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I. Brao



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    P2.07 - Immunology and Immunotherapy (ID 708)

    • Event: WCLC 2017
    • Type: Poster Session with Presenters Present
    • Track: Immunology and Immunotherapy
    • Presentations: 1
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      P2.07-044 - Thyroid Disfunction in Advanced NSCLC Patients Treated with Nivolumab out of Clinical Trial: A Real-World Data Analysis (ID 10028)

      09:30 - 09:30  |  Author(s): I. Brao

      • Abstract

      Background:
      Immune-related adverse events occur in a subset of patients (pts) treated with immune checkpoint inhibitors blocking PD1/PD-L1 interaction. It has been reported that NSCLC pts treated with pembrolizumab who developed thyroid dysfunction (TD) had better clinical outcome. In this retrospective study, we examined the prognostic value of TD in advanced NSCLC pts treated with nivolumab.

      Method:
      Ninety-seven pts with advanced NSCLC treated with nivolumab in second and latter lines out of clinical trial at the Institut Català d’Oncologia (Barcelona, Spain) between November 2015 and March 2017 were included in this analysis. Thyroid tests were assessed at baseline and at the clinician’s discretion during treatment. TD was defined as abnormal levels of TSH value during nivolumab treatment. Progression-free survival (PFS) and overall survival (OS) were calculated using the Kaplan-Meier method.

      Result:
      Of 97 pts, most patients received nivolumab in second line (73%). The median age was 63 years (38-82), most were men (76%), former or active smokers (87%), with adenocarcinoma (59%) or squamous cell carcinoma (31%), and had good performance status (88% ECOG PS 0-1). With a median follow-up of 8 months, 42 (43%) patients had died and 60 (62%) presented progressive disease. Sixteen pts (16.5%) developed TD that was G1 (9, 56%) or G2 (7, 44%). Two pts who developed G2 hyperthyroidism required steroid treatment and 5 pts who developed G2 hypothyroidism received substitutive hormone therapy. Median time until TD was 41 days (95% CI 37-45) and pts with TD received more cycles of nivolumab compared with euthyroid pts (11.5 versus 4, respectively). Pts with TD were more likely to achieve a tumor response compared to euthyroid pts (44% versus 14%, p=0.13). Median PFS and OS were significantly longer in pts who developed thyroid dysfunction compared with euthyroid pts. Median PFS was 3.7 months in euthyroid pts vs NR in pts with TD (p=0.001; odds ratio, 0.14; 95% CI 0.04-0.48) and median OS was 8.1 months vs NR, respectively (p=0.005; odds ratio, 0.15; 95% CI 0.03-0.69).

      Conclusion:
      This real-world data analysis showed that treatment-related TD predicts favorable clinical outcome from nivolumab in advanced NSCLC pts. A comprehensive analysis of thyroid stimulating hormone (TSH) kinetics will be presented at the meeting.

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    P3.08 - Locally Advanced Nsclc (ID 724)

    • Event: WCLC 2017
    • Type: Poster Session with Presenters Present
    • Track: Locally Advanced NSCLC
    • Presentations: 1
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      P3.08-006a - Predictive Value of Geriatric Assessment and Screening Tools in Elderly Patients with Stage III NSCLC for Concurrent Chemoradiation (ID 9856)

      09:30 - 09:30  |  Author(s): I. Brao

      • Abstract

      Background:
      Concurrent chemoradiotherapy (cCRT) has proven to increase survival in patients with inoperable, locally advanced non-small-cell lung cancer (ILA_NSCLC), however there is no consensus on the treatment of elderly population. Our aim was to determine the prognostic value and ability to predict toxicity of the comprehensive geriatric assessment (CGA) in this clinical setting.

      Method:
      Elderly patients (≥ 75 years) with LA-NSCLC underwent CGA (assessing comorbidity, polypharmacy, functional status, geriatric syndromes, mood, cognition and nutritional status), the Vulnerable Elders Survey (VES-13) screening tool and the Cancer and Aging Research Group (CARG) toxicity predictive tool. Patients were classified according to the CGA into fit and medium-fit who were deemed candidates for cCRT (platinum-based chemotherapy concurrent with thoracic radiation therapy) and unfit patients that were assigned to best supportive care.

      Result:
      85 elderly patients with LA-NSCLC were included. Based on CGA, 37%, 48% and 15% were classified in fit, medium-fit and unfit respectively, and 56% were considered vulnerable according VES-13 (≥ 3). Out of 72 fit and medium-fit patients initially considered candidates for cCRT, only 54 patients (75%) were actually treated. The reasons for not administering cCRTwere: non-suitable for radiotherapy (tumor extension or poor respiratory function) (n=8), specific contraindication to chemotherapy (n=8), and patient’s decision (n=2). According to CARG-risk, fit and medium-fit patients candidates to receive cCRT were classified as high 10%, medium 52% and low 38%. Forty-two (78%) patients completed the scheduled treatment without differences between both CGA groups. The major reasons for not completing cCRT were: toxicity (10%), cancer recurrence (4%), patient decision (4%) or aggravation of comorbidities (4%). Fit and medium-fit patients receiving cCRT (63.5%) had mOS of 21.1 m (95% CI 16.2 – 26.0). VES-13 ≥ 3 was associated with shorter mOS (16.33 vs. 24.3 m; p=0.027). The most common grade 3-4 adverse events were neutropenia (20%), febrile neutropenia (7.5%), asthenia/fatigue (11%), respiratory infection (13%) and radiation pneumonitis (13%). There were not differences between GGA groups related to grade 3-4 toxicity. Medium risk patients defined by CARG had a trend towards higher risk of developing grade 3-4 toxicity (p= 0.086).Vulnerable patients defined by VES-13 had significantly higher risk of grade 3-4 toxicity (OR=3.99, 95% CI 1.28-12.37, p=0.017).

      Conclusion:
      CGA is useful in selecting elderly patients with LA-NSCLC that might benefit from adapted cCRT. VES-13 showed independent prognostic value and, unlike CARG score, it was significantly associated with higher risk of G3-4 toxicity in this clinical setting.