Skip to main content

Advertisement

SpringerLink
Log in

Incidence of nausea and vomiting in breast cancer patients treated with anthracycline plus cyclophosphamide-based chemotherapy regimens in Italy: NAVY observational study

  • Original Article
  • Published:
Supportive Care in Cancer Aims and scope Submit manuscript

Abstract

Purpose

Chemotherapy-induced nausea and vomiting (CINV) is a common adverse event with cancer chemotherapy, despite the availability of effective antiemetic agents. This is a prospective observational study of Italian breast cancer patients treated with anthracycline plus cyclophosphamide (AC), assessed CINV incidence, adherence to national antiemetic guidelines (AIOM 2012), and the relationship with CINV outcomes.

Methods

Patients with breast cancer scheduled to receive their first cycle of an AC-based regimen were enrolled at 12 Italian centers and their clinical data prospectively recorded. CINV incidence was assessed from patient diaries after the first chemotherapy cycle. The relationship between guideline adherence and CINV outcomes was examined using multiple logistic regression.

Results

The overall incidence rates of nausea and vomiting among 246 evaluable patients were 63.0 and 25.4%, respectively. Most patients received a 5-HT3-RA agent and dexamethasone for acute phase CINV prophylaxis, whereas a triple combination including aprepitant (NK1-RA), consistent with national guidelines, was used in only 45.5% of cases. In the delayed phase, the guideline adherence was 48.8%, while the overall adherence was 43.5%. After adjusting for confounding factors, adherence to antiemetic prophylaxis guidelines was associated with a significant reduction in the odds of three endpoints, namely any nausea, “significant nausea,” and vomiting (OR = 0.49, OR = 0.54, and OR = 0.48, respectively), and a 90% increase in the odds of overall complete protection (OR = 1.90).

Conclusions

CINV is still a critical issue in AC-treated patients, despite antiemetic treatment. Non-adherence to antiemetic guidelines may lead to poorer outcomes and indicates the need for strategies to enhance the use of guidelines in clinical practice.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Similar content being viewed by others

References

  1. de Boer-Dennert M, de Wit R, Schmitz PI, Djontono J, v Beurden V, Stoter G, Verweij J (1997) Patient perceptions of the side-effects of chemotherapy: the influence of 5HT3 antagonists. Br J Cancer 76:1055–1061

    Article  Google Scholar 

  2. Cohen L, de Moor CA, Eisenberg P, Ming EE, Hu H (2007) Chemotherapy-induced nausea and vomiting: incidence and impact on patient quality of life at community oncology settings. Support Care Cancer 15:497–503

    Article  Google Scholar 

  3. Bloechl-Daum B, Deuson RR, Mavros P, Hansen M, Herrstedt J (2006) Delayed nausea and vomiting continue to reduce patients' quality of life after highly and moderately emetogenic chemotherapy despite antiemetic treatment. J Clin Oncol 24:4472–4478

    Article  CAS  Google Scholar 

  4. Hesketh PJ (2008) Chemotherapy-induced nausea and vomiting. N Engl J Med 358:2482–2494

    Article  CAS  Google Scholar 

  5. Feyer P, Jordan K (2011) Update and new trends in antiemetic therapy: the continuing need for novel therapies. Ann Oncol 22:30–38

    Article  CAS  Google Scholar 

  6. Basch E, Prestrud AA, Hesketh PJ, Kris MG, Feyer PC, Somerfield MR, Chesney M, Clark-Snow RA, Flaherty AM, Freundlich B, Morrow G, Rao KV, Schwartz RN, Lyman GH, American Society of Clinical Oncology (2011) Antiemetics: American Society of Clinical Oncology clinical practice guideline update. J Clin Oncol 29:4189–4198

    Article  Google Scholar 

  7. Hesketh PJ, Bohlke K, Lyman GH, Basch E, Chesney M, Clark-Snow RA, Danso MA, Jordan K, Somerfield MR, Kris MG, American Society of Clinical Oncology (2016) Antiemetics: American Society of Clinical Oncology focused guideline update. J Clin Oncol 34:381–386

    Article  Google Scholar 

  8. NCCN Guidelines (2017) Version 2.2017 Antiemesis https://www.nccn.org/professionals/physician_gls/pdf/antiemesis.pdf

  9. MASSC/ESMO Antiemetic Guideline (2016) http://www.mascc.org/assets/Guidelines-Tools/mascc_antiemetic_guidelines_english_2016_v.1.2.pdf

  10. AIOM Linee Guida Terapia Antiemetica (2012) http://www.aiom.it/area+pubblica/area+medica/prodotti+scientifici/linee+guida/Terapia+antiemetica/1,1976,0

  11. AIOM (2016) Linee Guida Terapia Antiemetica. http://www.aiom.it/C_Common/Download.asp?file=/$Site$/files/doc/LG/2016_LG_AIOM_Antiemetica.pdf

