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Fernando Franco



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    FP12 - Tumor Biology and Systems Biology - Basic and Translational Science (ID 188)

    • Event: WCLC 2020
    • Type: Posters (Featured)
    • Track: Tumor Biology and Systems Biology - Basic and Translational Science
    • Presentations: 1
    • Moderators:
    • Coordinates: 1/28/2021, 00:00 - 00:00, ePoster Hall
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      FP12.01 - Circulating Tumor DNA to the Identification of EGFR Positive NSCLC Long-Term Survivors (ID 3013)

      00:00 - 00:00  |  Presenting Author(s): Fernando Franco

      • Abstract
      • Slides

      Introduction

      Survival data supports the use of first-line osimertinib as standard of care for EGFR positive non-small lung cancer (NSCLC). However, it remains unclear whether upfront osimertinib is superior to sequential first- or second-generation tyrosine kinase inhibitor (TKI) followed by osimertinib for all patients. The impossibility of predicting which patients are at high risk of progression constitutes a major limitation of the sequential TKI approach.

      Methods

      Seven hundred and forty-five plasma samples from 192 stage IV, EGFR positive NSCLC patients who were treated with first-line TKI were analysed by digital PCR.

      Results

      Patients with EGFR sensitizing mutations in plasma with mutant allele frequency (MAF) <7% before treatment initiation had median OS 37.9 months (25.3-NR), compared 17.5 (95%CI: 11.3-25.5) months for patients with MAF≥7% (adjusted HR=0.43; 95%CI: 0.25-0.76, respectively). OS was achieved with 53.1% of the patients treated with a 2nd line treatment other than osimertinib. In the multivariable analysis, undetectable levels of circulating tumour DNA (ctDNA) after 3 and 6 months of treatment were associated with improved PFS and OS (P<0.001 in all cases). Patients who became ctDNA negative after 3 or 6 months of treatment with MAF<7% at diagnosis had more than two-thirds lower risk of progression and death compare to the rest of patients (adjusted HR=0.28; 95%CI: 0.17-0.46 and HR=0.24; 95%CI: 0.12-0.48 for PFS and OS, respectively).

      Conclusion

      Pre-treatment ctDNA levels identify patients at low risk of progression and death who could benefit from sequential TKI treatment. Information regarding EGFR sensitizing mutation clearance could improve patient selection.

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    P09 - Health Services Research/Health Economics - Real World Outcomes (ID 121)

    • Event: WCLC 2020
    • Type: Posters
    • Track: Health Services Research/Health Economics
    • Presentations: 1
    • Moderators:
    • Coordinates: 1/28/2021, 00:00 - 00:00, ePoster Hall
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      P09.12 - SARS- CoV2 Impact in a Spanish Lung Cancer Cohort? (ID 2995)

      00:00 - 00:00  |  Author(s): Fernando Franco

      • Abstract
      • Slides

      Introduction

      Madrid has been the epicenter of the SARS-CoV2 pandemic in Spain. We analyzed our experience with SARS-CoV2 infection and cancer patients (p).

      Methods

      The analysis was carried out from March 1 to April 30 at the Puerta de Hierro University Hospital in Madrid. All patients with diagnosis of SARS-CoV2 infection by RT-PCR were included.

      Results

      During the study period, overall in-hospital mortality of cancer p with COVID-19 was 15.2% (95%CI, 6.3; 5.2), similar to 12.7% (95%CI,11.1;4.4) (p=0.615) of the global COVID-19 hospitalised population and greater than patients admitted without SARS-CoV-2 infection during the same period 4.3% (95%CI; 3.6;5.2) p<0.001.

      Among the 653 patients receiving active cancer therapy, 24 (3.7%) developed COVID-19 and required admission, 4.2% of those were receiving chemotherapy, 9.5% immunotherapy and 2.1% targeted therapies. Lung and breast cancer were the most frequent (26.1%), followed by colorectal (19.6%) and breast cancer. Non-significant differences were found due to the cancer treatment received. Mortality in patients with lung cancer was the highest with 25%.

      The univariate analysis comparing patients who developed a serious event to those who did not (Table2), showed that the higher Brescia, CURB-65 scale, the lactate dehydrogenase (LDH) or C-reactive protein (CRP) levels were at admission, the greater the risk of developing severe complications, with statistically significant results (table 2).

      VARIABLE

      OTHER CANCER PATIENTS, N=34 (%)

      LUNG CANCER PATIENTS, N=12 (%)

      Gender (male)

      18 (52.9)

      6 (50)

      Age at hospitalization, mean (sd)

      63.9 (10.2)

      63.5 (15.5)

      Active Smoking

      0 (0.0)

      2 (16.7)

      Ex-smokers

      12 (35.3)

      6 (50)

      COMORBIDITIES

      Coronary heart disease

      3 (8.8)

      2 (16.7)

      Hypertension

      12 (35.3)

      5 (41.7)

      Hypothyroidism

      3 (8.8)

      0 (0.0)

      COPD

      3 (8.8)

      2 (16.7)

      Obesity

      2 (5.9)

      0 (0.0)

      Diabetes

      6 (17.7)

      0 (0.0)

      Dyslipidemia

      8 (23.5)

      3 (25.0)

      LINES OF TREATMENT

      First line

      18 (52.9)

      5 (41.7)

      Other lines

      8 (23.5)

      5 (41.7)

      Pending treatment

      8 (23.5)

      2 (16.7)

      Recent cancer treatment <30d

      11 (32.3

      8 (66.7)

      Active treatment

      23 (67.6)

      6 (50.0)

      Others

      10 (30.3)

      0 (0.0)

      SYMPTOMS

      OTHER CANCER PATIENTS (N=34)

      LUNG CANCER PATIENTS (N=12)

      p-value

      Neutropenia

      2 (6.1)

      0 (0.0)

      1.000

      Cough

      23 (67.6)

      5 (41.7)

      0.170

      Fever

      26 (76.5)

      9 (75.0)

      0.918

      Temperature

      37.1 (1.0)

      37.3 (1.1)

