ABSTRACT
OBJECTIVE: Vaccination against SARS-CoV-2 is essential to mitigate the personal, social and global impact of the coronavirus disease (COVID-19) as we move from a pandemic to an endemic phase. Vaccines are now required that offer broad, long-lasting immunological protection from infection in addition to protection from severe illness and hospitalisation. Here we present a review of the evidence base for a new COVID-19 vaccine, PHH-1V (Bimervax®; HIPRA HUMAN HEALTH S.L.U), and the results of an expert consensus. METHODS: The expert committee consisted of Spanish experts in medicine, family medicine, paediatrics, immunology, microbiology, nursing, and veterinary medicine. Consensus was achieved using a 4-phase process consisting of a face-to-face meeting during which the scientific evidence base was reviewed, an online questionnaire to elicit opinions on the value of PHH-1V, a second face-to-face update meeting to discuss the evolution of the epidemiological situation, vaccine programmes and the scientific evidence for PHH-1V and a final face-to-face meeting at which consensus was achieved. RESULTS: The experts agreed that PHH-1V constitutes a valuable novel vaccine for the development of vaccination programmes aimed towards protecting the population from SARS-CoV-2 infection and disease. Consensus was based on evidence of broad-spectrum efficacy against established and emerging SARS-CoV-2 variants, a potent immunological response, and a good safety profile. The physicochemical properties of the PHH-1V formulation facilitate handling and storage appropriate for global uptake. CONCLUSIONS: The physicochemical properties, formulation, immunogenicity and low reactogenic profile of PHH-1V confirm the appropriateness of this new COVID-19 vaccine.
Subject(s)
COVID-19 , Vaccines , Humans , Child , COVID-19 Vaccines , COVID-19/prevention & control , SARS-CoV-2 , VaccinationABSTRACT
AIMS: Childhood cancer survival is suboptimal in most low- and middle-income countries (LMICs). Radiotherapy plays a significant role in the standard care of many patients. To assess the current status of paediatric radiotherapy, the International Atomic Energy Agency (IAEA) undertook a global survey and a review of practice in eight leading treatment centres in middle-income countries (MICs) under Coordinated Research Project E3.30.31; 'Paediatric radiation oncology practice in low and middle income countries: a patterns-of-care study by the International Atomic Energy Agency.' MATERIALS AND METHODS: A survey of paediatric radiotherapy practices was distributed to 189 centres worldwide. Eight leading radiotherapy centres in MICs treating a significant number of children were selected and developed a database of individual patients treated in their centres comprising 46 variables related to radiotherapy technique. RESULTS: Data were received from 134 radiotherapy centres in 42 countries. The percentage of children treated with curative intent fell sequentially from high-income countries (HICs; 82%) to low-income countries (53%). Increasing deficiencies were identified in diagnostic imaging, radiation staff numbers, radiotherapy technology and supportive care. More than 92.3% of centres in HICs practice multidisciplinary tumour board decision making, whereas only 65.5% of centres in LMICs use this process. Clinical guidelines were used in most centres. Practice in the eight specialist centres in MICs approximated more closely to that in HICs, but only 52% of patients were treated according to national/international protocols whereas institution-based protocols were used in 41%. CONCLUSIONS: Quality levels in paediatric radiotherapy differ among countries but also between centres within countries. In many LMICs, resources are scarce, coordination with paediatric oncology is poor or non-existent and access to supportive care is limited. Multidisciplinary treatment planning enhances care and development may represent an area where external partners can help. Commitment to the use of protocols is evident, but current international guidelines may lack relevance; the development of resources that reflect the capacity and needs of LMICs is required. In some LMICs, there are already leading centres experienced in paediatric radiotherapy where patient care approximates to that in HICs. These centres have the potential to drive improvements in service, training, mentorship and research in their regions and ultimately to improve the care and outcomes for paediatric cancer patients.
