Effectiveness of Biologic Agents Among Hispanic Patients With Metastatic Colorectal Cancer.

BACKGROUND: Randomized clinical trials have defined the survival advantage with the addition of biologic drugs to chemotherapy in patients with metastatic colorectal cancer (mCRC). Under representation of Hispanics contributes to poorly defined outcomes in this group. We aim to determine whether the real-world benefit of biologics extends to Hispanics using a comparative effectiveness research approach. METHODS: This retrospective cohort study included all treatment centers contributing to SEER registry with available claims in the SEER-Medicare linked database (2001-2011) and 2 hospitals (2004-2016) catering to minorities. Metastatic CRC patients were classified as receiving chemotherapy or biochemotherapy (CT plus biologics; if initiated within 3 months of chemotherapy). The primary outcome was overall survival (OS) among the Hispanic patients calculated from time of administration of first dose of chemotherapy to death or last follow-up. A weighted Cox regression model was used to assess differences in survival. RESULTS: We identified 182 Hispanic patients with mCRC from the Patient Entitlement and Diagnosis Summary (PEDSF) file (n = 101) and hospital database (n = 81). Overall, 52% were women and 72% received biologics. The median OS was 11.3 and 17.0 months in chemotherapy and biochemotherapy group, respectively. Biochemotherapy offered a survival benefit compared with chemotherapy alone, with an average hazard rate reduction of 39% (95% CI 6%-60%, p = .0236) using inverse probability of treatment weighting (IPTW) based analysis. CONCLUSION: In this cohort of Hispanic patients with mCRC, biochemotherapy was associated with longer survival. Clinicians may offer biochemotherapy therapy to all patients regardless of race/ethnicity to maximize clinical benefit.

Effect of Medicaid Expansion in Reducing Racial Disparities in Early Onset Colorectal Cancer.

BACKGROUND: The burden of early onset colorectal cancer (EOCRC) falls disproportionately on minorities and individuals in specific geographic regions. While these disparities are likely multi-factorial, access to high-quality health care plays a significant role. We sought to determine if Medicaid expansion is associated with reducing racial disparities in EOCRC detection in Hispanics and non-Hispanic Blacks (NHB), compared to non-Hispanic Whites (NHW). METHODS: Analysis of data from National Cancer Database was undertaken to compare incidence of EOCRC among those aged 40-49 between Medicaid expansion states (ES) and non-expansion states (NES) by racial/ethnic groups. Data was classified by race (NHW, NHB, or Hispanic), state of residence (ES or NES), and time (pre- or post-expansion). The primary outcome was change in incidence rate of EOCRC among racial/ethnic groups, according to whether patients resided in Medicaid expansion or non-expansion states. RESULTS: Among Hispanics, the ES showed a significant increase in EOCRC incidence post expansion as compared to NES (p = 0.03). The rate of increase in annual incidence of EOCRC among Hispanics was 4.3% per year (pre-expansion) and 9.8% (post-expansion) for ES; and 6.4% (pre-expansion) and 1% (post-expansion) in NES. However, no difference was noted among NHB (p = 0.33) and NHW (p = 0.94). CONCLUSIONS: Medicaid expansion has improved detection rates of EOCRC in ES especially in Hispanic population. This is the first study to demonstrate the effect of Medicaid expansion on the incidence of EOCRC. Based on our study findings we suggest that racial and ethnic disparities should be considered in the earlier CRC screening debates.

Equitable Access to Clinical Trials: How Do We Achieve It?

The mismatch between the study populations participating in oncology clinical trials and the composition of the targeted cancer population requires urgent amelioration. Regulatory requirements can mandate that trial sponsors enroll diverse study populations and ensure that regulatory revue prioritizes equity and inclusivity. A variety of projects directed at increasing accrual of underserved populations to oncology clinical trials emphasize best practices: broadened eligibility requirements for trials, simplification of trial procedures, community outreach through patient navigators, decentralization of clinical trial procedures and institution of telehealth, and funding to offset costs of travel and lodging. Substantial improvement will require major changes in culture in the educational and professional practice, research, and regulatory communities and will require major increases in public, corporate, and philanthropic funding.

Induction Chemotherapy With FOLFIRINOX Followed by Chemoradiation With Gemcitabine in Patients With Borderline-Resectable Pancreatic Ductal Adenocarcinoma.

