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Feliciano Barron



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    MA08 - Clinical Trials in Brain Metastases (ID 906)

    • Event: WCLC 2018
    • Type: Mini Oral Abstract Session
    • Track: Advanced NSCLC
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/24/2018, 15:15 - 16:45, Room 203 BD
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      MA08.02 - Prophylactic Cranial Irradiation Reduces the Risk of Brain Metastases in High-Risk Lung Cancer Patients: EGFR and ALK Mutations (ID 13496)

      15:20 - 15:25  |  Author(s): Feliciano Barron

      • Abstract
      • Presentation
      • Slides

      Background

      Prophylactic Cranial Irradiation (PCI) is considered standard-of-care for small-cell lung cancer, due to consistent findings of a reduced risk of developing brain metastases (BM) and a survival benefit. The role of PCI for patients with Non-small cell lung cancer (NSCLC) is less well established, since a clear survival benefit has not been identified, although high-risk subgroups have been identified, including patients with driver mutations and with elevated carcinoembryonic antigen (CEA) levels.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      We assessed the use of PCI compared to observation in patients with stage IV NSCLC (NCT01603849). PCI dose was set 25 Gy/10 f. An amendment to the original record was requested so that patients who received PCI after January 2016 had hippocampal sparing. Primary end point was Intracranial Progression-Free survival (IPFS), secondary was overall survival (OS).

      4c3880bb027f159e801041b1021e88e8 Result

      84 patients were included, 43 were randomized to observation and 41 to PCI. 83.3% had a driver mutation (DM). Baseline characteristics were well balanced among groups. Median IPFS was 21.0 months (95%CI 16.2-25.9). Factors which were independently, positively associated with IPFS included ECOG (p=0.012) and therapeutic arm (p=0.006). PCI was associated with lower odds of progression to CNS (OR:0.16 (0.04–0.53), p=0.006).Cumulative incidence of BM at 1-yr was higher among patients without PCI (22% vs. 3%, p<0.001). Relative risk for IPFS in patients with DM was 0.29 (0.10-0.82, p=0.01), HR for OS was 0.48 (0.20-1.16, p=0.098). Median OS was higher in the PCI group compared to control [42.8 (95%CI: 28.1–57.6) vs. 25.9 (95%CI: 17.7 – 34.2)] months. Last, PCI was associated with lower hazards of death, 0.47 (0.24–0.95), p=0.035.rt-prof figure.png

      8eea62084ca7e541d918e823422bd82e Conclusion

      PCI significantly increases IPFS and decreases risk of death in patients with advanced NSCLC, without neurocognitive impairment or decreased QoL. This intervention appears to be particularly useful for patients with good performance status and driver mutations. PCI increased IPFS without neurocognitive impairment or decreased QoL.

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    MA25 - Oligometastasis: Defining, Treating, and Evaluating (ID 929)

    • Event: WCLC 2018
    • Type: Mini Oral Abstract Session
    • Track: Oligometastatic NSCLC
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/26/2018, 13:30 - 15:00, Room 203 BD
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      MA25.10 - Complete Response by PET-CT After Radical Treatment in Oligometastatic Non-Small Cell Lung Cancer Predicts Longer Survival   (ID 14232)

      14:35 - 14:40  |  Author(s): Feliciano Barron

      • Abstract
      • Presentation
      • Slides

      Background

      Evidence is rapidly accumulating for the use of radical treatment approaches for patients with oligometastatic Non-small cell lung cancer (NSCLC). Several limitations remain, however, to further strengthen the use of radical therapy as opposed to standard maintenance therapy, including a lack of robust markers to predict patient response. In this study, we assessed the utility of reaching a complete response (CR) by PET-CT in patients with oligometastatic disease after radical treatment (NCT02805530).

      a9ded1e5ce5d75814730bb4caaf49419 Method

      We included patients with stage IV NSCLC who presented with ≤5 synchronous, any-site metastases (oligometastatic disease) as assessed by PET-CT. Patients received 4 initial cycles of systemic treatment. Following, patients were evaluated by PET-CT and those with stable disease and partial response received radical treatment to the primary site and metastases (surgery, radiotherapy, chemotherapy plus radiotherapy, radiofrequency and SBRT alone or in any combination). Response to radical treatment was evaluated by PET-CT. Maintenance treatment was permitted.

