2154 - 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.

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 < 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 (OR 0.177, p < 0.035) and history of morning sickness (OR 5.038, p < 0.032).

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.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.