Lung cancer is a leading cause of cancer-related deaths in Latin America, with non-small cell lung cancer (NSCLC) being the most prevalent. The current study aimed to report real-world data on ...epidermal growth factor receptor (EGFR) mutational testing and treatment regimens at diagnosis and progression in patients with metastatic NSCLC across four Latin American countries (Argentina, Chile, Colombia and Uruguay). A retrospective, multicenter, observational study was conducted in patients with NSCLC using medical records from participating countries. The study population was categorized into two cohorts: Cohort 1 comprised of newly diagnosed, treatment-naive patients with stage IV NSCLC; and cohort 2 comprised of stage IV NSCLC EGFR mutation (EGFRm)-positive patients who had progressed after first- or second-generation EGFR-tyrosine kinase inhibitor (TKI) treatment. Measures included demographic variables, health characteristics, treatment regimen, molecular testing rate and turnaround time at diagnosis and at progression for cohorts 1 and 2, respectively. Descriptive statistics were used to summarize all study measures. Of the 462 patients enrolled, 431 were newly diagnosed or treatment naive with metastatic NSCLC. In cohort 1, the majority of patients with private health insurance (57.31%) underwent molecular diagnosis while only 41.3% of patients within the public sector had access to testing. The average molecular testing rate in cohort 1 varied across countries, with Argentina having the highest testing rate (79%) and Uruguay the lowest (27.63%). EGFRm was observed in 22% of patients. Cohort 2 comprised 31 patients who had progressed after first- or second-generation EGFR-TKI treatment and of these, only 22 (70.97%) underwent testing after progression. Access to molecular testing is still a challenge impacting the choice of first-line treatment in Latin American patients with NSCLC. These findings underline the unmet needs of ensuring early diagnosis, molecular profiling and use of correct treatment to alleviate NSCLC burden in the region. Key words: lung cancer, epidermal growth factor receptor, non-small cell lung cancer, Latin America, tyrosine kinase inhibitor
Malaria remains a global health burden. Elimination of the hypnozoite is required in patients infected with
P. vivax
to prevent relapse. In this report, the safety of a single dose of tafenoquine was ...similar to that of a 14-day course of primaquine in patients with normal G6PD activity.
Introduction. Acute myeloid leukemia (AML) is the most frequent leukemia among adults and representing 90% of all cases of acute leukemia in adults. Differences in incidence and burden of AML among ...regions of the world have been reported. When compared with registries from the US, UK and Sweden, Latin-America (LA) AML has a younger age at diagnosis (median age of 40-47 versus 64 -67 years old). Furthermore, single center studies have suggested poor treatment outcomes in LA. For example, Silveira et al reported a median age at diagnosis of 46 y, frequency of favorable cytogenetics of 26% and median overall survival (mOS) of 12 months in the Brazilian cohort of patients with newly diagnosed AML (nAML) whereas the respective values at Oxford University were 51.5y, 11% and 48 months in British patients. However, wider studies across the region are scarce and there is a need to further explore AML patient characteristics and treatment outcomes in LA. Methods. This is a non-interventional, retrospective multicenter study that aims to describe the epidemiology, clinical and demographic characteristics, treatment patterns, survival outcomes and healthcare resource use of adult patients with nAML in Argentina, Brazil, Chile, and Colombia. Data from medical records of eligible patients that met the inclusion criteria (≥ 18 years old at diagnosis, confirmed diagnosis of nAML between 01 January 2015 and 31 December 2019, and receiving at least one line of treatment) in these LA countries were considered for the analysis, which was descriptive in nature as no hypothesis has been tested. Results: A total of 518 nAML patients were included in the study, 166 from Argentina, 205 from Brazil, 63 from Chile, and 84 from Colombia. Table 1 shows the demographics and clinical characteristics. At treatment initiation, an evaluation of fitness (eligibility) for intensive chemotherapy was available for 94% of the patients (n=489). The majority were considered fit (75.5%; n=391) and received standard 7+3 therapy. About 