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Seung Hun Jang
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MA08 - Clinical Trials in Brain Metastases (ID 906)
- Event: WCLC 2018
- Type: Mini Oral Abstract Session
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 9/24/2018, 15:15 - 16:45, Room 203 BD
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MA08.07 - Real World Data of Osimertinib in Patients with Central Nervous System (CNS) Metastasis in ASTRIS Korean Subset. (ID 13581)
15:50 - 15:55 | Author(s): Seung Hun Jang
- Abstract
- Presentation
Background
More than 40% of non-small cell lung cancer (NSCLC) patients develop CNS metastasis in their lifetime. Osimertinib is a third-generation EGFR-TKI which selectively inhibits both EGFR-sensitizing and EGFR T790M resistance mutations. Clinical studies have shown superior efficacy of osimertinib in CNS compared to platinum chemotherapy. Treatment efficacy in patients with or without CNS metastasis were observed within the second interim analysis of ASTRIS (NCT02474355). Data cut-off (DCO) was 20 October 2017.
a9ded1e5ce5d75814730bb4caaf49419 Method
In ASTRIS, advanced NSCLC patients with a locally confirmed T790M mutation, WHO performance status 0-2, prior EGFR-TKI therapy were enrolled. Patients with stable CNS metastases were allowed. The primary endpoint was overall survival (OS); other endpoints included investigator-assessed response rate (RR), progression-free survival (PFS), time to treatment discontinuation (TTD) and safety. These endpoints were also analyzed according to presence of CNS metastasis.
4c3880bb027f159e801041b1021e88e8 Result
A total of 466 patients received at least one dose of osimertinib 80mg from 31 Korean sites. CNS metastasis was evaluated in 310 patients and was present in 211 (68.1%) patients (CNS-met); 181 brain only, 1 leptomeningeal only, 29 both. 99 (31.9%) patients did not have CNS metastasis (CNS-no), and 155 patients were not evaluated (CNS-ne). At DCO, 236 patients (50.6%) were ongoing and median duration of exposure was 11.2 (0–19) months. In patients evaluable for response, defined as at least one dose of osimertinib and one response assessment, RR was 71.0% (320/451; 95% CI, 66.5–75.1): Patients with (N=211), without (N=99), and not-evaluated CNS metastasis (N=155) had RR of 68% (134/197; 95% CI, 61.0-74.5), 79.6% (78/98; 95% CI, 70.3-87.1), and 69.7% (108/155; 95% CI, 61.8-76.8), respectively. Median PFS was 12.4 months (95% CI, 11.1-13.6 months); 10.8 months (95% CI, 9.5-11.5) in CNS-met,11.0 months (95% CI, 9.2-14.5) in CNS-no, and 15.1 months (95% CI, 13.6-18.2) in CNS-ne. Median TTD was 16.5 months (95% CI, 14.1-NC); 11.2 months (95% CI, 9.4-14.8) in CNS-met, 14.7 months (95% CI, 12.2-NC) in CNS-no, and NC (95% CI, 15.5-NC) in CNS-ne. OS was not reached (data maturity: 19.7%). Serious adverse event (AE) regardless of causality were reported in 116 patients (24.9%) and AEs leading to death in 13 patients (2.8%). ILD/pneumonitis-like events were reported in 8 patients (1.7%), and QTc prolongation in 7 patients (1.5%).
8eea62084ca7e541d918e823422bd82e Conclusion
In ASTRIS Korean subset, patients with or without CNS metastasis had comparable efficacy outcome. This data continues to support osimertinib’s clinical benefit on EGFRm T790M NSCLC patients with CNS metastasis.
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P3.01 - Advanced NSCLC (Not CME Accredited Session) (ID 967)
- Event: WCLC 2018
- Type: Poster Viewing in the Exhibit Hall
- Track:
- Presentations: 1
- Moderators:
- Coordinates: 9/26/2018, 12:00 - 13:30, Exhibit Hall
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P3.01-82 - Survival Impact of Surgery in the Treatment of Stage IIIB-IVA Non-Small Cell Lung Cancer (ID 12121)
12:00 - 13:30 | Author(s): Seung Hun Jang
- Abstract
Background
Surgery is usually not indicated in far advanced stage non-small cell lung cancer (NSCLC), but a few recent clinical trials demonstrated aggressive local therapy such as (chemo) radiotherapy or surgical resection improved survival outcomes in oligometastatic NSCLC. This study aimed to evaluate survival impact of cytoreductive surgery in stage IIIB-IVA (based on the 8th TNM classification) NSCLC in the era of effective anticancer drugs.
a9ded1e5ce5d75814730bb4caaf49419 Method
Patients with stage IIIB, IIIC or IVA NSCLC was recruited from the Hallym Lung Cancer Registry for this retrospective analysis. Other eligibility criteria were ECOG performance 0-1, age under 85 years old and good adherence to lung cancer treatment.
4c3880bb027f159e801041b1021e88e8 Result
A total of 203 patients were analyzed. All the patients received adequate anticancer drugs during their disease courses. Twenty-two patients (10.8%) received cytoreductive surgery. Significantly better overall survival (OS) was observed in surgery group compared with non-surgery group; Kaplan-Meier estimation for OS was 33.1 months [95% CI, 15.6-50.6] vs. 16.6 months [14.0-19.2] (p=0.007). The Cox proportional hazard ratio (HR) for death was 0.528 [0.290-0.961] (p=0.037) in surgery group when it was analyzed with covariates such as age, sex, performance, histology, stage, and smoking status. ECOG performance 0 and adenocarcinoma histology were also revealed as independent favorable prognostic factors for OS (HR .0.660 [0.474-0.919], p=0.014 and HR 0.481 [0.328-0.707], p<0.001, respectively).
Table. Cox proportional hazard ratio for death
Variable HR [95% CI] p-value AGE < 65 y.o. vs. ≥ 65 y.o. 0.722 0.520-1.002 0.052 Sex Female vs. Male 1.950 0.955-3.984 0.067 ECOG performance 0 vs. 1 0.660 0.474-0.919 0.014 Histology ADC vs. non-ADC 0.481 0.328-0.707 <0.001 Stage IIIB/C vs, IVA 0.761 0.520-1.114 0.160 Smoking ≤ 10 p.y. vs. > 10 p.y. 0.488 0.145-1.639 0.246 Surgery (+) vs. (-) 0.528 0.290-0.961 0.037
Surgery backed up with adequate anticancer treatments may be a treatment option in far advanced stage NSCLC.
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