Luis A. Cabrera-Miranda

Instituto Nacional de Cardiología

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ÓA

Óscar Arrieta

Instituto Nacional de Cancerología

Sandra I. Pérez-Álvarez

Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán

Maritza Ramos-Ramírez

Instituto Nacional de Cancerología

Francisco J. Lozano-Ruiz

Hospital Médica Sur

Mario E. Álvarez-Bojórquez

Laura M. Bolaño-Guerra

Instituto Nacional de Cancerología

Fernando Silva-Bravo

Mexican Social Security Institute

Raúl A. López-Saucedo

Xinqiao Hospital

Roberto Sánchez-Reyes

Centro Médico Nacional La Raza

Mónica Blake-Cerda

Centro Médico ABC

Cooperative Institutions

Instituto Nacional de Cancerología

Scottish Intercollegiate Guidelines Network

Instituto Nacional del Cáncer

Hospital de Clínicas

Mexican Social Security Institute

Instituto Nacional de Enfermedades Respiratorias

Centro Médico ABC

Institute for Social Security and Services for State Workers

Hospital Médica Sur

Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán

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Clinical practice guideline for the management of small cell lung cancer: extensive disease

Gaceta Mexicana de Oncología (2023)

Luis A. Cabrera-Miranda Diego A. Díaz-García José Francisco Corona-Cruz Francisco J. Lozano-Ruiz Roberto Sánchez-Reyes

Background: Small cell lung cancer (SCLC) represents 13-15% of all primary lung neoplasms and is characterized by its rapid growth rate and the rapid development of distant metastases.Objectives: The ovjective of the study was to guide and standardize the treatment of extensive disease SCLC in Mexico based on national and international clinical evidence.Material and methods: This document was developed as a collaboration between the National Cancer Institute and the Mexican Society of Oncology in compliance with international standards.An interdisciplinary group was formed, including medical oncologists, oncological surgeons, thoracic surgeons, radiation oncologists, and methodologists with experience in systematic reviews of the literature and clinical practice guidelines.Results: A consensus was reached, both by the Delphi method and in remote meetings, of extensive disease recommendations resulting from work questions.The scientific evidence that answers each of these clinical questions was identified and critically evaluated, before being incorporated into the body of evidence of the Guide.Conclusions: This Clinical Practice Guide provides clinical recommendations for the management of extensive disease of SCLC to contribute to the decision-making process of the clinicians involved with its management in our country, hoping that this will contribute to improving the quality of clinical care in these patients.

Guideline

Clinical Practice

Disease management

10.24875/j.gamo.m23000239

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Clinical practice guideline for the management of small cell lung cancer: limited disease

Gaceta Mexicana de Oncología (2023)

Luis A. Cabrera-Miranda Francisco J. Lozano-Ruiz Mónica Blake-Cerda José Francisco Corona-Cruz Roberto Sánchez-Reyes

Background: Small cell lung cancer (SCLC) represents 13-15% of all primary lung neoplasms and is characterized by rapid growth rate and development of distant metastases.Objectives: The objectives of the study were to guide and standardize the treatment of limited disease SCLC in Mexico based on national and international clinical evidence.Material and methods: This document was developed as a collaboration between the National Cancer Institute and the Mexican Society of Oncology in compliance with international standards.An interdisciplinary group was formed, including medical oncologists, oncological surgeons, thoracic surgeons, radiation oncologists, and methodologists with experience in systematic reviews of the literature and clinical practice guidelines.Results: Consensus recommendations were reached, both by the Delphi method and in remote meetings, for limited SCLC disease resulting from the same number of work questions.The scientific evidence that answers each of these clinical questions was identified and critically evaluated, before being incorporated into the body of evidence of the guide.Conclusion: This guide provides clinical recommendations for the management of limited disease SCLC to contribute to the decision-making process of the clinicians involved with its management in our country, hoping that this will contribute to improving the quality of clinical care in these patients.