INTRODUCTION: Perioperative therapy is standard for patients with borderline-resectable pancreatic ductal adenocarcinoma (BR-PDAC); however, an optimal neoadjuvant regimen is lacking. We assessed the efficacy of FOLFIRINOX chemotherapy followed by gemcitabine-based chemoradiation as preoperative therapy. METHODS: Patients received 4 cycles of FOLFIRINOX, followed by 6-weekly gemcitabine with concomitant intensity-modulated radiation. The primary endpoint was the R0 resection rate. Secondary outcomes included resection rate, overall-response, overall survival (OS), progression-free survival (PFS), and tolerability. The trial was terminated early due to slow accrual. A Simon's optimal two-stage phase II trial single arm design was used. The primary hypothesis of treatment efficacy was tested using a multistage group sequential inference procedure. The secondary failure time analysis endpoints were assessed using the Kaplan-Meier procedure and the Cox regression model. RESULTS: A total of 22 patients enrolled in the study, 18 (81.8%) completed neoadjuvant treatment. The bias corrected R0 rate was 55.6% (90% CI: 33.3, 68.3; P value = .16) among patients that received at least 1 cycle of FOLFIRINOX and was 80% among patients that underwent surgery. The median OS was 35.1 months. The median PFS among patients that underwent surgery was 34 months. CONCLUSION: An R0 resection rate of 55.6% is favorable. Neoadjuvant FOLFIRINOX followed by concomitant Gemcitabine with radiation was well-tolerated. NCT01897454.

Whole-genome landscape of adult T-cell leukemia/lymphoma.

Adult T-cell leukemia/lymphoma (ATL) is an aggressive neoplasm immunophenotypically resembling regulatory T cells, associated with human T-cell leukemia virus type-1. Here, we performed whole-genome sequencing (WGS) of 150 ATL cases to reveal the overarching landscape of genetic alterations in ATL. We discovered frequent (33%) loss-of-function alterations preferentially targeting the CIC long isoform, which were overlooked by previous exome-centric studies of various cancer types. Long but not short isoform-specific inactivation of Cic selectively increased CD4+CD25+Foxp3+ T cells in vivo. We also found recurrent (13%) 3'-truncations of REL, which induce transcriptional upregulation and generate gain-of-function proteins. More importantly, REL truncations are also common in diffuse large B-cell lymphoma, especially in germinal center B-cell-like subtype (12%). In the non-coding genome, we identified recurrent mutations in regulatory elements, particularly splice sites, of several driver genes. In addition, we characterized the different mutational processes operative in clustered hypermutation sites within and outside immunoglobulin/T-cell receptor genes and identified the mutational enrichment at the binding sites of host and viral transcription factors, suggesting their activities in ATL. By combining the analyses for coding and noncoding mutations, structural variations, and copy number alterations, we discovered 56 recurrently altered driver genes, including 11 novel ones. Finally, ATL cases were classified into 2 molecular groups with distinct clinical and genetic characteristics based on the driver alteration profile. Our findings not only help to improve diagnostic and therapeutic strategies in ATL, but also provide insights into T-cell biology and have implications for genome-wide cancer driver discovery.

Comparative Effectiveness of Biologic Agents Among Black and White Medicare Patients in the US With Metastatic Colorectal Cancer.

