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Virginia Calvo



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    ES06 - Perioperative Therapy for Early Stage NSCLC (ID 221)

    • Event: WCLC 2020
    • Type: Educational Session
    • Track: Early Stage/Localized Disease
    • Presentations: 1
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      ES06.01 - Neoadjuvant IO Monotherapy vs. Chemo-IO (ID 4046)

      14:15 - 15:15  |  Author(s): Virginia Calvo

      • Abstract
      • Slides

      Abstract

      Anti-PD1/PD-L1 (anti-PD(L)1) antibodies activity is based on the blockade of PD-1 protein in lymphocytes or PD-L1 in tumor cells, preventing lymphocytes inactivation and promoting tumor elimination. A great part of the knowledge of its mechanism is due to neoadjuvant immunotherapy studies. In the situation with the intact tumor, on one side, anti-PD(L)1 rejuvenates the tumor-specific cytotoxic T cells from the tumor microenvironment, causing them to activate, proliferate and mobilize to eliminate distant micrometastasis. Additionally, anti-PD(L)1 increases tumor antigen presentation by dendritic cells in the tumor-draining lymph nodes activating new tumor-specific T cells that then migrate to tumor sites. Both processes trigger a powerful systemic anti-tumor immune response and the generation of memory T-cells that may provide long-term protection. Conversely, the neoantigen repertoire is reduced when the primary tumor is resected, limiting this anti-tumor immune response in the adjuvant setting and representing a strong argument for the neoadjuvant approach. Moreover, several immunological pathways are disrupted by surgical stress. While essential for wound healing, surgical stress leads to the expansion of Tregs, MDSC, and M2 macrophages, resulting in an overall state of immunosuppression with PD-1/CTLA-4 increase and T-cell exhaustion. Immune checkpoint inhibitors in neoadjuvant settings might be advantageous in activating tumor-infiltrating T-cells prior to surgery, and avoiding PD-1 expression on immune cells in the postoperative period.

      Patients with NSCLC treated with neoadjuvant chemotherapy exhibited higher levels of PD-L1+ malignant cells and TILs than patients who underwent upfront tumor resection without neoadjuvant treatment. In patients who underwent neoadjuvant treatment, those with higher abundance of helper T cells and TAMs survived longer, suggesting that these cells may be important in chemotherapy response.

      The neoadjuvant treatment has theoretical advantages like assessment of response to chemotherapy in vivo and this, in turn, helps identify patients who will potentially benefit from this therapy; perhaps the better locoregional drug delivery because of intact vessels presurgery; better tolerability; early treatment of micrometastatic disease; downstaging with improved resectability and offers the possibility for the identification of surrogate clinical and biological markers that may correlate with response to therapy and a potential long-term outcome. However neoadjuvant therapy has potential disadvantages: delay in local therapy due to toxicity, risk progression in chemoresistant patients, and pre-operative complications.

      The prolonged duration of clinical trials for resectable stages I and III NSCLC, in which OS has been used as the primary endpoint, has resulted in slow progress and high expenses. There is a need for surrogate markers of efficacy outcome, aside from the traditional endpoints of OS or PFS, to accelerate the development of new therapies in early-stage NSCLC. Complete surgical resection, tumor downstaging, and complete and major pathologic responses after neoadjuvant chemotherapy have been associated with improved survival in resectable NSCLC.

      Multiple checkpoint inhibitors have been evaluated as neoadjuvant treatment, but their use in this setting remains investigational.

      Forde, et al. evaluated the feasibility of two doses of neoadjuvant PD-1 blockade in a recent pilot study in 21 patients with early-stage (I–IIIA) NSCLC (NCT02259621). Two preoperative doses of the anti-PD-1 inhibitor nivolumab (3mg/kg) were administered intravenously every two weeks, with surgery planned about 4 weeks after starting the neoadjuvant therapy. While only 10% of patients had objective responses on post-treatment CT-scans, MPR occurred in 45% of patients who went to surgery and 13% of patients had pathologic complete responses. Furthermore, MPR occurred in PD-L1-positive and PD-L1-negative tumors, and TMB was predictive of pathologic response to anti-PD-1 therapy.

      LCMC3 trial (NCT02927301) is a phase II single-arm study of neoadjuvant atezolizumab monotherapy in patients with resectable early-stage NSCLC. The initial safety analysis of the first 54 of 180 planned patients who received two cycles of atezolizumab (PD-L1 inhibitor) monotherapy every three weeks in patients with stages IB to selected IIIB (T3N2) resectable NSCLC prior to surgical resection. By RECIST, 6/82 patients had a partial response, 72 had stable disease and 4 had progressive disease. The MPR rate was 18% (95% CI: 11-28%) 15/82, 4 patients had CPR (5%).

