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*Only for medical professionals to read for reference, 1 minute a day, to give you professional "talking information" in the tumor circle! (If you need the original text of the literature, you can add it to the editor's WeChat yxj_oncology to obtain) Key points: JTO: Nirapali maintenance treatment can slightly improve platinum-responsive patients with extensive stage small cell lung cancer.
New drug positively correlated with the risk of gallbladder cancer: RET inhibitor pratinib has been included in the application for expanded indications for priority review.
New drug: the world’s first new indication for CD38 monoclonal antibody is about to be approved in China 01JTO: Nirapali can be maintained in maintenance therapy Slightly improve platinum-based responsiveness in patients with extensive-stage small cell lung cancer PFS April 25, 2021, the results of the ZL-2306-005 clinical trial published in the Journal of Thoracic Oncology showed that Nirapali, as a maintenance treatment, can slightly improve platinum-based response The progression-free survival (PFS) of patients with advanced stage small cell lung cancer (ES-SCLC), and the safety is good, the patients can tolerate it.
The corresponding author of the study is Professor Lu Shun from the Affiliated Chest Hospital of Shanghai Jiaotong University.
The article cover screenshot ZL-2306-005 is a randomized, double-blind, multi-center phase III clinical trial intended to evaluate the effectiveness and safety of niraparib as a first-line maintenance treatment for ES-SCLC.
In the study, patients with complete remission (CR) or partial remission (PR) of platinum-based first-line chemotherapy were randomly assigned to the niraparib group and the placebo group at a ratio of 2:1.
The trial was terminated early due to changes in the ES-SCLC treatment situation.
In the trial, 185 patients were randomly divided into groups, including 125 in the niraparib group (CR=1, PR=124) and 60 in the placebo group (CR=1, PR=59).
The results showed that the median PFS of the blinded independent center review (BICR) in the niraparib group was 1.
54 months (95%CI: 1.
41-2.
69); the placebo group was 1.
36 months (95%CI: 1.
31-1.
48); The hazard ratio (HR) was 0.
66 (95%CI: 0.
46-0.
95, p=0.
0242).
The median overall survival (OS) in the niraparib group was 9.
92 months (95% CI: 9.
33-13.
54), and in the placebo group was 11.
43 months (95% CI: 9.
53-not inferable); HR was 1.
03 (95 %CI: 0.
62-1.
73, p=0.
9052).
The median PFS assessed by the researchers in the niraparib group was 1.
48 months (95%CI: 1.
41-2.
56); the placebo group was 1.
41 months (95%CI: 1.
31-2.
00); the HR was 0.
88 (95%CI: 0.
61-1.
26, p=0.
4653).
In terms of safety, the incidence of adverse events of grade 3 and above were respectively in the niraparib group (34.
4%) and the placebo group (25%).
02IJC: Dietary intake of advanced glycation end products is positively correlated with the risk of gallbladder cancer.
On April 25, 2021, a study published in the International Journal of Cancer suggested that advanced glycation end products (AGEs) ) Intake is related to hepatocellular carcinoma (HCC) and gallbladder cancer.
Studies have pointed out that high intake of AGEs is negatively correlated with the risk of HCC, but positively correlated with the risk of gallbladder cancer.
Screenshot of the cover of the article.
The study is a prospective study spanning multiple countries, recruiting participants from 10 European countries including Denmark, France, Germany, Greece, and Italy from 1992 to 2000.
After screening, Ana-Lucia et al.
conducted a study on the relationship between dietary AGEs intake and the risk of liver and gallbladder cancer on the 450111 participants who were finally selected. Three AGEs are estimated based on the country-specific dietary questionnaire linked to the AGEs database, including: Nε-[carboxymethyl]lysine (CML), Nε-[1-carboxyethyl]lysine (CEL) and Nδ-[5-hydro-5-methyl-4-imidazolin-2-yl]ornithine (MG-H1).
The study showed that after a median follow-up time of 14.
9 years, a total of 255 cases of HCC, 100 cases of gallbladder cancer and 173 cases of biliary tract cancer were diagnosed.
The results suggest that high dietary AGEs intake is negatively correlated with the risk of HCC (HR-CML=0.
87, 95%CI: 0.
76-0.
99; HR-CEL=0.
84, 95%CI: 0.
74-0.
96; HR-MH-G1 =0.
84, 95%CI: 0.
74-0.
97).
On the contrary, it is positively correlated with the risk of gallbladder cancer (HR-CML=1.
28, 95%CI: 1.
05-1.
56; HR-CEL=1.
17, 95%CI: 0.
96-1.
40; HR-MH-G1=1.
27, 95%CI : 1.
06-1.
54).