      0.360

      Dyspnoea

      16 (47.0)

      11 (91.7)

      0.007

      Diarrhoea

      3(8.8)

      1 (8.3)

      1.000

      Lymphopenia

      22 (68.7)

      4 (36.4)

      0.080

      PROGNOSTIC CRITERIA

      IL6

      0.416

      <4,4

      28 (82.3)

      8 (66.7)

      ≥4,4

      6 (17.7)

      4 (33.3)

      D-DIMER

      0.9 (0.6; 2.2)

      0.9 (0.5; 2.7)

      0.574

      <0,5

      5 (17.9)

      3 (27.3)

      0.761

      0,5-7

      22 (78.6)

      8 (72.7)

      >7

      1 (3.5)

      0 (0.0)

      PCR

      107.7

      0.449

      <10

      7 (21.9)

      1 (9.1)

      10-150

      16 (50.0)

      8 (72.7)

      >150

      9 (28.1)

      2 (18.2)

      LDH

      266 (207; 326)

      290 (238; 352)

      0.195

      <246

      14 (46.7)

      3 (27.3)

      0.309

      ≥246

      16 (53.3)

      8 (72.7)

      FERRITIN

      562 (358; 933)

      1111 (392; 2672)

      0.158

      CHARLSON INDEX

      8 (6; 9)

      8 (6; 9)

      0.800

      CURB65 SCALE

      0.314

      0-1

      21 (61.8)

      5 (41.7)

      2

      13 (38.2)

      7 (58.3)

      BRESCIA SCALE

      0.178

      0-1

      30 (88.2)

      8 (66.7)

      2

      4 (11.8)

      4 (33.3)

      Table 1. General characteristics, symptoms at diagnosis and prognostic data.COPD: chronic obstructive pulmonary disease,Charlson index (Comorbidities), Curb65 scale (includes age, confusion, urea, breathing frequency, blood pressure), Brescia Scale (depends on oxygen needs). P-values: comparison between lung cancer patients and the other.

      VARIABLE

      N VALID (N=46)

      NON-SERIOUS EVENT (N=38)

      SERIOUS EVENT (N=8)

      P-VALUE

      OR (95% CI)

      Gender (male)

      46

      20 (52.6)

      4 (50.0)

      0.892

      0.9 (0.19; 4.14)

      Age at hospitalization

      40

      63.2 (11.6)

      67 (11.4)

      0.376

      1.04 (0.96; 1.21)

      Active Smoking

      46

      2 (5.3)

      0 (0.0)

      1

      ---

      Ex-smokers

      46

      16 (42.1)

      2 (25.0)

      0.453

      0.46 (0.08; 2.57)

      Hypertension

      46

      14 (36.8)

      3 (37.5)

      0.972

      1.02 (0.21; 4.97)

      COPD

      46

      4 (10.5)

      1 (12.5)

      0.871

      1.21 (0.12; 12.57)

      Dyslipidaemia

      46

      10 (26.3)

      1 (12.5)

      0.418

      0.40 (0.04; 3.67)

      Higher ferritin

      26

      598 (382; 1111)

      975 (903; 2403)

      0.396

      1.00 (0.99; 1.00)

      Higher IL6 4,4

      46

      8 (21.1)

      3 (37.5)

      0.330

      2.2 (0.44; 11.48)

      Higher D- Dimer

      41

      1.1 (0.7; 2.2)

      2.6 (1.5; 5.6)

      0.069

      1.39 (0.97; 1.99)

      First LDH

      41

      254 (195; 316)

      354 (266; 441)

      0.020

      1.01 (1.00; 1.03)

      Higher LDH

      40

      271 (227; 332)

      619 (354; 812)

      0.007

      1.01 (1.00; 1.03)

      First CRP

      43

      95 (11; 146)

      169 (89; 228)

      0.038

      1.01 (1.00; 1.02)

      Higher CRP

      42

      116 (43; 167)

      202 (130; 249)

      0.018

      1.02 (1.00; 1.03)

      Brescia

      44

      0.5 (0; 1)

      2 (2; 5)

      0.004

      19.5 (2.54; 149.7)

      CURB-65

      42

      1 (1; 2)

      2 (1; 3)

      0.060

      2.41 (0.97; 6.03)

      Table 2.

      Conclusion

      Cancer patients, especially lung ones, and SARS-CoV2 infection have a worse overall prognosis than the general population.

      Objective parameters such as LDH, CRP at admission, Brescia index or CURB-65 should alert us to a more serious evolution and suggest early an early intensive care unit (ICU) admission.

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    P25 - Mesothelioma, Thymoma and Other Thoracic Malignancies - Mesothelioma Preclinical, Prognostic and Predictive Factors (ID 139)

    • Event: WCLC 2020
    • Type: Posters
    • Track: Mesothelioma, Thymoma and Other Thoracic Malignancies
    • Presentations: 1
    • Moderators:
    • Coordinates: 1/28/2021, 00:00 - 00:00, ePoster Hall
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      P25.06 - Malignant Pleural Mesothelioma: Patient Characteristics, Treatments and Outcomes from a Spanish Center (ID 3005)

      00:00 - 00:00  |  Author(s): Fernando Franco

      • Abstract
      • Slides

      Introduction

      Malignant pleural mesothelioma (MPM) is a rare but aggressive tumour whose clinical and pathological diagnosis represents a challenge, due to delayed diagnosis and poor prognosis.

      The aim of this study is to describe the demographic and clinical characteristics of patients with malignant pleural mesothelioma, as well as their subsequent treatments and outcomes in Hospital Universitario Puerta de Hierro Majadahonda, Madrid, Spain.

      Methods

      We conducted a retrospective study including 51 patients with confirmed diagnosis of malignant pleural mesothelioma between 2008 and 2020. We collected information regarding epidemiology, treatments and survival patterns of patients with MPM. The cohort was divided in 3 groups depending on stage (I-II, III and IV), excluding non-treated patients. Progression-free survival (PFS) was calculated from the initiation of first-line treatment until the date of progression or death and overall survival (OS) was calculated from the initiation of first-line treatment until the date of last follow-up or death.

