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Satoshi Watanabe
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EP1.16 - Treatment in the Real World - Support, Survivorship, Systems Research (ID 206)
- Event: WCLC 2019
- Type: E-Poster Viewing in the Exhibit Hall
- Track: Treatment in the Real World - Support, Survivorship, Systems Research
- Presentations: 1
- Now Available
- Moderators:
- Coordinates: 9/08/2019, 08:00 - 18:00, Exhibit Hall
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EP1.16-27 - Observational Study to Investigate the Implementation Rate of Re-Biopsy in EGFR-TKI-Resistant Patients (NLCTG1602) (Now Available) (ID 1051)
08:00 - 18:00 | Author(s): Satoshi Watanabe
- Abstract
Background
In EGFR-TKI treatment, cannot perform re-biopsy in all cases for recurrent style and involvement.
Method
In the case that only cytodiagnosis can gather, we cannot perform an examination for T790M by the Cobas method even if we can obtain a specimen.The examination of plasma is useful, but the case which cannot but provide the next treatment as we cannot confirm a resistant mechanism may often occur by the true clinic because we cannot detect all resistance.
Examine the rate of use of re-biopsy in the EGFR-TKI-resistant case of the EGFR mutation in the gene-positive progress non-small cell lung cancer and histological diagnosis and rate of agreement of the T790M mutation detection by the Cobas method of the cytodiagnosis prospectively.
Result
＜subjects>Treated by EGFR-TKI, and do the case that an effect was able to continue with primary registration, and do it with the second registration when treatment was resistant, and do the laboratory procedure and results with registration when there are a recurrence point, PS, use or nonuse of re-biosy.
We added up the liquid as re-biosy after July, 2017.
Start registration of this study in February, 2017, and 197 primary registration, second registration completion become 127 cases as of January, 2019.We conducted the interim analysis in 80 second registration in October, 2018.
Conclusion
The Re-biopsy rate of use was 74/80 = 92.5%.The re-biopsy success rate was the whole, and 79.7%, the T790M positive rate were 41.9%.By the specimen distinction, the histological diagnosis, the cytodiagnosis, the re-biopsy success rate and the T790M positive rate by the examination of plasma were 92.3% /56.4%, 83.3%/8.3%, 56.5%/34 .8%, respectively.
It is during data cleaning work and is going to report end results now at the general meeting.
Section not applicable
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MA21 - Non EGFR/MET Targeted Therapies (ID 153)
- Event: WCLC 2019
- Type: Mini Oral Session
- Track: Targeted Therapy
- Presentations: 1
- Now Available
- Moderators:Benjamin Besse, Michael Thomas
- Coordinates: 9/10/2019, 14:30 - 16:00, Vienna (2016)
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MA21.05 - Phase II Trial of the Combination of Alectinib with Bevacizumab in ALK-Positive Nonsquamous Non-Small Cell Lung Cancer (Now Available) (ID 1306)
14:30 - 16:00 | Presenting Author(s): Satoshi Watanabe
- Abstract
- Presentation
Background
Alectinib is a 2nd generation highly selective anaplastic lymphoma kinase (ALK) inhibitor. Although alectinib has improved progression-free survival (PFS) in patients with ALK-positive Non-Small Cell Lung Cancer (NSCLC), there are limited treatment options after progression of alectinib. Recent evidences have described promising results of the combination of bevacizumab with EGFR-TKIs, cytotoxic chemotherapies and immune-checkpoint inhibitors. We report the results from a phase II study of the combination of alectinib with bevacizumab in ALK-positive Nonsquamous NSCLC patients who were treated with alectinib and showed disease progression (UMIN 000017828).
Method
Patients with ALK+ Nonsquamous NSCLC who had progressed after alectinib treatment were enrolled. Primary objective of this study was PFS and safety. Secondary endpoints included overall survival, objective response rate and disease control rate.
