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X. Ren



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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)

      09:15 - 09:25 AM  |  Author(s): X. Ren

      • 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 - 10:56 AM  |  Author(s): X. Ren

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

    • Event: WCLC 2015
    • Type: Poster
    • Track: Treatment of Advanced Diseases - NSCLC
    • Presentations: 1
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      P3.01-050 - A Interim Analysis of Randomized Phase III Trial of Nedaplatin or Cisplatin Combined with Docetaxel as First-Line Treatment for Advanced ASQC (ID 1225)

      09:30 - 09:30 AM  |  Author(s): X. Ren

      • Abstract
      • Slides

      Background:
      Cisplatin combined with docetaxel is one of the stand treatment in advanced squamous cell carcinoma(ASQC) of the lung. Nedaplatin combined with docetaxel has demonstrated potent activity in ASQC in phase II study. But until now there is no randomized phase III study comparing these 2 chemotherapy regimens. The aim of this study was to evaluate and compare the efficacy and safety between the combination chemotherapy of nedaplatin or cisplatin plus docetaxel in patients with ASQC.

      Methods:
      This is a multicentre, open-label, randomized, phase III study in China (NCT02088515). Chemo-naive stage IIIB/IV squamous NSCLC with Eastern Cooperative Oncology Group performance status 0/1 were randomized (1:1) to four cycles of nedaplatin (80 mg/m[2]) plus docetaxel(75 mg/m[2]) or cisplatin(75 mg/m[2]) plus docetaxel (75 mg/m[2]) . The primary endpoint was progression-free survival (PFS). Secondary end points were overall survival (OS), overall response rate (ORR), disease control rate (DCR) and quality of life.

      Results:
      From December 2013 to January 2015, 117 patients were accrued: nedaplatin plus docetaxel (n = 57) and cisplatin plus docetaxel (n = 60). The objective response rates were 27% and 31% and the disease control rate were 78.92 % and 82.67% in nedaplatin and cisplatin groups, respectively. There is no significance difference in nausea / vomiting(21% vs 30%) , diarrhea(3% vs 5%), liver dysfunction(12% vs 15%), neutropenia(60% vs 65%), thrombocytopenia(10% vs 12%), anemia(8% vs 7%) between the 2 arms. The renal dysfunction incidence is higher in the cisplatin group(3% vs 0%). Although there is no 3/4 grade toxicities difference between 2 arms including nausea / vomiting(0% vs 0%) , diarrhea(0% vs 1%), liver dysfunction(0% vs 0%), renal dysfunction(0% vs 0%) , neutropenia(4% vs 3%), thrombocytopenia(0% vs 0%), anemia(0% vs 0%) . This is an interim analysis and we haven't got the data of survival and quality of life.

      Conclusion:
      There is no ORR difference between the group of nedaplatin plus docetaxel and cisplatin plus docetaxel. But the toxicity of nedaplatin regiment is less toxicities, especially in renal toxicity,as first-line treatment for patients with advanced squamous NSCLC

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