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Luiz Henrique Araújo
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EP1.16 - Treatment in the Real World - Support, Survivorship, Systems Research (ID 206)
- Event: WCLC 2019
- Type: E-Poster Viewing in the Exhibit Hall
- Track: Treatment in the Real World - Support, Survivorship, Systems Research
- Presentations: 1
- Now Available
- Moderators:
- Coordinates: 9/08/2019, 08:00 - 18:00, Exhibit Hall
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EP1.16-39 - Prospective Epidemiological Study of Metastatic Non-Small Cell Lung Cancer (NSCLC) in Latin America – LATINO Lung (LACOG 0116) (Now Available) (ID 1405)
08:00 - 18:00 | Author(s): Luiz Henrique Araújo
- Abstract
Background
Non-small cell lung carcinoma (NSCLC) is the main cause of cancer-related death in Latin America. Nonetheless, there is insufficient information regarding its epidemiology, treatment and outcomes in the region. The goals of this study are to describe disease characteristics, treatment patterns and survival for advanced NSCLC in Latin America.
Method
LACOG 0116 LATINO Lung is a prospective cohort study aiming to include approximately 800 patients with advanced stage NSCLC (stage III/IV at diagnosis or distant relapse of early-stage disease) from 24 sites in Brazil, Argentina, Mexico, Colombia and Chile. All consecutive newly diagnosed patients seen at each site will be invited to participate. Data on socioeconomic and demographic characteristics, medical/oncologic history and clinical-pathological characteristics will be collected at baseline. Thereafter, patients will be followed every 6 months for 3 years in order to gather information regarding treatment patterns and sequencing, reasons for treatment discontinuation, response to treatment, disease progression and overall survival. Data will be collected during medical visits or telephone calls and by medical charts review. Primary endpoint is to estimate the overall survival. Descriptive analysis of treatments and outcomes are planned. Multivariable regression methods will be applied to assess possible independent prognostic or predictive factors.
Result
As of April 3rd, 2019, 107 patients have been included, all of them within 16 sites in Brazil. Currently, there are 2 sites from Argentina, 2 from Mexico, 3 from Colombia and 1 from Chile awaiting regulatory approval to begin enrollment. Recruitment is planned to last until December 2019, when the estimated sample size will be achieved.
Conclusion
LACOG 0116 LATINO Lung is the first Latin American lung cancer prospective cohort study that will generate real-world data on NSCLC. The study may identify gaps and inequities in a diverse population of NSCLC in Latin America and consequently raise the need for improvement and individualized approach of lung cancer care in the region.
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P1.09 - Pathology (ID 173)
- Event: WCLC 2019
- Type: Poster Viewing in the Exhibit Hall
- Track: Pathology
- Presentations: 2
- Now Available
- Moderators:
- Coordinates: 9/08/2019, 09:45 - 18:00, Exhibit Hall
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P1.09-02 - Comprehensive Genomic Profiling of Non-Small Cell Lung Cancer in Brazil (GBOT 0118/LACOG 0418) (Now Available) (ID 2048)
09:45 - 18:00 | Author(s): Luiz Henrique Araújo
- Abstract
Background
Lung cancer is the leading cause of cancer-related morbidity and mortality worldwide. Cancer driver mutations have been examined extensively and are the basis for modern precision therapy. The access of genomic tests in Brazil and, therefore, the prevalence of driver mutations of NSCLC in the country is not well described. The objective of this study is to carry out an epidemiological analysis of the somatic genetic profile of Brazilian NSCLC samples tested with FoundationOne®.
Method
GBOT 0118/LACOG 0418 is a retrospective cross-sectional study with patients diagnosed with NSCLC in Brazil and who performed comprehensive genomic profiling (CGP) using FoundationOne® or FoundationACT®. Raw data containing anonymous clinical-pathological characteristics and the results of CGP was analyzed. We described the molecular profile of patients using descriptive statistics. Categorical variables are presented as frequency and compared using the Chi-square test.
