Featured Article Oncology
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Sugemalimab plus chemotherapy improved progression-free survival and overall survival in advanced ESCC patients

A recent study demonstrated that the utilization of sugemalimab alongside chemotherapy significantly improved progression-free survival and overall survival in treatment-naïve individuals with advanced esophageal squamous cell carcinoma (ESCC). This study’s findings were published in the journal, Nature medicine.

A total of 540 adults, ranging in age from 18 to 75 years, who were diagnosed with locally advanced, unresectable, recurrent or metastatic ESCC and had not undergone any previous systemic treatment, were enrolled in this multicenter, double-blinded, randomized, phase 3 trial. The patients were randomly assigned in a 2:1 ratio to receive either sugemalimab, an anti-PD-L1 antibody at a dose of 1,200 mg or placebo every 3 weeks for a maximum period of 24 months. Additionally, all the randomized patients underwent chemotherapy consisting of cisplatin (80 mg m-2  on day 1) and 5-fluorouracil (800 mg m-2 day-1 on days 1-4) every 3 weeks for a maximum of six cycles.The study assessed both progression-free survival and overall survival outcomes.

With a median follow-up of 15.2 months, the extension of progression-free survival showed statistical significance when comparing sugemalimab plus chemotherapy to placebo plus chemotherapy (median 6.2 months vs 5.4 months). Additionally, overall survival was better with sugemalimab plus chemotherapy when compared to placebo plus chemotherapy (median 15.3 months vs 11.5 months). There was a notably higher objective response rate (60.1% vs 45.2%) observed with sugemalimab plus chemotherapy compared toplacebo plus chemotherapy.

Thus, it can be concluded that the combination of sugemalimab and chemotherapy led to a notable extension in both progression-free survival and overall survival among treatment-naïve individuals with advanced ESCC.

Sugemalimab plus chemotherapy improved progression-free survival and overall survival in advanced ESCC patients

A recent study demonstrated that the utilization of sugemalimab alongside chemotherapy significantly improved progression-free survival and overall survival in treatment-naïve individuals with advanced esophageal squamous cell carcinoma (ESCC). This study’s findings were published in the journal, Nature medicine.

A total of 540 adults, ranging in age from 18 to 75 years, who were diagnosed with locally advanced, unresectable, recurrent or metastatic ESCC and had not undergone any previous systemic treatment, were enrolled in this multicenter, double-blinded, randomized, phase 3 trial. The patients were randomly assigned in a 2:1 ratio to receive either sugemalimab, an anti-PD-L1 antibody at a dose of 1,200 mg or placebo every 3 weeks for a maximum period of 24 months. Additionally, all the randomized patients underwent chemotherapy consisting of cisplatin (80 mg m-2  on day 1) and 5-fluorouracil (800 mg m-2 day-1 on days 1-4) every 3 weeks for a maximum of six cycles.The study assessed both progression-free survival and overall survival outcomes.

With a median follow-up of 15.2 months, the extension of progression-free survival showed statistical significance when comparing sugemalimab plus chemotherapy to placebo plus chemotherapy (median 6.2 months vs 5.4 months). Additionally, overall survival was better with sugemalimab plus chemotherapy when compared to placebo plus chemotherapy (median 15.3 months vs 11.5 months). There was a notably higher objective response rate (60.1% vs 45.2%) observed with sugemalimab plus chemotherapy compared toplacebo plus chemotherapy.

Thus, it can be concluded that the combination of sugemalimab and chemotherapy led to a notable extension in both progression-free survival and overall survival among treatment-naïve individuals with advanced ESCC.

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Oncology
Oncology
2 Min Read
03 May

Sugemalimab plus chemotherapy improved progression-free survival and overall survival in advanced ESCC patients

A recent study demonstrated that the utilization of sugemalimab alongside chemotherapy significantly improved progression-free survival and overall survival in treatment-naïve individuals with advanced esophageal squamous cell carcinoma (ESCC). This study’s findings were published in the journal, Nature medicine.

A total of 540 adults, ranging in age from 18 to 75 years, who were diagnosed with locally advanced, unresectable, recurrent or metastatic ESCC and had not undergone any previous systemic treatment, were enrolled in this multicenter, double-blinded, randomized, phase 3 trial. The patients were randomly assigned in a 2:1 ratio to receive either sugemalimab, an anti-PD-L1 antibody at a dose of 1,200 mg or placebo every 3 weeks for a maximum period of 24 months. Additionally, all the randomized patients underwent chemotherapy consisting of cisplatin (80 mg m-2  on day 1) and 5-fluorouracil (800 mg m-2 day-1 on days 1-4) every 3 weeks for a maximum of six cycles. The study assessed both progression-free survival and overall survival outcomes.

With a median follow-up of 15.2 months, the extension of progression-free survival showed statistical significance when comparing sugemalimab plus chemotherapy to placebo plus chemotherapy (median 6.2 months vs 5.4 months). Additionally, overall survival was better with sugemalimab plus chemotherapy when compared to placebo plus chemotherapy (median 15.3 months vs 11.5 months). There was a notably higher objective response rate (60.1% vs 45.2%) observed with sugemalimab plus chemotherapy compared to placebo plus chemotherapy.

Thus, it can be concluded that the combination of sugemalimab and chemotherapy led to a notable extension in both progression-free survival and overall survival among treatment-naïve individuals with advanced ESCC.

Sugemalimab plus chemotherapy improved progression-free survival and overall survival in advanced ESCC patients

A recent study demonstrated that the utilization of sugemalimab alongside chemotherapy significantly improved progression-free survival and overall survival in treatment-naïve individuals with advanced esophageal squamous cell carcinoma (ESCC). This study’s findings were published in the journal, Nature medicine.

