Subcutaneous versus intravenous administration of Trastuzumab: a minimization cost analysis with real world data from a reference cancer centre in Peru.

Breast cancer (BC) is a global concern, with Peru experiencing a high incidence and mortality. Trastuzumab, a crucial treatment for human epidermal growth factor receptor 2-positive BC, is administered intravenously or subcutaneously (SC). This study evaluates the costs associated with both methods at Peru's Instituto Nacional de Enfermedades Neoplásicas. Real data indicate that SC administration reduces treatment costs by approximately S/15,049.09. Cross-continental comparisons highlight a global trend favouring SC administration for efficiency and cost-effectiveness. The analysis provides insights for informed decision-making in resource-constrained healthcare settings like Peru, emphasising the need to consider local contexts in optimising oncology care.

Subcutaneous Trastuzumab: An Observational Study of Safety and Tolerability in Patients With Early HER2-Positive Breast Cancer.

Purpose: In Peru, breast cancer (BC) stands as the most predominant malignancy neoplasm among women. Trastuzumab has marked a significant milestone in the management of this disease. It has been shown to improve prognosis in human epidermal growth factor receptor 2 (HER2)-expressing female patients, but its repercussions and efficacy are yet to be analyzed in a context with limited resources. Methods: The study population is made of woman patients aged 18 years and older diagnosed with HER2-positive BC at Instituto Nacional de Enfermedades Neoplásicas (INEN, Lima, Peru) during 2019-2021 and treated with at least one dose of subcutaneous trastuzumab. We reviewed medical records to register treatment characteristics, adverse events (AEs), disease progression, and survival status. We considered a median follow-up time of 36 and 45 months for progression and survival status. Results: The majority of patients were over 50 years old (54.29%). Tumor size averaged 19.7 ± 16.1 mm. Lymph nodes were present in 44.78% of patients. Most patients received adjuvant chemotherapy (63.8%) as first-line treatment. Descriptive analyses of treatment outcomes revealed a 30% toxicity rate, primarily attributed to arthralgia (47.62%), followed by diarrhea, fatigue, and injection site reactions, with relatively lower discontinuation rates compared to larger scale studies. Differences in demographic, clinical, and treatment characteristics were not statistically significant concerning the emergence of AEs (p > 0.05). Progression appeared in nine patients, and the overall survival (OS) rate stood at 98.6% and 92.8%, respectively, during a median follow-up of 36 and 45 months. Conclusion: The research suggests that subcutaneous trastuzumab is comparable in effectiveness and safety to the intravenous administration. Regional-specific studies may provide valuable insights into demographic factors influencing treatment outcomes in Peru or other countries. Furthermore, it could represent a more accessible alternative, potentially enhancing patient adherence and optimizing healthcare resource logistics.

Breast cancer subtype and clinical characteristics in women from Peru.

