NIV Congres

Introduction: Chemotherapy is a very important backbone in the treatment of cancer but has a lot of adverse effects, in particular nausea and/or vomiting. Levels of nausea are divided in three emetogenic levels: low, moderate and high. Despite the use of antiemetics more than 35% and in high emetogenic chemotherapy even 60% of patients still experience nausea. February 2011 a new antiemetics protocol was implemented in Orbis Medical Centre (OMC) based on MASCC, ASCO and ESMO guidelines.

Aim of the study: Our primary aim is to evaluate the effectiveness of this new antiemetics protocol in the three different subgroups.

Methods: A retrospective, single centre, observational study was performed at the hemato-oncology (in- and outpatient) clinic of OMC. Due to standardised and obligatory registration before each cycle of chemotherapy, the occurrence and the extent of side effects are recorded of all treated patients. The population was divided in two groups, a control and an intervention cohort. In order to demonstrate a clinical relevant difference of 33%, at least 156 patients per group (95% power, alpha 0.05) had to be included. For statistics we used SPSS version 19.0, in which a P-value < 0.05 was considered statistically significant. The results are analysed with the Chi-square and 2-sided t-test. Since there are confounders (gender and age) we performed a multivariable logistic regression analysis.

Results: The analysis was conducted with toxicity data of 723 patients. In these patients 2912 cycles of therapy were evaluated on nausea and/or vomiting toxicity. There were no significant differences in baseline characteristics in both cohorts, except for age. In the control cohort 238/390 patients (61%) indicated that they had one or more episodes of nausea and/or vomiting compared to 158/333 patients (47%) in the new protocol (OR 0.55; CI 0.406-0.743, p < 0.001). There was no significant difference in low emetogenic chemotherapy treatments (OR 1.56; CI 0.584-4.416, p = 0.376). However, we did find a significant difference in moderate en high emetogenic drugschemes. In the moderate emetogenic group 81/390 control cohort patients versus 59/333 patients in the intervention cohort experienced side effects (OR 0.47; CI 0.274-0.794, p = 0.005). In the high emetogenic chemotherapeutic drugschemes this was 138/231 (60%) vs. 78/184 (45%) patients respectively (OR 0.44; CI 0.269-0.727, p = 0.001).

Conclusion: The implementation of a new, standardized, antiemetics protocol has resulted into a significant decrease in the incidence and severity of nausea and/or vomiting, in particular in high emetogenic chemotherapy.