Effect of receiving a customizable brochure on breast cancer patients' knowledge about their diagnosis and treatment: A randomized clinical trial.

BACKGROUND: Patients' lack of knowledge about their own disease may function as a barrier to shared decision-making and well-being. This study aimed to evaluate the impact of written educational materials on breast cancer patients. METHODS: This multicenter, parallel, unblinded, randomized trial included Latin American women aged ≥18 years with a recent breast cancer diagnosis yet to start systemic therapy. Participants underwent randomization in a 1:1 ratio to receive a customizable or standard educational brochure. The primary objective was accurate identification of molecular subtype. Secondary objectives included identification of clinical stage, treatment options, participation in decision-making, perceived quality of information received, and illness uncertainty. Follow-up occurred at 7-21 and 30-51 days post-randomization. CLINICALTRIALS: gov identifier: NCT05798312. RESULTS: One hundred sixty-five breast cancer patients with a median age of 53 years and 61 days from diagnosis were included (customizable: 82; standard: 83). At first available assessment, 52%, 48%, and 30% identified their molecular subtype, disease stage, and guideline-endorsed systemic treatment strategy, respectively. Accurate molecular subtype and stage identification were similar between groups. Per multivariate analysis, customizable brochure recipients were more likely to identify their guideline-recommended treatment modalities (OR: 4.20,p = 0.001). There were no differences between groups in the perceived quality of information received or illness uncertainty. Customizable brochure recipients reported increased participation in decision-making (p = 0.042). CONCLUSIONS: Over one third of recently diagnosed breast cancer patients are incognizant of their disease characteristics and treatment options. This study demonstrates a need to improve patient education and shows that customizable educational materials increase patients' understanding of recommended systemic therapies according to individual breast cancer characteristics.

Current Scenario of Clinical Cancer Research in Latin America and the Caribbean.

In Latin America and the Caribbean (LAC), progress has been made in some national and regional cancer control initiatives, which have proved useful in reducing diagnostic and treatment initiation delays. However, there are still significant gaps, including a lack of oncology clinical trials. In this article, we will introduce the current status of the region's clinical research in cancer, with a special focus on academic cancer research groups and investigator-initiated research (IIR) initiatives. Investigators in LAC have strived to improve cancer research despite drawbacks and difficulties in funding, regulatory timelines, and a skilled workforce. Progress has been observed in the representation of this region in clinical trial development and conduct, as well as in scientific productivity. However, most oncology trials in the region have been sponsored by pharmaceutical companies, highlighting the need for increased funding from governments and private foundations. Improvements in obtaining and/or strengthening the LAC cancer research group's financing will provide opportunities to address cancer therapies and management shortcomings specific to the region. Furthermore, by including this large, ethnic, and genetically diverse population in the world's research agenda, one may bridge the gap in knowledge regarding the applicability of results of clinical trials now mainly conducted in populations from the Northern Hemisphere.

Low-dose aspirin use in the first trimester of pregnancy and odds of congenital anomalies: A meta-analysis of randomized controlled trials.

BACKGROUND: Daily low-dose aspirin (LDA) is recommended in high-risk pregnancies. However, its safety profile in the first trimester has not been well documented. OBJECTIVES: To determine if LDA exposure during the first trimester of pregnancy is associated with higher odds of congenital structural anomalies. SEARCH STRATEGY: PubMed, Embase, Web of Science, Cochrane Central Register of Controlled Trials, and ClinicalTrials.gov were systematically searched. SELECTION CRITERIA: Randomized controlled trials (RCTs) that assigned participants to LDA (≤150 mg) or placebo/no intervention at less than 14 weeks of pregnancy were eligible. DATA COLLECTION AND ANALYSIS: Random-effects models were performed using the inverse-variance method to calculate pooled effect sizes. Quality of evidence was appraised according to Grading of Recommendations, Assessment, Development and Evaluations (GRADE) criteria. MAIN RESULTS: Eight RCTs that included 7564 participants assigned to receive daily LDA and 7670 participants that served as controls were analyzed. Low-certainty evidence showed no significant difference in the odds of congenital anomalies (odds ratio 0.87, 95% confidence interval 0.62-1.23, I2  = 0%). CONCLUSIONS: In this meta-analysis, there is no evidence to suggest safety concerns regarding LDA teratogenicity. However, given the overall low quality of evidence, further research (e.g. individual participant data meta-analysis) is needed to confirm LDA safety profile.