Guideline

Clinical Practice

10.24875/j.gamo.m23000238

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Evaluation of a risk-sharing agreement for atezolizumab treatment in patients with non-small cell lung cancer: a strategy to improve access in low-income countries

The Oncologist (2024)

Óscar Arrieta Maritza Ramos-Ramírez Homero Garcés-Flores Luis A. Cabrera-Miranda Ana Pamela Gómez-García

Abstract Background Using immune checkpoint inhibitors (IO) is a promising approach to maximize clinical benefits for patients with non-small cell lung cancer (NSCLC). PD-L1 expression serves as a predictive factor for treatment outcomes with IO. However, the high cost of this treatment creates significant barriers to access. Substantial evidence demonstrates the sustained clinical benefits experienced by patients who respond to immunotherapy. While IOs show promise in NSCLC treatment, their high cost poses access barriers. Aim This study focused on a prospective cost analysis conducted at a high-specialty health facility to assess the economic implications of implementing a risk-sharing agreement (RSA) for atezolizumab in NSCLC. Methods The study included 30 patients with advanced NSCLC, with the pharmaceutical company funding the initial cycles. If patients responded, a government program covered costs until disease progression. Results A median progression-free survival of 4.67 months across populations, rising to 9.4 months for responders. The 2-year overall survival rate for the response group was 64%, significantly higher than for non-response. Without an RSA, a total treatment cost of $881 859.36 ($29 395.31/patient) was reported, compared to $530 467.12 ($17 682.24/patient) with an RSA, representing a 40% cost reduction. In responders, the average cost per year of life per patient dropped by 22%. Risk-sharing, assessed through non-parametric tests, showed a statistically significant difference in pharmacological costs (P < .001). Conclusion Implementing RSAs can optimize resource allocation, making IO treatment more accessible, especially in low-income countries.

Atezolizumab

Cost sharing

10.1093/oncolo/oyae272

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Guía de práctica clínica para el manejo del cáncer de pulmón de células pequeñas: enfermedad limitada

Gaceta Mexicana de Oncología (2023)

Luis A. Cabrera-Miranda Francisco J. Lozano-Ruiz Mónica Blake-Cerda José Francisco Corona-Cruz Roberto Sánchez-Reyes

Antecedentes: El cáncer de células pequeñas (CPCP) representa el 13-15% del total de neoplasias primarias de pulmón.Se caracteriza por su rapidez en la tasa de crecimiento y en el desarrollo de metástasis a distancia.Objetivos: Orientar y estandarizar el tratamiento del CPCP, enfermedad limitada, en México, basado en evidencia clínica nacional e internacional.Material y métodos: Este documento se desarrolló como una colaboración entre el Instituto Nacional de Cancerología y la Sociedad Mexicana de Oncología en cumplimiento con estándares internacionales.Se integró un grupo conformado por oncólogos médicos, cirujanos oncólogos, cirujanos de tórax, radio-oncólogos y metodólogos con experiencia en revisiones sistemáticas de la literatura y guías de práctica clínica.Resultados: Se consensuaron, por el método Delphi y en reuniones a distancia, las recomendaciones en CPCP enfermedad limitada, producto de las preguntas de trabajo.Se identificó y evaluó críticamente la evidencia científica que responde a cada una de dichas preguntas clínicas, antes de incorporarla a la guía.Conclusión: Esta guía proporciona recomendaciones clínicas para el manejo de la enfermedad limitada del CPCP y durante el proceso de toma de decisiones de los clínicos involucrados con su manejo en nuestro país para mejorar la calidad de la atención clínica en estos pacientes.

