Consolidation Osimertinib Versus Durvalumab Versus Observation After Concurrent Chemoradiation in Unresectable EGFR-Mutant NSCLC: A Multicenter Retrospective Cohort Study.
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Nassar Amin H, Kim So Yeon, Aredo Jacqueline V, Feng Jamie, Shepherd Frances, Xu Chao, Kaldas David, Gray Jhanelle E, Dilling Thomas J, Neal Joel W, Wakelee Heather A, Liu Yufei, Lin Steven H, Abuali Tariq, Amini Arya, Nie Yunan, Patil Tejas, Lobachov Anastasiya, Bar Jair, Fitzgerald Bailey, Fujiwara Yu, Marron Thomas U, Thummalapalli Rohit, Yu Helena, Owen Dwight H, Sharp John, Farid Saira, Rocha Pedro, Arriola Edurne, D'Aiello Angelica, Cheng Haiying, Whitaker Ryan, Parikh Kaushal, Ashara Yash, Chen Luxi, Sankar Kamya, Harris Jeremy P, Nagasaka Misako, Ayanambakkam Adanma, Velazquez Ana I, Ragavan Meera, Lin Jessica J, Piotrowska Zofia, Wilgucki Molly, Reuss Joshua, Luders Heike, Grohe Christian, Baena Espinar Javier, Feiner Ella, Punekar Salman R, Gupta Shruti, Leal Ticiana, Kwiatkowski David J, Mak Raymond H, Adib Elio, Naqash Abdul Rafeh, Goldberg Sarah B
Аннотация
METHODS: In this multi-institutional, international retrospective analysis across 24 institutions, we evaluated outcomes in patients with stage III EGFRmut NSCLC treated with concurrent CRT followed by consolidation therapy with osimertinib, durvalumab, or observation between 2015 and 2022. Kaplan-Meier method was used to estimate real-world progression-free survival (rwPFS, primary end point) and overall survival (secondary end point). Treatment-related adverse events (trAEs) during consolidation treatment were defined using Common Terminology Criteria for Adverse Events version 5.0. Multivariable Cox regression analysis was used.
RESULTS: Of 136 patients with stage III EGFRmut NSCLC treated with definitive concurrent CRT, 56 received consolidation durvalumab, 33 received consolidation osimertinib, and 47 was on observation alone. Baseline characteristics were similar across the three cohorts. With a median follow-up of 46 months for the entire cohort, the median duration of treatment was not reached (NR) for osimertinib (interquartile range: NR-NR) and was 5.5 (interquartile range: 2.4-10.8) months with durvalumab. After adjusting for nodal status, stage III A/B/C, and age, patients treated with consolidation osimertinib had significantly longer 24-month rwPFS compared to those treated with durvalumab or in the observation cohorts (osimertinib: 86%, durvalumab: 30%, observation: 27%, p < 0.001 for both comparisons). There was no difference in rwPFS between the durvalumab and the observation cohorts. No significant difference in overall survival across the three cohorts was detected, likely due to the limited follow-up. Any-grade trAE occurred in 52% (2 [6.1%] grade ≥3) and 48% (10 [18%] grade ≥3) of patients treated with osimertinib and durvalumab, respectively. Of 45 patients who progressed on consolidation durvalumab, 37 (82%) subsequently received EGFR tyrosine kinase inhibitors. Of these, 14 (38%) patients developed trAEs including five patients with pneumonitis (14%; 2 [5.4%] grade ≥3) and five patients with diarrhea (14%; 1 [2.7%] grade ≥3).
CONCLUSIONS: This study suggests that among patients with stage III unresectable NSCLC with a sensitizing EGFR mutation, consolidation osimertinib was associated with a significantly longer rwPFS compared to durvalumab or observation. No unanticipated safety signals were observed with consolidation osimertinib.