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Lei Deng



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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): Lei Deng

      • 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
    • Moderators:
    • Coordinates: 9/09/2019, 10:15 - 18:15, Exhibit Hall
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      P2.18-11 - Real-World Experience of Consolidation Durvalumab for Locally Advanced Non-Small Cell Lung Cancer (NSCLC)  (ID 1895)

      10:15 - 18:15  |  Author(s): Lei Deng

      • Abstract
      • Slides

      Background

      Durvalumab was recently approved as consolidation treatment following concurrent chemoradiation (CRT) in stage III NSCLC based on the positive PACIFIC trial demonstrating improved progression free survival (PFS) and overall survival (OS). Here, we examined the integration of durvalumab therapy after CRT in an urban comprehensive cancer care center serving a high proportion of Black and Hispanic patients. We aimed to examine treatment barriers in this diverse patient population and gain insights into real-world experience.

      Method

      Our study included patients treated with CRT for NSCLC (stage II-III) at Montefiore Medical Center (MMC) from 2007-2018. Retrospective analysis was conducted to evaluate patient characteristics, therapies and outcomes. Patients were grouped based on the PACIFIC trial eligibility criteria for durvalumab. PFS and OS were estimated using the Kaplan-Meier method, and comparisons between subgroups were made using log-rank testing, adjusted by Cox proportional hazards regression.

      Result

      146 patients completed CRT for locally advanced NSCLC from 2007 to 2018. 27% (n=40) would be considered ineligible for durvalumab based on the PACIFIC criteria (Table 1: reasons). Patient demographics were similar in ineligible vs. eligible groups: mean age 67.7 vs 67.9 years, male 57.6% vs 43.5%, Black 36.7% vs 43.5%, Hispanic 22.6% vs 30.1%. In the era of durvalumab therapy (since 9/2017), 68% (n=17) received durvalumab, including 4 patients that did not meet PACIFIC criteria due to co-morbidities and/or additional malignancy. The use of durvalumab therapy has increased with time in eligible patients from 33% in 9/2017-12/2017 to 100% in 10/2018-12/2018. The median time to initiate durvalumab following CRT has decreased from 56 days before 7/2018 to 30 days afterwards (p=0.02). Several eligible patients did not receive durvalumab due to questionable benefit in EGFR–mutant NSCLC (n=2), refusal of treatment (n=1), and unkown (n=1). Compared to patients who received durvalumab, patients who did not receive it were found to be of a lower socioeconomic status (p=0.086). Moreover, there was a trend toward improved 15-month OS rates in durvalumab-treated patients compared with patients who did not receive it (100% vs 87.5%, p=0.131).

      Table 1: Reasons for ineligibility based on PACIFIC criteria for durvalumab consolidation treatment
      Reasons for ineligibility N (%)
      Severe concurrent illness 13 (32%)
      Additional malignancy other than NSCLC 6 (15%)
      Not stage III 5 (12%)
      Progression after chemoRT 3 (7%)
      Persisting Grade 3 toxicity related to chemoRT 3 (7%)
      Incomplete chemoRT 2 (5%)
      Autoimmune disease 2 (5%)
      Recieved alternate study 2 (5%)
      Lost to follow up 2 (5%)
      Mixed small cell histology 1 (2%)
      Unknown 1 (2%)

      Conclusion

      Our results reveal more frequent use and improved time to initiate durvalumab following CRT, as well as promising initial survival data in a real world setting. A substantial proportion of patients would be ineligible as per PACIFIC criteria, yet several received durvalumab and remain disease controlled, suggesting that further investigation of durvalumab in this population is warranted.

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