The First Population-Level Description of Women Diagnosed With Invasive Breast Cancer in Costa Rica From 2008 to 2012: A Cross-Sectional Study.

INTRODUCTION: Breast cancer is the leading cause of cancer-related deaths among women worldwide. In Costa Rica, it ranks first in incidence and fourth in terms of mortality. However, there is a lack of comprehensive information on treatment patterns and outcomes for breast cancer patients in Costa Rica. METHODS: This study utilized data from the National Tumor Registry, which was merged with the Costa Rica Social Security Fund (CCSS) to ensure comprehensive access to clinical information. The study is prospective and focused on patients diagnosed with breast cancer between January 2008 and December 2012. This combined dataset allowed for a more comprehensive analysis of patient characteristics, treatment patterns, and outcomes related to breast cancer in Costa Rica. RESULTS: Among the 4775 patients diagnosed during this period, 3160 met the inclusion criteria for our study. The average age at diagnosis was 59.1 years, with 32.5% of patients being over the age of 65. Most of the patients (55.4%) identified themselves as homemakers, while 46.5% underwent core needle biopsy for diagnosis. Approximately 60% of women were diagnosed with early-stage disease (IA, IIA, and IIB), while 1.7% had metastatic disease, mainly affecting the bone. The mean interval between diagnosis and surgery was 72 days. Most patients (88.7%) received surgery as their initial treatment, and over half (54.4%) received some form of adjuvant therapy. Additionally, 85.6% of patients completed their prescribed treatment. CONCLUSION: This study provides a comprehensive and detailed description of the characteristics and treatment patterns among breast cancer patients in Costa Rica. The findings contribute to our understanding of the disease in this population and can serve as a foundation for further research and improvement in breast cancer management and care.

Personalizing Precision Oncology Clinical Trials in Latin America: An Expert Panel on Challenges and Opportunities.

The participation of patients in precision oncology trials needs to fulfill molecular-based selection criteria. This strongly limits accrual, and as a consequence, screening successes have decreased, costs have increased, and fewer subjects are enrolled. To achieve narrowed targets, studies have been forced to be multicenter and multinational to reach a larger pool of candidates. However, this globalization faces many challenges, as, for example, in the case of precision oncology trials. These trials have a complex structure that is dependent upon a high-tech infrastructure and knowledge in a dynamic environment. Given the movement of precision clinical cancer research to regions other than Europe and the U.S., it is important to evaluate the feasibility of performing such trials in lower-middle- and low-income countries. Here we critically discuss the advantages of conducting precision oncology clinical trials in Latin America and make suggestions on how to overcome the main challenges involved. IMPLICATIONS FOR PRACTICE: Precision clinical trials in oncology are studies that require candidates to have tumors with specific molecular alterations, which are considered the target for the trial experimental therapy. Because many molecular alterations are rare, fewer patients are enrolled. This has led to trials being forced to be multicenter and multinational, including trials in Latin America. This article discusses the challenges and opportunities to conduct precision oncology trials in Latin America, aiming to help sponsors and investigators to solve complex issues that ultimately lead to more of such trials being run in the region, potentially benefiting more Latin American patients with cancer.

Cyclin­dependent kinase 4/6 inhibitors in combination with fulvestrant for previously treated metastatic hormone receptor­positive breast cancer patients: A systematic review and meta­analysis of randomized clinical trials.

PURPOSE: To compare the efficacy and safety profile of the combination of cyclin-dependent kinase 4/6 (CDK 4/6) inhibitors and fulvestrant versus fulvestrant alone in previously treated patients with advanced hormone-receptor positive breast cancer. METHODS: Phase III randomized clinical trials (RCTs) were retrieved from a systematic review of electronic databases. A random-effect model was employed to determine the pooled hazard ratio (HR) for Progression-Free Survival (PFS) and Overall Survival (OS) using the inverse-variance method. The Mantel Haenszel method was used to calculate the pooled odds ratio (OR) for treatment-related side effects. Heterogeneity was measured using the tau-squared and I2 statistics. RESULTS: Three phase III RCTs (n = 1916) were included in the systematic review. Use of abemaciclib, palbociclib, or ribociclib in combination with fulvestrant was significantly associated with longer PFS compared to use of fulvestrant alone (HR: 0.53; 95%CI: 0.47-0.60; p<0.00001), with no significant heterogeneity found among trials. Similarly, OS was significantly longer for patients who received combination therapy in comparison with those allocated to receive fulvestrant alone (HR: 0.77; 95%CI: 0.67-0.89; p<0.0004). The overall odds ratio of serious adverse events (AE) was not significantly increased with the use of the combination therapy (OR: 1.51; 95%CI: 0.74-3.08), with significant heterogeneity found among trials (tau2=0.34; I2=86%; p = 0.0006). CONCLUSION: The addition of CDK 4/6 inhibitors (either abemaciclib, palbociclib, or ribociclib) to fulvestrant significantly improved PFS and OS in comparison with fulvestrant alone in patients previously treated with endocrine therapy for advanced breast cancer. No significant heterogeneity was found among CDK 4/6 inhibitors.

Cyclin-dependent kinase 4/6 inhibitors as first-line treatment for post-menopausal metastatic hormone receptor-positive breast cancer patients: a systematic review and meta-analysis of phase III randomized clinical trials.

