Randomized controlled trial on the skin toxicity of panitumumab in Japanese patients with metastatic colorectal cancer: HGCSG1001 study; J-STEPP. (February 2015)

• Record Type: Journal Article
• Authors: Kobayashi, Yoshimitsu; Komatsu, Yoshito; Yuki, Satoshi; Fukushima, Hiraku; Sasaki, Takahide; Iwanaga, Ichiro; Uebayashi, Minoru; Okuda, Hiroyuki; Kusumi, Takaya; Miyagishima, Takuto; Sogabe, Susumu; Tateyama, Miki; Hatanaka, Kazuteru; Tsuji, Yasushi; Nakamura, Michio; Konno, Jun; Yamamoto, Fumiyasu; Onodera, Manabu; Iwai, Kazuhiro; Sakata, Yuh; Abe, Riichiro; Oba, Koji; Sakamoto, Naoya
• Is Part Of: Future oncology. Volume 11:Number 4(2015)
• Page Start: 617
• Page End: 627
• Publication Date: 2015-02
• Subjects: colorectal cancer -- Japanese -- panitumumab -- pre-emptive -- skin toxicities; Oncology -- Periodicals; 616.99405
• DOI: 10.2217/fon.14.251
• Languages: English
• ISSNs: 1479-6694

Abstract

ABSTRACT : Aim: 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.Patients & 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.Conclusion: Pre-emptive skin treatment could reduce the severity of Pmab-associated skin toxicities in Japanese metastatic colorectal cancer patients.