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X. Liu



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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)

      16:15 - 17:45  |  Author(s): X. Liu

      • 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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    MO12 - Prognostic and Predictive Biomarkers III (ID 96)

    • Event: WCLC 2013
    • Type: Mini Oral Abstract Session
    • Track: Medical Oncology
    • Presentations: 1
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      MO12.03 - Biomarker analysis of a randomized, controlled, multicenter clinical trial comparing pemetrexed/cisplatin and gmcitabine/cisplatin as first-line treatment for advanced nonsquamous non-small cell lung cancer (ID 3483)

      10:30 - 12:00  |  Author(s): X. Liu

      • Abstract
      • Presentation
      • Slides

      Background
      The platinum-based doublet regimen was standard of care in advanced non-small cell lung cancer (NSCLC), but the biomarkers to predict the efficacy of first-line chemotherapy is still controversial.

      Methods
      We collected 239 tumor samples (83.0%) from a a randomized, controlled, multicenter clinical trial, which enrolled 288 treatment naïve nonsquamous NSCLC patients who were randomly assigned (1:1) to experimental group to receive cisplatin plus pemetrexed (PC) or the control group to receive gemcitabine plus cisplatin (GC) every 3 weeks for up to 6 cycles. We evaluated the EGFR mutation by Amplification Refractory Mutation System(ARMS) method and EML4-ALK fusion by real-time PCR. Meanwhile, the mRNA expression of excision repair cross complementation 1 (ERCC-1), thymidylate synthase (TS), ribonucleotide reductase M1(RRM-1), and folatereceptor 1(FR-1) was tested by real-time PCR. All of the EGFR mutation, ALK fusion and mRNA expression were analyzed for the correlation with progression free survival, the primary endpoint in the tiral.

      Results
      The EGFR mutation rate was 46.6%(110/236) in the overall population and the ALK fusion rate was 12.0%(29/233). The median PFS was similar between the EGFR mutated patients and wild-type patients(6.0m vs 5.7m,p=0.85), however, the patients of EGFR wild-type had better PFS in the PC group compared with GC group (5.7m vs 3.5m, p=0.03). There are no significant difference between groups in EGFR mutated patients(5.6m vs 6.1m, p=0.59). The patients with ALK fusion seem to have better PFS compared with fusion negative patients (7.7m vs 5.7m), but the difference is not significant(p=0.48). The mRNA expression level was available in 225 patients(94.1%) and we determined the median expression as the cutoff value. The TS expression is significantly correlated with ERCC-1(r=0.67,p<0.001) and negatively correlated with FR-1 expression(r=-0.21,p=0.002). EGFR mutation correlated with lower TS expression(p=0.034) and ALK fusion correlated with higher FR-1 expression(p=0.017). The differences of PFS between the high and low expression of ERCC-1, TS, RRM-1and FR-1 was not significant, in both PC group and GC group.

      Conclusion
      The expression level of ERCC-1, TS, RRM-1and FR-1 could not effectively predict the progression free survival of NSCLC patients receiving platinum-based doublet regimen. The pemetrexed plus cisplatin regimen should be the priority choice for EGFR wild type patients compared with gemcitabine plus cisplatin regimen.

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    P1.06 - Poster Session 1 - Prognostic and Predictive Biomarkers (ID 161)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Biology
    • Presentations: 1
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      P1.06-005 - The Clinical Significance of Serum BAP, TRACP 5b and ICTP as Bone Metabolic Markers for Bone Metastasis Screening in Lung Cancer Patients (ID 826)

      09:30 - 16:30  |  Author(s): X. Liu

      • Abstract

      Background
      The early diagnosis of bone metastasis (BM) may bring improvements of life quality and treatment to cancer patients. Although single-photon emission computed tomography (SPECT) is the most frequently used method for BM screening, it still has some shortages. This study was initiated to investigate the clinical significance of serum BAP, TRACP 5b and ICTP as bone metabolic markers for BM screening in lung cancer patients.

      Methods
      Newly diagnosed advance lung cancer patients with (N=130) and without (N=135) BM were enrolled in present study. In addition, newly diagnosed primary lung cancer patients (N=38) were enrolled as control. Serum BAP, TRACP 5b and ICTP were measured using enzyme-linked immunosorbent assay (ELISA) before the initiation of treatment. The differences in concentration of BAP, TRACP 5b and ICTP were analyzed by one-way analysis of variance (ANOVA) (or Kruskal-Wallis tests when appropriate). The screening effectiveness of BAP, TRACP 5b, ICTP and the combination of TRACP 5b and ICTP was assessed by receiver operating characteristic (ROC) curves analysis in patients with and without BM.

      Results
      For concentrations of BAP, TRACP 5b and ICTP, significant differences was found between patients with and without BM (all P<0.0001), as well as patients with solitary and multiple BM (BAP: P<0.0001, TRACP 5b: P=0.0008, ICTP: P=0.0474). ROC curves analysis reveals the area under curve (AUC) of BAP, TRACP 5b and ICTP was 0.760, 0.753 and 0.835 (all P=0.0001), respectively. The optimal cut-off value for BAP, TRACP 5b and ICTP was 21.8 μg/L (sensitivity=63.1%, specificity=77.0%), 7.8 U/L (sensitivity=58.5%, specificity=80.7%) and 8.8μg/L (sensitivity=63.1%, specificity=90.4%), respectively. When TRACP 5b and ICTP was combined for BM screening , AUC was elevated to 0.895 (P=0.0001), and the optimal cut-off value was TRACP 5b > 7.6 U/L and ICTP >8.4μg/L (sensitivity=71.5%, specificity=93.3%).

      Conclusion
      Our research has demonstrated that serum BAP, TRACP 5b and ICTP may serve as a useful supplement for SPECT in lung cancer BM screening. If the 3 markers can be properly used together with SPECT, BM screening would turn to be more timely and accurate.