Department of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea
Dae-Ho Choi , Myung-Ju Ahn , Miso Kim , Young Saing Kim , Keon Uk Park , Jang Ho Cho , Hongsik Kim , Ki Hyeong Lee , Heejoon Ahn , Il-Hwan Kim , Kyung-Hee Lee , Gyeong-Won Lee , Seong Yoon YI , Beung Chul AHN , Min-Young Lee , Hyun Ae Jung , Sehhoon Park , Jong-Mu Sun , Jin Seok Ahn , Se-Hoon Lee
Background: The role of maintenance durvalumab after definitive concurrent chemoradiotherapy (CCRT) in unresectable locally advanced non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) translocation remains unclear. We compared the effectiveness of durvalumab maintenance therapy in groups with EGFR/ALK wild-type versus those with EGFRor ALK mutations. Methods: In this retrospective multicenter observational study, patients with locally advanced NSCLC without progression after CCRT followed by maintenance durvalumab and available molecular test results (EGFR and ALK) were eligible. The primary objective was to compare progression-free survival (PFS) between EGFR/ALK wild-type and EGFRor ALKmutant NSCLC. Secondary objectives include overall survival according to EGFRor ALK mutation and programmed cell death-ligand 1 (PD-L1) expression. Results: Among 339 patients, 279 had wild-type EGFR/ALK, 41 had EGFR mutations and 19 had ALK translocations. The median age was 68 years with 276 males (81.4%) and 63 females (18.6%), 165 (49.3%) had adenocarcinoma, 149 (44.5%) had squamous cell carcinoma, and 21 (6.3%) had other histological types, 120 (35.4%) had stage IIIA, 168 (49.6%) stage IIIB, and 51 (15.0%) had stage IIIC. The majority of patients (n=288, 85%) achieved partial response to CCRT, 2 (0.6%) had a complete response, and 49 patients (14.4%) had stable disease. Excluding 4 patients with unknown PD-L1 tumor proportion score (TPS), 16 (4.8%) had a PD-L1 TPS of 0, 168 (50.1%) had 1-49, and 151 (45.1%) had 50 or higher. The median PFS was 21.4 months (95% CI 17.3–25.3) for the EGFR/ALK wild-type group and 21.0 months (95% CI 15.7–NA) for the EGFR or ALK mutant group with no significant difference (p=0.74). Significant differences occurred in PFS based on PD-L1 expression with values of 13.6 (95% CI 10.5–NA), 18.7 (95% CI 15.1–26.9), and 24.7 (95% CI 20.7–NA) months for TPS of 0, 1–49, and 50 or higher, respectively (p=0.02). Conclusions: Durvalumab maintenance therapy after definitive CCRT in unresectable locally advanced NSCLC patients with EGFRor ALK mutation demonstrates comparable clinical outcomes to those with wild-type EGFR/ALK when PD-L1 expression is present.
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