Abstract
Purpose
A considerable challenge when comparing antiemetic trials for chemotherapy-induced nausea and vomiting (CINV) is the large number of outcome measures for nausea and vomiting. The objective of this study is to determine the optimal definition of CINV control from the patients’ perspective.
Methods
Patients with early-stage breast cancer who had received anthracycline-cyclophosphamide-based chemotherapy were surveyed. They were asked about their experiences of CINV and perceptions of different CINV assessment tools.
Results
Of 201 patients approached, 168 (83 %) completed the survey. Patients consistently ranked nausea over vomiting as the “worst side effect from chemotherapy.” Despite the use of multi-agent antiemetic regimens, 71 % of patients experienced nausea and 26 % vomiting. Only 57 % of patients with any nausea or vomiting took rescue medications and only then when the symptom was severe. Most (76 %) patients believed that the primary end point of antiemetic trials should include the absence of both nausea and vomiting. Patients felt that CINV should be evaluated for the overall period post chemotherapy (i.e., days 1–5) and not simply the acute (the first 24 h) or delayed (days 2–5) periods.
Conclusions
Patients strongly favored a CINV end point that includes the absence of both nausea and vomiting. Patients’ experience with CINV is underestimated when nausea is not included in composite end points. “Use of rescue medication,” a commonly used surrogate for emesis control, is inappropriate as it underestimates nausea. A standardized primary end point that includes nausea is essential if CINV control is to be improved.
Similar content being viewed by others
References
Hesketh PJ (2008) Chemotherapy-induced nausea and vomiting. N Engl J Med 358:2482–2494. doi:10.1056/NEJMra0706547
Warr D, Pater J, Trip K (2013) Antiemetic working group. Antiemetic report. Clinical evidence for recommendations. Retrieved from https://www.cancercare.on.ca/CCO_DrugFormulary/Pages/FileContent.aspx?fileId=288895. Accessed 1 Sept 2014
Basch E, Prestrud A, Hesketh P et al (2011) Antiemetics: American Society of Clinical Oncology clinical practice guideline update. J Clin Oncol. doi:10.1200/JCO.2010.34.4614
Ettinger D, Armstrong D, Barbour S (2014) Clinical practice guidelines in oncology: antiemesis. Version 2.2014 NCCN. http://www.nccn.org/professionals/physician_gls/f_guidelines.asp#antiemesis. Accessed 20 Oct 2014
Roila F, Herrstedt J, Aapro M et al (2010) Guideline update for MASCC and ESMO in the prevention of chemotherapy- and radiotherapy-induced nausea and vomiting: results of the Perugia consensus conference. Ann Oncol Off J Eur Soc Med Oncol ESMO 21(Suppl 5):v232–v243. doi:10.1093/annonc/mdq194
Young S, Callaghan H, Trudeau M, Petrella T (2007) Chemotherapy-induced nausea and vomiting in breast cancer patients: a prospective observational study. J Support Oncol 5:374–380
Bouganim N, Dranitsaris G, Hopkins S et al (2012) Prospective validation of risk prediction indexes for acute and delayed chemotherapy-induced nausea and vomiting. Curr Oncol (Toronto, Ont) 19:e414–e421. doi:10.3747/co.19.1074
Hickok JT, Roscoe JA, Morrow GR et al (2003) Nausea and emesis remain significant problems of chemotherapy despite prophylaxis with 5-hydroxytryptamine-3 antiemetics: a University of Rochester James P. Wilmot Cancer Center Community Clinical Oncology Program Study of 360 cancer patients treated in the community. Cancer 97:2880–2886. doi:10.1002/cncr.11408
Ng TL, Clemons M, Hutton B, Dranistaris G (2014) Aprepitant versus dexamethasone to prevent delayed emesis after chemotherapy. J Clin Oncol Off J Am Soc Clin Oncol 32:2184–2185. doi:10.1200/JCO.2014.55.3503
Ng TL, Clemons M, Kuchuk I, Roscoe J, Hutton B (2013) Anti-emetic choice for breast cancer patients receiving anthracycline-based chemotherapy: using network meta-analyses to drive optimal care. Poster presented at: San Antonio Breast Cancer Symposium. December 10-14. San Antonio, Texas
