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Pilar Diz
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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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EP1.16-18 - EGFR Mutation Positive Non-Small Cell Lung Cancer: Management Approach and Survival Outcomes from the Hospital of Leon (Now Available) (ID 2613)
08:00 - 18:00 | Author(s): Pilar Diz
- Abstract
Background
Approximately 10-16% of non-small cell lung cancer (NSCLC) cases have the EGFR mutation. Studies have shown that EGFR tyrosine kinase inhibitors (TKIs) significantly prolong progression-free survival (PFS) in patients with advanced NSCLC in comparison to those treated with platinum-based chemotherapy doublets.
Our aim is to perform a real world analysis of patients treated with TKI as first line therapy at the Hospital of Leon (CAULE).
Method
We retrospectively reviewed a total of 74 patients diagnosed with EGFR mutation positive NSCLC between March 2011 to June 2018 in the CAULE. Data was obtained from their medical records. The impact of comorbidities and smoking status on the survival rate were evaluated, in addition to the PFS and overall survival (OS) outcomes in patients treated with first line TKI. The follow-up schedule for computed tomography (CT) imaging was realized every 8 to 12 weeks.
Result
A total of 74 patients were included in the study, out of which 55 were treated with a first line TKI. Exon 19 deletion was the most prevalent mutation subtype accounting for 53% of cases. 67% of patients were women. The average age was 69 years old. 44% had metastasis to more than 2 sites at the time of diagnosis; 6 patients had brain metastasis, 4 of which received prior whole brain radiotherapy, 1 surgical treatment, and 1 didn’t receive local treatment.
22% of patients had no medical comorbidities (including cardiovascular, pulmonary, neurological or psychiatric history). Results revealed that the presence of comorbidities had no statistical significance when analyzing its impact on survival outcomes (HR=0.85, 95%CI 0.37-1.83 p=0.64). Similar results were obtained when non-smokers (71%) were compared to smokers or former smokers, suggesting that smoking had no statistical significance when analyzing survival data (HR=0,94 95%CI: 0.43- 2.02 p=0.87).
50% (n= 28) of patients were treated with first line gefitinib, 32% (n=18) with erlotinib and 10% (n= 6) with afatinib. There was no statistical significance in survival rates amongst patients treated with gefitinib vs afatinib or erlotinib (HR=1.6 P=0.56 95%CI 0.84-3.2).
When analyzing best response to treatment, 63% of patient had a partial response, 20% demonstrated stable disease and 10% had progression of disease.
Median OS was 31 months (95%CI: 20,5-31,4 months) and the PFS was 17 months (95%IC 13,9-20,6 months). 30% were alive at the time of analysis. The main cause of death was disease progression.
Conclusion
This real-world analysis of the data gathered from the Hospital of Leon confirms that treatment with TKI is beneficial for patients diagnosed with EGFR mutation positive NSCLC. In fact, our OS outcomes are similar than those reported in clinical trials.
We have not observed significant differences amongst TKI treatment options, nor was there an impact on global survival rates in patients with underlying medical comorbidities.
Given the prevalence of EGFR mutation positive lung cancer, more clinical data is required in order to expand scientific evidence and determine the best driver mutation therapy option based on patient’s profile.
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P2.01 - Advanced NSCLC (ID 159)
- Event: WCLC 2019
- Type: Poster Viewing in the Exhibit Hall
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 9/09/2019, 10:15 - 18:15, Exhibit Hall
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P2.01-41 - EGFR Mutation Positive Non-Small Cell Lung Cancer: Management Approach and Survival Outcomes from the Hospital of Leon (ID 3139)
10:15 - 18:15 | Author(s): Pilar Diz
- Abstract
Background
Approximately 10-16% of non-small cell lung cancer (NSCLC) cases have the EGFR mutation. Studies have shown that EGFR tyrosine kinase inhibitors (TKIs) significantly prolong progression-free survival (PFS) in patients with advanced NSCLC in comparison to those treated with platinum-based chemotherapy doublets.
Our aim is to perform a real world analysis of patients treated with TKI as first line therapy at the Hospital of Leon (CAULE).
Method
We retrospectively reviewed a total of 74 patients diagnosed with EGFR mutation positive NSCLC between March 2011 to June 2018 in the CAULE. Data was obtained from their medical records. The impact of comorbidities and smoking status on the survival rate were evaluated, in addition to the PFS and overall survival (OS) outcomes in patients treated with first line TKI. The follow-up schedule for computed tomography (CT) imaging was realized every 8 to 12 weeks.
Result
A total of 74 patients were included in the study, out of which 55 were treated with a first line TKI. Exon 19 deletion was the most prevalent mutation subtype accounting for 53% of cases. 67% of patients were women. The average age was 69 years old. 44% had metastasis to more than 2 sites at the time of diagnosis; 6 patients had brain metastasis, 4 of which received prior whole brain radiotherapy, 1 surgical treatment, and 1 didn’t receive local treatment.
