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Y. Lu



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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): Y. Lu

      • 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)

      10:40 - 10:45  |  Author(s): Y. Lu

      • 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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    P1.09 - Poster Session 1 - Combined Modality (ID 212)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Combined Modality
    • Presentations: 1
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      P1.09-022 - A Multicenter, Randomized, Open-label, Phase II Trial of Erlotinibversus Etoposideplus Cisplatinwith Concurrent Radiotherapy in UnresectableStage III Non-smallCell Lung Cancer (NSCLC) with Activating Mutation of Epidermal Growth Factor Receptor (EGFR) in Exon 19 or 21(RECEL, ML28545, NCT01714908) (ID 1553)

      09:30 - 09:30  |  Author(s): Y. Lu

      • Abstract

      Background
      The standard treatment for unresectable stage IIIA/IIIB NSCLC patients with good PS is concurrent chemo-radiotherapy. However, local tumor control remains suboptimal and distant metastases remain the major failure. Moreover, the treatment related toxicities limit application. EGFR-targeting agents including tyrosine kinase inhibitor (TKI)such as erlotinibwere demonstrated to sensitize tumor cells to radiation by a variety of mechanisms in preclinical studies. Subsequently, Phase I/II studies forcombination of TKI with radiotherapy in different cancer types have been conducted. Based on those findings, the RECEL study is comparing efficacy and tolerability of erlotinib versus etoposide plus cisplatin with concurrent radiotherapy in unresectablestage III NSCLC with activating mutation of epidermal growth factor receptor (EGFR) in exon 19 or 21.

      Methods
      The study was designed as a prospective, open-labeled, randomized, multicenter phase II clinical trial.Patients aged between 18 and 75 with ECOG PS 0–1IIIA/IIIB NSCLCconfirmed by histopathology or cytology and clinically unresectablewith activating mutation ofEGFR in exon 19 (loss) or 21 (L858R point mutation)will be enrolled (n=100). The enrolled patientswould be randomly assigned (1:1) into two arms: erlotinibarm(erlotinib 150mg/day taken orally for up to 2 years which begin on day 1 of radiation) or EP chemotherapy arm(etoposide50mg/m[2]I.V. on days 1-5 and days29-33,cisplatin50mg/m[2]I.V. after etoposideon days 1,8,29,36. 28-day schedule for 2 cycleswhich begin on day 1 of radiation).Concurrent radiotherapy in both arms is prescribed at 200cGy/day, 5 days/week for a total of 30-33 fractions, total dose of 6000-6600cGy. Duration of the recruitment will be 36 months. Patients will receive long-term follow-up including chest and upper-abdominal CT scan every 3months, brain MRI every 6 months and bone scan every 12 months. Primary endpoint is progress free survival (PFS). Secondary endpoints areobjective response rate(ORR), local control rate (LCR), overall survival (OS), quality of life (QoL) and safety.Biomarker profile will be the exploratory research.

      Results
      Till June 2013, 24 patients were screened for EGFR mutation, and 4patient has been enrolled.

      Conclusion
      Concurrent erlotinib with radiation therapy might be a promising treatment strategy.