Adding immunotherapy to chemotherapy may improve survival after SCLC transformation in EGFR-mutant NSCLC: a multicenter real-world study.
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Demir Nazan, Kıkılı Cevat İlteriş, Kemik Fatih, Köylü Bahadır, Tural Deniz, Laçin Şahin, Gündüz Şeyda, Tunalı Didem, Mandel Nil Molinas, Yumuk Fulden, Inanc Mevlude, Cengiz Ayse Nuransoy, Uluç Başak Oyan, Ersoy Seval Ay, Busery Nisanur Sarıyar, Karakaya Serdar, Erdem Dilek, Akdoğan Orhun, Yazıcı Ozan, Kahraman Elanur, Bilgetekin İrem, Demirci Umut, Gür Hasibe Bilge, Ökten İlker Nihat, Karakaya Gökhan, Yıldız Oğuzhan, Eryılmaz Melek Karakurt, Canaslan Kübra, Seyyar Mustafa, Kaplan Muhammet Ali, Çubukçu Erdem, Akın Gül, Ersoy Mustafa, Sümbül Ahmet Taner, Özçelik Hakan, Özel Bozdağ Dilruba İlayda, Çiçek Ebru, Oflas Ülviye, Turkoz Fatma Paksoy, Garbioğlu Duygu Bayır, Selçukbiricik Fatih
Аннотация
METHODS: We conducted a multicenter retrospective cohort study across 26 oncology centers (2016-2025). Patients with histologically confirmed EGFR-mutant NSCLC and biopsy-proven SCLC transformation were included. Primary endpoints included PFS during first-line EGFR-TKI therapy (PFS1), time to transformation (TTT), PFS after transformation (PFS2), overall survival from metastatic diagnosis (OS-1), post-transformation survival (OS-2), and overall survival from initial NSCLC diagnosis (OS-3). Survival was assessed with Kaplan-Meier and Cox regression analyses.
RESULTS: A total of 59 patients were included (median age 57.8 years; 52.5 % male; exon 19 deletion 76.3 %). Median PFS1 was 14.0 months (95 % CI, 11.3-16.7); median TTT was 22.0 months (range, 3-110). Following transformation, 54 patients (91.5 %) received systemic therapy: carboplatin plus etoposide (CE) alone in 37 (68.5 %) and CE plus immunotherapy (atezolizumab, durvalumab, or durvalumab plus osimertinib) in 16 (29.6 %). ORR was 37.8 % with CE alone versus 71.4 % with CE plus immunotherapy; median PFS2 was 5.0 months (95 % CI, 3.5-6.5). Median OS-1 was 38.0 months (95 % CI, 32.0-53.0). Median OS-2 was 11.0 months (95 % CI, 7.5-14.5) overall, and significantly longer with CE plus immunotherapy versus CE alone (17.0 vs. 9.0 months; log-rank p = 0.026; HR 0.327, 95 % CI 0.139-0.767). Median OS-3 was 41.1 months.
CONCLUSION: In this large multicenter cohort, adding immune checkpoint inhibitors (ICIs) to CE was associated with improved post-transformation survival, challenging prior evidence of immunotherapy inefficacy in this setting. Systematic re-biopsy at progression on EGFR-TKI therapy is essential to confirm transformation and guide treatment. Prospective biomarker-driven studies are warranted.