Germline pathogenic variants in Mexican patients with hereditary triple-negative breast cancer.

OBJECTIVE: Describe the prevalence of breast cancer (BC)- associated germline pathogenic variants (PVs) among Mexican patients with triple-negative BC (TNBC). MATERIALS AND METHODS: The spectrum of PVs identified among patients with TNBC who were enrolled in a prospective registry and underwent genetic testing was analyzed. RESULTS: Of 387 patients with invasive TNBC and a median age at diagnosis of 39 years (range 21-72), 113 (29%) were carriers of PVs in BC-susceptibility genes: BRCA1 (79%), BRCA2 (15%), and other (6%: ATM, BRIP1, PALB2, PTEN, RAD51C, and TP53). PV carriers were younger at BC diagnosis (37 vs. 40 years, p=0.004) than non-carriers. CONCLUSION: A large proportion of TNBC in Mexican patients is associated with germline PVs, the vast majority in BRCA. The incremental yield of PVs in other BC-susceptibility genes was modest, and a stepwise approach starting with BRCA testing may be justified if it is more cost-effective than multigene panel testing.

Germline pathogenic variants in Mexican patients with hereditary triple-negative breast cancer / Variantes patóge nas de línea germinal en mexicanas con cáncer de mama triple negativo hereditario

Abstract: Objective: Describe the prevalence of breast cancer (BC)-associated germline pathogenic variants (PVs) among Mexican patients with triple-negative BC (TNBC). Materials and methods: The spectrum of PVs identified among patients with TNBC who were enrolled in a prospective registry and underwent genetic testing was analyzed. Results: Of 387 patients with invasive TNBC and a median age at diagnosis of 39 years (range 21-72), 113 (29%) were carriers of PVs in BC-susceptibility genes: BRCA1 (79%), BRCA2 (15%), and other (6%: ATM, BRIP1, PALB2, PTEN, RAD51C, and TP53). PV carriers were younger at BC diagnosis (37 vs. 40 years, p=0.004) than non-carriers. Conclusion: A large proportion of TNBC in Mexican patients is associated with germline PVs, the vast majority in BRCA. The incremental yield of PVs in other BC-susceptibility genes was modest, and a stepwise approach starting with BRCA testing may be justified if it is more cost-effective than multigene panel testing.

Resumen: Objetivo: Describir la prevalencia de variantes patógenas (VPs) germinales en genes asociados con cáncer de mama (CM) en pacientes mexicanos con CM triple negativo (CMTN). Material y métodos: Se analizó el espectro de VPs identificadas en pacientes con CMTN que fueron incluidos prospectivamente en un registro y se realizó un estudio genético. Resultados: Se analizó un total de 387 pacientes con una mediana de edad al diagnóstico de 39 años; 113 (29%) eran portadores de VPs en genes de susceptibilidad a CM: BRCA1 (79%), BRCA2(15%), y otros (6%: ATM, BRIP1, PALB2, PTEN, RAD51C y TP53). Los portadores de VPs eran más jóvenes al diagnóstico de CM (37 vs. 40 años, p=0.004). Conclusiones: Existe una alta prevalencia de VPs en pacientes mexicanos con CMTN y la mayoría se encuentra en genes BRCA. La realización de pruebas genéticas se puede optimizar mediante la adopción de un proceso escalonado para la detección de VPs.

Barriers and facilitators to provide multidisciplinary care for breast cancer patients in five Latin American countries: A descriptive-interpretative qualitative study.