A total of 540 adults, ranging in age from 18 to 75 years, who were diagnosed with locally advanced, unresectable, recurrent or metastatic ESCC and had not undergone any previous systemic treatment, were enrolled in this multicenter, double-blinded, randomized, phase 3 trial. The patients were randomly assigned in a 2:1 ratio to receive either sugemalimab, an anti-PD-L1 antibody at a dose of 1,200 mg or placebo every 3 weeks for a maximum period of 24 months. Additionally, all the randomized patients underwent chemotherapy consisting of cisplatin (80 mg m-2  on day 1) and 5-fluorouracil (800 mg m-2 day-1 on days 1-4) every 3 weeks for a maximum of six cycles. The study assessed both progression-free survival and overall survival outcomes.

With a median follow-up of 15.2 months, the extension of progression-free survival showed statistical significance when comparing sugemalimab plus chemotherapy to placebo plus chemotherapy (median 6.2 months vs 5.4 months). Additionally, overall survival was better with sugemalimab plus chemotherapy when compared to placebo plus chemotherapy (median 15.3 months vs 11.5 months). There was a notably higher objective response rate (60.1% vs 45.2%) observed with sugemalimab plus chemotherapy compared to placebo plus chemotherapy.

Thus, it can be concluded that the combination of sugemalimab and chemotherapy led to a notable extension in both progression-free survival and overall survival among treatment-naïve individuals with advanced ESCC.

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Oncology
2 Min Read
03 May

Sugemalimab plus chemotherapy improved progression-free survival and overall survival in advanced ESCC patients

A recent study demonstrated that the utilization of sugemalimab alongside chemotherapy significantly improved progression-free survival and overall survival in treatment-naïve individuals with advanced esophageal squamous cell carcinoma (ESCC). This study’s findings were published in the journal, Nature medicine.

A total of 540 adults, ranging in age from 18 to 75 years, who were diagnosed with locally advanced, unresectable, recurrent or metastatic ESCC and had not undergone any previous systemic treatment, were enrolled in this multicenter, double-blinded, randomized, phase 3 trial. The patients were randomly assigned in a 2:1 ratio to receive either sugemalimab, an anti-PD-L1 antibody at a dose of 1,200 mg or placebo every 3 weeks for a maximum period of 24 months. Additionally, all the randomized patients underwent chemotherapy consisting of cisplatin (80 mg m-2  on day 1) and 5-fluorouracil (800 mg m-2 day-1 on days 1-4) every 3 weeks for a maximum of six cycles. The study assessed both progression-free survival and overall survival outcomes.

With a median follow-up of 15.2 months, the extension of progression-free survival showed statistical significance when comparing sugemalimab plus chemotherapy to placebo plus chemotherapy (median 6.2 months vs 5.4 months). Additionally, overall survival was better with sugemalimab plus chemotherapy when compared to placebo plus chemotherapy (median 15.3 months vs 11.5 months). There was a notably higher objective response rate (60.1% vs 45.2%) observed with sugemalimab plus chemotherapy compared to placebo plus chemotherapy.

Thus, it can be concluded that the combination of sugemalimab and chemotherapy led to a notable extension in both progression-free survival and overall survival among treatment-naïve individuals with advanced ESCC.

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Urology
Urology
2 Min Read
02 May

Impact of intensified androgen blockade in patients with high-risk biochemically relapsed castration-sensitive prostate cancer

A recent study showed that intensified AR blockade for a finite period extends prostate-specific antigen progression-free survival (PSA-PFS) while maintaining a manageable safety profile, without negatively impacting the time needed for testosterone recovery. This study’s findings were published in the Journal of clinical oncology.

The PRESTO trial was a randomized, open-label, phase III study that involved 503 patients diagnosed with biochemically recurrent prostate cancer (BRPC) and PSA doubling time of 9 months or less. Patients were randomly divided into one of three groups in a 1:1:1 ratio. These groups consisted of a 52-week treatment course with ADT (androgen-deprivation therapy) control, ADT combined with apalutamide, or ADT combined with apalutamide and AAP (abiraterone acetate plus prednisone). The primary endpoint of the trial was to evaluate PSA-PFS, which was defined as having a serum PSA level exceeding 0.2 ng/mL after the completion of the assigned treatment.

The median PSA level was determined to be 1.8 ng/mL (IQR, 1.0-3.6). During the initial planned interim analysis, it was observed that both experimental groups exhibited a significant prolongation in PSA-PFS when compared to the control group (median, ADT + apalutamide was 24.9 months vs 20.3 months for ADT alone; median, ADT + apalutamide + AAP was 26.0 months vs 20.0 months for ADT alone). There was no notable difference in the median time for testosterone recovery across the different treatment arms.

The above results demonstrated that the use of intensified AR blockade for a finite period has been found to PSA-PFS while maintaining a manageable safety profile and not interfering with testosterone recovery time. Consideration should be given to adding apalutamide to androgen deprivation therapy in high-risk BRPC patients.

Impact of intensified androgen blockade in patients with high-risk biochemically relapsed castration-sensitive prostate cancer

A recent study showed that intensified AR blockade for a finite period extends prostate-specific antigen progression-free survival (PSA-PFS) while maintaining a manageable safety profile, without negatively impacting the time needed for testosterone recovery. This study’s findings were published in the Journal of clinical oncology.

The PRESTO trial was a randomized, open-label, phase III study that involved 503 patients diagnosed with biochemically recurrent prostate cancer (BRPC) and PSA doubling time of 9 months or less. Patients were randomly divided into one of three groups in a 1:1:1 ratio. These groups consisted of a 52-week treatment course with ADT (androgen-deprivation therapy) control, ADT combined with apalutamide, or ADT combined with apalutamide and AAP (abiraterone acetate plus prednisone). The primary endpoint of the trial was to evaluate PSA-PFS, which was defined as having a serum PSA level exceeding 0.2 ng/mL after the completion of the assigned treatment.

The median PSA level was determined to be 1.8 ng/mL (IQR, 1.0-3.6). During the initial planned interim analysis, it was observed that both experimental groups exhibited a significant prolongation in PSA-PFS when compared to the control group (median, ADT + apalutamide was 24.9 months vs 20.3 months for ADT alone; median, ADT + apalutamide + AAP was 26.0 months vs 20.0 months for ADT alone). There was no notable difference in the median time for testosterone recovery across the different treatment arms.

