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J.S. Jang



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    P2.03a - Poster Session with Presenters Present (ID 464)

    • Event: WCLC 2016
    • Type: Poster Presenters Present
    • Track: Advanced NSCLC
    • Presentations: 1
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      P2.03a-041 - Comparison between Combination and Mono Chemotherapy for Elderly Patients with Advanced Non-Small Cell Lung Cancer: A Population-Based Study (ID 4921)

      14:30 - 14:30  |  Author(s): J.S. Jang

      • Abstract

      Background:
      Despite the elderly patients represents the majority of lung cancer population, only 10~20% of study patients in clinical trials were elderly. Moreover, the studies examining combination versus single-agent therapy in an elderly with advanced non-small cell lung cancer (NSCLC) have showed conflicting results in terms of survival benefit. This population-based analyses aimed to assess the pattern of initial chemotherapeutic regimen and the survival benefit of combination chemotherapy compared with single-agent in elderly patients with advanced NSCLC.

      Methods:
      Patients ³ 70 years with advanced NSCLC incident from 2007 to 2012 were identified in the National Health Insurance Service database of Korea. Multivariate models examined the patient characteristics associated with receipt of combination compared with single-agent chemotherapy. Cox proportional-hazards regression model was used to examine the effect of treatment modality on survival. Propensity score analysis adjusted for confounding.

      Results:
      Among 41276 patients with de novo lung cancer, 8274 (20.0%) who received palliative chemotherapy were eligible for this study. Of 8274 patients with advanced NSCLC, 7298 (88.2%) who received cytotoxic chemotherapy were included in further analyses, except 976 (11.8%) who received first-line EGFR tyrosine kinase inhibitor. A total of 5636 (77.2%) patients received combination chemotherapy and 1662 (22.8%) received monotherapy. The most frequent regimen was gemcitabine + platinum doublet (44.7%) in combination group and gemcitabine single (46.7%) in monotherapy group. Multivariate analyses indicated that the lower use of combination chemotherapy with increasing age (odds ratio[OR] 0.73; 95% CI 0.67 to 0.79; P < .001) and female (OR 0.71; 95% CI 0.62 to 0.80; P < .001). Receipt of combination over single-agent chemotherapy was associated with reduction in the adjusted hazard of death (hazard ratio[HR] 0.91; 95% CI 0.86 to 0.96; P=0.001) and an increase in median overall survival from 9.7 to 10.8 months. In the propensity-matched cohort, survival was still significantly better in combination chemotherapy group (HR 0.89; 95% CI 0.80 to 0.98; P = .019 by stratified Log-rank test).

      Conclusion:
      In elderly patients with advanced NSCLC who are eligible for cytotoxic chemotherapy, there are clear survival benefit of combination chemotherapy compared with single-agent with controls for age, sex and comorbidity.

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    P3.02b - Poster Session with Presenters Present (ID 494)

    • Event: WCLC 2016
    • Type: Poster Presenters Present
    • Track: Advanced NSCLC
    • Presentations: 1
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      P3.02b-072 - A Multicenter Phase II Study of Gefitinib in Squamous NSCLC Patients Who Failed First-Line Chemotherapy (ID 4320)

      14:30 - 14:30  |  Author(s): J.S. Jang

      • Abstract
      • Slides

      Background:
      The role of EGFR tyrosine-kinase inhibitors in the second-line for patients with squamous non-small-cell lung cancer (NSCLC) remains unclear. We conducted a prospective phase II study to assess use of gefitinib in patients with squamous NSCLC as second-line chemotherapy, and investigated the predictive and prognostic value of a proteomic signature using VeriStrat test.

      Methods:
      Between December 2011 and October 2015, 56 patients with histologically confirmed, second-line, Stage IIIB or IV NSCLC were enrolled in 9 centres in Republic of Korea. Patients were treated with gefitinib (250 mg per day orally). The proteomic test classification was masked for patients and investigators. The primary end point was disease control rate (DCR) at 8-weeks, and the secondary end points included toxicity, progression-free survival (PFS), overall survival (OS), and correlation between the serum proteomic test classification and treatment. This study is registered with ClinicalTrials.gov, number NCT01485809.

      Results:
      The median age was 69 years (range, 41-83) and 55 (98%) patients were male, and 49 (88%) had an ECOG PS of 1. Fifty five (98%) of patients had received platinum-based chemotherapy. The DCR at 8 weeks was 50.0% (95% confidence interval [CI] 34.8-63.4). With a median follow-up of 5.5 months, the median PFS and OS were 2.8 (95% CI 1.3-4.3) and 6.4 (5.4-7.4) months, respectively. The most common adverse event were rash (16 [29%]) and diarrhea (14 [25%]). Pretreatment plasma was available for 50 samples, and VeriStrat testing was successful in 45 samples (90%) with 71% classified as Good. The median PFS were 3.2 (95% CI 1.9-4.7) and 2.4 (1.5-3.3) months for VeriStrat Good vs. Poor patients, respectively (p=0.639). The median OS of VeriStrat Good was longer than those of VeriStrat Poor (11.4 [5.7-17.0] vs 4.8 [2.5-7.0] months), which was not statistically significant (p=0.052).

      Conclusion:
      These data suggest that gefitinib is modest activity as second-line chemotherapy in patients with squamous NSCLC. Serum proteomic test using VeriStrat is not prognostic for both OS and PFS among squamous NSCLC patients treated with gefitinib.

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