Subject(s)
Neoplasms , Nuclear Energy , Radiation Oncology , Child , Developing Countries , Humans , International Agencies , Medical Oncology , Neoplasms/radiotherapyABSTRACT
Circulation of highly pathogenic avian influenza (HPAI) viruses poses a continuous threat to animal and public health. After the 2005-2006 H5N1 and the 2014-2015 H5N8 epidemics, another H5N8 is currently affecting Europe. Up to August 2017, 1,112 outbreaks in domestic and 955 in wild birds in 30 European countries have been reported, the largest epidemic by a HPAI virus in the continent. Here, the main epidemiological findings are described. While some similarities with previous HPAI virus epidemics were observed, for example in the pattern of emergence, significant differences were also patent, in particular the size and extent of the epidemic. Even though no human infections have been reported to date, the fact that A/H5N8 has affected so far 1,112 domestic holdings, increases the risk of exposure of humans and therefore represents a concern. Understanding the epidemiology of HPAI viruses is essential for the planning future surveillance and control activities.
Subject(s)
Communicable Diseases, Emerging/veterinary , Disease Outbreaks/veterinary , Influenza A Virus, H5N8 Subtype/pathogenicity , Influenza in Birds/epidemiology , Animals , Animals, Wild/virology , Communicable Diseases, Emerging/epidemiology , Communicable Diseases, Emerging/virology , Europe/epidemiology , Humans , Influenza A Virus, H5N8 Subtype/isolation & purification , Influenza in Birds/virology , Poultry/virology , Public HealthABSTRACT
Dromedary camels are the main reservoir of Middle East respiratory syndrome coronavirus (MERS-CoV), but other livestock species (i.e., alpacas, llamas, and pigs) are also susceptible to infection with MERS-CoV. Animal-to-animal transmission in alpacas was reported, but evidence for transmission in other species has not been proved. This study explored pig-to-pig MERS-CoV transmission experimentally. Virus was present in nasal swabs of infected animals, and limited amounts of viral RNA, but no infectious virus were detected in the direct contact pigs. No virus was detected in the indirect contact group. Furthermore, direct and indirect contact pigs did not develop specific antibodies against MERS-CoV. Therefore, the role of pigs as reservoir is probably negligible, although it deserves further confirmation.
Subject(s)
Camelus/virology , Coronavirus Infections/transmission , Disease Reservoirs/veterinary , Middle East Respiratory Syndrome Coronavirus/physiology , Animals , Coronavirus Infections/virology , Disease Models, Animal , Humans , RNA, Viral/analysis , SwineABSTRACT
Cancer is an infrequent disease in childhood. However, it is responsible for 13.06% of child deaths between 1 and 14 years in Cuba. The aim of our work was to describe the incidence of childhood cancer in the period 1986 to 1990 using data reported to the National Cancer Registry (NCR) of Cuba. All cancer cases between 0 and 14 years of age reported to the NCR in the period 1986 to 1990, were included. The cases were classified histologically, by age and gender. Average age-specific and age-standardized rates were calculated; 1428 children were registered, an average of 286 each year, with a mean annual rate of 117.8 per million. The world-population standardized rate was 120.7 and the male-to-female ratio was 0.98. Leukaemias, lymphomas and malignant tumours of the central nervous system were the most common childhood neoplasm groups. The majority of leukaemias were acute lymphoblastic leukaemias (ALL), and the incidence peak extended until 6 years of age. The first peak of incidence of Hodgkin's disease is found in older age-groups. Burkitt's lymphoma showed a male-to-female ratio of 0.44. Most of the hepatic tumours were carcinomas, and only one fourth were hepatoblastomas. In bone tumours, similar rates were observed for osteosarcomas and Ewing's sarcoma.
