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Y. Song



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    CALC - Chinese Alliance Against Lung Cancer Session (ID 79)

    • Event: WCLC 2013
    • Type: Other Sessions
    • Track: Other Topics
    • Presentations: 1
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      CALC.06 - Diagnosis of Lung Nodules by CT-Guided Lung Biopsy (ID 3873)

      Y. Song

      • Abstract
      • Slides

      Abstract
      CT-guided percutaneous needle biopsy(CT-guided PTNB) of the lung, with its high sensitivity, specificity, and accuracy, is an important diagnostic tool in the evaluation of pulmonary lesion, especially in malignant disease . And it’s specificity can reach 95 percent to 100 percent in malignant disease. Although PTNB of the lung is a mature technique, careful case selection is necessary to increase diagnostic yield and avoid unnecessary complications. It is indicated for indeterminate pulmonary nodules or masses, particularly those that will likely require chemotherapy or radiation rather than surgery. Pneumothorax and pulmonary hemorrhage are the most common complications of PTNB, whereas air embolism and tumor seeding are extremely rare. Attention to biopsy planning and technique and postprocedural care help to prevent or minimize most potential complications. A retrospective investigation of patients with CT-guided PTNB in Jinling Hospital between January 2000 to October 2010 was performed. The risk factors for complications were determined by multivariate analysis of variables related to patients’ demographics, lung lesions, biopsy procedures, and individual radiological features.1014 biopsy prcedures were enrolled. The total complication rate was 18.5 percent with pneumothorax 12.9 percent (131/1014), hemoptysis 5.6 percent (57/1014), and with no mortality. The diagnosis was cofirmed by PTNB in 961 patients (94.8 percent) with 639 patients as malignant disease (63 percent) and 322 patients as benign diease (31.8 percent). Taken into all the evidence, CT-guided percutaneous needle biopsy is a safe and effective means in the diagnosis of pulmonary occupying lesions.

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    O15 - NSCLC - Chemotherapy II (ID 109)

    • Event: WCLC 2013
    • Type: Oral Abstract Session
    • Track: Medical Oncology
    • Presentations: 1
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      O15.07 - Final results of CTONG 0806: a phase II trial comparing pemetrexed with gefitinib as second-line treatment of advanced non-squamous NSCLC patients with wild-type EGFR (ID 1920)

      Y. Song

      • Abstract
      • Presentation
      • Slides

      Background
      Both Pemetrexed and gefitinib are standard second-line treatments for advanced non-squamous NSCLC in East Asia. The CTONG 0806, a multi-center, randomized, controlled, open-label phase II trial was designed to explore the efficacy of pemetrexed versus gefitinib as second-line treatment in advanced non-squamous NSCLC with wild-type EGFR.

      Methods
      Patients with locally advanced or metastatic non-squamous NSCLC previously treated with platinum-based chemotherapy and with wild-type EGFR detected by direct sequencing were randomized to receive gefitinib orally 250 mg/day (G arm) or pemetrexed 500 mg/m[2] iv day 1 every 21 days (P arm) until disease progression or unacceptable toxicity. Primary endpoint was progression-free survival (PFS). Secondary endpoints included 4-month and 6-month PFS rate, overall survival (OS), objective response rate (ORR), disease control rate (DCR), quality of life and safety. Independent Review Committee (IRC) evaluated all pictorial data.

      Results
      From Feb. 2009 to Aug. 2012, 161 patients were enrolled and 157 were evaluable (81 in G arm and 76 in P arm). Baseline characteristics were balanced between arms. The primary endpoint of median PFS was met with 4.8 months in P arm versus 1.6 months in G arm(HR 0.54, 95% CI 0.40~0.75, P<0.001), which was confirmed by IRC evaluation (5.6 vs. 1.7 months, HR 0.53, 95% CI 0.38~0.75, P<0.001). Significant difference between two arms was also seen in terms of 4-month PFS rate, 6-month PFS rate and DCR (Table 1). Median OS showed the trend of superiority in P arm (12.4 vs. 9.6 months, HR 0.72, 95% CI 0.49 ~ 1.04, P=0.077). In 108 patients having enough tumor tissue, EGFR mutation status was tested again by Scorpion amplification refractory mutation system (ARMS) and 32 were found to be positive. In 76 patients with wild-type EGFR confirmed by ARMS (35 in P arm and 41 in G arm), median PFS was 4.0 vs. 1.3 months (HR 0.42, 95% CI 0.26~0.67, P<0.001). More skin rash and diarrhea were seen in G arm while more fatigue and ALT increase were in P arm. CTCAE grade 3 or 4 adverse events was 12.3% in G arm and 32.9% in P arm (P=0.002). The detailed survival analysis and biomarkers analysis will be presented on the ground.

