Aapro, Matti and Karthaus, Meinolf and Schwartzberg, Lee and Bondarenko, Igor and Sarosiek, Tomasz and Oprean, Cristina and Cardona-Huerta, Servando and Hansen, Vincent and Rossi, Giorgia and Rizzi, Giada and Borroni, Maria Elisa and Rugo, Hope (2017) NEPA, a fixed oral combination of netupitant and palonosetron, improves control of chemotherapy-induced nausea and vomiting (CINV) over multiple cycles of chemotherapy: results of a randomized, double-blind, phase 3 trial versus oral palonosetron. Supportive Care in Cancer, 25 (4). pp. 1127-1135. ISSN 0941-4355 (Print) 1433-7339 (Online)
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Abstract
Purpose Antiemetic guidelines recommend co-administration of targeted prophylactic medications inhibiting molecular pathways involved in emesis. NEPA is a fixed oral combination of a new NK1 receptor antagonist (RA), netupitant (NETU 300 mg), and palonosetron (PALO 0.50 mg), a pharmacologically distinct 5-HT3 RA. NEPA showed superior prevention of chemotherapy-induced nausea and vomiting (CINV) compared with oral PALO in a single chemotherapy cycle; maintenance of efficacy/safety over continuing cycles is the objective of this study. Methods This study is a multinational, double-blind study comparing a single oral dose of NEPA vs oral PALO in chemotherapy-naïve patients receiving anthracycline/ cyclophosphamide-based chemotherapy along with dexamethasone 12 mg (NEPA) or 20 mg (PALO) on day 1. The primary efficacy endpoint was delayed (25–120 h) complete response (CR: no emesis, no rescue medication) in cycle 1. Sustained efficacy was evaluated during the multicycle extension by calculating the proportion of patients with overall (0–120 h) CR in cycles 2–4 and by assessing the probability of sustained CR over multiple cycles. Results Of 1455 patients randomized, 1286 (88 %) participated in the multiple-cycle extension for a total of 5969 cycles; 76 % completed ≥4 cycles. The proportion of patients with an overall CR was significantly greater for NEPA than oral PALO for cycles 1–4 (74.3 vs 66.6 %, 80.3 vs 66.7 %, 83.8 vs 70.3 %, and 83.8 vs 74.6 %, respectively; p ≤ 0.001 each cycle). The cumulative percentage of patients with a sustained CR over all 4 cycles was also greater for NEPA (p < 0.0001). NEPA was well tolerated over cycles. Conclusions NEPA, a convenient, guideline-consistent, fixed antiemetic combination is effective and safe over multiple cycles of chemotherapy.
| Item Type: | Article |
|---|---|
| Additional Information: | DOI 10.1007/s00520-016-3502-x |
| Uncontrolled Keywords: | Neurokinin-1 receptor antagonist. NEPA. Netupitant. Palonosetron. CINV. Multiple cycles |
| Subjects: | Oncology |
| Divisions: | Departments > Department of Oncology and Medical Radiology |
| Depositing User: | Елена Шрамко |
| Date Deposited: | 08 Sep 2017 11:23 |
| Last Modified: | 08 Sep 2017 11:43 |
| URI: | http://repo.dma.dp.ua/id/eprint/1930 |
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