Background: Multidisciplinary care (MDC) remains a cornerstone for breast cancer management as it is associated with improved quality of care and patient outcomes. However, the adoption of MDC practice is heterogeneous and has been poorly explored in Latin America. The objective was to describe barriers and possible facilitators for providing MDC to breast cancer patients in five Latin American countries. Methods: A panel of experts with an active clinical practice in Bolivia, Colombia, Ecuador, Mexico, and Uruguay was convened to identify barriers and facilitators to MDC. This study is a qualitative synthesis of a structured discussion regarding the state of MDC in the setting of breast cancer. Findings: Experts recognized that most oncology practices in Latin America do not apply a multidisciplinary approach for breast cancer patients. Predominant barriers for MDC are fragmentation of health services, being understaffed, inadequate infrastructure, and geographic disparities. Access to MDC varies widely in the region, with significant heterogeneity documented within countries. MDC practice was described as being more common in the private sector in Ecuador and Uruguay, while it is more widely implemented in public institutions of Colombia and Bolivia. Interpretation: Establishing quality MDC remains a challenge for oncology practices in Latin America. Addressing regional issues and identifying specific local needs is warranted to encourage the adoption of an effective multidisciplinary approach and, consequently, improve clinical outcomes. Active involvement of all stakeholders is required to build locally solutions and should involve institutions, health professionals, and patients. Funding: Research was funded by Productos Roche S.A.

Immunogenicity and risk of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection after Coronavirus Disease 2019 (COVID-19) vaccination in patients with cancer: a systematic review and meta-analysis.

BACKGROUND: Patients with cancer are considered a priority group for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) vaccination given their high risk of contracting severe Coronavirus Disease 2019 (COVID-19). However, limited data exist regarding the efficacy of immunisation in this population. In this study, we assess the immunologic response after COVID-19 vaccination of cancer versus non-cancer population. METHODS: PubMed, Cochrane Central Register of Controlled Trials (CENTRAL), and Web of Science databases were searched from 01st March 2020 through 12th August 12 2021. Primary end-points were anti-SARS-CoV-2 spike protein (S) immunoglobulin G (IgG) seroconversion rates, T-cell response, and documented SARS-CoV-2 infection after COVID-19 immunisation. Data were extracted following the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines. Overall effects were pooled using random-effects models. RESULTS: This systematic review and meta-analysis included 35 original studies. Overall, 51% (95% confidence interval [CI], 41-62) and 73% (95% CI, 64-81) of patients with cancer developed anti-S IgG above the threshold level after partial and complete immunisation, respectively. Patients with haematologic malignancies had a significantly lower seroconversion rate than those with solid tumours after complete immunisation (65% vs 94%; P < 0.0001). Compared with non-cancer controls, oncological patients were less likely to attain seroconversion after incomplete (risk ratio [RR] 0.45 [95% CI 0.35-0.58]) and complete (RR 0.69 [95% CI 0.56-0.84]) COVID-19 immunisation schemes. Patients with cancer had a higher likelihood of having a documented SARS-CoV-2 infection after partial (RR 3.21; 95% CI 0.35-29.04) and complete (RR 2.04; 95% CI 0.38-11.10) immunisation. CONCLUSIONS: Patients with cancer have an impaired immune response to COVID-19 vaccination compared with controls. Strategies that endorse the completion of vaccination schemes are warranted. Future studies should aim to evaluate different approaches that enhance oncological patients' immune response.

Cancer control in Latin America and the Caribbean: recent advances and opportunities to move forward.

The increasing burden of cancer represents a substantial problem for Latin America and the Caribbean. Two Lancet Oncology Commissions in 2013 and 2015 highlighted potential interventions that could advance cancer care in the region by overcoming existing challenges. Areas requiring improvement included insufficient investment in cancer control, non-universal health coverage, fragmented health systems, inequitable concentration of cancer services, inadequate registries, delays in diagnosis or treatment initiation, and insufficient palliative services. Progress has been made in key areas but remains uneven across the region. An unforeseen challenge, the COVID-19 pandemic, strained all resources, and its negative effect on cancer control is expected to continue for years. In this Series paper, we summarise progress in several aspects of cancer control since 2015, and identify persistent barriers requiring commitment of additional resources to reduce the cancer burden in Latin America and the Caribbean.

Adjuvant endocrine therapy for premenopausal women with breast cancer: Patient adherence and physician prescribing practices in Mexico.

