The development of effective anti-emetic treatments has contributed to the resolution of emesis in chemotherapy patients (pts). There is a growing concern that the emesis focus is primarily on vomiting. Nausea seems to be underestimated and its incidence and impact remains a major unmet medical need. The study focused primarily on nausea in patients undergoing highly-, moderately- or low emetogenic chemotherapy (HEC, MEC, LEC). The primary endpoint was no nausea during the 120-hours overall phase after cycle 1. The analysis focused on the prevalence of nausea and time to nausea development following the first cycle of chemotherapy.
This prospective, observational single centre study enrolled 95 patients undergoing LEC (25 pts), MEC (24 pts) or HEC (46 pts) for malignancy. Prophylactic antiemetics were administered according to MASCC/ESMO 2016 guidelines. Patient diaries were used to collect data from day-1 to day-5, day-7 and day-10 beginning with cycle-1 for up to 3 cycles.
The incidence of nausea of the entire population was 59% compared to only 24% pts experiencing vomiting. (Chi2 = 23.5956; p > .000001). Significant variables predicted for nausea included gender, age and history of motion sickness. The level of emetogenicity did not correlate with the incidence of nausea (LEC = 25%, MEC = 60%, HEC = 67%), (Chi2 = 5.1893; p > .07). On univariate analysis, factors associated with shorter time to the first nausea episode included; age < 60 years (log-rank test p < 0.0213, Chi sq = 2), then motion sickness (p < 0.0229), gender (p < 0.0321) and emetogenicity (p < 0.29). In a Cox-proportional multivariate proportional hazard model age < 60 years, (p < 0.0213), gender (p < 0.0321) and motion sickness (p < 0.0229) retained its significance – while emetogenicity lost its significance.
Chemotherapy induced nausea is underreported and remains a major unmet medical need. Gender, age and motion sickness are significant risk factors associated with nausea independent of the level of emetogenicity of the chemotherapy utilized in patients receiving guideline-based antiemetic prophylaxic treatment.
Clinical trial identification
Legal entity responsible for the study
The Medical Oncology Centre of Rosebank.
Has not received any funding.
All authors have declared no conflicts of interest.