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

doi:10.1007/s00520-022-06874-1

Abstract

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). 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 2weeks 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 2weeks. 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. 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 8weeks. Incidence of grade 2 or higher FAfE tended to be lower in the RD group during the first 2weeks. 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. UMIN Clinical Trials Registry (UMIN000024113).

Highlights

Epidermal growth factor receptor (EGFR) inhibitors including monoclonal antibodies for epidermal growth factor receptor (EGFR) and tyrosine kinase inhibitors (TKIs) are effective therapeutic options for patients with colorectal cancer (CRC), non-small cell lung cancer (NSCLC) and squamous cell carcinoma of head and neck (SCCHN)
No significant differences in total numbers of grade 2 or higher facial AfE (FAfE) and inAEs caused by topical corticosteroids were observedbetweengroups during the 8-week
Considering long-term care of FAfE, the RU regimen appears suitableand should be considered the standard treatment for FAfEdue to EGFR inhibitor therapy

Summary

Introduction

Epidermal growth factor receptor (EGFR) inhibitors including monoclonal antibodies (mAbs) for EGFR and tyrosine kinase inhibitors (TKIs) are effective therapeutic options for patients with colorectal cancer (CRC), non-small cell lung cancer (NSCLC) and squamous cell carcinoma of head and neck (SCCHN). Patients receiving EGFR inhibitors commonly present with skin toxicities, including acneiform eruption (AfE), which sometimes cause discontinuation of the therapy. In the STEPP [2] and J-STEPP [3] studies, pre-emptive therapy with oral doxycycline or minocycline, topical corticosteroid of weak potency and skin moisturizer were shown to exert favorable effects in preventing AfE with panitumumab therapy, the effects of topical corticosteroid monotherapy on AfE remain unclear. Because of concerns regarding steroidinduced dermatitis (SID) [4] due to topical corticosteroid for facial lesions, weak- or medium-potency corticosteroids have been used for FAfE in clinical practice. Althoughpre-emptive therapy with oral tetracycline, moisturizer, sunscreen and topical corticosteroid isuseful for preventing acneiform eruption (AfE) due to epidermal growth factor receptor (EGFR) inhibitors, no studies have examinedthe efficacy of topical corticosteroids themselves, or investigated the optimal strength of the corticosteroid for treating facial AfE (FAfE)

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Conclusion