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Tetsu Kobayashi



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    P2.14 - Targeted Therapy (ID 183)

    • Event: WCLC 2019
    • Type: Poster Viewing in the Exhibit Hall
    • Track: Targeted Therapy
    • Presentations: 1
    • Now Available
    • Moderators:
    • Coordinates: 9/09/2019, 10:15 - 18:15, Exhibit Hall
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      P2.14-23 - Initial Analysis in NSCLC Part of Randomized Trial Evaluating Topical Corticosteroid for the Facial Acneiform Rash by EGFR Inhibitors (Now Available) (ID 551)

      10:15 - 18:15  |  Author(s): Tetsu Kobayashi

      • Abstract
      • Slides

      Background

      Epidermal growth factor receptor (EGFR) inhibitors commonly induce skin toxicities including facial acneiform rash. The incidence of facial acneiform rash with any grade estimetes 60-90% in previous clinical trials. This FAEISS study, NCCH1512, is designed to evaluate the effects of reactive topical corticosteroid therapies with serially ranking down from very strong levels compared with that with serially ranking up from weak levels for facial acneiform rash induced by EGFR inhibitors.

      Method

      Patients with EGFR-mutated non-small cell lung cancer (NSCLC) and RAS wild-type colorectal cancer who started treatment with EGFR inhibitors were enrolled first in this study (first-phase). All patients received pre-emptive therapy of oral minocycline 100 mg/day and heparinoid moisturizer from the initiation of EGFR inhibitors. Enrolled patients who developed facial acneiform rash within two weeks were randomised either to group A (ranking-up) and group B (ranking-down) (second-phase) by minimization method for balancing institution, type of EGFR inhibitors, and sex. Primary endpoint in this study was incidence of grade 2 (moderate) or higher facial acneiform rash during the 10-week skin treatment period. Here, we present the initial analysis in NSCLC patients who received EGFR tyrosine kinase inhibitors of afatinib and erlotinib. This study was registered with UMIN-CTR as UMIN000024113 (www.umin.ac.jp/ctr/).

      Result

      From November 2016 to August 2018, 51 NSCLC patients treated with afatinib (n=30) and erlotinib (n=21) were enrolled in first-phase. Thirty four patients were female and 17 were male, with a median age of 66 years (range 39-79). Thirty five patients (68.6%) didn’t develop facial acneiform rash within two weeks. While facial acneiform rash occurred in 16 patients (grade 1 [n=14, 27.4%] and grade 2 [n=2, 3.9%]). No patients developed severe facial acneiform rash (grade 3 or higher). Nine (30.0%) patients who received afatinib and seven (33.3%) who received erlotinib developed facial acneiform rash within two weeks. One patient treated with erlotinib was excluded due to hepatotoxicity by minocycline and 15 (29.4%) were assigned to second-phase (9 in group A and 6 in group B). Skin adverse events in second-phase (n=15) were non-facial acneiform rash (n=14), pruritus (n=8), paronychia (n=5), and dry skin (n=3). Major non-skin adverse events related to EGFR inhibitors were diarrhea (grade 3 [n=2]), ALT increased (grade 2 [n=2]), stomatitis (grade 3 [n=1]), and pneumonitis (grade 1 [n=1]).

      Conclusion

      In NSCLC patients who received EGFR tyrosine kinase inhibitors, pre-emptive therapy of oral minocycline and heparinoid moisturizer could be effective for prevention of facial acneiform rash.

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