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Y. Shi



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    JCHS - Joint IASLC - Chinese Society for Clinical Oncology - Chinese Alliance Against Lung Cancer Session (ID 239)

    • Event: WCLC 2015
    • Type: Joint Chinese/ English Session
    • Track: Other
    • Presentations: 1
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      JCHS.07 - First-Line Icotinib Versus Cisplatine/Pemetrexed plus Pemetrexed Maintenance in Advanced NSCLC Patients with EGFR Mutation (ID 3524)

      Y. Shi

      • Abstract
      • Presentation
      • Slides

      Background:
      Clinical studies with anti-EGFR agents demonstrate that EGFR TKIs play critical roles in the treatment of non-small cell lung cancer, especially in patients with positive EGFR mutation. Icotinib is an oral, selective EGFR TKIs. Phase 3 study showed that icotinib is non-inferior to gefitinib in treating unselected or EGFR-mutated advanced NSCLC patients as second-line therapy but better safety profile, which provide a rationale to examine icotinib in first-line setting. The objective of this study is to evaluate progression-free survival (PFS), overall survival (OS) and safety of icotinib in chemotherapy naïve NSCLC patients with EGFR mutation.

      Methods:
      In this phase 3, open-label, randomized study (CONVINCE, NCT01719536), 285 patients (pathologically confirmed NSCLC, positive 19/21 EGFR mutation, treatment naive) will be 1:1 randomized to receive oral icotinib (125 mg, three times daily) or cisplatine (intravenous [IV], 75 mg/m2, day 1) plus pemetrexed (IV, 500 mg/m2, day 1), patients achieving disease control after 4-cycle chemotherapy continue to receive single pemetrexed (IV, 500 mg/m2, day 1) as maintenance therapy until progression. Randomization will be stratified by performance status (0-1/2), smoking status (smoker/non-smoker), disease stage (IIIB/IV), and mutation type (19/21). A total of 228 events would provide 90% power to detect an HR for PFS of 1 at 2-sided significance level of 0.05. Response will be reviewed by both investigator and independent data monitoring committee. Patient enrollment was completed in June 2014, and the results are expected in June, 2015.

      Results:
      Not applicable

      Conclusion:
      Not applicable.

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    MINI 13 - Genetic Alterations and Testing (ID 120)

    • Event: WCLC 2015
    • Type: Mini Oral
    • Track: Biology, Pathology, and Molecular Testing
    • Presentations: 1
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      MINI13.04 - Characterization of Gene Mutations and Copy Number Alterations in Chinese Squamous Cell Lung Carcinomas (ID 3110)

      Y. Shi

      • Abstract
      • Presentation
      • Slides

      Background:
      Identification of driver mutations has led to the dramatic improvement in personalized therapy for lung adenocarcinoma. However, few targeted therapeutics are approved for treatment of squamous cell lung carcinoma. The identification of druggable molecular targets in SqCLC has been becoming a top research priority. Therefore, the aim of this study was to analyze the driver mutation profiles in a large cohort of Chinese squamous cell lung carcinomas to identify potential therapeutic targets.

      Methods:
      Approximately 2,800 COSMIC mutations from 50 oncogenes and tumor suppressor genes were analyzed on 159 samples by using Ion Torrent semiconductor-based next-generation sequencing. The gene copy numbers of FGFR1, EGFR, HER2, PDGFRA, CCND1, SOX2, CDKN2A, and PTEN were assessed by FISH on 250 samples. In addition, the status of PTEN expression was examined by immunohistochemistry on 250 samples.

