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Marileila Varella-Garcia
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IASLC Pre-Conference School of Pathology (ID 4)
- Event: LALCA 2019
- Type: Invited Speaker Session
- Track:
- Presentations: 2
- Moderators:
- Coordinates: 10/17/2019, 08:15 - 15:30, Feria 2-3
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PC4.08-4 - CAP Guidelines for NGS Validation and Challenge for Latin America Laboratories (ID 484)
08:15 - 15:30 | Presenting Author(s): Marileila Varella-Garcia
- Abstract
Abstract not provided
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PC4.09 - Case Presentations: 3 or 4 Cases (ID 49)
08:15 - 15:30 | Author(s): Marileila Varella-Garcia
- Abstract
Abstract not provided
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Session 12: Presidential Symposium (ID 27)
- Event: LALCA 2019
- Type: Oral Abstract Session
- Track:
- Presentations: 2
- Moderators:
- Coordinates: 10/19/2019, 09:15 - 09:50, Castillo A 1-4
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S2.04 - Results from the IASLC Global Survey on Molecular Testing in Lung Cancer (ID 108)
09:15 - 09:50 | Author(s): Marileila Varella-Garcia
- Abstract
Background:
The IASLC conducted an international survey to evaluate current practice and barriers to molecular testing (MT) in lung cancer. Here we compared results from Latin America (LA) to other regions of the world.
Method:
Surveys were available in 7 languages and translated into English for analysis. The survey included: a 7-question introduction, followed by three specific tracks: 32 questions on tests/treating patients, 45 questions on performing/interpreting assays, and 24 questions on tissue acquisition. Respondents also identified barriers to implementing/offering MT. IASLC criteria were used to group responses into the following geographic regions: LA, US/Canada, Asia, Europe, and the rest of the world (Other). Regional comparisons used the Chi-squared test, free-text was analyzed with Nvivo.
Results:
There were 2,537 responses from 102 countries. 11% of responses were from LA, 11% US/Canada, 52% Asia, 19% Europe, and 7% Other. Respondents varied by specialty, including 45% Medical Oncologists, 12% Pulmonologists, 12% Thoracic Surgeons, 9% Pathologists, and 22% scientists or other. The frequency of MT was low overall and varied by region. Respondents from LA reported a higher frequency of patients who did not receive testing compared to other regions (74% vs 61% in requesting/treating track, p<0.0001; 88% vs 67% in tissue specimen acquisition, p=0.0017). The most frequent barrier to MT in every region was cost. The second largest barrier in LA was access, similar to Europe/Other. 52% of respondents reported patients/physicians were unsure/not satisfied with the state of MT in their countries, with the highest dissatisfaction in LA (80%, p=0.0066). 82% of respondents who perform/interpret assays typically received results within 10 days, which occurred most frequently in LA (89%) (p<0.0001). 23% reported >10% of cases were rejected due to inadequate samples, with 26% reporting this in LA (p=0.5590). However, across all regions, 47% stated there was no policy or strategy to improve the quality of the tissue samples in their countries. Among respondents who request/treat, 37% had difficulty in understanding MT reports, most of whom cited a need for more technical and scientific knowledge. However, LA and Europe respondents reported the least difficulty in understanding (p<0.0001). Overall, only 67% of respondents were aware of CAP/IASLC/AMP guidelines, 70% for LA (p=0.0041).
Conclusion:
Adoption of MT in clinical practice for lung cancer is low in LA as well as across the globe, with cost and access being main barriers.Global and regional initiatives should be developed to address the barriers preventing MT in these regions.
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S2.05 - Presidential Symposium Discussion (ID 1085)
09:15 - 09:50 | Presenting Author(s): Marileila Varella-Garcia
- Abstract
Abstract not provided
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Session 3: 2019 American Society of Clinical Oncology (ASCO) / IASLC Symposia: Lung Cancer Pathology in the Era of Targeted Therapy (ID 15)
- Event: LALCA 2019
- Type: Invited Speaker Session
- Track:
- Presentations: 1
- Moderators:
- Coordinates: 10/18/2019, 10:30 - 11:30, Castillo A 1-4
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F3.03 - Molecular Markers Available in LATAM (ID 74)
10:30 - 11:30 | Author(s): Marileila Varella-Garcia
- Abstract
Access to lung cancer (LC) diagnostic and treatment methods varies extensively around the globe. Latin America (LA, including Caribbean) is a large area comprising 30+ countries and 650+ million people. Incidence of lung cancer ranked third among the new cancer cases but first in death rate. In order to capture information regarding current practices and barriers to molecular testing (MT) in lung cancer, the IASLC conducted a survey among three tracks of health professionals. T1 included professionals performing, interpreting and reporting the molecular assays, T2 included professionals requesting the tests and treating LC patients, and T3 included professionals responsible for tissue/specimen procurement for LC MT. There is an IASLC committee working on the data analyses and on their behalf I am preliminary presenting here some results from 254 participants from 17 LA countries, including 33 from T1 (13%), 169 from T2 (67%) and 52 from T3 (20%). These respondents represented respectively 8, 16 and 13 countries.
