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BACKGROUND: Transbulbar sonography for measuring optic nerve sheath diameter (ONSD) is noninvasive bedside technique for detection of raised intracranial pressure. This study aims to evaluate the number of sonographic evaluations required for a novice operator to learn proper measurement of ONSD after a formal training and supervised scanning session. METHODS: Three novice operators and one expert operator measured ONSD of 27 healthy volunteers using linear array transducer HFL38x (frequency range of 6-13 MHz) (MicroMaxx®; SonoSite, USA). In each eye, ONSD was measured three times by each observer and mean value was determined. Correlation coefficient was calculated between the novice and the experienced operator and in between the novice operators. Number of scans, after which the significant correlation developed between novice and the experienced operator and between the novice operators, was analyzed. RESULTS: Cronbach's alpha was tested to evaluate the reliability of the values obtained from intra- and interobservations. For all 27 cases, the value of Cronbach's alpha was high: 0.80-0.99 for the right eye and 0.69-0.97 for the left eye. The mean interobserver variations were plotted on a graph which fluctuated largely in the first 17 cases but oscillated around 0.5-0.30 in the last 10 cases. CONCLUSION: Learning curve for novice operators to measure ONSD is steep and they can be taught to measure ONSD in healthy volunteers by sonography in supervised clinical session with an acceptable clinical precision and accuracy comparable to an experienced operator.
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Cerebral venous thrombosis (CVT) is an uncommon cause of stroke. Paroxysmal nocturnal hemoglobinuria (PNH) is a rare type of hemolytic anemia, frequently associated with thrombophilia. PNH may rarely present with CVT. Approximately, one-third of the patients with CVT develop cerebral hemorrhage. Here, we present a rare combination of CVT presenting with intracerebral hemorrhage in a patient with PNH. High index of suspicion is needed to avoid misdiagnosis. Patient was successfully managed with anticoagulation therapy.
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Background: To address the shortage of oncologists in the wake of the rapidly increasing global cancer burden, general practitioners of oncology (GPOs) have been added to cancer care teams worldwide. GPOs are family physicians with additional training in oncology and their roles differ by both country and region. In this study, we aimed to learn about the roles and expectations of GPOs from the perspective of oncologists in Canada and Nepal. Methods: A survey was designed and administered to Canadian and Nepali Oncologists between February and November 2022 using Research Electronic Data Capture, a secure web-based software platform hosted at Queen's University in Kingston, Ontario, Canada. Participants were recruited through personal networks/social media in Nepal and the survey was distributed through an email list provided by the Canadian Association of Medical Oncologists. Results: The survey received 48 responses from Canadian and 7 responses from Nepali oncologists. Canadian respondents indicated that in terms of educational content delivery, clinics with oncologists followed by didactic lectures by oncologists were thought to be the most effective, followed by a small group learning and online education. Nepali oncologists also indicated didactic lectures by oncologists and small group learning would be the most effective teaching techniques, followed by online education and clinics with oncologists. Critical knowledge domains and skills most relevant for GPO training identified by Canadian respondents were managing pain and other common symptoms of cancers, as well as treatment of common side effects, followed by goals of care discussion, post-treatment surveillance for recurrence, and the management of long-term complications from treatment. Respondents from Nepal, however, suggested an approach to diagnosis to patient with increased risk of cancer, and cancer staging were the most critical knowledge domains and skills. The majority of oncologists in both countries thought a training program of 6-12 months was optimal. Conclusion: We found many similarities in oncologist's opinions of GPOs between the two countries, however, there were also some notable differences such as the need to provide cancer screening services in Nepal. This highlights the need to tailor GPO training programs based on local context.