The above results demonstrated that the use of intensified AR blockade for a finite period has been found to PSA-PFS while maintaining a manageable safety profile and not interfering with testosterone recovery time. Consideration should be given to adding apalutamide to androgen deprivation therapy in high-risk BRPC patients.

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Urology
2 Min Read
02 May

Impact of intensified androgen blockade in patients with high-risk biochemically relapsed castration-sensitive prostate cancer

A recent study showed that intensified AR blockade for a finite period extends prostate-specific antigen progression-free survival (PSA-PFS) while maintaining a manageable safety profile, without negatively impacting the time needed for testosterone recovery. This study’s findings were published in the Journal of clinical oncology.

The PRESTO trial was a randomized, open-label, phase III study that involved 503 patients diagnosed with biochemically recurrent prostate cancer (BRPC) and PSA doubling time of 9 months or less. Patients were randomly divided into one of three groups in a 1:1:1 ratio. These groups consisted of a 52-week treatment course with ADT (androgen-deprivation therapy) control, ADT combined with apalutamide, or ADT combined with apalutamide and AAP (abiraterone acetate plus prednisone). The primary endpoint of the trial was to evaluate PSA-PFS, which was defined as having a serum PSA level exceeding 0.2 ng/mL after the completion of the assigned treatment.

The median PSA level was determined to be 1.8 ng/mL (IQR, 1.0-3.6). During the initial planned interim analysis, it was observed that both experimental groups exhibited a significant prolongation in PSA-PFS when compared to the control group (median, ADT + apalutamide was 24.9 months vs 20.3 months for ADT alone; median, ADT + apalutamide + AAP was 26.0 months vs 20.0 months for ADT alone). There was no notable difference in the median time for testosterone recovery across the different treatment arms.

The above results demonstrated that the use of intensified AR blockade for a finite period has been found to PSA-PFS while maintaining a manageable safety profile and not interfering with testosterone recovery time. Consideration should be given to adding apalutamide to androgen deprivation therapy in high-risk BRPC patients.

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Paediatric
Paediatric
2 Min Read
26 Apr

Evaluation of the diagnostic accuracy of point-of-care ultrasound for pediatric distal forearm fractures

According to a recent study, clinician-performed point-of-care ultrasound proved to be more precise in diagnosing clinically nondeformed distal forearm injuries in children and adolescents compared to clinician-interpreted radiographic imaging. The findings of this study were published in the journal, Annals of emergency medicine.

This was an open-label, multicenter, diagnostic randomized controlled trial where 270 participants were enrolled. Eligible patients were randomly assigned to undergo initial imaging either through point-of-care ultrasound conducted by an emergency department (ED) clinician or through radiography (135 randomized to each imaging group). The primary outcome was the treating clinician's diagnostic accuracy in comparison to the reference standard diagnosis. The reference standard diagnosis was determined retrospectively by a panel of experts, which included an emergency physician, pediatric orthopedic surgeon, and pediatric radiologist. This panel thoroughly reviewed all imaging and follow-up data.

At the end of the study, it was observed that in the point-of-care ultrasound group, 132 (97.8%) participants were accurately diagnosed by ED clinicians, while in the radiograph group, 112 (83.0%) participants received correct diagnoses. Point-of-care ultrasound demonstrated superior accuracy in detecting "buckle" fractures (AD=18.5%) and "other" fractures (AD=17.1%).

Thus, it can be concluded that clinician-performed point-of-care ultrasound demonstrated superior accuracy in diagnosing clinically nondeformed distal forearm injuries in children and adolescents compared to clinician-interpreted radiographic imaging in the ED.

Evaluation of the diagnostic accuracy of point-of-care ultrasound for pediatric distal forearm fractures

According to a recent study, clinician-performed point-of-care ultrasound proved to be more precise in diagnosing clinically nondeformed distal forearm injuries in children and adolescents compared to clinician-interpreted radiographic imaging. The findings of this study were published in the journal, Annals of emergency medicine.

This was an open-label, multicenter, diagnostic randomized controlled trial where 270 participants were enrolled. Eligible patients were randomly assigned to undergo initial imaging either through point-of-care ultrasound conducted by an emergency department (ED) clinician or through radiography (135 randomized to each imaging group). The primary outcome was the treating clinician's diagnostic accuracy in comparison to the reference standard diagnosis. The reference standard diagnosis was determined retrospectively by a panel of experts, which included an emergency physician, pediatric orthopedic surgeon, and pediatric radiologist. This panel thoroughly reviewed all imaging and follow-up data.

At the end of the study, it was observed that in the point-of-care ultrasound group, 132 (97.8%) participants were accurately diagnosed by ED clinicians, while in the radiograph group, 112 (83.0%) participants received correct diagnoses. Point-of-care ultrasound demonstrated superior accuracy in detecting "buckle" fractures (AD=18.5%) and "other" fractures (AD=17.1%).

Thus, it can be concluded that clinician-performed point-of-care ultrasound demonstrated superior accuracy in diagnosing clinically nondeformed distal forearm injuries in children and adolescents compared to clinician-interpreted radiographic imaging in the ED.

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Paediatric
2 Min Read
26 Apr

Evaluation of the diagnostic accuracy of point-of-care ultrasound for pediatric distal forearm fractures

According to a recent study, clinician-performed point-of-care ultrasound proved to be more precise in diagnosing clinically nondeformed distal forearm injuries in children and adolescents compared to clinician-interpreted radiographic imaging. The findings of this study were published in the journal, Annals of emergency medicine.

This was an open-label, multicenter, diagnostic randomized controlled trial where 270 participants were enrolled. Eligible patients were randomly assigned to undergo initial imaging either through point-of-care ultrasound conducted by an emergency department (ED) clinician or through radiography (135 randomized to each imaging group). The primary outcome was the treating clinician's diagnostic accuracy in comparison to the reference standard diagnosis. The reference standard diagnosis was determined retrospectively by a panel of experts, which included an emergency physician, pediatric orthopedic surgeon, and pediatric radiologist. This panel thoroughly reviewed all imaging and follow-up data.