      Results

      Demographic characteristics of patients are shown in Table-1.

      70.6% of patients were male, and the mean age at diagnosis was 65.5 years. Asbestos exposure was reported in 13.7% of patients. Most patients were diagnosed by pleural biopsy (85%). The most frequent histological subtype was epithelioid (75%).

      Treatments and outcomes are shown in Table-2.

      Surgery was performed in 6 patients stage I-II (54.5%) and in 8 patients stage III (33.3%). The first-line of chemotherapy most used regardless of stage was a platinum-doublet with pemetrexed.

      Median OS was 17.0 months (95% CI, 9.08-24.92) with a median PFS of 8.0 months (95% CI, 2.25-13.75).

      Only 9.1% of patients were included in clinical trials and 6.8% received immunotherapy.

      Table-1. Demographic characteristics

      Sex

      Female = 15 (29.4%)

      Male = 36 (70.6%)

      Mean age (years, 95% CI)

      Mean: 65.51 (63.11-67.91)

      Range: 44 (35-79)

      Smoking habits

      Never smoker: 16 (33.3%)

      Current smoker: 9 (18.8%)

      Former smoker: 23 (47.9%)

      Non-available/unknown: 3 (5.8%)

      Packs-year (CI 95%)

      Mean: 37.121 (26.086-48.156)

      Comorbidities

      HTN: 26 (51%)

      DL: 21 (41.2%)

      Cardiopathy: 10 (19.6%)

      Charlson: 8.49 (8.15-8.83)

      Previous pleural pathology

      5 (9.8%)

      Simplified profession

      Industry/construction: 15 (29.4%)

      Others: 8 (15.7%)

      Painter: 3 (5.9%)

      Unknown: 25 (49%)

      Exposure to inhaled agents recorded

      12 (23.5%)

      Asbestos exposure identified

      7 (13.7%)

      ECOG

      0: 19 (37.3%)

      1: 17 (33.3%)

      2: 3 (5.8%)

      3: 1 (2.0%)

      Unknown: 11 (21.6%)

      Symptoms

      Dyspnea: 31 (60.8%)

      Cough: 16 (31.4%)

      Constitutional syndrome: 13 (25.5%)

      Costal pain: 7 (13.7%)

      Hemoptysis: 1 (2%)

      Diagnosis image tests

      PET-CT: 1 (2.0%)

      Chest CT: 42 (82.4%)

      Unknown: 8 (15.7)

      Test sensitivity

      Pleural cytology: 15 (38.5%)

      Pleural biopsy: 39 (84.8%)

      Stage

      I: 4 (7.8%)

      II: 8 (15.7%)

      III: 24 (47.1%)

      IV: 10 (19.6%)

      Unknown: 5 (9.8%)

      Metastatic location

      Lung: 6 (66.7%)

      Bone: 2 (22.2%)

      Hepatic: 1 (11.1%)

      Histology

      Epithelioid: 36 (75.0%)

      Biphasic: 6 (12.5%)

      Sarcomatoid: 2 (4.2%)

      Desmoplastic: 2 (4.2%)

      Non-available/unknown: 5 (9.8%)

      Table-2. Treatment and outcomes

      Variables

      Stages I-II (N = 11)

      Stage III (N = 24)

      Stage IV (N = 9)

      Age (mean, 95% CI, range)

      65.18 (57.14-73.22)

      44 (35-79)

      64.67 (61.68-67.65)

      23 (55-78)

      64.7 (57.32-72.01)

      31 (44-75)

      Sex

      Female = 7 (63.6%)

      Male = 4 (36.4%)

      Female = 6 (25.0%)

      Male = 18 (75.0%)

      Female = 2 (22.2%)

      Male = 7 (77.8%)

      First line

      Treatment

      Chemotherapy: 5 (45.5%)

      Neoadjuvant chemotherapy + surgery + adjuvant radiotherapy: 2 (18.2%)

      Surgery + adjuvant chemotherapy: 4 (36.4%)

      Chemotherapy: 12 (50%)

      Surgery + adjuvant radiotherapy + adjuvant chemotherapy: 5 (20.8%)

      Surgery + adjuvant chemotherapy: 2 (8.3%)

      Radiotherapy + chemotherapy: 2 (8.3%)

      Neoadjuvant chemotherapy + surgery + adjuvant radiotherapy: 1 (4.1%)

      Chemotherapy: 8 (88.9%)

      Chemotherapy + Radiotherapy: 1 (11.1%)

      Types of surgery

      Extended pneumonectomy: 3 (27.7%)

      Pleurodesis: 2 (18.2%)

      Not specified: 1 (9.1%)

      Pleurectomy + amplified decortication: 4 (16.7%)

      Extended pneumonectomy: 4 (16.7%)

      None

      Chemotherapy

      Cisplatin + pemetrexed: 3 (27.3%)

      Carboplatin + pemetrexed: 5 (45.5%)

      Gemcitabine: 1 (9.1%)

      Cisplatin + pemetrexed: 11 (45.8%)

      Carboplatin + pemetrexed: 9 (37.5%)

      Carboplatin + pemetrexed + bevacizumab + atezolizumab: 1 (4.2%)

      Carboplatin + pemetrexed: 5 (55.6%)

      Cisplatin + pemetrexed: 3 (33.3%)

      Carboplatin + pemetrexed + bevacizumab: 1 (11.1%)

      Cycles (95% CI)

      5.5 (4.32-6.68)

      4.9 (4.33-5.47)

      4.11 (2.93-5.29)

      Maintenance treatment

      1 (9.1%)

      7 (29.2%)

      2 (22.2%)

      Maintenance treatment

      Pemetrexed: 1 (9.1%)

      Pemetrexed: 6 (25%)

      Bevacizumab + atezolizumab: 1 (4.2%)

      Pemetrexed: 2 (22.2%)

      Best response

      Progressive disease: 5 (45.5%)

      Stable disease: 2 (18.2%)

      Partial response: 2 (18.2%)

      Progressive disease: 5 (20.8%)

