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Editor’s note iNature is China’s largest academic public account.
It is jointly created by a team of doctors from Tsinghua University, Harvard University, Chinese Academy of Sciences and other units.
The iNature talent public account is now launched, focusing on talent recruitment, academic progress, scientific research information, interested parties can Long press or scan the QR code below to follow us
.
iNature estimates that there are 567,000 new cases of thyroid cancer each year in the world, and China accounts for approximately 34% of all cases in the world
.
Differentiated thyroid cancer (DTC) is the most common type, accounting for more than 90% of thyroid cancers consisting of papillary carcinoma, follicular carcinoma, Hürthle cell carcinoma, and poorly differentiated carcinoma
.
Up to 30% of DTC patients will have disease recurrence.
30% of cancers will eventually be ineffective to radioactive iodine.
Patients with radioactive iodine refractory DTC (RAIR-DTC) have a poor prognosis, with a 10-year survival rate of 10% and limited treatment options
.
On December 16, 2021, the Chinese Academy of Medical Sciences/Peking Union Medical College Lin Yansong and Nanjing University of Traditional Chinese Medicine Qin Shukui jointly published an online newsletter entitled "Apatinib vs Placebo in Patients With Locally Advanced or Metastatic, Radioactive" in JAMA Oncology (IF=32) Iodine–Refractory Differentiated Thyroid Cancer, The REALITY Randomized Clinical Trial" research paper, the purpose of this study is to evaluate apatinib (a highly selective vascular endothelial growth factor (VEGFR-2) inhibitor) for progressive locally advanced Or the efficacy and safety of patients with metastatic RAIR-DTC
.
This randomized, double-blind, placebo-controlled phase 3 trial was conducted in 92 patients with progressive locally advanced or metastatic RAIR-DTC.
The data cut-off date for this analysis is March 25, 2020
.
Patients were randomly assigned (1:1) to apatinib (500 mg/day) or placebo
.
The primary endpoint is progression-free survival (PFS) as assessed by the investigator
.
Secondary endpoints include overall survival, objective response rate (ORR), disease control rate (DCR), duration of remission, time to objective remission, and safety
.
Of the 92 patients included in the trial, 56 were women (60.
9%); the mean (SD) age at baseline was 55.
7 years
.
Patients were randomly assigned to the apatinib group (n = 46) or placebo (n = 46) group
.
The median follow-up time was 18.
1 (IQR, 12.
7-22.
2) months
.
The median PFS of apatinib was 22.
2 months, while that of placebo was 4.
5 months (hazard ratio, 0.
26; 95% CI, 0.
14-0.
47; P <.
001); the confirmed ORR in the apatinib group was 54.
3 % (95% CI, 39.
0%-69.
1%), DCR was 95.
7% (95% CI, 85.
2%-99.
5%), ORR of the placebo group was 2.
2% (95% CI, 0.
1%-11.
5%) and DCR It was 58.
7% (95% CI, 43.
2%-73.
0%); the median overall survival of apatinib was not reached (95% CI, 26.
25-not reached), and the placebo was 29.
9 months (95% CI, 18.
96) -Not reached) (hazard ratio, 0.
42; 95% CI, 0.
18-0.
97; P = .
04)
.
The most common grade 3 or higher treatment-related adverse events in the apatinib group were hypertension (16 [34.
8%]), hand-foot syndrome (8 [17.
4%]), and proteinuria (7 [15.
2%]) And diarrhea (7 [15.
2%])-none of these occurred in the placebo group
.
In summary, the clinical trial found that in patients with progressive locally advanced or metastatic RAIR-DTC, apatinib has shown significant clinical benefits in prolonging PFS and overall survival, and its safety is controllable
.
According to the GLOBOCAN 2018 database, there are an estimated 567,000 new cases of thyroid cancer each year in the world, and China accounts for approximately 34% of all cases in the world
.
Differentiated thyroid cancer (DTC) is the most common type.
More than 90% of thyroid cancers are composed of papillary carcinoma, follicular carcinoma, Hürthle cell carcinoma, and poorly differentiated carcinoma
.
Up to 30% of DTC patients will have disease recurrence, 30% of cancers will eventually be ineffective to radioactive iodine, radioactive iodine refractory DTC (RAIR-DTC) patients have a poor prognosis, and the 10-year survival rate is 10%
.
