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Shugeng Gao



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    JCSE01 - Joint IASLC-CSCO-CAALC Session (ID 63)

    • Event: WCLC 2019
    • Type: Joint IASLC-CSCO-CAALC Session
    • Track:
    • Presentations: 1
    • Now Available
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      JCSE01.10 - Efficacy and Safety of Neoadjuvant PD-1 Blockade with Sintilimab in Resectable Non-Small Cell Lung Cancer (Now Available) (ID 3424)

      07:00 - 11:15  |  Author(s): Shugeng Gao

      • Abstract
      • Presentation
      • Slides

      Abstract
      Background
      NSCLC patients who have potentially resectable disease often subsequently relapse after surgery. New therapy that prevents relapse after surgery is desperately needed. In this study, we tested the efficacy and safety of neoadjuvant sintilimab, an anti-PD-1 antibody, for patients with resectable sqNSCLC in China.

      Methods
      All patients had treatment-naïve resectable sqNSCLC (stage IB-IIIA) that was confirmed by histopathology. Patients received two cycles of sintilimab (200 mg IV) on Day 1 and 22. Surgery was performed between Day 29-43. An enhanced PET/CT was obtained at baseline and seven days prior to surgery. Preliminary analysis of safety profile and efficacy was planned after at least 20 patients had received operation.

      Results
      As of Jan. 28, 2019, 22 patients (20 males and 2 females) with sqNSCLC received two doses of sintilimab followed by radical resection. The median age was 61.5 yr (range, 48 to 70). Six (27.3%) and four (18.2%) patients experienced neoadjuvant treatment emergent adverse events (TEAEs) and neoadjuvant treatment-related AEs (TRAEs), respectively. Most of the TEAEs and TRAEs were grade 1 or 2. Three patients achieved radiological partial response: an ORR of 13.6% based on RECIST 1.1. Ten patients (45.5%) achieved a major pathologic response (MPR, ≤10% viable tumor cells), including four (18.2%) had complete pathologic response (no viable tumor cell). There was a direct correlation between pathological response and decrease in the standardized uptake values (SUV) in the primary tumor. Among nine patients with > 30% decrease of SUV, eight had MPR, compared with no MRP response in the 11 patients with ≤30% decrease of SUV.

      Conclusion
      Neoadjuvant sintilimab for sqNSCLC patients was tolerable and the 45.5% MRP rate is encouraging. A decrease in SUV may be predictive of pathologic response after PD-1 therapy in sqNSCLC.

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    OA12 - Profiling the Multidisciplinary Management of Stage III NSCLC (ID 144)

    • Event: WCLC 2019
    • Type: Oral Session
    • Track: Treatment of Locoregional Disease - NSCLC
    • Presentations: 1
    • Now Available
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      OA12.06 - A Prospective Randomized Phase Ⅲ Study of Precise PORT for Patients with pⅢA-N2 NSCLC After Complete Resection and Adjuvant Chemotherapy (Now Available) (ID 2487)

      15:45 - 17:15  |  Author(s): Shugeng Gao

      • Abstract
      • Presentation
      • Slides

      Background

      For patients with completely resected pⅢA-N2 non-small cell lung cancer (NSCLC), the role of postoperative radiotherapy (PORT) is not well defined. 3D-conformal or simplified intensity modulated radiotherapy (3D-CRT/sIMRT) can precisely deliver high dose to the target volume while decreasing the toxicity of normal tissues, which may improve the treatment outcomes. This phase III randomized clinical trial (NCT00880971) is designed to evaluate the effect of precise PORT on survival and failure pattern in patients with pⅢA-N2 NSCLC after complete resection and adjuvant chemotherapy.

      Method

      After complete resection and four cycles of platinum based chemotherapy, patients with pⅢA-N2 NSCLC were randomized equally into PORT group or observation group. Using 3D-CRT/sIMRT techniques, PORT of 50 Gy by 25 fractions was given to the ipsilateral hilum, subcarinal region and ipsilateral mediastinum. The primary endpoint was disease free survival (DFS). Secondary endpoints include overall survival (OS), loco-regional recurrence free survival (LRFS), distant metastasis free survival (DMFS) and toxicity. Targeted accrue was 360 patients. With at least 230 DFS events it was designed to detect an improvement in 3-year DFS from 30% to 44% (equivalent to HR=0.69) at 1-sided type 1 error of 0.025 with 80% power. Intent-to-treat populations is used for primary analyses, supplemented with sensitivity analyses using per-protocol population. Log-rank test is used for time-to-event data comparisons.

