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NEPA efficacy and tolerability during (neo)adjuvant breast cancer chemotherapy with cyclophosphamide and doxorubicin
  1. Winnie Yeo1,
  2. Thomas KH Lau2,
  3. Carol CH Kwok3,
  4. Kwai T Lai4,
  5. Vicky TC Chan2,
  6. Leung Li2,
  7. Vivian Chan4,
  8. Ashley Wong2,
  9. Winnie MT Soo2,
  10. Eva WM Yeung2,
  11. Kam H Wong2,
  12. Nelson LS Tang4,
  13. Joyce JS Suen2 and
  14. Frankie KF Mo4
  1. 1 Department of Clinical Oncology, State Key Laboratory of Translational Oncology, Faculty of Medicine, Chinese University of Hong Kong, Hong Kong, Hong Kong
  2. 2 Department of Clinical Oncology, Prince of Wales Hospital, New Territories, Hong Kong
  3. 3 Department of Clinical Oncology, Princess Margaret Hospital, Hong Kong, Hong Kong
  4. 4 Department of Chemical Pathology, Li Ka Shing Institute of Health Sciences, Chinese University of Hong Kong, New Territories, Hong Kong
  1. Correspondence to Dr Winnie Yeo, Hong Kong, Hong Kong; winnieyeo{at}cuhk.edu.hk

Abstract

Objectives This is a prospective study evaluating NEPA in patients with breast cancer (the NEPA group), who received (neo)adjuvant AC chemotherapy (consisting of doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2). The primary objectives were to assess the efficacy and safety of NEPA in controlling chemotherapy-induced nausea and vomiting (CINV). The secondary objectives were to compare CINV between the NEPA group and historical controls (the APR group) who received aprepitant in an earlier prospective randomised study.

Patients and methods 60 patients participated in the NEPA group; 62 were in the APR group. Eligibility criteria of both groups were similar, that is, Chinese patients with breast cancer who were treated with (neo)adjuvant AC. NEPA group received NEPA and dexamethasone; APR group received aprepitant, ondansetron and dexamethasone. Individuals filled in self-reported diary, visual analogue scale for nausea and Functional Living Index-Emesis questionnaire.

Results Within the NEPA group, 70.0%, 85.7% and 60.0%, respectively reported complete response in the acute, delayed and overall phases in cycle 1 AC. When compared with the historical APR group during cycle 1 AC, NEPA group achieved significantly higher rates of complete response, complete protection, total control, ‘no significant nausea’ and ‘no nausea’ in the delayed phase; similar findings were noted in the overall phase with significantly better quality of life. Superior efficacy of NEPA was maintained over multiple cycles. Both antiemetic regimens were well tolerated.

Conclusion In this study on Chinese patients with breast cancer who were uniformly receiving AC, NEPA was effective in controlling CINV.

Trial registration number NCT03386617.

  • netupitant, palonosetron, Akynzeo, Emend, Asians
  • nausea and vomiting
  • quality of life

Data availability statement

Data are available on reasonable request. All data relevant to the study are included in the article or uploaded as supplementary information.

http://creativecommons.org/licenses/by-nc/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/bmjspcare-2019-002037

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    Data availability statement

    Data are available on reasonable request. All data relevant to the study are included in the article or uploaded as supplementary information.

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    Footnotes

    • Contributors WY conceived of the original idea for the study, obtained ethical approval, contributed to patient enrolment and the preparation of the dataset, interpreted results and edited the paper. FKFM carried out the statistical analysis, the preparation of the dataset, interpreted results and contributed to drafts of the paper. TKHL, CCHK, KTL, VTCC, LL, VC, AW, WMTS, EWMY, KHW, NLST and JJSS contributed to patient enrolment and the preparation of the dataset and commented on drafts of the paper.

    • Funding This study was supported by an education grant from Mundipharma and Madam Diana Hon Fun Kong Donation for Cancer Research.

    • Disclaimer Mundipharma supported the study design of NEPA but had no role in the study design of the APR group or the design of comparative analysis, data collection and analysis, decision to publish or preparation of the manuscript. Madam Diana Hon Fun Kong Donation for Cancer Research had no role in study design, data collection and analysis, decision to publish or preparation of the manuscript.

    • Competing interests WY has been involved in CINV Network in Asia and has been a speaker on CINV, organised by Mundipharma.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.