At the end of the study, it was observed that in the point-of-care ultrasound group, 132 (97.8%) participants were accurately diagnosed by ED clinicians, while in the radiograph group, 112 (83.0%) participants received correct diagnoses. Point-of-care ultrasound demonstrated superior accuracy in detecting "buckle" fractures (AD=18.5%) and "other" fractures (AD=17.1%).

Thus, it can be concluded that clinician-performed point-of-care ultrasound demonstrated superior accuracy in diagnosing clinically nondeformed distal forearm injuries in children and adolescents compared to clinician-interpreted radiographic imaging in the ED.

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Vitamin
Vitamin
2 Min Read
25 Apr

Effect of early vitamin D supplementation on the occurrence of preeclampsia in primigravid women

A recent study found that administration of a monthly dose (60,000 IU) of vitamin D supplementation during the early stages of pregnancy demonstrated a notable decrease in the occurrence of preeclampsia. The study results were published in the journal, BMC pregnancy and childbirth.

This randomised clinical trial included 1300 primigravid women (median maternal age: 21 years; the median gestational age: 15 weeks) who were randomly assigned in a 1:1 ratio to either the supplemented (A) or control (B) group. Pregnant women in group A received a monthly dose of cholecalciferol (60,000 IU) orally for 6 months during antenatal care, while the control group (B) did not receive any vitamin D supplementation or placebo. Serum 25(OH)D levels were checked at the beginning and at 34 weeks of gestation, with outcomes assessed monthly until delivery.

In the intervention group, there was a significant decrease in the risk of preeclampsia (RR = 0.36) and preterm delivery (RR = 0.5). Moreover, an RR of 0.43 was identified for low birth weight and the RR for caesarean section was 0.63. The supplemented group demonstrated significantly higher APGAR scores at the 5th minute and a larger size of newborns.

The above results demonstrate that a single monthly dosage of vitamin D supplementation in early pregnancy had a substantial impact on lowering the occurrence of preeclampsia, as well as mitigating the associated complications experienced by both the mother and the fetus.

Effect of early vitamin D supplementation on the occurrence of preeclampsia in primigravid women

A recent study found that administration of a monthly dose (60,000 IU) of vitamin D supplementation during the early stages of pregnancy demonstrated a notable decrease in the occurrence of preeclampsia. The study results were published in the journal, BMC pregnancy and childbirth.

This randomised clinical trial included 1300 primigravid women (median maternal age: 21 years; the median gestational age: 15 weeks) who were randomly assigned in a 1:1 ratio to either the supplemented (A) or control (B) group. Pregnant women in group A received a monthly dose of cholecalciferol (60,000 IU) orally for 6 months during antenatal care, while the control group (B) did not receive any vitamin D supplementation or placebo. Serum 25(OH)D levels were checked at the beginning and at 34 weeks of gestation, with outcomes assessed monthly until delivery.

In the intervention group, there was a significant decrease in the risk of preeclampsia (RR = 0.36) and preterm delivery (RR = 0.5). Moreover, an RR of 0.43 was identified for low birth weight and the RR for caesarean section was 0.63. The supplemented group demonstrated significantly higher APGAR scores at the 5th minute and a larger size of newborns.

The above results demonstrate that a single monthly dosage of vitamin D supplementation in early pregnancy had a substantial impact on lowering the occurrence of preeclampsia, as well as mitigating the associated complications experienced by both the mother and the fetus.

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Vitamin
2 Min Read
25 Apr

Effect of early vitamin D supplementation on the occurrence of preeclampsia in primigravid women

A recent study found that administration of a monthly dose (60,000 IU) of vitamin D supplementation during the early stages of pregnancy demonstrated a notable decrease in the occurrence of preeclampsia. The study results were published in the journal, BMC pregnancy and childbirth.

This randomised clinical trial included 1300 primigravid women (median maternal age: 21 years; the median gestational age: 15 weeks) who were randomly assigned in a 1:1 ratio to either the supplemented (A) or control (B) group. Pregnant women in group A received a monthly dose of cholecalciferol (60,000 IU) orally for 6 months during antenatal care, while the control group (B) did not receive any vitamin D supplementation or placebo. Serum 25(OH)D levels were checked at the beginning and at 34 weeks of gestation, with outcomes assessed monthly until delivery.

In the intervention group, there was a significant decrease in the risk of preeclampsia (RR = 0.36) and preterm delivery (RR = 0.5). Moreover, an RR of 0.43 was identified for low birth weight and the RR for caesarean section was 0.63. The supplemented group demonstrated significantly higher APGAR scores at the 5th minute and a larger size of newborns.

The above results demonstrate that a single monthly dosage of vitamin D supplementation in early pregnancy had a substantial impact on lowering the occurrence of preeclampsia, as well as mitigating the associated complications experienced by both the mother and the fetus.

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Oncology
Oncology
2 Min Read
24 Apr

Sacituzumab govitecan safe and significantly beneficial over chemotherapy in treating metastatic breast cancer

According to a recent study, sacituzumab govitecan was safe and significantly beneficial over chemotherapy in treating metastatic breast cancer. This study's result were published in the journal, Lancet.

The TROPiCS-02 was a randomized, phase 3, multi-centre, open-label trial that included 543 patients with confirmed hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+ and HER2-). They were randomly assigned in a 1:1 ratio to receive either sacituzumab govitecan (n=272) or chemotherapy (n=271; eribulin, vinorelbine, capecitabine, or gemcitabine). The patients had received at least one previous endocrine therapy, a taxane, as well as a CDK4/6 inhibitor in any setting and 2-4 previous chemotherapy regimens for metastatic disease. The study's primary endpoint was progression-free survival while the secondary endpoints included objective response rate (ORR), overall survival, and patient-reported outcomes.