      Table1. Efficacy of pemetrexed and gefitinib evaluated by investigators and IRC
      Evaluated by Investigators Evaluated by IRC
      Pemetrexed arm Gefitinib arm P Pemetrexed Gefitinib arm P
      PFS 4.8months 1.6months <0.001 5.6months 1.7months <0.001
      HR 0.54,95% CI 0.40 ~ 0.75 HR 0.53, 95% CI 0.38 ~ 0.75
      4-month PFS rate 59.0% 33.0% <0.001 62.0% 37.0% <0.001
      6-month PFS rate 43.0% 23.0% <0.001 48.0% 27.0% <0.001
      ORR 13.2% 13.6% 0.938 14.5% 12.3% 0.695
      DCR 60.5% 29.6% <0.001 61.9% 30.8% <0.001
      OS 12.4months 9.6months 0.077
      HR 0.72,95% CI 0.49 ~ 1.04

      Conclusion
      CTONG0806 is the first trial to show significant improvement in PFS, DCR and a trend of improving OS with pemetrexed compared with gefitinib in second-line setting for EGFR wild-type advanced non-squamous NSCLC.

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    P1.01 - Poster Session 1 - Cancer Biology (ID 143)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Biology
    • Presentations: 1
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      P1.01-027 - Long non-coding RNAs: a new frontier in the study of human diseases (ID 1502)

      Y. Song

      • Abstract

      Background
      With the development of whole genome and transcriptome sequencing technologies, long noncoding RNAs (lncRNAs) have received increased attention. Multiple studies indicate that lncRNAs act not only as the intermediary between DNA and protein but also as important protagonists of cellular functions. LncRNAs can regulate gene expression in many ways, including chromosome remodeling, transcription and post-transcriptional processing. Moreover, the dysregulation of lncRNAs has increasingly been linked to many human diseases, especially in cancers. Here, we reviewed the rapidly advancing field of lncRNAs and described the relationship between the dysregulation of lncRNAs and human diseases, highlighting the specific roles of lncRNAs in human diseases.

      Methods
      not applicable

      Results
      not applicable

      Conclusion
      Continuing advances in transcriptomics indicate that lncRNAs fulfill important functions in the regulation of gene expression. With this updated view of molecular biology, the central dogma may be re-written. In this review, we have described some examples of lncRNAs involved in disease-associated processes (such as cancer initiation and progression), as well as highlighted the diverse mechanisms of lncRNAs. As with the dysregulation of miRNAs, dysregulation of lncRNAs is becoming recognized as a hallmark feature of many types of diseases. Importantly, cancer-associated lncRNAs may serve as diagnostic or predictive biomarkers of cancer and also provide a new therapeutic strategy of selectively silencing cancer-associated lncRNAs. However, compared with coding RNA and miRNA, there are still significant gaps in our current understanding of lncRNA function. Further studies are needed to elucidate the networks of proteins, miRNAs and lncRNAs.

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    P2.10 - Poster Session 2 - Chemotherapy (ID 207)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Medical Oncology
    • Presentations: 2
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      P2.10-006 - Prognostic value of the Ratio of Positron Emission Uptake to Primary Tumor Size in advanced Non-Small Cell Lung Cancer (ID 369)

      Y. Song

      • Abstract

      Background
      In Surgically Resected Non–Small Cell Lung Cancer,a previous study has shown ratio of maximum standardized uptake value to primary tumor size is a more important indicator of prognosis than SUVmax alone. The objective of this study was to assess the prognostic value of patients with advanced non-small cell lung cancer (NSCLC). We have investigated whether SUVmax to tumor size ratio is associated with response to first-line therapy and survival in advanced Non–Small Cell Lung Cancer.