10.24875/j.gamo.22000121

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Guía de práctica clínica para el manejo del cáncer de pulmón de células pequeñas: enfermedad extensa

Gaceta Mexicana de Oncología (2023)

Luis A. Cabrera-Miranda Diego A. Díaz-García José Francisco Corona-Cruz Francisco J. Lozano-Ruiz Roberto Sánchez-Reyes

Antecedentes: El cáncer de células pequeñas (CPCP) representa el 13-15% del total de neoplasias primarias de pulmón.Se caracteriza por su rapidez en la tasa de crecimiento y en el desarrollo de metástasis a distancia.Objetivos: Orientar y estandarizar el tratamiento del CPCP enfermedad extensa en México basado en evidencia clínica nacional e internacional.Material y métodos: Este documento se desarrolló como una colaboración del Instituto Nacional de Cancerología y la Sociedad Mexicana de Oncología en cumplimiento con estándares internacionales.Se integró un grupo conformado por oncólogos médicos, cirujanos oncólogos, cirujanos de tórax, radio-oncólogos y metodólogos con experiencia en revisiones sistemáticas de la literatura y guías de práctica clínica.Resultados: Se consensaron, por el método Delphi y en reuniones a distancia, las recomendaciones en CPCP enfermedad extensa, producto de preguntas de trabajo.Se identificó y evaluó la evidencia científica que responde a cada una de dichas preguntas clínicas antes de incorporarla al cuerpo de la guía.Conclusión: Esta guía proporciona recomendaciones clínicas para el manejo de la enfermedad extensa del CPCP y du-rante el proceso de

10.24875/j.gamo.22000122

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Evaluation of a risk-sharing agreement for atezolizumab treatment in second- and third-line NSCLC patients: A strategy in order to improve access in low income countries.

Journal of Clinical Oncology (2023)

Óscar Arrieta Maritza Ramos-Ramírez Homero Garcés-Flores A. Valencia-Velarde Luis A. Cabrera-Miranda

e18683 Background: A targeted treatment approach using anti-PDL1 agents can maximize clinical benefits. However, this type of treatment is expensive, resulting in barriers to treatment access. PD-L1 expression is a predictor of outcomes for patients treated with immune checkpoint inhibitors. There is extensive evidence about the clinical benefits maintained in patients who respond to immunotherapy treatment. The aim of this study is to evaluate the economic implications of implementing a risk-sharing agreement (RSA) for atezolizumab in non-small cell lung cancer patients (NSCLC). Methods: We developed a prospective cost analysis of a RSA for atezolizumab as a second-line (or above) therapy in patients with advanced NSCLC at the Instituto Nacional de Cancerología (INCan) in México. All patients had an ECOG PS 0-1 and PDL1≥1%. The first 4 cycles were funded by the pharmaceutical company. If patients had response by RECIST or clinical benefit (RP), a special government program in the institution absorbed the cost of treatment until progression. A budget impact estimation was performed based on direct medical costs considering a time horizon of 1 year. Secondary endpoints were estimated for each strategy, expressed as the total amount expended and the average cost per patient with or without risk-sharing agreement. Costs and results are express in USD. Results: In total 30 patients were included for second line (n = 23) and third line (n = 7) therapy. The median PFS in all population was 4.67 months (95% CI 3.4-7.8). After 4 cycles, 47% (n = 14) of patients had a RP and increased PFS up to 9.4 months (p < 0.001). A median OS in all cohort was 7.59 months (95% CI 5.1-17.2), however it was longer in patients with RP; 19 months (95% CI 8.81-NR) (p = 0.03). In addition, 33% of patients had RP and PDL1 ≥ 5% whose median OS was not reached The total cost of treatment was $611,557.64 (average $20,385.25 p/p) without a risk-sharing agreement, compared to an overall cost of $260,165.41 (average of $8,672.18 p/p) implementing a risk-sharing agreement. Regarding risk-sharing, non-parametric test as well as paired t test on transformed costs data showed a statistically significant difference in pharmacological cost between the two strategies in relation to cost per patient (p < 0.001). The implementation of a risk-sharing agreement reduced the therapy cost by US$351,392.24 which represents 1.41% of the annual INCan drug budget. Conclusions: Risk-sharing agreement makes it possible to select those patients who have more benefit, thus ensuring that government resources are invested in the population with longer survival, which translates into saving for the state. In this study, the economic impact of risk-shared accounts for a 57.46% reduction in total cost. This is clearly a resource-efficient and treatable option for more patients, particularly in low-income countries.

Atezolizumab

Clinical endpoint

10.1200/jco.2023.41.16_suppl.e18683

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