title: Panitumumab in Japanese patients with unresectable colorectal cancer: a post-marketing surveillance study of 3085 patients.
abstract: OBJECTIVE
  Panitumumab was approved in Japan in April 2010 for the treatment of Kirsten rat sarcoma-2 virus oncogene wild-type unresectable and recurrent colorectal cancer. We conducted a post-marketing surveillance study to evaluate the safety and effectiveness of panitumumab.
  
  
  METHODS
  After panitumumab was commercially available in Japan, all patients to be treated with panitumumab were enrolled. Data on baseline characteristics, treatment outcome, and incidence and severity of adverse drug reactions were collected.
  
  
  RESULTS
  In total, 3091 patients were registered. In the safety analysis set (n = 3085), panitumumab was administered as monotherapy (40.7%) or combination therapy (59.4%). The median treatment duration was 113 days (range: 1-559 days), and 451 (14.6%) patients received panitumumab for ≥10 months. The overall incidence rate of adverse drug reactions was 84.1%, and the most common adverse drug reaction was skin disorders (78.4%). The incidence rates (all grades) of interstitial lung disease, infusion reaction, electrolyte abnormalities and cardiac disorders were 1.3% (mortality rate: 0.6%), 1.5, 19.3 and 0.2%, respectively. The median survival time of patients treated with panitumumab monotherapy as the third-line, or later, therapy was 10.3 months.
  
  
  CONCLUSIONS
  This post-marketing survey in clinical practice confirmed the safety and effectiveness of panitumumab. The benefit/risk balance for panitumumab in Japanese patients with unresectable colorectal cancer remains favorable.
authors: *Department of Clinical Oncology, St. Marianna University School of Medicine, 2-16-1, Sugao, Miyamae-ku, Kawasaki 216-8511, Japan. n.boku@marianna-u.ac.jp.
authors: Narikazu
authors: N
authors: Boku
authors: Kenichi
authors: K
authors: Sugihara
authors: Yuko
authors: Y
authors: Kitagawa
authors: Kiyohiko
authors: K
authors: Hatake
authors: Akihiko
authors: A
authors: Gemma
authors: Naoya
authors: N
authors: Yamazaki
authors: Kei
authors: K
authors: Muro
authors: Tetsuya
authors: T
authors: Hamaguchi
authors: Takayuki
authors: T
authors: Yoshino
authors: Ikuo
authors: I
authors: Yana
authors: Hiroshi
authors: H
authors: Ueno
authors: Atsushi
authors: A
authors: Ohtsu
mesh_terms: D000328:Adult; D000368:Aged; D000818:Animals; D000911:Antibodies, Monoclonal / Q000008:administration & dosage* / Q000009:adverse effects*; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage / Q000009:adverse effects; D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000009:adverse effects*; D044466:Asian People; D000068818:Cetuximab; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D005260:Female; D006333:Heart Failure / Q000139:chemically induced; D006801:Humans; D007564:Japan; D053208:Kaplan-Meier Estimate; D017563:Lung Diseases, Interstitial / Q000139:chemically induced; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy* / Q000401:mortality; D000077544:Panitumumab; D051381:Rats; D012867:Skin / Q000187:drug effects; D016896:Treatment Outcome; D014883:Water-Electrolyte Imbalance / Q000139:chemically induced
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents; D000077544:Panitumumab; D000068818:Cetuximab
keywords: colorectal cancer; panitumumab; post-marketing surveillance; safety