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Koichi Minato
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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): Koichi Minato
- 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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P3.01-43 - Predictive Value of Computed Tomography Characteristics for Nivolumab Response in Pretreated Non-Small Cell Lung Cancer (ID 13054)
12:00 - 13:30 | Author(s): Koichi Minato
- Abstract
Background
The efficacy and safety of nivolumab for the treatment of pretreated non-small cell lung cancer (NSCLC) have been established. We conducted a retrospective multicenter trial to determine the significance of computed tomography (CT) morphologic characteristics as a predictor of nivolumab efficacy for advanced NSCLC patients.
a9ded1e5ce5d75814730bb4caaf49419 Method
From April 2013 to March 2017, 78 pretreated NSCLC patients were enrolled. Our radiologist assessed the following tumor characteristics on CT before nivolumab treatment; interstitial septal thickening, peritumoral ground-glass opacity, spiculated margin, air bronchogram, cavity or necrosis, adjacent organ invasion, bulky lymph node (≥ 2.5 cm), and accumulation of small lymph nodes. After nivolumab treatment, objective response rate (ORR), disease control rate (DCR) and progression free survival (PFS) were analyzed with logistic regression and Cox proportional hazards regression models. Patient and CT morphologic characteristics were retrospectively analyzed. Significant parameters identified by univariate analysis were included in a multiple analysis.
4c3880bb027f159e801041b1021e88e8 Result
Of the 78 patients, 60 (77%) were male, and 72 (92%) patients were of performance status 0 to 1. Heavy smoking was related to higher ORR than light or never smoking (28% vs 0%, p=0.01)．No morphologic characteristics were related to ORR or DCR. Interstitial septal thickening was significantly associated with shorter PFS (p=0.015, 77 vs 126 days). Adjacent organ invasion was also significantly associated with shorter PFS (p=0.047, 72 vs 118 days). However, they were not found to be significant on multivariate analysis.
8eea62084ca7e541d918e823422bd82e Conclusion
Interstitial septal thickening and adjacent organ invasion may be negative prognostic factors of nivolumab treatment for NSCLC.
6f8b794f3246b0c1e1780bb4d4d5dc53