Result
Twelve patients received alectinib (600 mg/day) with bevacizumab (15 mg/kg, Q3W). Nine patients were treated with crizotinib and alectinib, and 2 patients were treated with crizotinib, alectinib and ceritinib before enrollment to this study. The median PFS was 3.1 months (95% CI 1.2-16.1) and the median survival time was 32 months (95% CI 8.3-NE). The median treatment cycle was 5 (range, 1-37) and 3 patients received alectinib with bevacizumab more than 20 cycles. The objective response rate and disease control rate were 8% and 67%, respectively. The most common treatment related adverse events were decreased appetite (42%), proteinuria (42%), hypertension (33%), anemia (33%) and fatigue (33%). Treatment related adverse events of grade > 3 were anemia (8%), proteinuria (8%), diarrhea (8%) and hypokalemia (8%). No severe adverse events were observed.
Conclusion
This is the first study to investigate the combination of alectinib and bevacizumab. This combination had clinical efficacy and was well tolerated.
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P2.14 - Targeted Therapy (ID 183)
- Event: WCLC 2019
- Type: Poster Viewing in the Exhibit Hall
- Track: Targeted Therapy
- Presentations: 1
- Moderators:
- Coordinates: 9/09/2019, 10:15 - 18:15, Exhibit Hall
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P2.14-52 - The Results from Plasma EGFR Mutation Analysis in NEJ026 Study (ID 602)
10:15 - 18:15 | Author(s): Satoshi Watanabe
- Abstract
Background
EGFR mutation analysis of plasma circulating tumor DNA (ctDNA) has been reported to be useful to detect resistant mutations and to predict the efficacy of treatment. In NEJ026 study, we demonstrated the PFS of erlotinib plus bevacizumab (BE) treatment was significantly superior to the erlotinib alone (E) in NSCLC patients harboring EGFR mutation. Evaluation of plasma EGFR mutations included in NEJ026 study as preplanned analysis.
Method
At the time points of pretreated (P0), 6 weeks after study treatment started (P1), and confirmed progressive disease (P2), the plasma samples were collected from the patients enrolled to NEJ026 study. The number of enrolled patients were 112 in BE and 114 in E. Plasma ctDNA analysis for detection of the activating EGFR mutation and T790M mutation were performed by modified PNA-LNA PCR clamp method.
Result
The total numbers of collected plasma samples in BE and E were 108 (96.4%) and 107 (95.5%) at P0, 95 (84.8%) and 97 (86.6%) at P1, and 42 (37.5%) and 53 (47.3%) at P2, respectively. In eligible patients having EGFR activating mutation detected by cytohistological specimens, detection rate of plasma EGFR mutation at P0 was 68% (147/215). The detection ratio of T790M mutation at P2 were similar in both arms: 8 (19.0%) in BE and 11 (20.8%) in E. By detection pattern of activating EGFR mutation, PFS was evaluated among three groups: type A (P0 (-),P1 (-)), type B (P0 (+), P1(-)), and type C (P0 (+), P1(+)). Type A achieved the best response to both TKI [Type A BE: 18.1 M (n = 32, 95% CI, 11.5 to upper limit not reached(NR)), E: 16.7 M (n = 26, 95% CI, 11.2 to NR )]. Type B also had better PFS to TKI and BE is more favorable effect than E compared to other types [type B BE: 15.5 M (n = 48, 95% CI, 12.4 to 23.3), E: 11.1 M (n = 57, 95% CI, 8.5 to 13.7)]. Type C showed worse response to both treatment [type C BE: 6.0M. (n = 12, 95% CI 2.6 to NR), E: 4.3 M (n = 10, 95% CI, 2.8 to 20.2)]. BE had better PFS in all types.
Conclusion
Frequency of T790M in P2 was similar among BE and E. When patients still had detectable activating EGFR mutation in plasma ctDNA after treatment for 6 weeks, you should consider that they might have poor response to both BE and E.
