Prospective, multicenter study on non-pharmacological, patient related predictive factors of chemotherapy induced nausea and vomiting (CINV): A NOGGO-EMRISK trial.

e24107 Background: Despite many years of clinical research and development, nausea and vomiting remain challenging toxicities related to chemotherapy. The aim of our study was assessment of non-pharmacological, patient-related risk factors for chemotherapy-induced nausea and vomiting and development of unique predictive score in patients with gynaecological malignancies planned for chemotherapy. Methods: A research-based questionnaire of 27 risk factors was generated and provided to patients diagnosed with gynaecological malignancies prior to indicated chemotherapy. The data on nausea and vomiting from at least 3 cycles therapy was collected. Variable selection via stepwise and LASSO regression combined with patients history was used to identify a small set of questions with high predictive power. As risk prediction model, a Bayesian logistic regression was implemented with a cut-off chosen to yield a sensitivity of 80%. Area under the curve analysis (AUC) was conducted, and accuracy of prediction was calculated. Results: In total 191 patients were enrolled. The most frequent diagnosis and chemotherapy was ovarian cancer (69%) and carboplatinum/paclitaxel combination (57.7%), respectively. Six factors (emetogenic potential of the therapy, educational status, nausea and vomiting due to other medication, motion sickness, anxiety from therapy in general and anxiety from nausea due to therapy) were identified as most important predictive factors. All questions were answered by 132 (69.1%) patients. Among those 97 (68%) reported nausea or vomiting. The AUC of the predictive score consisting mentioned factors was 0.741, with a sensitivity of 80.4%, specificity of 51.4% and an overall accuracy of 72.7%. Conclusions: Patients related risk factors are missing in selection of the antiemetic prophylaxis in patients under chemotherapy. Presented predictive score showed very promising predictive power and is going to be validated in further phase of the trial. Clinical trial information: DRKS-ID: DRKS00015151.