In the DECISION and SELECT trials, it was found that sorafenib (Sorafenib) and lenvatinib (lenvatinib, angiogenesis inhibitor) can prolong the progression-free survival (PFS) of patients with RAIR-DTC
.
However, with the exception of the subgroup of patients older than 65 years in the SELECT trial, no significant overall survival (OS) benefit was observed
.
Sorafenib and levatinib are not available for the treatment of thyroid cancer in China until 2017 (sorafenib) and 2020 (levatinib)
.
In addition, a relatively high proportion of patients with advanced disease in China, especially RAIR-DTC, may also lead to a poor prognosis
.
The large number of unmet clinical needs and limited treatment options are worth exploring alternative strategies for RAIR-DTC patients
.
Apatinib is a small molecule angiogenesis inhibitor with high selectivity for VEGFR-2
.
In a previous preliminary study, the effectiveness and safety of apatinib were evaluated in patients with RAIR-DTC in China
.
Ten eligible patients took apatinib 750 mg orally once a day for 8 weeks
.
The objective response rate (ORR) reached 90%, and the total diameter of the target lesion was reduced by 41%
.
All adverse events are acceptable and controllable
.
However, 5 patients developed Grade 3 hand-foot syndrome, indicating a relatively high incidence of treatment-related adverse events
.
Summary of article results (picture from JAMA Oncology) In a subsequent study, 10 RAIR-DTC patients were enrolled and received apatinib 500 mg/d treatment
.
After 6 courses of treatment, compared with apatinib 750 mg/d, 500 mg/d apatinib treatment showed similar disease control rate (DCR), tumor shrinkage, and reduced thyroglobulin levels, but 500 mg/d The incidence of adverse events related to apatinib treatment on d was lower than that on apatinib treatment at 750 mg/d
.
Based on the results of these studies, the study conducted a randomized, double-blind, placebo-controlled, multicenter phase 3 trial to evaluate the progressive locally advanced or metastatic RAIR of apatinib at an initial dose of 500 mg/d -Efficacy and safety in DTC patients
.
This randomized, double-blind, placebo-controlled phase 3 trial was conducted in 92 patients with progressive locally advanced or metastatic RAIR-DTC.
The data cut-off date for this analysis is March 25, 2020
.
Patients were randomly assigned (1:1) to apatinib (500 mg/day) or placebo
.
The primary endpoint is progression-free survival (PFS) as assessed by the investigator
.
Secondary endpoints include overall survival, objective response rate (ORR), disease control rate (DCR), duration of remission, time to objective remission, and safety
.
Of the 92 patients included in the trial, 56 were women (60.
9%); the mean (SD) age at baseline was 55.
7 years
.
Patients were randomly assigned to the apatinib group (n = 46) or placebo (n = 46) group
.
The median follow-up time was 18.
1 (IQR, 12.
7-22.
2) months
.
The median PFS of apatinib was 22.
2 months, while that of placebo was 4.
5 months (hazard ratio, 0.
26; 95% CI, 0.
14-0.
47; P <.
001); the confirmed ORR in the apatinib group was 54.
3 % (95% CI, 39.
0%-69.
1%), DCR was 95.
7% (95% CI, 85.
2%-99.
5%), ORR of the placebo group was 2.
2% (95% CI, 0.
1%-11.
5%) and DCR It was 58.
7% (95% CI, 43.
2%-73.
0%); the median overall survival of apatinib was not reached (95% CI, 26.
25-not reached), and the placebo was 29.
9 months (95% CI, 18.
96) -Not reached) (hazard ratio, 0.
42; 95% CI, 0.
18-0.
97; P = .
04)
.
The most common grade 3 or higher treatment-related adverse events in the apatinib group were hypertension (16 [34.
8%]), hand-foot syndrome (8 [17.
4%]), and proteinuria (7 [15.
2%]) And diarrhea (7 [15.
2%])-none of these occurred in the placebo group
.
In summary, the clinical trial found that in patients with progressive locally advanced or metastatic RAIR-DTC, apatinib has shown significant clinical benefits in prolonging PFS and overall survival, and its safety is controllable
.