11% of patients (n=9) were refractory to induction therapy. Median OS for fit patients was 11.9 months, whereas for unfit patients was 5.8 months. Mutational status of genes listed by the European LeukemiaNet (ELN) Classification of 2017 was not available for the majority of cases; risk categories were assigned based on cytogenetics. Patients in the favorable-risk category had a mOS of 30.5 months, whereas those in the intermediate- and unfavorable-risk had 11.1 and 9.1 months, respectively (Figure 1). The probability of 5year OS rates for favorable, intermediate- and unfavorable-risk groups were of 38.8%, 16.6% and 20.9%, respectively. Eighty-six patients (17%) discontinued treatment with reasons being adverse event/toxicity (33%; n=28), death (32%; n=27), and disease progression (17%; n=14). Only 24% of patients (n=125) underwent a subsequent stem cell transplantation (SCT), mainly allogenic (98%; n=121). For SCTs, identical (matched) related (50%; n= 59) and haploidentical donor (35%; n=41) were the most common. Patients not eligible to intensive chemotherapy were treated with HMA (9%; n=47) and LDAC (5%; n=25), with 10% of the patients receiving palliative/supportive care. The most common treatment protocols used in relapsed or refractory (R/R) patients were high-dose cytarabine (HDAC) (31%; n=85), followed by FLAG-IDA (24%; n=66). Conclusions: This study of newly diagnosed acute leukemia characterizes real-world treatment patterns and outcomes in LA clinical practices. Prior to this study, there has been limited published data on the epidemiology and treatment patterns across LA. This study highlights that for nAML patients, the most common treatment in LA is 7+3 and most patients are classified as fit. The vast majority of patients had their risk accessed by cytogenetics analysis only, reflecting the limited access to molecular tests. Fewer patients underwent stem cell transplantation as part of the treatment compared to that reported in US and Europe, probably due to restricted availability of hospital beds dedicated to bone marrow transplantation. When evaluating the overall survival, the study shows higher mOS for favorable risk. In addition, mOS for intermediate and poor cytogenetic risk were similar. A broader access in the region to molecular tests, transplant and new therapies are needed in order to reduce the gap in outcome, especially for patients with intermediate-risk.
Introduction. Acute lymphoblastic leukemia (ALL) frequently affects mainly children and young adults. ALL has seen important progresses in diagnosis techniques and treatment approaches in the last ...decade. However, in some developing countries, there are inequalities in ALL management, such as heterogeneous access to diagnosis technologies (e.g., cytogenetic and molecular profiling) and access to target therapies treatments. To date, there is scarce data on those impacts in treatment patterns and real-world outcomes of adult relapsed/refractory (R/R) B-cell ALL (R/R ALL) patients in Latin America (LA). Therefore, this study aims to describe treatment patterns, clinical characteristics, and outcomes of R/R ALL adult patients treated in LA. Methods. This was a retrospective multicenter non-interventional study to evaluate treatment patterns, clinical characteristics and outcomes conducted in Argentina, Brazil, and Colombia. The study included patients ≥ 18 years old at diagnosis with confirmed R/R ALL between January 1, 2015, to December 31, 2019 that received at least one line of treatment for R/R ALL. Data collected from medical records was considered for the analysis, which was descriptive in nature, as no hypothesis has been tested. Results: A total of 71 patients diagnosed with R/R ALL were included in the study (23 from Argentina, 27 from Brazil, and 21 from Colombia). Table 1 shows the demographics and clinical characteristics. The median age at diagnosis was 31 years (Q1-Q3: 24.0-46.0), 56.3% were male, and 50% were White/Caucasian patients. At diagnosis, the most common comorbidities were diabetes, hypertension, gastrointestinal disease, and thyroid disease, with 11% each. At diagnosis, most patients presented with poor or intermediate cytogenetic risk prognosis, in 55.1% and 31.6%, respectively. Most of the patients presented with good performance status, 50.9% ECOG 0 and 36.8% ECOG 1. As for treatment patterns, patients received up to six treatment lines (LOT-1 to LOT-6), with a median of 2.0 LOTs (Q1-Q3: 1.5-3.0) within the R/R setting. Fifty-three (74.6%) out