title: A postmarketing surveillance study on erbitux (cetuximab) in patients with metastatic colorectal cancer refractory to irinotecan-containing treatment.
abstract: OBJECTIVE
  This postmarketing surveillance study evaluated the safety and efficacy of cetuximab therapy in patients with epidermal growth factor receptor (EGFR)-expressing metastatic colorectal cancer (mCRC) in Taiwan.
  
  
  METHODS
  Patients with EGFR-expressing mCRC who had failed prior irinotecan-based chemotherapy and were receiving cetuximab therapy were monitored for treatment efficacy and safety from the time of first infusion until 28 days after the last infusion regardless of the reasons fordiscontinuation. The study followed 269 patients for approximately 2 years.
  
  
  RESULTS
  No unexpected adverse events associated with cetuximab therapy were reported, and most events were grade 1 or 2. The most common drug-related adverse events of any grade were rash (21.6%) and dermatitis acneiform (4.8%). Reported grade 3/4 events were rash (4.5%), dermatitis acneiform (0.4%), and diarrhea (0.4%). Cetuximab treatment for patients receiving second-/third-line (177 patients) or above therapy (92 patients) was associated with a median progression-free survival time of 3.37 and 3.90 months, respectively, and a median overall survival time of 17.6 and 21.1 months, respectively. The response rates for the second-/third-line treatment and fourth-line or above cetuximab treatment groups were similar (21.5% vs 17.4%; P = 0.428).
  
  
  CONCLUSIONS
  Cetuximab showed no unexpected safety findings and was efficacious in treating patients with EGFR-expressing mCRC in community practice in Taiwan.
authors.affiliation: From the *Department of Hematology and Oncology, Chi Mei Hospital, Liuying, Tainan; †Department of Colon and Rectal Surgery, Chang-Gung Memorial Hospital, Kaohsiung; ‡Department of Colon and Rectal Surgery, Chang-Gung Memorial Hospital; §Department of Hematology-Oncology, Ditmanson Medical Foundation Hospital, Chiayi; ∥Department of Hematology and Oncology, Chi Mei Hospital, Yongkang, Tainan; ¶Department of Hematology and Oncology, Chang-Gung Memorial Hospital, Keelung; **Department of Colon and Rectal Surgery, Taichung Veterans General Hospital, Taichung; ††Department of Hematology and Oncology, National Cheng Kung University Hospital, Tainan; ‡‡Department of Hematology and Oncology, Shin Kong Wu Ho-Su Memorial Hospital, Taipei; §§Department of Hematology and Oncology, Tainan Municipal Hospital, Tainan; ¶¶Department of Hematology and Oncology, Buddhist Tzu Chi General Hospital, Taipei; ***Department of Colon and Rectal Surgery, Chang-Gung Memorial Hospital, Linkou, New Taipei City; †††Department of Hematology and Oncology, Buddhist Tzu Chi General Hospital, Hualien; ‡‡‡Department of Colon and Rectal Surgery, Chung Shan Medical University Hospital, Taichung, Taiwan; §§§Merck Limited, Taipei, Taiwan, an affiliate of Merck KGaA, Darmstadt, Germany; and ¶¶¶Cancer Center, Mackay Memorial Hospital, Taipei, Taiwan.
authors.forename: Wen-Tsung
authors.initials: WT
authors.lastname: Huang
authors.forename: Hong-Hwa
authors.initials: HH
authors.lastname: Chen
authors.forename: Chung-Hung
authors.initials: CH
authors.lastname: Yeh
authors.forename: Yin-Che
authors.initials: YC
authors.lastname: Lu
authors.forename: Wei-Shou
authors.initials: WS
authors.lastname: Hwang
authors.forename: Jen-Seng
authors.initials: JS
authors.lastname: Huang
authors.forename: Chou-Pin
authors.initials: CP
authors.lastname: Chen
authors.forename: Peng-Chan
authors.initials: PC
authors.lastname: Lin
authors.forename: Wu-Ching
authors.initials: WC
authors.lastname: Uen
authors.forename: Yang-Cheng
authors.initials: YC
authors.lastname: Lee
authors.forename: Hwei-Ming
authors.initials: HM
authors.lastname: Wang
authors.forename: Hong-Cheng
authors.initials: HC
authors.lastname: Wu
authors.forename: Jinn-Shiun
authors.initials: JS
authors.lastname: Chen
authors.forename: Ruey-Ho
authors.initials: RH
authors.lastname: Kao
authors.forename: Chi-Chou
authors.initials: CC
authors.lastname: Huang
authors.forename: Hao-Hsuan
authors.initials: HH
authors.lastname: Jeng
authors.forename: Chia-Jung
authors.initials: CJ
authors.lastname: Lin
authors.forename: Ruey-Kuen
authors.initials: RK
authors.lastname: Hsieh
mesh_terms: D000368:Aged; D061067:Antibodies, Monoclonal, Humanized / Q000627:therapeutic use*; D002166:Camptothecin / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000068818:Cetuximab; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000556:secondary*; D005260:Female; D006801:Humans; D000077146:Irinotecan; D008297:Male; D008875:Middle Aged; D011358:Product Surveillance, Postmarketing / Q000379:methods*; D017211:Treatment Failure; D016896:Treatment Outcome
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D000077146:Irinotecan; D000068818:Cetuximab; D002166:Camptothecin