Importance: Randomized clinical trials have defined the survival benefit provided by the addition of biologic drugs to chemotherapy in patients with metastatic colorectal cancer (mCRC). However, Black patients may be underrepresented in trial populations, and outcomes in this group remain poorly defined. Objective: To determine whether the real-world benefit of biologic drugs in Black patients is consistent with the real-world benefit of biologic drugs in White patients using a comparative effectiveness research approach. Design, Setting, and Participants: Population-based retrospective comparative effectiveness analysis of a cohort of patients aged 65 years or older with mCRC diagnosed between 2004 and 2011 who had received at least 1 dose of chemotherapy and had complete Medicare claims data using the Surveillance, Epidemiology, and End Result (SEER)-Medicare linked database. Data were analyzed from August 1, 2020, to March 31, 2021. Interventions: Patient data were classified according to whether patients received chemotherapy (oxaliplatin, irinotecan, and 5-fluorouracil or capecitabine) or biochemotherapy (bevacizumab, cetuximab, panitumumab, ramucirumab, or aflibercept, started within 3 months of chemotherapy). Main Outcomes and Measures: Overall survival (OS) defined as the time from starting chemotherapy to death or last follow-up. A weighted Cox regression model was used to assess differences in survival. Results: A total of 5617 patients with mCRC were identified in the SEER-Medicare linked database, and 4542 patients were included in the main analysis. Of the 5617 patients, 3969 (70.7%) received biologic agents at any point between 2004 and 2011; biologic agent therapy was started within 3 months of chemotherapy in 2894 patients (72.9%). Among 4542 patients with data on race and ethnicity, the median age was 72 years (IQR, 68-78 years), 2365 (52.0%) were female, 3445 (75.8%) had colon as the primary site, 552 (12.2%) were Black patients, and 3990 (87.8%) were White patients. There was no difference in the receipt of 1 (76.7% and 74.8%) vs 2 or more (23.3% and 25.2%: P = .92) lines of therapy, and in the receipt of biologic agents (63.6% vs 64.3% P = .33), among White patients and Black patients, respectively. Biochemotherapy was associated with a significant survival benefit compared with chemotherapy alone in the overall population (biochemotherapy median OS, 17.9 [95% CI, 17.3-18.7] months vs chemotherapy median OS, 8.3 [95% CI, 9.1-9.9] months; P < .001). The survival benefit was similar among White patients (17.8 vs 9 months; average hazard ratio, 0.59; 95% CI, 0.55-0.64; P < .001) and Black patients (18.6 vs 9.9; average hazard ratio, 0.58; 95% CI, 0.47-0.71; P < .001). Conclusions and Relevance: In this comparative effectiveness analysis of a cohort of Medicare recipients with mCRC, biochemotherapy was associated with an improvement in OS with a similar rate of reduction in mortality among Black and White patients. Clinicians may offer biochemotherapy therapy to all patients to maximize clinical benefit, factoring in clinical variables, but not their race.

Immune-Based Cancer Treatment: Addressing Disparities in Access and Outcomes.

Avoidable differences in the care and outcomes of patients with cancer (i.e., cancer care disparities) emerge or worsen with discoveries of new, more effective approaches to cancer diagnosis and treatment. The rapidly expanding use of immunotherapy for many different cancers across the spectrum from late to early stages has, predictably, been followed by emerging evidence of disparities in access to these highly effective but expensive treatments. The danger that these new treatments will further widen preexisting cancer care and outcome disparities requires urgent corrective intervention. Using a multilevel etiologic framework that categorizes the targets of intervention at the individual, provider, health care system, and social policy levels, we discuss options for a comprehensive approach to prevent and, where necessary, eliminate disparities in access to the clinical trials that are defining the optimal use of immunotherapy for cancer, as well as its safe use in routine care among appropriately diverse populations. We make the case that, contrary to the traditional focus on the individual level in descriptive reports of health care disparities, there is sequentially greater leverage at the provider, health care system, and social policy levels to overcome the challenge of cancer care and outcomes disparities, including access to immunotherapy. We also cite examples of effective government-sponsored and policy-level interventions, such as the National Cancer Institute Minority-Underserved Community Oncology Research Program and the Affordable Care Act, that have expanded clinical trial access and access to high-quality cancer care in general.

B7-H3 and PD-L1 Expression Are Prognostic Biomarkers in a Multi-racial Cohort of Patients with Colorectal Cancer.

BACKGROUND: Immunotherapy has emerged as an effective and durable treatment modality for solid cancers. However, its use in colorectal cancer (CRC) is limited to deficient mismatch repair (dMMR) tumors. As such, assessing immune regulatory proteins from the B7-CD28 family, other than PD-1, PD-L1, and CTLA-4, is critical. This study aimed to evaluate the expression of novel protein regulators in a racially diverse population of patients with CRC. METHODS: A tumor microarray was created for 214 samples from a multiracial patient population with metastatic CRC, and expression of HHLA2, B7-H3, PD-L1, CK7, CK20, and CDX2 was determined. The expression pattern was scored as 0 to 12, based on tumor tissue prevalence and the intensity. Clinical information was obtained by chart review and vital statistics from the National Death Index. Associations between low and high expression groups for each protein by race/ethnic groups were assessed, and Kaplan-Meier curves were plotted to evaluate association with survival. RESULTS: The median age at diagnosis was 61 years, with a female predominance. The majority of the patients were diagnosed with de novo metastatic disease with left-sided, moderately differentiated tumors. There were no racial disparities in the expression of any protein. Overall, a high frequency of tumors had no expression of B7-H3 (62.5%) or PD-L1 (43.5%). Low expression of both PD-L1 and B7-H3 was a significant prognostic biomarker associated with better survival (median overall survival, 43.3 months vs. 24.6 months; P < .01). CONCLUSION: In this multiracial tumor microarray of CRC samples, low PD-L1 and B7-H3 expression was associated with an improved prognosis. There was no significant variation among races with respect to the relevant CRC protein markers.

