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K. Inoue



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    MO24 - NSCLC - Chemotherapy III (ID 110)

    • Event: WCLC 2013
    • Type: Mini Oral Abstract Session
    • Track: Medical Oncology
    • Presentations: 1
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      MO24.06 - Randomized Phase II study of Pemetrexed plus Carboplatin followed by Pemetrexed versus Paclitaxel plus Carboplatin followed by Pemetrexed in Advanced Non-squamous, Non-small Cell Lung Cancer (LOGIK 0904). (ID 2235)

      10:30 - 12:00  |  Author(s): K. Inoue

      • Abstract
      • Presentation
      • Slides

      Background
      PARAMOUNT study confirmed the improvement of overall survival with continuation maintenance chemotherapy with pemetrexed (PEM) compared with placebo after 4 cycles of cisplatin plus PEM induction chemotherapy recently. JMEN study also showed the usefulness of switch maintenance with PEM after 4 cycles of platinum doublet without PEM. In this study, we conducted the randomized phase II study comparing switch or continuation maintenance chemotherapy with PEM after standard doublet regimen.

      Methods
      Histologically/cytologically confirmed stage IIIb or IV non-squamous NSCLC patients with mesurable disease, ECOG PS 0-1, age over 20 years and adequate organ function were eligible for the study. Randomization was stratified by gender and stage of disease. Patients received 3 cycles of PEM 500mg/m2 plus CB AUC6 (Arm 1) or PAC 200mg/m2 plus CB AUC6 (Arm 2). All patients with non-PD after induction chemotherapy continued PEM 500mg/m2 until PD. Primary endopoint is progression free survival (PFS).

      Results
      140 pts were enrolled and assigned to Arm1 or Arm2 randomly. The clinical data of 132 pts were used as full analysis set (median age 64.5 yrs (42-83), 85 male, 120 stage IV, 58 PS0, 127 adenocarcinoma, 46 never smoker). 42 pts had prior treatment including 9 sugery, 1 adjuvant chemotherapy, 24 radiotherapy and 8 others. In both arms, 50% of pts entered into the maintenance treatment with PEM after completion of 3 cycles induction chemotherapy. The median PFS was 113 days in Arm 1 and 143 days in Arm 2, respectively. Cox-proportinal Hazard ratio was1.047, and 95% HR confidential interval was 0.707-1.549. Stratified Log-Rank test showed no significant difference in both arms.

      Conclusion
      There was no significant difference for PFS in Arm 1(PEM plus CB followed by PEM) and Arm 2 (PAC plus CB followed by PEM).

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    P2.11 - Poster Session 2 - NSCLC Novel Therapies (ID 209)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Medical Oncology
    • Presentations: 1
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      P2.11-027 - The response of non-adenocarcinoma non-small-cell lung cancer patients with EGFR mutations to EGFR-TKI: A retrospective multicenter study (LOGIK 1104) (ID 2021)

      09:30 - 16:30  |  Author(s): K. Inoue

      • Abstract

      Background
      The epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) such as gefitinib and erlotinib, are used to treat non-small cell lung cancer with EGFR sensitive mutations. The response rates to EGFR-TKI for mainly adenocarcinoma patients with EGFR mutations are very high, ranging from 62-85%, with a median progression-free survival (PFS) of 8.0-13.1 months and a median overall survival of 21.6-35.5 months. EGFR mutations can also be detected in a few non-adenocarcinoma tumors, however, the response of such cases to EGFR-TKIs is controversial. This study assessed the effectiveness of EGFR-TKIs in non-adenocarcinoma non-small cell lung cancer (non-adeno NSCLC) with EGFR mutations.

      Methods
      Nine institutions of the Lung Oncology Group in Kyushu (LOGIK) joined in this study. The primary endpoint was the response rate (RR), and the secondary endpoints were the disease control rate (DCR), overall survival, duration of disease control and the incidence of adverse events. A total of 43 cases of non-adeno NSCLC who were treated with EGFR-TKIs were retrospectively enrolled in this study.

      Results
      This study included 28 males and 15 females, and 18 of the 43 were never smokers. The ages of the patients ranged from 42 to 83 years, with a mean of 67 years. The pathological types were squamous cell carcinomas in 26 patients, adenosquamous cell carcinomas in six, large cell carcinomas in six, and others in five patients. Of these 43 cases, 18 with EGFR mutations were included in the analysis. The incidence of EGFR mutations was significantly higher in females than in males (80.0% vs. 21.4%, p<0.01), and in never smokers than in smokers (72.2% vs. 20.0%, p<0.01). The EGFR-TKIs administered were gefitinib in 27 patients and erlotinib in 16. In the patients with EGFR mutations, the RR and DCR were 83.8% and 93.8%, which were significantly superior to the rates in patients without EGFR mutations, which were 4.1% and 20.1%, respectively (p<0.01).

      Conclusion
      Even in patients with non-adeno NSCLC, the mutation of EGFR gene was a predictive factor for the response to EGFR-TKI treatment. In this meeting, we will show a detailed report based on the pathological analysis performed by the pathological committee of the LOGIK.