  12. Aapro M, Molassiotis A, Dicato M, Peláez I, Rodríguez-Lescure Á, Pastorelli D, Ma L, Burke T, Gu A, Gascon P, Roila F, investigators PEER (2012) The effect of guideline-consistent antiemetic therapy on chemotherapy-induced nausea and vomiting (CINV): the Pan European Emesis Registry (PEER). Ann Oncol 23:1986–1992

    Article  CAS  Google Scholar 

  13. Mertens WC, Higby DJ, Brown D, Parisi R, Fitzgerald J, Benjamin EM, Lindenauer PK (2003) Improving the care of patients with regard to chemotherapy-induced nausea and emesis: the effect of feedback to clinicians on adherence to antiemetic prescribing guidelines. J Clin Oncol 21:1373–1378

    Article  Google Scholar 

  14. Dranitsaris G, Leung P, Warr D (2001) Implementing evidence based antiemetic guidelines in the oncology setting: results of a 4-month prospective intervention study. Support Care Cancer 9:611–618

    Article  CAS  Google Scholar 

  15. Roila F (2004) Transferring scientific evidence to oncological practice: a trial on the impact of three different implementation strategies on antiemetic prescriptions. Support Care Cancer 12:446–453

    Article  Google Scholar 

  16. Grunberg SM, Deuson RR, Mavros P, Geling O, Hansen M, Cruciani G, Daniele B, De Pouvourville G, Rubenstein EB, Daugaard G (2004) Incidence of chemotherapy-induced nausea and emesis after modern antiemetics. Cancer 100:2261–2268

    Article  Google Scholar 

  17. Majem M, Moreno ME, Calvo N, Feliu A, Pérez J, Mangues MA, Barnadas A (2011) Perception of healthcare providers versus patient reported incidence of chemotherapy-induced nausea and vomiting after the addition of NK-1 receptor antagonists. Support Care Cancer 19:1983–1990

    Article  Google Scholar 

  18. Pastorelli D, Locatelli MA, Melotti B, Pisano C, Turano S, Mellino U, Provinciali N, Marchetti P, Dazzi C, Berretta M, Giordano A, Lorusso V (2013) The Pan European Emesis Registry (PEER): a critical appraisal of the Italian experience. J Chemother 25:309–317

    Article  CAS  Google Scholar 

  19. Ng TL, Hutton B, Clemons M (2015) Chemotherapy-induced nausea and vomiting: time for more emphasis on nausea? Oncologist 20:576–583

    Article  CAS  Google Scholar 

  20. Hutton B, Clemons M, Mazzarello S, Kuchuk I, Skidmore B, Ng T (2015) Identifying an optimal antiemetic regimen for patients receiving anthracycline and cyclophosphamide-based chemotherapy for breast cancer—an inspection of the evidence base informing clinical decision-making. Cancer Treat Rev 41:951–959

    Article  CAS  Google Scholar 

  21. The Italian Group for Antiemetic Research (2000) Dexamethasone alone or in combination with ondansetron for the prevention of delayed nausea and vomiting induced by chemotherapy. N Engl J Med 342:1554–1559

    Article  Google Scholar 

  22. Latreille J, Pater J, Johnston D, Laberge F, Stewart D, Rusthoven J, Hoskins P, Findlay B, McMurtrie E, Yelle L, Williams C, Walde D, Ernst S, Dhaliwal H, Warr D, Shepherd F, Mee D, Nishimura L, Osoba D, Zee B (1998) Use of dexamethasone and granisetron in the control of delayed emesis for patients who receive highly emetogenic chemotherapy. National Cancer Institute of Canada Clinical Trials Group. J Clin Oncol 16:1174–1178

    Article  CAS  Google Scholar 

  23. Goedhals L, Heron JF, Kleisbauer JP, Pagani O, Sessa C (1998) Control of delayed nausea and vomiting with granisetron plus dexamethasone or dexamethasone alone in patients receiving highly emetogenic chemotherapy: a double-blind, placebo-controlled, comparative study. Ann Oncol 9:661–666

    Article  CAS  Google Scholar 

  24. Tsukada H, Hirose T, Yokoyama A, Kurita Y (2001) Randomised comparison of ondansetron plus dexamethasone with dexamethasone alone for the control of delayed cisplatin-induced emesis. Eur J Cancer 37:2398–2404

    Article  CAS  Google Scholar 

  25. Warr DG, Hesketh PJ, Gralla RJ, Muss HB, Herrstedt J, Eisenberg PD, Raftopoulos H, Grunberg SM, Gabriel M, Rodgers A, Bohidar N, Klinger G, Hustad CM, Horgan KJ, Skobieranda F (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 23:2822–2830

    Article  CAS  Google Scholar 

  26. Rapoport BL, Jordan K, Boice JA, Taylor A, Brown C, Hardwick JS, Carides A, Webb T, Schmoll HJ (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 18:423–431

    Article  Google Scholar 

  27. Burmeister H, Aebi S, Studer C, Fey MF, Gautschi O (2012) Adherence to ESMO clinical recommendations for prophylaxis of chemotherapy-induced nausea and vomiting. Support Care Cancer 20:141–147

    Article  Google Scholar 

  28. Ng T, Mazzarello S, Wang Z, Hutton B, Dranitsaris G, Vandermeer L, Smith S, Clemons M (2016) Choice of study endpoint significantly impacts the results of breast cancer trials evaluating chemotherapy-induced nausea and vomiting. Breast Cancer Res Treat 155:337–344

    Article  CAS  Google Scholar 

Download references

Acknowledgements

We would like to thank Dr. Carlotta Galeone (Biostatistician, ScD, PhD) for her fundamental contribution in data analysis and interpretation of the study results. Medical writing assistance was provided by Editamed srl, Turin, Italy.