      Results:
      Somatic mutations were detected in 73.6% (117/159) of patients. The most commonly mutated gene detected in this study was TP53 (56.0%, 89/159), followed by CDKN2A (8.8%, 14/159), PI3KCA (8.8%, 14/159), KRAS (4.4%, 7/159), EGFR (3.1%, 5/159), FBXW7 (2.5%, 4/159), PTEN (2.5%, 4/159), FGFR3 (1.3%, 2/159), AKT1 (1.3%, 2/159) and KIT (0.6%, 1/159). Copy number alterations were present in 77.6% (191/246) of patients, including FGFR1 amplification (13.7%, 34/248), EGFR amplification (11.4%, 28/246), HER2 amplification (8.9%, 22/246), PDGFRA amplification (7.7%, 19/246), CCND1 amplification (11.0%, 27/246), SOX2 amplification (35.0%, 86/246), CDKN2A deletion (18.7%, 46/246), and PTEN deletion (29.3%, 72/246). The loss of PTEN expression was observed in 43.5% (108/248) of patients. TP53 mutations were significantly more common in men and smokers, while the frequency of EGFR mutation was significantly higher in women and never smokers. Amplification of FGFR1, CCND1 and SOX2 genes were significantly associated with smoking. The incidence of FGFR1 amplification in patients without lymph node metastasis was significantly higher than that in patients with lymph node metastasis (19.4% vs. 10.2%,P=0.043). The frequency of SOX2 amplification in tumors with moderate and poor differentiation was significantly higher than that in tumors with well differentiation (39.6% vs. 33.6% vs. 0%,P=0.036). The incidence of loss of PTEN protein expression in patients with pleural invasion was 51.2%, which was significantly higher than that in patients without pleural invasion (P=0.017). The loss of PTEN expression was significantly associated with PTEN gene deletion (P=0.001). No significant association was observed between the molecular abnormalities and disease-free survival and overall survival.

      Conclusion:
      Genetic alterations are common in squamous cell lung cancers. The findings of this study may facilitate the identification of molecular target candidates for precision medicine in patients with squamous cell lung cancers.

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    ORAL 01 - Chemotherapy Developments for Lung Cancer (ID 88)

    • Event: WCLC 2015
    • Type: Oral Session
    • Track: Treatment of Advanced Diseases - NSCLC
    • Presentations: 1
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      ORAL01.06 - S-1 and Cisplatin versus Docetaxel and Cisplatin in Patients with Untreated Advanced NSCLC: An Randomised, Multicenter, Phase 3 Trial (ID 2734)

      Y. Shi

      • Abstract
      • Presentation
      • Slides

      Background:
      Platinum-based doublet chemotherapy is the standard chemotherapeutic regimen for treatment-naïve advanced non-small cell lung cancer (NSCLC). S-1, an oral fluoropyrimidine, combined with carboplatin or cisplatin (CDDP) has demonstrated the non-inferiority to the standard platinum doublet chemotherapy in Japanese NSCLC patients. However, its effectiveness in Chinese NSCLC patients is uncertain. The purpose of this study is to compare the efficacy and safety of these chemotherapeutic regimens in Chinese NSCLC patients.

      Methods:
      We did this randomized controlled study in 21 sites in China. Eligible patients were those aged 18-70 years who was histologically or cytologically confirmed with locally advanced or metastatic NSCLC with no prior radiotherapy, molecular targeted therapy or chemotherapy. Patients were randomized to receive either S-1 orally 80 mg/m[2]/day (40 mg/m[2]2 b.i.d., 80–120 mg/day) with 60 mg/m[2] CDDP on day 8 every 5 weeks (SP) or docetaxel and CDDP (both 75 mg/m[2]) on day 1 every 3 weeks (DP) for up to 6 cycles. Randomisation was stratified by centre, pathological classification, disease stage and gender. The primary endpoint was progression free survival (PFS), analyzed in the full analysis set. The study is registered at ClinicalTrials.jp, number Japic CTI-111479.

      Results:
      Between March 2011 and November 2012, 246 patients from 21 institutions in China were randomly assigned and received SP or DP treatment (124 vs 122) with 18-month follow-up period from the last patient randomized. In the SP and DP group, median PFS was 5.9 and 5.7 months (HR=0.68; 95% CI, 0.48-0.96) respectively, median overall survival was 19.1 and 14.8 months, respectively (HR=0.84; 95% CI, 0.61-1.14). The most common grade 3 or worse adverse events in both treatment groups were neutropenia 3.3% vs 55.1%, leukopenia 1.7% vs 39.0%, and febrile neutropenia 0.8% vs 5.9%, of 121 patients in the SP group and of 118 patients in the DP group, respectively.

      Conclusion:
      The efficacy of SP was non-inferior to DP with a better safety profile. SP would be a new standard first-line chemotherapy regimen for Chinese patients with advanced NSCLC.

