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Sung Yong Lee
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P1.13 - Radiology/Staging/Screening (ID 699)
- Event: WCLC 2017
- Type: Poster Session with Presenters Present
- Track: Radiology/Staging/Screening
- Presentations: 1
- Moderators:
- Coordinates: 10/16/2017, 09:30 - 16:00, Exhibit Hall (Hall B + C)
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P1.13-006 - The Value of F-18 FDG PET/CT-guided EBUS-TBNA in Nodal Staging of NSCLC. (ID 8587)
09:30 - 16:00 | Presenting Author(s): Sung Yong Lee
- Abstract
Background:
Mediastinal lymph node staging in NSCLC is crucial to set treatment options. But correct nodal staging is also challenging, especially, in regions of endemic for granulomatous diseases. The purpose of the study is to evaluate the value of PET-guided EBUS-TBNA and the efficacy of PET/CT for prediction of cytopathological results of lymph node staging in NSCLC.
Method:
38 patients who underwent F-18 FDG PET/CT for initial staging of NSCLC and subsequent mediastinal node staging by EBUS-TBNA for clarification of the hilar,mediastinal nodes between Sep.2013 and Jul.2014 were retrospectively reviewed. The clinical nodal staging with PET/CT were correlated with cytopathological results after TBNA. Overall sensitivity, specificity, PPV, NPV,and accuracy were evaluated.
Result:
From 38 PET scans, total 112 thoracic lymph node stations had noticeable focal hypermetabolisms.82 FDG avid stations were suspected to have metastasis,16 stations were considered as inflammatory nodes,and 14 stations were reported as equivocal findings. The majority of the primary lung pathology which showed equivocal nodal PET findings were adenocarcinoma (9/14). Total 58 thoracic lymph nodes (PET positive 38, PET negative 12, and equivocal PET finding in 8 nodes, respectively) were aspirated in 38 patients. Malignancy was detected in 39 (67.2%) out of 58 lymph nodes. (Figure 1. flow chart)Figure 1 2 patients up-staged from N1 to N2,1 patient up-staged from N2 to N3,and 1 patient down-staged from N3 to N2 after PET-guided EBUS-TBNA. From 8 lymph nodes that showed equivocal PET finding,6 were enlarged and showed heterogenous hypoechogenicity on EBUS.4 node of those were proved to be cytologically metastatic lymph nodes. The sensitivity, specificity, PPV, NPV and diagnostic accuracy of PET-guided EBUS-TBNA on a node-based analysis was 94.9%, 63.2%, 84.1%, 85.8%, and 84.5%, respectively when we combined EBUS findings with PET.
Conclusion:
PET-guide EBUS-TBNA offers an effective, accurate, and minimally invasive strategy for evaluating lymph node staging in NSCLC.
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P2.01 - Advanced NSCLC (ID 618)
- Event: WCLC 2017
- Type: Poster Session with Presenters Present
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 10/17/2017, 09:00 - 16:00, Exhibit Hall (Hall B + C)
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P2.01-035 - Phase II Study: Weekly Docetaxel as First Line Chemotherapy for Elderly Patients with Squamous-Cell Non-Small-Cell Lung Cancer (ID 9329)
09:00 - 16:00 | Author(s): Sung Yong Lee
- Abstract
Background:
Docetaxel monotherapy is one of the standard treatments for non-small-cell lung cancer in elderly patients. Docetaxel is usually administered as a 3-week schedule, yet there is significant toxicity with this therapy. There is increasing interest in Docetaxel weekly schedule to reduce its toxicity. In this phase II clinical study, we investigate the efficacy and safety of a weekly schedule of docetaxel monotherapy in a first-line chemotherapy for advanced squamous-cell non-small-cell lung cancer in elderly patients.
Method:
Patients with stage IIIb, or stage IV squamous-cell non-small-cell lung cancer aged 65 years or older who had not previously received cytotoxic chemotherapy were enrolled. Patients received docetaxel 25 mg/m2 days 1, 8, and 15, every 4 weeks. The primary endpoint of this study was objective response rate (ORR). Secondary endpoints were progression-free survival (PFS), overall survival (OS), and toxicity profile.