of the 71 patients enrolled in the study received two lines of R/R treatment (up to LOT-2), and 27 patients (38%) received 3 lines (up to LOT-3). The median treatment duration of LOTs were 3.4 months (Q1-Q3: 1.14 - 5.7), 1.4 months (Q1-Q3: 0.62 - 2.6) and 0.9 months (Q1-Q3: 0.4 - 2.1) for LOT-1, -2 and -3, respectively. The most frequently used treatment regimens at LOT-1 were the Hyper-CVAD (22.9%), BFM (20.0%) and GRAAL (15.7%). The most reported reasons for patients discontinuing their regimen in LOT-1 were progression of disease (37.5%), followed by adverse events (25%). For LOT-2 discontinuation, adverse events and/or toxicity (33.3%) were most frequently reported, followed by progression of the disease (25%). Of the total number of R/R ALL patients, 26 (36.6%) underwent stem cell transplantation (SCT), with a median time from diagnosis to transplantation of 9.6 months. All those patients (n=26) received allogeneic hematological SCT (100%), and haploidentical donors were most common (42.3%), followed by identical (matched) related (34.6%), mismatched unrelated donor (15.4%), and identical (matched) unrelated donors (7.7%). For R/R ALL patients, the median overall survival (mOS) was 18.96 months, with a probability of survival of 66.6% at 1 year, 32.3% at 3 years, and 16.2% at 5 years. Philadelphia Chromosome (Ph) molecular results were reported in 53 patients: 38 (71.7%) were Ph- and 15 (28.3%) were Ph+. The mOS in Ph+ patients was 31.5 months, numerically longer than the 17.7 months seen in Ph- patients (p = 0.500); however, the Kaplan-Meiers crossed over and separation was not clearly evident within the follow-up period (Figure 1). Conclusions: This study enabled a better understanding of R/R ALL in LA in the real-world. Data from this study demonstrate the high heterogenicity within first salvage (LOT-1) treatment patterns in R/R ALL, likely due to no established single standard of care in the region and highlights that only a fraction of the patients undergo SCT, which should be the treatment goal following induction therapy. In addition, our study reinforces already published data that overall survival on R/R ALL adult patients remain poor. Consistent guidelines and access to new treatments and are needed to remove inequalities in the management of ALL in LA.
Introduction: The incidence of multiple myeloma (MM) has been increasing globally (Institute for Health Metrics and Evaluation ; Cancer Research UK 2021), particularly in high-income countries ...(Ferlay J et al. (2020); Cowan et al. 2018). However, low-income countries, including Colombia, have also experienced a progressive increase in new cases (Fondo Colombiano de Enfermedades de Alto Costo. Cuenta de Alto Costo (CAC) ; Martínez Cordero et al. 2020). In the context of MM, the duration of progression free survival decreases after each relapse rendering as highly important the election of and adequate treatment (Yong et al. 2016), yet there is a lack of local data on patients experiencing a second relapse in Colombia to guide these decisions. This study aims to characterize Colombian patients with MM in second relapse, the current treatment patterns, and assess clinical response to address this knowledge gap. Methods: An observational retrospective study was conducted, utilizing chart review data from five specialized cancer treatment institutions in Colombia. Adult MM patients with diagnosed second relapse between January 1, 2013 and June 30, 2021 who had received at least two prior lines of treatment including lenalidomide and a proteasome inhibitor were included. Patients receiving only palliative care were excluded. Data on the effectiveness and safety of treatment patterns were collected from the start of the second relapse treatment pattern until the occurrence of treatment withdrawal, death, initiation of treatment pattern for third relapse diagnosed, loss of follow-up or study cutoff date (June 30, 2022), whichever happened earlier. The main outcomes were progression free survival (PFS), time to treatment failure (TTF), overall survival (OS), and overall response rate (ORR). All variables were analyzed descriptively utilizing appropriate statistics measures such as, means or medians, with corresponding standard deviation or interquartile range for continuous variables, and frequencies and percentages for categorical variables. OS was determined using the Kaplan-Meier method. Results: A total of 84 Patients were included from 5 centers in 3 of the Colombian regions (Andean, Pacific and Caribbean), 47 (56%) were male. The mean age at the time of MM diagnosis was 62.3 (SD 11.7) years. On average, the time from initial diagnosis to the occurrence of the second relapse was 3.6 (SD 2.1, min: 0.6 max: 11.2) years. The most frequent type of relapse observed was biochemical relapse, accounting for 42 cases (51%). Immunoglobulin levels were used as biomarkers, with IgA M-protein (g/dL) measuring 0.7 (SD 2.8, min:0 max: 16.2) and IgG M-protein (g/dL) measuring 31.8 (SD 185.4, min 0, max: 1,144.3). Furthermore, 41 patients (49%) exhibited bone lesion as a sign of second relapse. The most frequent treatments received for second relapse included lenalidomide 33 (14.7%), carfilzomib 29 (12.9%), bortezomib 23 (10.3%) and daratumumab 22 (9.8%). Among the patients who received lenalidomide, 87.9% had received bortezomib as first-line therapy, while 18.2% leniladomide. Conversely, 75.8% had received lenalidomide as second-line therapy, and 45.5% bortezomib. Table 1 displays the main outcomes according to the treatment received. Regardless of the treatment, the average PFS was 12.7 (IQR 3.7-23.4) months, the TTF was 5.3 (IQR 1.9-12.9) months, and the ORR was 47.1%. Figure 1 illustrates the OS, revealing that at 27.5 months 50% of the study population had either died (21, 25%) or been censored (21, 25%). Treatment-emergent adverse events (TEAE) were reported in 10 patients (11.9%). The most frequent TEAE were anemia and neutropenia, reported in 2 patients. At the end of study cut off 21 patients (25%) had died, 8 (9.5%) had discontinued treatment, 42 (50%) had a third relapse, 4(4.8%) were lost to follow-up, 9 (10.7%) were still undergoing treatment. Conclusions: The FreedoMM study is the first to our knowledge, to describe comprehensively the characteristics, treatment patterns, and clinical response of Colombian patients experiencing a second relapse of MM. The study highlights the poor outcomes observed in this specific population. Indeed, the study underscore the clear necessity for additional research and the development of treatment guidelines tailored specifically to patients in their second of MM in Colombia and other similar countries.
Nivolumab is a human programmed death receptor-1 blocking antibody, used as treatment option in patients with advanced non-small-cell lung cancer (NSCLC). We assessed the nivolumab efficacy in terms ...of survival and response to treatment as second-line (2L) or third-line (3L) therapy in patients with advanced NSCLC. This is a multicentric observational study. Data of patients with advanced NSCLC who received nivolumab as 2L or 3L treatment were analyzed retrospectively. Information regarding patient demographics and clinical backgrounds, treatment patterns from diagnosis to post-nivolumab treatment, effectiveness, and safety of nivolumab treatment were collected. The outcomes evaluated were overall survival (OS), progression-free survival (PFS), and objective response rate (ORR) to treatment. OS and PFS were estimated with the Kaplan-Meier method and the differences were evaluated through the log-rank test. Data of 178 patients were included. The median follow-up was 26.8 months (interquartile range (IQR): 20.3-40.4). Nivolumab was commonly used as a 2L treatment (77.5%). The outcomes in this setting (2L) were as follows: ORR was 21.0%, and the median PFS and OS were 5.5 months (95% confidence interval (CI): 4.5-6.5) and 12.4 months (95% CI: 10.8-14.0), respectively. In 3L, the ORR with nivolumab was 15.0%, the median PFS and OS were 4.1 months (95% CI: 3.1-5.1) and 10.1 months (95% CI: 9.4-10.6), respectively. Three patients (1.7%) required discontinuation due to toxicity. Nivolumab effectiveness and safety in this scenario was consistent with that reported by previous trials and other real-world data.
In Colombia, all paid workers earning minimum wage or higher contribute part of their salary for access to the national health-care system through a type of insurance called contributive plan, which ...supports the remaining low-income population that is enrolled on the subsidised plan. During the COVID-19 pandemic, Colombia documented high mortality rate in patients with cancer, with higher mortality among low-income patients, according to data from our national registry of COVID-19 infection in patients with cancer. The aim of this research was to establish the differential access to COVID-19 vaccination depending on health insurance type, and its impact on mortality due to COVID-19 infection.