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    ORAL 17 - EGFR Mutant Lung Cancer (ID 116)

    • Event: WCLC 2015
    • Type: Oral Session
    • Track: Treatment of Advanced Diseases - NSCLC
    • Presentations: 1
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      ORAL17.01 - First-Line Icotinib Versus Cisplatine/Pemetrexed Plus Pemetrexed Maintenance in Advanced NSCLC Patients with EGFR Mutation (ID 742)

      Y. Shi

      • Abstract
      • Presentation
      • Slides

      Background:
      Clinical studies with anti-EGFR agents demonstrate that EGFR TKIs play critical roles in the treatment of non-small cell lung cancer, especially in patients with positive EGFR mutation. Icotinib is an oral, selective EGFR TKIs. Phase 3 study showed that icotinib is non-inferior to gefitinib in treating unselected or EGFR-mutated advanced NSCLC patients as second-line therapy but better safety profile, which provide a rationale to examine icotinib in first-line setting. The objective of this study is to evaluate progression-free survival (PFS), overall survival (OS) and safety of icotinib in chemotherapy naïve NSCLC patients with EGFR mutation.

      Methods:
      In this phase 3, open-label, randomized study (CONVINCE, NCT01719536), 285 patients (pathologically confirmed NSCLC, positive 19/21 EGFR mutation, treatment naive) will be 1:1 randomized to receive oral icotinib (125 mg, three times daily) or cisplatine (intravenous [IV], 75 mg/m2, day 1) plus pemetrexed (IV, 500 mg/m2, day 1), patients achieving disease control after 4-cycle chemotherapy continue to receive single pemetrexed (IV, 500 mg/m2, day 1) as maintenance therapy until progression. Randomization will be stratified by performance status (0-1/2), smoking status (smoker/non-smoker), disease stage (IIIB/IV), and mutation type (19/21). A total of 228 events would provide 90% power to detect an HR for PFS of 1 at 2-sided significance level of 0.05. Response will be reviewed by both investigator and independent data monitoring committee using Response Evaluation Criteria In Solid Tumors (RECIST version 1.1). Progression Between January, 2013 and August, 2014, 285 patients were randomized and treated at 18 centers from 13 cities in China. The data cut-off was planned at October, 2015 when 228 PFS events were observed in full analysis set (80% maturity). Final results were expected on December, 2015.

      Results:
      Not applicable

      Conclusion:
      Not applicable.

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    P2.07 - Poster Session/ Small Cell Lung Cancer (ID 222)

    • Event: WCLC 2015
    • Type: Poster
    • Track: Small Cell Lung Cancer
    • Presentations: 1
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      P2.07-009 - Cisplatin Combined with Irinotecan or Etoposide for Untreated Extensive-Stage Small Cell Lung Cancer (ID 2258)

      Y. Shi

      • Abstract
      • Slides

      Background:
      This study aims to evaluate the efficacy and safety of irinotecan/cisplatin (IP) and etoposide/cisplatin (EP) in extensive-stage small cell lung cancer (ES-SCLC) and the distribution of UGT1A1. Simultaneously, the relationship between UGT1A1 genotypes and patient outcomes were assessed.

      Methods:
      Patients with untreated ES-SCLC were randomly assigned to receive either IP or EP, and blood specimens were collected to test the genotypes of UGT1A1*28 and UGT1A1*6. The association of efficacy and toxicity of IP regimen with UGT1A1 genotype was analyzed.

      Results:
      Of the 62 patients enrolled from three institutions, 30 patients were in the IP and 32 patients were in the EP arms, respectively. Disease control rates (DCR) with IP and EP were 83.3% and 71.9%, respectively (P=0.043). Median progression-free survival (PFS) for IP and EP were both 6 months. Median overall survival (OS) for IP and EP was 18.1 and 15.8 months respectively, without significant difference. Grade 3-4 thrombocytopenia was more common with EP (18.8% versus 6.7%, P=0.035), while the incidence of diarrhea was higher with IP (70% versus 15.6%, P=0.008). The incidence of grade1-4 late-onset diarrhea of wild-type, heterozygous and homozygous UGT1A1*28 were 65.0%,85.7% and 66.7% respectively (P=0.037). UGT1A1*28 polymorphisms, Eastern Cooperative Oncology Group (ECOG) performance status, chemotherapy cycles were the essential factors affecting grade1-4 late-onset diarrhea in a logistic regression analysis.Figure 1Figure 2





      Conclusion:
      The efficacy of IP regimen was similar to EP regimen for untreated ES-SCLC. UGT1A1 polymorphisms was associated with late-onset diarrhea, however it has no influence on efficacy.