Subject(s)
Neoplasms/epidemiology , Adolescent , Age Factors , Child , Child, Preschool , Cuba/epidemiology , Female , Humans , Incidence , Infant , Infant, Newborn , MaleABSTRACT
PURPOSE: To analyse the results of the therapy administered to children with ALL in Cuba. PATIENTS AND METHODS: Four-hundred and twenty-five children (aged below 15 years), diagnosed of ALL in 8 different Cuban hospitals between 1973 and 1991, were evaluated. Five different therapeutic regimes were used: three "classic" GLATHEM protocols in the first period (1973-1981) and two intensive BFM-like protocols in the second period (1982-1991). The Kaplan-Meier method was applied for survival analysis, and the differences were evaluated by the log-rank and Mantel-Cox methods. RESULTS: Two-hundred and sixty-five patients were included in the first period, 81 with low-risk disease, 133 with standard risk and 51 with poor-risk leukaemia. The second period comprised 160 cases, 50 of low-risk, 83 with standard risk and 27 with poor-risk leukaemia. The disease-free survival probability at 60 months was 35% for the first group and 55% for the second (p < 0.0001). The 60-month survival (SV) as a whole was 45% for the "classic" treatments and 60% for the BFM-like protocols (p < 0.01). The disease-free survival (DFS) probability for each prognostic group was as follows: 50% for low-risk, 43% for standard risk, and 25% for poor-risk (p < 0.001) and the probability of survival as a whole was, respectively, 65%, 49% and 28% (p < 0.001). as for this compilation, 172 patients were out of any treatment for periods ranging between 14 and 168 months. CONCLUSIONS: 1) The percentage of remissions was similar for both groups of treatments. 2) The results attained with BFM-like protocols were better than those of the "classic" therapy with regard to the SV and DFS differences. 3) Significant differences can be appreciated between good- and poor-prognosis groups for both types of treatment.
Subject(s)
Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Precursor Cell Lymphoblastic Leukemia-Lymphoma/drug therapy , Adolescent , Child , Child, Preschool , Cuba , Female , Humans , Infant , Life Tables , Male , Remission Induction , Survival Analysis , Treatment OutcomeABSTRACT
Las úlceras cutáneas producidas por las radiaciones ionizantes o por extravasación de citostáticos, son una complicación frecuente en el tratamiento de los pacientes con neoplasias malignas. Estas lesiones son frecuentemente difíciles de tratar e introducen morbilidad adicional y deterioro de la calidad de vida. En este trabajo presentamos las primeras evidencias clínicas del efecto cicatrizante del factor de crecimiento epidérmico en úlceras cutáneas. Se trataron ocho pacientes(dos con úlceras radiógenas, cinco con úlceras por extravasación de citostáticos y uno con úlcera varicosa) mediante aplicación tópica dos veces al día, de una crema de factor de crecimiento epidérmico (EGF, 10*g/g en crema de sulfadiazina de plata al 1 %). Los dos pacientes con úlcera radiógena de larga evolución cicatrizaron 100 % y 70 % respectivamente. Igualmente, tres pacientes con úlceras por extravasación de epiadriamicina y mostaza nitrogenada tuvieron una respuesta parcial. En otros dos pacientes se pudo detectar precozmente la ulceración por extravasación de vincristina y en estos se logró una re-epitelización completa. La paciente tratada de úlcera varicosa crónica también logró una cicatrización completa en tres meses de tratamiento. Estos resultados constituyen el primer reporte de tratamiento de las úlceras cutáneas en pacientes oncológicos, empleando el factor de crecimiento epidérmico. Esta nueva modalidad puede tener importancia práctica en el tratamiento de tales complicaciones
Subject(s)
Adult , Middle Aged , Humans , Administration, Topical , Epidermal Growth Factor/therapeutic use , Skin Ulcer/drug therapyABSTRACT
