AI Article Synopsis
- - The study investigates the effectiveness and safety of consolidative stereotactic radiotherapy (SRT) in patients with EGFR-mutant non-small cell lung cancer (NSCLC) who have residual disease after initial treatment with EGFR-TKIs, enrolling 61 participants over two years.
- - Results showed a median progression-free survival (PFS) of 29.9 months with SRT combined with ongoing EGFR-TKIs, indicating a significant improvement compared to patients receiving only EGFR-TKIs.
- - Common side effects included pneumonitis and esophagitis, affecting 70% of participants, but overall, the treatment was deemed to have acceptable toxicity levels, suggesting the need for further research to
Article Abstract
Background: Prospective data is limited on the efficacy and safety of consolidative stereotactic radiotherapy (SRT) in metastatic epidermal growth factor receptor (EGFR)-mutant non-small cell lung cancer (NSCLC) patients harboring oligo-residual disease (ORD) after first-line third-generation EGFR-tyrosine kinase inhibitors (TKIs).
Methods: In this single-arm, phase II trial, 61 patients from two academic centers were enrolled from March 2021 to March 2023. All these patients had metastatic EGFR-mutant NSCLC and harbored ORD after first-line third-generation EGFR-TKIs. Consolidative SRT was performed and EGFR-TKIs were not held during SRT. The primary endpoint was progression-free survival (PFS) and the secondary endpoints included overall survival and treatment-related adverse events (TRAEs). A prespecified propensity score matched (PSM) comparison was conducted with a contemporary cohort of patients who developed ORD but received EGFR-TKIs alone. This trial was registered with ClinicalTrails.gov, NCT04764214.
Findings: All patients received consolidative SRT. With a median follow-up of 21.1 months, the median PFS was 29.9 (80% CI 22.4-32.4) months and the lower boundary exceeded the predefined threshold, meeting the primary endpoint. TRAEs occurred in 43 (70%) patients, with pneumonitis (27.9%) and esophagitis (26.2%) being the most common toxicities. Four patients (6.6%) reported grade ≥3 TRAEs, each for pneumonitis, esophagitis, leukopenia, and cranial radiation necrosis. PSM analysis showed significantly prolonged PFS in EGFR-TKI + SRT group compared to EGFR-TKI group (HR 0.46, 80% CI 0.20-0.61; = 0.002).
Interpretation: Consolidative SRT is associated with an encouraging PFS in first-line third-generation EGFR-TKI-treated metastatic NSCLC patients harboring ORD, with generally acceptable toxicities. Further confirmatory studies are warranted.
Funding: Hui Lan Public Welfare and the Chinese Society of Clinical Oncology Foundation.
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| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC11470411 | PMC |
| http://dx.doi.org/10.1016/j.eclinm.2024.102853 | DOI Listing |
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