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INTRODUCTION: With advances in therapeutics and longer survival across different cancer spectrums, the incidence of therapy-related acute myeloid leukemia (tAML) has continued to rise. This study aims to evaluate the trend of survival outcomes and their association with sociodemographic factors in tAML over the last 20 years. METHODS: We identified tAML patients between 2000 and 2020 from the Surveillance, Epidemiology, and End Results database. Patients were divided into 4 age groups: 18-39, 40-59, 60-69, and >= 70 years, and 4 diagnostic periods: 2000-2005, 2006-2010, 2011-2015, and 2016-2020. Overall survival (OS) was compared using Kaplan Meier and log-rank methods. RESULTS: The 1-year (and 5-year) OS in patients with tAML was 59.3% (33.7%), 48.2% (24.8%), 37.2% (11.1%), and 32.9% (5.5%) in age groups 18-39, 40-59, 60-69, and >=70 years, respectively. The 1-year (and 5-year) OS based on the year of diagnosis was 20.9% (13.2%), 36.8% (15.2%), 41.9% (13.88%), and 40.4% (not reached) for 2000-2005, 2006-2010, 2011-2015, and 2016-2020 respectively. Among the youngest cohort aged 18-39 years, 1-year OS was 35.7%, 57.7%, 66.7%, and 59.6%, respectively, in 4 diagnostic periods, whereas 1-year OS was 10.5%, 23.9%, 32.2%, and 36.9%, respectively, in the oldest cohort aged >=70 years. Age, year of diagnosis, and geographic location were independent prognostic markers of OS. CONCLUSION: Our study demonstrates a significant improvement in the 1-year OS of tAML patients over the last decade, but the long-term prognosis remains dismal. Older patients continue to show improved survival in recent years with the addition of newer intensive and nonintensive options.
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BACKGROUND: Total body irradiation (TBI) for hematopoietic stem cell transplant (HSCT) has certain distinct advantages, such as uniform dose distribution and lack of drug resistance, but it is not widely available in resource-constrained settings. To overcome the limitations of in-house radiotherapy services in hematology centers, we evaluated the feasibility of conducting HSCT programs in coordination with two physically distant centers using a reduced-intensity TBI protocol. METHODS: Thirty-two patients with a median age of 20.5 years were included in the study. Fifteen patients were diagnosed with aplastic anemia, 10 patients with acute myeloid leukemia (AML), 3 patients with acute lymphocytic leukemia (ALL), and 4 patients with other hematological conditions. Conditioning regimens used were fludarabine plus cyclophosphamide in 29 cases, fludarabine-cytarabine ATG in 2 cases, and busulfan plus fludarabine in 1 case. The TBI dose was 3 Gy in 28 cases and 2 Gy in 4 cases. Patients were followed monthly after TBI, and the major toxicities were recorded. RESULTS: The median follow-up was 22 months. The most common acute complication was acute graft-versus-host disease (GVHD), which occurred in 15.6% of patients. The major late complications were chronic GVHD (9.3%), Cytomegalovirus (CMV) infection (34.3%), and CMV-induced secondary graft failure (6.2%). Seventy-five percent of patients were alive, 21.9% were dead, and 1 patient was lost to follow-up. CONCLUSIONS: HSCT based on TBI is feasible even if the center lacks a radiotherapy facility by coordinating with a remote radiotherapy facility. without compromising the patient's outcome.
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Enfermedad Injerto contra Huésped , Trasplante de Células Madre Hematopoyéticas , Acondicionamiento Pretrasplante , Irradiación Corporal Total , Humanos , Trasplante de Células Madre Hematopoyéticas/métodos , Trasplante de Células Madre Hematopoyéticas/efectos adversos , Masculino , Femenino , Adulto , Acondicionamiento Pretrasplante/métodos , Adulto Joven , Adolescente , Enfermedad Injerto contra Huésped/etiología , Enfermedad Injerto contra Huésped/prevención & control , Niño , Persona de Mediana Edad , Preescolar , Vidarabina/análogos & derivados , Vidarabina/administración & dosificación , Vidarabina/uso terapéuticoAsunto(s)
Abuso Físico/estadística & datos numéricos , Médicos/estadística & datos numéricos , Violencia Laboral/estadística & datos numéricos , Humanos , Nepal , Abuso Físico/prevención & control , Abuso Físico/tendencias , Política , Factores Socioeconómicos , Violencia Laboral/prevención & control , Violencia Laboral/tendenciasRESUMEN
Diagnosis of hemophagocytic lymphohistiocytosis is a challenge in Nepal because of limited resources and the high prevalence of tropical febrile illness mimicking hemophagocytic lymphohistiocytosis. We retrospectively reviewed medical records of 21 patients who were diagnosed with hemophagocytic lymphohistiocytosis from 2010 to 2015 at a single center in Nepal. Two patients had a mutation in their perforin gene and underwent successful haploidentical stem cell transplantation. Marrow hemophagocytosis was found only in 57% of the patients. Five patients had hematological malignancy and were treated with disease-specific chemotherapy. Seven patients developed hemophagocytic lymphohistiocytosis secondary to an infection, including visceral leishmaniasis, scrub typhus, and Epstein Barr virus. EBV-associated hemophagocytic lymphohistiocytosis was refractory to hemophagocytic lymphohistiocytosis 94 protocol, including the addition of rituximab. Malignancy and infection-associated hemophagocytic lymphohistiocytosis was more common. The most common clinical presentations included fever, splenomegaly, hyponatremia, liver function derangement, hyperfibrinogenemia, hyperferritinemia, and cytopenia. With a mortality of 29% in our study cohort, hemophagocytic lymphohistiocytosis should be considered a lethal disease, and clinicians should maintain a high index of suspicion to diagnose this disease. Keywords: Hemophagocytic lymphohistiocytosis; infection; malignancy.
