High incidence of nausea during initial and repeated courses if intravenous chemotherapy in patients receiving guideline consistent antiemetic prophylaxis: A prospective, observational, real-world study

Abstract

Introduction Current research has focused on vomiting as the primary problem of chemotherapy-induced nausea and vomiting (CINV). The incidence and impact of nausea is under-reported and remains a major unmet medical need. Methods This prospective, observational single centre study enrolled 95 pts undergoing intravenous chemotherapy, receiving guideline consistent CINV prophylaxis (GCCP). There were LEC = 25 pts, MEC = 24 pts and HEC = 46 pts. 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. Nausea was reported by the pts using a visual analog scale (VAS). Vomiting episodes were recorded in the patient's diaries and data was analysed as a secondary end-point. Results The incidence of nausea of entire population was significantly higher than vomiting for cycle 1 (58% vs 14%; Chi2 22.271 p<0.0000); for cycle 2 (51% vs 14%; Chi2 26.964 p<0.0000) and for cycle 3 (46% vs 18%; Chi2 14.161 p<0.0002). Nausea was continuous in 25% of the patients in all 3 cycles. For patients with documented intermittent nausea, the mean duration was 3.8 hours. The median maximum intensity of nausea was 6 (range 1-10) for all three cycles. The median time to development of first episode of nausea was 29 hours (range 1 to 90). Significant variables predicted for nausea in cycle 1 included, age and history of morning sickness). Conclusions Despite GCCP, chemotherapy induced nausea remains a major unmet medical need in cancer pts. Further research should focus on treatment of nausea and patient's risk factors.