BACKGROUND: In resource-constrained settings, data regarding breast cancer patients' adherence to endocrine therapy (ET) and physicians' prescribing practices is limited. This study aims to decrease this knowledge gap in a real-world clinical practice. METHODS: Premenopausal women with stage 0-III hormone-sensitive breast cancer and receiving adjuvant ET during the past 1-5 years were identified in three Mexican referral centers. Participants' self-reported ET compliance, clinicopathologic characteristics, ET-related knowledge and beliefs, experienced adverse effects, social support, and patient-physician relationships were evaluated. Physician ET prescribing practices were compared with the gold standard according to international and national guidelines to assess clinicians' adherence to standard-of-care prescription. RESULTS: In total, 95/132 (72%) and 35/132 (27%) participants reported complete and acceptable adherence, respectively. Incomplete adherence was mainly attributed to forgetfulness, adverse effects, and unwillingness to take ET. Being employed/studying (p = 0.042), worrying about long-term ET use (p = 0.031), and experiencing >7 ET-related symptoms (p = 0.018) were associated with incomplete adherence. Guideline-endorsed regimens were prescribed in 84/132 (64%) patients, while the rest should have undergone ovarian function suppression (OFS) but instead received tamoxifen monotherapy. CONCLUSIONS: Premenopausal Mexican women self-report remarkably high rates of adequate ET adherence. However, a considerable proportion misses ≥1 doses/month, usually because of forgetfulness. Notably, only 64% receive standard-of-care ET due to suboptimal prescription of OFS. Interventions that remind patients to take their ET, refine physicians' knowledge on the importance of OFS in high-risk patients, and increase access to OFS could prove pivotal to enhance optimal ET implementation and adherence, which could translate into improved patient outcomes.

Improving Collection of Real-World Data: The Experience of the Joven & Fuerte Prospective Cohort for Mexican Young Women With Breast Cancer.

The prospective collection of clinical data can generate detailed information on heterogeneous populations. This article reviews the strengths and limitations of the collection of real-world data and provides insight into the feasibility of routine collection of high-quality evidence even in a resource-constrained setting. The acquisition of high-quality data to assess the clinical and psychosocial needs of young Mexican patients with breast cancer has been enhanced through the use of preplanned, standardized data definitions and instrumentation to provide internally and externally comparable results, optimization of data collection with web-based surveys, engagement of participants to minimize missing data, and routine review for data consistency. A similar approach by other research groups could improve the quality of real-world data and accomplish enhanced inference of information.

Influence of germline BRCA genotype on the survival of patients with triple-negative breast cancer.

The presence of BRCA pathogenic variants (PVs) in triple-negative breast cancer (TNBC) is associated with a distinctive genomic profile that makes the tumor particularly susceptible to DNA-damaging treatments. However, patients with BRCA PVs can develop treatment resistance through the appearance of reversion mutations and restored BRCA expression. As copy-number variants (CNV) could be less susceptible to reversion mutations than point mutations, we hypothesize that carriers of BRCA CNVs may have improved survival after treatment compared to carriers of other BRCA PVs or BRCA wild-type. Women diagnosed with stage I-III TNBC at ≤50 years at a cancer center in Mexico City were screened for BRCA PVs using a recurrent PV assay (HISPANEL; 77% sensitivity). The recurrence-free (RFS) and overall survival (OS) were compared according to mutational status. Among 180 women, 17 (9%) were carriers of BRCA1 ex9-12del CNV and 26 (14%) of other BRCA PVs. RFS at ten years for the whole cohort was 79.2% (95% CI 72.3-84.6%), with no significant differences according to mutational status. 10-year OS for the entire cohort was 85.3% (95%CI: 78.7-90.0%), with BRCA CNV carriers demonstrating numerically superior OS rates other PV carriers and non-carriers (100% vs. 78.6% and 84.7%; log-rank p=0.037 and p=0.051, respectively). This study suggests that BRCA1 ex9-12del CNV carriers with TNBC may have a better OS, and supports the hypothesis that the genotype of BRCA PVs may influence survival by limiting treatment resistance mediated by reversion mutations among CNV carriers.

Factors associated with the desire to undergo post-mastectomy breast reconstruction in a Mexican breast cancer center.