      Stable disease: 6 (25%)

      Partial response: 5 (20.8%)

      Complete response: 4 (16.7%)

      Progressive disease: 4 (44.4%)

      Stable disease: 1 (11.1%)

      Partial response: 2 (22.2%)

      Progression-free survival (months, 95% CI)

      Mean: 12.0 (8.48-15.26)

      Median: 8.0 (2.25-13.75)

      Overall survival (months, 95% CI)

      Mean: 21.6 (14.83-28.37)

      Median: 17.0 (9.08-24.92)

      Second line

      Relapse

      4

      15

      4

      Time to relapse/progression

      Local: 4 (36.4%)

      Distance: 2 (18.2%)

      Local: 15 (62.5%)

      Distance: 6 (25.0%)

      Local: 3 (33.3%)

      Distance: 4 (44.4%)

      Treated patients

      4 (36.4%)

      11 (45.8%)

      3 (33.3%)

      Treatment (%)

      Chemotherapy + radiotherapy: 2 (18.2%)

      Chemotherapy: 2 (18.2%)

      Chemotherapy: 7 (29.2%)

      Radiotherapy: 4 (16.7%)

      Chemotherapy: 3 (33.3%)

      Chemotherapy

      Vinorelbine: 1 (9.1%)

      Pemetrexed: 1 (9.1%)

      Not specified: 2 (18.2%)

      Vinorelbine: 5 (20.8%)

      Gemcitabine: 1 (4.2%)

      Irinotecan + lurbinectedin: 1 (4.2%)

      Vinorelbine: 1 (11.1%)

      Nivolumab: 1 (11.1%)

      Other immunotherapy: 1 (11.1%)

      Cycles

      Mean: 3.5

      Mean: 2.86

      Mean: 7.0

      Best response

      Progressive disease: 3 (27.3%)

      Stable disease: 1 (9.1%)

      Progressive disease: 7 (29.2%)

      Progressive disease: 2 (22.2%)

      Partial response: 1 (11.1%)

      Overall survival (months, 95% CI)

      Mean: 12.69 (5.34-20.03)

      Median: 7.0 (0-16.47)

      Third, fourth and fifth line

      Chemotherapy

      Cisplatin + pemetrexed (retreatment): 1 (9.1%)

      Gemcitabine: 1 (9.1%)

      Irinotecan: 1 (9.1%)

      Gemcitabine: 1 (4.2%)

      Carboplatin + pemetrexed (retreatment): 1 (4.2%)

      Gemcitabine: 2 (22.2%)

      Cisplatin + pemetrexed (retreatment): 1 (11.1%)

      Additional data

      Included in clinical trials

      4 (9.1%)

      Patients who received immunotherapy

      3 (6.8%)

      Survival rate

      First year: 58%

      Second year: 30 %

      Third year: 10%

      Fourth year: 3%

      Conclusion

      Our results confirm that overall survival in patients with new diagnosis of MPM remains poor. Cytology has a low sensitivity and most patients were diagnosed at advanced stage, limiting the possibility of radical approaches.

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    P52 - Staging - Prognosis and Staging (ID 186)

    • Event: WCLC 2020
    • Type: Posters
    • Track: Staging
    • Presentations: 2
    • Moderators:
    • Coordinates: 1/28/2021, 00:00 - 00:00, ePoster Hall
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      P52.08 - Thoracic Tumors Registry (RTT): Analysis of Clinical Features and Survival in Patients with mNSCLC in Spain. (ID 3022)

      00:00 - 00:00  |  Presenting Author(s): Fernando Franco

      • Abstract
      • Slides

      Introduction

      The lung cancer is the leading cause of death due to cancer in Western countries, the prognosis it depends on the tumor stage and the clinical, histological and molecular characteristics. The Thoracic Tumors Registry (RTT) of the Spanish Lung Cancer Group is a database who include the data of patients with lung malignant neoplasms.

      Methods

      The objective of this retrospective study is to descriptive the clinical and epidemiological aspects of non-small cell lung cancer (NSCLC) in the Spanish population.

      Results

      The total of patients included in the RTT is 12.897 (Aug 2016 - Jan 2020) and this report is based in the analysis of 5.049 of them. The clinical and demographic data are described in the table 1. Adenocarcinoma (72,2%), squamous cell carcinoma (SCC) (18,6%), others types. The sites of metastasis: contralateral lung (34.3%), bone (31%), liver (12.8%) and CNS (6.02%). The first-line of treatment was chemotherapy (CT) in 66,54%, oral target therapy 13,45%, immunotherapy (IO) 8,62% and CT+IO 2,46%. The median of PFS of 7.4 months (7.13-7.6 months) in all population with an estimated at 6, 12, 24, and 60 months of 58.3% (95%CI 56.81% - 59.74%), 29.97% (95%CI 28.56% - 31.4%), 13.4% (95%CI 12.2% - 14.6%) and 2.6% (95%CI 1.98%-3.5%) respectively. The median of OS was 15.5 months (14.8-16.4). According to the histological type (SCC vs non-SCC), the median (in months) of PFS was 6.67 (6.1- 7.1) vs 7.53 (7.3-7.9) (HR 0.78, 95% CI 0.72 - 0.85) and OS 13.8 (12.6-15.6) vs 16.9 (15.7 - 18) in non-SSC, p <0.001. The analysis of survival in patients with or without liver metastasis showed a median OS of 15 months (14.3-16m) vs 18.1 months (16.1- 19.9m), HR 0.88, 95%CI 0.79-0.98 (p<0.05).

      N=5049

      Age, Median

      68,29-y (25-96)

      Sex

      M: 71,16% - F: 28,83%

      Smoking habit

      Smoker

      Former smoker

      Never smoker

      42,42%

      41,06%

      15,56%

      Asbestos exposure

      2,14%

      Patient history of cancer

      13,5%

      Family history of cancer

      40,82%

      Conclusion

      The results of our study show a similarity in the clinical characteristics of patients with NSCLC in the Spanish population with the data in the western population previously describe. Both the histological subtype and the presence of liver metastases are predictive factors for survival.

