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H. Berard



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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)

      16:15 - 17:45  |  Author(s): H. Berard

      • 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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    MO08 - NSCLC - Early Stage (ID 117)

    • Event: WCLC 2013
    • Type: Mini Oral Abstract Session
    • Track: Medical Oncology
    • Presentations: 1
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      MO08.02 - Adjuvant pazopanib or placebo in resected stage I NSCLC patients: results of the NSCLC adjuvant randomized phase II trial (IFCT-0703) from the French collaborative Intergroup (ID 2274)

      16:15 - 17:45  |  Author(s): H. Berard

      • Abstract
      • Presentation
      • Slides

      Background
      Although UFT is approved in eastern countries, most guidelines do not recommend any adjuvant treatment in resected Stage I NSCLC. Pazopanib (P) is a potent, orally active multi-target receptor tyrosine kinase inhibitor of VEGFR-1, -2, -3, platelet derived growth factor (PDGFR) type-α and –β, approved in metastatic renal cell carcinoma and sarcoma. Neoadjuvant P demonstrated single-agent activity in patients with early stage NSCLC. We report the feasibility and tolerance of adjuvant P in stage I NSCLC.

      Methods
      In this double-blind randomized multicenter phase II/III trial, completely resected patients (pts) with stage I NSCLC (7[th] TNM edition) were randomized to receive either placebo or P 800 mg/d during 6 months. The Fleming’s two stage phase II primary endpoint was compliance (i.e. % of pts able to receive at least 3 months of P, whatever the dose). After 64 pts included (interim analysis), IDMC recommended to start with P 400 mg/d because of initial insufficient compliance. A one-step Fleming design was used with the new dose. Phase II design was not comparative.

      Results
      143 pts were randomized in 29 centers between March 2009 and August 2012, 71 and 72 in the placebo and P arms respectively. Most pts were male (61%) and smokers (91%), median age was 60. Pathological stage was IA in 111 pts (78%) and 16% were squamous cell carcinomas. Compliance for P800 was adequate in 38% (95% confidence interval [21-56]) vs. 87% [71-96] in placebo; for P400 in 69% [50-84] (p=0.01, compared to P800) vs. 93% [77-99] in placebo. Dose modifications were seen in 44% and 34% of P800 and P400 groups. The proportion of patient with at least one grade 3/4 toxicity was 53% [35-71] in P800 (13% [4-29] for placebo) and 38% [21-56] in P400 (27% [12-46] for placebo). No toxic deaths were observed. Only 2 pts has grade 4 toxicities in P800 (fatigue in P arm, GGT in the placebo arm). Most common toxicities G3 in P800 were diarrhea (9%), hypertension (9%), and increased transaminases (16% vs. 0% in P400); in P400 gastro-intestinal disorders (16%, 6% diarrhea) and hypertension (6%).

      Conclusion
      IFCT-0703 is the first feasibility study demonstrating that full dose of P is safe but not feasible in the adjuvant setting in NSCLC. Compliance and tolerance with reduced dose appeared acceptable for adjuvant settings.

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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 - 16:30  |  Author(s): H. Berard

      • 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.

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    P3.10 - Poster Session 3 - Chemotherapy (ID 210)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Medical Oncology
    • Presentations: 1
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      P3.10-041 - Impact of a Comprehensive Geriatric Assessment on management strategies in elderly patients with advanced no small cell lung cancer (NSCLC): a polled analysis of two phase 2 prospective study of the GFPC group. (ID 2418)

      09:30 - 16:30  |  Author(s): H. Berard

      • Abstract

      Background
      The impact of a systematic use of a Comprehensive Geriatric Assessment (CGA) on management strategies in elderly patients with no small cell lung cancer (NSCLC) is not well established. The objective of this study was to analyze if items of CGA may predict overall survival of elderly patients with NSCLC treated by chemotherapy or erlotinib in first or second lines setting.

      Methods
      Individuals data’s of GFPC 0504 study (population of fit elderly patients) and GFPC 0505 study (population of frail elderly patients) were pooled. The aim of these two prospective phase 2 trials were to compare a strategy using chemotherapy (doublet in fit patients, monotherapy in frail patients) in first line followed by erlotinib in second line to the reverse strategy (erlotinib in first line, followed by chemotherapy), in terms of progression-free survival (PFS) in second line period. Secondary outcomes were to compare first-line PFS, overall survival (OS), tolerance and costs. All patients had a complete comprehensive geriatric assessment, evaluating diverse areas as functional status, nutritional status, cognition, psychological functioning, and social support, at randomization. Predictive factors associated with OS were searched using Kaplan-Meier curves and logrank tests in the univariate analysis. A Cox model was used for the multivariate analysis.

      Results
      195 patients were included. Mean age was 77 years. 135 (70%) patients were males, 172 (89%) were stage IV and 109 (56%) were no or ex-smokers. At CGA assessment, 176 patients (70%) had an IADLD score of 3 or 4, 129 pts (66%) had a 0 or 1Charlson score, 167 pts (86%) had a simplified Charlson score < 8, 19 pts had a MMS score < 30, 146 pts (75%) had a situational score >10, 33 (17%) had a nutritional score <8. Factors predicting OS in the univariate analysis were 1-3 PS scores (1.5 [1.1 – 2.0], p=0.01); no or ex-smoker (0.70 [0.52–0.95], p = 0.02); 2-4 Charlson score (2.0 [1.4 – 2.7], p<0.0001, Simplified Charlson score ≥ 8 (1.50 [1.10–2.07],p=0.03), nutritional score>8 (0.60 [0.42 – 0.91], p= 0.01); 2 level mobility score (0.15 [0.04 – 0.62], p = 0.009). In the multivariate analysis, remained 1-3 PS (1.4 [1.02 – 1.9], p = 0.04), 2-4 Charlson score (1.46 [1.07 – 1.99], p=0.02), >8 nutritional score (0.69 [0.46 – 1.04], p= 0.07), level 2 mobility score level (0.25 [0.06 – 1.01], p = 0.06)

      Conclusion
      Comorbidities, nutritional and mobility scores, in this specific elderly population are predictive of OS. Prospective studies using large prospective cohort are needed to better select the more relevant management for elderly with advance NSCLC.