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Yukio Hosomi
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P1.01 - Advanced NSCLC (Not CME Accredited Session) (ID 933)
- Event: WCLC 2018
- Type: Poster Viewing in the Exhibit Hall
- Track:
- Presentations: 1
- Moderators:
- Coordinates: 9/24/2018, 16:45 - 18:00, Exhibit Hall
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P1.01-20 - Phase III Study Comparing Gefitinib (G) to Gefitinib Combined with Carboplatin and Pemetrexed (GCP) for NSCLC with EGFR Mutations (NEJ009). (ID 11263)
16:45 - 18:00 | Author(s): Yukio Hosomi
- Abstract
Background
Although EGFR-TKI alone has been a standard first-line treatment for patients with advanced NSCLC with EGFR mutations, our phase II study (NEJ005) showed promising efficacy of GCP. NEJ009, an open-label, randomized phase III study, was conducted to evaluate the superiority of GCP vs G in progression-free survival (PFS), PFS2, and overall survival (OS).
a9ded1e5ce5d75814730bb4caaf49419 Method
Patients with newly diagnosed stage III/IV/recurrent NSCLC harboring EGFR activating mutations (exon 19 deletion or exon 21 L858R) were randomized 1:1 to G 250 mg PO QD or GCP (G 250mg PO QD combined with carboplatin AUC 5 + pemetrexed 500mg/m2, every 3 weeks). The primary endpoints consisting of PFS, PFS2, and OS were sequentially analyzed according to a preplanned gate-keeping method. Secondary endpoints included objective response rate, safety, and quality of life.
4c3880bb027f159e801041b1021e88e8 Result
In Sep 2017, a preplanned required number of events of PFS2 was observed. The ITT population included 344 patients with baseline characteristics fairly well balanced between the arms. Although GCP demonstrated significantly better PFS compared to G, there was no difference in PFS2 between the arms as below. Additional OS analysis (G:101 events vs GCP:83 events) revealed that median survival time of GCP was much longer than that of G (52.2 months vs 38.8 months, HR: 0.695, p=0.013).
8eea62084ca7e541d918e823422bd82e Conclusion
NEJ009 was the first phase III study which evaluated the efficacy of a combination of EGFR-TKI and platinum doublet chemotherapy in untreated advanced NSCLC patients with EGFR mutations. Although GCP regimen failed to demonstrate its superiority in PFS2, it may increase long survivors.
6f8b794f3246b0c1e1780bb4d4d5dc53ITT Population GCP (N=169) G (N=172) Median (months) Median (months) HR PFS 20.9 11.2 0.493 [95%CI: 18.0, 24.2] [95%CI: 9.0, 13.4] [95%CI: 0.390, 0.623] P<0.001 PFS2 20.9 21.1 0.891 [95%CI: 18.0, 24.2] [95%CI: 17.9, 24.9] [95%CI: 0.708, 1.122] P=0.806
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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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P3.01-53 - Comparison of the Treatment Efficacy of Osimertinib in Young and Elderly Patients with T790M-Positive NSCLC (ID 11992)
12:00 - 13:30 | Author(s): Yukio Hosomi
- Abstract
Background
Osimertinib is a third generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI). The AURA3 trial showed that osimertinib is superior to platinum doublet chemotherapy in T790M-positive non-small cell lung cancer (NSCLC) with acquired resistance to first or second generation EGFR-TKIs in patients, irrespective of age. In contrast, another study showed that first or second generation EGFR-TKIs may have poorer efficacy and prognosis in young subjects than in elderly patients with EGFR mutation-positive NSCLC. Thus, we aimed to determine whether osimertinib exerted similar effects on young and old patients with T790M-positive NSCLC.
a9ded1e5ce5d75814730bb4caaf49419 Method
We retrospectively investigated T790M-positive NSCLC patients with acquired resistance to first or second generation EGFR-TKIs who were administered osimertinib therapy from May 2015 to January 2018 by referring to their charts in the Tokyo Metropolitan Cancer and Infectious disease Center, Komagome Hospital, Japan. We defined patients > 65 years old as elderly and those < 65 years old as young. We compared the clinical characters, overall response rate (ORR), progression-free survival (PFS), and overall survival (OS) of the two age groups.
4c3880bb027f159e801041b1021e88e8 Result
Total 31 patients with acquired resistance to first or second generation EGFR-TKIs were administered osimertinib. Twenty-three subjects belonged to the older age group, while 8 belonged to the younger age group. The median ages of the elderly and young patients were 75 years (range: 65–88 years) and 54 years (34–64) years, respectively. There were no significant differences in their clinical characteristics (sex, Eastern Cooperative Oncology Group Performance Status, smoking history, histology, type of de novo EGFR mutation, initial EGFR-TKI therapy, re-biopsy sample, central nervous system metastasis, and osimertinib line). The median PFS duration after initial EGFR-TKI treatment was greater in the elderly patients (17.2 vs. 10.5 months; hazard ratio; 2.86; 95% confidence interval [CI] , 1.03–7.97; P = 0.0022); the ORR of osimertinib in the elderly and young patients was 53.3% and 37.5%, respectively. The median follow up interval after osimertinib initiation was 10.1 months. The total median PFS duration was 5.6 months. The median PFS duration tended to be greater in elderly patients (3.5 vs. 9.1 months; hazard ratio; 1.90; 95% CI, 0.75–4.78; P = 0.17). The median OS duration after osimertinib initiation was significantly greater in elderly patients (5.3 months vs. NA; hazard ratio; 3.36; 95% CI, 1.11–10.1; P = 0.027).
8eea62084ca7e541d918e823422bd82e Conclusion
Osimertinib showed poorer efficacy in younger patients than in elderly patients with T790M positive NSCLC.
6f8b794f3246b0c1e1780bb4d4d5dc53