22% of patients had no medical comorbidities (including cardiovascular, pulmonary, neurological or psychiatric history). Results revealed that the presence of comorbidities had no statistical significance when analyzing its impact on survival outcomes (HR=0.85, 95%CI 0.37-1.83 p=0.64). Similar results were obtained when non-smokers (71%) were compared to smokers or former smokers, suggesting that smoking had no statistical significance when analyzing survival data (HR=0,94 95%CI: 0.43- 2.02 p=0.87).
50% (n= 28) of patients were treated with first line gefitinib, 32% (n=18) with erlotinib and 10% (n= 6) with afatinib. There was no statistical significance in survival rates amongst patients treated with gefitinib vs afatinib or erlotinib (HR=1.6 P=0.56 95%CI 0.84-3.2).
When analyzing best response to treatment, 63% of patient had a partial response, 20% demonstrated stable disease and 10% had progression of disease.
Median OS was 31 months (95%CI: 20,5-31,4 months) and the PFS was 17 months (95%IC 13,9-20,6 months). 30% were alive at the time of analysis. The main cause of death was disease progression.
Conclusion
This real-world analysis of the data gathered from the Hospital of Leon confirms that treatment with TKI is beneficial for patients diagnosed with EGFR mutation positive NSCLC. In fact, our OS outcomes are similar than those reported in clinical trials.
We have not observed significant differences amongst TKI treatment options, nor was there an impact on global survival rates in patients with underlying medical comorbidities.
Given the prevalence of EGFR mutation positive lung cancer, more clinical data is required in order to expand scientific evidence and determine the best driver mutation therapy option based on patient’s profile.
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P2.03 - Biology (ID 162)
- Event: WCLC 2019
- Type: Poster Viewing in the Exhibit Hall
- Track: Biology
- Presentations: 1
- Moderators:
- Coordinates: 9/09/2019, 10:15 - 18:15, Exhibit Hall
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P2.03-16 - Agreement Between Different Methodologies for Non-Invasive p.T790M and EGFR Sensitizing Mutation Testing (ID 1965)
10:15 - 18:15 | Author(s): Pilar Diz
- Abstract
Background
Tyrosine kinase inhibitors (TKIs) are the current standard of care for patients with advanced EGFR-mutant non-small cell lung cancer (NSCLC). However, most patients progressed within 1 to 2 years. The EGFR p.T790M mutation is the most common resistance mechanism to first and second generation EGFR TKIs. The identification of p.T790M mutation is of considerable clinical relevance as osimertinib has demonstrated clinical efficacy in this setting. Guidelines recommend testing for the p.T790M mutation in blood at relapse to TKIs, and re-biopsy only in case of a negative result. Several blood based methodologies for detection of EGFR mutations have been developed in the recent years. However, the number of comparison studies between platforms is very limited.
Method
This is a multicenter, cross-sectional study (ClinicalTrials.gov Identifier: NCT03363139) performed by the Spanish Lung Cancer Group. Samples from 75 consecutive EGFR mutant NSCLC patients were collected at disease progression to first line TKI treatment. The presence of EGFR mutations in the cfDNA was evaluated in 39 samples by 7 methodologies, namely: Cobas® EGFR Mutation Test v2 (Roche Diagnostics), Therascreen EGFR Plasma RGQ PCR Kit (Qiagen), QuantStudio® 3D Digital PCR System (Thermofisher), a 5′-nuclease real-time PCR (TaqMan®) assay in presence of PNA, OncoBEAM EGFR (Sysmex Inostics), NGS with two different gene panels: Oncomine® (Thermofisher) and Lung Cancer Panel (Qiagen). The agreement between methodologies was assessed using the kappa coefficient (K) and its corresponding 95% confidence intervals (95% CI). For quantitative variables the concordance correlation coefficient (ccc) was used.
Result
Complete results are available for 39 patients. Overall, the agreement between all methodologies for the detection of p.T790M mutation as well as the original EGFR sensitizing mutation was good (K=0.669; 95CI: 0.504-0.835 and K=0.750 95CI: 0.599-0.899 respectively). Remarkably, the agreement between FDA-approved methodologies for p.T790M detection was almost perfect (K=0.926; 95CI: 0.712-1) and good for the EGFR sensitizing mutations (K=0.657; 95CI: 0.417-0.902). Similarly, the agreement between NGS-based methodologies for the detection of p.T790M and the EGFR activating mutations was very high (K=0.843; 95CI: 0.567-1 and K=0.872 95CI: 0.595-1 respectively). Moreover, concordance between both technologies for p.T790M and EGFR sensitizing mutation mutant allele frequency was excellent (ccc=0.956; 95CI: 0.906-1 and ccc=0.980 95CI: 0.950-1 respectively). The proportion of samples that were positive for p.T790M detection varied from 28% (PCR based technologies) to 37% depending on the methodology.
Conclusion
NGS and PCR-based methodologies show a good to excellent agreement for the detection of EGFR mutations, including the p.T790M. Our results support the use of liquid biopsies for non-invasive testing of clinically relevant mutations (Data from the whole cohort will be presented at the meeting).
