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H. Lena



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    MO07 - NSCLC - Targeted Therapies II (ID 114)

    • Event: WCLC 2013
    • Type: Mini Oral Abstract Session
    • Track: Medical Oncology
    • Presentations: 1
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      MO07.09 - Feasibility and clinical impact of re-biopsy in advanced non-small cell lung cancer: a prospective multicentric study in real world setting (GFPC study 12-01) (ID 1045)

      17:00 - 17:05  |  Author(s): H. Lena

      • Abstract
      • Presentation
      • Slides

      Background
      In case of progression under initial treatment, repeat biopsy is a new option procedure in advanced non-small cell lung cancer (NSCLC). Its justification is based on the assessment of biological markers (comparison to the initial status, emergence of resistance to chemotherapy or new biomarkers). The aim of this pragmatic prospective multicenter study was to assess feasibility and clinical utility of re-biopsy in real world setting in advanced NSCLC.

      Methods
      Patient’s main inclusion criteria was advanced NSCLC with an indication of repeat biopsy by the referent clinician. The primary outcome was the percentage of successful procedures; secondary outcomes were localization of the new biopsy, type of procedure, new biological status (comparison to initial status, new biomarkers, resistance biomarkers) and tolerance of the procedure.

      Results
      From May 2012 to May 2013, 18 centers included 102 patients. The characteristics of the 67 first patients were: male: 40%; age: 64.8 ± 10.9 years; PS 0/1: 87%; adenocarcinoma: 85%; EGFR mutated: 46.2%; no biological available assessment: 16.4%; controlled disease as best response to first line: 70%. Repeat biopsy was possible in 80.6%. The main failure reasons were: inaccessible lesion: 4.5%, medical contraindications: 14.9%. Main procedures were: bronchial endoscopy: 48.1%, trans thoracic needle biopsy: 24.1%. The procedure permits to find, in EGFR wild type population, 3 patients with a driver oncogene (1 HER2, 1 Ros1, 1 EML4 ALK); in EGFR mutated patients, 2 T790M mutations and to obtain in 3 patients with no biological data’s at the diagnosis, a biological profile. Complications were very low: 2 cases of moderate bleeding and 1 case of pneumothorax.

      Conclusion
      Repeat biopsy is a feasible procedure with acceptable adverse events. Recommendations should be realized on the indications of re-biopsy, the timing and the recommended site (primary versus metastasis, progressive target versus no progressive). Analysis of the complete population (n=102) will be presented at the meeting. Supported by an academic grant from Boehringer Ingelheim Company and Hoffmann-La Roche Company.

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    O15 - NSCLC - Chemotherapy II (ID 109)

    • Event: WCLC 2013
    • Type: Oral Abstract Session
    • Track: Medical Oncology
    • Presentations: 1
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      O15.03 - Phase III, randomized, multicenter study comparing in elderly patients (≥70 years) with stage IV non small-cell lung cancer (NSCLC) a standard strategy of treatment allocation (carboplatin based bi-therapy or monotherapy with docetaxel) based on performance status (PS) and age with an experimental strategy allocating the same chemotherapies or best supportive care (BSC) according to a comprehensive geriatric assessment (CGA) - Study ESOGIA-GFPC-GECP 08-02. (ID 694)

      10:50 - 11:00  |  Author(s): H. Lena

      • Abstract
      • Presentation
      • Slides

      Background
      Incidence of advanced NSCLC in the elderly is increasing. The use of a CGA is recommended to detect the patient’s vulnerability but its integration in treatment decision making has never been prospectively evaluated. The main objective of this study was to show that, compared to a standard strategy based on PS and age, the use of a CGA can improve the management of NSCLC in first line.

      Methods
      Randomized, multicentric, prospective phase III study in patients ≥70 y, PS 0-2 with stage IV NSCLC. We compared in arm A a standard algorithm of chemotherapy allocation based on PS and age: carboplatin based doublet in PS≤1 and age ≤75y, mono-therapy in PS =2 or age >75y with in arm B an experimental strategy of treatment allocation based on CGA: carboplatin based doublet for fit patients, mono-therapy for vulnerable patients and BSC for frail patients. Carboplatin (AUC5,d1), was associated to pemetrexed (500 mg/m2,d1) in non-squamous tumors and to gemcitabine (1000 mg/m2, d1-8) in squamous tumors, monotherapy was docetaxel 38 mg/m2 (d1-8). Four cycles of chemotherapy were to be given every three weeks. The main endpoint was time to failure treatment (TTF=duration between the date of randomization and the date the patient was withdrawn from treatment for any reason (progression, toxicity, death), secondary endpoints were Overall Response Rate (ORR), overall survival (OS), toxicity and quality of life (QoL), survival adjusted on QoL .

