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H. Zhang



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    MO06 - NSCLC - Chemotherapy I (ID 108)

    • Event: WCLC 2013
    • Type: Mini Oral Abstract Session
    • Track: Medical Oncology
    • Presentations: 1
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      MO06.13 - BEYOND: a randomized, double-blind, placebo-controlled, multicentre, phase III study of first-line carboplatin/paclitaxel (CP) plus bevacizumab (Bv) or placebo (Pl) in Chinese patients with advanced or recurrent non-squamous non-small cell lung cancer (NSCLC) (ID 2756)

      17:25 - 17:30  |  Author(s): H. Zhang

      • Abstract
      • Slides

      Background
      Bevacizumab, a monoclonal antibody that inhibits angiogenesis via the vascular endothelial growth factor (VEGF) pathway, has proven efficacy in extending overall survival (OS) (Sandler et al, 2006) and progression-free survival (PFS) (Sandler et al, 2006; Reck et al, 2009) when added to platinum-doublet chemotherapy as first-line treatment for advanced non-squamous NSCLC. These pivotal studies included mainly Caucasian patients, however subgroup analyses in Asian patients also reported efficacy of the first-line Bv+CP regimen (Reck et al, 2009). The BEYOND study was initiated to confirm efficacy in a Chinese population.

      Methods
      Patients aged ≥18 years with histologically or cytologically confirmed, locally advanced, metastatic or recurrent advanced non-squamous NSCLC and an ECOG performance status of 0–1 were randomised 1:1 to receive CP (paclitaxel 175mg/m[2] i.v. and carboplatin AUC6 i.v. on day 1 of each 3-week cycle for up to 6 cycles), plus either Pl or Bv 15mg/kg i.v. on day 1 of each cycle, until progression, unacceptable toxicity, withdrawal of patient consent or death. Patients had no prior treatment for advanced NSCLC. Patients were stratified by gender, smoking status and age. The primary endpoint was PFS in the intent-to-treat (ITT) population; secondary endpoints included objective response rate (ORR), OS, exploratory biomarkers and safety. Collection of blood samples for biomarker analyses was mandatory (at baseline, every two cycles during treatment, at progression, and 4–6 weeks post-progression); tissue samples were optional.

      Results
      276 patients were randomised into the study, 138 to each arm. Baseline characteristics were similar in both treatment groups. PFS was prolonged with Bv+CP versus Pl+CP: hazard ratio 0.40 (95% CI 0.29–0.54); median 9.2 versus 6.5 months; p<0.0001 (ITT population). ORR was also improved with the addition of Bv to CP: 54.4% versus 26.3% with Pl+CP. Disease control rate was 94.4% versus 88.7% with Bv+CP and Pl+CP, respectively. Median duration of response was 8.0 months with Bv+CP versus 5.3 months with Pl+CP. OS data are not yet mature. Safety data were similar to previous studies of Bv+CP in NSCLC; no new safety signals were observed. Treatment discontinuation due to adverse events was 18.4% (Bv+CP) and 15.0% (Pl+CP). Treatment-related deaths were low in both arms (Bv+CP: 2.2%; Pl+CP: 0.0%). Detailed safety data and biomarker analyses will be reported.

      Conclusion
      This study confirms that the addition of bevacizumab to first-line platinum-based chemotherapy appears to provide similar PFS benefits in Chinese patients with advanced non-squamous NSCLC compared with global populations. No new safety concerns were reported.

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    O29 - Cancer Control & Epidemiology IV (ID 132)

    • Event: WCLC 2013
    • Type: Oral Abstract Session
    • Track: Prevention & Epidemiology
    • Presentations: 1
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      O29.06 - Prognostic Value of FDG-PET/CT Volumetric Prognostic Staging System in Non-small Cell Lung Caner (ID 2278)

      11:25 - 11:35  |  Author(s): H. Zhang

      • Abstract
      • Presentation
      • Slides

      Background
      Whole-body metabolic tumor volume (MTV~WB~) is a prognostic index independent of TNM staging, age, gender, performance status and treatment in non-small cell lung cancer (NSCLC). The current TNM staging system is also a prognostic index. However, it lacks advanced quantitative volumetric measurement in the 7[th] edition NSCLC TNM staging system. Integrating quantitative MTV~WB~ measurement into the current NSCLC staging system may make the staging system more quantitative and probably more prognostic. This study’s aim was to determine the utility of a FDG-PET volumetric prognostic (PVP) staging system based on univariate Cox regression models as a new prognostic index in NSCLC.

      Methods
      328 consecutive patients (156 males,172 females) with histologically proven NSCLC and median age of 68.3 years were identified for this retrospective analysis. The PET metabolic tumor volume in the whole body (MTV~WB~) was measured using a semi-automated 3D contouring program on baseline FDG PET/CT scans. The prognostic power for survival status of the PVP staging system was evaluated using the Kaplan–Meier method, Cox regression models, and compared with those of TNM staging system and ln(MTV~WB~) using C-statistic index (Gönen and Heller’s K concordance statistic).

      Results
      There were 46 cases with stage IA, 43 stage IB, 19 stage IIA, 18 stage IIB, 52 stage IIIA, 39 stage IIIB and 111 stage IV NSCLC. At the end of this investigation, 249 patients had died (88.4%). Median follow-up of 79 lost follow-up and known surviving patients was 58 months. On univariate survival analysis the HR of ln(MTV~WB~) was 1.56, and the HRs of TNM stages 2.25, 1.96, 2.89, 4.24, 4.93 and 7.63 for TNM stages IB, IIA, IIB, IIIA, IIIB and IV in reference to stage IA, respectively. These HRs were used for computing the PVP stage of each patient using following equation; PVP stage = [Hazard ratio of ln(MTV~WB~) × ln(MTV~WB~)] × [Hazard ratios of TNM stage]. There was a statistically significant association of better overall survival with lower PVP stage on both univariate [HR of 1.033 (95%CI =1.027 to1.039)] and multivariate [HR of 1.03 (95%CI =1.02 to1.04)] survival analyses. The range of the PVP stage were 0.06 to 87.57. For comparison with 7[th] edition of TNM stage and ln(MTV~WB~), the PVP stage and ln(MTV~WB~) were divided into 7 groups with similar numbers of patients. The C-statistic value of PVP staging system (mean±SE = 0.70±0.014) was statistically significantly higher than those of TNM stage (0.67 ±0.015, p=0.002) and ln(MTV~WB~) (0.67±0.015, p=0.02) on univariate survival analysis. In multivariate Cox regression models adjusted by patient’s age, gender, treatment types, tumor histology and tumor SUV~max~, the C-statistic value of PVP staging system (mean±SE=0.73±0.013) was also statistically significantly higher than that of TNM stage (0.71 ±0.015, p=0.036).

      Conclusion
      The PVP staging system from FDG-PET/CT has better prognostic ability and may prove to be a useful prognostic index in NSCLC. It can be treated as a complement to the TNM staging system.

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