68 PART TWO | CHEMOTHERAPY-INDUCED NAUSEA AND VOMITING Abstract Background: For the prevention of chemotherapy-induced nausea and vomiting (CINV) during the delayed phase (24-120 hr) after moderately emetogenic chemotherapy (MEC), the use of 3-day dexamethasone (DEX) is often recommended. This study compared the efficacy and safety of two DEX-sparing regimens with 3-day DEX, focusing on delayed nausea. Patientsandmethods: Thisopen-label, randomized, phase III studywasdesigned to demonstrate noninferiority of two DEX-sparing regimens: ondansetron + DEX on day 1, metoclopramide on days 2-3 (MCP arm), and palonosetron + DEX on day 1 (PAL arm) to ondansetron on day 1 + DEX on days 1-3 (DEX arm) in chemotherapy-naïve patients receiving MEC. Primary efficacy endpoint was total control (TC; no emetic episodes, no use of rescuemedication, no nausea) in the delayed phase. Noninferiority was defined as a lower 95%CI greater than the noninferiority margin set at -20%. Secondary endpoints included no vomiting, no rescue medication, no (significant) nausea, impact of CINV on quality of life, antiemetics-associated side effects. Results: Treatment arms were comparable for 189 patients analyzed: predominantly male (55.7%); median age 65.0 years; colorectal cancer (85.7%); oxaliplatin-based chemotherapy (81.5%). MCP demonstrated noninferiority to DEX for delayed TC (MCP 56.1% versus DEX 50.0%, 95% CI (-11.3%, 23.5%)). PAL also demonstrated noninferiority to DEX (PAL 55.6% versus DEX 50.0%, 95% CI (-12.0%, 23.2%)). There were no statistically significant differences for all secondary endpoints between treatment arms. Conclusions: This study showed that DEX-sparing regimens are noninferior to multiple-day DEX in terms of delayed TC rate in patients undergoing MEC. Key words: metoclopramide, dexamethasone, palonosetron, vomiting, nausea, moderately emeto-genic chemotherapy
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