Virtual Library
Start Your Search
Minoru Fukuda
Author of
-
+
P1.01 - Advanced NSCLC (ID 158)
- Event: WCLC 2019
- Type: Poster Viewing in the Exhibit Hall
- Track: Advanced NSCLC
- Presentations: 1
- Now Available
- Moderators:
- Coordinates: 9/08/2019, 09:45 - 18:00, Exhibit Hall
-
+
P1.01-47 - Prospective Study for Usefulness of Plasma DNA on Prediction of Third Generation EGFR Tyrosine Kinase Inhibitors (S-PLAT Study) (Now Available) (ID 1112)
09:45 - 18:00 | Author(s): Minoru Fukuda
- Abstract
Background
The AURA and FLAURA studies have shown that EGFR T790M mutation detected in cfDNA is correlated with efficacy of osimertinib as measured via overall response rate (ORR), and progression-free survival (PFS). However, the following clinical-related questions have been raised: Can other different assay systems confirm the results mentioned above? Does T790M level affect osimertinib treatment efficacy? Do mutations at loci other than EGFR influence treatment efficacy?
Method
This is a prospective observational study, joining 27 Japanese hospitals. Plasma samples from patients with non-small cell lung cancer (NSCLC) who acquired resistance to EGFR-TKI (gefitinib, erlotinib, afatinib) were collected between Feb 2017 and Jan 2019. We tested T790M by MBP-QP method which has been newly developed using cfDNA and investigated the concordance with the result by cobas EGFR mutation Test v.2 (tissue and/or plasma) which is commercially available. We also checked the allele frequency (AF) of T790M in cfDNA by ddPCR and the mutational status of cancer related actionable genes by cfDNA specific NGS (Guardant360). The major objectives were ORR, disease control rate (DCR) to osimertinib and PFS in patients with T790M positive by MBP-QP method.
Result
Among 145 NSCLC patients who acquired resistance to 1st or 2nd EGFR-TKI, T790M was detected in 57 patients by cobas (tissue and/or plasma), and these patients received osimertinib (80mg daily). T790M was detected by cobas in 16 patients from plasma, 44 patients from tissue, 3 patients from both samples. Among assessable patients, ORR, DCR and PFS in patients with T790M positive by cobas from plasma were 66.7%, 86.7%, 194 days, those of tissue were 53.5%, 97.7%, 186 days, respectively. In these 57 patients, MBP-QP also could detect T790M from 10 patients from plasma, and ORR, DCR and PFS in patients with T790M positive by MBP-QP from plasma were 75.0%, 87.5%, 184 days, respectively. These results suggest that T790M detection from cfDNA not only by cobas but also MBP-QP is correlated with RR of osimertinib. Now, using ddPCR and Guardant360, we have been investigating about the relationship between T790M AF and RR to osimertinib, and the influence of mutations at loci other on efficacy of osimertinib.
Conclusion
cfDNA analysis can be predictive for osimertinib efficacy, just as re-biopsy. Whether comprehensive approach including AF and coexistence of other actionable genes is more precisely informative for drug efficacy has been continuously analyzed.
-
+
P2.11 - Screening and Early Detection (ID 178)
- Event: WCLC 2019
- Type: Poster Viewing in the Exhibit Hall
- Track: Screening and Early Detection
- Presentations: 1
- Moderators:
- Coordinates: 9/09/2019, 10:15 - 18:15, Exhibit Hall
-
+
P2.11-43 - Management of Pulmonary Nodules Detected on CT: Multicenter Collaborative Study in Nagasaki Prefecture (ID 1774)
10:15 - 18:15 | Author(s): Minoru Fukuda
- Abstract
Background
Pulmonary nodules are frequently detected on low-dose CT screening of the chest. Most of them are benign and lung cancer is only a part, so handling of pulmonary nodules is a major issue. Although the guidelines of the Japanese Society of CT Screening have been published, the examination of their usefulness is not sufficient. Therefore, the pulmonary nodules detected on CT were handled according to the guideline (version 2), and the clinical significance and the usefulness of the guideline were examined.