      Methods
      A retrospective review of 186 consecutive patients who had a pretreatment 18F-FDG PET/CT done before receiving first-line therapy for advanced(III/IV) non-small cell lung cancer (NSCLC) was performed. Response was assessed by CT Response Evaluation Criteria in Solid Tumors (RECIST) at after every two cycles or emerge symptoms relate to disease progression . Overall survival(OS), progression-free survival (PFS), and post-progression survival(PPS) were Recorded. Primary tumor maximum standardized uptake value (SUVmax)、primary tumor size were all derived from the PET/CT data. Survival curves stratified by median SUVmax and SUVmax to tumor size ratio by the Kaplan-Meier method and statistical differences were assessed using the log-rank test. Multivariate proportional hazards (Cox) regression analyses were applied to test the SUVmax’s and SUVmax to tumor size ratio’s independency of other prognostic factors for the prediction of survival.A retrospective review of 186 consecutive patients who had a pretreatment 18F-FDG PET/CT done before receiving first-line therapy for advanced(III/IV) non-small cell lung cancer (NSCLC) was performed. Response was assessed by CT Response Evaluation Criteria in Solid Tumors (RECIST) at after every two cycles or emerge symptoms relate to disease progression . Overall survival(OS), progression-free survival (PFS), and post-progression survival(PPS) were Recorded. Primary tumor maximum standardized uptake value (SUVmax)、primary tumor size were all derived from the PET/CT data. Survival curves stratified by median SUVmax and SUVmax to tumor size ratio by the Kaplan-Meier method and statistical differences were assessed using the log-rank test. Multivariate proportional hazards (Cox) regression analyses were applied to test the SUVmax’s and SUVmax to tumor size ratio’s independency of other prognostic factors for the prediction of survival.

      Results
      Total 186 patients were enrolled into the current study. Median OS was 14.9 m (range, 3.1–64.0 m), PFS was 5.6 m (range, 0.8–41.1 mo), and PPS was 7.9m(range, 0–51.3 m). The statistical analysis data indicated that Low pretreatment SUV≤7.9(P=0.026), and SUVmax to tumor size ratio<2.2(0.000) were associated with response to first-line therapy. Clinical response was independent prognostic factors for PFS (OR= 3.152, P=0.000), low stage(Ⅲ) was associated with PPS independently, with OR=1.700, P= 0.027,and for OS, low SUVmax to tumor size ratio(OR= 1.764, P=0.027), tumor diameter (OR= 1.743, P=0.013)and clinical response(OR= 1.678, P=0.002) were all independent prognostic factors.

      Conclusion
      The ratio of SUVmax to tumor size may be a more important indicator of prognosis than SUVmax alone in patients with NSCLC.

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      P2.10-031 - Chinese randomized phase II trial of customized chemotherapy based on BRCA1-RAP80 mRNA expression in advanced non-small-cell lung cancer (NSCLC) patients (p) (ChiCTR-TRC-12001860/BREC-CHINA) (ID 1883)

      Y. Song

      • Abstract

      Background
      BRCA1 serves as a differential modulator of chemosensitivity to docetaxel (doc) and cisplatin (cis). RAP80 targets the BRCA1-BARD1 E3 ligase at double-strand breaks. A Spanish Lung Cancer Group (SLCG) phase II customized chemotherapy trial (NCT00883480) indicated that RAP80 and BRCA1 jointly influenced outcome in NSCLC p treated with cis- or doc-based chemotherapy. Based on these findings, the SLCG initiated a randomized phase III trial (NCT00617656/GECP-BREC), and we have performed a parallel phase II trial comparing non-customized cis/doc with customized therapy in metastatic NSCLC p in China.

      Methods
      Since October 2010, 104 p have been randomized 1:3 to control and three experimental arms. p in the control arm receive cis/doc; p in the experimental arm receive treatment according to their BRCA1 and RAP80 levels: p with low RAP80, regardless of BRCA1 levels, cis/gemcitabine (gem); p with intermediate/high RAP80 and low/intermediate BRCA1, cis/doc; p with intermediate/high RAP80 and high BRCA1, doc alone. The primary endpoint is progression-free survival (PFS).

      Results
      PFS was 4.15 months (m) in the control and 3.59 m in the experimental arm (P=0.68). Overall survival (OS) was 10.82 m in the control and 11.74 m in the experimental arm (P=0.68). Response rate (RR) was 23.3% in the control and 32.4% in the experimental arm (P=0.48). In ancillary analyses of p with low, intermediate and high BRCA1 levels, PFS in the control arm was 2.66, 4.15 m and 7.5 m, respectively, while PFS in the experimental arm was 10.66 m, 3.45 m and 3.06 m, respectively. In the multivariate analysis including PS, treatment arm, BRCA1, RAP80, histology and smoking status, only ex-smokers were associated with an increased risk of progression (HR, 1.906; P=0.029).

      Conclusion
      Customized chemotherapy based on BRCA1/RAP80 expression does not improve PFS. The predictive value of BRCA1 alone seems to be stronger than that of BRCA1/RAP80 combined.