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R. Kim
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MA 11 - Emerging Diagnostic/Biomarkers in NSCLC (ID 668)
- Event: WCLC 2017
- Type: Mini Oral
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:M.I. Abdul Wahid, Martin Reck
- Coordinates: 10/17/2017, 11:00 - 12:30, Room 313 + 314
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MA 11.09 - Real World Data of Rebiopsy, Mutation Status, and Its Association with Plasma Genotyping after EGFR TKI Failure in NSCLC (ID 8234)
12:00 - 12:05 | Author(s): R. Kim
- Abstract
- Presentation
Background:
After the introduction of third-generation epidermal growth factor receptor tyrosine kinase inhibitors (EGFR TKIs) in non-small cell lung cancer (NSCLC), the second tumor biopsy and EGFR mutation test to confirm T790M status is an established standard practice. But second biopsy is invasive, cost and time-consuming and occasionally impossible. We aimed to investigate the success rate of tissue rebiopsy and incidence of T790M mutation in tissue and plasma at the time of progression with earlier-generation EGFR TKIs in real world setting. Also, we studied the association between the efficacy of osimertinib and the status of tissue and/or plasma T790M mutation.
Method:
We analyzed patients who were screened and enrolled into ASTRIS trial in Yonsei Cancer Center (NCT02474355). Key inclusions were advanced/metastatic NSCLC with tissue and/or plasma T790M mutation and prior EGFR-TKI therapy. Tissue and plasma EGFR mutation tests were performed using PNAClamp[TM] and PANAMutyper[TM], respectively.
Result:
We screened 193 patients with NSCLC harboring EGFR-activating mutation who experienced disease progression upon earlier-generation EGFR TKIs during study period. The second biopsy including tissue and/or cytology was performed only in 60.1% of the patients (116/193) and the success rate was 86.2% (100/116). The reasons for not trying a biopsy were as follow: inaccessibility (n=25), poor PS (n=8), previously reported plasma T790M+ (n=8), and patients’ refusal (n=4). The parenchymal lung tissue (n=61) was most commonly targeted lesion and bronchoscopy was the most frequently used method (n=35). Six patients underwent video-assisted thoracoscopic surgery. Tumor T790M mutation was reported in only 25.9% of patients (50/193). Of 193 patients, 88 patients were enrolled into ASTRIS trial and 43 patients were registered based on the plasma test only. With a median follow-up of 25.1 weeks, the objective response rate (ORR), median progression-free survival (PFS), and duration of the response (DoR) were 44.3%, 32.7 weeks, and 27.0 weeks, respectively. Median overall survival (OS) was not reached. The ORR, median PFS and DoR of tumor T790M+ (n=45) vs. plasma T790M+ (n=54) were 57.8% vs. 35.2%, 45.0 vs. 20.4 weeks, and 26.3 vs. 25.9 weeks, respectively.
Conclusion:
With the increasing importance of tissue rebiopsy after EGFR-TKI failure, there is a growing interest to overcome the challenge of subsequent biopsy. Even though relatively lower ORR and shorter PFS in patients with plasma T790M+ compared with tissue T790M+, the plasma EGFR genotyping may be good alternative to the tissue biopsy in consideration of long DoR when treated with osimertinib and low yield rate of tissue T790M testing.
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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): R. 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.
