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H. Kim
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P3.01 - Advanced NSCLC (ID 621)
- Event: WCLC 2017
- Type: Poster Session with Presenters Present
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 10/18/2017, 09:30 - 16:00, Exhibit Hall (Hall B + C)
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P3.01-028 - Efficacy of Osimertinib for Brain Metastasis in Advanced NSCLC: Data from Single Center in ASTRIS Trial (ID 9114)
09:30 - 09:30 | Author(s): H. Kim
- Abstract
Background:
CNS (central nervous system) involvement is common in advanced NSCLC (non-small cell lung cancer). Osimertinib has shown activity in CNS in preclinical studies and phase II, III trials (AURA2, AURA3). We reported the efficacy of CNS metastases from an open label, multinational, multicenter, real world treatment study (ASTRIS, NCT02474355) in patients with T790M-positive advanced NSCLC who have progressed on or after prior epidermal growth factor receptor-tyrosine-kinase inhibitors (EGFR-TKI) therapy.
Method:
Patients with T790M-positive (from tissue, plasma or other fluids) advanced NSCLC received osimertinib 80mg once daily. Of the 88 patients who were enrolled in ASTRIS at Yonsei Cancer Center, 10 patients who did not have baseline brain workup and 15 patients without CNS metastases at the beginning of study were excluded from this analysis. A subgroup analysis was conducted in patients with CNS metastases at the baseline, as assessed by neuroradiologist, to define CNS overall response rate (ORR), duration of response (DOR), and progression-free-survival (PFS) by RECIST(Response Evaluation Criteria in Solid Tumors) v1.1. The CNS full analysis set (cFAS) included patients with ≥ 1 measurable and/or non-measurable CNS metastasis present on baseline scan; the CNS evaluable for response set (cEFR) included only patients with ≥ 1 measurable CNS metastasis.
Result:
Among the 63 patients who had CNS metastases at baseline, fifty-four (61.4%) patients were included in the subgroup analysis as cFAS, except for the 9 patients who did not follow up brain image during ASTRIS. In patients without brain metastases at the time of initiation of osimertinib (n=15), no experienced CNS progression during ASTRIS. CNS ORR was 81.3% (95% confidence interval [CI] 73.2-89.4) in the cEFR and 40.7% (95% CI 30.4-50.9) in the cFAS. In the cEFR and cFAS, median CNS DOR was “not reached” vs 40.1 weeks (95% CI 36.95-43.25). The median CNS PFS was not reached in both cFAS and cEFR. CNS ORR of 33.3%(95% CI 11.7-64.9) and 42.2% (95% CI 28.9-56.7) were observed for patients with CNS metastases within 3 months brain radiation and without prior radiation or ≥ 3months brain radiation, increasing to 75.0% (95% CI 28.9-96.6) and 83.3%(95% CI 54.0-96.5) respectively, for patients with measurable CNS disease only. CNS ORR of T790M-positive patients in tissue and plasma were 37.5%(95% CI 21.1-57.4) and 46.4% (95% CI 29.5-64.2) in the cFAS, vs 100%(95% CI 55.7-100.0) and 70.0%(95% CI 39.2-89.7) in the cEFR.
Conclusion:
Osimertinib had good CNS efficacy irrespective of radiation history in T790M-positive advanced NSCLC.
