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Chen Hu



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    MA05 - Improving Outcomes in Locoregional NSCLC II (ID 901)

    • Event: WCLC 2018
    • Type: Mini Oral Abstract Session
    • Track: Treatment of Locoregional Disease - NSCLC
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/24/2018, 13:30 - 15:00, Room 105
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      MA05.09 - PFS and Cardiac-Toxicity-Adjusted-PFS As Predictors of OS in Locally Advanced NSCLC Treated with Concurrent Chemoradiation (ID 12391)

      14:30 - 14:35  |  Presenting Author(s): Chen Hu

      • Abstract
      • Presentation
      • Slides

      Background

      Overall survival (OS) is the gold standard for LA-NSCLC with chemoradiation (CCRT), while the complex relationships among RT dosimetry, systemic therapies, cardiopulmonary toxicity, progression (PD) and OS are also of increasing scientific and clinical interest.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      NRG Oncology RTOG 0617 (NCT00533949) was a randomized phase 3 trial comparing standard (SD, 60 Gy) versus high-dose (HD, 74 Gy) CCRT +/- cetuximab from 11/07-06/11. This secondary analysis includes 469 patients (pts) given ≥50 Gy. A PFS event was defined as the first occurrence of local, regional, distant PD or death w/o documented PD. A CTA-PFS event was the first occurrence of grade 2+ treatment-related cardiac toxicity event or a PFS event. Landmark analyses at 6mo and 12mo were used to minimize the immortal time bias. Cox model with PD or CT/PD as a time-dependent covariate was used to evaluate their predictive roles. Median f/u time for surviving pts was 5.1 years.

      4c3880bb027f159e801041b1021e88e8 Result

      As previously reported, pts treated with HD had significantly lower OS rates (HR=1.28, 95%CI: 1.04-1.58, p=0.018) and CTA-PFS rates (HR=1.24, 95%CI: 1.02-1.51, p=0.035), and marginally lower PFS rates (HR=1.21, 95%CI: 0.99-1.47, p=0.06) than pts treated with SD. Median survival time (MST) among pts having PD within 6mo versus not were 13.4mo (95%CI: 10.0-19.0mo) and 30.7mo (95%CI: 28.0-37.0mo) (p<0.001). MST for pts having PD within 12mo versus not were 20.6mo (95%CI: 18.8-25.0mo) and 60mo (95%CI: 47.6-74.5mo)(p<0.001). Results are similar when using CTA-PFS with 6mo or 12mo cutoff (p<0.001). RT dose was no longer significantly associated with OS (p=0.08 or p=0.15) when PD or CT/PD was included in multivariable analysis (p<0.001), suggesting OS differences in HD/SD may be partially captured by PFS or CTA-PFS.

      8eea62084ca7e541d918e823422bd82e Conclusion

      Long-term survival results from RTOG 0617 suggest that PFS (or CTA-PFS) status at 6mo or 12mo predicts long-term OS, and may potentially be considered as a surrogate endpoint of OS in clinical trials. Pts who were progression-free at 12mo had a MST of 5 years. Further validation on external datasets and in the modern era of immunotherapy are needed.

      Funding: This project was supported by grants NCORP (UG1CA189867), NRG Operations (U10CA180868), NRG SDMC (U10CA180822), IROC (U24CA180803), and CTEP from the National Cancer Institute (NCI).

      6f8b794f3246b0c1e1780bb4d4d5dc53

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    OA01 - Improving Outcomes in Locoregional NSCLC I (ID 892)

    • Event: WCLC 2018
    • Type: Oral Abstract Session
    • Track: Treatment of Locoregional Disease - NSCLC
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/24/2018, 10:30 - 12:00, Room 107
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      OA01.01 - 10-Year Updated Analysis of NRG Oncology/RTOG 0214: A Phase III Comparison of PCI vs. Observation in Patients with LA-NSCLC. (ID 14189)

      10:30 - 10:40  |  Author(s): Chen Hu

      • Abstract
      • Presentation
      • Slides

      Background

      To determine if prophylactic cranial irradiation (PCI) improves survival in locally advanced non–small-cell lung cancer (LA-NSCLC), we conducted a prospective randomized phase III trial. Previously we reported that compared to observation, PCI significantly increased disease-free survival and reduced brain metastases. With extended follow-up, we sought to determine whether PCI conferred an overall survival benefit.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      Patients with stage III NSCLC without disease progression after treatment with surgery and/or radiation therapy (RT) with or without chemotherapy were eligible. Participants were stratified by stage (IIIA v IIIB), histology (nonsquamous v squamous), and therapy (surgery v none) and were randomly assigned to PCI or observation. PCI was delivered to 30 Gy in 15 fractions. The primary end point of the study was overall survival (OS). Secondary end points were disease-free survival (DFS), neurocognitive function (NCF), and quality of life. Kaplan-Meier and log-rank analyses were used for OS and DFS. The incidence of brain metastasis (BM) was evaluated with the logistic regression model.