Ng TL, Clemons M, Kuchuk I, et al (2013) Optimal anti-emetic choice for breast cancer patients receiving anthracycline and cyclophosphamide-based chemotherapy—a systematic review and network meta-analysis of randomized controlled trials. San Antonio Breast Cancer Symposium 2013. December 10-14, 2013
Clemons M (2014) Prevention of chemotherapy induced nausea and vomiting in breast cancer patient (ER11-02). ClinicalTrials.gov. National Library of Medicine (US), Bethesda (MD). 2000. http://clinicaltrials.gov/show/NCT01913990 NLM Identifier: NCT01913990. Accessed 20 Oct 2014
Aapro M, Fabi A, Nolè F et al (2010) Double-blind, randomised, controlled study of the efficacy and tolerability of palonosetron plus dexamethasone for 1 day with or without dexamethasone on days 2 and 3 in the prevention of nausea and vomiting induced by moderately emetogenic chemotherapy. Ann Oncol Off J Eur Soc Med Oncol ESMO 21:1083–1088. doi:10.1093/annonc/mdp584
Herrstedt J, Apornwirat W, Shaharyar A et al (2009) Phase III trial of casopitant, a novel neurokinin-1 receptor antagonist, for the prevention of nausea and vomiting in patients receiving moderately emetogenic chemotherapy. J Clin Oncol Off J Am Soc Clin Oncol 27:5363–5369. doi:10.1200/jco.2009.21.8511
Yeo W, Mo FK, Suen JJ et al (2009) A randomized study of aprepitant, ondansetron and dexamethasone for chemotherapy-induced nausea and vomiting in Chinese breast cancer patients receiving moderately emetogenic chemotherapy. Breast Cancer Res Treat 113:529–535. doi:10.1007/s10549-008-9957-9
Warr DG, Hesketh PJ, Gralla RJ et al (2005) Efficacy and tolerability of aprepitant for the prevention of chemotherapy-induced nausea and vomiting in patients with breast cancer after moderately emetogenic chemotherapy. J Clin Oncol Off J Am Soc Clin Oncol 23:2822–2830. doi:10.1200/JCO.2005.09.050
Herrstedt J, Muss HB, Warr DG et al (2005) Efficacy and tolerability of aprepitant for the prevention of chemotherapy-induced nausea and emesis over multiple cycles of moderately emetogenic chemotherapy. Cancer 104:1548–1555. doi:10.1002/cncr.21343
Herrington JD, Jaskiewicz AD, Song J (2008) Randomized, placebo-controlled, pilot study evaluating aprepitant single dose plus palonosetron and dexamethasone for the prevention of acute and delayed chemotherapy-induced nausea and vomiting. Cancer 112:2080–2087. doi:10.1002/cncr.23364
Rapoport B, Jordan K, Boice J et al (2010) Aprepitant for the prevention of chemotherapy-induced nausea and vomiting associated with a broad range of moderately emetogenic chemotherapies and tumor types: a randomized, double-blind study. Support Care Cancer Off J Multl Assoc Support Care Cancer 18:423–431. doi:10.1007/s00520-009-0680-9
Kaizer L, Warr D, Hoskins P et al (1994) Effect of schedule and maintenance on the antiemetic efficacy of ondansetron combined with dexamethasone in acute and delayed nausea and emesis in patients receiving moderately emetogenic chemotherapy: a phase III trial by the National Cancer Institute of Canada Clinical Trials Group. J Clin Oncol 12:1050–1057
Cruz FM, de Iracema Gomes Cubero D, Taranto P et al (2012) Gabapentin for the prevention of chemotherapy-induced nausea and vomiting: a pilot study. Support Care Cancer Off J Multl Assoc Suppor Care Cancer 20:601–606. doi:10.1007/s00520-011-1138-4
Navari R, Gray S, Kerr A (2011) Olanzapine versus aprepitant for the prevention of chemotherapy-induced nausea and vomiting: a randomized phase III trial. J Support Oncol 9:188–195. doi:10.1016/j.suponc.2011.05.002
Cella DF, Tulsky DS, Gray G et al (1993) The Functional Assessment of Cancer Therapy scale: development and validation of the general measure. J Clin Oncol Off J Am Soc Clin Oncol 11:570–579
Hickok JT, Roscoe JA, Morrow GR, et al (2005) Hydroxytryptamine-receptor antagonists versus prochlorperazine for control of delayed nausea caused by doxorubicin: a URCC CCOP randomised controlled trial. Lancet Oncol 6(10):765–772
