Author of

• 13420

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  P1.01 - Poster Session/ Treatment of Advanced Diseases – NSCLC (ID 206)

  • Event: WCLC 2015
  • Type: Poster
  • Track: Treatment of Advanced Diseases - NSCLC
  • Presentations: 1
  • Moderators:
  • Coordinates: 9/07/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)

  • 13435

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    P1.01-015 - Clinical-Pathological and Survival Analysis of Patients with Advanced NSCLC and EGFR Mutation Treated With a Drug Therapy Anti-T790M (ID 2324)

    09:30 - 17:00  |  Author(s): M.D. Mediano
    • Abstract

    Background:
    Multiple phase III trials have demonstrated the benefit in terms of RR and PFS of the EGFR TKIs versus platinum-based chemotherapy in patients with advanced NSCLC and EGFR mutation. Median PFS of these patients ranges from 9-13 months, time where a new therapy approach is needed, the most commonly chemotherapy nowadays. The main resistance mechanism described in this clinical situation is the development of T790M resistance mutation. There are no comparative efficacy data among chemotherapy and T790M targeted therapies. Our research included data from 15 patients treated in our Institution Phase I Unit with a T790M inhibitor analyzing the effectiveness according to their clinical features and mutational profile (T790M carriers or not)
    
    Methods:
    Descriptive clinico-pathological and efficacy analysis from October 2013 to March 2015 of patients with advanced NSCLC and EGFR mutation in progression and receiving T790M targeted therapy in the context of a phase I clinical trial performed in our Clinica Trial Unit.
    
    Results:
    Fifteen patients were included. The median age resulted 60 years (range 37-80 years) with a proportion of 8 (55%)/7 (45%) female/men. The entire study population was Caucasian and had an histological diagnosis of stage IV NSCLC with the presence of activating mutation of EGFR (66% L848R and del19 44%). In relation to smoking exposition, most of the patients were past-smokers (55%) or active (13%). All patients received a specific T790M inhibitor, 7 of them (45%) with a confirmed T790M mutation by local and/or local analysis. The average of prior lines of therapy before the experimental T790M inhibitor was 1,9. No grade 3/4 toxicities were reported. After an average follow up of 17 months, PFS of the overall population was 4,73 months, with a statistically significance difference between T790M positive patients (8,14 months) versus negative or unknown (1,8 months). We have no outcome at present of the OS for the active treatment of most the patients.
    
    Conclusion:
    Despite the limitation of the number of patients and follow-up time, our research suggested a clear survival benefit with the T790M inhibitor in the context of advanced NSCLC patients harboring T790M resistance mutation versus non in progression after EGFR TKI first line therapy.
    
    

• 14306

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  P2.01 - Poster Session/ Treatment of Advanced Diseases – NSCLC (ID 207)

  • Event: WCLC 2015
  • Type: Poster
  • Track: Treatment of Advanced Diseases - NSCLC
  • Presentations: 1
  • Moderators:
  • Coordinates: 9/08/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)

  • 14308

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    P2.01-002 - Immunotherapy as an Effective Treatment Option in the Metastatic NSCLC in Spite of PD-1 or PDL-1 Inhibition and Line of Therapy (ID 2275)

    09:30 - 17:00  |  Author(s): M.D. Mediano
    • Abstract

    Background:
    Lung cancer is the leading cause of cancer death globally. Important survival benefit has been recently obtained with targeted therapies against driver mutations. Immunotherapy approach under development will probably represent a new standard option of care in pretreated patients: clinical and/or pathological prognostic factors will further be needed to select the maximum benefit treated population.
    
    Methods:
    We reviewed retrospectively clinical, pathological and efficacy data from 28 patients with metastatic NSCLC treated with anti-PD1 (programmed cell death 1) and anti-PDL1 (programmed cell death-ligand 1) check-point inhibitors in our Institution between 2013 and 2015.
    
    Results:
    28 metastatic NSCLC patients were treated: 2 (7,14%) in first line, 14 (50%) in second line and 12 (40%) patients beyond third line. 82% were males, median age was 61 years old, and 71,4% adenocarcinomas. Mutation profile was defined as 1 patient (3,5%) EGFR positive and 1 patient ROS-1 positive (3,5%). PDL-1 resulted positive by immunohistochemistry on 43% of total population. 75% of patients received anti-PDL-1 therapy versus 25% anti-PD1 check point inhibitors. With a median follow up time of 22 months, overall response rate (ORR) was 10,7% and disease control rate (DCR) was 64,3%: no differences were seen by immunotherapy strategy. ORR, DCR, and median time for treatment (MTT) were analysed according to the line of therapy and type of immunotherapy. ORR 0%, DCR 100% and MTT 104 days at first line setting; ORR 7,14%, DCR 64,28% and MTT 98 days at second line; and finally, ORR 18,18%, DCR 63,63% and MTT 67 days at third line or beyond. Most of patients remain on treatment so survival data were not reached. The most common grade III-IV adverse events related with treatment were pneumonitis (14,3%), fatigue (3,6%), hyperamylasemia (3,6%), hypertransaminasemia (3,6%) and neurologic disorders (7%).
    
    Conclusion:
    Our retrospective and local analysis confirmed immunotherapy as a safe and effective therapy option with high rate of DCR and longer MTT than standard chemotherapy, independently PD-1 or PDL-1 inhibition or line of therapy used.