56 PART TWO | CHEMOTHERAPY-INDUCED NAUSEA AND VOMITING Table 1. Characteristics of randomized controlled trials. First author, year (ref) Total No. patients/ non-AC Tumor MEC regimen Study design Primary efficacy endpoint Intervention Results Palonosetron Kaushal, 2010 [19] 30/30 Head and neck TCF Randomized, crossover CR acute, delayed, and overall PAL vs. OND ondansetron NS Tian, 2011 [20] 144/108 Various Various Doubleblind, noninferiority, crossover CR acute PAL vs. GRA PAL not inferior Dexamethasone-sparing regimens Celio, 2011 [18] 332/215 Mainly breast/ CRC Various Open-label, noninferiority, parallel CR overall PAL + DEX day1 vs. PAL + DEX day1-3 PAL not inferior NK1 receptor antagonists Rapoport, 2009 [21] 848/444 Various Various Double-blind, parallel No vomiting overall APR vs. OND APR superior Hesketh, 2012 [22] 707/707 CRC Oxaliplatin Double-blind, parallel CR overall CAS vs. PLA NS Tanioka, 2013 [23] 91/91 GYN Carboplatin Double-blind, parallel, phase II CR overall APR vs. PLA NS NEPA Gralla, 2014 [24] 412/312 Various Various Double-blind, parallel CR acute, delayed, overall NEPA vs. APR + PAL NS Olanzapine Tan, 2009 [25] 229/121 Various Various Open-label, parallel CR acute, delayed, overall OLA day1-5 + AZA + DEX day1 vs. AZA + DEX day 1-5 OLA superior Megestrol acetate Zang, 2011 [26] 100/44 Various Various Single-blind, crossover CR acute, delayed, overall MEG vs. PLA MEG superior Abbreviations: APR, aprepitant; AZA, azasetron; CAS, casopitant; CR, complete response (defined as “no vomiting” and/or “no use of rescue antiemetics); CRC, colorectal cancer; DEX, dexamethasone; GRA, granisetron; GYN, gynecological cancers; MEC, moderately emetogenic chemotherapy; MEG, megestrol acetate; non-AC, not containing anthracyclines and cyclophosphamide; NEPA, netupitant/palonosetron; NS, not significant; OLA, olanzapine; PAL, palonosetron; PLA, placebo; OND, ondansetron; TCF, regimen containing docetaxel, carboplatin and 5-Fluorouracil Palonosetron An open-label, crossover trial was designed to evaluate the efficacy of palonosetron compared with ondansetron [19]. This study included 30 patients with head and neck
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