Reference message: https://jamanetwork.
com/journals/jamaoncology/fullarticle/2786815
It is jointly created by a team of doctors from Tsinghua University, Harvard University, Chinese Academy of Sciences and other units.
The iNature talent public account is now launched, focusing on talent recruitment, academic progress, scientific research information, interested parties can Long press or scan the QR code below to follow us
.
iNature estimates that there are 567,000 new cases of thyroid cancer each year in the world, and China accounts for approximately 34% of all cases in the world
.
Differentiated thyroid cancer (DTC) is the most common type, accounting for more than 90% of thyroid cancers consisting of papillary carcinoma, follicular carcinoma, Hürthle cell carcinoma, and poorly differentiated carcinoma
.
Up to 30% of DTC patients will have disease recurrence.
30% of cancers will eventually be ineffective to radioactive iodine.
Patients with radioactive iodine refractory DTC (RAIR-DTC) have a poor prognosis, with a 10-year survival rate of 10% and limited treatment options
.
On December 16, 2021, the Chinese Academy of Medical Sciences/Peking Union Medical College Lin Yansong and Nanjing University of Traditional Chinese Medicine Qin Shukui jointly published an online newsletter entitled "Apatinib vs Placebo in Patients With Locally Advanced or Metastatic, Radioactive" in JAMA Oncology (IF=32) Iodine–Refractory Differentiated Thyroid Cancer, The REALITY Randomized Clinical Trial" research paper, the purpose of this study is to evaluate apatinib (a highly selective vascular endothelial growth factor (VEGFR-2) inhibitor) for progressive locally advanced Or the efficacy and safety of patients with metastatic RAIR-DTC
.
This randomized, double-blind, placebo-controlled phase 3 trial was conducted in 92 patients with progressive locally advanced or metastatic RAIR-DTC.
The data cut-off date for this analysis is March 25, 2020
.
Patients were randomly assigned (1:1) to apatinib (500 mg/day) or placebo
.
The primary endpoint is progression-free survival (PFS) as assessed by the investigator
.
Secondary endpoints include overall survival, objective response rate (ORR), disease control rate (DCR), duration of remission, time to objective remission, and safety
.
Of the 92 patients included in the trial, 56 were women (60.
9%); the mean (SD) age at baseline was 55.
7 years
.
Patients were randomly assigned to the apatinib group (n = 46) or placebo (n = 46) group
.
The median follow-up time was 18.
1 (IQR, 12.
7-22.
2) months
.
The median PFS of apatinib was 22.
2 months, while that of placebo was 4.
5 months (hazard ratio, 0.
26; 95% CI, 0.
14-0.
47; P <.
001); the confirmed ORR in the apatinib group was 54.
3 % (95% CI, 39.
0%-69.
1%), DCR was 95.
7% (95% CI, 85.
2%-99.
5%), ORR of the placebo group was 2.
2% (95% CI, 0.
1%-11.
5%) and DCR It was 58.
7% (95% CI, 43.
2%-73.
0%); the median overall survival of apatinib was not reached (95% CI, 26.
25-not reached), and the placebo was 29.
9 months (95% CI, 18.
96) -Not reached) (hazard ratio, 0.
42; 95% CI, 0.
18-0.
97; P = .
04)
.
The most common grade 3 or higher treatment-related adverse events in the apatinib group were hypertension (16 [34.
8%]), hand-foot syndrome (8 [17.
4%]), and proteinuria (7 [15.
2%]) And diarrhea (7 [15.
2%])-none of these occurred in the placebo group
.
In summary, the clinical trial found that in patients with progressive locally advanced or metastatic RAIR-DTC, apatinib has shown significant clinical benefits in prolonging PFS and overall survival, and its safety is controllable
.
According to the GLOBOCAN 2018 database, there are an estimated 567,000 new cases of thyroid cancer each year in the world, and China accounts for approximately 34% of all cases in the world
.
Differentiated thyroid cancer (DTC) is the most common type.
More than 90% of thyroid cancers are composed of papillary carcinoma, follicular carcinoma, Hürthle cell carcinoma, and poorly differentiated carcinoma
.
Up to 30% of DTC patients will have disease recurrence, 30% of cancers will eventually be ineffective to radioactive iodine, radioactive iodine refractory DTC (RAIR-DTC) patients have a poor prognosis, and the 10-year survival rate is 10%
.
