Consensus on clinical diagnosis, treatment, and prevention of chemotherapy-induced neutropenia in China (2023 edition) / 中华肿瘤杂志

Chemotherapy-induced neutropenia (CIN) is a common hematological adverse events and dose-limiting toxicities of chemotherapy. CIN may lead to dose reduction and delay of chemotherapeutic agents, febrile neutropenia and severe infection, which results in increased treatment cost, reduced efficacy of chemotherapy, and even life-threatening morbidities. Assessment of risk of CIN, early detection of FN and infection, and proper prevention and treatment play a crucial role in reducing the occurrence of CIN-related morbidities, improving patient treatment safety and anticancer efficacy. Based on evidence and expert opinion, the expert committee of Chinese Anti-Cancer Association issued "the consensus on diagnosis and treatment of chemotherapy-induced neutropenia in China (2023 edition)", which is an update version of the 2019 edition, aiming to provide reference for the diagnosis and treatment of CIN for Chinese oncologists.

A phase III, randomized, non-inferiority study comparing the efficacy and safety of biosimilar filgrastim versus originator filgrastim for chemotherapy-induced neutropenia in breast cancer patients

OBJECTIVES: To compare the efficacy and safety of two filgrastim formulations for controlling chemotherapy-induced neutropenia and to evaluate the non-inferiority of the test drug relative to the originator. METHODS: This phase III non-inferiority study had a randomized, multicenter, and open-label design. The patients were randomized at a ratio of 1:1 with a follow-up period of 6 weeks for each patient. In both study arms, filgrastim was administered subcutaneously at a daily dose of 5 mg/kg body weight. The primary endpoint was the rate of grade 4 neutropenia in the first treatment cycle. The secondary endpoints were the duration of grade 4 neutropenia, the generation of anti-filgrastim antibodies, and the rates of adverse events, laboratory abnormalities, febrile neutropenia, and neutropenia of any grade. RESULTS: The primary efficacy analysis demonstrated the non-inferiority of the test drug compared with the originator drug; the upper limit of the 90% confidence interval (CI) for the rate of neutropenia between the two groups (12.61%) was lower than the established margin of non-inferiority. The two treatments were similar with respect to the secondary endpoints and safety. CONCLUSION: The efficacy and safety profile of the test drug were similar to those of the originator product based on the rate of grade 4 neutropenia in the first treatment cycle. This study supports Anvisa’s approval of the first biosimilar drug manufactured by the Brazilian industry (Fiprima¯).

Resumenes de articulos de la literatura pediatrica: predictores de riesgo en paciente pedíatricos con cámcer y fiebre mas neutropenia / Abstracts of articles in the pediatric literature: predictors of risk in pediatric patients with neutropenia CAMC and fever greater

El estudio identifica factores predictivos de infección o de complicaciones en pacientes pediátricos con neutropenia febril (NF), establece puntos clínicos decorte y destaca la importancia de la impresión clínica inicial y 24 horas de observación.

Utilidad del factor estimulador de colonias de granulocitos (G-CSF) en episodios de neutropenia febril de alto riesgo en niños con cáncer / Usefulness of G-CSF in pediatric high risk cancer patients with fever and neutropenia

La neutropenia febril (NF) secundaria a quimioterapia es causa importante de morbilidad y mortalidad en los pacientes oncológicos pediátricos. El uso de factor estimulante de colonias de granulocitos (G-CSF) después de ciclos de quimioterapia intensa ha disminuido la frecuencia de complicaciones infecciosas asociadas, pero su utilización durante el episodio de NF es controvertida. Se analizaron 35 episodios de NF de alto riesgo. En forma randomizada 18 pacientes recibieron G-CSF asociado al tratamiento antimicrobiano habitual (grupo A) y 17 no lo recibieron (grupo B). Ambos grupos tenía parámetros biomédicos y clínicos similares. No se encontró diferencias significativas con respecto a la duración de la hospitalización (promedio grupo A 8 días vs grupo B 7 días) ni del tratamiento antimicrobiano (promedio 8 vs 7 días), de la fiebre (promedio 2 vs 3 días) y del período de neutropenia (promedio 3 vs 4 días). Considerando la revisión de la literatura y la experiencia local creemos que el uso de G-CSF no estaría recomendado en el manejo de pacientes oncológicos con episodios de NF.

Recombinant human erythropoietin in anemia of prematurity.

OBJECTIVE: To evaluate safety and efficacy of recombinant human erythropoietin (r-HuEPO)in reducing the need for red cell transfusions in anemia of prematurity. METHODS: forty -two preterm infants (gestational age <32 weeks) were randomly assigned to a "treatment" group (r-HuEPO 400 units/kg every alternate day * 10 doses) or "no treatment" (control) group. All infants on enteral feeds received oral iron 3 mg/kg/day, graded up to 6 mg/kg/day. RESULTS: Higher reticulocyte counts in week 2 and 3 and higher hemoglobin levels in week 4 were noted after treatment with r-HuEPO. Despite stumulated erythropoiesis, the frequency of transfusions could not be reduced with r-HuEPO therapy.Overall, Phlebotomy losses, frequency and volume of redcell transfusions were significantly more in neonates with birthweight <1000 grams compared with those with birthweight >1000 grams (p<0.05). Associated side effects of r-HuEPO such as neutropenia,sepsis, hypertension or increased risk of late death did not occur. CONCLUSION:r-HuEPO therapy was safe without any side effects.Inability of r-HuEPO therapy to minimize red cell transfusions for anemia of prematurity may be explained by a relatively strict red-cell transfusion policy and the desired degree of treatment effect.