Thesis

77 4 CHEMOTHERAPY-INDUCED NAUSEA AND VOMITING | PART TWO Figure 3. Percentage of patients with no or minimal impact on daily life (NIDL) based on the overall FLIE scores. Abbreviations: DEX, 3-day dexamethasone; FLIE, Functional Living Index-Emesis; MCP, metoclopramide; PAL, palonosetron Differences in NIDL scores on day 2 were not statistically significant between the MCP and DEX arms (p = 0.80) or between the PAL and DEX arms (p = 0.50). On day 6, mean FLIE score was 114 (SD, 16.1) in the DEX arm, 114 (SD, 21.5) in the MCP arm, and 114 (SD, 21.2) in the PAL arm. A higher proportion of patients in the PAL arm reported NIDL (80%), compared with 70.9% and 78.1% of the patients reporting NIDL in the DEX and PAL arm, respectively. Differences in NIDL scores were not statistically significant between the MCP and DEX arms ( p = 0.37), nor between the PAL and DEX arms (p = 0.21). Safety Table 3 shows the incidence of moderate to severe DEX-associated side effects (DSQ score 3-4). Increased appetite, rash/acne of the face, and indigestion/reflux were the most common side effects in all treatment arms. All side effects were easily manageable and controllable. Differences in incidence were not statistically significant between treatment arms. Metoclopramide-associated dyskinesias rarely occurred: six patients (9.1%) suffered from mild (AIMS grade 2) involuntary movements of the oral or facial musculature; four patients (6.1%) from mild involuntary movements of the upper or lower limbs. Severe involuntary movement of the facial musculature (AIMS grade 4) was reported by only one patient (1.5%). Severe involuntary movement of the jaw was also experienced by one patient. There were no DEX- or metoclopramide-associated side effects leading to withdrawal from the study.

RkJQdWJsaXNoZXIy MjY0ODMw