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Jacques Le Treut



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    EP1.01 - Advanced NSCLC (ID 150)

    • Event: WCLC 2019
    • Type: E-Poster Viewing in the Exhibit Hall
    • Track: Advanced NSCLC
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/08/2019, 08:00 - 18:00, Exhibit Hall
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      EP1.01-05 - EGFR-2013-CPHG, a Real-World Study of EGFR Mutant Advanced Non-Small-Cell Lung Cancer Patients Treated with Erlotinib (ID 892)

      08:00 - 18:00  |  Author(s): Jacques Le Treut

      • Abstract
      • Slides

      Background

      Erlotinib (E) is a first-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor labelled in France and effective as a first-line treatment in advanced non-small-cell lung cancer (NSCLC). E has demonstrated a better efficacy than chemotherapy in EGFR mutant NSCLC in phase III trials.

      Method

      We undertook a multicentric study in 42 French Nonacademic Hospital Centres. Patients aged 18 years and older with histologically confirmed stage IIIB or IV NSCLC and harboring a confirmed activating mutation of EGFR received oral E (150 mg/day). We report here patient characteristics, progression-free survival (PFS), overall survival (OS), and safety data. Statistical analyses by R software were based on a Cox model and Kaplan-Meier method.

      Result

      Between April 1st, 2014 and March 31st, 2016, 184 patients were recruited: mean age = 72 years old, 125 (69.5%) female, 158 (90.8%) Caucasians, 112 (63.6%) non-smokers, 167 (94.9%) adenocarcinoma (21 stage IIIB and 156 stage IV), 127 (65.6%) ECOG 0-1, 40 (26%) brain metastasis at inclusion and 75 (42.4%) were treated by E in second- or latter line. 179 patients were included in the PFS and OS analysis. Median follow-up was 23.8 months, median PFS was 11.7 months and median OS was 25.8 months. Median survival rates at one year were 48.6% for PFS and 75% for OS. Risk of death was not correlated with brain metastasis (HR=1.15, IC95:0.67-1.97, p=0.296) but with ECOG = 2 (HR=4.55, IC95:2.05-10.10, p<0,001). E had a manageable safety profile (7.7% grade 3-4 adverse events at 6 months) and no new safety signals were identified.

      N %
      Patients 184
      Mean age (years) 72
      Sex

      Males

      Females

      59

      125

      30.5

      69.5

      Race
      Caucasians 158 90.8
      Smoking status
      Non-smokers 112 63.6
      Histological type
      Adenocarcinoma 167 94.9
      Staging

      Stade IIIB

      Stade IV

      21

      156

      ECOG
      0 or 1 127 65.7
      Brain metastases at inclusion 40 26
      Second-lind therapeutic strategy and more
      Erlotinib 75 42.4
      Progression-free survival and overall survival 179

      Median Progression-free survival (Months)

      Median Overall Survival (Months)

      11.7

      25.8

      Conclusion

      Data from EGFR-2013-CPHG real-world study are consistent with the efficacy and safety of E in EGFR mutant NSCLC patients seen in phase III clinical trials.

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    OA15 - Targeted Agents and Immunotherapy for Small Cell Lung Cancer (ID 152)

    • Event: WCLC 2019
    • Type: Oral Session
    • Track: Small Cell Lung Cancer/NET
    • Presentations: 1
    • Now Available
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      OA15.02 - Carboplatin-Etoposide Versus Topotecan as Second-Line Treatment for Sensitive Relapsed Small-Cell Lung Cancer: Phase 3 Trial (Now Available) (ID 546)

      14:30 - 16:00  |  Author(s): Jacques Le Treut

      • Abstract
      • Presentation
      • Slides

      Background

      Topotecan is currently the only drug approved in Europe in second line setting for small-cell lung cancer (SCLC). This study investigates whether the doublet carboplatin-Etoposide was superior to topotecan monotherapy as second-line treatment in patients with sensitive relapsed SCLC.

      Method

      this open-label, multicenter, phase 3 trial randomized patients with SCLC that responded to first-line platin etoposide doublet treatment but showed evidence of disease relapse or progression at least 90 days after completion of the first-line treatment. Enrolled patients were randomly assigned (1:1) to receive combination chemotherapy (Six cycles of 3-weeks Carboplatin, AUC 5, day 1 and Etoposide 100 mg/Sqm/d 1-3, intra-venous) or oral Topotecan (2.3 mg/Sqm/d 1-5, every 3 weeks). Primary endpoint was progression free survival (PFS). Secondary endpoints were overall survival (OS), objective response rate (ORR), quality of life and tolerance in the intention-to-treat population, (clinical trialgouv: NCT02738346)

      Result

      178 patients were screened and 164 randomized in 36 centers, with 82 assigned to each treatment group (age: 64.5 ± 7.2 years, men: 72.8%, PS 0/1/>1: 34.7%/56.3%/ 9%. Median PFS was significantly longer in combination chemotherapy group (4.7 months, 95% CI: 3.9-5.5) compare to topotecan group (2.7 months, 95% CI: 2.3-3.2), HR: 0.6, 95% CI 0.4-0.8, p < 0.002. The ORR were significantly more important in the combination chemotherapy than in topotecan arm (ORR 49 % vs 25 %, p < 0,002), but without difference in term of median OS, 7.5 months (95% CI: 5.4-8.7) in combination chemotherapy group versus 7.4 months (95% CI.6.0-9.3) in topotecan arm. Grade 3/4 neutropenia were significantly more common in the topotecan group than in the combination chemotherapy group (35.8% vs 19.7 %, p < 0.001. There is a non-significant trend for more febrile neutropenia in topotecan arm compare to combination arm (13.6 % 6.2 %, p = 0.19, and no difference for grade 3/4 thrombopenia, 35.8 % vs 30.9 %, and anemia, 24.6 % vs 21 %, for topotecan and combination arms, respectively. Two treatment-related deaths occurred in the topotecan arm (febrile neutropenia with sepsis), none in the combination arm. Results of quality of life outcomes will be presented at the meeting.

      Conclusion

      platin - etoposide re-challenge can be considered as a standard second-line chemotherapy for sensitive relapsed SCLC.

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