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L. Jiang



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    P1.11 - Poster Session 1 - NSCLC Novel Therapies (ID 208)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Medical Oncology
    • Presentations: 2
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      P1.11-036 - The efficacy and safety of sunitinib in EGFR-TKI pretreated advanced non-small cell lung cancer: a retrospective review from Chinese patients at a single institution (ID 2534)

      09:30 - 09:30  |  Author(s): L. Jiang

      • Abstract

      Background
      Sunitinib is an oral, selective multi-targeted tyrosine kinase inhibitor (TKI) with antiangiogenic and antitumor activities. The result from a previous study suggested that the treatment of sunitinib might present favorable survival outcomes for the EGFR-TKI pretreated NSCLC Chinese patients. This study was therefore to evaluate the efficacy and toxicity of this therapeutic strategy.

      Methods
      This is a retrospective review of 30 stage IV NSCLC patients who received sunitinib as salvage therapy in Shanghai Chest hospital, from January 2009 until August 2011. All of the patients had previously been treated with EGFR-TKIs. Kaplan-Meier method was employed to estimate the median progression-free survival (PFS) and overall survival (OS). Univariate and multivariate Cox proportional hazard regression analyses were carried out to determine the important prognostic risk factors influencing NSCLC survival.

      Results
      The median PFS of all 30 treated patients was 1.25 months (95% CI: 0.90-1.9 months), and the median OS was 3.40 months (95% CI: 3.00-6.80 months). Of the 29 patients eligible for efficacy evaluation, none achieved partial response. Cox regression analysis suggested that Eastern Cooperative Oncology Group (ECOG) performance status (PS) is predictive of both PFS (p=0.001) and OS (p<0.001). Hand-foot syndrome (53.3%), mucositis (40.0%), rash (36.7%) and diarrhea (33.3%) were most commonly reported adverse events.

      Conclusion
      In this study, the sunitinib treatment did not demonstrate overall clinical benefits to the EGFR-TKI pretreated NSCLC Chinese patients. Most side effects were mild to moderate. These results need further validation in prospective studies.

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      P1.11-039 - A randomized phase II trial of celecoxib combined with platinum-based chemotherapy as first-line and with icotinib as second-line treatment for advanced non-small cell lung cancer (ID 2820)

      09:30 - 09:30  |  Author(s): L. Jiang

      • Abstract

      Background
      To evaluate the anti-tumor effect and safety of COX-2 inhibitors through a randomized controlled study by treating advanced non-small cell lung caner (NSCLC) with celecoxib + platinum-based chemotherapy as first-line treatment and celecoxib + icotinib as second-line treatment; to investigate the mechanism of action and efficacy predictors related to COX-2 inhibitors by detecting and monitoring serum VEGF, MMP-9 and E-cardrin in the course of treatment.

      Methods
      81 untreated patients with stage III-IV NSCLC were randomized into vinorelbine/cisplatin + celecoxib group and vinorelbine/cisplatin chemotherapy group. If disease progression was found in the followed-up visits in the middle or after the end of the 4[th] cycle, the patients would enter second-line icotinib + continued celecoxib group, while the mono-chemotherapy group became the second-line icotinib monotherapy group until the disease progressed. The patients’ serum VEGF, MMP-9 and E-cardrin were detected by ELISA assay at different time points before initial chemotherapy and after chemotherapy.

      Results
      First-line treatment and second-line celecoxib group showed significant differences in disease control rate (73.2% vs. 65.0%, P=0.036; 56.5% vs. 55.6%, p=0.078). PFS in the second-line celecoxib group was superior to that in the monotherapy group (5.3m vs. 5.0m, p=0.045). One case in the celecoxib group during second-line treatment experienced arrhythmia after continuous use of celecoxib, while the treatment was well tolerated in the other patients. After chemotherapy, serum VEGF, MMP-9 and E-cardrin were decreased, the decline in serum VEGF in the experimental group was significantly greater than that in the control group (p=0.027). Serum VEGF, MMP-9 and E-cardrin in the experimental group after chemotherapy were significantly lower than before chemotherapy (respectively: p=0.025, 0.035, 0.002). The efficacy of chemotherapy in patients with lower baseline serum VEGF and E-cardrin levels in the experimental group was better (p=0.033, 0.047). After chemotherapy, the efficacy of chemotherapy in patients with greater decline in VEGF and MMP-9 levels was better (p=0.038, 0.039). Only baseline serum VEGF was found to be related to the efficacy of chemotherapy in the control group (p=0.023). Baseline serum VEGF levels and the decline after chemotherapy were significantly associated with the patients’ PFS (p=0.019, 0.035).

      Conclusion
      COX-2 inhibitor celecoxib can improve disease control rate and be well tolerated by patients when combined with either chemotherapy for first-line treatment or targeted therapy for second-line treatment. Serum VEGF level is a good biomarker to predict efficacy and survivals, while serum MMP-9 and E-cardrin are potential biomarkers requiring large-sample studies.

