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Randomized controlled trial on the skin toxicity of panitumumab in third line treatment of KRAS Exon2 wild-type mCRC: Japanese Skin Toxicity Evaluation Protocol with Panitumumab: J-STEPP/HGCSG1001: updated analysis of anti-tumor efficacy

Date

19 Dec 2015

Session

Poster presentation 1

Presenters

Satoshi Yuki

Citation

Annals of Oncology (2015) 26 (suppl_9): 42-70. 10.1093/annonc/mdv523

Authors

S. Yuki1, Y. Komatsu2, H. Nakatsumi2, T. Muranaka2, Y. Kobayashi3, T. Miyagishima3, N. Ehira4, I. Iwanaga4, H. Okuda5, M. Tateyama6, Y. Tsuji7, K. Hatanaka8, M. Nakamura9, M. Kudo10, H. Fukushima11, H. Hisai12, R. Abe13, N. Sakamoto1, K. Oba14, Y. Sakata15

Author affiliations

  • 1 Gastroenterology And Hepatology, Hokkaido University Hospital, 060-8638 - Sapporo/JP
  • 2 Cancer Center, Hokkaido University Hospital, 060-8638 - Sapporo/JP
  • 3 Medical Oncology, Kushiro Rosai Hospital, Kushiro/JP
  • 4 Medical Oncology, Japanese Red Cross Kitami Hospital, Kitami/JP
  • 5 Medical Oncology, Keiyukai Sapporo Hospital, 003-0027 - Sapporo/JP
  • 6 Internal Medicine, Tomakomai Nisshou Hospital, Tomakomai/JP
  • 7 Medical Oncology, Tonan Hospital, 060-0001 - Sapporo/JP
  • 8 Gastroenterology, Hakodate Municipal Hospital, Hakodate/JP
  • 9 Gastroenterology, Sapporo City General Hospital, 060-8604 - Sapporo/JP
  • 10 Gastroenterology, Sapporo Hokuyu Hospital, Sapporo/JP
  • 11 Gastroenterology, Sapporo Hokushin Hospital, Sapporo/JP
  • 12 Gastroenterology, Date Red Cross Hospital, Date/JP
  • 13 Dermatology, Hokkaido University Graduate School of Medicine, Sapporo/JP
  • 14 Biostatistics, School of Public Health, Graduate School of Medicine, The University of Tokyo, Tokyo/JP
  • 15 Ceo, Misawa City Hospital, 033-0022 - Misawa/JP
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Aim/Background

We had already reported that pre-emptive skin treatment could reduce the severity of panitumumab (Pmab)-associated skin toxicities in Japanese metastatic colorectal cancer patients (Kobayashi Y, et al. Future Oncol, 2015). Therefore, we performed analysis to investigate whether pre-emptive skin treatment affected anti-tumor efficacy.

Methods

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. In this analysis, we compared the two groups for anti-tumor efficacy on the final survival data.

Results

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]). On the final survival analysis, there were no statistical differences in overall response rate (13.3% vs 18.2%; P = 0.530), progression free survival (3.6 vs 4.0 months; hazard ratio [HR], 1.270; 95% CI, 0.833 to 1.938; P = 0.267), overall survival (8.2 vs 12.1 months, [HR, 1.150; 95% CI, 0.754 to 1.755; P = 0.515]) between pre-emptive and reactive treatment groups.

Conclusions

Pre-emptive skin treatment could reduce the severity of skin toxicities during Pmab treatment. On the final survival analysis, pre-emptive skin treatment did not affect the anti-tumor efficacy of Pmab. Our data clearly validate that pre-emptive treatment can also be recommended in Japanese patients. This analysis had been presented at the European Cancer Congress 2015 (Kobayashi Y, et al. Abstract number was 2 094).

Clinical trial identification

UMIN000004883

Disclosure

Y. Komatsu: Honoraria: Yakult Honsha Co., Ltd., Takeda Pharmaceutical Co., Ltd. Research fund: Yakult Honsha Co., Ltd., Daiichi Sankyo Co., Ltd., Takeda Pharmaceutical Co., Ltd. Y. Sakata: Honoraria Daiichi Sankyo Co., Ltd. Yakult Honsha Co., Ltd. All other authors have declared no conflicts of interest.

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