Abstract 1573P
Background
Despite many years of clinical research, nausea and vomiting remain one of the most common side effects related to chemotherapy. The aim of our study was to determine non-pharmacological, patient-related risk factors for chemotherapy-induced nausea and vomiting (CINV) and to develop a unique predictive score in patients with gynaecological cancers planned for chemotherapy.
Methods
A research-based questionnaire of 27 risk factors was created. It was handed out to chemotherapy naïve patients and data on nausea and vomiting from at least 3 cycles of 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. Bayesian logistic regression (a risk prediction model) 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
A total of 191 patients were enrolled. The most frequent diagnosis was ovarian cancer (69%) and the most frequent chemotherapy the carboplatinum/paclitaxel combination (57.7%). The most important predictive factors for CINV were: 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. All questions were answered by 132 (69.1%) patients. Among those, 97 (68%) reported nausea or vomiting. The AUC of the predictive score based on the above mentioned factors was 0.741, with a sensitivity of 80.4%, a specificity of 51.4% and an overall accuracy of 72.7%.
Conclusions
Until now, a patient-related predictive model for the occurrence of CINV is missing. The score featured in our study showed a very promising predictive power and is currently under validation in the next phase of the trial.
Clinical trial identification
Entwicklung eines Risikomodells für das Auftreten von Übelkeit und Erbrechen unter Chemotherapie (EmRISK / NOGGO S18) DRKS-ID: DRKS00015151.
Editorial acknowledgement
Legal entity responsible for the study
North-Eastern German Society of Gynaecological Oncology e.V. (NOGGO e.V.).
Funding
Esteve Pharmaceuticals GmbH.
Disclosure
J. Sehouli: Financial Interests, Research Grant: Roche Pharma, AstraZeneca, Bayer, Clovis, GlaxoSmith, Lilly, Tesaro; Financial Interests, Honorary: Tesaro, GlaxoSmith, PharmaMar, AstraZeneca, Clovis, Bayer, Roche, Vifor Pharma, Hexal AG, Novartis Pharma; Financial Interests, Consulting: Tesaro, Merck, Pfizer, PharmaMar, Clovis Oncolo, AstraZeneca, RochePharma, GlaxoSmith, MSD, Eisai, Novocure, Oncoinvent. G. Oskay-Öczelik: Financial Interests, Advisory Board: AMgen, AstraZeneca, Daiichi Sankyo, MSD, Organon, Pfizer; Financial Interests, Invited Speaker: AMgen, AstraZeneca, Daiichi Sankyo, MSD, Organon, Pfizer. D. Zocholl: Financial Interests, Institutional: Merck Group. P. Wimberger: Financial Interests, Institutional, Advisory Board: Amgen; Financial Interests, Institutional, Funding: Amgen; Financial Interests, Institutional, Honoraria/expenses: Amgen; Financial Interests, Advisory Board: AstraZeneca, MSD, Novartis, Pfizer, Lilly, Roche, Teva, Eisai, Clovis, GSK; Financial Interests, Funding: AstraZeneca, MSD, Novartis, Pfizer, Roche, Clovis, GSK; Financial Interests, Honoraria/expenses: AstraZeneca, MSD, Novartis, Pfizer, Lilly, Roche, Teva, Eisai, Clovis, GSK. W. Ruhwedel: Financial Interests, Full or part-time Employment: Klinikum Gütersloh. T.N. Fehm: Financial Interests, Institutional, Honoraria: Novartis, Roche, Pfizer, Daiichi Sankyo. M. Markert: Financial Interests, Full or part-time Employment, Hospital: Vidia Kliniken Karlsruhe. A. Zorr: Financial Interests, Advisory Board: KLS Martin Group, Aesculap AG; Financial Interests, Full or part-time Employment: Klinikum Konstanz GLKN- Frauenklinik. J.P. Grabowski: Financial Interests, Personal, Honoraria: Clovis, Roche, Tesaro, GSK, AstraZeneca, Pfizer; Financial Interests, Personal, Honoraria/Honoraria: MSD; Financial Interests, Advisory Role: GSK, Tesaro, AstraZeneca, MSD; Financial Interests, Speaker’s Bureau: GSK, Tesaro, AstraZeneca, MSD, Pfizer, Clovis, Roche; Financial Interests, Expert Testimony: GSK, Tesaro, AstraZeneca, MSD, Pfizer, Clovis, Roche; Financial Interests, Institutional, Research Grant, /Funding: AstraZeneca, MSD, Tesaro, GSK, Clovis, Riemser; Financial Interests, Travel/Accommodation/Expenses: AstraZeneca, Tesaro, GSK, Riemser. All other authors have declared no conflicts of interest.