PMID- 35113224 OWN - NLM STAT- MEDLINE DCOM- 20220325 LR - 20220325 IS - 1433-7339 (Electronic) IS - 0941-4355 (Linking) VI - 30 IP - 5 DP - 2022 May TI - 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). PG - 4497-4504 LID - 10.1007/s00520-022-06874-1 [doi] AB - 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). CI - (c) 2022. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature. FAU - Kikuchi, Katsuko AU - Kikuchi K AD - Tohoku University School of Medicine, Sendai, Japan. kkikuchi@derma.med.tohoku.ac.jp. AD - Sendai Taihaku Dermatology Clinic, AEON Supercenter 2F, 1-21-1 Kagitori Honcho, Taihaku Ku, Sendai, Miyagi, 982-0805, Japan. kkikuchi@derma.med.tohoku.ac.jp. FAU - Yamazaki, Naoya AU - Yamazaki N AD - Department of Dermatologic Oncology, National Cancer Center Hospital, Tokyo, Japan. FAU - Nozawa, Keiko AU - Nozawa K AD - Department of Nursing, Faculty of Nursing, Mejiro University, Saitama, Japan. AD - Appearance Support Center, National Cancer Center Hospital, Tokyo, Japan. FAU - Fukuda, Haruhiko AU - Fukuda H AD - Data Management Division, National Cancer Center Hospital, Tokyo, Japan. FAU - Shibata, Taro AU - Shibata T AD - Biostatistics Section, Research Management Division, National Cancer Center Hospital, Tokyo, Japan. FAU - Machida, Ryunosuke AU - Machida R AD - Biostatistics Section, Research Management Division, National Cancer Center Hospital, Tokyo, Japan. FAU - Hamaguchi, Tetsuya AU - Hamaguchi T AD - Department of Medical Oncology, Saitama Medical University International Medical Center, Saitama, Japan. FAU - Takashima, Atsuo AU - Takashima A AD - Department of Gastrointestinal Medical Oncology, National Cancer Center Hospital, Tokyo, Japan. FAU - Shoji, Hirokazu AU - Shoji H AD - Department of Gastrointestinal Medical Oncology, National Cancer Center Hospital, Tokyo, Japan. FAU - Boku, Narikazu AU - Boku N AD - Department of Gastrointestinal Medical Oncology, National Cancer Center Hospital, Tokyo, Japan. FAU - Takatsuka, Sumiko AU - Takatsuka S AD - Department of Dermatology, Niigata Cancer Center Hospital, Niigata, Japan. FAU - Takenouchi, Tatsuya AU - Takenouchi T AD - Department of Dermatology, Niigata Cancer Center Hospital, Niigata, Japan. FAU - Nishina, Tomohiro AU - Nishina T AD - Department of Gastrointestinal Medical Oncology, National Hospital Organization Shikoku Cancer Center, Matsuyama, Japan. FAU - Yoshikawa, Shusuke AU - Yoshikawa S AD - Dermatology Division, Shizuoka Cancer Center Hospital, Sunto-gun, Japan. FAU - Takahashi, Masanobu AU - Takahashi M AD - Department of Medical Oncology, Tohoku University Hospital, Sendai, Japan. FAU - Hasegawa, Akiko AU - Hasegawa A AD - Department of Medical Oncology, Osaka International Cancer Institute, Osaka, Japan. FAU - Kawazoe, Akihito AU - Kawazoe A AD - Department of Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa, Japan. FAU - Masuishi, Toshiki AU - Masuishi T AD - Department of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan. FAU - Mizutani, Hitoshi AU - Mizutani H AD - Department of Dermatology, Mie University Hospital, Tsu, Japan. FAU - Kiyohara, Yoshio AU - Kiyohara Y AD - Dermatology Division, Shizuoka Cancer Center Hospital, Sunto-gun, Japan. LA - eng GR - JP17ck0106326/Japan Agency for Medical Research and Development/ PT - Journal Article PT - Randomized Controlled Trial DEP - 20220203 PL - Germany TA - Support Care Cancer JT - Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer JID - 9302957 RN - 0 (Glucocorticoids) RN - EC 2.7.10.1 (EGFR protein, human) RN - EC 2.7.10.1 (ErbB Receptors) RN - PQX0D8J21J (Cetuximab) SB - IM MH - *Acneiform Eruptions/chemically induced/drug therapy/prevention & control MH - Cetuximab/adverse effects MH - *Colonic Neoplasms MH - *Colorectal Neoplasms/drug therapy/pathology MH - ErbB Receptors MH - Glucocorticoids/therapeutic use MH - Humans MH - Quality of Life OTO - NOTNLM OT - Acneiform eruption OT - Anti-EGFR antibody OT - Colorectal cancer OT - Epidermal growth factor receptor (EGFR) OT - Skin toxicity OT - Topical corticosteroid EDAT- 2022/02/04 06:00 MHDA- 2022/03/26 06:00 CRDT- 2022/02/03 12:17 PHST- 2021/08/13 00:00 [received] PHST- 2022/01/27 00:00 [accepted] PHST- 2022/02/04 06:00 [pubmed] PHST- 2022/03/26 06:00 [medline] PHST- 2022/02/03 12:17 [entrez] AID - 10.1007/s00520-022-06874-1 [pii] AID - 10.1007/s00520-022-06874-1 [doi] PST - ppublish SO - Support Care Cancer. 2022 May;30(5):4497-4504. doi: 10.1007/s00520-022-06874-1. Epub 2022 Feb 3.