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    P3.01 - Poster Session/ Treatment of Advanced Diseases – NSCLC (ID 208)

    • Event: WCLC 2015
    • Type: Poster
    • Track: Treatment of Advanced Diseases - NSCLC
    • Presentations: 2
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      P3.01-039 - Patient Characteristics and Treatment Outcome of Advanced Non-Squamous NSCLC with over 6-Month Disease Control from Icotinib (ID 2806)

      Y. Shi

      • Abstract
      • Slides

      Background:
      Epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) has an established role in the treatment of advanced non-squamous non-small cell lung cancer (NSCLC). Icotinib is an EGFR-TKI with non-inferior efficacy but milder toxicities compared with gefitinib. Disease control for over 6 months suggests that the case is not primary resistant to the drug. The present study investigated the patient characteristics and treatment outcome of advanced non-squamous NSCLC with at least 6-month disease control from icotinib.

      Methods:
      Non-squamous NSCLC patients with disease control after 6-month icotinib treatment were enrolled and retrospectively analyzed. Clinical characteristics were collected from the medical records. Efficacy and outcome data were analyzed.

      Results:
      A total of 87 patients were enrolled onto this study in which 56 were female, 18 with brain metastasis, and 32 patients harbored known EGFR mutation. For the overall population, 42(48.3%) patients achieved partial response. Response rate were 65.6%(21/32)and 38.2%(21/55)in patients with EGFR mutation and those with unknown mutation status, respectively(P=0.014). Patients with brain metastasis appeared to have lower response rate (26.7% vs 56.9%, p=0.033).The median progression-free survival (PFS) after 6 months’ icotinib treatment was 9.7 months (95% CI 4.1-15.4 months) for the overall population, and 5.0 months (95% CI 0.6-3.9 months) and 12.9 months (95% CI 3.4-6.2 months) for those with and without brain metastasis, respectively. Median progression-free survival in patients with PR or SD showed no statistically significant difference (15.5 months vs 9.3 months, P=0.477).

      Conclusion:
      The present study provided evidence from a relatively large single institutional study of icotinib in clinical practice. Patients with disease control for over 6 months showed similar clinical features to those with EGFR mutation. Those patients will have prolonged clinical benefits with continuous icotinib therapy after 6 months, regardless of PR or SD. Brain metastasis is a potential unfavorable predictive factor for PFS for those patients

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      P3.01-061 - A Prognostic Model for Platinum-Doublet Regimens as Second-Line Chemotherapy in Advanced Non-Small-Cell Lung Cancer (NSCLC) Patients (ID 1228)

      Y. Shi

      • Abstract
      • Slides

      Background:
      Poor prognosis of advanced non-small-cell lung cancer (NSCLC) patients and the promising therapeutic effect of platinum urge the oncologists to evaluate the role of platinum-doublet as second-line chemotherapy and establish the definition of platinum sensitivity in NSCLC.

      Methods:
      We retrospectively analyzed 364 advanced NSCLC patients who received platinum-doublet regimens as second-line chemotherapy after platinum-based first-line treatment. Patients were divided into four groups by their time-to-progression (TTP) after first-line chemotherapy: 0-3, 4-6, 7-12, and >12months group, respectively. Treatment efficacy of patients’ overall survival (OS), progression-free survival (PFS) and response rate (RR), as well as treatment-related toxicity, were compared among the four groups. A prognosis score system was established by Cox proportional hazard model.

      Results:
      All patients had Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-1. As part of the platinum-doublet regimen,145(39.8%) patients received taxol, 81(22.3%) received gemcitabine, 99(27.2%) received pemetrexed, 32(8.8%) received vinorelbine, 4(1.1%) received etoposide, and 3(0.8%) received irinotecan. The most frequent grade 3/4 toxicity was neutropenia (20.1%) and nausea/vomiting (3.3%).The median follow-up time was 11.0 months. Patients with TTP> 12 months had significant longer survival than the rest of the group after second-line platinum-rechallenge (HR, 0.809; 95% CI: 0.703-0.931;P=0.003).Prognostic score (TAF score) was calculated by adding 1 point each for any of the following: TTP>12 months, age≤60 years, and female, all of which were independent prognostic factors for patient survival (P=0.015, P=0.002, P=0.012, respectively). Median OS were equal to 25.0, 16.0 and 11.0 months for best (2-3 points), intermediate (1 point) and worst (0 point) category, respectively (P<0.0001, Figure 1). Figure 1 Kaplan–Meier curves of overall survival according to patients’ TAF Score. After second-line platinum-based chemotherapy, patients with a TAF Score of 2-3 had significant better survival than those scored 0 or 1 (P<0.0001). Figure 1



      Conclusion:
      A TAF score of 2 or 3 points indicates a good prognosis if advanced NSCLC patients received platinum-rechallenge after disease progression.

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