1647 - Primary analysis results of randomized controlled trial evaluating reactive topical corticosteroid strategies for the facial acneiform rash by EGFR inhibitors (EGFRIs) in patients (pts) with RAS wild-type (wt) metastatic colorectal cancer (mCRC) -FAEISS study-

Background

The management strategies regarding the strength of reactive topical corticosteroids have not been well evaluated in clinical trials. This FAEISS study is designed to confirm the superior efficacy of reactive topical corticosteroid strategies with serially ranking-DOWN from very strong levels compared with those with serially ranking-UP from weak levels for facial acneiform rash induced by EGFRI.

Methods

Pts with RAS wt mCRC were enrolled in the first registration. All pts received pre-emptive therapy with oral minocycline 100 or 200 mg/day and heparinoid moisturizer from the initiation of EGFRIs. Enrolled pts who developed facial acneiform rash within 8 weeks were randomized either to ranking-UP group (UP group) or ranking-DOWN group (DOWN group) (second registration) using minimization method for balancing institution, type of EGFRIs, and sex. Primary endpoint was incidence of Grade2 (moderate) or higher facial acneiform rash during 8 weeks after randomization.

Results

172 RAS wt mCRC pts, of whom 22 pts and 84 pts received cetuximab and panitumumab, respectively, were enrolled and 106 pts were randomized. There was no significant difference in the incidence of Grade 2 ≧ facial acneiform rash between UP group (18 times) and DOWN group (20 times) (stratified Wilcoxon’s rank sum test, one-sided: p = 0.86221). As for secondary end points, proportion of Grade3 or higher facial acneiform rash was 13.2% for UP group and 11.3% for DOWN group, showing no significant difference between the groups (Fisher’s exact test: p = 1.0000). There was no problem of safety concern in both groups.

Conclusions

Topical corticosteroids ranking UP from weak levels was confirmed to be standard therapy for the management of facial acneiform rash in pts with RAS wt mCRC. It would follow that minocycline and heparinoid moisturizer have a prophylactic efficacy while topical corticosteroids have a therapeutic efficacy for facial acneiform rash.

Clinical trial identification

UMIN000024113.

Editorial acknowledgement

Legal entity responsible for the study

FAEISS Study Group.

Funding

AMED.

Disclosure

N. Yamazaki: Honoraria (self), Research grant / Funding (institution): Takarabio; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Ono; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Bristol-Myers Squibb; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): MSD; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Novartis. K. Kikuchi: Research grant / Funding (institution): POLA; Research grant / Funding (institution): Maruho. H. Fukuda: Honoraria (self): Taiho/chugai; Research grant / Funding (self): National Cancer Center. T. Hamaguchi: Honoraria (self), Research grant / Funding (institution): Ono; Honoraria (self): Takeda; Honoraria (self): Bayer. N. Boku: Honoraria (self), Research grant / Funding (institution): Taiho; Honoraria (self), Research grant / Funding (institution): Ono; Honoraria (self), Research grant / Funding (institution): Bristol-Myers Squibb. T. Takenouchi: Speaker Bureau / Expert testimony: Ono; Speaker Bureau / Expert testimony: MSD; Speaker Bureau / Expert testimony: Novartis . T. Nishina: Honoraria (self), Research grant / Funding (institution): Taiho; Honoraria (self), Research grant / Funding (institution): Chugai; Honoraria (self), Research grant / Funding (institution): Merck Serono. S. Yoshikawa: Honoraria (self): Ono; Honoraria (self): Novertis; Honoraria (self): Bristol-Myers Squibb. K. Yamazaki: Honoraria (self): Chugai; Honoraria (self): Daiichi Sankyo. M. Takahashi: Speaker Bureau / Expert testimony, Research grant / Funding (institution): Ono; Speaker Bureau / Expert testimony: Daiichi Sankyo. T. Masuishi: Honoraria (self): Taiho; Honoraria (self): Merck Serono; Honoraria (self): Yakult Honsha. Y. Kiyohara: Honoraria (self), Research grant / Funding (institution): MSD; Honoraria (self), Research grant / Funding (institution), Travel / Accommodation / Expenses: Ono; Honoraria (self), Research grant / Funding (institution): BMS. All other authors have declared no conflicts of interest.