No AGEs intake was found to be associated with the risk of intra- and extra-hepatic cholangiocarcinoma.
The study shows that high intake of AGEs is negatively correlated with the risk of HCC, and positively correlated with the risk of gallbladder cancer.
The former is contrary to the previous hypothesis, which generally believes that dietary AGEs may increase the risk of cancer.
The specific results have yet to be confirmed by research.
03New drug: The application for the extended indication of RET inhibitor pratinib has been included in the priority review CStone Pharmaceuticals today announced that the application for the extended indication of the selective RET inhibitor pratinib has been accepted by the National Medical Products Administration (NMPA) It has been included in the priority review.
The extended indications include advanced or metastatic transfection rearrangement (RET) gene mutation medullary thyroid carcinoma (MTC) that requires systemic treatment, and systemic treatment that is refractory to radioiodine ( If radioactive iodine is applicable) advanced or metastatic RET fusion-positive thyroid cancer (TC). In March of this year, NMPA approved pratinib for the sale of RET gene fusion-positive adult patients with locally advanced or metastatic non-small cell lung cancer who have previously received platinum-containing chemotherapy.
04New drug: The world's first new indication for CD38 monoclonal antibody is about to be approved in China.
Recently, the official website of NMPA showed that Xi'an Janssen's new indication for daratumumab injection (acceptance number: JXSS2000019/JXSS2000020) had In the "under review" stage.
The indication is combined with lenalidomide and dexamethasone or combined with bortezomib and dexamethasone to treat adult patients with multiple myeloma who have received at least first-line treatment in the past.
This will be the product's domestic approval The second indication. References: [1]Xinghao Ai,Yueyin Pan,Jianhua Shi,et al.
Efficacy and Safety of Niraparib as Maintenance Treatment in Patients with Extensive-Stage Small Cell Lung Cancer after First-Line Chemotherapy:A Randomized,Double-Blind,Phase 3 Study.
JTO.
Published:Apr 25th,2021,https://doi.
org/10.
1016/j.
jtho.
2021.
04.
001[2]Ana‐Lucia Mayén,Elom K.
Aglago,Viktoria Knaze,et al.
Dietary intake of advanced glycation endproducts and risk of hepatobiliary cancers: a multinational cohort study.
IJC.
Published:Apr 25th,2021https://doi.
org/10.
1002/ijc.
33612[3]https://mp.
weixin.
qq.
com/ s/qJXgHv_0Lj90eVSX7ZpUzg[4]https://mp.
weixin.
qq.
com/s/ENd_IZi2B7XvfVnl3pkRDg
New drug positively correlated with the risk of gallbladder cancer: RET inhibitor pratinib has been included in the application for expanded indications for priority review.
New drug: the world’s first new indication for CD38 monoclonal antibody is about to be approved in China 01JTO: Nirapali can be maintained in maintenance therapy Slightly improve platinum-based responsiveness in patients with extensive-stage small cell lung cancer PFS April 25, 2021, the results of the ZL-2306-005 clinical trial published in the Journal of Thoracic Oncology showed that Nirapali, as a maintenance treatment, can slightly improve platinum-based response The progression-free survival (PFS) of patients with advanced stage small cell lung cancer (ES-SCLC), and the safety is good, the patients can tolerate it.
The corresponding author of the study is Professor Lu Shun from the Affiliated Chest Hospital of Shanghai Jiaotong University.
The article cover screenshot ZL-2306-005 is a randomized, double-blind, multi-center phase III clinical trial intended to evaluate the effectiveness and safety of niraparib as a first-line maintenance treatment for ES-SCLC.
In the study, patients with complete remission (CR) or partial remission (PR) of platinum-based first-line chemotherapy were randomly assigned to the niraparib group and the placebo group at a ratio of 2:1.
The trial was terminated early due to changes in the ES-SCLC treatment situation.
In the trial, 185 patients were randomly divided into groups, including 125 in the niraparib group (CR=1, PR=124) and 60 in the placebo group (CR=1, PR=59).
The results showed that the median PFS of the blinded independent center review (BICR) in the niraparib group was 1.
54 months (95%CI: 1.
41-2.
69); the placebo group was 1.
36 months (95%CI: 1.
31-1.
48); The hazard ratio (HR) was 0.
66 (95%CI: 0.
46-0.
95, p=0.
0242).
The median overall survival (OS) in the niraparib group was 9.
92 months (95% CI: 9.
33-13.
54), and in the placebo group was 11.
43 months (95% CI: 9.
53-not inferable); HR was 1.
03 (95 %CI: 0.
62-1.
73, p=0.
9052).
The median PFS assessed by the researchers in the niraparib group was 1.
48 months (95%CI: 1.
41-2.
56); the placebo group was 1.
