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Manuela Pedraza



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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): Manuela Pedraza

      • Abstract
      • Slides

      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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    P1.16 - Treatment in the Real World - Support, Survivorship, Systems Research (ID 186)

    • Event: WCLC 2019
    • Type: 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, 09:45 - 18:00, Exhibit Hall
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      P1.16-17 - Getting to Know Our Weapons Better. Analyze from Real Life Data from León, Spain (Now Available) (ID 2241)

      09:45 - 18:00  |  Author(s): Manuela Pedraza

      • Abstract
      • Slides

      Background

      The way immunotherapy alters the tumor environment is perceived but still not completely known. Although clinical trials revealed good results, data from real life settings is still lacking. We reviewed patients treated with immunotherapy at our center.

      Method

      We retrospectively reviewed 83 lung cancer patients treated with immunotherapy at our Hospital between September 2015 and July 2018.75 patientsreceived immunotherapy after previous treatment. Data was obtained from medical records. Primary endpoint was to report immunotherapy efficacy and safety in the 75 pretreated patients with advanced NSCLC of our everyday clinical practice. Secondary aim was to analyze efficacy according to immune related toxicity and other basal features.

      Result

      60 were men, 15 women. Median age 66 years (range 48-84). 50 were former smokers, 23 still smoking, 2 were never smokers. 44 were adenocarcinomas, 26 squamous cell carcinoma, 5 NOS. 18 were stage III, 57 stage IV. 36 had at least one metastatic organ. 11 had liver while 10 had brain metastases. PDL1 was assessed in 12: <1%, 3; 1-49%, 3; >50%, 6. 3 were EGFR-positive, 3 ALK+, 2 KRAS+. Median number of lines was 1 (range=1-5). Best response to any previous treatment was stable disease (SD) 38.7% (n=29); partial response (PR) 36% (n=27); complete response 2.7% (n=2). 71 patients received Nivolumab vs 4 Pembrolizumab. Best response to immunotherapy was PR 21.3% (n=16) with SD 34.7% (n=26). Median number of cycles was 10 (range=1-77). 68 (90.7%) were PS<=1 before immunotherapy while 43 (57.3) still PS<=1 after. Median overall survival (OS) was 18 months (95%CI 7.03-28.69). Median progression free survival (PFS) was 4 months (95%CI 2.52-5.47). OS were higher in former smokers (median OS: 31 months vs 14 p<0.05); in PS<=1 before immunotherapy (median OS: 22 months vs 6 p<0.05) and in those with any grade of toxicity (mean 29 months vs 13 p<0.05). 42.7% (n=32) had any grade of immune-related toxicity (80% <=grade 2). Skin rash and hypothyroidism were the most common toxicities. 32% (n=24) needed corticosteroids to control toxicity. Immunotherapy stopping reasons were progression 47 (62.6%) and toxicity 9 (12%). 33.3% (n=24) received treatment after progression. Best response to treatment after immunotherapy was PR 38.1% (n= 8) with 90.5% disease control rate. 37 (49.3%) patients died at data cut-off.

      Conclusion

      Compared with previous publications we had less treatment-related toxicity but the same discontinuation due to it. Best response and PFS is similar while median OS is slightly higher in our center. After immunotherapy we obtained better disease control with chemotherapy. Toxicity was related with better OS as in previous works.

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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): Manuela Pedraza

      • 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.

  • +

    P2.16 - Treatment in the Real World - Support, Survivorship, Systems Research (ID 187)

    • Event: WCLC 2019
    • Type: Poster Viewing in the Exhibit Hall
    • Track: Treatment in the Real World - Support, Survivorship, Systems Research
    • Presentations: 1
    • Now Available
    • Moderators:
    • Coordinates: 9/09/2019, 10:15 - 18:15, Exhibit Hall
    • +

      P2.16-43 - Immunotherapy in Elderlies. Real World Data (Now Available) (ID 2366)

      10:15 - 18:15  |  Author(s): Manuela Pedraza

      • Abstract
      • Slides

      Background

      Because of its tolerability immunotherapy is suitable for unfit patients. Elderly patients are under-represented in clinical trials due to the association between aging and a significant prevalence of comorbid diseases. We analyzed our elderly patients treated with immunotherapy and tried to find any impact on overall survival (OS) from other non-comorbidity factors.

      Method

      24 NSCLC patients older than 70 years received immunotherapy after previous treatment at our hospital from September 2015 and July 2018 according to pharmacy records. Data was collected from medical records. Retrospective observational study whose primary end point was to analyze safety and efficacy in elderly patients was made. Secondary endpoint was to find if toxicity had any impact in OS.

      Result

      23 were men. 17 were former smokers, 6 still smoking. 10 were adenocarcinoma, 12 squamous cell carcinoma, 2 NOS. 7 were stage III, 17 stage IV. 14 had at least one metastatic organ. 2 had liver while 2 had brain metastases. Median number of previous lines was 1 (range=1-4). Best response to any previous treatment was stable disease (SD) 37.5% (n=9); partial response (PR) 37.5% (n=9). All received Nivolumab. Best response to immunotherapy was PR 8.3% (n=2) with SD 37.5% (n=9); unfortunately, 9 were not valuable. Median number of cycles was 9 (range=1-55). 20 (83.3%) were PS<=1 before immunotherapy while 11 (45.8%) still PS<=1 after. Median overall survival (OS) was 10 months (95%CI 1.33-18.66). Median progression free survival (PFS) was 4 months (95%CI 0.65-7.39). Compared with under 70 years old patients -at our center- OS was not statistically longer in older patients (median OS: 22 vs 10months). OS was higher in those with any grade of toxicity (mean OS: 23 months vs 8 p<0.05); in those with less previous lines (median OS: 17 months in <=1 vs 3 months in more p<0.05); in PS<=1 before immunotherapy (median OS: 17 months vs 2 p<0.05) and in PS<=1 after immunotherapy (mean OS: 22 months vs 7 p<0.05). 37.5% (n=9) had any grade of immune-related toxicity (77.8% <=grade 2). Hypothyroidism was the most common toxicity. 41.7% (n=10) needed corticosteroids to control toxicity. Immunotherapy stopping reasons were progression 16 (66.7%) and related G3-4 toxicity in three out of four cases while the other one was due to persistent grade 2 toxicity. There were no deaths due to immune related toxicities. 29.2% (n=7) received treatment after progressionbeing all of them PS1 after immunotherapy. Best response to treatment after immunotherapy was SD 60% (n=3), PR 40% (n= 2) -in those that could be analysed- with 100% disease control rate. 13 (54.2%) patients died at cut-off.

      Conclusion

      Although it is a small number of patients, as in other published studies, it suggests that elderly patients behave to immunotherapy as younger counterparts do.In the analysis made in our center in population under 70 years old, immunotherapy median number of cycles, toxicity frequency, and cause of treatment stop were similar in both populations and there were no statistically differences in OS.Any grade of toxicity was related with higher OS.Elderly people must be considered for immunotherapy treatment just like young patients.

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