Author of

• 17556

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  P2.03a - Poster Session with Presenters Present (ID 464)

  • Event: WCLC 2016
  • Type: Poster Presenters Present
  • Track: Advanced NSCLC
  • Presentations: 1
  • Moderators:
  • Coordinates: 12/06/2016, 14:30 - 15:45, Hall B (Poster Area)

  • 17601

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    P2.03a-045 - Safety of Bevacizumab (B) in Elderly Stage IV Non-Squamous NSCLC Patients Selected by Geriatric Assessment: A Phase II Study (ID 5518)

    14:30 - 14:30  |  Author(s): S. Blasco Cordellat
    • Abstract

    Background:
    The addition of B to platinum-doublet chemotherapy in first-line treatment for non-squamous NSCLC showed improvement of progression free survival (PFS) and overall survival (OS) (ECOG 4599). However, in a subset analysis of this trial, grade 3 to 5 toxicities occurred more frequently in elderly patients treated with CPB compared with patients treated with CP and in elderly patients compared with younger patients. Grade 3/4 neutropenia was 34% in elderly patients. GIDO1201 is the first trial addressed specifically to assess the safety of B in elderly patients. We hypothesized that an adjusted dose-regimen administered to elderly patients selected by an adapted geriatric assessment could decrease the rate of neutropenia to 20%.
    
    Methods:
    Elderly (≥70 years old) chemotherapy-naive stage IIIB/IV or recurrent non-squamous NSCLC patients, ECOG-PS 0-1, measurable target lesion, and adequate organ functions were eligible for this study. After an Adapted Geriatric Assessment, elderly patients with NSCLC received a modified regimen consisting on triweekly C AUC 4 + P 175 mg/m[2] + B 7.5 mg/kg
    
    Results:
    Twenty-six eligible patients (20 male, 6 female; median age, 76 years) were enrolled between August 2013 and June 2015. Six and 20 patients had ECOG-PS of 0 and 1, respectively. The median number of CPB treatment cycles received was 4 (2-6). 17 patients (66%) received B maintenance (median number of cycles 7). At the time of analysis, 3 patients are still on treatment. Grade 3/4 neutropenia was observed only in one patient (3.8%). Grade 3/4 non-haematological and haematological toxicities were observed in 10 (38.5%) and 4 (15.4%). pts, respectively. The most common grade 3/4 AEs included anaemia (11.5%) and hypertension (15.4%). One fatal AE was observed. At the time of this preliminary analysis, median PFS was 8.22 months (6.0-10.3) and median OS was 11.6 (8.0-15.1)
    
    Conclusion:
    CPB triweekly followed by BEV showed an acceptable toxicity profile with a favourable grade 3-4 neutropenia of 3.8% compared with previously reported. Efficacy of this first-line regimen for selected elderly non-squamous NSCLC patients was similar to younger patients. However, this study has the limitation of the small number of patients, although a simple size of 51 patients was needed to test this hypothesis, the study was halted after the inclusion of 26 patients due to the slow recruitment.