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Hiroshi Tanaka
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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): Hiroshi Tanaka
- 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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MA13 - Going Back to the Roots! (ID 139)
- Event: WCLC 2019
- Type: Mini Oral Session
- Track: Advanced NSCLC
- Presentations: 1
- Now Available
- Moderators:Maurice Perol, Kaoru Kubota
- Coordinates: 9/09/2019, 14:00 - 15:30, Vancouver (2003)
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MA13.07 - Phase I/II Study of Carboplatin Plus Weekly Nab-Paclitaxel in Aged ≥75 Patients with Squamous-Cell Lung Cancer: TORG1322 (Now Available) (ID 1369)
14:00 - 15:30 | Author(s): Hiroshi Tanaka
- Abstract
- Presentation
Background
Combination chemotherapy of carboplatin (CBDCA) plus weekly nab-paclitaxel (nab-PTX) showed a favorable efficacy for elderly (70 year or older) patients with squamous non-small cell lung cancer (Sq-NSCLC) in a subgroup analysis of the CA031 study. We conducted a phase I/II study of CBDCA plus nab-PTX in chemo-naïve elderly patients with advanced Sq-NSCLC.
Method
Patients aged ≥75 years with untreated, measurable lesion, advanced Sq-NSCLC, performance status (PS) 0-1, and adequate organ function were eligible. In a phase I study, doses of carboplatin at an area under the curve (AUC) of 5 or 6 mg/mL min on day 1 (levels 1 and 2, respectively) were administered along with weekly nab-PTX (100 mg/m2) on days 1, 8, and 15 every 4 weeks up to 6 cycles using a modified 3 + 3 design. The primary endpoint for the phase II study was the 6-month progression-free survival (6m PFS) rate and hypothesis required 36 patients to be enrolled with expecting and threshold values for the primary endpoints of 40% and 25% (one-sided alpha = 0.05; beta = 0.2).
Result
A total of 46 patients were enrolled in this study. The median age was 78 (range 75-85 years); male (n = 41); PS 0/1, (n = 15/31). Ten patients were enrolled in the phase I part. At dose level 1, 2/7 patients showed dose-limiting toxicities (DLTs) of grade 3 diarrhea and febrile neutropenia, and at dose level 2, 1/3 patient showed DLT of grade 3 anorexia. The recommended dose was determined to be level 2. Additional 36 patients were enrolled, and a total of 39 patients were evaluated in the phase II study. The median number of cycles was 4 (range 1-6), and the median follow-up time was 17.5 months (range 5.6-28.9). The 6m PFS rate was 59% (90% CI, 44.8-71.4), and the primary endpoint was met. The median overall survival time was 23.5 months (95% CI, 11.6-35.4), and the median PFS was 6.8 months (95% CI, 5.4-9.1). The response rate was 54% and disease control rate was 92%. Nineteen patients (49%) received post-study treatment and 14 out of 19 patients (74%) received immunotherapy. Common toxicities of grade 3 or 4 were neutropenia (61.5%), anemia (46.2%), thrombocytopenia (17.9%), and febrile neutropenia (15.4%). There was no treatment-related death.
Conclusion
Combination chemotherapy of CBDCA plus weekly nab-PTX had a promising efficacy and acceptable toxicities in elderly (aged ≥75) patients with advanced Sq-NSCLC. Clinical trial information: UMIN000011216.
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