title: Evaluation of palonosetron and dexamethasone with or without aprepitant to prevent carboplatin-induced nausea and vomiting in patients with advanced non-small-cell lung cancer.
abstract: OBJECTIVE
  Although antiemetic management has improved, better control of chemotherapy-induced nausea and vomiting (CINV), particularly during the delayed phase, is needed. The benefit of combination therapy using dexamethasone and the second-generation 5-hydroxytryptamine-3 receptor antagonist palonosetron compared with that of other such receptor antagonists in carboplatin-based chemotherapy is unclear. The effectiveness of adding aprepitant for CINV treatment in moderate emetogenic chemotherapy is also unknown. We compared the efficacy and safety of triple antiemetic therapy using aprepitant, palonosetron, and dexamethasone with that of double antiemetic therapy using palonosetron and dexamethasone in patients with advanced non-small-cell lung cancer receiving carboplatin-containing chemotherapy.
  
  
  METHODS
  Chemotherapy-naïve patients with non-small-cell lung cancer were enrolled in this prospective controlled study. Eighty patients were randomly assigned to groups receiving either double antiemetic therapy with palonosetron and dexamethasone, or triple antiemetic therapy with aprepitant, palonosetron, and dexamethasone. Complete response rate (no vomiting episode and no rescue therapy) was evaluated as the primary endpoint during the 5-day post-chemotherapy period.
  
  
  RESULTS
  The aprepitant add-on and double therapy groups showed overall complete response rates of 80.5% (95% confidence interval [CI]: 68.4-92.6%) and 76.9% (95% CI: 63.7-90.1%; odds ratio [OR]: 0.81; 95% CI; 0.27-2.36; p=0.788), respectively. Complete responses in the acute and delayed phases and overall incidences of treatment-related adverse events were similar between groups.
  
  
  CONCLUSIONS
  According to the selection design, triple antiemetic therapy with aprepitant, palonosetron, and dexamethasone was not considered as an option for further studies.
authors.affiliation: Second Division, Department of Internal Medicine, Hamamatsu University School of Medicine, 1-20-1 Handayama, Hamamatsu 431-3192, Japan.
authors.forename: Hideki
authors.initials: H
authors.lastname: Kusagaya
authors.affiliation: Second Division, Department of Internal Medicine, Hamamatsu University School of Medicine, 1-20-1 Handayama, Hamamatsu 431-3192, Japan; Department of Clinical Pharmacology and Therapeutics, Hamamatsu University School of Medicine, 1-20-1 Handayama, Hamamatsu 431-3192, Japan. Electronic address: inui@hama-med.ac.jp.
authors.forename: Naoki
authors.initials: N
authors.lastname: Inui
authors.affiliation: Second Division, Department of Internal Medicine, Hamamatsu University School of Medicine, 1-20-1 Handayama, Hamamatsu 431-3192, Japan; Department of Clinical Oncology, Hamamatsu University School of Medicine, 1-20-1 Handayama, Hamamatsu 431-3192, Japan.
authors.forename: Masato
authors.initials: M
authors.lastname: Karayama
authors.affiliation: Second Division, Department of Internal Medicine, Hamamatsu University School of Medicine, 1-20-1 Handayama, Hamamatsu 431-3192, Japan.
authors.forename: Tomoyuki
authors.initials: T
authors.lastname: Fujisawa
authors.affiliation: Second Division, Department of Internal Medicine, Hamamatsu University School of Medicine, 1-20-1 Handayama, Hamamatsu 431-3192, Japan.
authors.forename: Noriyuki
authors.initials: N
authors.lastname: Enomoto
authors.affiliation: Department of Respiratory Medicine, Ensyu Hospital, 1-1-1 Chuou, Hamamatsu 430-0929, Japan.
authors.forename: Shigeki
authors.initials: S
authors.lastname: Kuroishi
authors.affiliation: Second Division, Department of Internal Medicine, Hamamatsu University School of Medicine, 1-20-1 Handayama, Hamamatsu 431-3192, Japan.
authors.forename: Yutaro
authors.initials: Y
authors.lastname: Nakamura
authors.affiliation: Department of Respiratory Medicine, Japanese Red Cross Shizuoka Hospital, 8-2 Otemachi, Shizuoka 420-0853, Japan.
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Matsuda
authors.affiliation: Department of Respiratory Medicine, Seirei Mikatahara General Hospital, 3453 Mikatahara-cho, Hamamatsu 433-8558, Japan.
authors.forename: Koshi
authors.initials: K
authors.lastname: Yokomura
authors.affiliation: Department of Respiratory Medicine, Fujieda Municipal General Hospital, 4-1-11 Surugadai, Fujieda 426-8677, Japan.
authors.forename: Naoki
authors.initials: N
authors.lastname: Koshimizu
authors.affiliation: Department of Respiratory Medicine, Hamamatsu Rosai Hospital, 25 Shougen-cho, Hamamatsu 434-8525, Japan.
authors.forename: Mikio
authors.initials: M
authors.lastname: Toyoshima
authors.affiliation: Department of Respiratory Medicine, Iwata City Hospital, 513-2 Ohkubo, Iwata 438-8550, Japan.
authors.forename: Shiro
authors.initials: S
authors.lastname: Imokawa
authors.affiliation: Department of Respiratory Medicine, Shizuoka City Shizuoka Hospital, 10-93 Ote-cho, Shizuoka 420-8630, Japan.
authors.forename: Takashi
authors.initials: T
authors.lastname: Yamada
authors.affiliation: Department of Respiratory Medicine, Shizuoka General Hospital, 4-27-1 Kita-ando, Shizuoka 420-0881, Japan.
authors.forename: Toshihiro
authors.initials: T
authors.lastname: Shirai
authors.affiliation: Department of Respiratory Medicine, Tenryu Hospital, 4201-2 Oro, Hamamatsu 434-8511, Japan.
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Hayakawa
authors.affiliation: Second Division, Department of Internal Medicine, Hamamatsu University School of Medicine, 1-20-1 Handayama, Hamamatsu 431-3192, Japan.
authors.forename: Takafumi
authors.initials: T
authors.lastname: Suda
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000932:Antiemetics / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects* / Q000627:therapeutic use; D016190:Carboplatin / Q000008:administration & dosage; D002289:Carcinoma, Non-Small-Cell Lung / Q000150:complications* / Q000188:drug therapy / Q000473:pathology; D003907:Dexamethasone / Q000008:administration & dosage; D005260:Female; D006801:Humans; D007546:Isoquinolines / Q000008:administration & dosage; D008175:Lung Neoplasms / Q000150:complications* / Q000188:drug therapy / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000209:etiology* / Q000517:prevention & control*; D009367:Neoplasm Staging; D016017:Odds Ratio; D000077924:Palonosetron; D011812:Quinuclidines / Q000008:administration & dosage; D016896:Treatment Outcome; D014839:Vomiting / Q000209:etiology* / Q000517:prevention & control*
chemical_list: D000932:Antiemetics; D007546:Isoquinolines; D011812:Quinuclidines; D000077924:Palonosetron; D003907:Dexamethasone; D016190:Carboplatin
keywords: Antiemetic; Aprepitant; Carboplatin; Chemotherapy-induced nausea and vomiting; Non-small-cell lung cancer; Palonosetron