title: Randomized controlled trial on the skin toxicity of panitumumab in Japanese patients with metastatic colorectal cancer: HGCSG1001 study; J-STEPP.
abstract: OBJECTIVE
  We planned a randomized, open-label trial to evaluate differences between pre-emptive and reactive skin treatment for panitumumab (Pmab)-associated skin toxicities in Japanese patients with metastatic colorectal cancer.
  
  
  METHODS
  Patients receiving third-line Pmab-containing regimens were randomized to pre-emptive or reactive treatment. The primary end point was the cumulative incidence of ≥grade 2 skin toxicities during 6 weeks. Retrospectively, a dermatologist reviewed skin toxicities, in a blinded manner.
  
  
  RESULTS
  A total of 95 patients were enrolled (pre-emptive: 47, reactive: 48). The primary end point was achieved (21.3 and 62.5% [risk ratio: 0.34; p < 0.001], for pre-emptive and reactive treatment, respectively). A similar trend was observed in central review.
  
  
  CONCLUSIONS
  Pre-emptive skin treatment could reduce the severity of Pmab-associated skin toxicities in Japanese metastatic colorectal cancer patients.
authors: Department of Gastroenterology & Hepatology, Hokkaido University Graduate School of Medicine, Sapporo, Japan.
authors: Yoshimitsu
authors: Y
authors: Kobayashi
authors: Yoshito
authors: Y
authors: Komatsu
authors: Satoshi
authors: S
authors: Yuki
authors: Hiraku
authors: H
authors: Fukushima
authors: Takahide
authors: T
authors: Sasaki
authors: Ichiro
authors: I
authors: Iwanaga
authors: Minoru
authors: M
authors: Uebayashi
authors: Hiroyuki
authors: H
authors: Okuda
authors: Takaya
authors: T
authors: Kusumi
authors: Takuto
authors: T
authors: Miyagishima
authors: Susumu
authors: S
authors: Sogabe
authors: Miki
authors: M
authors: Tateyama
authors: Kazuteru
authors: K
authors: Hatanaka
authors: Yasushi
authors: Y
authors: Tsuji
authors: Michio
authors: M
authors: Nakamura
authors: Jun
authors: J
authors: Konno
authors: Fumiyasu
authors: F
authors: Yamamoto
authors: Manabu
authors: M
authors: Onodera
authors: Kazuhiro
authors: K
authors: Iwai
authors: Yuh
authors: Y
authors: Sakata
authors: Riichiro
authors: R
authors: Abe
authors: Koji
authors: K
authors: Oba
authors: Naoya
authors: N
authors: Sakamoto
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000911:Antibodies, Monoclonal / Q000008:administration & dosage / Q000009:adverse effects*; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D015179:Colorectal Neoplasms / Q000150:complications* / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D066246:ErbB Receptors / Q000037:antagonists & inhibitors; D005260:Female; D006801:Humans; D007564:Japan; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D000077544:Panitumumab; D012871:Skin Diseases / Q000209:etiology* / Q000473:pathology; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000911:Antibodies, Monoclonal; D000970:Antineoplastic Agents; D000077544:Panitumumab; D066246:ErbB Receptors
keywords: Japanese; colorectal cancer; panitumumab; pre-emptive; skin toxicities