PURPOSE: To assess the proportion of breast cancer patients treated with total mastectomy who are interested in undergoing breast reconstruction, the factors associated with their desire to undergo this procedure, and the motives stated for their decision. METHODS: Women with stage I-III breast cancer, public health insurance, and history of total mastectomy treated at a center in Monterrey, Mexico, were invited to answer a series of questionnaires regarding their clinical and demographic characteristics, information received about breast reconstruction, body image, and relationship satisfaction. RESULTS: A total of 100 patients were interviewed, of which 68% desired to undergo breast reconstruction. Only 35% recalled talking about this procedure with a physician and 85% claimed not to have enough information to make an informed decision. Those who desired breast reconstruction were younger (p < 0.001), more likely to be in a relationship (p = 0.025), and had a higher probability of having talked to a physician about the procedure (p = 0.019). Furthermore, they felt less sexually attractive (p < 0.001), more deformed (p = 0.006), and less feminine (p = 0.005) since the mastectomy. The main motives to undergo this procedure were to have breast symmetry and greater freedom on which clothes to wear, while the main deterrent was the high economical cost. CONCLUSIONS: Insufficient information about the procedure and high economical cost were identified as potential barriers to undergo breast reconstruction. The findings of this study emphasize the pressing need to optimize patient care by providing information in a standardized manner and improving access to breast reconstruction within the Mexican public healthcare system.

Aneurysms of the Lenticulostriate Artery: A Systematic Review.

BACKGROUND: Lenticulostriate artery aneurysms (LSAs) are rare vascular aberrations. Despite the potentially catastrophic sequelae of aneurysmal rupture, the optimal management strategy for LSA aneurysms has not been determined. The aim of the present review is to provide an overview of the clinical presentation and treatment strategies for LSA aneurysms. METHODS: Using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, a literature search was conducted in the PubMed, Cochrane, EBSCOhost, Scopus, Web of Science, and ProQuest search engines to identify reported studies of LSA aneurysms until July 1, 2020. A descriptive analysis was performed. RESULTS: A total of 71 studies with 112 cases of LSA aneurysms were included. Patient age ranged from 2 months to 83 years (median, 44.5 years). Male and female patients were affected similarly (49% and 51%, respectively). The most common presentation was aneurysmal rupture (78%), and headache was the most frequently reported symptom (36%). Overall, 48% of the patients had undergone underwent surgical treatment, 30% conservative management, 21% endovascular treatment, and 1% radiosurgery. Four patients died, all of whom had presented with aneurysmal rupture. CONCLUSION: We have summarized the reported cases of LSA aneurysms, with their clinical presentation, management, and outcomes, for physicians who may be confronted with this diagnosis. Future studies that use available classification systems and include as much detail as possible should be encouraged to fully elucidate the optimal management strategy for these patients.

Coexisting arachnoid cyst and tentorial sinus: A therapeutic dilemma.

A 4-year-old male presented with a large arachnoid cyst over the left temporal region causing displacement of adjacent structures. Cerebral angiography showed dilatation of the tentorial sinus without other apparent vascular alterations. The association of these two anomalies raises a therapeutic dilemma as no information is available about how the variants of the venous system can modify cerebrospinal fluid hydrodynamics and thus affect arachnoid cyst's prognosis. In this case, the patient was treated conservatively and has remained stable for 2 years.

Clinical utility of genomic signatures in young breast cancer patients: a systematic review.

Risk stratification by genomic signatures has been shown to improve prognostication and guide treatment decisions among patients with hormone-sensitive breast cancer. However, their role in young women has not been fully elucidated. In this review, a systematic search was conducted for published articles and abstracts from major congresses that evaluated the use of genomic signatures in young breast cancer patients. A total of 71 studies were analyzed, including 561,188 patients of whom 27,748 (4.9%) were young. Women aged ≤40 years were subjected to genomic testing at a similar rate to older women but had a higher proportion of intermediate- to high-risk tumors when classified by EndoPredict (p = 0.04), MammaPrint (p < 0.01), and Oncotype DX (p < 0.01). In young women with low genomic risk, 6-year distant recurrence-free survival was 94%, while 5-year overall survival was nearly 100%. Nonetheless, young patients classified as low-risk had a higher tendency to receive chemotherapy compared to their older counterparts. In conclusion, genomic tests are useful tools for identifying young patients in whom chemotherapy omission is appropriate.

