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M. Martín



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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
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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): M. Martín

      • 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.

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    P3.02c - Poster Session with Presenters Present (ID 472)

    • Event: WCLC 2016
    • Type: Poster Presenters Present
    • Track: Advanced NSCLC
    • Presentations: 1
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      P3.02c-084 - Predictive and Prognostic Clinical and Pathological Factors of Nivolumab Efficacy in Non-Small-Cell Lung Cancer (NSCLC) Patients (ID 5085)

      14:30 - 14:30  |  Author(s): M. Martín

      • Abstract

      Background:
      Immunotherapy with anti-PD1 and anti-PDL1 monoclonal antibodies significantly increases overall response rate (ORR) and overall survival (OS) of patients with advanced NSCLC in comparison with second line conventional chemotherapy. Prognostic and predictive factors able to distinguish those patients with a higher benefit from immunotherapy are warranted. Our work retrospectively analyses several clinical, pathological and analytical variables with an eventual potential prognostic and predictive value in daily patients with advanced NSCLC receiving Nivolumab.

      Methods:
      A retrospective review of clinical charts of patients with advanced NSCLC from fourteen centres of the GIDO group receiving Nivolumab between May-2015 and May-2016 was performed. Age, sex, stage, Performance Status (PS), location of metastases, presence of tumour-related symptoms and comorbidities, number of organs with metastasis, previous chemotherapy, antiangiogenic and radiotherapy treatments, and analytical data from standard blood count and biochemistry were collected and statistically analyzed.

      Results:
      A total of 175 patients fulfilled inclusion criteria. Median age was 61.5 years. One hundred and twenty-eight male (73.1%), 136 ECOG-PS 0-1 (77.7%), 150 stage IV (86,7%) and 135 had non-squamous carcinoma histology (77.1%). Sixty-five received Nivolumab in second line (37.1%), 66 as third line (37.1%) and 44 as forth or further line of treatment (25.1%). Seventeen patients (9.7%) received antiangiogenic drug in previous line of treatment, and 30 were treated with radiotherapy within 30 days before Nivolumab. Thirty-eight patients had brain metastasis (22%), 39 liver metastasis (22.3%) and 126 had more than one metastatic location (72%). 140 patients were evaluable for response, the ORR was 15.7%, median Progression Free Survival was 2.8 months, and median OS 5.81 months. Stage III (OR 3.57) and time since the beginning of previous line of treatment longer than 6 months (OR 2.52) were associated in multivariable analysis with higher probability of response to Nivolumab. PS 2 vs 0-1 (HR 1.83), time since the beginning of previous line of treatment <6 vs >6 months (HR 1,70) and more than one metastatic location vs one location (HR 1.79) were independently associated with shorter overall OS in multivariable analysis.

      Conclusion:
      Poor Performance Status, short period of time since the beginning of previous treatment and more than one metastatic location are the clinical-pathological features associated with poorer prognostic in patients with advanced NSCLC treated with Nivolumab. Limitations of the study are the small numbers and the retrospective nature