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

Abstract Background The development of effective anti-emetic treatments has contributed to the resolution of emesis in chemotherapy patients (pts). Current research has focused on vomiting as the primary problem of chemotherapy-induced nausea and vomiting (CINV). The incidence and impact of nausea, particularly in cancer pts undergoing chemotherapy is under-reported and remains a major unmet medical need. Methods The study focused on nausea in pts undergoing chemotherapy. The primary endpoint was no nausea during the 120-hours overall phase after the first 3 consecutive cycles of treatment. Secondary endpoints included no nausea during day-7 and day-10 of cycle 1. This prospective, observational single centre study enrolled 95 pts undergoing intravenous chemotherapy, receiving guideline consistent CINV prophylaxis. There were LEC = 25 pts, MEC = 24 pts and HEC (included cisplatin and doxorubicin/cyclophosphamide-based chemotherapy) = 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 the entire population was significantly higher than vomiting for cycle 1 (58% vs 14%; Chi2 22.271 p\xa0 Conclusions Despite the usage of guidelines consistent antiemetic prophylaxis, 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. Legal entity responsible for the study The authors. Funding Has not received any funding. Disclosure All authors have declared no conflicts of interest.