Matti Aapro1, Zoe Caprariu2, Petio Chilingirov3, Marika Chrápavá4, Razvan-Ovidiu Curca5, Laurentia Gales6, Alexandru C Grigorescu7, Joanna Huszno8, Bára Karlínová4, Renata Kellnerová9, Miroslava Malejčíková10, Mihai Marinca11, Edgar Petru12, Adam Płużanski13, Petra Pokorná14, Zuzana Pribulova15, Maryna Rubach16, Gunther G Steger17, Petra Tesařová18, Lubica Valekova19, Nicolay Yordanov20, Anna Walaszkowska-Czyz21. 1. Oncology Department, Genolier Cancer Center, Clinique de Genolier, Genolier, Switzerland. Electronic address: maapro@genolier.net. 2. Oncomed, Timisoara, Romania. 3. Complex Oncology Center, Stara Zagora, Stara Zagora, Bulgaria. 4. Institute of Biostatistics and Analyses, Ltd., Brno, Czech Republic. 5. Emergency County Hospital, Alba Iulia, Romania. 6. Department of Medical Oncology, Clinical Hospital for Nephrology "Carol Davila" Bucharest, Bucharest, Romania; Carol Davila University of Medicine and Pharmacy, Bucharest, Romania. 7. Department of Medical Oncology, Clinical Hospital for Nephrology "Carol Davila" Bucharest, Bucharest, Romania. 8. Radiotherapy Department, Genetic Outpatient Clinic, Maria Skłodowska-Curie National Research Institute of Oncology, Gliwice, Poland. 9. Medical Department, Angelini Pharma, Česká republika s.r.o., Brno, Czech Republic. 10. Clinical Oncology Department, National Cancer Institute, Bratislava, Slovak Republic. 11. Grigore T. Popa University of Medicine and Pharmacy, Regional Oncology Institute, Iasi, Romania. 12. Department of Obstetrics and Gynecology, Medical University of Graz, Graz, Austria. 13. Lung Cancer and Chest Tumors Department, Maria Sklodowska Curie National Research Institute of Oncology, Warsaw, Poland. 14. Department of Oncology, 2(nd) Faculty of Medicine, Charles University in Prague and Motol University Hospital, Prague, Czech Republic. 15. Department of Oncology, East Slovakian Institute of Oncology, Košice, Slovak Republic. 16. Chemotherapy Day Ward, Maria Sklodowska Curie National Research Institute of Oncology, Warsaw, Poland. 17. Division of Oncology, Department of Internal Medicine I and Gaston H. Glock - Research Center, Medical University of Vienna, Vienna, Austria. 18. Department of Oncology, 1st Faculty of Medicine, Charles University and General University Hospital, Prague, Czech Republic. 19. University Hospital Martin, Martin, Slovak Republic. 20. Department Medical Oncology, Medical University - Sofia, Affiliation - Vratsa, Comprehensive Cancer Center - Vratsa, Vratsa, Bulgaria. 21. Szpital Świętej Rodziny, Oddział Onkologiczny, Warsaw, Poland.
Abstract
BACKGROUND: Evidence-based antiemetic guidelines offer predominantly consistent recommendations for chemotherapy-induced nausea and vomiting (CINV) prophylaxis. However, studies suggest that adherence to these recommendations is suboptimal. We explored inconsistencies between clinical practice and guideline-recommended treatment with a registry evaluating the effect of guideline-consistent CINV prophylaxis (GCCP) on patient outcomes. PATIENTS AND METHODS: This was a prospective, non-interventional, multicentre study. The primary objective was to assess the overall (Days 1-5) complete response (CR: no emesis/no rescue use) rates in patients who received GCCP or guideline-inconsistent CINV prophylaxis (GICP) using diaries for 5 days following chemotherapy. Cycle 1 results are presented in patients who received either (1) anthracycline/cyclophosphamide (AC) highly emetogenic chemotherapy (HEC), non-AC HEC or carboplatin, with GCCP for all these groups consisting of prophylaxis with an NK1 receptor antagonist (RA), 5-HT3RA and dexamethasone prior to chemotherapy or (2) moderately emetogenic chemotherapy (MEC), with GCCP consisting of a 5-HT3RA and dexamethasone prior to chemotherapy as per MASCC/ESMO 2016 guidelines, in place at the time of the study. RESULTS: 1,089 patients were part of the cycle 1 efficacy evaluation. Overall GCCP was 23%. CR rates were significantly higher (P < 0.05) in patients receiving GCCP (62.2%) versus GICP (52.6%) in the overall population, as well as in the subsets of patients receiving AC/non-AC HEC (60.2% versus 47.8%), MEC (73.8% versus 57.8%) and in those non-naïve to the chemotherapy received (65.9% versus 53.8%). No impact on daily living due to CINV (FLIE assessment) was observed in 43.4% patients receiving GCCP versus 28.5% GICP (P < 0.001). CONCLUSION: Consistent with prior studies, GCCP was very low; a significant benefit of almost 10% improved prevention of CINV was observed with GCCP. As per MASCC/ESMO guidelines, such an absolute difference should be practice changing. Comprehensive multifaceted strategies are needed to achieve better adherence to antiemetic guidelines.
BACKGROUND: Evidence-based antiemetic guidelines offer predominantly consistent recommendations for chemotherapy-induced nausea and vomiting (CINV) prophylaxis. However, studies suggest that adherence to these recommendations is suboptimal. We explored inconsistencies between clinical practice and guideline-recommended treatment with a registry evaluating the effect of guideline-consistent CINV prophylaxis (GCCP) on patient outcomes. PATIENTS AND METHODS: This was a prospective, non-interventional, multicentre study. The primary objective was to assess the overall (Days 1-5) complete response (CR: no emesis/no rescue use) rates in patients who received GCCP or guideline-inconsistent CINV prophylaxis (GICP) using diaries for 5 days following chemotherapy. Cycle 1 results are presented in patients who received either (1) anthracycline/cyclophosphamide (AC) highly emetogenic chemotherapy (HEC), non-AC HEC or carboplatin, with GCCP for all these groups consisting of prophylaxis with an NK1 receptor antagonist (RA), 5-HT3RA and dexamethasone prior to chemotherapy or (2) moderately emetogenic chemotherapy (MEC), with GCCP consisting of a 5-HT3RA and dexamethasone prior to chemotherapy as per MASCC/ESMO 2016 guidelines, in place at the time of the study. RESULTS: 1,089 patients were part of the cycle 1 efficacy evaluation. Overall GCCP was 23%. CR rates were significantly higher (P < 0.05) in patients receiving GCCP (62.2%) versus GICP (52.6%) in the overall population, as well as in the subsets of patients receiving AC/non-AC HEC (60.2% versus 47.8%), MEC (73.8% versus 57.8%) and in those non-naïve to the chemotherapy received (65.9% versus 53.8%). No impact on daily living due to CINV (FLIE assessment) was observed in 43.4% patients receiving GCCP versus 28.5% GICP (P < 0.001). CONCLUSION: Consistent with prior studies, GCCP was very low; a significant benefit of almost 10% improved prevention of CINV was observed with GCCP. As per MASCC/ESMO guidelines, such an absolute difference should be practice changing. Comprehensive multifaceted strategies are needed to achieve better adherence to antiemetic guidelines.