title: Comparison between hypersensitivity reactions to cycles of modified FOLFOX6 and XELOX therapies in patients with colorectal cancer.
abstract: OBJECTIVE
  Although hypersensitivity reactions (HSRs) to oxaliplatin (L-OHP) therapy are well-documented, few reports have compared different therapies in terms of HSR occurrence. In this study, we compared the frequency and pattern of HSRs to modified FOLFOX6 (mFOLFOX6; 5-fluorouracil, levofolinate calcium and L-OHP infusions) and XELOX (capecitabine and L-OHP) therapies, and sought to identify risk factors associated with HSRs.
  
  
  METHODS
  Patients who had received mFOLFOX6 or XELOX chemotherapeutic regimens for unresectable colon or rectal cancer or as adjuvant chemotherapy following colon cancer surgery between April 2012 and August 2015 were included. Potential correlation between treatment modalities (regimen, dosage and route of administration of L-OHP, and injection timing for dexamethasone administration) and HSRs was assessed.
  
  
  RESULTS
  Among the 240 patients included in the study, 136 had received mFOLFOX6 therapy and 104 had received XELOX therapy. Although the frequency of HSRs did not differ between the two groups, incidence of HSRs in the first cycle was higher in the XELOX therapy group. Treatment method or cumulative dosage was not identified as a risk factor for HSR; however, the incidence of ≥grade-2 HSR was higher in cases where the cumulative L-OHP dosage was ≥600 mg/m2and in patients in whom dexamethasone was not co-infused with L-OHP.
  
  
  CONCLUSIONS
  Although HSR rates were comparable among patients treated with mFOLFOX6 and XELOX, HSRs tended to occur more frequently during the first cycle of XELOX therapy as compared to that with mFOLFOX6 therapy. Our findings warrant careful assessment of ≥grade-2 HSRs in patients who are prescribed cumulative L-OHP dosages of ≥600 mg/m2.
authors.affiliation: Department of Clinical Pharmacy, Fujita Health University School of Medicine, 1-98 Dengakugakubo, Kutsukake-cho, Toyoake, 470-1192, Japan.|Department of Pharmacy, Fujita Health University Hospital, Toyoake, Japan.
authors.forename: Hideki
authors.initials: H
authors.lastname: Ohta
authors.affiliation: Department of Clinical Pharmacy, Fujita Health University School of Medicine, 1-98 Dengakugakubo, Kutsukake-cho, Toyoake, 470-1192, Japan. taka-h@fujita-hu.ac.jp.|Department of Pharmacy, Fujita Health University Hospital, Toyoake, Japan. taka-h@fujita-hu.ac.jp.
authors.forename: Takahiro
authors.identifier: http://orcid.org/0000-0002-9686-6903
authors.initials: T
authors.lastname: Hayashi
authors.affiliation: College of Pharmacy, Kinjo Gakuin University, Nagoya, Japan.
authors.forename: Sumie
authors.initials: S
authors.lastname: Murai
authors.affiliation: College of Pharmacy, Kinjo Gakuin University, Nagoya, Japan.
authors.forename: Hideyo
authors.initials: H
authors.lastname: Shiouchi
authors.affiliation: Department of Clinical Pharmacy, Fujita Health University School of Medicine, 1-98 Dengakugakubo, Kutsukake-cho, Toyoake, 470-1192, Japan.|Department of Pharmacy, Fujita Health University Hospital, Toyoake, Japan.
authors.forename: Yosuke
authors.initials: Y
authors.lastname: Ando
authors.affiliation: Department of Clinical Pharmacy, Fujita Health University School of Medicine, 1-98 Dengakugakubo, Kutsukake-cho, Toyoake, 470-1192, Japan.|Department of Pharmacy, Fujita Health University Hospital, Toyoake, Japan.
authors.forename: Satomi
authors.initials: S
authors.lastname: Kumazawa
authors.affiliation: Department of Pharmacy, Fujita Health University Hospital, Toyoake, Japan.|Department of Hematology, Fujita Health University School of Medicine, Toyoake, Japan.
authors.forename: Kaori
authors.initials: K
authors.lastname: Ito
authors.affiliation: College of Pharmacy, Kinjo Gakuin University, Nagoya, Japan.
authors.forename: Yoshiaki
authors.initials: Y
authors.lastname: Ikeda
authors.affiliation: Department of Surgery, Fujita Health University School of Medicine, Toyoake, Japan.
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Matsuoka
authors.affiliation: Department of Surgery, Fujita Health University School of Medicine, Toyoake, Japan.
authors.forename: Kotaro
authors.initials: K
authors.lastname: Maeda
authors.affiliation: Department of Medical Oncology, Fujita Health University School of Medicine, Toyoake, Japan.
authors.forename: Kenji
authors.initials: K
authors.lastname: Kawada
authors.affiliation: College of Pharmacy, Kinjo Gakuin University, Nagoya, Japan.
authors.forename: Kimio
authors.initials: K
authors.lastname: Yasuda
authors.affiliation: Department of Clinical Pharmacy, Fujita Health University School of Medicine, 1-98 Dengakugakubo, Kutsukake-cho, Toyoake, 470-1192, Japan.|Department of Pharmacy, Fujita Health University Hospital, Toyoake, Japan.
authors.forename: Shigeki
authors.initials: S
authors.lastname: Yamada
mesh_terms: D000368:Aged; D000893:Anti-Inflammatory Agents / Q000627:therapeutic use; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage; D000970:Antineoplastic Agents / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D000069287:Capecitabine; D015179:Colorectal Neoplasms / Q000150:complications* / Q000188:drug therapy / Q000601:surgery; D003131:Combined Modality Therapy; D003841:Deoxycytidine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D003907:Dexamethasone / Q000627:therapeutic use; D004342:Drug Hypersensitivity / Q000453:epidemiology*; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D006801:Humans; D015994:Incidence; D002955:Leucovorin / Q000008:administration & dosage; D008297:Male; D008875:Middle Aged; D009944:Organoplatinum Compounds / Q000008:administration & dosage; D000077150:Oxaliplatin; D010071:Oxaloacetates; D012189:Retrospective Studies; D012307:Risk Factors
chemical_list: D000893:Anti-Inflammatory Agents; D000964:Antimetabolites, Antineoplastic; D000970:Antineoplastic Agents; D009944:Organoplatinum Compounds; D010071:Oxaloacetates; D000077150:Oxaliplatin; D003841:Deoxycytidine; D000069287:Capecitabine; D003907:Dexamethasone; D002955:Leucovorin; D005472:Fluorouracil
keywords: Colorectal cancer; FOLFOX therapy; Hypersensitivity reactions; Oxaliplatin; XELOX therapy