting, no comparison trial in moderately emetogenic chemotherapy (MEC) had been reported. The purpose of this study was to find out which drug combinations are preferable for patients receiving MEC. METHODS: Chemotherapy-naive patients receiving MEC were randomized to two groups; group A first received PALO therapy [PALO plus 1-day dexamethasone (DEX)], and group B first received fosaprepitant (FAPR) therapy [FAPR, granisetron (GRAN), and DEX]. Patients were re-allocated to the other therapy, respectively, for the second cycle of chemotherapy. We administered intravenous PALO (0.75 mg) and DEX (9.9 mg) to the PALO therapy group, and FAPR (150 mg), DEX (4.95 mg), and GRAN (3 mg) to the FAPR therapy group, on Day 1. Complete response (CR) was the primary endpoint; complete control (CC), total control (CT), and the therapy chosen by the patients for their third and following cycles of antiemetic therapy were the secondary endpoints. We evaluated CR, CC, and TC in the acute phase, in the delayed phase, and over the whole period. RESULTS: A total of 35 patients and 70 cycles of therapy was evaluable for analysis. No significant difference was found at all evaluation points. Overall CR rates for PALO and FAPR therapy were 74 vs 69 % (P = 0.567), CC rates 66 vs 69 % (P = 0.521), and TC rates 46 vs 60 % (P = 0.235), respectively. Patients also showed no clear preference for their third and following cycles of chemotherapy, choosing both regimens almost equally often (PALO 10 vs FAPR 13). CONCLUSIONS:PALO and 1-day DEX is almost equivalent to FAPR, GRAN, and DEX for MEC.
Authors: Bernardo L Rapoport; Karin Jordan; Judith A Boice; Arlene Taylor; Carole Brown; James S Hardwick; Alexandra Carides; Timothy Webb; Hans-Joachim Schmoll Journal: Support Care Cancer Date: 2009-07-01 Impact factor: 3.603
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: M S Aapro; S M Grunberg; G M Manikhas; G Olivares; T Suarez; S A Tjulandin; L F Bertoli; F Yunus; B Morrica; F Lordick; A Macciocchi Journal: Ann Oncol Date: 2006-06-09 Impact factor: 32.976
Authors: Lucas Vieira dos Santos; Fabiano Hahn Souza; Andre Tesainer Brunetto; Andre Deeke Sasse; João Paulo da Silveira Nogueira Lima Journal: J Natl Cancer Inst Date: 2012-08-21 Impact factor: 13.506
Authors: Alexander Molassiotis; Peter A Coventry; Carrie T Stricker; Caroline Clements; Beth Eaby; Luke Velders; Cynthia Rittenberg; Richard J Gralla Journal: J Pain Symptom Manage Date: 2007-05-23 Impact factor: 3.612
Authors: Luigi Celio; Sergio Frustaci; Angela Denaro; Angela Buonadonna; Antonio Ardizzoia; Elena Piazza; Alessandra Fabi; Alba Maria Capobianco; Luciano Isa; Luigi Cavanna; Alessandro Bertolini; Ettore Bichisao; Emilio Bajetta Journal: Support Care Cancer Date: 2010-06-25 Impact factor: 3.603