Objective： The aim of the study was to compare the hematologic toxicity of gemcitabine between fixed-dose rate （FDR） infusion and 30-minute standard infusion in the treatment of malignancy. Methods： The 25 maligna...Objective： The aim of the study was to compare the hematologic toxicity of gemcitabine between fixed-dose rate （FDR） infusion and 30-minute standard infusion in the treatment of malignancy. Methods： The 25 malignancy patients confirmed by histopathology or cytology received single-agent gemcitabine or gemcitabine in combination with other chemo- therapeutic agents. These patients were randomly divided into gemcitabine 1000 mg/m2 on dl, d8 at a rate of 10 mg/m2/min arm （FDR arm） or 30 rain arm （standard arm）, every 21 days one cycle. Hematologic toxicity was evaluated at the end of each cycle. Results： The 13 of 25 patients received gemcitabine FDR therapy, a total of 28 cycles was completed, and 32 cycles in the others （12 of 25 patients） with the standard arm. All patients were evaluable for hematologic toxicity. The result showed that the grades 3-4 leucopenia was significantly different between the two arms （14.3% vs 0, P 〈 0.05）, and no significant differences of neutropenia, thrombocytopenia and hemoglobin suppression of grades 3-4 （14.3% vs 3.1%, 10.7% vs 3.1%, 3.6% vs 9.4%, P 〉 0.05, respectively） were observed between the two arms, no grade 4 of hemoglobin suppression was observed. Conclusion： Hematologic toxicity of gemcitabine therapy at a fixed-dose rate for malignancy is tolerable.展开更多
Introduction: The objective of our study was to determine the prevalence of hematological toxicity during breast cancer chemotherapy. Patients and Methods: This was a cross-sectional descriptive study that took place ...Introduction: The objective of our study was to determine the prevalence of hematological toxicity during breast cancer chemotherapy. Patients and Methods: This was a cross-sectional descriptive study that took place in the cancerology and internal medicine department during the period from January 1, 2021 to December 31, 2021, i.e. a period of 1 year. Were included in our study: patients with and histological diagnosis, and having received at least two cycles of chemotherapy and having presented hematological toxicity: anemia and/or neutropenia. The variables studied were: Age, level of study, socioeconomic level, stage of extension, type of chemotherapy, type of toxicity: neutropenia and anemia. Bivariate analysis was done between anemia, neutropenia and type of chemotherapy. Results: The average age of the patients was 50.35 ± 13.6 years. The extremes were 27 years and 79 years old. The most represented age group was the age group from 37 to 46 years with 18 cases or 33.33%. The most represented level study in our study was the primary level 63%, followed by secondary level 26% and the upper or superior level 11%. Metastatic stage of location was represented in 16.6% of cases, the local stage was represented in 16.7% of cases. The most common chemotherapy used was FAC protocol in 50% of cases, followed by FAC + DOCETAXEL in 47% of cases, AC protocol was used in 3% of cases. The most represented grade of neutropenia was grade 3 in 53% of cases, followed by grade 2 in 27% of cases and grade 1 in 20%. Grade 1 anemia was the most represented in 70% of cases, followed respectively by grade 2 in 27%. The majority of patients had received more than 3 courses of chemotherapy in 83% of cases. Grade 3 neutropenia was observed mostly in the advanced stages, 15 cases at the locoregional stage. Grade 1 anemia was most common in patients who received more than 3 courses of chemotherapy. The FAC chemotherapy protocol was responsible for more grade 3 anemia in 14 cases. FAC-type chemotherapy was associated with grade 3 and 2 neutropenia in 8 cases and 4 cases, but the results were not significant. FAC + DOCEAXEL type chemotherapy was also responsible for grade 3 and 2 neutropenia in 8 cases and 4 cases P > 5% respectively. Conclusion: Hematological toxicity in the context of our limited resources is dominated by anemia and neutropenia. The knowledge of this hematological toxicity is necessary for the limitation of the delay of chemotherapy.展开更多
