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Netupitant/palonosetron (NEPA) and dexamethasone for prevention of emesis in breast cancer patients receiving adjuvant anthracycline plus cyclophosphamide: a multi-cycle, phase II study.
- Source :
-
BMC cancer [BMC Cancer] 2020 Mar 19; Vol. 20 (1), pp. 232. Date of Electronic Publication: 2020 Mar 19. - Publication Year :
- 2020
-
Abstract
- Background: NEPA is an oral fixed-dose combination of netupitant, a new highly selective neurokinin-1 receptor antagonist, and palonosetron. This study was conducted to evaluate whether the efficacy of NEPA against chemotherapy-induced nausea and vomiting (CINV) in cycle 1 would be maintained over subsequent chemotherapy cycles in breast cancer patients receiving adjuvant anthracycline plus cyclophosphamide (AC). The study also describes the relationship between efficacy on day 1 through 5 (overall period) and control of CINV on day 6 through 21 (very late period) in each cycle.<br />Methods: In this multicentre, phase II study, patients received both NEPA and dexamethasone (12 mg intravenously) just before chemotherapy. The primary efficacy endpoint was overall complete response (CR; no emesis and no rescue medication use) in cycle 1. Sustained efficacy was evaluated during the subsequent cycles by calculating the rate of CR in cycles 2-4 and by assessing the probability of sustained CR over multiple cycles. The impact of both overall CR and risk factors for CINV on the control of very late events (vomiting and moderate-to-severe nausea) were also examined.<br />Results: Of the 149 patients enrolled in the study, 139 were evaluable for a total of 552 cycles; 97.8% completed all 4 cycles. The proportion of patients with an overall CR was 70.5% (90% CI, 64.1 to 76.9) in cycle 1, and this was maintained in subsequent cycles. The cumulative percentage of patients with a sustained CR over 4 cycles was 53%. NEPA was well tolerated across cycles. In each cycle, patients with CR experienced a significantly better control of very late CINV events than those who experienced no CR. Among the patients with CR, the only predictor for increased likelihood of developing very late CINV was pre-chemotherapy (anticipatory) nausea (adjusted odds ratio = 0.65-0.50 for no CINV events on cycles 3 and 4).<br />Conclusion: The high anti-emetic efficacy seen with the NEPA regimen in the first cycle was maintained over multiple cycles of adjuvant AC for breast cancer. Preliminary evidence also suggests that patients achieving a CR during the overall period gain high protection even against very late CINV events in each chemotherapy cycle.<br />Trial Registration: This trial was retrospectively registered at Clinicaltrials.gov identifier (NCT03862144) on 05/Mar/2019.
- Subjects :
- Adult
Aged
Anthracyclines therapeutic use
Antiemetics administration & dosage
Antineoplastic Agents, Alkylating therapeutic use
Chemotherapy, Adjuvant
Cyclophosphamide therapeutic use
Dexamethasone administration & dosage
Drug Combinations
Female
Humans
Middle Aged
Neurokinin-1 Receptor Antagonists administration & dosage
Palonosetron administration & dosage
Pyridines administration & dosage
Anthracyclines adverse effects
Antiemetics therapeutic use
Antineoplastic Agents, Alkylating adverse effects
Breast Neoplasms drug therapy
Cyclophosphamide adverse effects
Dexamethasone therapeutic use
Neurokinin-1 Receptor Antagonists therapeutic use
Palonosetron therapeutic use
Pyridines therapeutic use
Vomiting chemically induced
Vomiting prevention & control
Subjects
Details
- Language :
- English
- ISSN :
- 1471-2407
- Volume :
- 20
- Issue :
- 1
- Database :
- MEDLINE
- Journal :
- BMC cancer
- Publication Type :
- Academic Journal
- Accession number :
- 32188417
- Full Text :
- https://doi.org/10.1186/s12885-020-6707-9