In the DECISION and SELECT trials, it was found that sorafenib (Sorafenib) and lenvatinib (lenvatinib, angiogenesis inhibitor) can prolong the progression-free survival (PFS) of patients with RAIR-DTC
.
However, with the exception of the subgroup of patients older than 65 years in the SELECT trial, no significant overall survival (OS) benefit was observed
.
Sorafenib and levatinib are not available for the treatment of thyroid cancer in China until 2017 (sorafenib) and 2020 (levatinib)
.
In addition, a relatively high proportion of patients with advanced disease in China, especially RAIR-DTC, may also lead to a poor prognosis
.
The large number of unmet clinical needs and limited treatment options are worth exploring alternative strategies for RAIR-DTC patients
.
Apatinib is a small molecule angiogenesis inhibitor with high selectivity for VEGFR-2
.
In a previous preliminary study, the effectiveness and safety of apatinib were evaluated in patients with RAIR-DTC in China
.
Ten eligible patients took apatinib 750 mg orally once a day for 8 weeks
.
The objective response rate (ORR) reached 90%, and the total diameter of the target lesion was reduced by 41%
.
All adverse events are acceptable and controllable
.
However, 5 patients developed Grade 3 hand-foot syndrome, indicating a relatively high incidence of treatment-related adverse events
.
Summary of article results (picture from JAMA Oncology) In a subsequent study, 10 RAIR-DTC patients were enrolled and received apatinib 500 mg/d treatment
.
After 6 courses of treatment, compared with apatinib 750 mg/d, 500 mg/d apatinib treatment showed similar disease control rate (DCR), tumor shrinkage, and reduced thyroglobulin levels, but 500 mg/d The incidence of adverse events related to apatinib treatment on d was lower than that on apatinib treatment at 750 mg/d
.
Based on the results of these studies, the study conducted a randomized, double-blind, placebo-controlled, multicenter phase 3 trial to evaluate the progressive locally advanced or metastatic RAIR of apatinib at an initial dose of 500 mg/d -Efficacy and safety in DTC patients
.
This randomized, double-blind, placebo-controlled phase 3 trial was conducted in 92 patients with progressive locally advanced or metastatic RAIR-DTC.
The data cut-off date for this analysis is March 25, 2020
.
Patients were randomly assigned (1:1) to apatinib (500 mg/day) or placebo
.
The primary endpoint is progression-free survival (PFS) as assessed by the investigator
.
Secondary endpoints include overall survival, objective response rate (ORR), disease control rate (DCR), duration of remission, time to objective remission, and safety
.
Of the 92 patients included in the trial, 56 were women (60.
9%); the mean (SD) age at baseline was 55.
7 years
.
Patients were randomly assigned to the apatinib group (n = 46) or placebo (n = 46) group
.
The median follow-up time was 18.
1 (IQR, 12.
7-22.
2) months
.
The median PFS of apatinib was 22.
2 months, while that of placebo was 4.
5 months (hazard ratio, 0.
26; 95% CI, 0.
14-0.
47; P <.
001); the confirmed ORR in the apatinib group was 54.
3 % (95% CI, 39.
0%-69.
1%), DCR was 95.
7% (95% CI, 85.
2%-99.
5%), ORR of the placebo group was 2.
2% (95% CI, 0.
1%-11.
5%) and DCR It was 58.
7% (95% CI, 43.
2%-73.
0%); the median overall survival of apatinib was not reached (95% CI, 26.
25-not reached), and the placebo was 29.
9 months (95% CI, 18.
96) -Not reached) (hazard ratio, 0.
42; 95% CI, 0.
18-0.
97; P = .
04)
.
The most common grade 3 or higher treatment-related adverse events in the apatinib group were hypertension (16 [34.
8%]), hand-foot syndrome (8 [17.
4%]), and proteinuria (7 [15.
2%]) And diarrhea (7 [15.
2%])-none of these occurred in the placebo group
.
In summary, the clinical trial found that in patients with progressive locally advanced or metastatic RAIR-DTC, apatinib has shown significant clinical benefits in prolonging PFS and overall survival, and its safety is controllable
.
Reference message: https://jamanetwork.
com/journals/jamaoncology/fullarticle/2786815