Introduction: Breast cancer is a heterogeneous disease, and the distribution of the different subtypes varies by race/ethnic category in the United States and by country. Established breast cancer-associated factors impact subtype-specific risk; however, these included limited or no representation of Latin American diversity. To address this gap in knowledge, we report a description of demographic, reproductive, and lifestyle breast cancer-associated factors by age at diagnosis and disease subtype for The Peruvian Genetics and Genomics of Breast Cancer (PEGEN-BC) study. Methods: The PEGEN-BC study is a hospital-based breast cancer cohort that includes 1943 patients diagnosed at the Instituto Nacional de Enfermedades Neoplásicas in Lima, Peru. Demographic and reproductive information, as well as lifestyle exposures, were collected with a questionnaire. Clinical data, including tumor Hormone Receptor (HR) status and Human Epidermal Growth Factor Receptor 2 (HER2) status, were abstracted from electronic medical records. Differences in proportions and mean values were tested using Chi-squared and one-way ANOVA tests, respectively. Multinomial logistic regression models were used for multivariate association analyses. Results: The distribution of subtypes was 52% HR+HER2-, 19% HR+HER2+, 16% HR-HER2-, and 13% HR-HER2+. Indigenous American (IA) genetic ancestry was higher, and height was lower among individuals with the HR-HER2+ subtype (80% IA vs. 76% overall, p=0.007; 152 cm vs. 153 cm overall, p=0.032, respectively). In multivariate models, IA ancestry was associated with HR-HER2+ subtype (OR=1.38,95%CI=1.06-1.79, p=0.017) and parous women showed increased risk for HR-HER2+ (OR=2.7,95%CI=1.5-4.8, p<0.001) and HR-HER2- tumors (OR=2.4,95%CI=1.5-4.0, p<0.001) compared to nulliparous women. Multiple patient and tumor characteristics differed by age at diagnosis (<50 vs. >=50), including ancestry, region of residence, family history, height, BMI, breastfeeding, parity, and stage at diagnosis (p<0.02 for all variables). Discussion: The characteristics of the PEGEN-BC study participants do not suggest heterogeneity by tumor subtype except for IA genetic ancestry proportion, which has been previously reported. Differences by age at diagnosis were apparent and concordant with what is known about pre- and post-menopausal-specific disease risk factors. Additional studies in Peru should be developed to further understand the main contributors to the specific age of onset and molecular disease subtypes in this population and develop population-appropriate predictive models for prevention.

Linfoma de células grandes T anaplásico: experiencia de 10 años en el Instituto Nacional de Enfermedades Neoplásicas, Lima - Perú / Anaplastic large T-cell lymphoma: 10-year experience at the National Institute of Neoplastic Diseases, Lima ­ Peru

Introducción: El Linfoma de Células Grandes T Anaplásico es una patología infrecuente, determinada por la expresión del CD30, con diferentes características en su presentación y ser de carácter más agresivos de acuerdo a la expresión del ALK. Objetivos: El presente estudio busca determinar las características epidemiológicas, clinicopatológicas y pronóstico de los pacientes con Linfoma de Células Grandes T Anaplásico. Métodos: Estudio descriptivo, retrospectivo de pacientes diagnosticados con Linfoma de Células Grandes T Anaplásico del Instituto Nacional de Enfermedades Neoplásicas (INEN) entre los años 2006 al 2016. Resultados: Se analizaron y revisaron la patología de 86 pacientes, 57% fueron hombres y 33% mujeres, de la población total 21,9% fueron positivos para ALK. 48 de los pacientes se encontraron en EC I y II y 36 entre estadios III y IV. 57 pacientes presentaban riesgo bajo o intermedio bajo mientras que 26 entre riesgo intermedio alto y alto. La sobrevida global estimada fue 40,8% a los 5 años, en el grupo de pacientes con ALK + fue 67,4% y en el grupo con ALK- se estimó en 30,2%. Conclusiones: El Linfoma de Células Grandes T Anaplásico es una enfermedad agresiva, con distribución heterogénea respecto a la edad y ligeramente más frecuente en varones, con el ALK y el índice pronóstico internacional como factores pronósticos importantes.

Introduction: Anaplastic Large T-Cell Lymphoma is an infrequent pathology, determined by the expression of CD30, with different characteristics in its presentation and being more aggressive according to the expression of ALK. Objectives: The present study seeks to determine the epidemiological, clinicopathological and prognostic characteristics of patients with Anaplastic Large T-Cell Lymphoma. Methods: Descriptive, retrospective study of patients diagnosed with Anaplastic Large T-Cell Lymphoma of the National Institute of Neoplastic Diseases (INEN) between 2006 and 2016. Results: The pathology of 86 patients was analyzed and reviewed, 57% were men and 33% women, of the total population 21.9% were positive for ALK. 48 of the patients were found in CD I and II and 36 between stages III and IV. 57 patients had low or low-intermediate risk, while 26 had high-intermediate and high risk. The estimated overall survival was 40.8% at 5 years, in the group of patients with ALK + it was 67.4% and in the group with ALK- it was estimated at 30.2%. Conclusions: Anaplastic Large T-Cell Lymphoma is an aggressive disease, with a heterogeneous distribution with respect to age and slightly more frequent in males, with ALK and the international prognostic index as important prognostic factors.