Roscoe JA, Heckler CE, Morrow GR et al (2012) Prevention of delayed nausea: a University of Rochester Cancer Center Community Clinical Oncology Program study of patients receiving chemotherapy. J Clin Oncol Off J Am Soc Clin Oncol 30:3389–3395. doi:10.1200/JCO.2011.39.8123
Wood J, Chapman K, Eilers J (2011) Tools for assessing nausea, vomiting, and retching. Cancer Nurs 34(1):E14–E24
Beusterien K, Grinspan J, Kuchuk I et al (2014) Use of conjoint analysis to assess breast cancer patient preferences for chemotherapy side effects. Oncologist 19:127–134. doi:10.1634/theoncologist.2013-0359
Kuchuk I, Bouganim N, Beusterien K et al (2013) Preference weights for chemotherapy side effects from the perspective of women with breast cancer. Breast Cancer Res Treat 142:101–107. doi:10.1007/s10549-013-2727-3
Farrell C, Brearley SG, Pilling M, Molassiotis A (2013) The impact of chemotherapy-related nausea on patients’ nutritional status, psychological distress and quality of life. Support Care Cancer Off J Multl Assoc Support Care Cancer 21:59–66. doi:10.1007/s00520-012-1493-9
Gilmore JW, Peacock NW, Gu A et al (2014) Antiemetic guideline consistency and incidence of chemotherapy-induced nausea and vomiting in US community oncology practice: INSPIRE study. J Oncol Pract Am Soc Clin Oncol 10:68–74. doi:10.1200/JOP.2012.000816
Celio L, Aapro M (2013) Research on chemotherapy-induced nausea: back to the past for an unmet need? J Clin Oncol 31:1376–1377. doi:10.1200/JCO.2012.47.2209
Merck&CO (2006) EMEND (Aprepitant) FDA label. Merck&CO, INC., Whitehouse Station
Hesketh P, Gralla R, Bois A, Tonato M (1998) Methodology of antiemetic trials: response assessment, evaluation of new agents and definition of chemotherapy emetogenicity. Support Care Cancer Off J Multl Assoc Support Care Cancer 6:221–227. doi:10.1007/s005200050157
Gore L, Chawla S, Petrilli A et al (2009) Aprepitant in adolescent patients for prevention of chemotherapy-induced nausea and vomiting: a randomized, double-blind, placebo-controlled study of efficacy and tolerability. Pediatr Blood Cancer 52:242–247. doi:10.1002/pbc.21811
Warr DG, Grunberg SM, Gralla RJ et al (2005) The oral NK(1) antagonist aprepitant for the prevention of acute and delayed chemotherapy-induced nausea and vomiting: pooled data from 2 randomised, double-blind, placebo controlled trials. Eur J Cancer (Oxford, England : 1990) 41:1278–1285. doi:10.1016/j.ejca.2005.01.024
Dranitsaris G, Clemons M (2014) Risk prediction models for chemotherapy-induced nausea and vomiting: almost ready for prime time? Support Care Cancer Off J Multl Assoc Support Care Cancer 22:863–864. doi:10.1007/s00520-014-2134-2
Dranitsaris G, Bouganim N, Milano C et al (2013) Prospective validation of a prediction tool for identifying patients at high risk for chemotherapy-induced nausea and vomiting. J Support Oncol 11:14–21. doi:10.1016/j.suponc.2012.05.001
Acknowledgments
The EPIC study was funded by the Canadian Breast Cancer Foundation—Ontario Chapter. The authors would like to thank all patients from the EPIC study who agree to participate in the current survey.
Conflict of interest
Brian Hutton received Honoraria for attendances at advisory boards from Amgen Canada. Catalina Hernandez-Torres, Sasha Mazzarello, Terry Ng, George Dranitsaris, Stephanie Smith, Amy Munro, Carmel Jacobs, and Mark Clemons have no conflicts to declare.
Author information
Authors and Affiliations
Corresponding author
Appendices
Appendix 1 EPIC ER 11-02 sub study survey
.
Appendix 2
Appendix 3
Rights and permissions
About this article
Cite this article
Hernandez Torres, C., Mazzarello, S., Ng, T. et al. Defining optimal control of chemotherapy-induced nausea and vomiting—based on patients’ experience. Support Care Cancer 23, 3341–3359 (2015). https://doi.org/10.1007/s00520-015-2801-y
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s00520-015-2801-y