Result:
The patient characteristics are showed in table below. Among 12 eligible patients, the ORR was 0%, (5 patients were confirmed with stable disease, 7 patients were progressive disease. Median OS and PFS were each days and days. There were 3 adverse event of grade 3/4 (2 were dizziness and 1 was diarrhea). Neutropenia was reported on only 1 patients and was grade 1.Patient Characteristics
Age (years) 78.16 ± 4.72 Sex (male / female) 18 / 1 Stage IIIB (%) 6 (31.58) IV (%) 13 (68.42) Performance Status 0-1 (%) 15 (78.95) 2 (%) 4 (21.05) Smoking Never (%) 1 (5.26) Former (%) 13 (68.42) Current (%) 5 (26.32) Amounts (pack years) 49.05 ± 28.22 FEV1 (mL) 1.53 ± 0.53
Conclusion:
Our data failed to demonstrate the efficacy of docetaxel weekly regimen. Because our patients were mostly elderly and of poor general conditions, our result might show poor overall response rate. However, the incidence of side effects include neutropenia was lower than docetaxel 3-week regimen as previous reported. Further larger studies are need to confirm the efficacy and safety of docetaxel weekly regimen.
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P3.01 - Advanced NSCLC (ID 621)
- Event: WCLC 2017
- Type: Poster Session with Presenters Present
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 10/18/2017, 09:30 - 16:00, Exhibit Hall (Hall B + C)
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P3.01-050 - A Real World Treatment Study of Osimertinib: ASTRIS Study Korean Subgroup Analysis (ID 9678)
09:30 - 16:00 | Author(s): Sung Yong Lee
- Abstract
Background:
ASTRIS (NCT02474355) is an open-label, single-arm, multination, real world treatment study, investigating the safety and efficacy of osimertinib in patients with T790M-positive advanced non-small cell lung cancer (NSCLC), who have previously received EGFR-TKI. We report the first results of Korean subset from ASTRIS which is the largest real world treatment study of osimertinib to date.
Method:
Eligible patients had advanced NSCLC harbouring a T790M mutation determined by local validated molecular tests, received prior EGFR-TKI therapy, acceptable organ and bone marrow function and no history of interstitial lung disease (ILD) or QTc prolongation. Enrollment of patients with asymptomatic, stable CNS metastases were permitted. Patients received osimertinib 80 mg once daily. The primary efficacy outcome was overall survival; other outcomes included investigator-assessed response rate (RR), progression-free survival (PFS) and time to treatment discontinuation (TTD). Safety assessment was also conducted. Data cut-off (DCO) was 3 November 2016; results from 1,217 patients in the global study have been presented previously (ASCO 2017 Abstract 9036).
Result:
A total of 371 patients received at least one dose of osimertinib from 30 Korean sites (full analysis set); at DCO, 319 patients (81.4%) were ongoing and median follow-up time was of 3.1 (0–8) months. Baseline patients’ characteristics were median age 61.1 (27–85) years old, female 65.5%, PS 0/1 88%, prior chemotherapy 47%, prior radiotherapy 48%. Tissue was the most common specimen source to test T790M mutation as well as other EGFR mutations (287/371, 77.4%) and plasma was the next (39/371, 13.1%). Fifty two patients (13.3%) had discontinued treatment; median duration of exposure 3.3 (0–7) months, 30 pts (7.7%) had disease progression and 24 patients (6.5%) died. In patients evaluable for response, defined as at least one dose of osimertinib and one response assessment, the investigator-assessed RR was 72.1% (212/294; 95% CI 66.6 – 77.2). Due to limited follow-up period, OS, PFS, and TTD were immature to analyze. Adverse events (AEs) leading to dose modification and treatment discontinuation were reported in 26 patients (7%) and 14 patients (3.8%), respectively. Serious AEs were reported in 50 patients (13.5%) and AEs leading to death in 8 patients (2.2%). ILD/pneumonitis-like events were reported in 9 patients (2.4%), and QTc prolongation (>470ms) in 5 patients (1.3%).
Conclusion:
At DCO for the 1[st] interim analysis of ASTRIS, Korean subgroup results demonstrated similar clinical activities (RR) to that observed in the osimertinib clinical trial program with no new safety signals.