Association between Ancestry-Specific 6q25 Variants and Breast Cancer Subtypes in Peruvian Women.

BACKGROUND: Breast cancer incidence in the United States is lower in Hispanic/Latina (H/L) compared with African American/Black or Non-Hispanic White women. An Indigenous American breast cancer-protective germline variant (rs140068132) has been reported near the estrogen receptor 1 gene. This study tests the association of rs140068132 and other polymorphisms in the 6q25 region with subtype-specific breast cancer risk in H/Ls of high Indigenous American ancestry. METHODS: Genotypes were obtained for 5,094 Peruvian women with (1,755) and without (3,337) breast cancer. Associations between genotype and overall and subtype-specific risk for the protective variant were tested using logistic regression models and conditional analyses, including other risk-associated polymorphisms in the region. RESULTS: We replicated the reported association between rs140068132 and breast cancer risk overall [odds ratio (OR), 0.53; 95% confidence interval (CI), 0.47-0.59], as well as the lower odds of developing hormone receptor negative (HR-) versus HR+ disease (OR, 0.77; 95% CI, 0.61-0.97). Models, including HER2, showed further heterogeneity with reduced odds for HR+HER2+ (OR, 0.68; 95% CI, 0.51-0.92), HR-HER2+ (OR, 0.63; 95% CI, 0.44-0.90) and HR-HER2- (OR, 0.77; 95% CI, 0.56-1.05) compared with HR+HER2-. Inclusion of other risk-associated variants did not change these observations. CONCLUSIONS: The rs140068132 polymorphism is associated with decreased risk of breast cancer in Peruvians and is more protective against HR- and HER2+ diseases independently of other breast cancer-associated variants in the 6q25 region. IMPACT: These results could inform functional analyses to understand the mechanism by which rs140068132-G reduces risk of breast cancer development in a subtype-specific manner. They also illustrate the importance of including diverse individuals in genetic studies.

Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer Is Associated with Indigenous American Ancestry in Latin American Women.

Women of Latin American origin in the United States are more likely to be diagnosed with advanced breast cancer and have a higher risk of mortality than non-Hispanic White women. Studies in U.S. Latinas and Latin American women have reported a high incidence of HER2 positive (+) tumors; however, the factors contributing to this observation are unknown. Genome-wide genotype data for 1,312 patients from the Peruvian Genetics and Genomics of Breast Cancer Study (PEGEN-BC) were used to estimate genetic ancestry. We tested the association between HER2 status and genetic ancestry using logistic and multinomial logistic regression models. Findings were replicated in 616 samples from Mexico and Colombia. Average Indigenous American (IA) ancestry differed by subtype. In multivariate models, the odds of having an HER2+ tumor increased by a factor of 1.20 with every 10% increase in IA ancestry proportion (95% CI, 1.07-1.35; P = 0.001). The association between HER2 status and IA ancestry was independently replicated in samples from Mexico and Colombia. Results suggest that the high prevalence of HER2+ tumors in Latinas could be due in part to the presence of population-specific genetic variant(s) affecting HER2 expression in breast cancer. SIGNIFICANCE: The positive association between Indigenous American genetic ancestry and HER2+ breast cancer suggests that the high incidence of HER2+ subtypes in Latinas might be due to population and subtype-specific genetic risk variants.