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Infecciones por Virus de Epstein-Barr , Linfohistiocitosis Hemofagocítica , Humanos , Linfohistiocitosis Hemofagocítica/diagnóstico , Linfohistiocitosis Hemofagocítica/terapia , Linfohistiocitosis Hemofagocítica/complicaciones , Infecciones por Virus de Epstein-Barr/complicaciones , Infecciones por Virus de Epstein-Barr/diagnóstico , Infecciones por Virus de Epstein-Barr/tratamiento farmacológico , Estudios Retrospectivos , Herpesvirus Humano 4 , NepalRESUMEN
The number of hematopoietic stem cell transplantations (HCTs) is increasing annually worldwide, and the Asia-Pacific (AP) region is no exception. We report on the absolute number of HCTs in 2018 and 2019 and the trends in graft selection and disease indication in the past few decades. In 2018, 24,292 HCTs were performed in the AP region, of which 8,754 (36.0%) were autologous and 15,538 (64.0%) were allogeneic. Among the allogeneic HCTs, 10,552 (67.9%) of the recipients were related to their donors, whereas 4,986 (32.1%) were unrelated. In 2019, 27,583 HCTs were reported, of which 17,613 (63.9%) were allogeneic and 9,970 (36.1%) were autologous. Although, in 2010, there was a nearly equal number of related and unrelated HCTs, the difference has shown an annual increase, with more than double (2.05) the number of related than unrelated HCTs in 2019. Recent trends in the AP region show that peripheral blood has overwhelmingly surpassed the bone marrow as a graft source for both related and unrelated HCTs, with the haploidentical donor type being preferred; however, their trends in each country/region were quite different among countries/regions. In 2019, the main conditions requiring HCT were acute myelogenous leukemia (n=6,629 [24.0%]), plasma cell disorders (PCD) (n=4,935 [17.9%]), malignant lymphoma (ML) (n=4,106 [14.9%]), acute lymphoblastic leukemia (AML) (n=3,777 [13.7%]), myelodysplastic syndrome or myelodysplastic/myeloproliferative neoplasm (n=1,913 [6.9%]), severe aplastic anemia (n=1,671 [6.1%]), and hemoglobinopathy (n=910 [3.3%]). PCD and ML were the main indications for autologous HCT, and the number of PCD cases has grown more prominent than the corresponding of ML. The increased number of allogeneic transplants for hemoglobinopathy remains prominent, as well as that of AML and acute lymphocytic leukemia for the past 5 years. There was a significant regional variation in the number of facilities performing HCTs, ranging from one in Mongolia and Nepal to 313 in Japan, and differing regional densities varying from 0.1 in Indonesia and Pakistan to 24.7 in Japan. The total transplant density per 10 million population in each country/region also differed (0.2 in Indonesia and 627 in New Zealand). This annual Activity Survey aims to help all participating countries/regions understand the changes in HCT, serve as an asset in promoting HCT activities in the AP region, and be used as a reference for comparison with other registries from Europe and the United States.
