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P1.01 - Poster Session/ Treatment of Advanced Diseases – NSCLC (ID 206)
- Event: WCLC 2015
- Type: Poster
- Track: Treatment of Advanced Diseases - NSCLC
- Presentations: 1
- Coordinates: 9/07/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)
P1.01-074 - Phase III Study of WBRT with or without Erlotinib for Brain Metastasis NSCLC (ID 321)
09:30 - 17:00 | Author(s): B. Zhu
More effective treatment strategies are required for pts with brain metastasis (BM) from non-small cell lung cancer although whole-brain radiotherapy (WBRT) remains the standard treatment. Erlotinib, an effective TKI in EGFR mutant NSCLC, has shown evidence of intracranial accumulation, and has been proven with well tolerability and favorable objective response rate (71%) when concurrent with WBRT. One phase II study (n=80) reported no advantage in median neurological PFS or OS for concurrent erlotinib (100mg/d) and WBRT (20 Gy/5f) in pts with predominantly EGFR wild-type NSCLC compared to WBRT alone, while another single arm phase II study (n=40) found that pre-treatment with erlotinib (150mg/d for 1 wk) followed by concurrently with WBRT (35 Gy/12f) could extend median OS to 11.8 months in all population and 19.1 months in EGFR mut pts. The optimal administration schedule for erlotinib concurrent with WBRT for BM NSCLC is controversial, which should be confirmed in a randomized controlled trial in a more larger population. This phase III trial is to investigate the efficacy and safety of erlotinib pre-treatment followed by combination of erlotinib and WBRT in comparison to WBRT alone in multiple BM NSCLC pts.
This was an open-labeled, randomized, multicenter phase III clinical trial. Pts, aged≥18 and KPS≥70, with at least two BMs of NSCLC from 7 medical centers were recruited began in August 2013. Pts with previous use of EGFR-TKI need to withdraw≥4 weeks if assigned to the experimental arm. ARMs for detection of EGFR mutation in tumor tissue is mandatory. The major exclusion criteria included previous brain radiotherapy, or any uncontrolled or symptomatic major medical illnesses or neurologic/psychiatric illnesses. The enrolled pts would be randomly assigned to either erlotinib (150mg/day) concurrent WBRT (2.0Gy/day, 5 days/week, total dose 40Gy) or WBRT alone group with a 1:1 allocation (Fig.1). Only pts with EGFR sensitive mutation will continue to use erlotinib until disease progression or intolerable adverse events. The primary endpoint is the time to neurologic progression (TTP), defined as evidence of progression of brain metastasis (The total of longest diameter more than 20% enhanced area in MRI) or of emergency of new intracranial metastases. The secondary endpoints include, OS, ORR and QoL and subgroup analyses. Till February 12, 2015, 125 of planned 224 pts have been enrolled. This study is registered in clnicaltrials.gov (NCT01887795). Figure 1
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