Mauricio Lema

Background/Objectives: The management of advanced HER2-positive and HER2-low breast cancer is evolving rapidly. This study aimed to generate national, evidence-based clinical recommendations for Colombia, addressing the lack of standardized local guidance. Methods: A systematic literature search (2020–2024) was conducted. The evidence was evaluated using AGREE II, RoB 2, ROBINS-I, and JBI tools. Recommendations were developed using the GRADE approach and a structured modified Delphi consensus process involving 34 national experts. Results: A total of 22 clinical recommendations were formulated. These address HER2 quantification and reporting, first-line and subsequent-line therapy, and management of brain metastases. Five recommendations (23%) were classified as strong, supported by high-certainty evidence, while 17 (77%) were conditional, reflecting the need for adaptation to local contexts and resource availability. Conclusions: This consensus provides updated, context-specific clinical guidance to optimize the care of patients with advanced HER2-positive and HER2-low breast cancer in Colombia. The recommendations are designed to standardize care, improve patient outcomes, and promote equitable access to innovative therapies within the Colombian healthcare system.

Introducción: el cáncer de mama es la neoplasia más frecuente en Colombia, con más de 17.000 casos diagnosticados anualmente. La Guía de Práctica Clínica (GPC) nacional publicada por última vez en 2017, no han sido actualizadas, lo que limita su aplicabilidad frente a los avances terapéuticos recientes. Ante la ausencia de una revisión oficial, se desarrolló un consenso regional en Antioquia que incorpora nueva evidencia y adapta las recomendaciones al contexto colombiano. Métodos: se conformó un consenso de panel de expertos (CPE) con trece médicos líderes con experiencia en el tratamiento del cáncer de mama. Las recomendaciones fueron evaluadas en dos rondas mediante la metodología Delphi. Se consideró que existía consenso cuando el nivel de acuerdo era igual o superior al 60 %. El documento se estructuró conforme a los lineamientos AGREE II y RIGHT. Resultados: se alcanzó consenso en 97 de 127 recomendaciones en la primera ronda y en 25 de 30 en la segunda. Las recomendaciones abordan aspectos clave del diagnóstico patológico, estudios de estadificación y estrategias terapéuticas según la extensión de la enfermedad (temprana, localmente avanzada, metastásica) y los subtipos histológicos (HR+/HER2−, HER2+ y triple negativo). Conclusión: la metodología del CPE ofrece un marco práctico y adaptable para actualizar el manejo del cáncer de mama en contextos donde las GPC oficiales están desactualizadas. La GPC-SGSSS de 2017 ya no es suficiente para orientar adecuadamente la atención de las pacientes con cáncer de mama en Colombia.

Antecedentes: La terapia hormonal es clave para tratar el cáncer de mama, pero se reporta baja adherencia terapéutica y existe poca evidencia sobre los predictores que contribuyen a mejorar esta adherencia terapéutica en esta población. Objetivo: Identificar factores asociados a la adherencia a la terapia hormonal en mujeres con cáncer de mama, en una Clínica Oncológica de Medellín-Colombia. Métodos: Estudio transversal analítico. Se incluyeron mujeres >18 años con cáncer de mama con receptores hormonales positivos, en tratamiento con terapia hormonal. Se aplicó la escala MMAS-8 para medir y clasificar a las mujeres en baja, mediana y alta adherencia terapéutica. Los datos fueron analizados mediante regresión logística multinomial. Resultados: Se incluyeron 178 pacientes, con edad mediana de 64.0. El 50.0% estaba siendo tratado con tamoxifeno. La prevalencia de adherencia incompleta fue de 48.9%. El 70.2 % presentó efectos adversos por la terapia hormonal y el olvido fue el principal motivo por el que las pacientes dejaban de tomar el medicamento (76.2%). La edad se asoció con la adherencia terapéutica, siendo las mujeres mayores las más adherentes (83.5%). Las mujeres que presentaron efectos adversos, que pertenecían a estadios III-IV, a niveles socioeconómicos y educativos bajos y no contaban con red de apoyo mostraron tener menor adherencia terapéutica. Conclusión: Se evidencia elevada prevalencia de mediana y baja adherencia terapéutica en las mujeres más jóvenes, de estratos socioeconómicos y niveles educativos más bajos. Se requieren estrategias preventivas que mitiguen factores que impactan negativamente en la adherencia terapéutica.

Purpose: This is the first report of an institutional-based cancer registry in Clínica de Oncología Astorga, in Medellín, Colombia. It was created to produce local information on socio-demographic and clinical characteristics, therapies, and survival outcomes of patients with the most frequent tumors in the institution. Methods: All consecutive patients with cancers of the breast (BC), prostate (PC), lung (LC), colorectal (CRC), ovarian, stomach, pancreas, cervical, and melanoma, diagnosed after January 1/2019, and treated at the institution were included. A description of the entire cohort and of the five most frequent tumor types was performed. Kaplan-Meier curves for each tumor stage were used to estimate overall survival (OS) and progression-free survival (PFS). Statistical analysis was performed using SPSS v22. Results: Data from 729 patients were analyzed. The median follow-up was 12.0 months (IQR 5.8-18.1). The main diagnoses were BC, PC, CRC, LC, and cervical cancer in 57.2%, 10.2%, 8.0%, 7.7%, and 5.8% of patients, respectively. The most frequent stage at diagnosis was: stage II for BC (36.6%) and PC (35.1%), stage III for CRC (62.1%) and cervical cancer (50.0%), and stage IV for LC (62.5%). In BC cases, the median PFS for stage IV patients was 10.8 months (95%CI: 8.7-13.0). In LC cases, median PFS and OS for stage IV were 5.6 months (95%CI: 4.1-7.0), and 6.8 months (95%CI: 2.5-11.1), respectively. Conclusion: Even though follow-up is short in this first report, PFS for metastatic BC and PFS and OS for metastatic LC reflect the aggressive nature of these conditions in Colombia.