Successful Implementation of a Quality Improvement Intervention Toward a QOPI-Certified Breast Cancer Center in Mexico.

INTRODUCTION: As part of a quality improvement (QI) project undertaken during the 2018 edition of the American Society of Clinical Oncology's Quality Training Program (QTP), we evaluated our practice's compliance to 70 measures regarding the Core, Symptom/Toxicity and Breast Cancer modules from the Quality Oncology Practice Initiative (QOPI) database. Thirteen measures were identified as being consistently low in documentation rate in our medical records (MR). METHODS: After establishing a multidisciplinary QI team, we defined to accomplish 100% documentation rate of these 13 QOPI measures in ≥ 80% of the monthly new patient MRs during the 6-month QTP. We designed a Microsoft Word MR template and implemented a new pre-consultation process. Monthly Plan-Do-Study-Act cycles were conducted to assess the performance of the intervention. RESULTS: After the 6-month QI intervention, > 80% of our monthly MRs achieved 100% compliance to the aimed-for 13 QOPI measures. Furthermore, our new pre-consultation process proved to be valuable in facilitating the documentation of data without interfering with the oncology appointment. CONCLUSION: The development of a systematic QI approach effectively enhanced our compliance to 13 QOPI measures over a 6-month period. These results led to the standardization of the current model of care at our institution. To our knowledge, Hospital Zambrano Hellion's Breast Cancer Center is the first Mexican cancer center to pursue a QOPI certified practice.

Molecular Subtype Discordance in a Young Woman with Synchronous Bilateral Breast Cancer: A Case Report.

Molecular subtype discordance in bilateral synchronous breast cancer is a relatively uncommon entity that poses unique therapeutic challenges. Here we report the case of a 35-year-old woman who presented to our clinic with synchronous bilateral breast cancer (SBBC), with stage IIA triple-negative disease in the right breast and a stage IIB hormone-sensitive tumor in the left breast. She was treated with bilateral modified radical mastectomy and axillary node dissection followed by adjuvant chemotherapy, radiotherapy, and a five-year regimen with daily tamoxifen. To date, the patient remains asymptomatic and free of disease recurrence 78 months after initiating treatment. Little is known about SBBC with a discordant molecular subtype and reports about this entity are scarce. Future studies aimed at identifying the optimal management strategy for this disease are needed.

Cost analysis of materials used in the endovascular treatment of unruptured intracranial aneurysms in Mexico.

BACKGROUND: To prevent the potentially fatal consequences of intracranial aneurysmal rupture, exclusion from the circulation can be achieved through an endovascular approach. However, the elevated cost of such procedures can be prohibitive for patients in low resource settings. The objective of this study is to identify the factors that modify the cost of the materials used for endovascular treatment of unruptured intracranial aneurysms. METHODS: Medical records of patients who underwent an endovascular treatment for unruptured intracranial aneurysms between June 2013 and June 2019 in a hospital located in Northeast Mexico were reviewed. Descriptive statistics of the cost of consumable materials used during the procedure was performed, and a regression model was undertaken to examine potential associations between the studied variables and total cost of the intervention. RESULTS: A total of 128 patients were included in this analysis. The average intervention cost was $21,687.22 USD. The variables associated with increased material cost were aneurysm size (p = 0.03), aneurysm neck size (p < 0.001), and aneurysm localization in the cavernous segment of the internal carotid artery (p = 0.01). Other variables such as patient age and sex, other aneurysm localizations, laterality of the aneurysm, performing neurointerventionalist, and presence of intervention complications were not statistically significant. CONCLUSIONS: To our knowledge, this is the first study that examines the variables associated with the material cost of endovascular treatment of unruptured intracranial aneurysms. Awareness of which elements are important drivers of materials' costs provides a strategic advantage when making hospital administrative decisions and attempting to improve access to endovascular treatment in countries of low income.