Tumor Protein p53 and K-ras Gene Mutations in Peruvian Patients with Gallbladder Cancer

Background: Recent studies have shown that genetic alterations are associated with the effect of patient geographic location on gallbladder cancer development. Peru has a high incidence of gallbladder cancer, but causative factors have not yet been identified. We examined the frequency of mutations in TP53 and K-ras genes in Peruvian patients with gallbladder cancer, and compared this with data from Bolivia, Hungary, Chile, and Japan, which have a high gallbladder cancer incidence. Methods: DNA was extracted from formalin-fixed paraffin-embedded gallbladder tissue sections of 30 gallbladder cancer patients (9 men and 21 women) obtained using microdissection. Mutations in exons 5 to 8 of TP53 and codons 12, 13, and 61 of K-ras were examined using direct sequencing. Results: TP53 mutations were observed in 10 (33.3%) of patients, but K-ras mutations were absent. Nine (90%) TP53 mutations were point mutations (7 missense and 2 silent mutations), and the most frequent substitution was a G:C to A:T transition. G:C to A:T transitions at the CpG site or G:C to T:A transversions were found in one patient each. No significant differences were found in the frequency of TP53 and K-ras mutations among patients in the 5 countries. Conclusions: Our findings suggest that endogenous mechanisms and exogenous carcinogens may affect the carcinogenic process in Peruvian gallbladder cancer patients, similar to that in Bolivian patients. Further studies with a larger sample size are needed to clarify these findings.

Construcción de un sistema participativo de garantía con y para la Arac (Asociación Red Agroecológica Campesina) en el municipio de Subachoque, Cundinamarca, en 2015 / Construction of a participatory guarantee system with and for the peasant agroecological network association (Arac for its acronym in spanish) in the municipality of Subachoque, Cundinamarca, in 2015

Introducción. Una de las principales necesidades manifiestas de la ARAC en 2014, era el mejoramiento y ampliación de sus canales de comercialización, así como la falta de confianza y verificación de sus procesos productivos para ser coherentes con su misión en producción agroecológica. Objetivo. En este contexto, la presente investigación tuvo como objetivo la creación de un Sistema Participativo de Garantía (SPG) con y para la organización ARAC. Metodología. Se desarrolló una Investigación Acción Participativa (IAP) durante el año 2015. El proceso incluyó a todos los productores, aunque no contó con los consumidores por la dificultad de coordinar sus tiempos. Las cuatro fases de la investigación incluyeron: diagnóstico, estructuración del SPG de la ARAC, visitas de certificación y Escuelas Agroecológicas de Campo (EAC). Resultados. Como resultados se creó el SPG-ARAC con un comité vinculado a la estructura orgánica de la asociación y un reglamento que reúne normas y procedimientos a seguir en la implementación de los procesos productivos, así como mecanismos de control y verificación inspirados en los principios agroecológicos de la ARAC y en la Resolución 187 de 2006 del Ministerio de Agricultura y Desarrollo Rural (MADR). Se realizaron visitas de certificación a 22 sistemas de producción agropecuaria o de procesamiento y cuatro EAC. Conclusión. La implementación del SPG-ARAC demuestra que fue posible desarrollar un SPG con y para la ARAC, y que la organización se encuentra cerca de completar la transición agroecológica en los subsistemas de producción agrícola, mientras en los sistemas de producción pecuaria y de transformación se encuentran varias dificultades. Las principales limitantes identificadas gracias al SPG, para lograr la transición agroecológica de la organización son: la consecución de semillas y pie de cría ecológicos, el abastecimiento continuo de agua, la producción de pastos y forrajes ecológicos para la alimentación animal, y el uso de medicina alopática.

Introduction: One of the main obvious needs of the ARAC in 2014 was the improvement and expansion of its commercialization channels, as well as the lack of trust and verification of its productive processes, to be consistent with its mission in agroecological production. Objective: In this context, this research aimed to create a Participatory Guarantee System (SPG by its acronym in Spanish) with and for the ARAC organization. Methodology: A Participatory Action Research strategy (IAP for its acronym in Spanish) was applied during 2015. The process included all producers, although there were no consumers due to the difficulty for coordinating their times. The four phases of the research included: diagnosis, structuring of the SPG-ARAC, certification visits, and Agroecological Field Schools (EAC for its acronym in Spanish). Results: As a result, the SPG-ARAC was created with a committee linked to the organizational structure of the association, and a regulation that gathers standards and procedures to follow in the implementation of production processes, as well as control and verification mechanisms inspired by the agroecological principles of ARAC and stated in Resolution 187 of 2006 of the Ministry of Agriculture and Rural Development (MADR for its acronym in Spanish). Certification visits were made to 22 agricultural or processing production systems and to 4 EAC. Conclusions: The implementation of the SPG-ARAC demonstrates that it was possible to develop an SPG with and for the ARAC, and that the organization is close to completing the agroecological transition in the agricultural production subsystems, while in the livestock production and transformation systems there are several difficulties. The main limitations identified thanks to the SPG to achieve the agroecological transition of the organization are: the achievement of organic seeds and breeding stock, the continuous supply of water, the production of pastures and organic forages for animal feed, and the use of allopathic medicine.