Result
We obtained a total of 513 CGP results, 457 (89.0%) from Foundation One® and 56 (10.9%) from FoundationACT®. Adenocarcinoma was the most common histological subtype (83.8%) followed by NSCLC NOS (16.1%). Median age at testing date was 64 years, and 51.27% were male. EGFR activating mutations were detected in 23.39% patients, ALK rearrangements in 5.65%, ROS1 rearrangements in 2.34%, RET alterations in 2.53%, BRAF mutations in 5.46%, KRAS mutations in 25,15% and NTRK fusions in 0,58% . Tumor mutational burden (TMB) analysis was available for 80.51% of samples tested and was measured in mutation per megabase. TMB were divided into three groups based on the Foundation Medicine reports: low (1-5 mutations/mb), intermediate (6-19 mutations/mb) and high (≥ 20 mutations/mb). The of tumors had low (42.69%) or intermediate (32.36%) TMB, and only 5.46% had high TMB.
Table 1. Frequency of somatic genetic alterations in tumors tested with FoundationOne® and availability of targeted therapies in Brazil.
GENE
Frequency in NSCLC (%)
Availability in Brazil
EGFR
23.39
Approved
ALK
5.65
Approved
ROS1
2.43
Approved
BRAF
5.46
Approved
KRAS
25.15
No drugs available
RET
2,53
Drugs available but not approved
NTRK
0,58
Drugs available but not approved
Conclusion
This is the most comprehensive study describing CGP of NSCLC in Brazil using FoundationOne® or ACT. Our study shows rates of EGFR mutations and ALK rearrangements similar to those previously described. The knowledge of the molecular patterns of NSCLC in Brazil may help to improve health policies and access to targeted agents in the country.
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P1.09-04 - Comprehensive Genomic Profiling in a Brazilian Cohort of Lung Cancer Patients: Real-World Impact (Now Available) (ID 2712)
09:45 - 18:00 | Author(s): Luiz Henrique Araújo
- Abstract
Background
The implementation of comprehensive genomic profiling (CGP) for every patient would ideally inform on all types of alterations, both frequent and rare events that might be useful for treatment. However, less than 50% of Brazilian lung cancer patients have access to any molecular testing. Giving the lack of literature data regarding CGP and clinical practice change, we aimed to evaluate how CGP changed patient treatment in a fully-annotated cohort of lung cancer in Brazil.
Method
A retrospective study was conducted to review lung cancer patients for whom CGP was performed from October 2017 to February 2019 in a national, private oncology institution. Patients with all histological subtypes tested with Foundation One (F1) were included. Data regarding microsatellite instability (MSI), tumor mutational burden (TMB) and genomic findings were collected, as well as therapies/ clinical trials with possible clinical benefit. Demographic data were collected from chart review.
Result
From 25 patients included in this cohort, 56% were male with a median age of 64-year-old. Tissue and blood sample were analyzed in 80% and 20%, respectively. The most common histological subtype was adenocarcinoma (68%) followed by squamous cell carcinoma (12%). CGP was ordered in 16% of treatment-naive patients; 52% in the first-line treatment and 8% and 12% after second and third line, respectively. None of them had MSI and 12% had high TMB. The most frequent genomic alterations were TP53 (64%); KRAS (32%); STK11 and ARID1A (16%); PIK3, CDKN2AB, and RB1 (12%); ATM, CTNNB1, ERBB2, MLL2, MSH2, PTPN11 and BRCA (8%). One patient was negative for EGFR mutation, tested by COBAS, but was found to have EGFR mutation by CGP. Although CGP showed up to 15 therapies and 37 clinical trials available for this cohort, none of the physicians have changed treatment after testing results due to limited access to clinical trials or one death before the beginning of anti-EGFR therapy.
Conclusion
In our cohort, 25 patients with lung cancer had CGP tested during 16 months of follow-up, highlighting the limited access to the test. For most cases, CGP was ordered later during the treatment which could negatively impact on patient outcome. Furthermore, due to a paucity of available clinical trials and lack of access to new drugs in the country, the use of CGP had a limited impact in clinical decision making.
