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M. Duruisseaux



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    MINI 17 - WT EGFR, Angiogenesis and OMD (ID 131)

    • Event: WCLC 2015
    • Type: Mini Oral
    • Track: Treatment of Advanced Diseases - NSCLC
    • Presentations: 1
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      MINI17.12 - Survival Analysis of Stage IV NSCLC with Synchronous Isolated Metastasis in a Large Retrospective Cohort (ID 752)

      17:50 - 17:55  |  Author(s): M. Duruisseaux

      • Abstract
      • Presentation
      • Slides

      Background:
      Stage IV Non-Small Cell Lung Cancer (NSCLC) is considered as an incurable disease with median survival of 6 to 12 months. Palliative platinum based chemotherapy is the standard therapy. It has been suggested that patients with one synchronous isolated metastasis (SIM) suitable for local therapy have longer survival.

      Methods:
      Database of the Multidisciplinary Thoracic Oncology Group of our centre was retrospectively screened from 1993 to 2012. Consecutive NSCLC of any stage were included. Median overall survivals (OS) between stage III and stage IV (SIM and non SIM) were compared with log-rank test. For the multivariate analyses Cox models were performed.

      Results:
      4917 patients were registered, 85 were excluded because of missing data. Among the study population, 1335 (27.6%) patients were stage III NSCLC, 1483 (31%) non SIM stage IV and 109 (2%) SIM stage IV. SIM site were mainly brain (n=70, 64%) and adrenal gland (n=16, 15%). Clinical and histological data differed substantially between each stage (Table 1). Median OS was significantly longer in SIM stage IV compared to non-SIM stage IV (18 [IQR, 9-33] months vs 6 [IQR, 2-13] months respectively, p-value<10[-4]) and not significantly different between SIM stage IV and stage III (14 months [IQR, 6-31], p-value=0.05). In multivariate analysis (Table 2), we still observed that median survival of SIM stage IV and stage III were not significantly different (p-value= 0.47).Figure 1 Figure 2





      Conclusion:
      OS of SIM stage IV is remarkably improved compared to non SIM stage IV, and comparable to stage III. This data supports aggressive treatment in the subgroup of SIM stage IV.

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    ORAL 33 - ALK (ID 145)

    • Event: WCLC 2015
    • Type: Oral Session
    • Track: Treatment of Advanced Diseases - NSCLC
    • Presentations: 1
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      ORAL33.01 - Crizotinib Outcome and Post-Progression Management in ALK+ NSCLC: IFCT-1302 CLINALK (ID 1355)

      16:45 - 16:56  |  Author(s): M. Duruisseaux

      • Abstract
      • Presentation
      • Slides

      Background:
      Phase III trials have demonstrated the superiority of the ALK tyrosine kinase inhibitor (ALK-TKI) crizotinib compared to standard chemotherapy in advanced ALK positive non-small cell lung cancers (ALK+ NSCLC) in first line and second line setting. Objective response rate (ORR) with crizotinib ranged from 65 to 75% and median progression free survival (PFS) from 7.7 to 10.9 months. However a resistance to crizotinib always occurs. The French Cooperative Thoracic Intergroup (IFCT)-1302 CLINALK study aimed to describe clinical outcome and post-progression management in a large cohort of French patients with ALK+ NSCLC treated with crizotinib.

      Methods:
      IFCT-1302 CLINALK is a multicentric observational retrospective study. Patients with ALK+ NSCLC from centers of the IFCT network were included according to the main following criteria: advanced stage III or stage IV NSCLC, ALK immunochemistry (IHC) and/or ALK FISH positivity, crizotinib treatment in the setting of the French expanded access cohort program or as approved drug. Epidemiological and clinical data, crizotinib efficacy (objective response based on RECIST, PFS, overall survival (OS)), duration of treatment with crizotinib after disease progression and post progression outcome were collected on a case report form. The study inclusion period was from November 18 2011 to December 31 2013. The data cut-off was December 31 2014.

      Results:
      318 patients were included (median age 58.3, female 49.4%, caucasian 98.6%, non-smoker 55.1%, performance status 0/1 78.7%, adenocarcinoma 91.7%, stage III 14.5%, stage IV 85.5%, brain metastasis 35.9%). IHC was positive in 151/173 patients and FISH in 279/283 patients. Before crizotinib treatment, patients received platinum-based chemotherapy in 89% of cases and pemetrexed-based chemotherapy in 76.1%. Crizotinib was prescribed as first-line treatment in 17 patients (5.3%), second-line in 168 patients (52.8%), third-line in 58 patients (18.2%) and more than third-line in 75 patients (23.7%). Objective response was complete response in 1 patient (0.3%), partial response in 126 patients (40.0%), stable disease in 62 patients (19.7%) and progression in 58 patients (18.4%). ORR was 40.3 % (95%CI, 34.9-45.7). 262/318 patients presented progressive disease (82.4%) at time of analysis. Median PFS was 6.9 months (95%CI, 5.7-8.6). Median OS with crizotinib was 18.7 months (95%CI, 15.2-22.5). Median duration of treatment with crizotinib after disease progression was 56 days (29-203). Among 143 patients with subsequent treatments, crizotinib was rechallenged in 32 patients (22.4%). 58/143 patients (40.6%) were treated after crizotinib failure with another ALK-TKI, either alectinib (19/58, 32.8%) or ceritinib (40/58, 69.0%). The ALK-TKI sequence was crizotinib-alectinib in 18 patients, crizotinib-ceritinib in 39 patients and crizotinib-alectinib-ceritinib in 1 patient.

      Conclusion:
      This retrospective study of 318 patients with ALK+ NSCLC showed a remarkable efficacy of crizotinib, with a 18.7 months median OS, a 40.3% ORR and a 6.9 months median PFS. However, ORR and mPFS were lower than those reported in phase III trials, which may be due to less stringent selection criteria. Analysis of predictive factors of response and survival including post-progression strategies will be presented.

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