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Ana Laura Ortega Granados
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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): Ana Laura Ortega Granados
- Abstract
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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OA01 - Established Drugs in Special Populations and New Drugs in Established Populations (ID 226)
- Event: WCLC 2020
- Type: Oral
- Track: Immunotherapy (Phase II/III Trials)
- Presentations: 1
- Moderators:
- Coordinates: 1/29/2021, 09:15 - 10:15, Scientific Program Auditorium
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OA01.07 - A Phase II Study of the Oral Selective AXL Inhibitor Bemcentinib with Pembrolizumab in Patients with Advanced NSCLC (ID 3647)
09:15 - 10:15 | Author(s): Ana Laura Ortega Granados
- Abstract
- Presentation
Introduction
AXL is a mediator of resistance to immunotherapy and a negative prognostic factor for NSCLC. Bemcentinib (BGB324), a first-in-class, oral, selective and potent AXL kinase inhibitor, enhances checkpoint inhibitor (CPI) efficacy in pre-clinical models through tumor-immune mechanisms. Increasingly, the combination of doublet chemotherapy with checkpoint inhibitors (Chemo-CPI) is a commonly used option for advanced NSCLC, and recurrence following such first line therapy represents an area of great unmet need. BGBC008 addresses the unmet need for NSCLC patients who fail 1L SOC.
Methods
BGBC008 is a PhII single-arm, 2-stage study with bemcentinib (200mg/d) and pembrolizumab (200 mg/q3wk) for previously-treated Stage IV lung adenocarcinoma comprising 3 cohorts: chemotherapy-failed IO-naïve patients (post-Chemo), patients progressing on prior CPI therapy (post-CPI monotherapy) and platinum-doublet chemotherapy in combination with pembrolizumab (post-Chemo-CPI). Primary endpoint was ORR according to RECIST1.1 with pre-defined criteria to proceed from the first to second stage in each cohort. Secondary endpoints included DCR, PFS, OS and safety. Exploratory endpoints include biomarker analysis and correlation with clinical endpoints, including composite (tumor and immune cell) cAXL score, PD-L1 TPS, and genome-wide mutational and transcriptome analyses.
Results
As of August 2020, enrollment in the post-Chemo cohort and stage 1 of the post-CPI monotherapy cohort is completed. Results of the post-Chemo cohort (n=50) and post-CPI monotherapy stage 1 cohort (n=16) were previously presented. Stage 2 of the post-CPI monotherapy cohort and stage 1 of the post-Chemo-CPI cohort are currently recruiting into the study.
In patients treated to date, common TEAEs (>25% of patients) for NSCLC patients receiving the bemcentinib + pembrolizumab combination were: increased ALT (29%; 10% G3+), AST (29%; 5% G3+), and diarrhoea (29%; 1% G3+). All cases of treatment-related transaminase increase were reversible and managed with concomitant administration of steroids and treatment interruption.
Having previously demonstrated a very high clinical benefit rate in post-Chemo and post-CPI monotherapy (stage 1) in cAXL-positive patients (73% and 85%, respectively), and low probability of clinical benefit in cAXL-negative patients (40% and 0%, respectively) further focus on the predictive value of cAXL in second line patients following either CPI monotherapy or Chemo-CPI relapse will be reported, together with transcriptional analysis to identify gene based predictive signatures.
Conclusion
Overall, bemcentinib in combination with pembrolizumab was well-tolerated and shows promising clinical activity in relapsed lung cancer. The key unmet need population of second line patients refractory to CPI monotherapy or Chemo-CPI will be presented together with translational data. Clinical Trial Registration: NCT03184571
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OA05 - Value and Quality in Lung Cancer (ID 216)
- Event: WCLC 2020
- Type: Oral
- Track: Health Services Research/Health Economics
- Presentations: 1
- Moderators:
- Coordinates: 1/29/2021, 15:30 - 16:30, Scientific Program Auditorium
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OA05.04 - Clinical and Economic Impact of the Current Testing Scenario for ALK Rearrangements in Spain Compared to a Hypothetical No-Testing Scenario. (ID 1788)
15:30 - 16:30 | Presenting Author(s): Ana Laura Ortega Granados
- Abstract
- Presentation
Introduction
Nowadays biomarkers play an essential role in diagnosis, treatment, and management of cancer. Determination of ALK rearrangements in non-small cell lung cancer (NSCLC), along with EGFR, ROS1, BRAF and PD-L1 analysis, is mandatory for an adequate treatment decision. The aim of this study is to determine the clinical and economic impact of current ALK testing scenario in Spain.
Methods
A hybrid decision-analytic model (decision tree plus Markov model) was developed to estimate the cost and health outcomes of NSCLC patients in Spain comparing current testing scenario vs no-testing scenario. Non-squamous and never-smoker squamous NSCLC patients were included in the model. Current distribution of ALK testing techniques and the sensitivity and specificity data were retrieved from the literature. The assignment of the target treatment based on test results (true positive, false positive, true negative, false negative) was established by a panel of experts. For each treatment, a 3-states Markov model was developed, where progression free survival (PFS) and overall survival (OS) curves were parameterized using exponential extrapolations to model transition of patients among health states. A Spanish Health System perspective was used so only medical direct costs were included (€, 2019). A lifetime horizon was analysed and a discount rate of 3% was applied. Both deterministic and probabilistic sensitivity analyses were performed to address uncertainty.