Racial/ethnic disparities in early-onset colorectal cancer: implications for a racial/ethnic-specific screening strategy.

INTRODUCTION: Early-onset colorectal cancer (EO-CRC) is a public health concern. Starting screening at 45 years has been considered, but there is discrepancy in the recommendations. Racial disparities in EO-CRC incidence and survival are reported; however, racial/ethnic differences in EO-CRC features that could inform a racial/ethnic-tailored CRC screening strategy have not been reported. We compared features and survival among Non-Hispanic White (NHW), Non-Hispanic Black (NHB), and Hispanics with EO-CRC. METHODS: CRC patients from SEER 1973-2010 database were identified, and EO-CRC was defined as CRC at <50 years. Clinical/pathological features and survival were compared between NHW, NHB, and Hispanics. Cancer-specific survival (CSS) predictors were assessed in a multivariable Cox proportional hazard model. RESULTS: Of 166,416 patients with CRC, 16,545 (9.9%) had EO-CRC. The EO-CRC frequencies in NHB and Hispanics were higher than NHW (12.7% vs. 16.5% vs. 8.7%, p < 0.001). EO-CRC in NHB presents more frequently in females, with well/moderately differentiated, stage IV, and is less likely to present in locations targetable by sigmoidoscopy than NHW (54.6% vs. 67.7% OR:1.7, 95% p < 0.001). 5-year CSS was lower in NHB (59.4% vs. 72.8%, HR: 1.7; 95% CI: 1.54-1.82) and Hispanics (66.4% vs. 72.8%, HR: 1.3; 95% CI: 1.16-1.39) than NHW. A regression model among patients with EO-CRC showed that being NHB or Hispanic were independent predictors for cancer-specific mortality, after adjusting for gender, grade, stage, and surgery. CONCLUSION: EO-CRC is more likely in NHB and Hispanics. Racial disparities in clinical/pathological features and CSS between NHB and NHW/Hispanics were evidenced. A racial/ethnic specific screening strategy could be considered as an alternative for patients younger than 50 years.

Case Fatality Rate of Cancer Patients with COVID-19 in a New York Hospital System.

Patients with cancer are presumed to be at increased risk from COVID-19 infection-related fatality due to underlying malignancy, treatment-related immunosuppression, or increased comorbidities. A total of 218 COVID-19-positive patients from March 18, 2020, to April 8, 2020, with a malignant diagnosis were identified. A total of 61 (28%) patients with cancer died from COVID-19 with a case fatality rate (CFR) of 37% (20/54) for hematologic malignancies and 25% (41/164) for solid malignancies. Six of 11 (55%) patients with lung cancer died from COVID-19 disease. Increased mortality was significantly associated with older age, multiple comorbidities, need for ICU support, and elevated levels of D-dimer, lactate dehydrogenase, and lactate in multivariate analysis. Age-adjusted CFRs in patients with cancer compared with noncancer patients at our institution and New York City reported a significant increase in case fatality for patients with cancer. These data suggest the need for proactive strategies to reduce likelihood of infection and improve early identification in this vulnerable patient population. SIGNIFICANCE: COVID-19 in patients with cancer is associated with a significantly increased risk of case fatality, suggesting the need for proactive strategies to reduce likelihood of infection and improve early identification in this vulnerable patient population.This article is highlighted in the In This Issue feature, p. 890.

World Health Organization (WHO) antibiotic regimen against other regimens for the treatment of leprosy: a systematic review and meta-analysis.