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      P52.10 - Profile of Comorbidities and Cancer History in Patients with mNSCLC in the Spanish Population (Thoracic Tumors Registry). (ID 3024)

      00:00 - 00:00  |  Presenting Author(s): Fernando Franco

      • Abstract
      • Slides

      Introduction

      Lung cancer is the most commonly diagnosed cancer worldwide and places a considerable burden on public health. The prognosis depends on the tumor stage and the clinical, histological and molecular characteristics. However, the comorbidities are also an important factor, not only in the diagnostic procedures but on the oncologic treatment strategies. The Thoracic Tumors Registry (RTT) of the Spanish Lung Cancer Group is a database that includes the data of patients with lung malignant neoplasms

      Methods

      The objective of this retrospective study is to describe the profile of comorbidities and cancer history in patients with NSCLC in the Spanish population.

      Results

      The total of patients included in the RTT is 12.897 (Aug 2016 - Jan 2020) and this report is based in the analysis of 5.049 of them. The median of age was 68,9-y (25-96). The most prevalent histology was the adenocarcinoma (72,2%) followed by the squamous cell carcinoma (SCC) (18,6%), others types include sarcomatoids, large cell, neuroendocrine and NOS carcinoma. Seventy-one percent of patients were male and 28,83% female and, according to the smoking habit, 42,42% were smoker, 41,06% former smoker and 15,56% never smoker. The asbestos exposure was informing in 108 cases (2,14%). A total of 4153 patients (82.25%) had comorbidities and these including: hypertension (50,13%), dyslipemia (34,36%), diabetes mellitus (22,9%), COPD (21,04%), heart disease (16,23%), depressive syndrome / anxiety (7,89%), vasculopathy (6,79%), obesity (4,94%), among others. 681 patients had a previous history of cancer (13,49%), the mains include the bladder and urinary tracts (14,39%), head and neck (10,43%), colorectal (10%), breast (8.08%), non-melanoma skin (6,31%), lung (2,5%), lymphoma (2,5%), among others.

      Conclusion

      Our study shows the real comorbidity profiles of patients with NSCLC in Spain. The cardiovascular and pulmonary diseases and the metabolic disorders are the most common pathologies in our patients. Theses comorbidities may have determined the selection of the treatment and influence the prognosis in lung cancer as well as and pose a major clinical challenge in the care of cancer patients.

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    P60 - Tumor Biology and Systems Biology - Basic and Translational Science - Immune Bio (ID 198)

    • Event: WCLC 2020
    • Type: Posters
    • Track: Tumor Biology and Systems Biology - Basic and Translational Science
    • Presentations: 2
    • Moderators:
    • Coordinates: 1/28/2021, 00:00 - 00:00, ePoster Hall
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      P60.07 - TMB and Selected Mutations in Resectable Stage IIIA NSCLC Patients Receiving Neo-Adjuvant Chemo-Immunotherapy from NADIM Trial (ID 2142)

      00:00 - 00:00  |  Author(s): Fernando Franco

      • Abstract
      • Slides

      Introduction

      Tumor Mutational Burden (TMB) assessment and identification of specific mutations associated to anti-PD1 blockade therapy resistance have become a novel approach to predict the clinical benefit to anti-PD1/PDL1 therapy. However, the clinical relevance of these parameters in terms of pathological response and PFS in neo-adjuvant chemo-immunotherapy has not been established. To answer this question we analysed samples from the NADIM study (NCT03081689), in which resectable stage IIIA NSCLC patients were treated with neoadjuvant chemo-immunotherapy with Nivolumab.

      Methods

      Pretreatment TMB, defined as the number of nonsynonymous variants (missense and nonsense single nucleotide variants (SNVs)), plus insertion and deletion variants (INDELs) detected per megabase (Mb) of exonic sequence, was estimated from 27 patients that had enough diagnostic material for next generation sequencing using the Oncomine Tumor mutation Load assay (ThermoFisher) following manufacturer’s instructions. The panel covers 1.7 Mb of 409 genes with known cancer associations. Regarding pathological responses, patients were classified into 3 groups: pathologic complete response (pCR) (0% viable tumour at any localization tested), major pathologic response (MPR, <10% viable tumour) and pathologic incomplete response (pIR) (>10% of viable tumour). At data analysis, median follow-up time was 22.7 months.

      Results

      Median TMB was 5.89 (range 1.68 – 73.95). No differences in TMB value between histologies (adenocarcinoma vs squamous cell), smoking status (former vs current), age or sex were observed. Somatic mutations were identified in lung cancer driver genes such as TP53, KRAS, EGFR, CDKN2A, NOTCH1, BRAF and in specific genes associated with resistance to immunotherapy such as STK11, KEAP1, and RB1. No genomic alterations in ALK, ROS1, PTEN or ERBB2 were found.

      Based on literature, a poor prognosis mutation signature (presence of EGFR, STK11, KEAP1 or RB1 mutations) was generated. A third of the sequenced patients (9/27) harboured at least one mutation in one of these genes.

      Pathological response data was available from 23 out of 27 patients sequenced. Both the TMB value and the presence of these resistance mutations were not associated with the degree of pathological response.

      Regarding PFS, TMB alone was not predictive of disease progression using different thresholds. However, the presence of these resistance mutations was associated with shorter PFS (log-rank p-value=0.032). The median PFS for mutated patients was 21.4 months (95% CI 16-26 months) while median PFS was not reached in non-mutated patients.

      Additionally, the combination of this mutational signature with TMB (absence of resistance mutations and TMB-Higher than median) was able to distinguish patients that strongly benefit from this therapy. Although the median PFS was not reached in both groups yet, statistically significant differences were observed (log-rank p-value=0.046). PFS at 18 and 24 months was 100% (95% CI not estimable) for Non-mutated patients with TMB-High vs 70% (95% CI 50-89%) and 58% (95% CI 35-81%) for the rest of patients (mutated patients plus Non-mutated patients with TMB-Low).

