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C.G. Ferreira
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P1.01 - Advanced NSCLC (ID 757)
- Event: WCLC 2017
- Type: Poster Session with Presenters Present
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 10/16/2017, 09:30 - 16:00, Exhibit Hall (Hall B + C)
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P1.01-045 - Companion Diagnostic Tests for EGFR, ALK and ROS-1 vs NGS in Advanced NSCLC Patients - Which Is the Best in Terms of Cost and Effective? (ID 10464)
09:30 - 09:30 | Author(s): C.G. Ferreira
- Abstract
Background:
Success of a target therapy is directly correlated with the accuracy of its companion diagnostic test. Without a corresponding biomarker, target therapy may yield shorter survival, waste time, increase burdens and costs. As important as conducting cost-effectiveness studies for therapies, it is also valuable to compare different molecular tests. In lung cancer, the mutational status of EGFR and translocation of ALK and ROS-1 are commonly tested to offer the best intervention. Our objective is to evaluate the cost-effectiveness of a unique exam using NGS versus other routinely used tests such as the ones which involve RT-PCR and FISH.
Method:
Target population is NSCLC, adenocarcinoma, and candidates to first-line therapy. Strategy 1: test EGFR mutation if EGFR test negative, individual follow to FISH for ALK; if FISH negative, follow to FISH for ROS-1. Strategy 2: differs from 1 since FISH for ALK and ROS are requested together. Strategy 3: all individuals are submitted to NGS (multicomplex platform which include EGFR/ALK/ROS-1 and other genes). Prevalence of biomarker, test accuracy and proportion of unknown results were used to calculate each decision tree branch. Sensitivity and specificity was obtained from literature review using Sanger as reference standard for RT-PCR tests and NGS. The study was analyzed from a healthcare-payer perspective based on Brazilian private sector. Costs were based on data from diagnostic companies, ANS and AMB-CBHPM 2016. Survival time and utilities were based from randomized clinical trials. Decision tree model was designed to select an appropriate treatment regimen according to test results; and microsimulation model (M) simulate costs and survival from the corresponding treatment. If EGFR test was positive, M1: gefitinib 1ºline>pemetrexed+cisplatin>docetaxel; if ALK or ROS1 were positive, M2: crizotinib1ºline>pemetrexed+cisplatin>docetaxel; if EGFR/ALK/ROS negative or test unknow, M3: pemetrexed+cisplatin>docetaxel>gemcitabine.
Result:
The use of NGS added 24% extra cases correct identified as well as extra costs (US$ 800.76; PPP 2015) attributed to the molecular testing. The ICER comparing NGS with sequential tests was US$ 3,381.82/correct case detected. Comparing strategy 2:1, the ICER was US$937.86/correct case detected. Therefore, when treatment was incorporated into the model, the effectiveness was diluted between arms. The NGS improves slight gain in life years and quality-adjusted life years, but this could be explained by minor differences in global survival time between treatments.
Conclusion:
: this study is part of an effort to integrate companion diagnostics discussions on precision medicine and covered drugs in the Brazilian health system. Studies considering liquid biopsy could be worth value to highlight effectiveness between tests in clinical routine.
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P1.02 - Biology/Pathology (ID 614)
- Event: WCLC 2017
- Type: Poster Session with Presenters Present
- Track: Biology/Pathology
- Presentations: 1
- Moderators:
- Coordinates: 10/16/2017, 09:30 - 16:00, Exhibit Hall (Hall B + C)
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P1.02-036 - Fine Needle Aspiration as a Diagnostic Tool in Lung Cancer: Worth Pursuing? (ID 9581)
09:30 - 09:30 | Author(s): C.G. Ferreira
- Abstract
Background:
The diagnosis of lung cancer can be challenging due to different forms of disease presentation, coupled with institutional familiarity with specific techniques. Transthoracic fine needle aspiration (FNA) is relatively simple and inexpensive, yielding diagnostic material in 70-95% of cases. In the era of personalized oncology where immunohistochemical and molecular assays may be required, the role of FNA to provide enough material should be reassessed.
