Results of the non-small cell lung cancer part of a phase III, open-label, randomized trial evaluating topical corticost
- PDF / 378,494 Bytes
- 8 Pages / 595.276 x 790.866 pts Page_size
- 34 Downloads / 198 Views
ORIGINAL ARTICLE
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) Kazumi Nishino 1 & Yutaka Fujiwara 2,3 & Yuichiro Ohe 2 & Ryota Saito 4 & Eisaku Miyauchi 4 & Tetsu Kobayashi 5 & Yasuo Nakai 6 & Toshiaki Takahashi 7 & Taro Shibata 8 & Tetsuya Hamaguchi 9 & Katsuko Kikuchi 10,11 & Naoya Yamazaki 12 & Haruhiko Fukuda 13 & Keiko Nozawa 14 & Yoshio Kiyohara 15 Received: 18 May 2020 / Accepted: 8 September 2020 # The Author(s) 2020
Abstract Purpose This FAEISS study was designed to confirm the superior efficacy of reactive topical corticosteroid strategies employing serially ranking-DOWN from very strong steroid levels for the treatment of facial acneiform rash induced by epidermal growth factor receptor (EGFR) inhibitors (EGFRIs), in comparison with strategies employing serially ranking-UP from weak steroid levels. This article reports the primary results of the non-small cell lung cancer (NSCLC) part of the trial. Methods Patients with EGFR-mutated advanced NSCLC treated with erlotinib or afatinib were enrolled in the first registration. All patients received preemptive therapy with oral minocycline and heparinoid moisturizer from the initiation of an EGFR inhibitor. Enrolled patients who developed facial acneiform rash within 2 weeks were randomized at second registration to either a ranking-UP (WEAK) group or a ranking-DOWN group. The primary endpoint was incidence of grade ≥ 2 facial acneiform rash over 8 weeks. Results Fifty-one patients were enrolled at the first registration and received EGFRIs (n = 30 for afatinib, n = 21 for erlotinib). However, 35 patients did not develop facial acneiform rash within 2 weeks; one patient discontinued preemptive treatment. Fifteen patients (29.4%) were enrolled in the second registration; nine were assigned to the WEAK group and six to the DOWN group. There was no significant difference in the incidence of grade ≥ 2 facial acneiform rash between the WEAK group (one patient, twice) and the DOWN group (one patient, twice; p = 0.8417). No patients developed severe facial acneiform rash within 10 weeks. Conclusion In NSCLC patients who received EGFRIs, preemptive therapy of oral minocycline and heparinoid moisturizer reduced facial acneiform rash incidence. Trial registration UMIN000024113 Keywords Facial acneiform rash . Non-small cell lung cancer . Epidermal growth factor receptor . Topical corticosteroid . Minocycline . Heparinoid moisturizer
Introduction Epidermal growth factor receptor (EGFR) inhibition is an established and effective treatment option for patients with
* Kazumi Nishino [email protected] Extended author information available on the last page of the article
non-small cell lung cancer (NSCLC) [1–4], colorectal cancer (CRC) [5, 6], and squamous cell carcinoma of the head and neck (SCCHN) [7]. Many EGFR inhibitors are approved for clinical
Data Loading...