      4c3880bb027f159e801041b1021e88e8 Result

      37 patients were included in the analysis. Mean age was 55.7. At diagnosis 43.2% of patients presented with CNS metastases. After 4 cycles of first-line therapy, 100% of patients received treatment to the primary site, while 83.8% also received therapy to metastases. Following radical treatment, 19 (51.4%) patients achieved a CR by PET-CT, while 18 (48.6%) had a partial response (NON-CR). Median PFS was 26.2 months (95%CI 12.2-40.1), and was positively affected by CR by PET-CT (NR vs. 14.3 [95%CI 11.9-16.7]; p<0.001). Median overall survival (OS) was NR. OS was also positively affected by CR by PET-CT (42-month survival: 82.5%±18 for CR vs. 34.4%±28 for NON-CR by PET-CT; p=0.01).

      8eea62084ca7e541d918e823422bd82e Conclusion

      Patients with oligometastatic NSCLC who undergo radical treatment and reach a CR by PET-CT show a significant improvement in survival outcomes. Our results suggest that CR by PET-CT could serve as a surrogate marker for prolonged survival in this patient sufigure rc petct.pngbgroup.

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    P1.01 - Advanced NSCLC (Not CME Accredited Session) (ID 933)

    • Event: WCLC 2018
    • Type: Poster Viewing in the Exhibit Hall
    • Track:
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/24/2018, 16:45 - 18:00, Exhibit Hall
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      P1.01-03 - Effect of Prophylactic Cranial Irradiation on Cognitive Function and QoL in NSCLC Patients at High Risk of Brain Metastases (ID 14166)

      16:45 - 18:00  |  Author(s): Feliciano Barron

      • Abstract
      • Slides

      Background

      Up to 50% of NSCLC patients develop brain metastases (BM). Prophylactic Cranial Irradiation (PCI) is a potentially useful strategy to prevent this event, although its use remains controversial due to inherent risks. Therefore, actions such as dose adjustment for Whole Brain Radiotherapy (WBRT), or hippocampal-sparing techniques have been explored. We evaluated the impact of PCI on cognitive function and Quality of Life (QoL).

      a9ded1e5ce5d75814730bb4caaf49419 Method

      Within the clinical trial NCT01603849 we evaluated a total of 84 histologically-confirmed NSCLC patients with high risk of developing BM (adenocarcinomas harboring oncodrivers (EGFR or ALK) and/or carcinoembryonic antigen (CAE) level at diagnosis ≥20 pg/mL). Patients were randomized 1:1, 41 to receive PCI and 43 to observation. Cognitive function (CF) was evaluated before and after treatment and at 6, 9 and 12 months with Mini Mental State Examination (MMSE). Reliable Change Index was used to evaluate the effect on CF. QoL was assessed through the European Organization for Research and Treatment of Cancer (EORTC-QLQ-30). Differences between groups were compared with Mann Whitney U and Friedman test. OS was estimated from the first MRI assessing the absence of BM until death/last follow-up with Kaplan-Meier and compared with Log-Rank test.

      4c3880bb027f159e801041b1021e88e8 Result

      83.3% of patients presented an EGFR-mutation (n=60) or ALK-rearrangement (n=6). Median OS was 42.8 vs. 25.9 months among patients with or without PCI (p=0.031). MMSE scores and median score values for global QoL, fatigue and cognitive functioning did not differ among groups or at baseline and follow-up. There were also no differences in percentual change at 1-yr (Table).

