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Jaeho Cho



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    FP03 - Immuno-biology and Novel Immunotherapeutics (Phase I and Translational) (ID 151)

    • Event: WCLC 2020
    • Type: Posters (Featured)
    • Track: Immuno-biology and Novel Immunotherapeutics (Phase I and Translational)
    • Presentations: 1
    • Moderators:
    • Coordinates: 1/28/2021, 00:00 - 00:00, ePoster Hall
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      FP03.02 - Interim Analysis of Neoadjuvant Chemoradiotherapy and Durvalumab for Potentially Resectable Stage III Non-Small Cell Lung Cancer (NSCLC) (ID 804)

      00:00 - 00:00  |  Author(s): Jaeho Cho

      • Abstract
      • Presentation
      • Slides

      Introduction

      Although definitive concurrent chemoradiotherapy (CRT) is considered standard of care for most stage III NSCLC patients, neoadjuvant-CRT (N-CRT) followed by surgery is an accepted practice with a potential survival benefit. Regarding synergistic effects of combining PD-1/PD-L1 blockade to CRT, we designed a two-stage phase Ib trial (ACTS-30) which assesses the safety and feasibility of the combination of N-CRT with durvalumab (PD-L1 inhibitor) in potentially resectable stage III NSCLC (ClinicalTrials.gov identifier: NCT03694236).

      Methods

      Patients with histologically confirmed, potentially resectable stage III NSCLC were eligible. N-CRT comprised intravenous weekly paclitaxel 45 mg/m2 and carboplatin AUC 2 with radiotherapy of 45 Gy in 25 fractions and durvalumab (Day 1 and 29, 1500mg) during 5 weeks and patients who completed N-CRT subsequently underwent surgery. After surgery, one year of adjuvant durvalumab was planned (every 4 weeks, 1500 mg). The primary objective was to determine the safety and tolerability of N-CRT + durvalumab regimen. The trial was composed of two-stages and the first stage included 9 patients and the trial was planned to proceed to the second stage (n = 21) if treatment-related adverse events (TRAEs) grade≥3 occurred in less than 50% of patients. The secondary endpoints are objective response rate (ORR), R0 resection rate, event-free survival (EFS), overall survival (OS), clinical or pathological downstaging rate, pathologic complete response (pCR) rate, and major pathologic response (MPR) rate. The exploratory analyses including immune marker assessment by FACS, whole-exome sequencing, single-cell RNA sequencing, and multispectral immunohistochemical staining using the specimen of pre-treatment, after surgery, and after recurrence will be performed.

      Results

      At the data cut-off (25th-Feb-2020), a total of 14 patients were enrolled. The median age was 66; 50% were male, and 50% were adenocarcinoma histology including two EGFR mutations. Since there was only one grade 3 TRAE (i.e., neutropenia) during the first stage, the trial entered the second stage. Overall, the grade 3 or more rate of TRAE was 7% (1/14). Currently, 11 patients underwent surgery (R0 resection) while one patient experienced cardiac pacemaker infection grade 3 (not considered as TRAE) and was not able to undergo surgical resection and two others are awaiting surgery. There was no postoperative in-hospital mortality. Among eleven resected patients, the pCR rate and MPR rate were 36.4% (3/11) and 72.7% (8/11), respectively. When excluding two EGFR mutant, the MPR rate was 88.9% (8/9).

      Conclusion

      These early data suggested that the N-CRT regimen with immunotherapy in stage III NSCLC was safe and feasible and had the potential to provide clinical benefit. The trial is ongoing and the final results and the biomarker analyses will be provided in the future congress and scientific journal.

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    P05 - Early Stage/Localized Disease - Radiotherapy (ID 114)

    • Event: WCLC 2020
    • Type: Posters
    • Track: Early Stage/Localized Disease
    • Presentations: 1
    • Moderators:
    • Coordinates: 1/28/2021, 00:00 - 00:00, ePoster Hall
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      P05.01 - Multicenter Retrospective Study of Stereotactic Body Radiotherapy in Non-Small Cell Lung Cancer in South Korea (KROG 17-09) (ID 2033)

      00:00 - 00:00  |  Author(s): Jaeho Cho

      • Abstract
      • Slides

      Introduction

      Korean radiation oncology group conducted a multicenter retrospective study to evaluate the clinical outcomes of stereotactic body radiotherapy (SBRT) in patients with early stage non-small cell lung cancer (NSCLC) (KROG 17-09).

      Methods

      From 10 major academic centers, a total of 234 patients with newly diagnosed T1-2N0M0 NSCLC patients from 2005 to 2014 were included. Most were diagnosed pathologically (N=213, 91.0%). Seventeen patients (7.3%) were confirmed as N0 using pathologic mediastinal lymph node evaluation, while the others (92.7%) were confirmed as N0 radiologically. The patients who received additional surgery or systemic therapy were excluded. Various SBRT schedules were used in each center. The median radiation dose and fraction size were 60 Gy (range, 40-70 Gy) and 12 Gy (range, 5-20 Gy), respectively. The representative dose schedules are as follows; 60 Gy/4 fractions, 60 Gy/5 fractions, 48 Gy/4 fractions and 54 Gy/3 fractions in 67 (28.6%), 40 (17.1%), 31 (13.2%) and 16 (6.8%) patients, respectively. Disease failures were categorized as local, regional, and distant, defined as the evidence of progressive soft tissue abnormalities, any intrathoracic lymph node recurrence, and contralateral or extra-thoracic failure, respectively.

      Results

      The median age was 76.5 years (range, 44-91 years), and the majority were male (N=180, 76.9%). While 152 patients (65.0%) had an ECOG performance status of 0 to 1, 82 (35.0%) had an ECOG of 2 to 3, and 120 (51.3%) had underlying lung disease. The median tumor size was 25 mm (range, 7-58 mm), and 154 patients (65.8%) were T1 according to 7th AJCC staging system. After the median follow-up of 28.5 months, 84 patients (35.9%) had disease failure; local failure in 39 (16.7%), regional failure in 27 (11.5%) and distant failure in 52 (22.2%). Among 39 local failures, 29 (12.4%) were in-field/marginal failures, and the other 10 (4.3%) were out-field failures at the same lobe. The 3-year primary tumor control, local control, regional control and distant control was 85.5%, 79.9%, 83.3% and 75.3%, respectively. The 3-year overall survival, cancer-specific survival and disease-free survival was 54.1%, 66.9% and 43.2%, respectively. Grade ≥3 treatment-related toxicities were reported in 16 patients (6.9%).

      Conclusion

      In this study, we were able to report the characteristics and clinical outcomes of SBRT in patients with early stage NSCLC in South Korea. We could confirm that the SBRT is a relatively safe and effective treatment modality. The results would be a meaningful reference to set future research directions.

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