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The ecancer Kathmandu 2022 workshop on the 24th-25th September 2022 was the first ecancer conference organised in Nepal, a Southeast Asian nation sandwiched between India and China. It was focused on critical appraisal skills for evidence-based practice and was organised in partnership with the Karnali Academy of Health Sciences and the Civil Service Hospital from Nepal, and the Queen's Global Oncology Program from Canada. The workshop emphasised the need for critical thinking in understanding clinical research, and also motivated the delegates to undertake meaningful clinical research relevant to the local setting. The sessions highlighted the features of a good clinical research, identify pitfalls in the reporting of clinical trials, implementation of the research into locally relevant practice and development of local clinical guidelines. Furthermore, the faculty also discussed how to write a good scientific paper, the do's and don'ts of a systematic review and meta-analysis, the role of peer-review and how to do one properly and what do editors look for in evaluating papers submitted for publication. The audience learned the importance of finding a good mentor and fostering local and international collaboration. The local faculty also highlighted their own personal journeys and how mentorship and global collaboration played an important role in their own academic career. The enthusiastic panel discussion was a highlight of the programme where the delegates learned about several important topics from the faculties, such as work-life balance, the role of mentorship in building careers and building networks.
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Background: Paragonimiasis presents with nonspecific symptoms and radiologic findings, allowing for the possibility of misdiagnosis. Diagnosis is generally delayed due to lack of suspicion and presentation similar to pulmonary tuberculosis. Methods: A prospective observational study was carried out on 20 subjects at Civil Service Hospital of Nepal from March 2015 to June 2019 who presented with eosinophilia and pulmonary symptoms, and were treated empirically with Anti-tubercular therapy for suspicion of pulmonary tuberculosis. Results: The median age of the patient was 34 years. Mean blood absolute eosinophil count was 16678/ul. Fever was present in 80% (n=16). Cough was present in 90% (n=18). Pleural effusion was noticed in 100% (n=20). Chest computed tomography showed ground-glass opacities in 65% (n=13) of patients. Pleural fluid eosinophilia (>10%) was evident in all patients. Pleural fluid LDH was elevated in 85% (n=17) of patients. Similarly, ADA was high (>40U) in 75% (n= 15) of patients, and pleural fluid sugar was low in 80% (n=16) of patients. All patients (100%) gave a history of crab or snail consumption. Paragonimus egg was detected in five (25%) patients. Twenty patients fulfilled definite or probable diagnostic criteria of paragonimiasis. Ninety-five (n=19) patients responded to praziquantel. Conclusion: Unavailability of serologic tests or failure to demonstrate parasitic egg under the microscope should not discourage physicians to consider the diagnosis of paragonimiasis when marked eosinophilia, high LDH levels, and low glucose levels are identified in pleural fluid of a patient with a history of raw crab or snail consumption.
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Blood and marrow transplantation (BMT) is rarely available in many low- to middle-income countries (LMICs). In 2012, Civil Service Hospital, a government hospital in Kathmandu, partnered with the University of Illinois at Chicago to consult on the establishment of BMT in their hospital, train staff, and promote educational activities. The implementation of BMT occurred in 3 phases over 4 years and included regular onsite visits, training of personnel in Chicago, continuous remote communication, and co-organization of educational events in Kathmandu. The Nepalese government funded the construction of a state-of-the art BMT unit and stem cell laboratory inside Civil Hospital. Autologous (auto) hematopoietic stem cell transplantation (HSCT) was started in 2016, and allogeneic (allo) HSCT from matched related donors (MRDs) or haploidentical (haplo) donors was initiated in 2017. The cost of transplantation was $5200 for auto-HSCT, $10,000 for MRD HSCT, and $13,300 for haplo HSCT. The major socioeconomic determinants reported by Nepalese BMT providers were the cost of transplantation, loss of revenue of the patient and/or caregiver, and cost of transportation. All patients (n = 66) received peripheral blood stem cell grafts, and all allo-HSCT recipients were given post-transplantation cyclophosphamide as graft-versus-host disease (GVHD) prophylaxis. Among recipients of auto-HSCT (n = 30), with a median follow-up of 1029 days (range, 130 to 1653 days), 87% were alive, and transplantation-related mortality (TRM) was 10%. Among allo-HSCT recipients (n = 36), all patients engrafted, and at a median follow-up of 204 days (range, 12 to 1131 days), 75% of them were alive (MRD, 71%; haplo, 83%), with a TRM of 19%. Only 3 of 36 patients developed acute GVHD grade II-IV. The median overall survival in auto-HSCT recipients was 1610 days and was not reached in allo-HSCT recipients. The long-lasting partnership with University of Illinois at Chicago helped build capacity and allowed the Civil Service Hospital team to establish a BMT program in Nepal that has high quality standards at an affordable cost for the majority of patients.