La radioterapia es una de las modalidades terapéuticas más empleadas en las neoplasias malignas. Una de las complicaciones más frecuentes es la radiodermitis, que obliga frecuentemente a interrumpir el tratamiento. En este trabajo presentamos una evaluación del efecto del factor de crecimiento epidérmico (EGF) en la prevención de la radiodermitis. Se incluyeron 59 pacientes con diagnóstico histològico de carcinoma de piel, los cuales recibieron 2 Gy diarios de roentgenterapia superficial (80 kV) hasta completar 60 Gy. Los pacientes fueron asignados, al azar, a tres grupos: el primer grupo recibió aplicación tópica del EGF (10 *g/g en crema de sulfadiazina de plata al 1 %) en el área irradiada, dos veces al día durante todo el tiempo de tratamiento; el segundo recibió aplicaciones de la crema de sulfadiazina de plata sin EGF y el tercer grupo no recibió tratamiento local. El porcentaje de aparición de radiodermitis fue de 4 %, 41 % y 64 % en los tres grupos, respectivamente. La diferencia en la frecuencia de aparición de radiodermitis entre el grupo tratado con EGF y los restantes fue estadísticamente significativa (p<0,001). Otro grupo de pacientes -en este caso cinco niños que recibieron radioterapia sobre ojo y órbita-, fue tratado con colirio de kanamicina que contenía, además, EGF humano recombinante (10 *g/ml), aplicando 2 gotas cada 4-6 horas durante todo el período de tratamiento. Solamente uno de estos pacientes presentó conjuntivitis radiógena ligera, a una dosis acumulada de radiaciones de 50 Gy, lo cual se compara favorablemente con la experiencia histórica en que la mayoría de estos pacientes padecen conjuntivitis radiógena. Estos resultados constituyen la primera evidencia clínica de efecto radioprotector del EGF humano recombinante, en la piel y en el epitelio ocular, lo cual tiene importancia práctica en el tratamiento radiante de los tumores malignos
Subject(s)
Infant , Child, Preschool , Child , Humans , Conjunctivitis/drug therapy , Epidermal Growth Factor/therapeutic use , Radiation Injuries/drug therapy , Radiodermatitis/drug therapyABSTRACT
La radioterapia es una de las modalidades terapéuticas más empleadas en las neoplasias malignas. Una de las complicaciones más frecuentes es la radiodermitis, que obliga frecuentemente a interrumpir el tratamiento. En este trabajo presentamos una evaluación del efecto del factor de crecimiento epidérmico (EGF) en la prevención de la radiodermitis. Se incluyeron 59 pacientes con diagnóstico histològico de carcinoma de piel, los cuales recibieron 2 Gy diarios de roentgenterapia superficial (80 kV) hasta completar 60 Gy. Los pacientes fueron asignados, al azar, a tres grupos: el primer grupo recibió aplicación tópica del EGF (10 *g/g en crema de sulfadiazina de plata al 1
) en el área irradiada, dos veces al día durante todo el tiempo de tratamiento; el segundo recibió aplicaciones de la crema de sulfadiazina de plata sin EGF y el tercer grupo no recibió tratamiento local. El porcentaje de aparición de radiodermitis fue de 4
, 41
y 64
en los tres grupos, respectivamente. La diferencia en la frecuencia de aparición de radiodermitis entre el grupo tratado con EGF y los restantes fue estadísticamente significativa (p<0,001). Otro grupo de pacientes -en este caso cinco niños que recibieron radioterapia sobre ojo y órbita-, fue tratado con colirio de kanamicina que contenía, además, EGF humano recombinante (10 *g/ml), aplicando 2 gotas cada 4-6 horas durante todo el período de tratamiento. Solamente uno de estos pacientes presentó conjuntivitis radiógena ligera, a una dosis acumulada de radiaciones de 50 Gy, lo cual se compara favorablemente con la experiencia histórica en que la mayoría de estos pacientes padecen conjuntivitis radiógena. Estos resultados constituyen la primera evidencia clínica de efecto radioprotector del EGF humano recombinante, en la piel y en el epitelio ocular, lo cual tiene importancia práctica en el tratamiento radiante de los tumores malignos
Subject(s)
Infant , Child, Preschool , Child , Humans , Epidermal Growth Factor/therapeutic use , Radiodermatitis/drug therapy , Conjunctivitis/drug therapy , Radiation Injuries/drug therapyABSTRACT
Las úlceras cutáneas producidas por las radiaciones ionizantes o por extravasación de citostáticos, son una complicación frecuente en el tratamiento de los pacientes con neoplasias malignas. Estas lesiones son frecuentemente difíciles de tratar e introducen morbilidad adicional y deterioro de la calidad de vida. En este trabajo presentamos las primeras evidencias clínicas del efecto cicatrizante del factor de crecimiento epidérmico en úlceras cutáneas. Se trataron ocho pacientes(dos con úlceras radiógenas, cinco con úlceras por extravasación de citostáticos y uno con úlcera varicosa) mediante aplicación tópica dos veces al día, de una crema de factor de crecimiento epidérmico (EGF, 10*g/g en crema de sulfadiazina de plata al 1