      Clinical changes (MMSE)

      3 months

      6 months

      9 months

      1 yr

      n/N (%)

      n/N (%)

      n/N (%)

      n/N (%)

      Without PCI

      Without Changes

      38/43 (88.4)

      34/42 (81)

      34/42 (81.0)

      29/37 (78.4)

      Cognitive Deterioration

      0/43 (0)

      2/42 (4.8)

      0/42 (0)

      0/37(0)

      Cognitive Improvement

      5/43 (11.6)

      6/42 (14.2)

      8/42 (19.0)

      8/37 (21.6)

      With PCI

      Without Changes

      39/41 (95.1)

      31/34 (91.2)

      31/34 (91.2)

      27/31(87.1)

      Cognitive Deterioration

      1/41 (2.4)

      0/34 (0)

      0/34 (0)

      1/31(3.2)

      Cognitive Improvement

      1/41 (2.4)

      3/34 (8.8)

      3/34 (8.8)

      3/31 (9.7)

      Baseline

      3 months

      6 months

      9 months

      1 yr

      p-Value (*)

      Diff. at 1 yr

      Median (IQR)

      Median (IQR)

      Median (IQR)

      Median (IQR)

      Median (IQR)

      Median (IQR)

      Global QoL

      Without PCI

      66.7 (50.0 - 83.3)

      66.7 (50.0 - 83.3)

      66.7 (64.6 - 83.3)

      83.3 (66.7 - 85.4)

      83.3 (75.0 - 87.5)

      <0.001

      8.3 (0.0 - 29-2)

      With PCI

      66.7 (50.0 - 83.3)

      66.7 (50.0 - 83.3)

      66.6 (66.7 - 83.3)

      83.3 (66.7 - 83.3)

      83.3 (75.0 - 83.3)

      <0.001

      0.0 (0 - 25.0)

      p-Value (diff between groups)

      0.956

      0.786

      0.903

      0.172

      0.595

      0.791

      Fatigue

      Without PCI

      22.2 (11.1 - 44.4)

      33.3 (22.2 - 44.4)

      22.2 (11.1 - 44.4)

      22.2 (11.1 - 44.4)

      22.2 (11.1 - 33.3)

      <0.001

      0.0 (-22.2 - 0.0)

      With PCI

      22.2 (5.6 -33.3)

      33.3 (11.1 - 33.3)

      22.2 (8.3 - 33.3)

      22.2 (8.3 - 33.3)

      22.2 (0.0 - 33.3)

      <0.001

      0 (0 - 0)

      p-Value (diff between groups)

      0.493

      0.132

      0.942

      0.931

      0.93

      0.553

      Cognitive

      Without PCI

      83.3 (66.7 - 100.0)

      83.3 (66.7 - 100.0)

      83.3 (66.7 - 100.0)

      73.3 (83.3 - 100.0)

      73.3 (83.3 - 100.0)

      0.004

      0 (0 - 0)

      With PCI

      83.3 (66.7 - 100.0)

      83.3 (66.7 - 100.0)

      83.3 (66.7 - 100.0)

      91.7 (70.8 - 100.0)

      83.3 (83.3 - 100.0)

      0.017

      0.0 (0.0 - 0.0)

      p-Value (diff between groups)

      0.854

      0.983

      0.521

      0.411

      0.757

      0.734

      8eea62084ca7e541d918e823422bd82e Conclusion

      PCI was not associated with significant differences in MMSE and QoL scores, furthermore there were no differences when assessing specific subscales (e.g. fatigue and cognitive functioning). These results along with the clinical benefit in OS highlight the benefit of this approach particularly among patients at high risk of developing BM.

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    P1.09 - Pathology (Not CME Accredited Session) (ID 941)

    • Event: WCLC 2018
    • Type: Poster Viewing in the Exhibit Hall
    • Track:
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/24/2018, 16:45 - 18:00, Exhibit Hall
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      P1.09-21 - Circulating Tumor DNA Improves Genotypification and Detection of Targetable Alterations in Selected Lung Cancer Patients (ID 12218)

      16:45 - 18:00  |  Author(s): Feliciano Barron

      • Abstract
      • Slides

      Background

      Several studies have shown that NSCLC genomic background among Hispanics differs from other populations. The finding of low frequency genomic alterations in cfDNA to increase diagnostic accuracy in NSCLC could refine the treatment. We hypothesized that cfDNA can be an alternative or complement for detection of low frequency genomic targets. We aimed to understand the landscape of cfDNA-identified genomic drivers in a cohort of patients (pts) with NSCLC of Hispanic ancestry.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      We collected data from 51 Hispanic pts (Mexico and Colombia) with advanced NSCLC (Stage III/IV) who previously underwent tissue screening for ALK, EGFR, and ROS1. CfDNA was extracted from plasma and analyzed by a commercial NGS test (Guardant360â) which detects genomic alterations (alts) in up to 73 genes.