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Enfermedad Injerto contra Huésped , Trasplante de Células Madre Hematopoyéticas , Enfermedad Injerto contra Huésped/epidemiología , Humanos , Nepal/epidemiología , Estudios Retrospectivos , Donante no EmparentadoRESUMEN
The Asia-Pacific Blood and Marrow Transplantation Group (APBMT) has been conducting annual surveys on the activity of hematopoietic stem cell transplants since 2007. The APBMT Data Center collected the following data in 2017. A total of 21,504 transplants were registered from 733 transplant centers of 20 countries/regions in the Asia-Pacific (AP) region. Five countries/regions comprised 89.4% of all transplants - China (6,979), Japan (5,794), South Korea (2,626), India (2,034), and Australia (1,789). The number of centers in these five countries/regions also comprised 88.9% of all centers: Japan (373), China (123), India (66), Australia (45), and South Korea (44). The overall ratio between autologous and allogeneic transplants was 37.0% and 63.0%, respectively, but the ratios varied significantly among countries/regions. Autologous transplants have surpassed allogeneic transplants in Thailand, Australia, Vietnam, New Zealand, Singapore, and Iran. In contrast, the proportion of allogeneic transplants comprised over 70% of all transplants in Pakistan, China, and Hong Kong. These ratios were compared by the Data Center among countries/regions that performed more than 50 transplants. The proportion of related and unrelated transplants also differed among countries/regions. The number of unrelated transplants was more than related ones in Japan (2,551 vs. 1,202) and Australia (329 vs. 291), whereas more than 80% of all transplants were related transplants in Malaysia (90.9%), India (89.5%), Iran (87.2%), Vietnam (85.7%), China (80.9%), and Thailand (80.6%). All transplant activities were related transplants in Pakistan, the Philippines, Myanmar, and Nepal, and no allogeneic transplants were performed in Bangladesh and Mongolia. Regarding the indications for transplants, acute myeloid leukemia (AML) was the most common disease for allogeneic transplant (4,759, 35.1% of allogeneic transplants), while plasma cell disorder (PCD) was the most common disease for autologous transplant (3,701, 27.3% of all autologous transplants). Furthermore, the number of transplants for hemoglobinopathy has steeply increased in this region compared with the rest of disease indications (677, 3.1% of all transplants). APBMT covers a broad area globally, including countries/regions with diverse disease distribution, development of HSCT programs, population, and economic power. Consistent and continuous activity surveys considering those elements in each country/region revealed the HSCT field's diverse characteristics and background factors in this region.
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Over the past decade, therapeutic options in multiple myeloma (MM) have changed dramatically. Given the unprecedented efficacy of novel agents, the role of hematopoietic cell transplantation (HCT) in MM remains under scrutiny. Rapid advances in myeloma immunotherapy including the recent approval of chimeric antigen receptor (CAR) T-cell therapy will impact the MM therapeutic landscape. The American Society for Transplantation and Cellular Therapy convened an expert panel to formulate clinical practice recommendations for role, timing, and sequencing of autologous (auto-HCT), allogeneic (allo-HCT) and CAR T-cell therapy for patients with newly diagnosed (NDMM) and relapsed/refractory MM (RRMM). The RAND-modified Delphi method was used to generate consensus statements. Twenty consensus statements were generated. The panel endorsed continued use of auto-HCT consolidation for patients with NDMM as a standard-of-care option, whereas in the front line allo-HCT and CAR-T were not recommended outside the setting of clinical trial. For patients not undergoing auto-HCT upfront, the panel recommended its use in first relapse. Lenalidomide as a single agent was recommended for maintenance especially for standard risk patients. In the RRMM setting, the panel recommended the use of CAR-T in patients with 4 or more prior lines of therapy. The panel encouraged allo-HCT in RRMM setting only in the context of clinical trial. The panel found RAND-modified Delphi methodology effective in providing a formal framework for developing consensus recommendations for the timing and sequence of cellular therapies for MM.