      Results
      493 patients were randomized from 01/2010 to 01/2013 by 45 centers. Patients characteristics were: male: 74%, median age: 77 (70-91) years, non-squamous histology: 71.8%, PS 0-1: 81.4%, ADL<6:13.9%, IADL<4:27.5%, Charlson’s index ≥2: 23%, score GDS 5≥3:2.5%. The 2 arms were well-balanced for patients characteristics except for ADL<6 (17.4% in arm A vs 10.3% in arm B). Respectively in arms A and B, 34.4% and 47% patients received a carboplatin based doublet, 65.6% and 31.5% received docetaxel and in arm B 21.5% received BSC. There was no significant difference in terms of TTF, respectively for arm A and arm B: median TTF was 99 days (d), 95%CI:[89; 126] vs. 98 d, 95%CI:[81;135], p=0.7149 and in terms of mOS: 196 d in arm A, 95%CI [171;231] vs. 185 d in arm B ,95%CI [148;235], p=0.7784. All grades toxicities were significantly less frequent in arm B than in arm A (93% vs.86.2%, p=0.016), but there was no difference in terms of grade 3-4 toxicities. All the secondary endpoints data will be updated at time of the meeting.

      Conclusion
      this large phase III study failed to show a superiority of a CGA based strategy of treatment allocation in terms of TTF. In experimental arm, 21.5% of frail patients according to Balducci’s criteria were enrolled and received an exclusive BSC management. Carboplatin-based doublets with pemetrexed and gemcitabine according to histology are feasible with a good profile of tolerance in selected elderly patients. This study will help to precise the most relevant geriatric tools and their cut-off in order to improve the management of the elderly with advanced NSCLC.

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    P1.14 - Poster Session 1 - Mesothelioma (ID 194)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Mesothelioma
    • Presentations: 1
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      P1.14-008 - Clinical features and current management of malignant pleural mesothelioma in France. TheGFPC 0804 study. (ID 2378)

      09:30 - 09:30  |  Author(s): H. Lena

      • Abstract

      Background
      Malignant pleural mesothelioma (MPM) is a rare and aggressive primitive pleural tumour, which is associated with exposure to asbestos. Chemotherapy is the main part of therapy with new cytotoxic agents resulting in superior survival time. Recently the European Respiratory Society and the European Society of Thoracic Surgeons proposed practical and up-to-date guidelines on the management of MPM. The objective of this study was to assess the current management of MPM in France between January 2005 and December 2008.

      Methods
      Observational, multicentric, national, study. The medical records of patients with MPM diagnosed during the study period in the 37 participating centers were retrospectively reviewed. Epidemiological data, clinical data, diagnosis procedures and several components of management were recorded. Mains inclusion criteria’s were a new diagnosis of MPM, a histology diagnosis and a management in the center.

      Results
      Four hundred and six patients (males: 76%) were included; median age: 68.9± 9.8 years; > 75 years: 27.8%; Asbestos exposure was found out in 259(63.8%) patients (251 professional exposure, 8 environmental exposure). Histological diagnosis was: epithelial MPM: 82.9%, sarcomatoid MPM: 10%, biphasic MPM 7.1%. The main diagnosis procedure was thoracoscopy (296 (73.1%)). Thirty patients underwent surgery (25 radical surgery, 5 pleurectomy). Pleurodesis was performed 191 times. Prophylactic drain site radiotherapy was performed in 268. Three hundred and three patients (74.6%) received first-line combination chemotherapy (mean cycles: 4.7 ± 1.7, median 6); 162 (40.2%) received second line chemotherapy (mean cycles: 3.5 ± 1.9, median 3); 56 ( 13 %) received third line chemotherapy (3.1± 2, median 3). One and two year survival rates will be updated at the congress.

      Conclusion
      This study provides an assessment of diagnosis modes and therapeutic strategies for the management of MPM in France. Further analyses are needed to model the management strategies and assess the cost-effectiveness of this disease.