BACKGROUND: To evaluate the effectiveness and safety of the World Health Organization antibiotic regimen for the treatment of paucibacillary (PB) and multibacillary (MB) leprosy compared to other available regimens. METHODS: We performed a search from 1982 to July 2018 without language restriction. We included randomized controlled trials, quasi-randomized trials, and comparative observational studies (cohorts and case-control studies) that enrolled patients of any age with PB or MB leprosy that were treated with any of the leprosy antibiotic regimens established by the WHO in 1982 and used any other antimicrobial regimen as a controller. Primary efficacy outcomes included: complete clinical cure, clinical improvement of the lesions, relapse rate, treatment failure. Data were pooled using a random effects model to estimate the treatment effects reported as relative risk (RR) with 95% confidence intervals (CI). RESULTS: We found 25 eligible studies, 11 evaluated patients with paucibacillary leprosy, while 13 evaluated patients with MB leprosy and 1 evaluated patients of both groups. Diverse regimen treatments and outcomes were studied. Complete cure at 6 months of multidrug therapy (MDT) in comparison to rifampin-ofloxacin-minocycline (ROM) found RR of 1.06 (95% CI 0.88-1.27) in five studies. Whereas six studies compare the same outcome at different follow up periods between 6 months and 5 years, according to the analysis ROM was not better than MDT (RR of 1.01 (95% CI 0.78-1.31)) in PB leprosy. CONCLUSION: Not better treatment than the implemented by the WHO was found. Diverse outcome and treatment regimens were studied, more statements to standardized the measurements of outcomes are needed.

Epidemiology and survival trend of adult T-cell leukemia/lymphoma in the United States.

BACKGROUND: Globally, 5 million to 10 million people are infected with human T-cell leukemia virus type 1, which causes adult T-cell leukemia/lymphoma (ATLL) in 2% to 5% of the carriers. ATLL is a rare but extremely aggressive malignancy that can be challenging to diagnose. Very little data exist on the incidence patterns of ATLL in the United States. METHODS: ATLL cases reported to the National Program of Cancer Registries, the Surveillance, Epidemiology, and End Results (SEER) program, and the New York State Cancer Registry were used for the study. Age-adjusted incidence rates were calculated by age, race/ethnicity, sex, and year of diagnosis. The 5-year survival rate was compared among race/ethnicity groups with the SEER data. RESULTS: During 2001-2015, 2148 ATLL cases were diagnosed in the United States, 18% of which were in New York State. New York State had the highest incidence rate for ATLL, with a rising trend especially among non-Hispanic blacks (NHBs), whereas the incidence was stable across the remainder of the United States. NHBs were diagnosed at a younger median age (54 years) and had a shorter overall survival (6 months). In New York City, only 22.6% of the ATLL cases diagnosed were born in North America. CONCLUSIONS: This is the largest epidemiological study of ATLL in the United States and shows a rising incidence in New York City. NHBs have a younger age at presentation and poor overall survival. The rising incidence is largely due to NHBs originating from the Caribbean.

High prevalence of pulmonary findings in computed tomographies of HTLV-1-infected patients with and without adult-T cell leukemia/lymphoma - implications for staging.

Lung involvement has been reported in HTLV-1 carriers and in patients with ATLL. Whether there are differences in the pattern of lung involvement between ATLL and HTLV carriers in North American patients is unknown. We aimed to compare CT pulmonary findings among patients with HTLV-1 infection with and without ATLL. Among 140 patients with HTLV-1 diagnosis, 97 had CT chest available. Of these, 72 (74.2%) had ATLL and 25 (25.8%) did not have ATLL. CT chest abnormalities were present in 90 (92.8%) participants (94.4% in ATLL; 88% in non-ATLL). Higher rates of lymphadenopathy (69.4% versus 24%, p < .01) and lower rates of bronchiectasis (25% versus 48%, p = .04) were seen in ATLL compared to non-ATLL. Our study supports that staging of lung involvement in ATLL should consider HTLV-associated pulmonary findings as not all CT chest abnormalities necessarily represent malignant infiltration.

Barriers to Allogeneic Hematopoietic Stem Cell Transplantation for Human T Cell Lymphotropic Virus 1-Associated Adult T Cell Lymphoma-Leukemia in the United States: Experience from a Large Cohort in a Major Tertiary Center.