Results
A target population of 7,628 NSCLC (non-squamous and never-smoker squamous) patients per year was estimated. Over a lifetime horizon, the current ALK testing scenario produced additional 4,291 and 3,363 life years (LYs) and quality adjusted life years (QALYs), respectively, compared with no-testing scenario. Total direct costs were increased up to € 33,147,595 for testing scenario. The incremental cost-effectiveness ratio (ICER) was 9.855 €/QALY. Other parameters were measured such as median cost and median QALYs of the four possible test results plus no tested patients. The sensitivity analyses carried out confirmed the robustness of the base-case results, being the sensitivity and specificity variables the key drivers of the model.
Conclusion
ALK testing in non-squamous and never-smoker squamous NSCLC patients is a cost-effectiveness strategy and it generates more than 3,000 QALYs in Spain over a lifetime horizon. Comparing this gain in health outcomes with the incremental costs (associated mainly to targeted treatments), the resulting ICER shows that testing non-squamous and never-smoker squamous NSCLC is a cost-effective strategy in our country.
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P52 - Staging - Prognosis and Staging (ID 186)
- Event: WCLC 2020
- Type: Posters
- Track: Staging
- Presentations: 4
- Moderators:
- Coordinates: 1/28/2021, 00:00 - 00:00, ePoster Hall
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P52.05 - Lung Cancer Symptoms at Diagnosis: Data from the Thoracic Tumors Registry (TTR Study). (ID 3023)
00:00 - 00:00 | Author(s): Ana Laura Ortega Granados
- Abstract
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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P52.06 - “High Tumor Burden” in Metastatic Non-Small Cell Lung Cancer: Defining the Concept (ID 3302)
00:00 - 00:00 | Author(s): Ana Laura Ortega Granados
- Abstract
Introduction
Identifying patient characteristics that define a worse prognosis for the disease or a “high tumor burden” (HTB) status is essential for clinical decision-making and treatment selection in metastatic non-small cell lung cancer (mNSCLC). This study aimed to define this concept based on the oncologist’s experience in clinical practice.
Methods
A representative sample of Spanish experts was selected and asked to complete an online survey regarding the definition of “high tumor burden” according to their personal experience.
Results
HTB was identified by the oncologists (N = 81) among the main factors influencing first-line treatment decision-making. According to experts, the number of metastatic lesions (n = 45, 56%), location (n = 34, 42%), tumor size (sum of diameters of target lesions; n = 26, 32%) and liver involvement (n = 24, 30%) mainly defined HTB. High lactate dehydrogenase (LDH) levels were associated with HTB too. Almost half of respondents (n = 33, 41%) believed that one metastatic lesion was sufficient to consider a patient to present HTB, 72% (n = 58) considered that two were necessary and 99% (n = 80) three. Interestingly, liver (n = 76, 100%) followed by brain (n = 65, 86%) were the main metastatic locations associated with HTB. Tumor size ranging from 6 cm to 10 cm as well as high LDH levels (three times above the upper limit) defined the concept for 82% (n = 62) and 100% (n = 76) of oncologists, respectively.
Conclusion
In the real-world setting, HTB is defined by the number of metastatic lesions, location of metastases, size of tumors and by high LDH levels according to experts’ opinion. Given the relevance of this concept, efforts should be made to unify its definition, and to further explore its potential as a prognostic factor for mNSCLC patients.
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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 | Author(s): Ana Laura Ortega Granados
- Abstract
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 | Author(s): Ana Laura Ortega Granados
- Abstract
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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P76 - Targeted Therapy - Clinically Focused - EGFR (ID 253)
- 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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P76.42 - OsimertinibTreatment in Non-Small Cell Lung Cancer (NSCLC) EGFR-T790M+. Activity in Patients with CNS Metastases. OSIREX (ID 1860)
00:00 - 00:00 | Author(s): Ana Laura Ortega Granados
- Abstract
Introduction
Based on the lack of real-life results the Spanish Lung Cancer Group (SLCG) proposed to organize a retrospective study in which we can describe the experience in efficacy and safety of osimertinib in p with NSCLC EGFRm T790M and central nervous system CNS) metastases.
Methods
Observational, non-interventional, multicentre, one-arm, non comparative, retrospective study in T790M positive NSCLC p with advanced or metastatic disease. A total of 155 p were included. The observation period was from August 2016 to December 2018 in 30 Spanish hospitals. This corresponds to a total period of 29 months.
Results
155 p were included (108 women (69.7%), median age: 67 (37-88), 64% (99/155) were non-smokers and 99 % (154/155) had adenocarcinoma. Most p had received at least one prior treatment (97.4%, 151/155): 76.8% previous EGFR-TKIs, and 20.6% had received prior cytotoxic chemotherapy. At data cutoff, median duration of follow-up was 11.7 months (0.4-32).
A total of 155 p were evaluable for response analysis, 87(56%) as 1st and 2nd line therapy and 68 as ≥3rd line. 45 patients (30%) had CNS metastases at baseline. PFS was inferior en patients with CNS metastases than in those without (median, 7.2 months (95% CI, 3.9 to 10.6) vs 10.3 months (95% CI, 7.8 to 12.8) HR: 1.54 (95% CI, 1.03 to 2.32).
Conclusion
This retrospective study to assess the real-world clinical impact of osimertinib in p with advanced NSCLC and CNS metastases. Osimertinib had demonstrated greater penetration of blood brain barrier than gefitinib or erlotinib and these results could recommend us to use in first line.