Method
Pulmonary nodules with 5mm or larger in size on initial chest CT were followed up prospectively at five facilities in Nagasaki Prefecture. CT Images and clinical data were collected in one center, and analysis was performed on the same workstation (Aquarius Net Station ver. 1.5). In the central review, measurement at the workstation and evaluation of visual characteristics of the nodules were performed by two or more experienced radiologists, and the results were returned to the participating facilities to be reflected in the handling and follow-up of the nodules.
Result
131 cases were registered in total, 39 cases were excluded and the remaining 92 cases were analyzed (57 women, 35 men, average age 65.6 (39-87) years old). 39 cases were solid nodule, 17 cases were part solid ground-glass nodule (GGN) and 36 cases were pure GGN. 20 cases were surgically resected, and histological findings were obtained for 17 nodules: 14 adenocarciomas (two solid nodules, 7 part solid GGNs and 5 pure GGNs), two squamous cell carcinomas (two solid nodules), one lung metastasis (solid nodule). Fifteen cases shrank or disappeared overtime (7 solid nodules, 4 part solid GGNs and 4 pure GGNs). Twenty-four month follow-up was completed in 57 cases (27 solid nodules, 3 part solid GGNs and 27 pure GGNs).
Conclusion
Although handling of pulmonary nodules detected on chest CT was conventionally left to the discretion of the institution /in-charge doctor, using this guideline made the policy of clearer and became possible to evaluate the natural history of pulmonary nodules correctly. There were no cases that became inoperable due to the appearance of distant metastasis during follow-up, and this guideline was considered appropriate.
-
+
P2.12 - Small Cell Lung Cancer/NET (ID 180)
- Event: WCLC 2019
- Type: Poster Viewing in the Exhibit Hall
- Track: Small Cell Lung Cancer/NET
- Presentations: 1
- Moderators:
- Coordinates: 9/09/2019, 10:15 - 18:15, Exhibit Hall
-
+
P2.12-07 - Phase I Study of Amrubicin and Cisplatin with Concurrent Thoracic Radiotherapy (TRT) in Limited-Disease Small Cell Lung Cancer (LD-SCLC) (ID 47)
10:15 - 18:15 | Presenting Author(s): Minoru Fukuda
- Abstract
Background
Amrubicin and cisplatin is one of active regimens for patients with extensive-disease small cell lung cancer (ED-SCLC). Combined modality of combination chemotherapy and concurrent thoracic radiotherapy has been recognized as standard treatment for LD-SCLC. This study aimed to determine the maximum tolerated dose (MTD), and dose limiting toxicity (DLT) of amrubicin and cisplatin with concurrent TRT in LD-SCLC.
Method
Patients fulfilling the following eligibility criteria were enrolled: chemotherapy-naïve, PS0-1, age =<75, LD-SCLC, and adequate organ function. Patients received escalating doses of amrubicin on days 1, 2, and 3, under a fixed 60 mg/m2 of cisplatin on day 1. Four cycles of chemotherapy were repeated every 4 weeks. TRT of once-daily 2Gy/day commenced on day 2 of the first cycle of chemotherapy. The initial doses of amrubicin was 20 mg/m2 (level 1), and the dose was escalated to 25 (level 2) and 30 (level 3) mg/m2.
Result
Eight patients were enrolled at three dose levels. male/female=3/5; PS 0/1=4/4; median age (range) =68.5 (60-73). Two of two in level 3 experienced DLTs. The presentation of DLTs was grade4 neutropenia and leukopenia lasting more than four days. The MTD determined level 3, and level 2 was recommended for this combined modality. Evaluation of responses were 7 partial response and 1 progressive disease (response rate 87.5%) and the median overall survival time was 24.7 months, and suggested the regimen seemed to be modest activity.
Conclusion
In combined modality of this chemotherapy with TRT for LD-SCLC, MTD was amrubicin 30 mg/m2 and cisplatin 60 mg/m2, and DLTs were neutropenia and leukemia.