At the end of the study, it was observed that sacituzumab govitecan significantly improved overall survival. Also, ORR was significantly improved with sacituzumab govitecan as was time to deterioration of global health status and quality of life. The safety profile of sacituzumab govitecan was in accordance with those of the ASCENT trial and primary analysis of TROPiCS-02.

Based on the results of this study, it can be concluded that sacituzumab govitecan may be used as a new treatment option for patients with  pretreated metastatic breast cancer as it may demonstrate statistically significant and clinically meaningful benefits with a manageable safety profile.

Sacituzumab govitecan safe and significantly beneficial over chemotherapy in treating metastatic breast cancer

According to a recent study, sacituzumab govitecan was safe and significantly beneficial over chemotherapy in treating metastatic breast cancer. This study's result were published in the journal, Lancet.

The TROPiCS-02 was a randomized, phase 3, multi-centre, open-label trial that included 543 patients with confirmed hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+ and HER2-). They were randomly assigned in a 1:1 ratio to receive either sacituzumab govitecan (n=272) or chemotherapy (n=271; eribulin, vinorelbine, capecitabine, or gemcitabine). The patients had received at least one previous endocrine therapy, a taxane, as well as a CDK4/6 inhibitor in any setting and 2-4 previous chemotherapy regimens for metastatic disease. The study's primary endpoint was progression-free survival while the secondary endpoints included objective response rate (ORR), overall survival, and patient-reported outcomes.

At the end of the study, it was observed that sacituzumab govitecan significantly improved overall survival. Also, ORR was significantly improved with sacituzumab govitecan as was time to deterioration of global health status and quality of life. The safety profile of sacituzumab govitecan was in accordance with those of the ASCENT trial and primary analysis of TROPiCS-02.

Based on the results of this study, it can be concluded that sacituzumab govitecan may be used as a new treatment option for patients with  pretreated metastatic breast cancer as it may demonstrate statistically significant and clinically meaningful benefits with a manageable safety profile.

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Oncology
2 Min Read
24 Apr

Sacituzumab govitecan safe and significantly beneficial over chemotherapy in treating metastatic breast cancer

According to a recent study, sacituzumab govitecan was safe and significantly beneficial over chemotherapy in treating metastatic breast cancer. This study's result were published in the journal, Lancet.

The TROPiCS-02 was a randomized, phase 3, multi-centre, open-label trial that included 543 patients with confirmed hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+ and HER2-). They were randomly assigned in a 1:1 ratio to receive either sacituzumab govitecan (n=272) or chemotherapy (n=271; eribulin, vinorelbine, capecitabine, or gemcitabine). The patients had received at least one previous endocrine therapy, a taxane, as well as a CDK4/6 inhibitor in any setting and 2-4 previous chemotherapy regimens for metastatic disease. The study's primary endpoint was progression-free survival while the secondary endpoints included objective response rate (ORR), overall survival, and patient-reported outcomes.

At the end of the study, it was observed that sacituzumab govitecan significantly improved overall survival. Also, ORR was significantly improved with sacituzumab govitecan as was time to deterioration of global health status and quality of life. The safety profile of sacituzumab govitecan was in accordance with those of the ASCENT trial and primary analysis of TROPiCS-02.

Based on the results of this study, it can be concluded that sacituzumab govitecan may be used as a new treatment option for patients with  pretreated metastatic breast cancer as it may demonstrate statistically significant and clinically meaningful benefits with a manageable safety profile.

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Paediatric
Paediatric
2 Min Read
23 Apr

Efficacy and safety of dupilumab with concomitant topical corticosteroids for severe atopic dermatitis in children

According to a recent study, dupilumab demonstrated notable improvements in the quality of life of young children who suffer from severe atopic dermatitis (AD), while maintaining an acceptable level of safety. The study’s findings were published in the journal, Advances in therapy.

In this pre-specified subgroup analysis, data of 125 patients aged 6 months to 5 years with severe AD at baseline (Investigator's Global Assessment [IGA] = 4) from a randomized, double-blind, placebo-controlled, phase III trial of dupilumab was examined. Patients were assigned randomly to receive either subcutaneous dupilumab (200/300 mg) [n=63] or a placebo [n=62] every 4 weeks, in addition to low-potency topical corticosteroids for a duration of 16 weeks. The study’s co-primary endpoints at week 16 included the proportion of patients displaying a ≥ 75% improvement from the baseline in Eczema Area and Severity Index (EASI-75) and the proportion of patients achieving IGA ≤ 1 (representing clear or almost clear skin). Secondary endpoints at week 16 included pruritis, mean changes in EASI, sleep loss, skin pain, and quality of life.

At week 16, a significantly higher percentage of patients who were given dupilumab compared to those who were given a placebo had achieved IGA ≤ 1 (14.3% vs. 1.6%) and EASI-75 (46.0% vs. 6.6%). Notable enhancements with dupilumab were seen in all secondary endpoints measured, with a least squares mean reduction of 48.9% in pruritus. The overall occurrence of adverse events (AEs) was comparable in both the dupilumab group (66.7%) and the placebo group (73.8%). No AEs related to dupilumab were severe or led to treatment discontinuation.

Based on the above results, it can be concluded that dupilumab may lead to significant improvement in the signs, symptoms, and overall quality of life for children between the ages of 6 months and 5 years with severe AD. Furthermore, the dupilumab treatment exhibited an acceptable level of safety.

Efficacy and safety of dupilumab with concomitant topical corticosteroids for severe atopic dermatitis in children

According to a recent study, dupilumab demonstrated notable improvements in the quality of life of young children who suffer from severe atopic dermatitis (AD), while maintaining an acceptable level of safety. The study’s findings were published in the journal, Advances in therapy.