Breast cancer subtype and survival among Indigenous American women in Peru.

Latina women in the U.S. have relatively low breast cancer incidence compared to Non-Latina White (NLW) or African American women but are more likely to be diagnosed with the more aggressive "triple negative" breast cancer (TNBC). Latinos in the U.S. are a heterogeneous group originating from different countries with different cultural and ancestral backgrounds. Little is known about the distribution of tumor subtypes in Latin American regions. Clinical records of 303 female Peruvian patients, from the Peruvian National Cancer Institute, were analyzed. Participants were diagnosed with invasive breast cancer between 2010 and 2015 and were identified as residing in either the Selva or Sierra region. We used Fisher's exact test for proportions and multivariable Cox Proportional Hazards Models to compare overall survival between regions. Women from the Selva region were more likely to be diagnosed with TNBC than women from the Sierra region (31% vs. 14%, p = 0.01). In the unadjusted Cox model, the hazard of mortality was 1.7 times higher in women from the Selva than the Sierra (p = 0.025); this survival difference appeared to be largely explained by differences in the prevalence of TNBC. Our results suggest that the distribution of breast cancer subtypes differs between highly Indigenous American women from two regions of Peru. Disentangling the factors that contribute to this difference will add valuable information to better target prevention and treatment efforts in Peru and improve our understanding of TNBC among all women. This study demonstrates the need for larger datasets of Latin American patients to address differences between Latino subpopulations and optimize targeted prevention and treatment.

The implementation of the Plan Esperanza and response to the imPACT Review.

Following the implementation of the National Cancer Prevention and Control Results-based Budget Programme (PpR Cancer-024) in 2011, the Peruvian Government approved the Plan Esperanza-a population-based national cancer control plan-in 2012. Legislation that ensured full government-supported funding for people who were otherwise unable to access or afford care and treatment accompanied the Plan. In 2013, the Ministry of Health requested an integrated mission of the Programme of Action for Cancer Therapy (imPACT) report to strengthen cancer control in Peru. The imPACT Review, which was executed in 2014, assessed Peru's achievements in cancer control, and areas for improvement, including cancer control planning, further development of population-based cancer registration, increased prevention, early diagnosis, treatment and palliative care, and the engagement and participation of civil society in the health-care system. This Series paper gives a brief history of the development of the Plan Esperanza, describes the innovative funding model that supports it, and summarises how funds are disseminated on the basis of disease, geography, and demographics. An overview of the imPACT Review, and the government's response in the context of the Plan Esperanza, is provided. The development and execution of the Plan Esperanza and the execution of and response to the imPACT Review demonstrates the Peruvian Government's commitment to fighting cancer across the country, including in remote and urban areas.

Factores de riesgo para enfermedad cardiovascular en aspirantes a una empresa de obras civiles en Yopal - Casanare, 2010 / Risk factors for cardiovascular disease in applicants to a civil works company in Yopal-Casanare, 2010

