title: Addition of the Neurokinin-1-Receptor Antagonist (RA) Aprepitant to a 5-Hydroxytryptamine-RA and Dexamethasone in the Prophylaxis of Nausea and Vomiting Due to Radiation Therapy With Concomitant Cisplatin.
abstract: OBJECTIVE
  To assess, in a prospective, observational study, the safety and efficacy of the addition of the neurokinin-1-receptor antagonist (NK1-RA) aprepitant to concomitant radiochemotherapy, for the prophylaxis of radiation therapy-induced nausea and vomiting.
  
  
  METHODS
  This prospective observational study compared the antiemetic efficacy of an NK1-RA (aprepitant), a 5-hydroxytryptamine-RA, and dexamethasone (aprepitant regimen) versus a 5-hydroxytryptamine-RA and dexamethasone (control regimen) in patients receiving concomitant radiochemotherapy with cisplatin at the Department of Radiation Oncology, University Hospital Halle (Saale), Germany. The primary endpoint was complete response in the overall phase, defined as no vomiting and no use of rescue therapy in this period.
  
  
  RESULTS
  Fifty-nine patients treated with concomitant radiochemotherapy with cisplatin were included in this study. Thirty-one patients received the aprepitant regimen and 29 the control regimen. The overall complete response rates for cycles 1 and 2 were 75.9% and 64.5% for the aprepitant group and 60.7% and 54.2% for the control group, respectively. Although a 15.2% absolute difference was reached in cycle 1, a statistical significance was not detected (P=.22). Furthermore maximum nausea was 1.58 ± 1.91 in the control group and 0.73 ± 1.79 in the aprepitant group (P=.084); for the head-and-neck subset, 2.23 ± 2.13 in the control group and 0.64 ± 1.77 in the aprepitant group, respectively (P=.03).
  
  
  CONCLUSIONS
  This is the first study of an NK1-RA-containing antiemetic prophylaxis regimen in patients receiving concomitant radiochemotherapy. Although the primary endpoint was not obtained, the absolute difference of 10% in efficacy was reached, which is defined as clinically meaningful for patients by international guidelines groups. Randomized phase 3 studies are necessary to further define the potential role of an NK1-RA in this setting.
authors.affiliation: Department of Hematology/Oncology, Martin-Luther-University Halle-Wittenberg, Halle (Saale), Germany. Electronic address: franziska.jahn@uk-halle.de.
authors.forename: Franziska
authors.initials: F
authors.lastname: Jahn
authors.affiliation: Department of Gastroenterology, Martin-Luther-University Halle-Wittenberg, Halle (Saale), Germany.
authors.forename: Anica
authors.initials: A
authors.lastname: Riesner
authors.affiliation: Nursing Research Unit, Martin-Luther-University Halle-Wittenberg, Halle (Saale), Germany.
authors.forename: Patrick
authors.initials: P
authors.lastname: Jahn
authors.affiliation: Department of Radiation Oncology, Martin-Luther-University Halle-Wittenberg, Halle (Saale), Germany.
authors.forename: Frank
authors.initials: F
authors.lastname: Sieker
authors.affiliation: Department of Radiation Oncology, Martin-Luther-University Halle-Wittenberg, Halle (Saale), Germany.
authors.forename: Dirk
authors.initials: D
authors.lastname: Vordermark
authors.affiliation: Department of Hematology/Oncology, Martin-Luther-University Halle-Wittenberg, Halle (Saale), Germany.
authors.forename: Karin
authors.initials: K
authors.lastname: Jordan
mesh_terms: D000932:Antiemetics / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects*; D000077608:Aprepitant; D059248:Chemoradiotherapy / Q000009:adverse effects*; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D003907:Dexamethasone / Q000627:therapeutic use*; D004359:Drug Therapy, Combination / Q000379:methods; D004938:Esophageal Neoplasms / Q000628:therapy; D005260:Female; D006258:Head and Neck Neoplasms / Q000628:therapy; D006801:Humans; D007211:Indoles / Q000627:therapeutic use; D008175:Lung Neoplasms / Q000628:therapy; D008297:Male; D008875:Middle Aged; D009025:Morpholines / Q000627:therapeutic use*; D009325:Nausea / Q000209:etiology / Q000517:prevention & control*; D064729:Neurokinin-1 Receptor Antagonists / Q000627:therapeutic use; D017294:Ondansetron / Q000627:therapeutic use; D011446:Prospective Studies; D012702:Serotonin Antagonists / Q000627:therapeutic use*; D000077526:Tropisetron; D002583:Uterine Cervical Neoplasms / Q000628:therapy; D014839:Vomiting / Q000209:etiology / Q000517:prevention & control*
chemical_list: D000932:Antiemetics; D000970:Antineoplastic Agents; D007211:Indoles; D009025:Morpholines; D064729:Neurokinin-1 Receptor Antagonists; D012702:Serotonin Antagonists; D000077608:Aprepitant; D017294:Ondansetron; D000077526:Tropisetron; D003907:Dexamethasone; D002945:Cisplatin