To the Editor:Immunotherapy has overtaken chemotherapy(Chemo)as the frontline mode of treatment for advanced non-small cell lung cancer(NSCLC).The efficacy of immunotherapies such as immune checkpoint inhibitors(ICIs)...To the Editor:Immunotherapy has overtaken chemotherapy(Chemo)as the frontline mode of treatment for advanced non-small cell lung cancer(NSCLC).The efficacy of immunotherapies such as immune checkpoint inhibitors(ICIs)can be further increased by combining them with Chemo and/or anti-angiogenic therapy.However,these combination treatments are associated with more adverse events,which need to be carefully managed.Although previous meta-analyses have shown that ICI use increased gastrointestinal and skin toxicities,the association between ICIs and hematological toxicity has not been adequately assessed.A study by Kramer et al[1]found that 0.6%of the 7626 ICI-treated patients experienced hematological adverse events;however,only 16%of this group of patients received ICIs+Chemo.Thus,the risks associated with combining ICIs and Chemo may not be fully appreciated.The present study reviewed data from phase III trials of ICIs used in combination with Chemo and/or anti-angiogenic agents to evaluate the hematological toxicity in advanced NSCLC.展开更多
Objective:Artemether is a semi-synthetic derivative of artemisinin and is widely used in the treatment of Plasmodium(P.)falciparum malaria.This study aimed to characterize the safety profile of artemether based on 15-...Objective:Artemether is a semi-synthetic derivative of artemisinin and is widely used in the treatment of Plasmodium(P.)falciparum malaria.This study aimed to characterize the safety profile of artemether based on 15-year data retrived from FDA adverse event reporting system(FAERS).Methods:This is a retrospective analysis on 15-year data of artemether-related adverse effects(AEs)retrieved from the FAERS.AEs were classified according to System Organ Class(SOC)and Preferred Terms(PT).Signal detection was performed using Reporting Odds Ratios(ROR),Proportional Reporting Ratios(PRR),and Empirical Bayes Geometric Mean(EBGM).Stratified analyses examined the impact of demographic factors such as sex,age,and time-to-onset.Temporal patterns and associated risk factors were also investigated.Results:Haemolytic anaemia and haemolysis emerged as the most frequently reported AEs,exhibiting significantly elevated RORs(males:ROR 381.36,95%CI 247.06-588.60;females:ROR 455.11,95%CI 286.43-723.12).Sex-specific differences were evident,with females showing a higher incidence of reproductive-related AEs,including spontaneous abortion and premature labour.Temporal trend analysis revealed that the majority of AEs occurred within the first 30 days after the initiation of artemether administration,indicating a rapid onset.The most affected SOCs were blood and lymphatic system disorders and hepatobiliary disorders.Conclusions:Artemether is associated with a notable frequency of early-onset AEs,particularly hematological and hepatobiliary disorders.The observed sex-specific vulnerability to reproductive AEs highlights the need for sex-conscious clinical approaches.Enhanced post-treatment monitoring and further investigations into the drug’s pharmacokinetics and mechanistic pathways are recommended.展开更多
基金Supported by the grants of the National Natural Science Foundation of China(No.30872591)Shanghai Science and Technology Commission(No.02.04.11.006)
文摘Objective： The aim of the study was to compare the hematologic toxicity of gemcitabine between fixed-dose rate （FDR） infusion and 30-minute standard infusion in the treatment of malignancy. Methods： The 25 malignancy patients confirmed by histopathology or cytology received single-agent gemcitabine or gemcitabine in combination with other chemo- therapeutic agents. These patients were randomly divided into gemcitabine 1000 mg/m2 on dl, d8 at a rate of 10 mg/m2/min arm （FDR arm） or 30 rain arm （standard arm）, every 21 days one cycle. Hematologic toxicity was evaluated at the end of each cycle. Results： The 13 of 25 patients received gemcitabine FDR therapy, a total of 28 cycles was completed, and 32 cycles in the others （12 of 25 patients） with the standard arm. All patients were evaluable for hematologic toxicity. The result showed that the grades 3-4 leucopenia was significantly different between the two arms （14.3% vs 0, P 〈 0.05）, and no significant differences of neutropenia, thrombocytopenia and hemoglobin suppression of grades 3-4 （14.3% vs 3.1%, 10.7% vs 3.1%, 3.6% vs 9.4%, P 〉 0.05, respectively） were observed between the two arms, no grade 4 of hemoglobin suppression was observed. Conclusion： Hematologic toxicity of gemcitabine therapy at a fixed-dose rate for malignancy is tolerable.