      Result

      Between Jan. 2009 and Dec. 2017, 364 consecutive eligible patients were randomized, including 184 in the PORT group and 180 in the observation group. For this initial reporting of planned final analysis, as Jan 31, 2019, 230 DFS events were reported and the median follow up time was 53.3 months. The clinical features were comparable between the two groups. The 3-year DFS rates in PORT and observation were 42.7% vs. 34.5% (mDFS: 26.5 vs 22.7 months, HR=0.85, 95% CI: 0.65-1.10, 1-sided p=0.10), with OS of 81.5% vs. 85.4% (mOS: not reached vs 90.9 months, HR=1.01, 95% CI: 0.68-1.51, 2-sided p=0.94), LRFS of 69.8% vs. 62.4% (HR=0.71, 95% CI: 0.51-0.97, 2-sided p=0.03), and DMFS of 44.8% vs. 43.5% (HR=0.93, 95% CI 0.71-1.22, 2-sided p=0.60), respectively. For 310 per-protocol patients (140 with PORT and 170 without PORT), PORT marginally improve the DFS (44.8% vs 32.6%, HR=0.76, 95% CI: 0.57-1.00, 2-sided p=0.05), but not OS (85.7% vs 85.0%, HR=0.83, 95% CI: 0.53-1.30, p=0.41). Relapses of any type were observed in 110 (59.8%) and 116 patients (64.4%) in the PORT and observation groups, respectively. Forty-seven over 50 deaths (94.0%) in the PORT group and 42 over 47 deaths (89.4%) in the observation group died of cancer progression, respectively. No radiotherapy-related grade 5 AE was observed.

      Conclusion

      For pⅢA-N2 NSCLC patients after complete resection and adjuvant chemotherapy, precise PORT has not been shown to significantly improve DFS or OS , though it can significantly improve LRFS.

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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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      P1.18-06 - Efficacy and Safety of Neoadjuvant PD-1 Blockade with Sintilimab in Resectable Non-Small Cell Lung Cancer (ID 2999)

      09:45 - 18:00  |  Author(s): Shugeng Gao

      • Abstract
      • Slides

      Background

      Non-small cell lung cancer (NSCLC) patients with potentially resectable disease most would experience relapse after surgery. New strategy preventing recurrence is in urgent need. In the current study, we first evaluated the safety and efficacy of neoadjuvant sintilimab in Chinese patients with resectable NSCLC.

      Method

      Patients with treatment-naïve resectable NSCLC (stage IB-IIIA) received two cycles of sintilimab (200 mg IV) on Day 1 and 22. Surgery was performed between Day 29-43. The tumor imaginations were obtained at baseline and within seven days prior to surgery. The primary endpoint was safety, and efficacy endpoints include disease free survival, rate of major pathologic response (MPR, ≤10% viable tumor cells) and objective response rate (ORR). Expression of programmed death ligand 1 (PD-L1) in baseline biopsy tissues and surgical samples were investigated. (Registration Number: ChiCTR-OIC-17013726).

      Result

      A total of 40 patients with NSCLC were enrolled, among which 32 (80%) were male; 33 (82.5%) had squamous-cell carcinoma; 35 (87.5%) had stage IIA to IIIB disease; and 33 (82.5%) were former or current smokers. As of June 15th, 2019, all of the patients received 2 doses of sintilimab, and 37 patients underwent radical resection. Among 40 patients, 18 (45%) patients experienced neoadjuvant treatment-related adverse events (TRAEs). Two (5%) patient experienced grade 3-4 neoadjuvant TRAE. One treatment related surgery delay was reported because of grade 1 hyperthyroidism. None of the patients has confirmed recurrence to date. Among 37 patients, 8 patients achieved radiological partial response (PR), resulted in an ORR of 21.6% regarding RECIST 1.1. Fifteen (40.5%) patients achieved MPR, and 6 (16.2%) patients had complete pathologic response (cPR) (Figure 1). There’s no correlation between baseline characteristics and MPR (Table 1). Maximum standardized uptake values (SUVmax) reduction of primary tumor after sintilimab treatment was significantly corelated with pathological response (correlation coefficient = 0.86, p <0.00001). However, there was no significant correlation between decrease in sum of lesion diameter (SLD) and pathological response (correlation coefficient = 0.21, p = 0.2104). Squamous cell carcinoma showed a better MPR (15/33, 45.5%) compared with adenocarcinoma (0/6 0%). Baseline PD-L1 expression of stromal cells was correlated with pathological regression (p= 0.0471). In 18 patients with post-surgery pathologically positive lymph nodes, heterogeneity of response between primary tumor and lymph nodes were found by comparing MPR, change of SUVmax and SLD.

      Conclusion

      Neoadjuvant sintilimab for Chinese NSCLC patients was well tolerated and the 40.5% MRP rate is encouraging. A SUVmax reduction may be more predictive of pathologic response than decrease in SLD after neoadjuvant PD-1 therapy in NSCLC. Heterogeneity exists between primary tumor and lymph nodes.

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