      NEOSTAR study (NCT03158129) is a phase II study of induction checkpoint blockade for untreated patients with stage I-IIIA (single N2) NSCLC. The patients received three doses of nivolumab 3 mg/kg or nivolumab 3 mg/kg plus ipilimumab 1 mg/kg q2w followed by surgery. Five of the 31 patients initially scheduled for surgery did not proceed to resection (one with hypoxemia grade 3, two with high surgical risk and two were no longer resectable). In the 26 resected patients, MPR rate was 28% with nivolumab and 31% with the combination. In ASCO 2019 updated data were presented, 39 of 44 underwent surgery, 89% resectability. The MPR rate was 24% overall, 17% with nivolumab, and 33% with the combination therapy. Secondary adverse events were 4%, including 2 bronchopleural fistulas and 8 air leaks.

      As for combined ICI and chemotherapy, there are also different studies.

      NADIM trial (NCT03081689) is a prospective, open-label, single-arm phase 2 trial, that evaluated the safety and efficacy of neoadjuvant chemotherapy paclitaxel + carboplatin plus nivolumab followed by adjuvant nivolumab in 46 patients with resectable stage IIIA (N2 or T4) NSCLC. The primary endpoint was progression‑free survival (PFS) at 24 months. Forty-one of 46 patients had undergone surgery and all tumors were resectable with R0 resection. At 24 months, progression-free survival was 77%. Intention to treat analysis shows 34 patients (83%) achieved MPR of which 26 (63%) had complete pathologic response (CPR). Downstaging was seen in 37 (90%) of cases. This is the first multi-center study to explore chemotherapy and immunotherapy in the neoadjuvant setting in stage IIIA.

      In Shu C trial (NCT02716038), from Columbia University, patients received neoadjuvant treatment with atezolizumab, nab-paclitaxel, and carboplatin. Results show that 17/30 patients (57%) achieved MPR of which 10 (33%) had CPR.

      Immunotherapy has revolutionized the treatment of advanced stages of lung cancer, becoming early stages of its next challenge.

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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  |  Author(s): Virginia Calvo

      • 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: 2
    • 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  |  Presenting Author(s): Virginia Calvo

      • 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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      P09.50 - Lung Cancer Hospitalization Burden. Generating Knowledge from Administrative Data to Optimize Management. (ID 3565)

      00:00 - 00:00  |  Presenting Author(s): Virginia Calvo

      • Abstract
      • Slides

      Introduction

      Hospitalization secondary to lung cancer is a common event and causes significant resource consumption. From a basic set of administrative data of mandatory registration for all admissions, with demographic and clinical information recorded according to International Classification of Diseases (ICD), we aim to evaluate real-world health results and understand the hospitalization needs of lung cancer patients.

      Methods

      We conducted a retrospective observational study selecting all patients with lung cancer admitted to the Hospitalization Unit of the Medical Oncology Department at Puerta de Hierro University Hospital between 2009 and 2015. Administrative, epidemiological and diagnosis information encoded by ICD-9-MC version was analysed. A classification algorithm was coded to link morphological codes and diagnosis codes of ICD to identify subgroups of lung cancer. Our objective was to describe the lung cancer hospitalization burden and assess the quality of care.

      Results

      Between 2009 and 2015 there were 5440 admissions in the Medical Oncology Department, 1460 (26,8%) were lung cancer patients.

      The main results of the study are summarized in the attached table.

      tabla iaslc 2.jpg

      Conclusion

      Lung cancer is the neoplasm with the highest burden of hospitalization in our department (26,8%). NSCLC accounts for 87.1% of admissions (46.7% adenocarcinomas). ED admissions account for 71.4% and 97.3% for NSCLC and SCLC respectively. The average stay of 7.6 days, a hospital exitus rate of 16% and a readmission rate in 7 days of 5.2% allow to assess the quality of care.

      A key issue addressed by our study is to develop a culture of evaluation of health results. The main limitation is that data entry is carried out by the admission department, so the applicability in clinical management must be taken with caution.

      Automating the analysis of hospital activity through data science approaches will be essential for the development of learning health care systems.

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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): Virginia Calvo

      • 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: 1
    • Moderators:
    • Coordinates: 1/28/2021, 00:00 - 00:00, ePoster Hall
    • +

      P52.05 - Lung Cancer Symptoms at Diagnosis: Data from the Thoracic Tumors Registry (TTR Study). (ID 3023)

      00:00 - 00:00  |  Presenting Author(s): Virginia Calvo

      • Abstract
      • Slides

      Introduction

      Lung cancer is the most common cancer worldwide and is the leading cause of cancer death in Western countries. Despite its high incidence and mortality there are few studies that describe its symptoms at diagnosis and their relationship with tumor stage and tobacco use. The objective of this study is to describe the frequency of the most common symptoms of non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC) at diagnosis and their connection with stage of disease and smoking habit.

      Methods

      This was a case series study that analysed cases collected from the Thoracic Tumour Registry (TTR) sponsored by the Spanish Lung Cancer Group (SLCG) from August 2016 to June 2019.