Funding

This study was funded by an unrestricted grant from MSD.

Author information

Authors and Affiliations

  1. Division of Breast Medical Oncology, Department of Breast and Thoracic Oncology, Istituto Nazionale Tumori - IRCCS - Fondazione G. Pascale, Napoli, Italy

    Michelino De Laurentiis

  2. Medical Oncology Department, “A.O.U. Città della Scienza e della Salute di Torino”, Turin, Italy

    Chiara Bonfadini

  3. Medical Oncology Department, National Cancer Institute, Giovanni Paolo II, Bari, Italy

    Vito Lorusso

  4. Oncohematology Hospital “Casa Sollievo della Sofferenza”, San Giovanni Rotondo, Italy

    Giuseppina Cilenti

  5. Medical Oncology, Department of Senology, National Cancer Institute, Fondazione G.Pascale Naples, Naples, Italy

    Francesca Di Rella

  6. Human Pathology Department, Medical Oncology, University of Messina, Messina, Italy

    Giuseppe Altavilla

  7. Oncology Division, AORN “Cardarelli”, Naples, Italy

    Manuela Otero

  8. Oncology Department, ASST Lecco, Lecco, Italy

    Antonio Ardizzoia

  9. Clinical and Molecular Medicine Department, Sant’Andrea Hospital, Sapienza University of Rome, Rome, Italy

    Paolo Marchetti

  10. Medical Oncology Department, IRCCS Istituto Nazionale dei Tumori, Milan, Italy

    Giorgia Peverelli

  11. Medical Oncology, Ospedale Versilia, Tuscan Tumor Institute (ITT), Lido di Camaiore, Italy

    Domenico Amoroso

  12. Oncologia Medica 2, IRCCS San Martino IST, Genoa, Italy

    Stefania Vecchio

  13. Department of Oncology, Azienda Ospedaliera Universitaria Integrata, Verona, Italy

    Elena Fiorio

  14. Medical Affairs Department, MSD Italy, Rome, Italy

    Simona Orecchia

Authors
  1. Michelino De Laurentiis
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Chiara Bonfadini
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Vito Lorusso
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Giuseppina Cilenti
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Francesca Di Rella
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. Giuseppe Altavilla
    View author publications

    You can also search for this author in PubMed Google Scholar

  7. Manuela Otero
    View author publications

    You can also search for this author in PubMed Google Scholar

  8. Antonio Ardizzoia
    View author publications

    You can also search for this author in PubMed Google Scholar

  9. Paolo Marchetti
    View author publications

    You can also search for this author in PubMed Google Scholar

  10. Giorgia Peverelli
    View author publications

    You can also search for this author in PubMed Google Scholar

  11. Domenico Amoroso
    View author publications

    You can also search for this author in PubMed Google Scholar

  12. Stefania Vecchio
    View author publications

    You can also search for this author in PubMed Google Scholar

  13. Elena Fiorio
    View author publications

    You can also search for this author in PubMed Google Scholar

  14. Simona Orecchia
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Michelino De Laurentiis.

Ethics declarations

Conflict of interest

P.M. attended board and funding from MSD, BMS, Novartis, Astellas, Roche, Boeringer, Bayer, Celgene, Ipsen, Italfarmaco, Jansenn, Lilly. M.D.L. played an advisory role for Roche, Novartis, Pfizer, Astra-Zeneca, Italfarmaco, and Amgen and received speaker’s honoraria from Roche, Novartis, Pfizer, Astra-Zeneca, Italfarmaco, and Amgen and research funding from Roche, Astra-Zeneca, Helsinn. S.O. is a MSD employee. The other authors have no conflict of interest to disclose.

Ethical approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. The study protocol was approved by the local ethics committee and was in accordance with the 1964 Helsinki declaration and its later amendments; signed written informed consent was obtained from all patients.

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

De Laurentiis, M., Bonfadini, C., Lorusso, V. et al. Incidence of nausea and vomiting in breast cancer patients treated with anthracycline plus cyclophosphamide-based chemotherapy regimens in Italy: NAVY observational study. Support Care Cancer 26, 4021–4029 (2018). https://doi.org/10.1007/s00520-018-4259-1

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s00520-018-4259-1

Keywords

Search

Navigation