41 months (95%CI: 1.
31-2.
00); the HR was 0.
88 (95%CI: 0.
61-1.
26, p=0.
4653).
In terms of safety, the incidence of adverse events of grade 3 and above were respectively in the niraparib group (34.
4%) and the placebo group (25%).
02IJC: Dietary intake of advanced glycation end products is positively correlated with the risk of gallbladder cancer.
On April 25, 2021, a study published in the International Journal of Cancer suggested that advanced glycation end products (AGEs) ) Intake is related to hepatocellular carcinoma (HCC) and gallbladder cancer.
Studies have pointed out that high intake of AGEs is negatively correlated with the risk of HCC, but positively correlated with the risk of gallbladder cancer.
Screenshot of the cover of the article.
The study is a prospective study spanning multiple countries, recruiting participants from 10 European countries including Denmark, France, Germany, Greece, and Italy from 1992 to 2000.
After screening, Ana-Lucia et al.
conducted a study on the relationship between dietary AGEs intake and the risk of liver and gallbladder cancer on the 450111 participants who were finally selected. Three AGEs are estimated based on the country-specific dietary questionnaire linked to the AGEs database, including: Nε-[carboxymethyl]lysine (CML), Nε-[1-carboxyethyl]lysine (CEL) and Nδ-[5-hydro-5-methyl-4-imidazolin-2-yl]ornithine (MG-H1).
The study showed that after a median follow-up time of 14.
9 years, a total of 255 cases of HCC, 100 cases of gallbladder cancer and 173 cases of biliary tract cancer were diagnosed.
The results suggest that high dietary AGEs intake is negatively correlated with the risk of HCC (HR-CML=0.
87, 95%CI: 0.
76-0.
99; HR-CEL=0.
84, 95%CI: 0.
74-0.
96; HR-MH-G1 =0.
84, 95%CI: 0.
74-0.
97).
On the contrary, it is positively correlated with the risk of gallbladder cancer (HR-CML=1.
28, 95%CI: 1.
05-1.
56; HR-CEL=1.
17, 95%CI: 0.
96-1.
40; HR-MH-G1=1.
27, 95%CI : 1.
06-1.
54).
No AGEs intake was found to be associated with the risk of intra- and extra-hepatic cholangiocarcinoma.
The study shows that high intake of AGEs is negatively correlated with the risk of HCC, and positively correlated with the risk of gallbladder cancer.
The former is contrary to the previous hypothesis, which generally believes that dietary AGEs may increase the risk of cancer.
The specific results have yet to be confirmed by research.
03New drug: The application for the extended indication of RET inhibitor pratinib has been included in the priority review CStone Pharmaceuticals today announced that the application for the extended indication of the selective RET inhibitor pratinib has been accepted by the National Medical Products Administration (NMPA) It has been included in the priority review.
The extended indications include advanced or metastatic transfection rearrangement (RET) gene mutation medullary thyroid carcinoma (MTC) that requires systemic treatment, and systemic treatment that is refractory to radioiodine ( If radioactive iodine is applicable) advanced or metastatic RET fusion-positive thyroid cancer (TC). In March of this year, NMPA approved pratinib for the sale of RET gene fusion-positive adult patients with locally advanced or metastatic non-small cell lung cancer who have previously received platinum-containing chemotherapy.
04New drug: The world's first new indication for CD38 monoclonal antibody is about to be approved in China.
Recently, the official website of NMPA showed that Xi'an Janssen's new indication for daratumumab injection (acceptance number: JXSS2000019/JXSS2000020) had In the "under review" stage.
The indication is combined with lenalidomide and dexamethasone or combined with bortezomib and dexamethasone to treat adult patients with multiple myeloma who have received at least first-line treatment in the past.
This will be the product's domestic approval The second indication. References: [1]Xinghao Ai,Yueyin Pan,Jianhua Shi,et al.
Efficacy and Safety of Niraparib as Maintenance Treatment in Patients with Extensive-Stage Small Cell Lung Cancer after First-Line Chemotherapy:A Randomized,Double-Blind,Phase 3 Study.
JTO.
Published:Apr 25th,2021,https://doi.
org/10.
1016/j.
jtho.
2021.
04.
001[2]Ana‐Lucia Mayén,Elom K.
Aglago,Viktoria Knaze,et al.
Dietary intake of advanced glycation endproducts and risk of hepatobiliary cancers: a multinational cohort study.
IJC.
Published:Apr 25th,2021https://doi.
org/10.
1002/ijc.
33612[3]https://mp.
weixin.
qq.
com/ s/qJXgHv_0Lj90eVSX7ZpUzg[4]https://mp.
weixin.
qq.
com/s/ENd_IZi2B7XvfVnl3pkRDg