      4c3880bb027f159e801041b1021e88e8 Result

      Median age was 56 years (31-83). Most pts were female (64.7%) and never smokers (76.5%). 94% of cases (48/51) had cfDNA detectable alts with a mean number of 3.37 cfDNA alts per test (range, 1 -10). Of the 48 pts with cfDNA genomic alts, 23 (47.9%) had a known genomic driver (EGFR (27.4%), TP53 (13.7%), ALK (7.8%), KRAS (5.8%), and BRAF (3.9%)). Interestingly, cfDNA was able to detect some genomic alts previously undetected by tissue biopsy (either due to false negatives or to technical limitations such as insufficient or low-quality DNA). In the case of EGFR, 12 pts had EGFR alts through cfDNA which were previously undetected by tissue biopsy. Similarly, cfDNA detected 3 alterations in ALK which were previously undetected by tissue sample. Of 48 pts, 35.4% were switched to a targeted therapy as a result of alts detected through cfDNA, with adequate responses: disease control rate was 82.4% (partial response 47.2% and stable disease 35.2%) and progression free survival was 7.4 months (95%CI 2.6-28.1).

      8eea62084ca7e541d918e823422bd82e Conclusion

      In a selected population of young Hispanics (especially never smokers and women) with NSCLC the use of comprehensive cfDNA analysis allowed a treatment change in 35% of the cases. Our data confirms the usefulness of Guardant360â as non-invasive panel to identify genomic alts in cfDNA.

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    P2.01 - Advanced NSCLC (Not CME Accredited Session) (ID 950)

    • Event: WCLC 2018
    • Type: Poster Viewing in the Exhibit Hall
    • Track:
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/25/2018, 16:45 - 18:00, Exhibit Hall
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      P2.01-11 - Characteristics of Non-Small Cell Lung Cancer: Differences by Sex and Hormonal Status in a Hispanic Population (ID 12789)

      16:45 - 18:00  |  Presenting Author(s): Feliciano Barron

      • Abstract
      • Slides

      Background

      Non-small Cell Lung Cancer (NSCLC) appears to be a different disease between women and men. Clinical features and lung cancer behavior by sex and particularly by hormonal status has been poorly approached. We describe the differences in NSCLC by sex and by hormonal status among women in a Hispanic population.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      We performed a retrospective study among NSCLC patients from the National Cancer Institute of Mexico. We assessed clinic-pathological (tobacco, wood smoke and asbestos exposure, histology, disease stage, ECOG, Body Index Mass, Metastases sites) and molecular characteristics (EGFR and KRAS mutation profile). Overall survival (OS) according to sex and hormonal status were estimated using the Kaplan-Meier method and compared using the Log-rank test. Multivariate cox-proportional analysis was performed adjusting for clinical and statistically relevant features.

      4c3880bb027f159e801041b1021e88e8 Result

      Among the 1,104 patients 52.7% were men and 47.3% were women. Compared to men, women were more likely to be non-smokers (68% vs. 23%, p<0.001), reported higher frequencies of wood-smoke exposure (50% vs 28.2%, p<0.001), and of EGFR-sensitizing mutations (38.8% vs 18.7%, p<0.001), had a better ECOG performance (<2) (76.2% vs 69.9%, p=0.020) and showed a higher frequency of BMI ³25 (48.4% vs 41.5% p=0.003). Likewise, women, showed better OS (p=0.021) compared to men as well as overweight patients (vs. normal or obese patients) (p=0.045), non-smokers (p=0.002) and patients with lower ECOG status (p=0.006). Differences were found also when considering hormonal status. Postmenopausal women showed higher wood-smoke exposure (52.5% vs 41.7%, p=0.037) and wood-smoke exposure index (113.2% vs 50.6%, p=0.006) as well as tobacco smoking exposure index (19.8 vs 10.2, p=0.017) compared to premenopausal younger women who exhibited higher frequencies of exposure to asbestos (16.7% vs 7.0%, p=0.001) compared to postmenopausal. OS was better in postmenopausal women compared to premenopausal (31.1 vs 19.4 months, p=0.046). No differences were found between premenopausal and postmenopausal women stratified by EGFR mutation status regarding their clinic-pathological and molecular characteristics, neither in the OS.

