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Yu Men



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    EP1.04 - Immuno-oncology (ID 194)

    • Event: WCLC 2019
    • Type: E-Poster Viewing in the Exhibit Hall
    • Track: Immuno-oncology
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/08/2019, 08:00 - 18:00, Exhibit Hall
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      EP1.04-09 - A Cross-Sectional Study of Clinical Trials on Radiotherapy Combined with Immunotherapy for Lung Cancer (ID 1292)

      08:00 - 18:00  |  Author(s): Yu Men

      • Abstract

      Background

      For patients with lung cancer, remarkable advances have been made in Immune-Oncology (IO) therapy, especially immune checkpoint inhibitors (ICI). However, multi-modality treatment is needed to improve the efficacy or enlarge the beneficial populations of IO treatment. This study is to comprehensively summarize and analyze the clinical trials focusing on radiotherapy (RT) combined with IO therapy, explore the trend of research, as well as provide a view of the latest landscape of combination strategies.

      Method

      Trials registered on the electronic database(https://clinicaltrials.gov)between Jan.2009 and Jan.2019 were searched using “Radiotherapy AND Immunotherapy | Recruiting, Not yet recruiting, Active, not recruiting, Completed, Enrolling by invitation Studies | Interventional Studies | Lung Cancer”. SPSS 20.0 was used to analyze the data.

      Result

      Totally 69 clinical trials of RT and IO combination therapy for lung cancer were recorded, including 54 active and 15 completed. Geographically, most of the trials were carried out in the USA (n=47, 68.1%), followed by the European countries (n=18, 26.1%). From timeline, the past 2 years has seen a soaring number of 40 clinical trials accounting for 58.0% of the total. The combination therapy trials were more often in non-small cell lung cancer (NSCLC) (n=52, 75.4%) than small cell lung cancer (SCLC) (n=10, 14.5%), with the remaining 7 trials unspecified. As for combination strategies, trials of tumor vaccine combined with RT were the most frequent before 2016. But at present, ICI has exceeded tumor vaccine in the combination with RT and makes up the absolute most (n=62, 89.9%). On the whole, most of the combination therapy trials are in phase I/II (n=64, 92.8%). Although most trials are set for advanced or metastatic cancers (n=43, 62.3%), there are a few exploring the safety and effectiveness of combination therapy for early stage cancers or as adjuvant therapy (n=9, 13.0%). One trial was set as neo-adjuvant therapy. As for RT details, 22 trials were SBRT combined with IO therapy. Two trials were exploring the optimal sequence of RT and IO therapy. And one trial is to compare high versus low dose RT in the combination with ICI in NSCLC.

      Conclusion

      From the trials of RT and IO combination therapy for lung cancer, those of ICI combined with RT are increasing rapidly, although most are in phase I/II. Further studies are needed to explore the more detailed rational combination strategies, such as the sequencing, fractionation and dose of RT, and the optimal IO agent.

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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): Yu Men

      • 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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    P2.18 - Treatment of Locoregional Disease - NSCLC (ID 191)

    • Event: WCLC 2019
    • Type: Poster Viewing in the Exhibit Hall
    • Track: Treatment of Locoregional Disease - NSCLC
    • Presentations: 1
    • Now Available
    • Moderators:
    • Coordinates: 9/09/2019, 10:15 - 18:15, Exhibit Hall
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      P2.18-05 - Patients with ypN2 NSCLC After Neoadjuvant Chemotherapy Followed by Surgery Can Benefit from PORT – A Retrospective Study of SEER Database (Now Available) (ID 2390)

      10:15 - 18:15  |  Author(s): Yu Men

      • Abstract
      • Slides

      Background

      Neoadjuvant chemotherapy followed by surgery (NCS) is a common therapy pattern of resectable non-small cell lung cancer (NSCLC). However, for patients with ypN2 disease after aforementioned treatment, there is no evidence that postoperative radiotherapy (PORT) should be adopted or not. Our study is to evaluate the effect of PORT on survival of patients with ypN2 NSCLC after NCS from Surveillance, Epidemiology, and End Results (SEER) database.

      Method

      We filtrated data from SEER database by the inclusion criteria of patients with NSCLC diagnosed at 2004-2015, treated with NCS, and with ypN2 disease (2004-2009 AJCC 6th, 2010-2015 AJCC 7th). We excluded patients with unclear basic information (such as sex, histology or cause of death), multiple primary malignant tumor and M1 disease. All data were analyzed using the SPSS Statistics (version 25) and propensity-score matched analysis was used to match the base-line characteristics between PORT group and non-PORT group. Kaplan-Meier method was used to estimate overall survival (OS) and cancer specific survival (CSS). Univariable and multivariable Cox proportional hazards models were adopted to estimate hazard ratios (HR) of predictors of survival.

      Result

      From 331 patients receiving NCS, 215 meeting the criteria were included in the final analysis. There were 112 patients (52.1%) with PORT. The baseline characteristics of majority were as follows: age≤65 (55.3%), white (82.3%), female (54.4%), grade 3-4 (63.3%), adenocarcinoma (60.0%), tumor size of 3-5 cm (38.6%), lobectomy (80.0%) and positive lymph nodes≥4 (51.2%). There were 200 patients remained after the prosperity score matching between the PORT group and the non-PORT group, with 100 cases in each. The median OS of the two groups were 36 months vs 26 months and 5-year OS rates were 36.2% vs 20.3%, respectively (P=0.011). The median CSS were 36 months versus 27 months and 5-year CSS were 38.5% vs 21.1%, respectively (P=0.010). Univariable analysis showed that only PORT significantly improved OS (HR=0.648, P=0.013) and CSS (HR=0.639, P=0.012). Multivariable analysis confirmed that PORT was the only significant predictor of OS (HR=0.615, P=0.011) and CSS (HR=0.614, P=0.013).

      Conclusion

      For patients with ypN2 NSCLC after NCS, PORT can significantly improve the OS and CSS . However, the result needs to be clarified by prospective randomized clinical trials.

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