title: Safety and efficacy of NEPA, an oral fixed combination of netupitant and palonosetron, in older patients.
abstract: Prevention of chemotherapy-induced nausea and vomiting is critical in older patients with cancer. NEPA is an oral fixed combination of netupitant 300mg, a new NK1receptor antagonist (RA), and palonosetron 0.5mg, a pharmacologically distinct 5-HT3RA. This retrospective analysis evaluated the efficacy and safety of NEPA in older patients.
  
  
  
  Patients aged ≥65 and ≥70years from one phase II and two phase III trials were considered. Chemotherapy-naive patients with malignant tumors were treated with anthracycline-cyclophosphamide (AC), non-AC-based moderately emetogenic chemotherapy (non-AC MEC), or highly emetogenic chemotherapy (HEC). Following single-dose NEPA, patients received oral dexamethasone on day 1 (AC and non-AC MEC) or days 1-4 (HEC). Efficacy was evaluated through complete response (CR) in cycle 1. Safety was evaluated by AEs and ECGs. Data were summarized by descriptive statistics.
  
  
  
  Overall, 214 patients were ≥65years and 80 were ≥70years. A higher CR was observed in older patients versus the total population; in the acute phase >90% of patients ≥65years experienced CR. Efficacy was maintained over multiple cycles of chemotherapy. No significant nausea rates were generally higher in the older patients versus total population. Similar rates of AEs in the first treatment cycle were reported for patients ≥65years, ≥70years, and total population (72.9% vs 67.5% vs 70.0%, respectively). No cardiac safety concerns were raised.
  
  
  
  NEPA is highly effective in older patients receiving MEC or HEC regimens. NEPA is also well tolerated, demonstrating suitability for use in older patients who may have comorbidities.
authors.affiliation: Breast Center, IMO Clinique de Genolier, Switzerland. Electronic address: gdupuis@genolier.net.
authors.forename: Matti
authors.initials: M
authors.lastname: Aapro
authors.affiliation: Department of Internal Medicine IV, Hematology/Oncology, Martin-Luther-University Halle/Wittenberg, Ernst-Grube-Str. 40, 06120 Halle/Saale, Germany. Electronic address: Karin.jordan@uk-halle.de.
authors.forename: Karin
authors.initials: K
authors.lastname: Jordan
authors.affiliation: Jacobi Medical Center, 1400 Pelham Parkway South Building 1, Room 3N20, Bronx, NY 10461, USA. Electronic address: richard.gralla@nbhn.net.
authors.forename: Richard J
authors.initials: RJ
authors.lastname: Gralla
authors.affiliation: Corporate Clinical Development, Helsinn Healthcare SA, PO Box 357, 6915 Pambio-Noranco, Lugano, Switzerland. Electronic address: Giada.Rizzi@helsinn.com.
authors.forename: Giada
authors.initials: G
authors.lastname: Rizzi
authors.affiliation: Corporate Drug Safety, Helsinn Healthcare SA, PO Box 357, 6915 Pambio-Noranco, Lugano, Switzerland. Electronic address: Giorgia.Rossi@helsinn.com.
authors.forename: Giorgia
authors.initials: G
authors.lastname: Rossi
authors.affiliation: Corporate Clinical Development, Helsinn Healthcare SA, PO Box 357, 6915 Pambio-Noranco, Lugano, Switzerland. Electronic address: Marco.Palmas@helsinn.com.
authors.forename: Marco
authors.initials: M
authors.lastname: Palmas
authors.affiliation: Federal State Institution, Privolzhsky District Medical Center, Federal Medical-Biological Agency of Russia, Urology Department #2, Nizhny Novgorod 603001, Russian Federation. Electronic address: alyasovaav68@mail.ru.
authors.forename: Anna V
authors.initials: AV
authors.lastname: Alyasova
authors.affiliation: St. Petersburg Clinical Oncology Dispensary, 3/5 Nizhne-Volzhskaya Nab, Nizhny Novgorod 603001, Russia. Electronic address: lisyanskaya.onc@mail.ru.
authors.forename: Alla S
authors.initials: AS
authors.lastname: Lisyanskaya
authors.affiliation: Department of Supportive Oncology, Institute for Oncology and Radiology of Serbia, Pasterova 14, 11000 Belgrade, Serbia. Electronic address: nena.bosnjak@gmail.com.
authors.forename: Snežana M
authors.initials: SM
authors.lastname: Bošnjak
authors.affiliation: Lahey Hospital & Medical Center, 41 Mall Road, Burlington, MA 01805, USA. Electronic address: paul.hesketh@lahey.org.
authors.forename: Paul J
authors.initials: PJ
authors.lastname: Hesketh
mesh_terms: D000368:Aged; D018943:Anthracyclines / Q000008:administration & dosage; D000932:Antiemetics / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects*; D003520:Cyclophosphamide / Q000008:administration & dosage; D004338:Drug Combinations; D005260:Female; D006801:Humans; D007546:Isoquinolines / Q000627:therapeutic use*; D008297:Male; D009325:Nausea / Q000139:chemically induced / Q000517:prevention & control*; D011725:Pyridines / Q000627:therapeutic use*; D011812:Quinuclidines / Q000627:therapeutic use*; D016896:Treatment Outcome; D014839:Vomiting / Q000139:chemically induced / Q000517:prevention & control*
chemical_list: D018943:Anthracyclines; D000932:Antiemetics; D004338:Drug Combinations; D007546:Isoquinolines; D011725:Pyridines; D011812:Quinuclidines; C000595957:netupitant, palosentron drug combination; D003520:Cyclophosphamide
keywords: 5-Hydroxytryptamine receptor antagonist; CINV; Highly emetogenic chemotherapy; Moderately emetogenic chemotherapy; Multiple chemotherapy cycles; NEPA; Netupitant; Neurokinin-1 receptor antagonist; Older patients; Palonosetron