      8eea62084ca7e541d918e823422bd82e Conclusion

      Our results support the differences in lung cancer presentation by sex and also by hormonal status. It is important to highlight that wood-smoke exposure and tobacco consumption were associated with hormonal status. Furthermore, premenopausal women (which showed a younger age at diagnosis) showed a worse OS regardless of other molecular features (e.g. EGFR, KRAS) which highlights the need of investigating in detail hormonal profiles when considering the clinical approach of NSCLC diagnosis and treatment.

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    P2.04 - Immunooncology (Not CME Accredited Session) (ID 953)

    • Event: WCLC 2018
    • Type: Poster Viewing in the Exhibit Hall
    • Track:
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/25/2018, 16:45 - 18:00, Exhibit Hall
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      P2.04-01 - Associations Histological Subtype of Lung Adenocarcinoma and Programmed Death Ligand 1 (PD-L1) Expression in Tumor Cells. (ID 12995)

      16:45 - 18:00  |  Author(s): Feliciano Barron

      • Abstract
      • Slides

      Background

      The analysis by immunohistochemistry (IHC) of the programmed cell death-ligand 1 (PD-L1) protein expression is the most extensively explored biomarker for response to immunotherapy in non-small cell lung cancer (NSCLC). However, there are differences concerning diverse IHC assays and cut-off criteria: Pembrolizumab with the 22C3 assay with cut-off ranges of >1%, 1-49% and >50%; and Nivolumab with the 28-8 assay and ranges of <1%, 1-5%, 5 -10% and >10%. Furthermore, there is lack of information regarding the association between the histological subtype of adenocarcinoma and PD-L1 expression. In this work, we assessed the frequency of PD-L1 expression according with to histological subtype of adenocarcinoma.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      PD-L1 expression was assessed using the PD-L1 IHC 22C3 pharmDx immunohistochemistry assay (Dako North America, Inc.). We correlated histological subtype of adenocarcinoma with the frequency and intensity of PD-L1 expression, smoking history, EGFR and ALK status.

      4c3880bb027f159e801041b1021e88e8 Result

      Tissue samples from one hundred and sixty-two were analyzed, of which 33 (20.4%) were excluded due to insufficient material for PD-L1asessment. Among them, 106 patients (71,55%) were female, the median age was 63 years (range 31-86 years), 69 (53.5%) were never-smokers with no exposition to wood smoke or asbestos (79,61.2% and 117, 90.7% respectively). Among the 129 adenocarcinomas, 31.0% were acinar histological subtype; 27.1% solid, 17.1% papillary, 3.9% lepidic, 1.6% micropapillary and 54.3% had a moderated tumor differentiation grade. According to PD-L1 score, 49 (38%) of the patients were classified as negative (PD-L1<1%), 71(55%) as poor PD-L1 expression (1 - 49%), and 9 (7%) as strong PD-L1 expression (≥50%). According to the IASLC/ATS adenocarcinoma histological subtype was associated with PD-L1 expression (p=0.003). Solid and acinar adenocarcinomas were more likely to present strong PD-L1 expression (55.6% & 33.3%, respectively) compared to lepidic, papillary, micropapillary and unspecified tumors, which presented a strong PD-L1 expression in up to 11.1%. Median PFS to first line therapy was 10.3 (95% CI: 6.1–14.5) months. Tobacco exposure was the only factor independently associated with an increase in the hazard of progression to first line therapy (either CT or TKI) from any cause among NSCLC patients (HR, 95% CI: 1.56-12.1). The median OS was 41.9 (95% CI: 10.9–72.9) months. Median OS differences were not found among PD-L1 (negative vs. positive: 60.6 vs. 31.3 months, p=0.685).

      8eea62084ca7e541d918e823422bd82e Conclusion

      Patients with adenocarcinoma tumors, solid histological subtype and poor differentiation grade can be more benefited with a PD-1 based immunotherapy. PD-L1 score can be a predictor factor for the response to first line chemotherapy.

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