      Conclusion

      TMB did not predict benefit from chemo-immunotherapy induction in our cohort. However, the presence of EGFR/STK11/KEAP1/RB1 mutations alone, or in combination with TMB, may help identify patients that unlikely benefit from neo-adjuvant chemo-immunotherapy

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      P60.11 - TCR Repertoire Predicts Pathological Response in NSCLC Patients Receiving Neoadjuvant Chemoimmunotherapy from NADIM Trial (ID 3417)

      00:00 - 00:00  |  Author(s): Fernando Franco

      • Abstract
      • Slides

      Introduction

      Characterization of the T-cell receptor (TCR) repertoire has become a novel approach to monitor immunotherapy responses, however there is lack of knowledge about its clinical relevance as predictive biomarker of pathological response in neoadjuvant chemoimmunotherapy. For this purpose, we analysed samples from the NADIM study (NCT03081689), in which resectable stage IIIA NSCLC patients were treated with neoadjuvant Paclitaxel + Carboplatin + Nivolumab for 3 cycles, achieving a 63% of complete pathologic responses (CPR). PD-L1 TPS and TMB as CPR biomarkers showed AUC ROC of 0.77 and 0.55, respectively, reinforcing the need for new biomarkers (Provencio, M. et al. 2020).

      Methods

      TCR repertoires from primary tumours or lymph nodes of 19 NSCLC patients were obtained, at both time points: diagnosis and after neoadjuvant treatment. TCR repertoire was analysed in terms of convergence, diversity, evenness and clonal space, defined as the summed frequency of clones belonging to a frecuency group (top 1%, top 1% to 2%, 2% to 5%, and >5%) relative to the total T-cell repertoire. The results were correlated with pathological response groups and ROC curve analysis was performed to test if TCR repertoire-derived parameters could identify patients with CPR.

      Results

      There were no statistically significant differences observed in TCR repertoire in biopsy samples in terms of diversity (p = 0,797) or convergence (p = 0,202) between the three pathological response groups or between biopsy and surgery samples. However, we observed differences in terms of evenness in biopsy samples between the pathologic response groups (p=0.037), which were lower in those patients who achieved CPR. The AUC for evenness was 0.844 (IC: 0.667-1.000), p=0,011. An evenness value of <0.8639 showed a sensitivity of 50% and specificity of 100% identifying patients with CPR.

      Moreover, the clonal space of the TOP 1% clones in diagnostic samples was higher in patients that achieved CPR (p=0.002). The AUC of this novel biomarker was 0.9667 (IC: 0.897-1.036) (p=0.0006). A TOP 1% clonal space higher than 0.1607 showed a sensitivity of 90% and specificity of 88.9% identifying patients with CPR.

      nadim trasl_tcr_image.jpg

      Conclusion

      Our results support the association between the uneven distribution of T-lymphocytes clones proportions present in the tissue at diagnosis and response to chemoimmunotherapy. Specifically, higher clonal space occupied by the TOP 1% clones seems to outperform PD-L1 and TMB as predictive biomarker of CPR in NSCLC patients receiving neoadjuvant chemoimmunotherapy.

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    P66 - Tumor Biology and Systems Biology - Basic and Translational Science - Outcomes (ID 205)

    • Event: WCLC 2020
    • Type: Posters
    • Track: Tumor Biology and Systems Biology - Basic and Translational Science
    • Presentations: 1
    • Moderators:
    • Coordinates: 1/28/2021, 00:00 - 00:00, ePoster Hall
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      P66.04 - Real World Data: Immunotherapy in Lung Cancer Patients over 65 Years Old in Spain (ID 3641)

      00:00 - 00:00  |  Author(s): Fernando Franco

      • Abstract
      • Slides

      Introduction

      In the last decade, immunotherapy (IT) has become a key therapeutic tool in lung cancer treatment. The number of elderly patients with this pathology in Spain has been progressively increased in recent years, becoming a representative subgroup nowadays. Studies carried out with IT in these patients are a minority and controversial, generating a need in clinical practice.

      The aim of the study is to establish clinical and toxicity differences between patients older and younger than 65 years, treated with IT.

      Methods

      Retrospective study that includes all epidemiological, clinical and pathological data of patients > 65 and <65 years diagnosed with lung cancer at Puerta de Hierro Hospital from January 2014 to March 2020, and who received treatment with IT, either in the first line or successive.

      Results

      A total of 155 patients were analyzed. Table 1 summarizes the main characteristics between both populations. The mean number of treatments received in both groups was similar (3.0 in <65 years vs 2.7 in> 65).

      When both groups were compared, no statistically significant differences in the percentage of patients who needed to interrupt IT due to toxicity were observed, being 15.9% of those <65 years and 17.9% of those> 65 years (p = 0.576) who required this interruption.

      There were also no differences in toxicity between grade 3 or 4 (10.2% vs 10.4%, p = 0.99) or in the number of admissions due to immune-related toxicity (IR) (9.0% vs 4.5%, p = 0.19).
      Neither group required immunosuppressive treatment for severe toxicity, but they did require steroids at high doses. There were no deaths secondary to IT toxicity, being the majority due to disease progression.

      Table 1.

      Characteristics

      <65 years (88)

      >65 years (67)