In this pre-specified subgroup analysis, data of 125 patients aged 6 months to 5 years with severe AD at baseline (Investigator's Global Assessment [IGA] = 4) from a randomized, double-blind, placebo-controlled, phase III trial of dupilumab was examined. Patients were assigned randomly to receive either subcutaneous dupilumab (200/300 mg) [n=63] or a placebo [n=62] every 4 weeks, in addition to low-potency topical corticosteroids for a duration of 16 weeks. The study’s co-primary endpoints at week 16 included the proportion of patients displaying a ≥ 75% improvement from the baseline in Eczema Area and Severity Index (EASI-75) and the proportion of patients achieving IGA ≤ 1 (representing clear or almost clear skin). Secondary endpoints at week 16 included pruritis, mean changes in EASI, sleep loss, skin pain, and quality of life.

At week 16, a significantly higher percentage of patients who were given dupilumab compared to those who were given a placebo had achieved IGA ≤ 1 (14.3% vs. 1.6%) and EASI-75 (46.0% vs. 6.6%). Notable enhancements with dupilumab were seen in all secondary endpoints measured, with a least squares mean reduction of 48.9% in pruritus. The overall occurrence of adverse events (AEs) was comparable in both the dupilumab group (66.7%) and the placebo group (73.8%). No AEs related to dupilumab were severe or led to treatment discontinuation.

Based on the above results, it can be concluded that dupilumab may lead to significant improvement in the signs, symptoms, and overall quality of life for children between the ages of 6 months and 5 years with severe AD. Furthermore, the dupilumab treatment exhibited an acceptable level of safety.

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Paediatric
2 Min Read
23 Apr

Efficacy and safety of dupilumab with concomitant topical corticosteroids for severe atopic dermatitis in children

According to a recent study, dupilumab demonstrated notable improvements in the quality of life of young children who suffer from severe atopic dermatitis (AD), while maintaining an acceptable level of safety. The study’s findings were published in the journal, Advances in therapy.

In this pre-specified subgroup analysis, data of 125 patients aged 6 months to 5 years with severe AD at baseline (Investigator's Global Assessment [IGA] = 4) from a randomized, double-blind, placebo-controlled, phase III trial of dupilumab was examined. Patients were assigned randomly to receive either subcutaneous dupilumab (200/300 mg) [n=63] or a placebo [n=62] every 4 weeks, in addition to low-potency topical corticosteroids for a duration of 16 weeks. The study’s co-primary endpoints at week 16 included the proportion of patients displaying a ≥ 75% improvement from the baseline in Eczema Area and Severity Index (EASI-75) and the proportion of patients achieving IGA ≤ 1 (representing clear or almost clear skin). Secondary endpoints at week 16 included pruritis, mean changes in EASI, sleep loss, skin pain, and quality of life.

At week 16, a significantly higher percentage of patients who were given dupilumab compared to those who were given a placebo had achieved IGA ≤ 1 (14.3% vs. 1.6%) and EASI-75 (46.0% vs. 6.6%). Notable enhancements with dupilumab were seen in all secondary endpoints measured, with a least squares mean reduction of 48.9% in pruritus. The overall occurrence of adverse events (AEs) was comparable in both the dupilumab group (66.7%) and the placebo group (73.8%). No AEs related to dupilumab were severe or led to treatment discontinuation.

Based on the above results, it can be concluded that dupilumab may lead to significant improvement in the signs, symptoms, and overall quality of life for children between the ages of 6 months and 5 years with severe AD. Furthermore, the dupilumab treatment exhibited an acceptable level of safety.

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Neuro
Neuro
2 Min Read
22 Apr

Efficacy and safety of ticagrelor versus clopidogrel among patients with minor stroke or transient ischemic attack

A recent study found that ticagrelor- acetylsalicylic acid (ASA) conferred more benefit to patients with elevated homocysteine levels, especially women, among patients with minor ischemic stroke or transient ischemic attack (TIA). The results of this study were published in the journal, CMAJ (Canadian Medical Association Journal).

A post hoc analysis was carried out on the CHANCE-2 trial (The Clopidogrel in High-risk Patients with Acute Nondisabling Cerebrovascular Events-II). Participants were randomly assigned to receive treatment with either ticagrelor-ASA (n=2740) or clopidogrel-ASA (n=2700). The primary efficacy outcome of the study was recurrent stroke within 90-day follow-up while the primary safety outcome of the study was severe or moderate bleeding within 90 days.

It was observed that use of ticagrelor-ASA was linked to a reduced risk of recurrent stroke among participants with increased homocysteine levels (74 v. 119). The benefits of ticagrelor-ASA with regard to recurrent stroke seemed to increase with increasing homocysteine levels. Also, a significant interaction between homocysteine levels and therapy was found with regard to recurrent stroke in female participants.

Based on the above comparison between clopidogrel-ASA and ticagrelor-ASA, it can be concluded that more benefit may be conferred to patients with elevated homocysteine levels, particularly to females among patients with minor ischemic stroke or TIA.

Efficacy and safety of ticagrelor versus clopidogrel among patients with minor stroke or transient ischemic attack

A recent study found that ticagrelor- acetylsalicylic acid (ASA) conferred more benefit to patients with elevated homocysteine levels, especially women, among patients with minor ischemic stroke or transient ischemic attack (TIA). The results of this study were published in the journal, CMAJ (Canadian Medical Association Journal).

A post hoc analysis was carried out on the CHANCE-2 trial (The Clopidogrel in High-risk Patients with Acute Nondisabling Cerebrovascular Events-II). Participants were randomly assigned to receive treatment with either ticagrelor-ASA (n=2740) or clopidogrel-ASA (n=2700). The primary efficacy outcome of the study was recurrent stroke within 90-day follow-up while the primary safety outcome of the study was severe or moderate bleeding within 90 days.

It was observed that use of ticagrelor-ASA was linked to a reduced risk of recurrent stroke among participants with increased homocysteine levels (74 v. 119). The benefits of ticagrelor-ASA with regard to recurrent stroke seemed to increase with increasing homocysteine levels. Also, a significant interaction between homocysteine levels and therapy was found with regard to recurrent stroke in female participants.

Based on the above comparison between clopidogrel-ASA and ticagrelor-ASA, it can be concluded that more benefit may be conferred to patients with elevated homocysteine levels, particularly to females among patients with minor ischemic stroke or TIA.

