PMID- 29080920 OWN - NLM STAT- MEDLINE DCOM- 20190304 LR - 20200306 IS - 1433-7339 (Electronic) IS - 0941-4355 (Print) IS - 0941-4355 (Linking) VI - 26 IP - 4 DP - 2018 Apr TI - Preventing chemotherapy-induced nausea and vomiting in patients with lung cancer: efficacy of NEPA (netupitant-palonosetron), the first combination antiemetic. PG - 1151-1159 LID - 10.1007/s00520-017-3936-9 [doi] AB - PURPOSE: Patients receiving platinum-based chemotherapy are at high risk of chemotherapy-induced nausea and vomiting (CINV), a distressing side effect of treatment. This post-hoc subgroup analysis of two pivotal trials evaluated the efficacy of NEPA in preventing CINV in subsets of patients with lung cancer who received cisplatin or carboplatin. METHODS: In each study, the efficacy endpoints complete response (CR; defined as no emetic episodes and no rescue medication) and no significant nausea (NSN; defined as a score of < 25 mm on a visual analog scale of 0-100 mm) during the acute (0-24 h), delayed (25-120 h), and overall (0-120 h) phases post-chemotherapy in cycle 1 (study 1) and cycles 1-4 (study 2) were assessed. Safety was evaluated by recording treatment-emergent adverse events (AEs) and treatment-related AEs. RESULTS: NEPA treatment resulted in high CR rates across the acute, delayed, and overall phases (cisplatin: > 88% overall CR; carboplatin: > 75% overall CR), with higher CR rates for NEPA-treated patients than those receiving palonosetron; moreover, CR rates were sustained over multiple chemotherapy cycles (> 75%). High rates of NSN observed during cycle 1 (> 79%) were also maintained over multiple chemotherapy cycles. NEPA was well tolerated in all patients. CONCLUSIONS: NEPA appears to be effective and well tolerated in patients with lung cancer receiving platinum-based chemotherapy, across the acute, delayed, and overall phases and throughout multiple cycles. As a highly effective oral combination antiemetic agent administered as a single dose once per cycle, NEPA may offer a convenient, simplified prophylactic antiemetic. FAU - Hesketh, Paul J AU - Hesketh PJ AD - Lahey Health Cancer Institute, Lahey Hospital & Medical Center, 41 Mall Road, Burlington, MA, 01805, USA. paul.hesketh@lahey.org. FAU - Palmas, Marco AU - Palmas M AD - Corporate Clinical Development, Helsinn Healthcare SA, Lugano, Switzerland. FAU - Nicolas, Pierre AU - Nicolas P AD - Helsinn Healthcare SA, Lugano, Switzerland. LA - eng PT - Clinical Trial, Phase II PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial DEP - 20171028 PL - Germany TA - Support Care Cancer JT - Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer JID - 9302957 RN - 0 (Antiemetics) RN - 0 (Pyridines) RN - 5D06587D6R (Palonosetron) RN - 7732P08TIR (netupitant) SB - IM MH - Adult MH - Aged MH - Antiemetics/*therapeutic use MH - Double-Blind Method MH - Humans MH - Male MH - Middle Aged MH - Nausea/chemically induced/*prevention & control MH - Palonosetron/pharmacology/*therapeutic use MH - Pyridines/pharmacology/*therapeutic use MH - Vomiting/chemically induced/*prevention & control PMC - PMC5847067 OTO - NOTNLM OT - Carboplatin OT - Chemotherapy-induced nausea and vomiting (CINV) OT - Cisplatin OT - Lung cancer OT - NEPA COIS- DATA: Authors have full control of all primary data and agree that the journal may review the data if requested. CONFLICT OF INTEREST: PJH has no conflicts of interest to declare. MP and PN are employees of Helsinn and may hold stock. STATEMENT OF HUMAN RIGHTS: For this type of study, formal consent is not required. STATEMENT ON THE WELFARE OF ANIMALS: This article does not contain any studies with animals performed by any of the authors. STATEMENT ON INFORMED CONSENT: Informed consent was obtained from all individual participants included in the study. EDAT- 2017/10/31 06:00 MHDA- 2019/03/05 06:00 PMCR- 2017/10/28 CRDT- 2017/10/30 06:00 PHST- 2017/03/29 00:00 [received] PHST- 2017/10/16 00:00 [accepted] PHST- 2017/10/31 06:00 [pubmed] PHST- 2019/03/05 06:00 [medline] PHST- 2017/10/30 06:00 [entrez] PHST- 2017/10/28 00:00 [pmc-release] AID - 10.1007/s00520-017-3936-9 [pii] AID - 3936 [pii] AID - 10.1007/s00520-017-3936-9 [doi] PST - ppublish SO - Support Care Cancer. 2018 Apr;26(4):1151-1159. doi: 10.1007/s00520-017-3936-9. Epub 2017 Oct 28.