In the United States adult T cell lymphoma-leukemia (ATLL) carries a dismal prognosis and mainly affects immigrants from human T cell lymphotropic virus 1 endemic areas. Allogeneic hematopoietic stem cell transplant (alloHSCT) can be effective and is recommended as an upfront treatment in the National Comprehensive Cancer Network guidelines. We studied the barriers to alloHSCT in one of the largest ATLL populations in the United States. Comprehensive chart and donor registry reviews were conducted for 88 ATLL patients treated at Montefiore Medical Center from 2003 to 2018. Among 49 patients with acute and 32 with lymphomatous subtypes, 48 (59.5%) were ineligible for alloHSCT because of early mortality (52%), loss to follow-up (21%), uninsured status (15%), patient declination (10%), and frailty (2%). Among 28 HLA-typed eligible patients (34.6%), matched related donors were identified for 7 (25%). A matched unrelated donor (MUD) search yielded HLA-matched in 2 patients (9.5%), HLA mismatched in 6 (28.5%), and no options in 13 (62%). Haploidentical donors were identified for 6 patients (46%) with no unrelated options. There were no suitable donors for 7 (25%) alloHSCT-eligible patients. The main limitation for alloHSCT after donor identification was death from progressive disease (82%). AlloHSCT was performed in 10 patients (12.3%) and was associated with better relapse-free survival (26 versus 11 months, P = .04) and overall survival (47 versus 10 months, P = .03). Early mortality and progressive disease are the main barriers to alloHSCT, but poor follow-up, uninsured status, and lack of suitable donor, including haploidentical, are also substantial limitations that might disproportionally affect this vulnerable population. AlloHSCT can achieve long-term remissions, and strategies aiming to overcome these barriers are urgently needed to improve outcomes in ATLL.

Natural history and clinical outcomes in patients with portal vein thrombosis by etiology: A retrospective cohort study.

BACKGROUND: Portal vein thrombosis (PVT) is an unusual-site thrombosis commonly encountered in patients with malignancies, cirrhosis, and acute abdominal inflammatory conditions (AIC). Current recommendations suggest that anticoagulation may improve recanalization rates but there is limited information on venous thromboembolism (VTE) recurrence rates and whether the etiologies of PVT respond similarly with anticoagulation. OBJECTIVE: To characterize the natural clinical course and outcomes of patients diagnosed with PVT based on etiology. PATIENTS/METHODS: Patients with a diagnosis of PVT between 2005 and 2015 who were followed for at least one year and had revised imaging at 12 months ±â€¯3 months were identified. Comorbidities, demographics, anticoagulation choice and clinical outcomes including VTE recurrence, cavernous transformation, PVT recanalization, progression and mortality were obtained. RESULTS: Of 698 patients diagnosed with PVT, 85 patients were evaluable according to criteria: 54 had cirrhosis (63.5%), 15 malignancy (17.6%) and 16 AIC (18.8%). Mean age was 55.6 ±â€¯13.1 years. At presentation, 40% patients were symptomatic and 29.4% received anticoagulation. Patients with AIC were anticoagulated more frequently compared to those with malignancy or cirrhosis (87.5% vs. 33.3% vs. 11.1%). Overall, patients with cirrhosis had lower rates of PVT progression (0% vs. 13.3%, p = 0.02) and patients with AIC had higher rates of cavernous transformation compared to cirrhosis or malignancy-associated PVT (31.3% vs. 7.4% vs. 0%, p = 002). Among untreated patients, those with malignancy had significantly higher rates of VTE recurrence and PVT progression than patients with cirrhosis (20% vs. 4.2% and 20% vs. 0%). CONCLUSIONS: The natural course of PVT differs among etiologies. In the absence of anticoagulation, patients with malignancy are more prone to VTE recurrence and PVT progression compared to patients with cirrhosis. Given the high rate of VTE recurrence at 12 months in patients with malignancy-associated PVT, anticoagulation should be considered for this group.

Perspectives, Decision Making, and Final Mode of Delivery in Pregnant Women With a Previous C-Section in a General Hospital in Peru: Prospective Analysis.