      Gender

      Male

      Woman

      54.5%

      45.6%

      74.6%

      25.4%

      Median age

      58

      72

      ECOG

      0-1

      ≥2

      93.2%

      4.5%

      97.0%

      3.0%

      Charlson index

      8

      10

      Stage

      I – 3.4%

      II – 6.8%

      III - 33.0%

      IV – 56.8%

      I – 3.0%

      II – 11.9%

      III – 23.9%

      IV – 61.2%

      Histology

      Adenocarcinoma

      Squamous cell carcinoma

      Small cell

      Others

      59.1%

      27.3%

      2.3%

      11.4%

      56.7%

      25.4%

      4.5%

      13.4%

      PDL-1

      Positive

      Negative

      Unknown

      29.5%

      9.1%

      13.6%

      32.8%

      16.4%

      7.5%

      Disease situation at the toxicity moment

      Complete response

      Partial response

      Stable disease

      Progression

      8.2%

      13.7%

      20.5%

      47.9%

      1.6%

      27.9%

      23.0%

      32.8%

      Toxicity types

      Asthenia

      Anemia

      Pneumonitis

      Thyroid disorders

      Cutaneous

      Colitis

      Nephritis

      Hepatitis

      Others

      11.4%

      1.1%

      14.8%

      10.2%

      9.1%

      6.8%

      0%

      3.4%

      13.6%

      13.4%

      0%

      11.9%

      11.9%

      9.0%

      4.5%

      4.5%

      1.5%

      9.0%

      Toxicity grade

      1

      2

      3

      4

      17.0%

      6.8%

      5.7%

      3.4%

      14.9%

      13.4%

      8.9%

      1.5%

      Conclusion

      Patients > 65 years with lung cancer who received IT treatment in our center do not experience more serious adverse events, do not require more treatment interruptions or more admissions, compared to those <65 years. Consequently, IT should be a valid treatment option in this population and its management should be optimized, with the aim of offering the best possible quality of care to this subgroup of patients.

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    P84 - Targeted Therapy - Clinically Focused - ALK (ID 261)

    • Event: WCLC 2020
    • Type: Posters
    • Track: Targeted Therapy - Clinically Focused
    • Presentations: 1
    • Moderators:
    • Coordinates: 1/28/2021, 00:00 - 00:00, ePoster Hall
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      P84.16 - Treatment Options for Patients with Brain Metastases in Oncogene-Driven Non-Small Cell Lung Cancer (ID 3699)

      00:00 - 00:00  |  Author(s): Fernando Franco

      • Abstract
      • Slides

      Introduction

      The brain is a frequent site of metastases in non-small cell lung cancer (NSCLC), specially in those with driver gene mutations. Treatment strategies include surgical resection, central nervous system (CNS) radiotherapy (RT), what includes: whole-brain radiation therapy (WBRT) and stereotactic radiotherapy, and drug therapy like tyrosine kinase inhibitors (TKIs).

      Methods

      We conducted a single centre retrospective review including 60 (25.3%) NSCLC patients with driver gene mutations (EGFR, ALK, ROS1) and brain metastases from a total of 237 patients treated with TKIs in Hospital Universitario Puerta de Hierro (Spain) between 2008 and 2020. We collected information regarding epidemiology, treatments, response and survival patterns. We analysed patients treated with TKIs alone and specifically patients who were treated with newly developed TKIs that can efficiently penetrate the blood-brain barrier (osimertinib, alectinib, ceritinib, brigatinib, lorlatinib). Radiotherapy-free survival was calculated from the initiation of first-line TKI until the date of CNS RT.

      Results

      Global characteristics regarding clinical characteristics, treatment and survival are shown in Table-1.

      56.7% were female and mean age at diagnosis was 60.0 years. Driver gene mutations were EGFR (80.0%), ALK (20.0%) and ROS1 (0%). 56.7% received CNS RT and median OS was 31.0 months (95% CI, 21.4-46.6) with a median TKI time-treatment 27.0 months (95% CI, 22.0-31.9).

      Specific data from patients treated with TKIs alone at the diagnosis of brain metastases and those treated with new generation TKIs are shown in Table-2.

      CNS RT was performed in 24% with a RT-free survival mean of 45.15 months (95% CI, 28.85-61.51). Newly developed TKIs achieved a partial or complete CNS response in 42.9%.

      Table-1. Global characteristics

      Clinical characteristics (n = 60)

      Sex

      Male: 26 (43.3) Female: 34 (56.7)

      Age (years, range)

      Mean: 60.0 (56.95-63.09)

      Histology

      Adenocarcinoma: 58 (96.7)

      Neuroendocrine carcinoma: 1 (1.7)

      Squamous cell carcinoma: 1 (1.7)

      Driver gene mutations

      EGFR: 48 (80.0)

      ALK: 12 (20.0)

      ROS1: 0

      Mutations reported

      Non-reported: 22 (36.7)

      Exon 21 L858R: 13 (21.7)

      Exon 21 L861Q: 1 (1.7)

      Exon 21 (non-specified): 2 (3.3)

      Exon 19 deletion: 18 (30.0)

      Exon 18 (G719X): 2 (3.3)

      Exon 18 (non-specified): 1 (1.7)

      Exon 20 (insertion): 1 (1.7)

      Smoking status

      Smoker: 10 (16.7)

      Former smoker: 15 (25.0)

      Never smoker: 31 (51.7)

      Non-reported: 4 (6.7)

      Packs-year (95% CI)

      Mean: 26.75 (20.76-32.73)

      Comorbidities

      Hypertension: 14 (23.3)

      Dyslipidemia: 9 (15.0)

      Diabetes: 5 (8.3)

      Alcohol consumption: 9 (15.0)

      First degree family history of cancer

      29 (48.3)

      ECOG:

      0: 31 (51.7)

      1: 22 (36.7)

      2: 1 (1.7)

      Non-reported: 6 (10)

      CNS initial affection

      43 (71.7%)

      CNS type of affection

      Unique: 11 (18.3)

      Multiple: 47 (78.3)

      Non-reported: 2 (3.3)

      Radiological findings

      Intracranial hypertension: 13 (21.7)

      Meningeal carcinomatosis: 16 (26.7)

      First TKI treatment (n = 60)

      TKI

      Erlotinib: 22 (36.7)

      Afatinib: 10 (16.7)

      Gefitinib: 12 (20.0)

      Osimertinib: 5 (8.3)

      Crizotinib: 8 (13.3)

      Alectinib: 3 (5.0)

      Best CNS response

      Progressive disease: 3 (5.0)

      Stable disease: 12 (20.0)

      Partial response: 16 (26.7)

      Complete response: 5 (8.3)

      Unknown: 24 (40.0)

      Best global response

      Progressive disease: 5 (8.3)

      Stable disease: 11 (18.3)

      Partial response: 25 (41.7)

      Complete response: 6 (10.0)

      Unknown: 13 (21.7)