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Neuro
2 Min Read
22 Apr

Efficacy and safety of ticagrelor versus clopidogrel among patients with minor stroke or transient ischemic attack

A recent study found that ticagrelor- acetylsalicylic acid (ASA) conferred more benefit to patients with elevated homocysteine levels, especially women, among patients with minor ischemic stroke or transient ischemic attack (TIA). The results of this study were published in the journal, CMAJ (Canadian Medical Association Journal).

A post hoc analysis was carried out on the CHANCE-2 trial (The Clopidogrel in High-risk Patients with Acute Nondisabling Cerebrovascular Events-II). Participants were randomly assigned to receive treatment with either ticagrelor-ASA (n=2740) or clopidogrel-ASA (n=2700). The primary efficacy outcome of the study was recurrent stroke within 90-day follow-up while the primary safety outcome of the study was severe or moderate bleeding within 90 days.

It was observed that use of ticagrelor-ASA was linked to a reduced risk of recurrent stroke among participants with increased homocysteine levels (74 v. 119). The benefits of ticagrelor-ASA with regard to recurrent stroke seemed to increase with increasing homocysteine levels. Also, a significant interaction between homocysteine levels and therapy was found with regard to recurrent stroke in female participants.

Based on the above comparison between clopidogrel-ASA and ticagrelor-ASA, it can be concluded that more benefit may be conferred to patients with elevated homocysteine levels, particularly to females among patients with minor ischemic stroke or TIA.

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Vitamin
Vitamin
2 Min Read
19 Apr

Effect of high-dose cholecalciferol supplementation in obese infertile men

A recent study suggests that that infertile men with obesity and low vitamin D status can attain adequate serum calcidiol (25OHD) levels through the supplementation of high-dose cholecalciferol (vitamin D3). This study’s findings were published in The British journal of nutrition.

The study was a double-blinded, randomized clinical trial conducted at a single center, with 307 infertile men assigned to either active treatment or a placebo for a period of 150 days. Participants in the active group were given an initial oral bolus of 300 000 mg of vitamin D3, followed by daily supplementation of 1400 mg of vitamin D3 and 500 mg of calcium.

At baseline, it was observed that men with a normal weight (BMI < 25 kg/m2) had notably higher levels of serum 25OHD compared to men who were overweight (BMI 25-30 kg/m2) and obese (BMI > 30 kg/m2) (48 nmol/l vs. 45 nmol/l and 39 nmol/l, respectively). Subsequently, after the intervention, it was found that men with normal weight, overweight, and obesity who received vitamin D3 treatment exhibited significantly higher levels of serum 25OHD in comparison to men in the corresponding placebo group (92 nmol/l vs. 53 nmol/l, 87 nmol/l vs. 49 nmol/l, and 85 nmol/l vs. 48 nmol/l; respectively).

Based on the above results, it can be concluded that high-dose vitamin D3 supplementation in obese infertile men with low vitamin D levels is effective in attaining optimal serum 25OHD levels.

Effect of high-dose cholecalciferol supplementation in obese infertile men

A recent study suggests that that infertile men with obesity and low vitamin D status can attain adequate serum calcidiol (25OHD) levels through the supplementation of high-dose cholecalciferol (vitamin D3). This study’s findings were published in The British journal of nutrition.

The study was a double-blinded, randomized clinical trial conducted at a single center, with 307 infertile men assigned to either active treatment or a placebo for a period of 150 days. Participants in the active group were given an initial oral bolus of 300 000 mg of vitamin D3, followed by daily supplementation of 1400 mg of vitamin D3 and 500 mg of calcium.

At baseline, it was observed that men with a normal weight (BMI < 25 kg/m2) had notably higher levels of serum 25OHD compared to men who were overweight (BMI 25-30 kg/m2) and obese (BMI > 30 kg/m2) (48 nmol/l vs. 45 nmol/l and 39 nmol/l, respectively). Subsequently, after the intervention, it was found that men with normal weight, overweight, and obesity who received vitamin D3 treatment exhibited significantly higher levels of serum 25OHD in comparison to men in the corresponding placebo group (92 nmol/l vs. 53 nmol/l, 87 nmol/l vs. 49 nmol/l, and 85 nmol/l vs. 48 nmol/l; respectively).

Based on the above results, it can be concluded that high-dose vitamin D3 supplementation in obese infertile men with low vitamin D levels is effective in attaining optimal serum 25OHD levels.

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Vitamin
2 Min Read
19 Apr

Effect of high-dose cholecalciferol supplementation in obese infertile men

A recent study suggests that that infertile men with obesity and low vitamin D status can attain adequate serum calcidiol (25OHD) levels through the supplementation of high-dose cholecalciferol (vitamin D3). This study’s findings were published in The British journal of nutrition.

The study was a double-blinded, randomized clinical trial conducted at a single center, with 307 infertile men assigned to either active treatment or a placebo for a period of 150 days. Participants in the active group were given an initial oral bolus of 300 000 mg of vitamin D3, followed by daily supplementation of 1400 mg of vitamin D3 and 500 mg of calcium.

At baseline, it was observed that men with a normal weight (BMI < 25 kg/m2) had notably higher levels of serum 25OHD compared to men who were overweight (BMI 25-30 kg/m2) and obese (BMI > 30 kg/m2) (48 nmol/l vs. 45 nmol/l and 39 nmol/l, respectively). Subsequently, after the intervention, it was found that men with normal weight, overweight, and obesity who received vitamin D3 treatment exhibited significantly higher levels of serum 25OHD in comparison to men in the corresponding placebo group (92 nmol/l vs. 53 nmol/l, 87 nmol/l vs. 49 nmol/l, and 85 nmol/l vs. 48 nmol/l; respectively).

Based on the above results, it can be concluded that high-dose vitamin D3 supplementation in obese infertile men with low vitamin D levels is effective in attaining optimal serum 25OHD levels.