      4c3880bb027f159e801041b1021e88e8 Result

      Among 356 patients entered to this study, 340 are eligible for analysis. The median follow-up time was 2.1 years for all patients, and 9.2 years for living patients. The survival estimates and hazard ratio indicate that there appears to be no improvement in survival with the use of PCI (p=0.12, HR=1.23, 95% CI: 0.95-1.59). Of note, with the current data there is only 45% power to detect the hypothesized difference HR=1.25 at 1-sided significance level of 0.025. The DFS estimates are better in the PCI arm (p=0.03, HR=1.32, 95% CI: 1.03-1.69). Patients in the observation arm were 2.33 times more likely to develop BM than those in the PCI arm (p= 0.004). On multivariate analysis PCI was significantly associated with decreased BM and improved DFS, but not OS. However, among the 225 non-surgical patients, use of PCI was associated with higher OS (p=0.026, HR=1.42, 95% CI: 1.04-1.94) and DFS (p=0.014), and lower BM (p=0.003). NCF was previously published (Sun, JCO 2011 and Gondi, IJROBP 2013), however, with longer follow-up, there is insufficient data for further analysis.

      8eea62084ca7e541d918e823422bd82e Conclusion

      In this 10-year updated analysis, use of PCI continued to significantly improve DFS and reduce brain metastases. However, the early accrual closure failed to provide adequate power to detect the hypothesized difference in OS and the survival rates were not significantly different between PCI and observation. Subgroup analyses based on stratification factors suggest that PCI may improve survival among non-surgical patients.

      6f8b794f3246b0c1e1780bb4d4d5dc53

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    P2.01 - Advanced NSCLC (Not CME Accredited Session) (ID 950)

    • Event: WCLC 2018
    • Type: Poster Viewing in the Exhibit Hall
    • Track:
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/25/2018, 16:45 - 18:00, Exhibit Hall
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      P2.01-103 - Neutrophil-to-Lymphocyte Ratio as a Predictor of Immunotherapy Treatment Outcomes in Advanced Non-Small Lung Cancer (ID 12633)

      16:45 - 18:00  |  Author(s): Chen Hu

      • Abstract
      • Slides

      Background

      Immune checkpoint inhibitors (ICIs) are a new class of therapy for patients with non-small cell lung cancer (NSCLC). Immunologic markers, such as serum neutrophil-to-lymphocyte ratio (NLR), are prognostic in patients with a variety of malignancies, with preliminary findings in patients on immunotherapy. In this study, we evaluate the association between NLR and ICI outcomes in NSCLC, including the development of immune-related adverse events (irAEs).

      a9ded1e5ce5d75814730bb4caaf49419 Method

      We conducted a retrospective analysis of advanced or recurrent NSCLC patients receiving ICI from 2011 to 2017. Demographics, disease and treatment history, and pretreatment labs were recorded. An NLR³5 was defined as high and <5 as low, based on meta-analyses. Cox proportional hazards models and univariate and multivariate regressions were used to assess the association between NLR and overall survival (OS), progression-free survival (PFS), disease control rate at 10 weeks (DCR), and irAEs.

      4c3880bb027f159e801041b1021e88e8 Result

      183 patients were identified: 55.2% male, 76.5% Caucasian, mean age 65.3 years (range 38–90 years). Male sex, smoking history, prior radiotherapy, and pretreatment albumin were significantly associated with high versus low NLR (p < 0.05). In univariate analyses, pretreatment NLR was a significant predictor of OS (HR 1.47, p < 0.05, Fig. 1), PFS (HR 1.44,, p < 0.05), and DCR (OR 0.49, p < 0.05), but not irAEs (OR 1.37, p = 0.33). These findings persisted with multivariate analyses (OS HR 1.76, PFS HR 1.64, DCR OR 0.24, all p < 0.01; irAE OR 1.52, p = 0.33).nlr survival.png

      8eea62084ca7e541d918e823422bd82e Conclusion

      High NLR was positively associated with OS, PFS, and DCR but not irAEs in NSCLC patients receiving ICI. Our results support the use of NLR as a biomarker for clinical outcomes. Prospective studies are needed to study this measure in patients undergoing ICI therapy, and further studies to identify predictive biomarkers of irAEs are warranted.

      6f8b794f3246b0c1e1780bb4d4d5dc53

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