      Reported toxicities

      31 (51.7)

      Grade of toxicity

      1: 14 (23.3)

      2: 5 (8.3)

      3: 7 (11.7)

      4: 1 (1.7)

      Non-grade reported: 4 (6.7)

      Treatment interruption due toxicity

      11 (18.3)

      Treatment dose-reduction

      4 (6.7)

      Second TKI treatment (n =28)

      TKI

      Erlotinib: 4 (16.0)

      Afatinib: 6 (21.4)

      Gefitinib: 2 (7.1)

      Osimertinib: 6 (21.4)

      Brigatinib: 1 (3.5)

      Crizotinib: 1 (3.5)

      Alectinib: 6 (21.4)

      Ceritinib: 2 (7.1)

      Non-TKI second line: 32

      Best CNS response

      Progressive disease: 6 (21.4)

      Stable disease: 3 (10.7)

      Partial response: 6 (21.4)

      Complete response: 1 (3.5)

      Unknown: 12 (42.9)

      Best global response

      Progressive disease: 6 (21.4)

      Stable disease: 7 (25.0)

      Partial response: 10 (35.7)

      Complete response: 0

      Unknown: 5 (17.8)

      Reported toxicities

      10 (35.7)

      Grade of toxicity

      1: 4 (16.0)

      2: 2 (7.1)

      3: 2 (7.1)

      4: 1 (3.5)

      Non-grade reported: 1 (3.5)

      Treatment interruption due toxicity

      3 (10.7)

      Treatment dose-reduction

      1 (3.5)

      Third TKI treatment (n =9)

      TKI

      Erlotinib (retreatment): 2 (22.2)

      Afatinib: 1 (11.1)

      Gefitinib: 1 (11.1)

      Osimertinib: 3 (33.3)

      Brigatinib: 1 (11.1)

      Lorlatinib: 1 (11.1)

      Best CNS response in first line

      Progressive disease: 3 (33.3)

      Partial response: 2 (22.2)

      Unknown: 4 (44.4)

      Local CNS treatment (n = 60)

      CNS Radiotherapy

      34 (56.7)

      CNS Radiotherapy type

      Whole-brain radiotherapy (WBRT): 24 (40.0)

      Stereotactic radiotherapy: 8 (13.3)

      Both: 2 (3.3)

      Reported toxicity

      6 (10.0)

      Best CNS response due to RT

      Progressive disease: 11 (18.3)

      Stable disease: 6 (10.0)

      Partial response: 8 (13.3)

      Complete response: 3 (5.0)

      Unknown: 6 (10.0)

      CNS surgery

      2 (3.3)

      Survival

      Total TKI treatment time (months, 95% CI)

      Mean: 33.3 (23.4-43.2)

      Median: 27.0 (22.0-31.9)

      Overall survival, (months, 95% CI)

      Mean:

      Global: 42.6 (28.6-56.6)

      EGFR: 35.1 (24.7-45.5)

      ALK: 64.3 (29.1-99.6)

      Median:

      Global: 31.0 (21.4-46.6)

      EGFR: 29.0 (17.9-40.1)

      ALK: 34.0 (21.4-46.6)

      Table-2. Patients treated with TKIs alone at the diagnosis of brain metastases and those treated with new generation TKIs

      Patients treated with TKI alone (n = 25)

      Targetable driver mutation

      EGFR: 22 (88.0)

      ALK: 3 (12.0)

      Radiotherapy at progression

      6 (24.0)

      Radiotherapy type

      Whole-brain radiotherapy (WBRT): 5 (20.0)

      Stereotactic radiotherapy: 1 (4.0)

      Best CNS RT response

      Progressive disease: 2 (8.0)

      Partial response: 3 (12.0)

      Unknown: 1 (4.0)

      Radiotherapy-free survival (months, 95% CI)

      Mean: 45.15 (28.85-61.51)

      First TKI treatment (n = 25)

      TKI

      Erlotinib: 8 (32.0)

      Afatinib: 4 (16.0)

      Gefitinib: 5 (20.0)

      Osimertinib: 5 (20.0)

      Crizotinib: 1 (4.0)

      Alectinib: 2 (8.0)

      Best CNS response

      Progressive disease: 6 (24.0)

      Stable disease: 0

      Partial response: 11 (44.4)

      Complete response: 3 (12.0)

      Unknown: 5 (20.0)

      Best global response

      Progressive disease: 3 (12.0)

      Stable disease: 5 (20.0)

      Partial response: 11 (44.0)

      Complete response: 1 (4.0)

      Unknown: 5 (20.0)

      Second TKI treatment (n = 8)

      TKI

      Erlotinib: 1 (12.5)

      Gefitinib: 1 (12.5)

      Afatinib: 2 (25.0)

      Osimertinib: 3 (37.4)

      Alectinib: 1 (12.5)

      Best CNS response

      Progressive disease: 1 (12.5)

      Stable disease: 1 (12.5)

      Partial response: 1 (12.4)

      Complete response: 0

      Unknown: 5 (62.5)

      Best global response

      Progressive disease: 2 (25.0)

      Stable disease: 0

      Partial response: 5 (62.5)

      Complete response: 0

      Unknown: 1 (12.5)

      Third TKI treatment (n = 4)

      TKI

      Erlotinib (retreatment): 1 (25.0)

      Gefitinib: 1 (25.0)

      Osimertinib: 1 (25.0)

      Lorlatinib: 1 (25.0)

      Best CNS response

      Partial response: 1 (25.0)

      Unknown: 3 (75.0)

      Brain penetration TKI data (n = 28)

      TKI included

      Alectinib: 9 (32.1)

      Brigatinib: 2 (7.1)

      Ceritinib: 2 (7.1)

      Lorlatinib: 1 (3.6)

      Osimertinib: 14 (50.0)

      Conclusion

      Our study shows that deferring CNS RT in oncogene-driven NSCLC and CNS involvement is a valid option due to CNS metastases response to TKIs, especially to those that can penetrate the blood-brain barrier, in order to avoid side-effects derived from CNS radiation.

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