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Dermatologic prophylaxis and impact on patient-reported outcomes in first-line EGFR -mutant advanced NSCLC treated with amivantamab plus lazertinib: Results from the phase 2 COCOON trial.

作者:Jill Libles Feldman, Byoung Chul Cho, Weimin Li, Nicolas Girard, Milena Perez Mak, Maxwell Sauder, Farastuk Bozorgmehr, Jiunn-Liang Tan, Jin‐Yuan Shih, Danny Nguyen, Enriqueta Felip, Julia Schuchard, Tonatiuh Romero, Karen Xia, Joshua Bauml, Jairo Simoes, Parthiv J. Mahadevia, Mark Wildgust, Alexander I. Spira · 发表于:Journal of Clinical Oncology · 年份:2025 · DOI:10.1200/jco.2025.43.16_suppl.8641 · 被引用次数:4 · 研究领域:Lung Cancer Treatments and Mutations、Colorectal Cancer Treatments and Studies、Gastric Cancer Management and Outcomes

8641 Background: The phase 2 COCOONtrial (NCT06120140) is evaluating the impact of enhanced dermatologic management (DM) in combination with amivantamab (ami) + lazertinib (laz) on reduction of skin and nail adverse events (AEs). At the interim analysis, enhanced DM (COCOON DM) significantly reduced the incidence of grade ≥2 dermatologic AEs by Wk 12 vs standard of care dermatologic management (SoC DM). We assessed patient-reported outcomes (PROs) from COCOON to determine if reducing dermatologic AEs impacts the quality of life (QoL) of patients with EGFR -mutant advanced NSCLC. Methods: Participants (pts) with previously untreated EGFR -mutant (Ex19del/L858R) advanced NSCLC were randomized 1:1 to receive COCOON DM or SoC DM per site practice. Pts received the approved doses of IV ami + oral laz. COCOON DM included oral doxycycline/minocycline (100 mg BID Wks 1–12), clindamycin 1% lotion on scalp (QD Wks 13–52), chlorhexidine 4% to wash hands and feet QD, and non-comedogenic ceramide-based moisturizer to body and face QD. The COCOON DM arm received a digital health tool with training on dermatologic AEs and reminders to increase adherence to the DM regimen. Dermatologic symptoms and impact on pts’ health-related QoL were measured with PRO instruments every 2 weeks. The Skindex-16 questionnaire assesses the impact of skin conditions on QoL using 3 subscales (functioning, emotional, symptoms) and an average score (0 – no effect to 100 – effect experienced all the time). Patient...