Topical corticosteroid therapy for facial acneiform eruption due to EGFR inhibitors in metastatic colorectal cancer patients: a randomized controlled trial comparing starting with a very strong or a weak topical corticosteroid (FAEISS study, NCCH1512, colorectal part)

Katsuko Kikuchi, Naoya Yamazaki, Keiko Nozawa, Haruhiko Fukuda, Taro Shibata, Ryunosuke Machida, Tetsuya Hamaguchi, Atsuo Takashima, Hirokazu Shoji, Narikazu Boku, Sumiko Takatsuka, Tatsuya Takenouchi, Tomohiro Nishina, Shusuke Yoshikawa, Masanobu Takahashi, Akiko Hasegawa, Akihito Kawazoe, Toshiki Masuishi, Hitoshi Mizutani, Yoshio Kiyohara

研究成果: Article査読

1 被引用数 (Scopus)

抄録

Background: Although pre-emptive therapy with oral tetracycline, moisturizer, sunscreen, and topical corticosteroid is useful for preventing acneiform eruption (AfE) due to epidermal growth factor receptor (EGFR) inhibitors, no studies have examined the efficacy of topical corticosteroids themselves, or investigated the optimal potency of corticosteroid for treating facial AfE (FAfE). Patients and methods: Screened patients with RAS wild-type colorectal cancer started pre-emptive therapy with oral minocycline and moisturizer on initiation of cetuximab or panitumumab therapy. Patients who developed grade 1 or 2 FAfE were randomly allocated to two groups: a ranking-down (RD) group that started with a very strong corticosteroid and serially ranked down every 2 weeks unless FAfE exacerbated; and a ranking-up (RU) group that started with a weak corticosteroid and serially ranked up at exacerbation. FAfE grade, patient quality of life, and adverse events (AEs) with topical corticosteroid were evaluated every 2 weeks. The primary endpoint was the total number of times grade 2 or higher FAfE was identified in the central review of the 8-week treatment period. Results: No significant differences in total numbers of grade 2 or higher FAfE or in AEs caused by topical corticosteroids were observed between groups during the 8 weeks. Incidence of grade 2 or higher FAfE tended to be lower in the RD group during the first 2 weeks. Conclusion: Considering the long-term care of FAfE, the RU regimen appears suitable and should be considered the standard treatment for FAfE due to EGFR inhibitor therapy. Trial registration: UMIN Clinical Trials Registry (UMIN000024113).

本文言語English
ページ(範囲)4497-4504
ページ数8
ジャーナルSupportive Care in Cancer
30
5
DOI
出版ステータスPublished - 2022 5月

ASJC Scopus subject areas

  • 腫瘍学

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