). Los dos pacientes con úlcera radiógena de larga evolución cicatrizaron 100
y 70
respectivamente. Igualmente, tres pacientes con úlceras por extravasación de epiadriamicina y mostaza nitrogenada tuvieron una respuesta parcial. En otros dos pacientes se pudo detectar precozmente la ulceración por extravasación de vincristina y en estos se logró una re-epitelización completa. La paciente tratada de úlcera varicosa crónica también logró una cicatrización completa en tres meses de tratamiento. Estos resultados constituyen el primer reporte de tratamiento de las úlceras cutáneas en pacientes oncológicos, empleando el factor de crecimiento epidérmico. Esta nueva modalidad puede tener importancia práctica en el tratamiento de tales complicaciones
Subject(s)
Adult , Middle Aged , Aged , Humans , Epidermal Growth Factor/therapeutic use , Skin Ulcer/drug therapy , Administration, TopicalABSTRACT
Soft-tissue sarcomas arising in parameningeal sites are characterized by the potential of a direct meningeal invasion. In order to improve survival rates, we started a treatment program which included whole cranial irradiation with a dose of 24-30 Gy and primary tumor irradiation with 55-65 Gy, and polychemotherapy with vincristine, actinomycin D and cyclophosphamide, and, in some cases, adriamycin. Results in a series of 9 children treated by this program were compared with a historical group of 12 children without cranial irradiation. In the group with extended irradiation to brain, survival was 40%, stabilized at the 13th month of treatment, and 38.1%, respectively, if orbitary tumors were excluded. In the historical group these values were only 20.83% and 15.67%, respectively. The differences were statistically significant.
Subject(s)
Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Meningeal Neoplasms/radiotherapy , Sarcoma/radiotherapy , Soft Tissue Neoplasms/radiotherapy , Child , Child, Preschool , Combined Modality Therapy , Cyclophosphamide/administration & dosage , Dactinomycin/administration & dosage , Doxorubicin/administration & dosage , Female , Follow-Up Studies , Humans , Male , Meningeal Neoplasms/drug therapy , Sarcoma/drug therapy , Soft Tissue Neoplasms/drug therapy , Vincristine/administration & dosageABSTRACT
Se estudiaron 205 niños con leucemia linfoide aguda tratado con 3 esquemas terapéuticos. De los 205 pacientes, 191 (93,1) alcanzaron la remisión completa. La duración de la remisión completa a los 60 meses, según el método de la sobrevida actuarial, fue del 31 y al de la sobrevida el 38. Los factores pronósticos más importantes fueron: edad en el momento del diagnóstico, cifra inicial de leucocitos y coloración de PAS en los linfoblastos. La duración de la remisión completa a los 60 meses en niños menor o igual a 10 años fue del 35 y en los de mayor de 10 años, el 17, en aquellos con menor o igual a 50 x 10
Subject(s)
Leukemia, Lymphoid/diagnosis , ChildABSTRACT
Cytogenetic studies were carried out in peripheral blood lymphocytes of 31 children with cancer (12 retinoblastomas, 9 non-Hodgkin's lymphomas, 7 neuroblastomas and 3 Wilms' tumors) with the purpose of investigating the prevalence and persistence of chromosomal aberrations before onset of antineoplastic treatment and at different intervals thereafter. The number of treated patients with chromosomal anomalies was significantly higher (p less than 0.01) and so was the percent of cells with aberrations, as compared to untreated patients or healthy controls. The most frequent aberrations were of chromatid type. One patient had a number five trisomy in the third posttreatment study and another presented abnormal aneuploid cells in the third and fourth posttreatment studies. Congenital chromosomal anomalies were not observed, nor anomalies described for some of these tumors. There was no regularity in the effected chromosomes. We conclude that the observed chromosomal aberrations were due to treatment. We consider a prolonged and stringent cytogenetic follow up of such patients necessary to detect the induced aberrations.