Objective: Explore the perspectives, decision-making process, and final mode of delivery among pregnant women with a previous C-section (Cesarean section) in a general public sector hospital in Lima, Peru. Methods: A qualitative prospective study using semistructured interviews at two time points in the outpatient obstetrics and gynecology clinic of a public sector, university-affiliated reference hospital in Lima, Peru. Seventeen adult pregnant women with a prior C-section who were deemed by their attending obstetrician to be candidates for a trial of labor were interviewed. The first interview was between 37 and 38 weeks of pregnancy, and the second interview was 24 to 48 hours after delivery. MAIN OUTCOME MEASURES: Predelivery decision-making process and final mode of delivery. Results: Among the 17 participants, about half (9) of the participants stated that the physician explained that they had two approaches for delivery, a trial of labor after C-section (TOLAC) or elective repeated C-section (ERCD). Two women stated that their respective providers explained only one option, either an ERCD or TOLAC. However, 6 women did not receive any information from their providers about their delivery options. Of the 10 participants that decided TOLAC, 8 ended up having a C-section, and of the 7 patients that had planned an ERCD, 1 ended up having a vaginal delivery. Conclusion: Many participants affirmed that they made the decision about their approach of delivery. However, most of the participants that decided a TOLAC ended up having a C-section because of complications during the final weeks of pregnancy or during labor.

Low HDL cholesterol as a cardiovascular risk factor in rural, urban, and rural-urban migrants: PERU MIGRANT cohort study.

INTRODUCTION: Whilst the relationship between lipids and cardiovascular mortality has been well studied and appears to be controversial, very little has been explored in the context of rural-to-urban migration in low-resource settings. OBJECTIVE: Determine the profile and related factors for HDL-c patterns (isolated and non-isolated low HDL-c) in three population-based groups according to their migration status, and determine the effect of HDL-c patterns on the rates of cardiovascular outcomes (i.e. non-fatal stroke and non-fatal myocardial infarction) and mortality. METHODS: Cross-sectional and 5-year longitudinal data from the PERU MIGRANT study, designed to assess the effect of migration on cardiovascular risk profiles and mortality in Peru. Two different analyses were performed: first, we estimated prevalence and associated factors with isolated and non-isolated low HDL-c at baseline. Second, using longitudinal information, relative risk ratios (RRR) of composite outcomes of mortality, non-fatal stroke and non-fatal myocardial infarction were calculated according to HDL-c levels at baseline. RESULTS: Data from 988 participants, rural (n = 201), rural-to-urban migrants (n = 589), and urban (n = 199) groups, was analysed. Low HDL-c was present in 56.5% (95%CI: 53.4%-59.6%) without differences by study groups. Isolated low HDL-c was found in 36.5% (95%CI: 33.5-39.5%), with differences between study groups. In multivariable analysis, urban group (vs. rural), female gender, overweight and obesity were independently associated with isolated low HDL-c. Only female gender, overweight and obesity were associated with non-isolated low HDL-c. Longitudinal analyses showed that non-isolated low HDL-c increased the risk of negative cardiovascular outcomes (RRR = 3.46; 95%CI: 1.23-9.74). CONCLUSIONS: Isolated low HDL-c was the most common dyslipidaemia in the study population and was more frequent in rural subjects. Non-isolated low HDL-c increased three-to fourfold the 5-year risk of cardiovascular outcomes.

Adherence to pharmacotherapy and medication-related beliefs in patients with hypertension in Lima, Peru.

OBJECTIVE: To characterize adherence to pharmacological medication and beliefs towards medication in a group of patients with hypertension in a large national hospital. MATERIALS AND METHODS: Cross-sectional survey among patients with hypertension attending the outpatient clinic of a large national hospital. Exposure of interest was the patient's beliefs towards general medication and antihypertensive drugs, i.e. beliefs of harm, overuse, necessity and concern, measured using the Beliefs about Medication questionnaire. Main outcome was adherence measured using the Morisky Medication Adherence Scale-8. Multivariate analysis was conducted using Poisson distribution logistic regression, prevalence ratios and 95% confidence intervals were calculated. RESULTS: Data from 115 participants, 67% females and mean age 62.7 years were analyzed. Low adherence was found in 57.4%. Highest scores were on the ideas of necessity and one of the most rated statements was "physicians would prescribe less medication if they spent more time with patients". Beliefs of harm about medications and concerns about antihypertensive drugs were higher in the low adherence group (p<0.01). Those who scored higher on ideas of harm were 52% less likely of being high adherents (PR 0.48; 95% CI 0.25-0.93) and those with higher scores on concerns were 41% less likely of being high adherents (PR 0.59; 95% CI 0.39-0.91). Patients whose ideas of necessity outweighed their concerns were more likely to be adherent (PR 2.65; 95% CI 1.21-5.81). CONCLUSIONS: Low adherence to antihypertensive medication is common. High scores on ideas of harm, concern and a high necessity-concern differential were predictors of medication adherence.