A cohort study was conducted with data from the Colombian National Cancer and COVID-19 Registry. Data were collected between June 1, 2021, when COVID-19 vaccines became available for patients with cancer in Colombia, and Oct 31, 2021. Included patients were aged 18 years or older, had a diagnosis of a solid tumour, were receiving active treatment or on follow-up, and had a confirmed SARS-CoV-2 infection. The cumulative incidence of mortality in the vaccinated and unvaccinated cohorts was compared. The estimation of the effect was done through relative risk (RR), and a multivariate analysis (generalised linear model, binomial family) was then done to estimate the effect of the type of health insurance.
896 patients were included. 470 (52%) were older than 60 years; 530 (59%) were women and 366 (41%) were men. 172 (19%) patients were vaccinated and 724 (81%) patients were not vaccinated (resulting in a ratio of 1:4). According to the type of health insurance, the vaccine was administered to 26 (12%) of 211 patients in the subsidised plan and to 146 (21%) of 685 patients in the contributive plan. The rate of vaccination according with socioeconomic status was 69 (16%) of 430 patients in the low-income group, 75 (23%) of 329 in middle-income group, and 12 (29%) of 42 in high-income group. The cumulative incidence of mortality for all causes was 17% (n=123) in the non-vaccinated cohort and 5% (n=8) in vaccinated cohort. The cumulative incidence of mortality per health-care insurance was 24% (n=50) in the subsidised plan and 12% (n=81) in the contributive plan. The adjusted RR for mortality was 3·4 (95% CI 1·7–6·8) in unvaccinated versus vaccinated patients, and 1·8 (1·3–2·4) in patients on the subsidised versus the contributive plan.
Patients on the subsidised health plan in Colombia had higher mortality due to COVID-19 infection and less access to vaccines than patients with a contributive plan. Strategies to promote COVID-19 vaccination for all patients with cancer should be strengthened, with implementation of special measures to improve care for the low-income population.
None.
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Background: According to results of previous ACHOC-C19 study, mortality in patients with cancer and COVID 19 infection in Colombia is 26%. The impact of vaccination was not evaluated prior to ...the implementation of this strategy worldwide in patients with cancer. We aimed to characterize SARSCOV 2 infection in a local cohort of vaccinated oncologic patients. Methods: The ACHOCC-19 VAC registry is a national multi-center observational cohort study. Data were collected between April 2021 and March 2022. Inclusion criteria were: age more than 18 years, confirmed diagnosis of cancer (solid tumors), be receiving treatment or being followed-up and have received at least one dose of COVID-19 vaccine. 11 oncologists from 10 health institutions participated. The primary outcome was 30 days mortality due to COVID 19 infection. Secondary outcome was to describe adverse effects related to vaccination. A descriptive univariate and inferential analysis were performed. Results: 720 patients were included, average age was 60 years, 91% lived in urban areas, 12% had low income. 73% (525) were women. The most frequent diagnosis were: breast cancer 47% (338), prostate cancer 7% (50) and lung cancer 4.6% (36). ECOG 0-1 and 2 in 91.7% and 6.1% of population respectively. 41.40% had no comorbidities and 59.4% had 1 or more comorbidity. 29.1% presented metastatic cancer, 59.3% were receiving oncological treatment of which, 32.7% were neoadjuvant or adjuvant and 28.6% palliative. 31.66% were being followed up without treatment. 32.6% had stable disease and 5.9% had cancer in progression. Administered vaccines were CoronaVac (40%), BNT162b2 (35%) others 25%, in accordance with initial availability of vaccines for oncologic population in Colombia. 93.9% of population received 2 doses. COVID19 infection was acquired by 35.9% of the population, 30 days mortality due to infection was 3%. Table 1. Frequency of adverse effects with first and second dose were 14.8% and 12.2%, mild intensity in 93% and 100% respectively, being myalgias (5%), arthralgias (2-3%) and fever (3.5%) the most frequent. Conclusions: In our population, the efficacy of the vaccine against COVID 19 is consistent with available reports in the scientific literature. The incidence of 30 days mortality due to SARCOV 2 infection is very low. Vaccine-related adverse effects had frequency of less than 15% and mild intensity. These findings reinforce the need to promote and intensify vaccination in the oncologic patients. Table: see text Table: see text
