Virtual Library
Start Your Search
N. Yamamoto
Author of
-
+
P1.07 - Poster Session with Presenters Present (ID 459)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: SCLC/Neuroendocrine Tumors
- Presentations: 1
- Moderators:
- Coordinates: 12/05/2016, 14:30 - 15:45, Hall B (Poster Area)
-
+
P1.07-005 - A Retrospective Study of Sequential Chemoradiotherapy for LD-SCLC Patients in Whom Concurrent Therapy is Not Indicated (ID 4066)
14:30 - 14:30 | Author(s): N. Yamamoto
- Abstract
Background:
The standard treatment for limited-disease small-cell lung cancer (LD-SCLC) is a combination of cisplatin-doublet chemotherapy and concurrent thoracic radiotherapy. However, sequential radiotherapy, rather than concurrent radiotherapy, is selected for some cases because of concerns regarding the irradiation field, patient age, comorbidities, or performance status. Nevertheless, the efficacy of sequential chemoradiotherapy in patients in whom concurrent chemoradiotherapy is contraindicated is not well known.
Methods:
We retrospectively analyzed 286 patients with LD-SCLC at the National Cancer Center Hospital and the NTT Medical Center in Japan between 2000 and 2014. We then compared the clinical characteristics and treatment outcomes of patients undergoing sequential radiotherapy with those undergoing concurrent radiotherapy.
Results:
One hundred and eighty-three patients received concurrent chemoradiotherapy and 30 received sequential chemoradiotherapy. The median age of the patients was 64 years (range, 18-81 years) for the concurrent group and 71.5 years (50-83 years) for the sequential group. The concurrent group contained 43 women (23%), while the sequential group contained 9 women (30%). The major reasons for the selection of sequential radiotherapy were patient age (13 patients), a large irradiation field (8 patients), and comorbidities (5 patients). In the sequential group, 23 (77%) received conventional radiotherapy, whereas 7 (23%) received accelerated hyperfractionated radiotherapy. The median overall survival period was 34.5 months for the concurrent group and 27.6 months for the sequential group (P = 0.39). The 2-, 3-, and 5-year survival rates were 71%, 50%, and 40% for the concurrent group and 56%, 56%, and 35% for the sequential group. Recurrence was seen in 149 patients (81%) in the concurrent group and 19 patients (63%) in the sequential group.
Conclusion:
We obtained treatment outcomes for patients who could not receive concurrent radiotherapy but could complete sequential radiotherapy that were comparable with the outcomes for those who received concurrent radiotherapy. For patients in whom concurrent chemoradiotherapy is not indicated, sequential chemoradiotherapy should be considered.
-
+
P2.03b - Poster Session with Presenters Present (ID 465)
- 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)
-
+
P2.03b-017 - Differences of Central Nerve System Metastasis during Gefitinib or Erlotinib Therapy in Patients with EGFR-Mutated Lung Adenocarcinoma (ID 4879)
14:30 - 14:30 | Author(s): N. Yamamoto
- Abstract
Background:
A few reports have suggested a difference in the incidences of new metastasis to the central nerve system (CNS) during gefitinib and erlotinib therapy. However, a direct comparison of these two therapies has not yet been reported. We planned a retrospective study to investigate the incidences of CNS metastasis progression (new CNS metastasis or progression of existing CNS metastasis) during gefitinib and erlotinib therapy in patients with non-small cell lung cancer (NSCLC) harboring EGFR mutation.
Methods:
We retrospectively analyzed the incidences of CNS metastasis progression and the outcomes of NSCLC patients harboring EGFR mutation who received gefitinib or erlotinib as a first-line EGFR-TKI treatment at the National Cancer Center Hospital between 2008 and 2014.
Results:
A total of 175 patients were analyzed; 148 patients had received gefitinib, and 27 had received erlotinib. The median (range) ages were 64.5 (32-81) years and 62.0 (27-68) years, respectively; exon 19 deletion/L858R point mutations were present in 84/64 (56.7%/43.3%) and 17/10 (63.0%/37.0%) cases, respectively. The status of CNS metastasis before EGFR-TKI therapy was negative/positive in 105/43 (71.0%/29.0%) cases in the gefitinib group and 21/6 (77.8%/22.2%) cases in the erlotinib group, respectively. The incidence of CNS metastasis progression in the gefitinib group tended to be higher than that in the erlotinib group (29.0% vs. 11.1%; P = 0.051). In patients without CNS metastasis before EGFR-TKI therapy, the incidence of new CNS metastasis during EGFR-TKI treatment was significantly higher in the gefitinib group than in the erlotinib group (24.7% vs. 4.8%, P = 0.04). The progression-free survival (PFS) and overall survival (OS) periods of the patients who presented with CNS progression were shorter than those of the patients who presented without CNS progression (median PFS, 9.5 vs. 12.6 months, P = 0.034; median OS, 23.8 vs. 34.1 months, P = 0.002). Fifty-six patients underwent re-biopsy after the failure of EGFR-TKI therapy, but no difference in the incidences of EGFR T790M mutation was seen between patients with and those without CNS metastasis progression (40.0% for patients without CNS progression vs. 63.6% for patients with CNS metastasis progression, P = 0.19).