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    P2.06 - Poster Session 2 - Prognostic and Predictive Biomarkers (ID 165)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Biology
    • Presentations: 1
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      P2.06-027 - Low frequency KRAS mutations in colorectal cancer patients and the presence of multiple mutations in oncogenic drivers in non-small cell lung cancer patients (ID 2401)

      09:30 - 09:30  |  Author(s): L. Jiang

      • Abstract

      Background
      Intra-tumor heterogeneity can confound mutational status in oncodriver genes and challenge targeted cancer therapy strategies. Ultra-deep sequencing can detect low-frequency and expanded clonal mutations in primary tumors to better inform treatment decisions

      Methods
      KRAS coding exons in 61 treatment-naïve colorectal cancer (CRC) tumors were sequenced, along with KRAS, EGFR, ALK, and MET in lung tumors from 3 Chinese non-small cell lung cancer (NSCLC) patients

      Results
      Forty-two percent of CRC patients (28/61) harbored mutations in the KRAS active domain, 12 patients harbored >1 mutation, and eleven patients (18%), of which 5 had frequencies <10%, were not detected by Sanger sequencing. Low frequency KRAS active (G12R) and EGFR kinase domain mutations (G719A) were identified in one NSCLC patient. Multiple low frequency mutations in KRAS, EGFR, and MET and ALK gene copy number increases were found in a second NSCLC patient; a third NSCLC patient had EML4-ALK fusion with ALK, EGFR, and MET mutations. Multiple low frequency mutations occurred within individual gene in all three patients.

      Conclusion
      A complex pattern of intrinsic low frequency driver mutations in well-known tumor oncogenes may exist prior to treatment, potentially resulting in resistance to targeted therapies. Ultra-deep sequencing can characterize intra-tumor heterogeneity and identify such mutations which could ultimately impact treatment decisions.

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    P2.12 - Poster Session 2 - NSCLC Early Stage (ID 205)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Medical Oncology
    • Presentations: 1
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      P2.12-001 - Erlotinib as neoadjuvant treatment in patients with stage IIIA-N2 non-small cell lung cancer (NSCLC) with activating Epidermal Growth Factor Receptor (EGFR) mutation (NCT01217619, EASTERN): study update (ID 260)

      09:30 - 09:30  |  Author(s): L. Jiang

      • Abstract

      Background
      Approximately 15% of patients with NSCLC are diagnosed with stage IIIA-N2 disease, the treatment modalities of which are not clearly defined due to its heterogeneous character. Patients with stage IIIA N2 NSCLC have poor outcomes with 5-year survival rate of approximately 15% after treatment with surgical resection or chemo-radiotherapy. Tyrosine kinase inhibitor mono-therapy as the first line treatment could significantly improve tumor response rate and disease progression free survival (PFS) for metastatic NSCLC patients with activating EGFR mutation. The objective of this trial is to explore the efficacy and safety profile of erlotinib as neoadjuvant treatment in patients of stage IIIA-N2 NSCLC with activating EGFR mutation.

      Methods
      This is a prospective, single arm, phase Ⅱ clinical trial. Patients with Endobronchial Ultrasound(EBUS) confirmed stage ⅢA-N2 NSCLC with activating EGFR mutation in exon 19 or 21 will be enrolled into the study. All the recruitment patients will be treated by erlotinib 150mg orally per day for 56 days for neoadjuvant period. Patients will be assessed after erlotinib treatment and those who get response from neoadjuvant therapy and are technically resectable will undergo surgery treatment. The adjuvant regime is decided by the investigator taking patients’ benefits into consideration. The primary endpoint is radical resection rate. The secondary endpoints are pathological complete resection rate(pCR), objective response rate(ORR), disease free survival(DFS), overall survival(OS), quality of life(QoL) and safety profile. Patients after surgery and therapy will receive long-term follow-up including regular chest CT and ultrasound examination.

      Results
      Eighty-eight(88) patients have been screened and 15 patients have been enrolled since first patients in (FPI) on 30th April, 2011. Excluded reasons including ineligible pathological diagnosis (n=23), ineligible stage (n=36), without EGFR mutation (n=10) and poor compliance (n=4). Ineligible stage including T1-3N0M0 (n=11), T1-3N1M0 (N=8), T1-3N3M0 (N=8), T1-3N2M1 (N=7) and T4N2M0 (N=2). 41% patients who were diagnosed with stage IIIA-N2 non-small cell lung cancer when in chest CT examinations were not in the stage after endobronchial ultrasound(EBUS) , and became the main reason for screening failure in this study. Seven patients had partial response, 3 patients with stable disease and 2 patients were still on treatment (DCR 66.6%). 3 patients with progress disease. Due to active hepatitis and technical infeasibility, 2 patients with partial disease didn’t receive surgery. However, one stable disease patient and five partial response patients (40%) received R0 surgery.

      Conclusion
      Neoadjuvant erlotinib therapy might be a promising treatment for IIIA-N2 NSCLC patients with EGFR activating mutation. EBUS helps the judgment of mediastinal lymph node metastasis and is better than CT scan.