78 PART TWO | CHEMOTHERAPY-INDUCED NAUSEA AND VOMITING Table 3. Dexamethasone-associated side effects. DSQ DEX arm (n = 60), n (%) MCP arm (n = 66), n (%) PAL arm (n = 63), n (%) Indigestion/ reflux 1 (1.7) 5 (7.6) 5 (7.9) Insomnia 3 (5) 3 (4.5) 3 (4.8) Increased appetite 10 (16.7) 8 (12.1) 9 (14.3) Hiccups 2 (3.3) 0 (0)0 0 (0) Agitation 2 (3.3) 0 (0) 1 (1.6) Depression 3 (5.0) 1 (1.5) 2 (3.2) Rash/acne 4 (6.7) 7 (10.6) 3 (4.8) Thrush/oral yeast infection 2 (3.3) 2 (3.0) 6 (9.5) Abbreviations: DEX, 3-day dexamethasone; DSQ, Dexamethasone Symptom Questionnaire; MCP, metoclopramide; PAL, palonosetron a3-day dexamethasone (DEX) arm b2-day metoclopramide (MCP arm cPalonosetron (PAL) arm All data are N (%) unless otherwise indicated Only moderate to severe dexamethasone-associated side-effects (DSQ score 3 or 4) are shown Discussion The present study demonstrates noninferiority of two DEX-sparing regimens consisting of single-dose DEX plus palonosetron, or a three-drug regimen with single-dose DEX plus ondansetron and 2-day metoclopramide to standard treatment with DEX beyond 24 h in terms of delayed TC rate in patients undergoing MEC. There were no statistically significant differences for any of the secondary endpoints between treatment arms. Our findings suggest that both DEX-sparing regimens may be effective and safe alternatives to multiple-day DEX for control of delayed nausea and vomiting. This study is the first to include nausea assessment as a part of the primary study outcome to better gauge the effectiveness of CINV control and patients’ experience. Due to the subjective nature of nausea, its most reliable index is to measure no nausea rather than no significant nausea. The slightly higher TC rates in the MCP arm were reflected in a quality of life benefit, with a correspondingly higher proportion of patients with no impact on their functioning due to acute and delayed CINV. While the differences were small and not statistically significant, it is encouraging that DEX-sparing strategies demonstrated some potential to improve quality of life.
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