Virtual Library
Start Your Search
H. Hayashi
Author of
-
+
P2.03a - Poster Session with Presenters Present (ID 464)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 12/06/2016, 14:30 - 15:45, Hall B (Poster Area)
-
+
P2.03a-009 - Clinical Outcome of Node-Negative Oligometastatic Non-Small Cell Lung Cancer (ID 4357)
14:30 - 14:30 | Author(s): H. Hayashi
- Abstract
Background:
The concept of “oligometastasis” has emerged as a basis on which to identify patients with stage IV non–small cell lung cancer (NSCLC) who might be most amenable to curative treatment. Although such patients without regional lymph node metastases tend to have a longer overall survival (OS) than those with regional lymph node involvement, limited data have been available regarding the survival of patients with node-negative oligometastatic NSCLC. We have therefore now evaluated the clinical outcome of stage IV node-negative oligometastatic NSCLC.
Methods:
Consecutive patients with advanced NSCLC who attended Kindai University Hospital between January 2007 and January 2016 were recruited to this retrospective study. Patients with regional lymph node–negative disease and a limited number of metastatic lesions (≤5) per organ site and a limited number of affected organ sites (1 or 2) were eligible.
Results:
Eighteen patients were identified for analysis during the study period. The most frequent metastatic site was the central nervous system (CNS, 72%). Most patients (83%) received systemic chemotherapy, with only three (17%) undergoing aggressive surgery, for the primary lung tumor. The CNS failure sites for patients with CNS metastases were located outside of the surgery or radiosurgery field. The median OS for all patients was 15.9 months, with that for EGFR mutation–positive patients tending to be longer than that for EGFR mutation–negative patients.
Conclusion:
Our results indicate that a cure is difficult to achieve with current treatment strategies for NSCLC patients with synchronous oligometastases, although a few long-term survivors and a smaller number of patients alive at last follow-up were present among the study cohort. There is an urgent clinical need for prospective evaluation of surgical resection as a treatment for oligometastatic NSCLC negative for driver mutations.
-
+
P3.02a - Poster Session with Presenters Present (ID 470)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 12/07/2016, 14:30 - 15:45, Hall B (Poster Area)
-
+
P3.02a-005 - The Association between the Percentage of Anaplastic Lymphoma Kinase(ALK)-Positive Cells and Efficacy of ALK Inhibitor (ID 4621)
14:30 - 14:30 | Author(s): H. Hayashi
- Abstract
Background:
The purpose of the study was to explore the association between the percentage of ALK+ cells in fluorescent in situ hybridization (FISH) and the clinical efficacy of ALK inhibitor.
Methods:
A total of 73 patients (pts) with ALK rearrangement who were identified the percentages of ALK+ cells in FISH and were treated with ALK inhibitor, were enrolled at three participating institutions. Retrospectively, we evaluated progression-free survival (PFS) by log-rank test and Kaplan–Meier method.
Results:
Median % ALK+ cells in FISH was 54% (range 15-100%). Fifty (68.5％) pts used crizotinib (CRZ) and 23 (31.5%) pts used alectinib (ALC) as the first ALK inhibitor. Among 57 pts who were evaluated by immunohistochemical (IHC) staining, 10 had no detectable expression of the ALK protein and the percentage of ALK+ cells was all within 15-29%. The PFS of pts with 15-29% ALK+ cells was shorter than that with 30% or more ALK+ cells (CRZ group: 1.4 months [95% CI: 0.2-4.2] in 15-19% ALK+ cells, 3.25 months [0.47-Not Estimated (NE)] in 20-29%, 6.77 months [4.27-12.6] in 30-100%, p < .001. ALC group: 6.4 months [3.03-16.8] in 20-29%, 23.1 months [7.8-NE] in 30-100%, p = 0.547). Moreover, among pts with 15-29% ALK+ cells, median PFS of pts with IHC- was significantly shorter than that with IHC+ (CRZ group: 1.3 vs 5.6 months, p = 0.009. ALC group: 0.87 vs 40.3 months, p = 0.004).
Conclusion:
The case in 15-29% ALK+ cells and IHC- could not obtain the benefit of the ALK inhibitor. However, if the case is IHC+, the long PFS could be expected despite the percentage of ALK+ cells in FISH.
-
+
P3.02b - Poster Session with Presenters Present (ID 494)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 12/07/2016, 14:30 - 15:45, Hall B (Poster Area)
-
+
P3.02b-086 - ASP8273 Tolerability and Antitumor Activity in TKI-Naïve Japanese Subjects with EGFRmut+ NSCLC: Preliminary Results (ID 4126)
14:30 - 14:30 | Author(s): H. Hayashi
- Abstract
Background:
ASP8273, an orally administered epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI) that inhibits EGFR-activating mutations, has demonstrated clinical activity in ongoing Phase 1/2 studies in subjects with EGFR mutation-positive non-small cell lung cancer (NSCLC).
Methods:
EGFR TKI-naïve adult subjects (≥20 years) with EGFR mutation-positive metastatic or advanced unresectable NSCLC were enrolled in this ongoing, open-label, Phase 2 single-arm study conducted in Japan (NCT02500927). Subjects received once-daily ASP8273 300 mg until discontinuation criteria were met. The primary endpoint was tolerability; the secondary endpoint was antitumor activity (defined by RECIST v1.1).
Results:
As of 23 February 2016, 31 subjects (12M/19F; median age 64 years [range: 31–82]) with EGFR mutation-positive NSCLC have been enrolled; 25 subjects (81%) were still on study. Based on local testing, 27 (87%) of the 31 enrolled subjects had an ex19del (n=13, 42%) or a L858R (n=14, 45%) EGFR activating mutation; 4 subjects (13%) had other EGFR activating mutations, including 2 subjects (6%) with L861Q. Moreover, 3 subjects (10%) were found to have both an activating mutation as well as the T790M resistance mutation. Tolerability of ASP8273 is presented in Table 1; gastrointestinal disorders were the most commonly reported treatment-emergent adverse events (eg, diarrhea [n=24, 77%], nausea [n=12, 39%], and vomiting [n=8, 26%)]). All subjects had at least 1 post-baseline scan; 1 subject (3%) achieved a confirmed complete response, 13 subjects (42%) had a confirmed partial response, and 15 subjects (48%) had confirmed stable disease (disease control rate: 94% [n=29/31]) per investigator assessment. Figure 1
Conclusion:
These preliminary data showed that ASP8273 300 mg is generally well tolerated and demonstrates antitumor activity in TKI-naïve Japanese subjects with EGFR mutation-positive NSCLC.
