title: Combination antiemetic therapy with aprepitant/fosaprepitant in patients with colorectal cancer receiving oxaliplatin-based chemotherapy in the SENRI trial: analysis of risk factors for vomiting and nausea.
abstract: BACKGROUND
  We previously reported in the SENRI trial on the usefulness of aprepitant for the prevention of chemotherapy-induced nausea and vomiting (CINV) in colorectal cancer patients receiving an oxaliplatin-based regimen which is classified as moderately emetogenic cancer chemotherapy. In the present subgroup analysis of the SENRI trial, we assessed the risk factors for CINV in colorectal cancer patients who received oxaliplatin-based chemotherapy.
  
  
  METHODS
  Multivariate logistic regression models were used to assess the impact of aprepitant use and patient characteristics on vomiting and nausea. We also assessed the proportion of CINV in patients by gender.
  
  
  RESULTS
  Female gender and aprepitant use were associated with the incidence of vomiting and no significant nausea. Significantly more men achieved no vomiting than women (92.9 vs 84.5 % in men and women, respectively; P = 0.0001). The rate of no nausea, complete response, complete protection, and total control was also higher in men. The rate rescue therapy use was significantly higher in women than men. We compared the rate of CINV between aprepitant and control groups and found a significant difference in male patients who achieved no vomiting and complete protection in the overall phase. In women, the rate of no nausea, no vomiting, and total control was higher in the aprepitant group than in the control group.
  
  
  CONCLUSIONS
  Gender and aprepitant use were risk factors for CINV in colorectal patients who received oxaliplatin-based chemotherapy. Aprepitant therapy was more effective for women than for men in the prevention of CINV in colorectal cancer patients receiving an oxaliplatin-based regimen.
authors.affiliation: Department of Surgery, Kinki Central Hospital, Kurumaduka 3-1, Itami, Hyogo, Japan.
authors.forename: Hiroyoshi
authors.initials: H
authors.lastname: Takemoto
authors.affiliation: Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine, Yamadaoka 2-2, Suita, Osaka, Japan. jnishimura@gesurg.med.osaka-u.ac.jp.
authors.forename: Junichi
authors.initials: J
authors.lastname: Nishimura
authors.affiliation: Department of Surgery, Toyonaka Municipal Hospital, Shibahara 4-14-1, Toyonaka, Osaka, Japan.
authors.forename: Takamichi
authors.initials: T
authors.lastname: Komori
authors.affiliation: Department of Surgery, Rinku General Medical Center, Rinku Ourai Kita 2-23, Izumisano, Osaka, Japan.
authors.forename: Ho Min
authors.initials: HM
authors.lastname: Kim
authors.affiliation: Department of Digestive Surgery, Ikeda City Hospital, Jyounan 3-1-18, Ikeda, Osaka, Japan.
authors.forename: Hirofumi
authors.initials: H
authors.lastname: Ota
authors.affiliation: Department of Surgery, Itami City Hospital, Koyaike 1-100, Itami, Hyogo, Japan.
authors.forename: Rei
authors.initials: R
authors.lastname: Suzuki
authors.affiliation: Department of Surgery, Higashiosaka City General Hospital, Nishiiwata 3-4-5, Higashiosaka, Osaka, Japan.
authors.forename: Masakazu
authors.initials: M
authors.lastname: Ikenaga
authors.affiliation: Department of Surgery, National Hospital Organization, Osaka National Hospital, Hoenzaka 2-1-14, Osaka, Osaka, Japan.
authors.forename: Masataka
authors.initials: M
authors.lastname: Ikeda
authors.affiliation: Division of Health Sciences, Graduate School of Medicine, Department of Molecular Pathology, Osaka University, Yamadaoka 1-7, Suita, Osaka, Japan.
authors.forename: Hirofumi
authors.initials: H
authors.lastname: Yamamoto
authors.affiliation: Department of Frontier-Science for Cancer and Chemotherapy, Graduate School of Medicine, Osaka University, Yamadaoka 2-2, Suita, Osaka, Japan.
authors.forename: Taroh
authors.initials: T
authors.lastname: Satoh
authors.affiliation: Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine, Yamadaoka 2-2, Suita, Osaka, Japan.
authors.forename: Taishi
authors.initials: T
authors.lastname: Hata
authors.affiliation: Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine, Yamadaoka 2-2, Suita, Osaka, Japan.
authors.forename: Ichiro
authors.initials: I
authors.lastname: Takemasa
authors.affiliation: Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine, Yamadaoka 2-2, Suita, Osaka, Japan.
authors.forename: Tsunekazu
authors.initials: T
authors.lastname: Mizushima
authors.affiliation: Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine, Yamadaoka 2-2, Suita, Osaka, Japan.
authors.forename: Yuichirou
authors.initials: Y
authors.lastname: Doki
authors.affiliation: Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine, Yamadaoka 2-2, Suita, Osaka, Japan.
authors.forename: Masaki
authors.initials: M
authors.lastname: Mori
mesh_terms: D000328:Adult; D000368:Aged; D000932:Antiemetics / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects* / Q000627:therapeutic use; D000077608:Aprepitant; D015179:Colorectal Neoplasms / Q000188:drug therapy*; D005260:Female; D006801:Humans; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D009025:Morpholines / Q000008:administration & dosage / Q000627:therapeutic use; D009325:Nausea / Q000139:chemically induced* / Q000517:prevention & control; D009944:Organoplatinum Compounds / Q000008:administration & dosage / Q000009:adverse effects; D000077150:Oxaliplatin; D012307:Risk Factors; D014839:Vomiting / Q000139:chemically induced* / Q000517:prevention & control
chemical_list: D000932:Antiemetics; D009025:Morpholines; D009944:Organoplatinum Compounds; D000077150:Oxaliplatin; D000077608:Aprepitant; C579707:fosaprepitant
keywords: Aprepitant; CINV; Colorectal cancer; Gender; Oxaliplatin; Risk factors; Subgroup analysis