Subject(s)
Chromosome Aberrations , Neoplasms/genetics , Child , Child, Preschool , Female , Humans , Infant , Lymphocytes/ultrastructure , Male , Neoplasms/therapyABSTRACT
Results obtained in 50 children with abdominal non-Hodgkin's lymphoma after a treatment program that comprised entire abdominal irradiation and chemotherapy are presented. Actuarial survival of the series at 3, 5 and 10 years is 65.8%, with 75.2% for patients in Stage II and 58.6% in Stage III. Patients in 5-9-year age group, or in Stage II comported with a better prognosis, with significant differences. Majority of deaths occurred during the first 6 months with stabilization of survival after the second year of treatment.
Subject(s)
Abdominal Neoplasms/drug therapy , Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Lymphoma/drug therapy , Abdominal Neoplasms/mortality , Abdominal Neoplasms/radiotherapy , Actuarial Analysis , Adolescent , Child , Child, Preschool , Combined Modality Therapy , Cuba , Drug Administration Schedule , Female , Humans , Infant , Laparotomy , Lymphoma/mortality , Lymphoma/radiotherapy , Male , Neoplasm StagingABSTRACT
Tumors of the nervous system are the third most common malignant disease in Cuban children, after leukemia and lymphoma. In 138 patients with the diagnosis of brain tumor results of treatment by surgery and radiation were studied. The survival rate at 1, 3 and 5 years was 50, 40 and 37.6%. The best results were achieved in astrocytomas, mid grain and brain stem tumors and oligodendrogliomas.
Subject(s)
Brain Neoplasms/radiotherapy , Astrocytoma/radiotherapy , Brain Neoplasms/surgery , Brain Stem , Cerebellar Neoplasms/radiotherapy , Child , Craniopharyngioma/radiotherapy , Cuba , Ependymoma/radiotherapy , Glioblastoma/radiotherapy , Humans , Medulloblastoma/radiotherapy , Mesencephalon , Pituitary Neoplasms/radiotherapy , PrognosisABSTRACT
Treatment results in 391 patients with oral carcinoma after radiation therapy are reported. In the total series 5- and 10-year actuarial survival were 30.8 and 25.2 per cent, respectively. After irradiation alone the corresponding figures were 21.5 and 18.5 per cent, after combined radiologic and surgical treatment 33.3 and 28.7 per cent, and after interstitial radium therapy 56.1 and 43.8 per cent, respectively. These differences were mainly an expression of selection factors. Tumor doses above 60 Gy gave a higher survival than lower doses. The presence of neck node metastases was prognostically unfavourable.
Subject(s)
Mouth Neoplasms/radiotherapy , Actuarial Analysis , Adult , Aged , Female , Humans , Lymphatic Metastasis , Male , Middle Aged , Mouth Neoplasms/mortality , Prognosis , Radiotherapy DosageABSTRACT
Survival data in 1 106 patients with cervical carcinoma treated between 1967 and 1972 are presented. Survival figures decrease when doubtful or evident activity of the tumor persists at the end of the irradiation.
