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W. Li



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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)

      07:30 - 10:30  |  Author(s): W. Li

      • 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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    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)

      10:45 - 12:15  |  Author(s): W. Li

      • 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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    ORAL 32 - EGFR WT and MT Targeting (ID 144)

    • Event: WCLC 2015
    • Type: Oral Session
    • Track: Treatment of Advanced Diseases - NSCLC
    • Presentations: 1
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      ORAL32.06 - Intercalating and Maintenance Use of Gefitinib plus Chemotherapy versus Chemotherapy Alone in Selected Advanced NSCLC: A Phase III Study (ID 2108)

      16:45 - 18:15  |  Author(s): W. Li

      • Abstract
      • Presentation
      • Slides

      Background:
      This study investigated whether intercalating and maintenance use of gefitinib with chemotherapy improves clinical outcomes versus chemotherapy alone in selected, chemotherapy-naive patients with advanced non-small cell lung cancer (NSCLC) after receiving two cycles of gemcitabine plus carboplatin with stable disease.

      Methods:
      We undertook an open-label, randomized, phase III trial at 14 centres in China. Non-smoking patients with previously untreated stage IIIB/IV lung adenocarcinoma with EGFR mutation status unknown (tissue not available) firstly received two cycles of gemcitabine (1,250 mg/m2 days 1 and 8) plus carboplatin (AUC=5, day 1). The patients with stable disease and Eastern Cooperative Oncology Group performance status of 0 or 1 were randomly assigned (1:1) to receive either gefitinib (250mg/d) on days 15 to 25 with a 4-week cycle of gemcitabine and carboplatin or a 4-week cycle of gemcitabine and carboplatin alone. A maximum of four cycles of chemotherapy was allowed in both arms after which time patients continued to receive gefitinib or observation until disease progression or unacceptable toxicity. The primary endpoint was progression-free survival (PFS). Secondary endpoints included overall survival (OS) and safety. The trial is registered at ClinicalTrials.gov, number NCT01404260, and has completed enrolment; patients are still in follow-up.

      Results:
      From June 2011 to August 2014, 219 patients with stable disease were randomized to intercalating and maintenance use of gefitinib with chemotherapy (n=109) or chemotherapy alone (n=110). The number of PFS events is 84 cases for the gefitinib plus chemotherapy group and 93 cases for the chemotherapy alone group. PFS was significantly longer in the patients receiving gefitinib and chemotherapy than in those receiving chemotherapy alone (median 10.0 vs 4.4 months, respectively; hazard ratio 0.475, 95% CI 0.349-0.646; p<0.0001). The median follow-up duration for OS is 24.5 months; OS of maturity 34.7% was not statistically different between these two arms (32.2 vs 32.5 months, respectively; hazard ratio 1.01, 95% CI 0.64-1.58; p=0.97). The addition of gefitinib to chemotherapy was well tolerated, with no increase in haematologic toxicity and no treatment-related interstitial lung disease.

      Conclusion:
      Intercalating and maintenance use of gefitinib with gemcitabine/carboplatin led to a significant improvement in PFS versus gemcitabine/carboplatin alone for Chinese nonsmoking patients with advanced pulmonary adenocarcinoma (EGFR mutation status unknown) who had previously achieved stable disease after receiving two cycles of gemcitabine/carboplatin; immature OS was not statistically different.

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