Abstract 1306P
Background
In patients with advanced non-small cell lung cancer (NSCLC) and brain metastasis (BM), the role and the timing of brain radiotherapy (BR) are not well established. This study investigates whether the upfront BR is superior to “at progression” BR in patients with NSCLC and asymptomatic BM.
Methods
This open-label, multicenter, phase 3 trial, randomized (1:1) patients with non squamous NSCLC and asymptomatic BM, between upfront or “at progression” BR (whole brain or stereotaxic), associated with chemotherapy (platin-pemetrexed and bevacizumab in eligible patients, followed by pemetrexed with or without bevacizumab as maintenance). Primary endpoint was progression free survival (PFS), secondary endpoints were overall survival (OS), global and cerebral objective response rate (ORR), toxicity, quality of life (NCT02162537).
Results
The trial has been stopped early because of a slow recruitment; 95 patients were included and 91 randomized from 01/2014 to 01/2018 in 24 centers, 45 in upfront BR, 46 in “at progression” BR arm (age: 60 ± 8,3, men: 74%, PS 0/1: 51.7%/48.3%; adenocarcinoma: 92.2%, extra cerebral metastases: 57.8%), without differences between arms. Significantly more patients received BR in upfront arm compare to “at progression” arm (87% versus 20%, p<0.001); Duration of chemotherapy was identical (4 months) in both arms. Respectively 42.2% and 43.5% received a second line treatment (mainly docetaxel), in upfront and “at progression” arms; there is no differences in term of median PFS (4.7, 95% CI: 3.4-7.5 versus 4.8, 95% CI 2.4-6.5 months,), cerebral and extra cerebral ORR (ORR 27 % vs 13 %, p =0.064, and 30% vs 41%, p=0.245) and median OS (8.5, months 95%CI 5.6-11.1 versus 8.3 months, 95% CI 4.5-11.5 respectively). There is a trend for more gr 3/4 neutropenia in “at progression” compare to upfront arm (13% vs 6%, p = 0.045), and no difference for the other toxicities.
Conclusions
The significant difference in terms of proportion of BR performed in the two arms suggests that upfront BR is not mandatory in this situation.
Clinical trial identification
NCT02162537.
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Lilly, Roche.
Disclosure
All authors have declared no conflicts of interest.