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Young Mog Shim
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MA08 - Pawing the Way to Improve Outcomes in Stage III NSCLC (ID 127)
- Event: WCLC 2019
- Type: Mini Oral Session
- Track: Treatment of Locoregional Disease - NSCLC
- Presentations: 1
- Now Available
- Moderators:Simon Ekman, Helena A Yu
- Coordinates: 9/08/2019, 15:15 - 16:45, Tokyo (1982)
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MA08.03 - Adjuvant Pembrolizumab in N2 Positive NSCLC Treated with Concurrent Chemoradiotherapy Followed by Surgery: Phase II, Prospective Study (Now Available) (ID 1744)
15:15 - 16:45 | Author(s): Young Mog Shim
- Abstract
- Presentation
Background
The standard treatment option for stage IIIA-N2 subgroup is still under discussion with controversies. We hypothesize that immune checkpoint inhibitor consolidation therapy could have an additional role in prolongation of the disease-free survival (DFS) for stage IIIA-N2 NSCLC treated with tri-modalities therapy.
Method
This is a phase 2 study evaluating the clinical efficacy of pembrolizumab treatment after CCRT with curative resection in stage IIIA-N2 NSCLC pts (NCT03053856). Pathologically confirmed pts were treated with five cycles of CCRT, weekly paclitaxel (50mg/m2) and cisplatin (25mg/m2) combined with radiotherapy (total of 44Gy over 22 fractions) followed by curative resection. Adjuvant Pembrolizumab (200mg fixed dose) is applied every three weeks up to 2 years or until disease recurrence. The primary objective is disease-free survival of more than 20 months. The first patient was recruited in October 2017, and the data for this abstract was locked at 20th of January, 2019.
Result
Total of 40 pts were screened, and 37 pts received treatment. Median age was 64 years (range 39-74), and twenty-three pts were male (62.2%). As a curative surgery, pts received lobectomy (n=34), bi-lobectomy (n=2), or pneumonectomy (n=1). Adenocarcinoma was predominant (n=27, 73.0%). After the neoadjuvant CCRT, down-staging were observed in nine pts (24.3%). The median follow-up duration was 10.6 months (range 3.1-17.2), and pts received a median of 11 cycles (range 1-22) of adjuvant pembrolizumab. DFS is not reached. Fourteen patients discontinued treatment due to disease progression (n=9), adverse events (n=4) and withdraw consent (n=1). There was a case of grade 4 pneumonitis and a case of grade 3 autoimmune hepatitis which lead to discontinuation of the treatment. Otherwise, grade 1-2 hypothyroidism (n=6), pneumonitis (n=5), skin rash (n=3) were observed. Patients with severe immune-related adverse event showed a significantly high percentage of Ki-67 + cells among CD8 T-cells in peripheral blood.
Conclusion
This study is the first study to demonstrate the feasibility of adjuvant pembrolizumab monotherapy in stage IIIA-N2 patients. Updated clinical outcome will be presented at the conference.
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P1.18 - Treatment of Locoregional Disease - NSCLC (ID 190)
- Event: WCLC 2019
- Type: Poster Viewing in the Exhibit Hall
- Track: Treatment of Locoregional Disease - NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 9/08/2019, 09:45 - 18:00, Exhibit Hall
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P1.18-24 - Neoadjuvant Therapy versus Upfront Surgery for NSCLC Patients with Clinically Suspected Subaortic or Paraaortic Lymph Nodes (ID 2568)
09:45 - 18:00 | Author(s): Young Mog Shim
- Abstract
Background
Subaortic lymph nodes (#LN5) and para-aortic lymph nodes (#LN6) cannot be accessed by routine mediastinoscopy and E(B)US-FNA but need additional invasive surgical staging methods such as VATS or anterior mediastinotomy. Therefore, a considerable number of patients with suspected #LN5 or #LN6 receive multimodal treatment or, upfront surgery based on imaging staging only. We investigated survival outcomes of each therapeutic strategy.
Method
An institutional lung cancer database of consecutive patients between 2007 and 2016 (N=134) was reviewed retrospectively. Eligible patients had pathologically confirmed non-small cell lung cancer with clinically suspected #LN5 or #LN6 involvement by CT or PET-CT without clinical or pathological evidence of other N2 station involvement. Excluded are those with involvement of other N2 stations, unexpected N2, low grade malignancy, and prior history of cancer. Patients in group 1 received neoadjuvant therapy followed by surgery (n=68) and those in group 2 underwent upfront surgery (n=66).
Result
Group 1 consisted of patients with clinically suspected (n=39, 57%), and biopsy-proven #LN5 or #LN6 (n=29, 43%) by VATS (n=19), anterior mediastinotomy (n=6), or EUS-FNA (n=4). They received preoperative chemoradiation (n=62, 91%) and the rest received chemotherapy (n=6, 9%). Nodal down-staging was occurred in 36 (53%) patients whereas persistent N2 in 32 (47%). On the contrary, group 2 consisted of patients with clinically suspected #LN5 or 6 (n=66). After surgery, 30 (45%) patients were confirmed to have pathologic N0 or N1. The rest 36 (55%) patients were confirmed pathologic N2, and 29 (81%) of them received adjuvant therapy: chemoradiation in 23, and chemotherapy in 6. Overall survival rate at 5-year (5YOS) were 50.5% in group 1 versus 58.9% in group 2 (p=0.55); recurrence-free survival at 5-year (5YRFS) was 42.2% versus 46.7% (p=0.98), respectively. In subgroup, the 5YOS were 44.6% in pathologic N2 in group 2, which were similar to persistent N2 (52.8%, p=0.6), down-staged (49.2%, p=0.89), or biopsy-proven N2 (57.8%, p=0.54) in group 1. The 5YRFS were 26.7% in pathologic N2 in group 2, which were similar to persistent N2 (30.3%, p=0.89) and biopsy-proven N2 (43.9%, p=0.15), but lower than down-staged (53%, p=0.03) in group 1.
Conclusion
Upfront surgery or omission of invasive mediastinal staging for #LN5 or 6 may not compromise survival outcomes. Each therapeutic strategy is effective in terms of oncologic outcomes.