Introducción: en Colombia, según estadísticas recientes, las enfermedades cardiovasculares representan la segunda causa de mortalidad. En tal sentido, para Casanare, en 2009, la mortalidad fue de 54,3%. Objetivo: determinar la prevalencia de factores de riesgo cardiovascular y establecer el riesgo coronario a diez años, en aspirantes a ingresar a una empresa de obras civiles atendidos por salud ocupacional/laboral en una Institución Prestadora de Servicios de Salud en Yopal-Casanare, durante 2010. Métodos: estudio descriptivo transversal a partir del total de historias clínicas de personal masculino con exámenes de laboratorio. Análisis con Epi-Info-3.3.2® y SPSS-15.0® mediante medidas de frecuencia-dispersión-tendencia central, asociación: Χ2, razón de verosimilitudes, odds ratio (OR) y riesgo coronario según tabla de Framingham. Resultados: se revisaron 142 historias clínicas, con edad promedio de 34,7 (rango= 19-66) años; factores de riesgo cardiovascular 98,6%, sobrepeso/obesidad 48,6%, hipercolesterolemia 43,7%, hipertrigliceridemia 57,0%, colesterol-HDL 17,6%, hiperglucemia 7,0%, dislipidemia 28,9%, hipertensión 8,5%. Prevalencia de hábito de fumar 9,9%, consumo de alcohol 31,7%, sedentarismo 81,7%. Antecedentes familiares: hipertensión 7,7%, diabetes 5,6%, enfermedad coronaria 1,4%. Relación entre fumar/hipercolesterolemia-OR=3,77 (IC 95%=1,01-15,22), actividad-física/colesterol-HDL-OR=0,3 (IC 95%=0,1-0,88), fumar/riesgo-cardiovascular-OR=34,64 (IC 95%=2,79-947,4). Estimación según Framingham, bajo riesgo coronario <1 5%= 97,2%. Conclusiones: pocos individuos manifestaron no fumar, consumir alcohol y practicar actividad física lo cual podría representar el "efecto de trabajador sano". Se evidenció bajo riesgo coronario, fuerte relación entre fumar/hipercolesterolemia así como en protección de la actividad física versus niveles de riesgo en el colesterol-HDL. Recomendaciones: fortalecer acciones de información-educación-comunicación para prevenir factores de riesgo cardiovascular, generar programas laborales en estilos de vida saludables y realizar estudios de cohorte para hacer más exacto el pronóstico de riesgo del evento a diez años en el país.

Introduction: according to recent statistics, in Colombia cardiovascular diseases represent the second cause of mortality. In Casanare, mortality in 2009 due to cardiovascular disease was 54.3%. Objective: to determine the prevalence of cardiovascular risk factors and establish coronary risk at ten years in applicants aspiring to join a civil works company cared by an occupational health service institution in Yopal (Casanare) in 2010 . Methods: cross-sectional study from medical records of male personnel with laboratory tests. Analysis with Epi-Info-3.3.2-15.0® and SPSS® by measures of frequency, central trend and dispersion. Bivariate analysis was checked by Χ2, likelihood ratio, odds ratio (OR) and 10-year coronary risk according to Framingham table. Results: we reviewed 142 medical records; mean age was 34.7 years (range 19-66). 98.6% had cardiovascular risk factors, 48.6% presented overweight / obesity, 43.7% had hypercholesterolemia, 57.0% hypertriglyceridemia ,17.6% HDL cholesterol, 7.0% hyperglycemia, 28.9% dyslipidemia, and 8.5% hypertension. Smoking prevalence was 9.9%, alcohol consumption 31.7%, and 81.7% had a sedentary life. Family history: hypertension 7.7%, 5.6% diabetes, coronary heart disease 1.4%. Relationship between smoking / hypercholesterolemia, OR = 3.77 (95% CI = 1.01-15.22), physical activity/HDL cholesterol OR = 0.3 (95% CI = 0.1-0.88 ), smoking / cardiovascular risk OR = 34.64 (95% CI = 2.79-947.4). Estimate according to Framingham, low coronary risk <1 5% = 97.2%. Conclusions: few individuals reported not smoking, drinking alcohol and doing physical activity, which could present the "healthy worker effect". Low coronary risk was revealed, as well as strong relationship between smoking / hypercholesterolemia and protection of the physical activity versus HDL cholesterol risk levels.