Conclusion:
The incidence of the progression of CNS metastasis during gefitinib therapy was higher than that during erlotinib therapy. In addition, the difference in this incidence was more remarkable among patients who had not developed CNS metastasis prior to the start of EGFR-TKI therapy.
-
+
P2.06 - Poster Session with Presenters Present (ID 467)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Scientific Co-Operation/Research Groups (Clinical Trials in Progress should be submitted in this category)
- Presentations: 1
- Moderators:
- Coordinates: 12/06/2016, 14:30 - 15:45, Hall B (Poster Area)
-
+
P2.06-002 - Phase I Study of DS-6051b, a ROS1/NTRK Inhibitor, in Japanese Subjects with Advanced Solid Tumors Harboring Either a ROS1 or NTRK Fusion Gene (ID 4366)
14:30 - 14:30 | Author(s): N. Yamamoto
- Abstract
Background:
Oncogenic gene fusions of ROS1 or NTRK have been reported in various cancers. DS-6051b is an orally available small molecule receptor tyrosine kinase inhibitor with high affinity for the ROS1 and NTRK receptors. Non-clinical pharmacology studies demonstrated anticancer activity of DS-6051b against several types of human tumor harboring ROS1 or NTRK fusion gene in cultured cells and xenograft models.
Methods:
This is an ongoing phase 1 study in Japanese subjects with advanced solid tumors harboring either a ROS1 or NTRK fusion gene. Subjects receive doses of DS-6051b from 400mg to 800mg once daily (QD). Pharmacokinetics (PK) samples are collected from Day1 to Day22. Primary objective is to assess the safety profile and secondary objectives are to determine the maximum tolerated dose (MTD), the recommended phase 2 dose (RP2D), and to assess the PK profile. The efficacy of DS-6051b is an exploratory assessment performed by investigator judgment per RECIST v.1.1.
Results:
As of June 27, 2016, a total of 9 subjects were enrolled. Median age was 51 (43-69) years, 56% were female, all 9 subjects were ROS1 fusion positive non-small cell lung cancer patients, and 3 subjects had prior crizotinib treatment. Subjects received DS-6051b at doses of 400mg QD (n=6) and 800mg QD (n=3). There were no DLTs in the 400mg QD cohort, and 2 out of 3 subjects in the 800mg QD cohort experienced DLT with grade 3 AST/ALT increased. To evaluate the MTD and RP2D more in detail, 600mg QD cohort is planned. Common adverse events were AST increased, ALT increased, diarrhea, and constipation. Among 7 patients who had target lesion, 4 subjects showed partial response, 3 subjects showed stable disease. PK data indicated the plasma drug concentration increases as the dose increases.
Conclusion:
This study is categorized as “Clinical Trial in Progress”. This study was initiated from February 2016 and estimated primary completion date will be September 2018.
-
+
P3.02c - Poster Session with Presenters Present (ID 472)
- 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)
-
+
P3.02c-097 - Nivolumab in Elderly or Poor Performance Status Patients with Advanced Non-Small Cell Lung Cancer (ID 4213)
14:30 - 14:30 | Author(s): N. Yamamoto
- Abstract
Background:
Nivolumab showed durable antitumor activity and survival benefit in previously treated patients with advanced non-small cell lung cancer (NSCLC). The aim of this study was to evaluate the efficacy and safety of nivolumab in elderly (≥75 year old) or poor performance status (PS; ≥2) patients with NSCLC, most of who have been excluded from clinical trials.
Methods:
This was a retrospective cohort study investigating the outcome of patients with advanced or post-operative recurrence NSCLC who received nivolumab from January to April 2016 in the National Cancer Center Hospital. Patient characteristics, the efficacy of nivolumab, survival, and adverse events were analyzed. Immunohistochemical (IHC) expression of programmed cell death ligand 1 (PD-L1) in pretreatment tissue (10 biopsy and 3 operation specimens) was assessed using the rabbit monoclonal PD-L1 antibody (clone 28-8; Abcam). Staining of ≥1% of tumor cells was considered as the cut-off value of positive PD-L1 expression.
Results:
A total of 20 patients, including 10 elderly patients with non-squamous NSCLC and 10 poor PS patients (7 with non-squamous and 3 with squamous NSCLC), received nivolumab. Objective responses were observed in 6 patients: 4 (40%) elderly and 2 (20%) poor PS patients. The median progression-free survival was 2.8 months and 1.7 months in the elderly and poor PS groups, respectively. Of 13 cases with quantifiable IHC results, 10 cases were positive for PD-L1. PD-L1 expression was not predictive of a response, which occurred in 4 of 10 (40%) patients with PD-L1-postive tumors, 1 of 3 (33%) patients with PD-L1-negative tumors, and 1 of 7 (14%) patients with an unknown PD-L1 status (p = 0.52). Treatment-related adverse events led to discontinuation of nivolumab in 6 patients (1 elderly and 5 poor PS patients). Figure 1
Conclusion:
Nivolumab had a clinically meaningful response for elderly or poor PS advanced NSCLC patients, but toxicity led to the discontinuation of nivolumab.