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Trasplante de Células Madre Hematopoyéticas , Mieloma Múltiple , Receptores Quiméricos de Antígenos , Trasplante de Células Madre Hematopoyéticas/métodos , Humanos , Mieloma Múltiple/terapia , Recurrencia Local de Neoplasia , Receptores Quiméricos de Antígenos/uso terapéutico , Trasplante Homólogo , Estados UnidosRESUMEN
INTRODUCTION: Due to the increasing global burden of cancer and the shortage of trained medical oncologists, training General Practitioners (GPs) in Oncology (known as GPOs) has been proposed as a means to potentially ease some burden on medical oncologists with heavy workloads, especially in low-and-middle-income countries (LMICs), by task-sharing and task-shifting. We undertook a scoping review to identify and characterise the existing training programmes and curricula for GPOs globally. DESIGN: We searched three major electronic databases: EMBASE, Medline/PubMed and Education Source for articles that described a medical oncology training programme for GPs. All study types were eligible in this review. We followed a two-stage standardised screening process using two independent reviewers to evaluate the eligibility of the articles. RESULTS: Five peer-reviewed articles were included in our review and grey literature scans identified an additional seven GPO training programmes for a total of 12 programmes and their curricula. All of the included studies were from high-income countries. The duration of programmes varied from comprehensive programmes structured over 2 years (n = 2) to shorter duration medical oncology training activities (n = 2), a short, 1.5-day workshop and a 10-hour course. In the grey literature, GPO training programme durations ranged from 2 weeks to 13 months. A mixture of delivery methods was employed including didactic lectures and clinical rotations. CONCLUSION: This scoping review identified a small number of heterogeneous studies and grey literature sources that described and/or evaluated medical oncology training programmes for GPs. The information synthesised here can be used to foster the collaboration needed for the continued development of GPO programmes that could help address the problem of lack of workforce to meet the rising burden of cancer, especially in LMICs.
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National lockdown to control the spread of COVID-19 in Nepal started in March 2020. This lockdown mandated closure of private and public transportation. The patients with hematological malignancies were at risk of delayed consultation, admission and missing scheduled chemotherapy. Since there is no official tele-health or e-health system established in hospitals, we decided to use Viber, a free text and call app to trace and provide information about patient admission and treatment schedule. This use of Viber during the pandemic was found to be very helpful, none of the patients missed chemotherapy and we were able to admit more patients than before. Patients found this strategy very convenient and cost-effective and suggested that we continue this service in future even after the lockdown is lifted. This preliminary experience of using Viber for cancer care consultations in Nepal at the time of the COVID-19 pandemic suggests the utility and acceptability of using mobile technology to improve access to health care services in a low-income country. Further pre-planned well conducted studies are needed to assess the outcomes of using this technology.
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INTRODUCTION: Distress is a major concern during diagnosis and treatment of hematological malignancies. The Distress Thermometer is a commonly used screening tool to detect distress. The objectives of this study was to know the prevalence and identify distress score among patients with hematological malignancies in Nepal. METHODS: A descriptive cross sectional study was carried out at the Hematology Unit of Civil Service Hospital after obtaining an ethical approval from the Institutional Review Committee (reference number 931/076/077). A convenient sampling technique was used for this study. Statistical Package for the Social Sciences version 20.0 was used. All patients within one week of diagnosis and before the start of definitive treatment of hematological malignancies were included in the study. National Comprehensive Cancer Network Psychosocial Distress Screening Tool was used to measure the seriousness of distress. RESULTS: A total of 100 patients were enrolled in the study, among them 56 (56%) were male and 44 (44%) were female. The mean distress score in our study was found to be 5.68±1.75. Mean distress score among male and female patients were 5.84±1.65 and 5.48±1.86 respectively. Thirty three percentage (n=33) of patient had mild distress whereas, sixty six percentage (n=67) of patients experienced moderate to severe distress. CONCLUSIONS: There was a significant level of distress among the patients with hematological malignancies in Nepal. Therefore, distress screening should be done to all the patients when initial diagnosis is made.