      Results

      9,876 patients were included. 74% male, the median age was 65 years (57-72), 12% were never smokers. The most frequent histologic type was adenocarcinoma (52%) followed by squamous cell carcinoma (24%) and small cell lung cancer (12.5%). 46.6% of the patients was stage IV at diagnosis. The most common symptoms were cough (33.9%) and dyspnoea (26.7%). No symptom was present in 59% of patients diagnosed stage I NSCLC and in 27.7% of patients stage IV NSCLC. The number of symptoms was similar across the respective smoking categories in NSCLC and differences between the symptoms analysed did not exceed 7% in any case

      TABLE:

      Table. 1 Symptom description by tobacco consumption: NSCLC

      Symptoms at diagnosis+

      Never smokers**

      Ex-smokers**

      Current smokers**

      p-trend

      Cough

      387 (34.1)

      1,310 (31.7)

      1,099 (34.5)

      0.163

      Pain

      318 (28.0)

      990 (24.0)

      1,008 (31.6)

      <0.001

      Dyspnoea

      330 (29.1)

      1,014 (24.5)

      823 (25.8)

      0.365

      Haemoptysis

      70 (6.2)

      511 (12.4)

      389 (12.2)

      <0.001

      Weight loss

      223 (19.7)

      678 (16.4)

      842 (26.4)

      <0.001

      Anorexia

      66 (5.8)

      185 (4.5)

      226 (7.1)

      0.001

      Asthenia

      114 (10.1)

      315 (7.6)

      331 (10.4)

      0.024

      Superior vena cava syndrome

      3 (0.3)

      6 (0.1)

      15 (0.5)

      0.039

      Aphonia or voice alterations

      331 (2.7)

      100 (2.4)

      104 (3.3)

      0.085

      Number of symptoms++

      0

      1

      2

      3

      4 or more

      341 (30.1)

      252 (31.0)

      236 (20.8)

      127 (11.2)

      78 (6.9)

      1,531 (37.0)

      1,121 (27.1)

      812 (19.6)

      427 (10.3)

      242 (5.8)

      879 (27.6)

      887 (27.8)

      694 (21.8)

      454 (14.2)

      272 (8.4)

      <0.001

      0.263

      0.113

      <0.001

      <0.001

      **Never smoker: participant smoked less than 100 cigarettes in lifetime. Ex-smoker: stopped smoking more than 1 year before diagnosis. Current smoker: declared smoking during the year before diagnosis. 89 participants had unknown tobacco consumption.

      +Percentages calculated as a total of the sample.

      ++Totals calculated for each smoking category.

      Conclusion

      In conclusion, this study provides valuable information on the frequency and type of lung cancer symptoms at diagnosis and their relationship with stage and tobacco use. The most relevant findings are that 28% of stage IV lung cancers do not present any symptoms at diagnosis, and that there are no relevant differences in symptom presentation by reference to smoking status. This information confirms the lack of specificity of lung cancer symptoms and the fact that the absence of the most frequent symptoms (i.e., cough, pain, dyspnoea) should in no case lead to a decision to rule out the presence of this disease.

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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
    • +

      P66.04 - Real World Data: Immunotherapy in Lung Cancer Patients over 65 Years Old in Spain (ID 3641)

      00:00 - 00:00  |  Presenting Author(s): Virginia Calvo

      • 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: 2
    • Moderators:
    • Coordinates: 1/28/2021, 00:00 - 00:00, ePoster Hall
    • +

      P84.14 - Identification of Mechanisms of Resistance to ALK Inhibitors. Next-Generation Sequencing-Based Liquid Biopsy Profiling. (ID 3612)

      00:00 - 00:00  |  Author(s): Virginia Calvo

      • Abstract
      • Slides

      Introduction

      Despite impressive and durable responses, patients treated with ALK inhibitors (ALK-Is) ultimately progress. We investigated potential resistance mechanisms in a series of ALK-positive non-small cell lung cancer (NSCLC) patients progressing on different types of ALK-Is.

      Methods

      26 plasma and 2 cerebrospinal fluid samples collected upon disease progression to an ALK-I, from 24 advanced ALK-positive NSCLC patients, were analyzed by next-generation sequencing (NGS). A tool to retrieve variants at the ALK locus was developed.

      Results

      61 somatic mutations were detected in 14 genes: TP53, ALK, PIK3CA, SMAD4, MAP2K1 (MEK1) FGFR2, FGFR3, BRAF, EGFR, IDH2, MYC, MET, CCND3 and CCND1. Overall, We identified at least one mutation in ALK locus in 10 (38.5%) plasma samples, being the G1269A and G1202R mutations the most prevalent among patients progressing to first- and second-generation ALK-I treatment, respectively. An exon 19 deletion in EGFR was identified in a patient showing primary resistance to ALK-I. Likewise, the G466V mutation in BRAF and the F129L mutation in MAP2K1 (MEK1) were identified as the underlying mechanism of resistance in three patients who gained no or little benefit from second-line treatment with an ALK-I. Putative ALK-I resistance mutations were also found in PIK3CA and IDH2. Finally, a c-MYC gain, along with a loss of CCND1 and a FGFR3, were detected in a patient progressing on a first-line treatment with crizotinib.

      Conclusion

      NGS analysis of liquid biopsies upon disease progression identified putative ALK-I resistance mutations in most cases, being a valuable approach to devise therapeutic strategies upon ALK-I failure.

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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): Virginia Calvo

      • 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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