Kazumi Nishino1, Yutaka Fujiwara2,3, Yuichiro Ohe2, Ryota Saito4, Eisaku Miyauchi4, Tetsu Kobayashi5, Yasuo Nakai6, Toshiaki Takahashi7, Taro Shibata8, Tetsuya Hamaguchi9, Katsuko Kikuchi10,11, Naoya Yamazaki12, Haruhiko Fukuda13, Keiko Nozawa14, Yoshio Kiyohara15. 1. Department of Thoracic Oncology, Osaka International Cancer Institute, Osaka, Japan. kazumi.nishino@oici.jp. 2. Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo, Japan. 3. Department of Respiratory Medicine, Mitsui Memorial Hospital, Tokyo, Japan. 4. Department of Respiratory Medicine, Tohoku University Hospital, Miyagi, Japan. 5. Department of Pulmonary and Critical Care Medicine, Mie University Graduate School of Medicine, Mie, Japan. 6. Department of Dermatology, Mie University Graduate School of Medicine, Mie, Japan. 7. Division of Thoracic Oncology, Shizuoka Cancer Center, Shizuoka, Japan. 8. Biostatistics Division, Center for Research Administration and Support, National Cancer Center, Tokyo, Japan. 9. Department of Gastroenterological Oncology, Saitama Medical University International Medical Center, Saitama, Japan. 10. Department of Dermatology, Tohoku University Graduate School of Medicine, Miyagi, Japan. 11. Sendai Taihaku Dermatology Clinic, Miyagi, Japan. 12. Department of Dermatological Oncology, National Cancer Center Hospital, Tokyo, Japan. 13. Data Management Division, National Cancer Center Hospital, Tokyo, Japan. 14. Appearance Support Center, National Cancer Center Hospital, Tokyo, Japan. 15. Department of Dermatology, Shizuoka Cancer Center, Shizuoka, Japan.
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 witherlotinib 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.
RCT Entities:
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 NSCLCpatients who received EGFRIs, preemptive therapy of oral minocycline and heparinoid moisturizer reduced facial acneiform rash incidence. TRIAL REGISTRATION: UMIN000024113.
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