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Neoplasias Hematológicas , Tamizaje Masivo , Estudios Transversales , Femenino , Neoplasias Hematológicas/diagnóstico , Neoplasias Hematológicas/epidemiología , Humanos , Masculino , Nepal/epidemiología , PrevalenciaRESUMEN
PURPOSE: The purpose of the study was to compare efficacy and toxicity of olanzapine (OLN; a higher-cost drug) and haloperidol (HAL; a lower-cost drug) in the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients who receive highly emetogenic chemotherapy (HEC). PATIENTS AND METHODS: In a randomized, phase II trial, patients were randomly assigned to receive either OLN 10 mg orally on days 1 to 4 or HAL 1 mg orally on day 1 and 0.5 mg twice daily on days 2 to 4. Both groups received ondansetron 16 mg and dexamethasone 12 mg intravenously on day 1. Patients recorded their nausea using the Edmonton Symptom Assessment Scale (ESAS) and recorded daily episodes of vomiting from day 1 to day 5. The primary end point was complete nausea prevention (CNP; ie, ESAS of 0). Secondary end point was complete emesis prevention (CEP). RESULTS: Sixty-five patients were randomly assigned, and 64 received their allocated treatment (n = 32 in each arm). There was no difference in CNP during the overall period (days 1 to 5) between OLN and HAL (68.7% v 71.8%; P = .78). In the acute period (day 1) and the delayed period (days 2 to 5), CNP was similar between OLN and HAL (acute: 84.3% v 81.2%; delayed: 68.7% v 75%). No difference was identified in the rate of CEP during the overall period (81.2% with OLN v 78.1% with HAL; P = .75), during the acute period (93.7% with OLN v 90.6% with HAL), or during the delayed period (84.3% with OLN v 84.3% with HAL). No difference in toxicities was noted between treatment arms. CONCLUSION: In this study, HAL had comparable efficacy to OLN in the management of CINV, which suggests that it is the higher-value option in patients who receive HEC in resource-scarce countries.
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Antieméticos/administración & dosificación , Protocolos de Quimioterapia Combinada Antineoplásica/efectos adversos , Haloperidol/administración & dosificación , Náusea/prevención & control , Olanzapina/administración & dosificación , Vómitos/prevención & control , Administración Intravenosa , Administración Oral , Adulto , Antieméticos/efectos adversos , Antieméticos/economía , Protocolos de Quimioterapia Combinada Antineoplásica/administración & dosificación , Dexametasona/administración & dosificación , Dexametasona/efectos adversos , Esquema de Medicación , Femenino , Haloperidol/efectos adversos , Haloperidol/economía , Humanos , Masculino , Persona de Mediana Edad , Náusea/inducido químicamente , Neoplasias/tratamiento farmacológico , Olanzapina/efectos adversos , Olanzapina/economía , Ondansetrón/administración & dosificación , Ondansetrón/efectos adversos , Distribución Aleatoria , Resultado del Tratamiento , Vómitos/inducido químicamente , Adulto JovenRESUMEN
PURPOSE: The purpose of this study was to evaluate the clinical significance of the biomarkers procalcitonin (PCT) and C-reactive protein (CRP) in patients with febrile neutropenia (FN) undergoing chemotherapy for acute leukemia. METHODS: We conducted a prospective, observational study in patients who developed FN while undergoing chemotherapy for acute leukemia. PCT and CRP were obtained in patients who presented with FN. Blood cultures also were obtained. The primary goals were to evaluate the ability of PCT and CRP to predict bacteremia in patients with FN. The secondary goals were to assess the prognostic role of PCT and CRP and to assess the microbiologic profile and culture sensitivity patterns in the study population. RESULTS: A total of 124 episodes of FN that involved 67 patients with acute leukemia occurred in the study. PCT was superior to CRP in the prediction of bacteremia. The median PCT level in the bacteremia group was 3.25 ng/mL compared with 0.51 ng/mL in the group without bacteremia (P < .01). The median values of CRP in the bacteremia and without-bacteremia groups were 119.3 mg/L and 94.5 mg/L, respectively (P = .07). There were no differences in median PCT and CRP in patients who died and those who improved. Of the 42 positive cultures, Gram-negative bacteremia was common (86%), and Escherichia coli was the most frequent organism isolated. Carbapenem resistance was seen in 39% of positive cultures. CONCLUSION: PCT is an effective biomarker to predict bacteremia in patients with FN undergoing chemotherapy for acute leukemia.