During the COVID-19 pandemic, regulatory approval or indication expansion was obtained for several antineoplastic agents in Colombia. Simultaneously, due to various reasons, the practicing medical community faced difficulties in accessing updated information on these new indications. Therefore, this review aims to examine the new approvals by the National Institute for Surveillance of Drugs and Food (INVIMA) for original antineoplastic agents with approval issued between March 2020 and May 2022. Methods: A search was conducted for new indications of original oral medications (including targeted therapy and endocrine therapy), cytotoxic agents, and monoclonal antibody antineoplastics (excluding immune checkpoint inhibitors addressed in part 2), by requesting INVIMA's records of new approvals from the 10 pharmaceutical companies represented in Colombia and through the INVIMA electronic platform while it was available. For cost information, Circular 12 for regulated medications or the reference prices from the Drug Price Information System (SISMED) for non-regulated medications were consulted. A brief literature review was performed for each indication, emphasizing study design, primary outcomes, grade 3 or higher toxicities, along with estimated costs in Colombia. Results: Regulatory approval or indication expansion in Colombia was documented for 13 medications based on phase 3 studies that demonstrated benefits in progression-free survival (or disease-free survival for non-metastatic disease) or overall survival. These include androgen receptor antagonists such as apalutamide and darolutamide; kinase inhibitors and targeted therapy such as abemaciclib, cabozantinib, ixazomib, lenvatinib, osimertinib, regorafenib, larotrectinib, olaparib, pertuzumab, venetoclax, as well as the cytotoxic agent eribulin. The approvals expand therapeutic options in Colombia for prostate cancer, breast cancer, thyroid cancer, hepatocellular carcinoma, and renal cancer. Most of the new indications were in the context of advanced cancer, but there were also studies in early stages. Conclusion: The expansion of regulatory approvals for antineoplastic agents in Colombia represents an additional opportunity for the benefit of cancer patients.

During the COVID-19 pandemic, regulatory approval or expanded indications were granted for several immune checkpoint inhibitors in cancer treatment in Colombia. However, for various reasons, the practicing medical community faced difficulties in accessing updated information on these new indications. Objective: to review the new approvals by the National Institute for Food and Drug Surveillance (INVIMA) for immune checkpoint inhibitors with approvals issued between March 2020 and May 2022. Methods: New indications for immune checkpoint inhibitors were searched on the INVIMA website and in media sources. For cost information, Circular 12 for regulated drugs or the reference prices from the Drug Price Information System (SISMED) for unregulated drugs were consulted. A brief literature review was conducted for each indication, with a focus on study design, primary outcomes, grade 3 or higher toxicities, and estimated costs in Colombia. Results: New therapeutic indications were found for ipilimumab (anti-CTLA4), nivolumab (anti-PD1), pembrolizumab (anti-PD1), atezolizumab (anti-PD-L1), durvalumab (anti-PD-L1), and avelumab (anti-PD-L1). Nine new indications were approved between March 2020 and May 2022. Pembrolizumab obtained four new indications, including for colorectal cancer with microsatellite instability or DNA mismatch repair deficiency, triple-negative breast cancer, esophageal cancer, and Hodgkin's lymphoma. The combination of atezolizumab and bevacizumab is indicated for advanced hepatocellular carcinoma. Ipilimumab plus nivolumab (with chemotherapy) is approved for metastatic non-small cell lung cancer. Durvalumab in combination with chemotherapy is indicated for extensive-stage small cell lung cancer. Avelumab is approved for maintenance therapy in advanced urothelial cancer and in combination with axitinib for metastatic renal cell carcinoma. The toxicities observed in the registration studies are consistent with the expected profile for this class of agents. Conclusion: The expansion of the number and scope of regulatory approvals for immune checkpoint inhibitors in Colombia presents an additional opportunity for the benefit of cancer patients.

Objetivos: el cáncer de mama (CM) es la neoplasia más frecuente en Colombia. La supervivencia global a 5 años es <80 %, siendo el país latinoamericano con el peor pronóstico. Las estrategias preventivas como la identificación de población con riesgo de síndrome de CM y ovario hereditario (HBOC), tiene el potencial de reducir la incidencia de CM y disminuir los diagnósticos en estadios avanzados. La mayoría de los estudios publicados en población colombiana, han evaluado variantes reportadas como fundadoras, denominadas el “Perfil Colombia” o en población seleccionada con alta probabilidad de presentar HBOC. En este estudio realizamos un análisis genómico a gran escala para evaluar mutaciones germinales en pacientes con CM no seleccionadas, en múltiples regiones del país.

Objetivo: La prueba genómica de recurrencia de 21 genes (Oncotype DX, Genomic Health) (ODx®) permite determinar la utilidad de quimioterapia adyuvante en pacientes con cáncer de mama temprano tipo luminal. De forma segura se puede omitir la quimioterapia adyuvante en pacientes con un puntaje de riesgo bajo (RB). También se han desarrollado otros modelos predictivos basados en variables clínicas e histopatológicas estándar. Estos incluyen las ecuaciones de Magee (EM), el modelo Predict (MP) y la puntuación del nomograma de Tennessee (NT). El objetivo de este estudio es evaluar la concordancia entre ODx® y los modelos predictivos.