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Ivan Lyra Gonzalez



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    OA11 - Decomplexifying Molecular Targets, Immunotherapy and Treatment Settings in the Real World (ID 137)

    • Event: WCLC 2019
    • Type: Oral Session
    • Track: Treatment in the Real World - Support, Survivorship, Systems Research
    • Presentations: 1
    • Now Available
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      OA11.05 - Optimizing Resources with Immunotherapy in Developing Countries: Experience in a Reference Center in Mexico (Now Available) (ID 2867)

      14:00 - 15:30  |  Author(s): Ivan Lyra Gonzalez

      • Abstract
      • Presentation
      • Slides

      Background

      Immunotherapy has proven clinical benefit in several tumors as a first line therapy or after standard treatment failure. Pivotal trials with immunotherapy were designed using a weight-based dose. However, recently as part of an effort to standardize the dose of the most common drugs (Nivolumab and Pembrolizumab) the Regulatory Agencies and Pharmaceutics have changed its prescription to fixed doses. In those pivotal studies, the median weight was around 70 to 80 kg. Our hypothesis estimates that a fixed dose increases the use of drug above effective thresholds increasing unnecessary expenses.

      Method

      We analyzed a cohort of patients treated with immunotherapy due to lung cancer (NSCLC) diagnosis either during first or second-line of treatment between 2016 and 2018 in the Thoracic Tumors Clinic at National Cancerology Institute in Mexico. We analyzed and estimated the median body in our population. Then, we compared treatment costs between weight-based doses (Nivolumab 3mg/Kg q.2 weeks and Pembrolizumab 2mg/Kg q.3 weeks) versus flat dose treatment (Nivolumab 240mg q.2 weeks and Pembrolizumab 200mg q.3 weeks).

      Result

      792 patients were included with and a median weight of 65 kg (SD ±13.11) was determined. Fixed dose of pembrolizumab administered during one year (17 applications) had an annual cost of $135,218 dlls. while the cost with weight-based dose was $87,913 dlls. with a net difference of $47,305 dlls. In the case of Nivolumab, an annual fixed-dose treatment (26 applications) has a cost of $114,816 dlls, while the weight-based dose has a cost of $93,392 dlls. with a net difference of $21,424 dlls (table1).

      PEMBROLIZUMAB (2 mg/Kg) Q3W vs 200mg Q3W

      Comparison

      Total dose per cycle

      Cost per cycle

      Excess cost per cycle

      Dose difference

      Annual cost treatment (17 cycles)

      Net difference annual cost per patient

      Weight based dose

      (Median 65Kg)

      130 mg

      $5171.4

      $2,782.6

      70mg

      $87,913

      $47,305

      Fixed-dose

      200mg

      $7,954

      NA

      NA

      $135,218

      NA

      NIVOLUMAB (3mg/Kg) Q2W vs 240mg Q2W

      Comparison

      Total dose per cycle

      Cost per cycle

      Excess cost per cycle

      Dose difference

      Annual cost treatment (26 cycles)

      Weight based dose

      (Median 65Kg)

      195mg

      $3,592

      $824

      45mg

      $93,392

      $21,424

      Fixed-dose

      240mg

      $4,416

      NA

      NA

      $114,816

      NA

      Conclusion

      General population in developing countries like Mexico are experiencing serious difficulties to get access to immunotherapy due to lack of coverage through Public Health Care System based in costs. According with our study, optimization of resources with weight-base dose could allow us to increase the rate of treated patients. Then, according with our analysis, in the case of Pembrolizumab we calculated coverage of 154 treatments instead of 100 using same budget and favoring the use of weight-based dose. While, in the case of Nivolumab we could increase the number of patients treated from 100 to 126 using weight-based dose. Therefore, our results support that therapies like immunotherapy should be calculated based on body weight as an attempt to increase access and avoid unnecessary expenses in Health Care Systems with limited resources.

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    P1.09 - Pathology (ID 173)

    • Event: WCLC 2019
    • Type: Poster Viewing in the Exhibit Hall
    • Track: Pathology
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/08/2019, 09:45 - 18:00, Exhibit Hall
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      P1.09-22 - Programmed Death Ligand-1 Expression in Non-Small Cell Lung Cancer in Mexican Population and Correlation with Clinicopathologic Features (ID 2912)

      09:45 - 18:00  |  Author(s): Ivan Lyra Gonzalez

      • Abstract
      • Slides

      Background

      Immune checkpoint inhibition is an important therapeutic option in patients with non-small cell lung cancer. Programmed cell death ligand-1 (PD-L1) expression may serve as a predictive and prognostic factor for anti-PD-1/PD-L1 therapies. We conducted a national, retrospective, observational study to determine PDL1 prevalence and correlation with clinicopathologic features.