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PainAnalgesia
PainAnalgesia
2 Min Read
18 Apr

Efficacy of ultrasound-guided radiofrequency ablation for chronic osteoarthritis knee pain

According to a recent study, ultrasound guidance in radiofrequency ablation (RFA) targeting knee nerves has been shown to significantly decrease pain caused by knee osteoarthritis (KOA), enhance the function of the knee joint, improve patient satisfaction, and present a practical, safe, and successful minimally invasive procedure for elderly patients with moderate to severe KOA. This study’s findings were published in the journal, Pain Physician.

This prospective randomized controlled study included 120 patients who were aged 50 years or older, experiencing chronic knee joint pain for a minimum of 6 months, with a numeric rating scale (NRS) score of at least 4, and classified as grade III-IV based on the Kellgren-Lawrence system. The principle for selecting the target nerves was as follows: for medial knee pain, the inferior medial genicular nerve (IMGN) branch and superomedial genicular nerve (SMGN) branch of the saphenous nerve were chosen; for lateral pain, the superolateral genicular nerve (SLGN) branch of the femoral nerve was selected; and for total knee pain, the SMGN, IMGN, and SLGN branches were selected. The main outcomes measured were the NRS pain score (including the most severe pain), the percentage of patients who achieved a pain reduction of more than 2 points, and the average pain. The Western Ontario McMaster University Osteoarthritis Index (WOMAC) score was the secondary outcome measure. In the RFA group, RFA at 70ºC was conducted for 120 seconds per patient, while knee nerve blocks were administered in the control group.

At the end of the study, significant variations were observed in the mean NRS scores and worst pain levels among the treatment groups during the first, third, and, sixth months post-treatment. The mean WOMAC pain, physical function, and total scores differed significantly between the treatment groups and over time. Following treatment, the proportion of patients needing analgesic drugs was notably lower in the RFA group than in the control group.

Thus, it can be concluded that ultrasound guidance in RFA-applied knee nerves has been found to significantly alleviate pain caused by KOA. This minimally invasive procedure is considered safe and efficacious for elderly patients with moderate to severe KOA.

Efficacy of ultrasound-guided radiofrequency ablation for chronic osteoarthritis knee pain

According to a recent study, ultrasound guidance in radiofrequency ablation (RFA) targeting knee nerves has been shown to significantly decrease pain caused by knee osteoarthritis (KOA), enhance the function of the knee joint, improve patient satisfaction, and present a practical, safe, and successful minimally invasive procedure for elderly patients with moderate to severe KOA. This study’s findings were published in the journal, Pain Physician.

This prospective randomized controlled study included 120 patients who were aged 50 years or older, experiencing chronic knee joint pain for a minimum of 6 months, with a numeric rating scale (NRS) score of at least 4, and classified as grade III-IV based on the Kellgren-Lawrence system. The principle for selecting the target nerves was as follows: for medial knee pain, the inferior medial genicular nerve (IMGN) branch and superomedial genicular nerve (SMGN) branch of the saphenous nerve were chosen; for lateral pain, the superolateral genicular nerve (SLGN) branch of the femoral nerve was selected; and for total knee pain, the SMGN, IMGN, and SLGN branches were selected. The main outcomes measured were the NRS pain score (including the most severe pain), the percentage of patients who achieved a pain reduction of more than 2 points, and the average pain. The Western Ontario McMaster University Osteoarthritis Index (WOMAC) score was the secondary outcome measure. In the RFA group, RFA at 70ºC was conducted for 120 seconds per patient, while knee nerve blocks were administered in the control group.

At the end of the study, significant variations were observed in the mean NRS scores and worst pain levels among the treatment groups during the first, third, and, sixth months post-treatment. The mean WOMAC pain, physical function, and total scores differed significantly between the treatment groups and over time. Following treatment, the proportion of patients needing analgesic drugs was notably lower in the RFA group than in the control group.

Thus, it can be concluded that ultrasound guidance in RFA-applied knee nerves has been found to significantly alleviate pain caused by KOA. This minimally invasive procedure is considered safe and efficacious for elderly patients with moderate to severe KOA.

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PainAnalgesia
2 Min Read
18 Apr

Efficacy of ultrasound-guided radiofrequency ablation for chronic osteoarthritis knee pain

According to a recent study, ultrasound guidance in radiofrequency ablation (RFA) targeting knee nerves has been shown to significantly decrease pain caused by knee osteoarthritis (KOA), enhance the function of the knee joint, improve patient satisfaction, and present a practical, safe, and successful minimally invasive procedure for elderly patients with moderate to severe KOA. This study’s findings were published in the journal, Pain Physician.

This prospective randomized controlled study included 120 patients who were aged 50 years or older, experiencing chronic knee joint pain for a minimum of 6 months, with a numeric rating scale (NRS) score of at least 4, and classified as grade III-IV based on the Kellgren-Lawrence system. The principle for selecting the target nerves was as follows: for medial knee pain, the inferior medial genicular nerve (IMGN) branch and superomedial genicular nerve (SMGN) branch of the saphenous nerve were chosen; for lateral pain, the superolateral genicular nerve (SLGN) branch of the femoral nerve was selected; and for total knee pain, the SMGN, IMGN, and SLGN branches were selected. The main outcomes measured were the NRS pain score (including the most severe pain), the percentage of patients who achieved a pain reduction of more than 2 points, and the average pain. The Western Ontario McMaster University Osteoarthritis Index (WOMAC) score was the secondary outcome measure. In the RFA group, RFA at 70ºC was conducted for 120 seconds per patient, while knee nerve blocks were administered in the control group.

At the end of the study, significant variations were observed in the mean NRS scores and worst pain levels among the treatment groups during the first, third, and, sixth months post-treatment. The mean WOMAC pain, physical function, and total scores differed significantly between the treatment groups and over time. Following treatment, the proportion of patients needing analgesic drugs was notably lower in the RFA group than in the control group.

Thus, it can be concluded that ultrasound guidance in RFA-applied knee nerves has been found to significantly alleviate pain caused by KOA. This minimally invasive procedure is considered safe and efficacious for elderly patients with moderate to severe KOA.

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