A phase III, open-label, randomized trial evaluating topical corticosteroid therapy for the facial acneiform dermatitis by EGFR Inhibitors: Stepwise rank down from potent corticosteroid.

Conditions

Lung cancer Colorectal cancer

Kikuchi K, Yamazaki N, Nozawa K, Fukuda H, Shibata T, Machida R, Hamaguchi T, Takashima A, Shoji H, Boku N, Takatsuka S, Takenouchi T, Nishina T, Yoshikawa S, Takahashi M, Hasegawa A, Kawazoe A, Masuishi T, Mizutani H, Kiyohara Y.

2022-02-035 citations

10.1007/s00520-022-06874-1

Results of the non-small cell lung cancer part of a phase III, open-label, randomized trial evaluating topical corticosteroid therapy for facial acneiform dermatitis induced by EGFR inhibitors: stepwise rank down from potent corticosteroid (FAEISS study, NCCH-1512).

Nishino K, Fujiwara Y, Ohe Y, Saito R, Miyauchi E, Kobayashi T, Nakai Y, Takahashi T, Shibata T, Hamaguchi T, Kikuchi K, Yamazaki N, Fukuda H, Nozawa K, Kiyohara Y.

2020-09-114 citations

10.1007/s00520-020-05765-7

Interventions

A pre-emptive therapy with daily 100mg (200mg in some institution) of minocycline hydrochloride, topical heparinoid moisturizer (two times a day) and EGFR inhibitors are followed with weak topical 0.0

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Eligible patients have following (1) or (2). (1) patient with non-small cell lung cancer with mutated EGFR, and is planned to treat with erlotinib or afatinib. (2) patient with colorectal cancer with wild type KRAS and NRAS, and is planned to treat with cetuximab or panitumumab. 2)Histopathologically the samples from surgery or biopsy specimen was diagnosed following (1)or (2). (1) Non-small cell lung cancer (SCC, adenocarcinoma, large cell cancer {except large cell endocrine cancer}, adenosquamous cell cancer, unclassified cancer), (2) Colorectal adenocarcinoma (including mucinous adenocarcinoma and signet ring cell carcinoma) by the 8th edition as the JSCCR guidelines for the treatment of colorectal cancer. 3) Unresectable or relapse after curative resection 4) 20 years old and more, and 79 years old and younger. 5) An Eastern Cooperative Oncology Group performance status of 0 or 1 6) No bacterial, fungal, syphilis, and viral infection of the face. 7) No history of EGFR inhibitor therapy (history of therapy with cytotoxic drugs is acceptable). 8) Absence of esophageal stenosis or obstruction 9) Written informed consent.

Exclusion criteria

Exclusion criteria: 1) Current topical corticosteroid therapy for facial lesion of atopic dermatitis and other skin diseases. 2) Presence of the metastatic skin lesions of lung or colorectal cancer. 3) Presence of the skin lesions including burn, frost bite, trauma or scar that influence to evaluation of the facial lesions. 4) Administration of following drugs: warfarin, sulphonylurea, digoxin, oral contraceptives, vitamin A analog, retinoid, steroid 5) History of allergy or serious side effects by minocycline hydrochloride

Design outcomes

Primary

Measure	Time frame
Incidence of more than grade 2 (moderate) facial acneiform dermatitis during the 10-week skin treatment period (by central review).	—

Secondary

Measure	Time frame
? Proportion of more than grade 2 (moderate) facial acneiform dermatitis (by central review) ? Proportion of more than grade 3 (severe) facial acneiform dermatitis (by central review) ? Proportion of switching EGFR therapies due to facial acneiform dermatitis ? Proportion of continuing EGFR therapy at the end of protocol treatment ? Proportion of more than grade 1 (mild) facial acneiform dermatitis at the end of protocol treatment (by central review) ? Incidence of adverse events on the face (by central review). ? Proportion of non-worsening in QOL scores	—

Measure

Time frame

? Proportion of more than grade 2 (moderate) facial acneiform dermatitis (by central review) ? Proportion of more than grade 3 (severe) facial acneiform dermatitis (by central review) ? Proportion of switching EGFR therapies due to facial acneiform dermatitis ? Proportion of continuing EGFR therapy at the end of protocol treatment ? Proportion of more than grade 1 (mild) facial acneiform dermatitis at the end of protocol treatment (by central review) ? Incidence of adverse events on the face (by central review). ? Proportion of non-worsening in QOL scores

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Countries

Japan

Outcome results

None listed