Based on the T1 data, the genes most commonly tested were EGFR, BRAF and KRAS for mutations, ALK and ROS1 for rearrangements and PDL1 for protein expression. Other genes less frequently tested were ERBB2 (HER2), RET and MET. In most labs (59%), single assays still prevailed, whereas 41% of labs multiplexed their assays. In most of the T1 respondents labs (74%) the fraction of cases rejected due to sample inadequacy was low, although in some labs these cases ranged between 10% and 30% of the workload. Two major factors influencing the failure to generate a result were insufficient amount of tumor cells in the specimen and poor tissue quality usually consequence of inadequate fixation. Enrichment for tumor cells through micro and macrodissection was often performed (85%). Twelve labs acknowledged offering MT on liquid biopsies. The average turnaround time (TAT) for providing results was listed as under 10 business days by most T1 respondents (89%). In most cases, the labs had costs reimbursed by pharmaceutical companies but patient direct payment, private health insurance system and government funds were also relevant financial resources. Most labs acknowledged conducting validation tests before implementation of new assays and regularly participating in proficiency testing efforts. Few T1 respondents (N=4) considered that LC patients/physicians in their countries were satisfied with the MT conditions, although N=10 respondents indicated that they were satisfied.
Based on the T2 data, we learned that 81% of respondents requested MT for all LC patients, while 17% requested only in special conditions, such as cases with adenocarcinoma histology or component, never-smoker, female, and young age. 30% of T2 respondents were not aware of the CAP/IASLC/AMP guidelines. Approximately 30% used labs in the same institution/city, 40% referred to a central lab in their country and 40% outsourced to a lab in another country. Tests more commonly ordered were EGFR and BRAF mutations, ALK and ROS1 rearrangements, and PDL1 expression. Less common, KRAS and HER2 mutations, MET amplification and exon 14 skipping, and RET rearrangement. Rebiopsy at disease progression was common when LC patient was on an EGFR TKI (85%), less common when other TKI was in use (52%). Overall, request for MT on liquid biopsy was common (74%). The MT was reported to fail to generate a conclusive result in <10%, 10 to 30%, or >30% of cases, respectively, by 58%, 31% and 11% of T2 respondents. The perception of TAT by T2 respondents was longer than the TAT declared by T1 respondents, 47% agreed to have received reports within 10 business days while 53% extended to >10 business days. About 23% of T2 respondents were not aware of test technical details but the knowledgeable ones have agreed with the T1 respondents in that single assays prevailed over multiplex assays. Most T2 respondents admitted to understand the MT report well (87%) but 13% recognized lack of scientific or technical knowledge or complained about poor quality of the report.
Among T3 respondents, only 38 worked actively in procurement of LC specimens for MT and only 76% of them conceded to know the ideal conditions for preservation of LC specimens for MT and have them available in their practice. 38% of T3 respondents had only a fair/poor degree of knowledge about how LC MT is performed but 72% have close pathologist assistance to evaluate tissue sufficiency and oversee tissue processing and handling after the procedure through detailed protocols, phone call or discussion in multidisciplinary meetings. Unfortunately, 29% of T3 respondents are not informed when a specimen they have procured fails to generate a result in the molecular lab.
Multidisciplinary meetings to discuss clinical cases at least once a month were common in the respondents institutions. These meetings are attended by physicians of different specialties such as pathologists, medical oncologists, thoracic surgeons, intervention radiologists, pulmonologists, hematologists, and by other health care professionals closely related to lung cancer care such as nurses, cancer scientists, biologists, biochemists, biotechnologists, biostatisticians, and bioinformaticians,
The perception of the T2 and T3 respondents regarding the fraction of LC patients who were molecularly tested differed when they compared the settings of their own clinic and of their country. Considering the 4 categories of LC patients tested as <25%, 25%-49%, 50%-74%, and 75%-100%, the T2 respondents estimated the frequencies of patients in their own clinic as 18%, 7%, 29% and 46%, and in their country as 39%, 35%, 22% and 4%, respectively. The T3 respondents estimated the frequencies of patients in their own clinic as 34%, 22%, 29% and 15%, and in their country as 66%, 22%, 10% and 2%, respectively. These differences strongly suggest that T2 and T3 respondents are not an unbiased representation of their peers in their countries.
Despite the limitation of the small sampling size, this study represents a significant effort in surveying the conditions of MT in LC in the LA region. These analyses identified strengths and weaknesses, and the detailed assessment will support regional initiatives to improve specific conditions and provide best therapeutic options to LC patients.
Special acknowledgments to Murry W. Wynes, Matthew P. Smeltzer, and Meghan B. Taylor for providing preliminary data.