Method:
This is a prospective study designed to evaluate the feasibility and safety of FNA as a primary technique in the diagnosis of lung tumors. Patients were randomized in a 1:1 ratio into two arms, one using conventional FNA needle (control arm) and another using coaxial needle (experimental arm). Eligible patients were at least 18 years old and had a lung mass suspicious of lung cancer. The procedure was performed in an outpatient clinic, under local anesthesia, by an experienced thoracic surgeon in the presence of a pathologist. The primary endpoint was a positive cell block containing at least 40% of neoplastic cells, a surrogate for successful additional assays. We present the first interim analysis. This study was approved by the Ethics Committee.
Result:
Between January 2013 and May 2015, 34 patients were enrolled, 17 in each arm. The cohort was mostly comprised of males (62%) and smokers (91%), with a median age of 66 years (range 51-85). Most cases were assessed with a computed tomography (94%), with target tumor measuring a median of 8.2 cm (range 1-13 cm). Baseline characteristics were well balanced between the 2 arms, except for gender (82% males in the experimental arm, 41% in the control arm). A positive cell block was acquired in 9 (53%) and 7 (41%) cases in the experimental and control arms, respectively. Altogether, a positive cell block was acquired in 16 cases (47%). A diagnosis was obtained in 82% of cases, but histological subtyping was only possible in 73%. The cell block positivity rate was significantly associated with histological subtyping (p<0.001). Local pain was the only adverse event, reported in 2 cases in each arm.
Conclusion:
FNA was a safe procedure in both arms, but yielded enough tumor material in less than half patients and was less than optimal to determine histological subtyping. No relevant difference was observed between conventional and coaxial needle, neither for safety nor for efficacy. FNA alone should not be considered a standard procedure in most cases suspicious for lung cancer.
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P3.02 - Biology/Pathology (ID 620)
- Event: WCLC 2017
- Type: Poster Session with Presenters Present
- Track: Biology/Pathology
- Presentations: 1
- Moderators:
- Coordinates: 10/18/2017, 09:30 - 16:00, Exhibit Hall (Hall B + C)
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P3.02-097f - Rare Actionable Mutations in a Lung Adenocarcinoma Cohort in Brazil (ID 9864)
09:30 - 09:30 | Presenting Author(s): C.G. Ferreira
- Abstract
Background:
The detection of driver mutations and targeted therapy have brought precision medicine into the treatment landscape of non-small cell lung cancer (NSCLC). EGFR mutations and ALK rearrangement were the first actionable driver alterations identified in lung adenocarcinomas. Further actionable mutations include ROS, BRAF, HER2, MET, and RET. These genes are less frequently mutated than EGFR/ALK, nevertheless, each of these mutations appear to be sensitive to clinically available targeted therapies. Brazil has a genetically admixed population and an emerging economy in which access to novel technologies may be limited. Our group have studied different aspects on the implementation of precision medicine to lung cancer patients in the country. Multiplex diagnosis platforms can optimize treatment decisions and we have recently shown it may be cost-effective in the Brazilian context. In this study, using Next Generation Sequencing (NGS), we describe the prevalence of oncogene rare mutations in a representrative Brazilian cohort.
Method:
We included consecutive adenocarcinoma patients referred to a private reference center in Brazil from November-2015 to May-2017. DNA and RNA were extracted from paraffin-embedded tissue. NGS was performed for target regions using the Oncomine® Focus Assay on an Ion PGM platform. This panel evaluates 132 hotspot sites of driver mutations in 35 genes, copy number variations in 19 genes and 23 gene fusions.
Result:
To date 262-lung adenocarcinoma have been included. Genetic alterations were detected in 72% (189 of 262) of all patients. Corroborating previous data from different groups, including ours, the most common actionable alteration detected in this study were EGFR mutation (23%) and ALK rearrangement (7%). Oncogene rare mutations were detected in 68 patients. HER2 mutations were found in 4% and BRAF in 2% of tested patients. ROS were the second most common fusion (3%) followed by RET (2%) and MET exon 14 mutation in 1.5%. PIK3CA was seen 5% of patients. Other rare mutations such as MTOR, CTNNB1, FGFR2, JAK2, SMO, KIT, IDH1, GNA11, ERBB3, PGFRA, FGFR1 and MAP2K1 were detected each with less than 1%.
Conclusion:
In a representative Brazilian cohort, the percentage of rare mutations detected matches data published elsewhere. An extended cohort and health economics data will be presented during the meeting and will allow a better description of the rare mutations and the potential impact they may have in the landscape of lung adenocarcinoma treatment in Brazil. These data may support drug access decisions in the country.