      Method

      Patients with histologic confirmed stage III/IV NSCLC and available tissue block were included. PDL1 tumor expression was performed with PDL1 IHC (SP263) assay on a Ventana Benchmark XT platform. Tumor cell PD-L1 expression was scored as Tumor Proportion Score (TPS) and classified as negative (<1%), 1-49% and  ≥  50% for correlation with clinicopathologic features.

      Result

      Of a total of 948 patients included in the study, 170 (18%) were TPS >50%, 333 (35%) and 445 (47%) were TPS 1-49% and negative (<1%) respectively. The TPS was higher in squamous cell carcinomas (p=0.001) due to increased proportion of strong expression (>50%). Among the 778 non-squamous carcinomas, 187 (24%) had EGFR mutations and 31 (4%) showed ALK translocations. A TPS >50% was seen in 25% (47/187) and 21% (6/31) EGFR mutant and ALK translocated tumors, respectively.

      image1.jpg

      Conclusion

      The overall prevalence of TPS ≥ 50% is slightly lower than previously reported. TPS was significantly higher in squamous cell carcinomas and there was no correlation between PD-L1 expression and molecular abnormalities, or age, gender and smoking status.

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    P2.10 - Prevention and Tobacco Control (ID 176)

    • Event: WCLC 2019
    • Type: Poster Viewing in the Exhibit Hall
    • Track: Prevention and Tobacco Control
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/09/2019, 10:15 - 18:15, Exhibit Hall
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      P2.10-09 - Environmental Pollution in the City of Mexico as a Risk Factor for Lung Cancer and Its Prognostic Impact (ID 2834)

      10:15 - 18:15  |  Author(s): Ivan Lyra Gonzalez

      • Abstract
      • Slides

      Background

      Lung cancer is the leading cancer in incidence and mortality worldwide. Smoking is the main risk factor, however, in Mexico up to 40% of the population has no history of smoking and its development has been associated with other risk factors such as chronic exposure to wood smoke and environmental pollution. Mexico City and the Metropolitan Area of ​​the State of Mexico have high levels of environmental pollution. In this work, we analyze the prognostic impact of environmental pollution in lung cancer among patients diagnosed with lung cancer who live in those highly polluted areas.

      Method

      We retrospectively analyzed patients diagnosed with non-small cell lung cancer (NSCLC) treated at the National Institute of Cancer, who lived in Mexico City or in the State of Mexico within 10 years before diagnosis of NSCLC. We correlated pollution indexes according with the Atmospheric Monitoring System of the Goverment of Mexico City (http://www.aire.cdmx.gob.mx/default.php?opc=%27YqBhnmU=%27), with the coordinates of their home (Google Maps / Earth R Studio program) to analyze the intensity of contamination with survival. In addition, we correlated the contamination indexes with the degree of differentiation, molecular profile, gender and with the stage at the time of diagnosis.

      Result

      We analyzed the information of 422 patients diagnosed with NSCLC treated in the period between 2011 and 2018. The median age was 62.4 years (SD ± 12.5), 56.6% were women, 41.5% were non-smokers. At the time of diagnosis, 80% were stage IV and 15% stage III. The histology was adenocarcinoma (83%), squamous (10.4%) and small cells (4%). EGFR mutation was detected in 26.5% of the patients and PD-L1 was positive in 2.6% (analyzed 128/422, clone SP263). At the time of this analysis, 43% of the patients had died. The risk of death was higher among patients with the combination of smoking and living in highly polluted areas (RR 9.3), followed those living in highly polluted rates (RR 6.1). Patients living in highly polluted areas showed an increased incidence of poorly differentiated tumors than those who lived in different areas (72% vs 23%); also, a lower incidence of EGFR mutations was detected.

      Conclusion

      High pollution rates are associated with more aggressive tumors and poor prognosis. According with our results, combination of high levels of environmental pollution and smoking had a significant impact in decreased survival. More studies are required to confirm the association between pollution and survival outcomes, also, this study established a baseline to new analysis like massive sequencing of genes to identify associations between NSCLC diagnosis and smoking versus NSCLC and environmental pollution, which could have prognostic and therapeutic implications (eg, response to immunotherapy).

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