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Background: In our experience during the first year of development of ACHOC-C19 study, we observed 26% mortality in patients with cancer and COVID 19 infection. The impact of vaccination was ...not evaluated prior to the implementation of this strategy worldwide in this kind of population. It was proposed to evaluate the effectiveness of immunization during the second phase of our investigation. Methods: Cohort study derived from the National Registry of Patients with Cancer and COVID-19 (ACHOCC-19). Data were collected from June 2021 since vaccine was available. Patients were: older than 18 years, diagnosed with cancer (solid tumors), treated and/or under follow-up, and with COVID-19 infection. The comparative analysis of the vaccinated and non-vaccinated cohort is presented. Outcomes included: all-cause mortality within 30 days of infection diagnosis, hospitalization, and mechanical ventilation. Effect estimation was performed through relative risk (RR) and multivariate analysis for each event, using generalized linear models of the binomial family. Results: 896 patients were included, 470 were older than 60 years (52.4%) and 59% women (n = 530). 172 patients were recruited in the vaccinated cohort and 724 in the non-vaccinated cohort (ratio: 1 to 4.2). The cumulative incidence of hospitalization among the unvaccinated was 42.4% (n = 307), and among the vaccinated, 29% (n = 50); invasive mechanical ventilation requirement was 8.4% (n = 61) in unvaccinated, and 4.6% (n = 8) in vaccinated. The cumulative incidence of mortality from all causes in the unvaccinated was 17% (n = 123) and in the vaccinated 4.65% (n = 8). Table summarizes the multivariate analysis. The adjusted RR for mortality for the unvaccinated is 3.4 (95% CI: 1.7-6.8), for hospitalization 1.36 (95% CI: 1.08-1.72), and for mechanical ventilation 2.1 (95% CI: 1.02-4.2). Conclusions: The incidence of complications and death in patients with cancer and COVID-19 infection is significantly higher in those who have not received a vaccination schedule compared to those who have been vaccinated. Immunization should be promoted and intensified in this population group.Table: see text
Introduction: During the pandemic, it has been recommended that vaccination against COVID-19 be a priority for patients with cancer; however, these patients were not included in the initial studies ...evaluating the available vaccines. Objective: To define the impact of vaccination against COVID-19 in preventing the risk of complications associated with the infection in a cohort of patients with cancer in Colombia. Methods: An analytical observational cohort study, based on national registry of patients with cancer and COVID 19 infection ACHOC-C19, was done. The data was collected from June 2021, until October 2021. Inclusion criteria were: Patients older than 18 years with cancer diagnosis and confirmed COVID-19 infection. Data from the unvaccinated and vaccinated cohorts were compared. Outcomes evaluated included all-cause mortality within 30 days of COVID-19 diagnosis, hospitalization, and need for mechanical ventilation. The estimation of the effect was made through the relative risk (RR), the absolute risk reduction (ARR) and the number needed to treat (NNT). Multivariate analysis was performed using generalized linear models. Results: 896 patients were included, of whom 470 were older than 60 years (52.4%) and 59% were women (n=530). 172 patients were recruited in the vaccinated cohort and 724 in the non-vaccinated cohort (ratio: 1 to 4.2). The cumulative incidence of clinical outcomes among the unvaccinated vs vaccinated patients were: for hospitalization 42% (95% CI: 38.7%-46.1%) vs 29%; (95% CI: 22.4%-36.5%); for invasive mechanical ventilation requirement 8.4% (n=61) vs 4.6% (n=8) and for mortality from all causes 17% (n=123) vs 4.65% (n=8). Conclusion: In our population, unvaccinated patients with cancer have an increased risk of complications for COVID -19 infection, as hospitalization, mechanical ventilation, and mortality. It is highly recommended to actively promote the vaccination among this population.
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