BACKGROUND: To compare the efficacy and toxicity of the combination of cyclin-dependent kinase 4/6 (CDK 4/6) inhibitors and nonsteroidal aromatase inhibitors (AI) versus AI alone as first-line therapy for patients with advanced hormone receptor-positive breast cancer. MATERIALS AND METHODS: Phase III randomized clinical trials (RCT) were identified after a systematic review of electronic databases. A random-effect model was used to determine the pooled hazard ratio (HR) for progression-free survival (PFS) using the inverse-variance method. The Mantel-Haenszel method was used to calculate the pooled odds ratio (OR) for overall response, clinical benefit rate and treatment-related side effects. Heterogeneity was measured using the tau-squared and I2 statistics. RESULTS: After a systematic search, three phase III RCT (n = 1827) were included. The use of CDK 4/6 inhibitors (abemaciclib, palbociclib, and ribociclib) in combination with an AI was significantly associated with longer PFS compared to the use of letrozole or anastrozole alone (HR: 0.57; 95% CI 0.50-0.65; p < 0.00001), with no significant heterogeneity among trials. Similarly, overall response rate and clinical benefit rate were higher for patients who received the combination therapy than for patients allocated to AI alone. Grade 3 or higher treatment-related side effects were more frequently reported for patients who received CDK 4/6 inhibitors (OR: 7.51; 95% CI 6.01-9.38; p < 0.00001), these included mainly neutropenia, leukopenia and anemia. CONCLUSION: The addition of CDK 4/6 inhibitors (either abemaciclib, palbociclib, or ribociclib) to an AI (anastrozole or letrozole) significantly improved PFS, overall response rate, and clinical benefit rate in comparison with a nonsteroidal AI alone.

Epidemiology and Outcomes of Bloodstream Infections in Patients With Solid Tumors in a Central American Population at Mexico Hospital, San Jose, Costa Rica.

PURPOSE: Bloodstream infections (BSIs) are an important cause of mortality in patients with solid tumors. We conducted a retrospective study to evaluate the epidemiologic profile and mortality of patients with solid tumors who have BSIs and were admitted to Mexico Hospital. This is the first study in Costa Rica and Central America describing the current epidemiologic situation. METHODS: We analyzed the infectious disease database for BSIs in patients with solid tumors admitted to Mexico Hospital from January 2012 to December 2014. Epidemiology and mortality were obtained according to microorganism, antibiotic sensitivity, tumor type, and presence of central venous catheter (CVC). Descriptive statistics were used. RESULTS: A total of 164 BSIs were recorded, the median age was 58 years, 103 patients (63%) were males, and 128 cases of infection (78%) were the result of gram-negative bacilli (GNB). Klebsiella pneumoniae (21%), Escherichia coli (21%), and Pseudomonas aeruginosa (15%) were the most common microorganisms isolated. Gram-positive cocci (GPC) were found in 36 patients, with the most frequent microorganisms being Staphylococcus aureus (10%) and Staphyloccocus epidermidis (6%). With respect to tumor type, BSIs were more frequent in the GI tract (57%) followed by head and neck (9%) and genitourinary tract (8%). Regarding antibiotic susceptibility, only 17% (GNB) expressed extended-spectrum beta-lactamase and 12% (GPC) had methicillin resistance. Patients with CVCs (n = 59) were colonized mainly by GNB (78%). Overall the mortality rate at 30 days was about 30%. CONCLUSION: GNB are the most frequent cause of BSIs in solid tumors and in patients with CVCs. GI cancers had more BSIs than other sites. Mortality and antibiotic sensitivity remained stable and acceptable during this observational period in this Latin American population.

Liver Metastasectomy and Systemic Therapy Improve Overall Survival Compared With Surgery Alone After Curative Liver Resection of Colorectal Metastases in a Developing Country (Costa Rica).

BACKGROUND: Resection of liver-isolated metastases of colorectal cancer (CRC) offers the greatest likelihood of cure. Nevertheless, recurrence rates after this procedure are high, and chemotherapy is a reasonable choice with inconclusive evidence. We aimed to determine if there is a survival difference between patients receiving systemic therapy with surgery versus surgery alone for resection of liver metastases. METHODS: From a source population of 170 patients treated in our National Centre (Centro Nacional de Cirugía Hepatobiliar, San José, Costa Rica), with liver metastases from various primary sites, we selected 51 patients with CRC who underwent hepatic resection with curative intent. We categorized patients according to the treatment received (fluoropyrimidine-based chemotherapy plus or minus monoclonal antibody and surgery v surgery alone) and then calculated the overall survival (OS) rate according to the Kaplan-Meier method. A Cox proportional hazard model was used to assess the influence of potential confounding variables on OS. RESULTS: After a median follow-up of 41.6 months, OS was significantly better for patients treated with systemic therapy (before and/or after hepatic resection) versus surgery alone (3-year OS: 66.7% v 41.7%; hazard ratio, 0.37; 95% CI, 0.15 to 0.91; log-rank test: P = .025). There were no differences among patients who underwent neoadjuvant (48.7%), perioperative (46.2%), and adjuvant therapy (5.1%). The use of systemic therapy was significantly associated with better OS after adjustment for confounding variables (hazard ratio, 0.23; 95% CI, 0.07 to 0.92; P = .03). CONCLUSION: Our findings support the use of systemic therapy (either perioperative, neoadjuvant, or adjuvant) as part of isolated hepatic metastasectomy from CRC.