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
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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.
Patient consent for publication Not required.
Ethics approval The study was approved by the Joint CUHK-NTEC Institution Review Board of the Chinese University of Hong Kong and of the Hong Kong Hospital Authority, and the Kowloon West Cluster Research Ethics Committee of the Hong Kong Hospital Authority.
Provenance and peer review Not commissioned; externally peer reviewed.
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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