文摘Introduction: The objective of our study was to determine the prevalence of hematological toxicity during breast cancer chemotherapy. Patients and Methods: This was a cross-sectional descriptive study that took place in the cancerology and internal medicine department during the period from January 1, 2021 to December 31, 2021, i.e. a period of 1 year. Were included in our study: patients with and histological diagnosis, and having received at least two cycles of chemotherapy and having presented hematological toxicity: anemia and/or neutropenia. The variables studied were: Age, level of study, socioeconomic level, stage of extension, type of chemotherapy, type of toxicity: neutropenia and anemia. Bivariate analysis was done between anemia, neutropenia and type of chemotherapy. Results: The average age of the patients was 50.35 ± 13.6 years. The extremes were 27 years and 79 years old. The most represented age group was the age group from 37 to 46 years with 18 cases or 33.33%. The most represented level study in our study was the primary level 63%, followed by secondary level 26% and the upper or superior level 11%. Metastatic stage of location was represented in 16.6% of cases, the local stage was represented in 16.7% of cases. The most common chemotherapy used was FAC protocol in 50% of cases, followed by FAC + DOCETAXEL in 47% of cases, AC protocol was used in 3% of cases. The most represented grade of neutropenia was grade 3 in 53% of cases, followed by grade 2 in 27% of cases and grade 1 in 20%. Grade 1 anemia was the most represented in 70% of cases, followed respectively by grade 2 in 27%. The majority of patients had received more than 3 courses of chemotherapy in 83% of cases. Grade 3 neutropenia was observed mostly in the advanced stages, 15 cases at the locoregional stage. Grade 1 anemia was most common in patients who received more than 3 courses of chemotherapy. The FAC chemotherapy protocol was responsible for more grade 3 anemia in 14 cases. FAC-type chemotherapy was associated with grade 3 and 2 neutropenia in 8 cases and 4 cases, but the results were not significant. FAC + DOCEAXEL type chemotherapy was also responsible for grade 3 and 2 neutropenia in 8 cases and 4 cases P > 5% respectively. Conclusion: Hematological toxicity in the context of our limited resources is dominated by anemia and neutropenia. The knowledge of this hematological toxicity is necessary for the limitation of the delay of chemotherapy.
基金funded by the China National Science Foundation(Nos.82022048 and 82373121)the Science and Technology Planning Project of Guangzhou(No.202206080013)the National Key Research&Development Programme(No.2022YFC2505100).
文摘To the Editor:Immunotherapy has overtaken chemotherapy(Chemo)as the frontline mode of treatment for advanced non-small cell lung cancer(NSCLC).The efficacy of immunotherapies such as immune checkpoint inhibitors(ICIs)can be further increased by combining them with Chemo and/or anti-angiogenic therapy.However,these combination treatments are associated with more adverse events,which need to be carefully managed.Although previous meta-analyses have shown that ICI use increased gastrointestinal and skin toxicities,the association between ICIs and hematological toxicity has not been adequately assessed.A study by Kramer et al[1]found that 0.6%of the 7626 ICI-treated patients experienced hematological adverse events;however,only 16%of this group of patients received ICIs+Chemo.Thus,the risks associated with combining ICIs and Chemo may not be fully appreciated.The present study reviewed data from phase III trials of ICIs used in combination with Chemo and/or anti-angiogenic agents to evaluate the hematological toxicity in advanced NSCLC.
文摘Objective:Artemether is a semi-synthetic derivative of artemisinin and is widely used in the treatment of Plasmodium(P.)falciparum malaria.This study aimed to characterize the safety profile of artemether based on 15-year data retrived from FDA adverse event reporting system(FAERS).Methods:This is a retrospective analysis on 15-year data of artemether-related adverse effects(AEs)retrieved from the FAERS.AEs were classified according to System Organ Class(SOC)and Preferred Terms(PT).Signal detection was performed using Reporting Odds Ratios(ROR),Proportional Reporting Ratios(PRR),and Empirical Bayes Geometric Mean(EBGM).Stratified analyses examined the impact of demographic factors such as sex,age,and time-to-onset.Temporal patterns and associated risk factors were also investigated.Results:Haemolytic anaemia and haemolysis emerged as the most frequently reported AEs,exhibiting significantly elevated RORs(males:ROR 381.36,95%CI 247.06-588.60;females:ROR 455.11,95%CI 286.43-723.12).Sex-specific differences were evident,with females showing a higher incidence of reproductive-related AEs,including spontaneous abortion and premature labour.Temporal trend analysis revealed that the majority of AEs occurred within the first 30 days after the initiation of artemether administration,indicating a rapid onset.The most affected SOCs were blood and lymphatic system disorders and hepatobiliary disorders.Conclusions:Artemether is associated with a notable frequency of early-onset AEs,particularly hematological and hepatobiliary disorders.The observed sex-specific vulnerability to reproductive AEs highlights the need for sex-conscious clinical approaches.Enhanced post-treatment monitoring and further investigations into the drug’s pharmacokinetics and mechanistic pathways are recommended.
