552P - Randomized controlled trial on the skin toxicity of panitumumab in third line treatment of KRAS wild-type metastatic colorectal cancer: HGCSG1001 (...

Date 29 September 2014
Event ESMO 2014
Session Poster Display session
Topics Anticancer Agents
Complications/Toxicities of Treatment
Colon and Rectal Cancer
Biological Therapy
Presenter Michio Nakamura
Citation Annals of Oncology (2014) 25 (suppl_4): iv167-iv209. 10.1093/annonc/mdu333
Authors M. Nakamura1, Y. Kobayashi2, S. Yuki3, H. Nakatsumi4, H. Hayashi4, I. Iwanaga5, Y. Tsuji6, K. Hatanaka7, H. Okuda8, J. Konno9, F. Yamamoto10, K. Iwai11, M. Onodera12, T. Takagi13, H. Hisai14, M. Koike15, R. Abe16, K. Oba17, Y. Sakata18, Y. Komatsu19
  • 1Gastroenterology, Sapporo City General Hospital, 060-8604 - Sapporo/JP
  • 2Internal Medicine, Kushiro Rosai Hospital, Kushiro/JP
  • 3Gastroenterology And Hepatology, Hokkaido University Hospital, 064-0804 - Sapporo/JP
  • 4Gastroenterology And Hepatology, Hokkaido University Hospital, 060-8638 - Sapporo/JP
  • 5Gastroenterology, Japanese Red Cross Kitami Hospital, Kitami/JP
  • 6Medical Oncology, Tonan Hospital, Sapporo/JP
  • 7Gastroenterology, Hakodate Municipal Hospital, 041-8680 - Hakodate/JP
  • 8Medical Oncology, Keiyukai Sapporo Hospital, Sapporo/JP
  • 9Gastroenterology, Hakodate Central General Hospital, Hakodate/JP
  • 10Gastroenterology, Tomakomai City Hospital, Tomakomai/JP
  • 11Surgery, Oji General Hospital, Tomakomai/JP
  • 12Gastroenterology, Abashiri Kosei General Hospital, Abashiri/JP
  • 13Gastroenterology, Sapporo Hokushin Hospital, Sapporo/JP
  • 14Gastroenterology, Date Red Cross Hospital, Date/JP
  • 15Surgery, KKR Sapporo Medical Center, Sapporo/JP
  • 16Dermatology, Hokkaido University Graduate School of Medicine, Sapporo/JP
  • 17Translational Research And Clinical Trial Center, Hokkaido University Hospital, Sapporo/JP
  • 18Ceo, Misawa City Hospital, JP-033-0022 - Misawa/JP
  • 19Cancer Center, Hokkaido University, 060-8638 - Sapporo/JP



Panitumumab (Pmab) has demonstrated efficacy in patients with KRAS wild-type metastatic colorectal cancer (mCRC). Although the STEPP study (Lacouture M. E. et al. J Clin Oncol. 2010; 28: 1351-7.) showed that pre-emptive skin treatment reduced skin toxicities compared with reactive treatment among patients receiving Pmab, data for Asians has not been reported. We planned a randomized, open-label trial to verify the differences between pre-emptive and reactive treatment for skin toxicities in Japanese patients.


Patients receiving third-line Pmab-containing regimens for mCRC were randomly assigned 1:1 to pre-emptive (skin moisturizers, sunscreen, topical steroid, and minocycline) or reactive (only skin moisturizers) skin treatment. The primary endpoint was the cumulative incidence of ≥grade 2 skin toxicities during the 6-week treatment period. Retrospectively, a dermatologist reviewed skin toxicities, in a blinded manner, using photographs.


Of 95 enrolled patients, 47 were assigned to pre-emptive, and 48 to reactive treatment. The incidence of ≥grade 2 skin toxicities during the 6-week treatment period (investigators’ assessment) was 21.3% and 62.5% (risk ratio [RR], 0.34; 95% CI, 0.19 to 0.62; P < 0.001) for the pre-emptive and reactive treatment groups, respectively. A similar trend was observed in central review (18.6% and 50.0%, respectively [RR, 0.37; 95% CI, 0.19 to 0.74; P = 0.002]). There were no statistical differences in QOL assessed by using the DLQI (Dermatology Life Quality Index) in slope (P = 0.832), at 3 weeks (P = 0.222), at 7 weeks (P = 0.243), and 13 weeks (P = 0.874).


Although pre-emptive skin treatment could not be affected with QOL, it could reduce the severity of skin toxicities during Pmab treatment. Our data clearly validate that pre-emptive treatment can also be recommended in Japanese patients.


M. Nakamura: Takeda Pharmaceutical, Chugai Pharmaceutical, Bayer Yakuhin; S. Yuki: Taiho Pharmaceutical, Chugai Pharmaceutical, Bristol-Myers Squibb, Merck Serono, Takeda Pharmaceutical, Yakult Honsha; Y. Sakata: Taiho Pharmaceutical, Daiichi Sankyo, Yakult Honsha, Otsuka Pharmaceutical, Merck Serono, Bristol-Myers Squibb, Synergy International; Y. Komatsu: Yakult Honsha, Taiho Pharmaceutical, Chugai Pharmaceutical, Merck Serono, Pfizer Japan, Novartis Pharma, Sawai Pharmaceutical, Ono Pharmaceutical, Daiichi Sankyo, Takeda Pharmaceutical, Eli Lilly Japan, Kureha Corporation. All other authors have declared no conflicts of interest.