Effect and safety of combining bevacizumab and fractionated stereotactic radiotherapy for brain metastases in patients with non-small cell lung cancer: A phase II trial.

Abstract

e21132 Background: W e aimed to assess the efficacy and safety of c ombining b evacizumab and fractionated stereotactic radiotherapy ( FSRT ) for brain metastases (BMs) in non-small cell lung cancer ( NSCLC ) patients with stable extracranial disease status in this study. Methods: NSCLC patients with BMs were recruited between J anuary 20 20 and J anuary 202 2 . P atients were assigned to receive FSRT of 40Gy in 10 fractions (BED 56eGy) or 30Gy in 5 fractions (BED 48eGy). Meanwhile, bevacizumab was administered before FSRT (d1) and after FSRT (d21) with a dosage of 7.5mg/Kg. The primary endpoint of the study is intra-cranial progression-free survival (IPFS) . The secondary endpoints contained overall survival (OS), progression-free survival (PFS) , quality of life (QOL) score and toxicities. All time-to-event endpoints (IPFS, OS and PFS) were measured from the end of radiotherapy. Results: From J anuary 2020 and J anuary 202 2, 108 patients were recruited with a median follow-up duration was 15.2 months . The 1-year IPFS and OS rate were 82.9% ( 95% confidence interval (CI), 79.6%-86.2% ) and 80.4% ( 95% CI, 76.8%-84.0% ), respectively . The median PFS was 15.0 months ( 95% CI, 9.50-20.50 months ). The median IPFS and OS had not been reached at the time of the last follow-up. The treatment-related toxicities were mild with low incidence. Reversible mild hypertension and cerebral radio-necrosis were observed in 2 and 1 patients, respectively. No signs of ex tra-lesional haemorrhage and progression of peri-lesional oedema was found during the assessment period of treatment response. More importantly, significant improvent of QOL was observed in symptomatic patients. Conclusions: The combination of FSRT with bevacizumab in patients with NSCLC was well tolerated and achieved promising intracranial disease control. Patients maintained satisfactory QOL after receiving the combined regimen with low incidence of cerebral radio-necrosis. Clinical trial information: NCT04345146 .