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The 2021 CSCO Guide Conference kicked off in Beijing on April 23 with a combination of online and offline methods.
In the digestive tract tumor special session on the morning of the 24th, Professor Wang Fenghua from the Cancer Center of Sun Yat-sen University interpreted the updated part of the CSCO gastric cancer diagnosis and treatment guidelines in the 2021 edition of the CSCO gastric cancer diagnosis and treatment guidelines.
General Principles of Medical Treatment For patients with no chance of radical surgery or metastatic gastric cancer, it is currently recognized that comprehensive treatment based on systemic drug therapy should be adopted.
Anti-tumor drugs include: chemotherapy drugs, molecular targeted drugs, immune checkpoint inhibitors.
Chemotherapy drugs: relatively sufficient evidence-based medicine evidence and rich clinical practice experience.
Targeted drugs: There are many studies.
Currently, only the anti-HER2 drug trastuzumab and the anti-angiogenesis pathway drug apatinib are currently in clinical practice.
Other effective molecular targeted drugs are still lacking.
Immune checkpoint inhibitor: PD-1 monoclonal antibody has made breakthrough progress in the treatment of advanced gastric cancer.
Gastric cancer has strong temporal and spatial heterogeneity, and the tumor microenvironment is complex.
There are differences in epidemiological characteristics, clinicopathological characteristics, treatment modes, and drug choices between Eastern and Western populations.
Chinese patients are encouraged to actively participate in clinical research.
The value and timing of local treatment methods such as palliative surgery, radiotherapy, and intraperitoneal perfusion interventional therapy.
If the population is properly selected, it will help prolong survival and improve the quality of life; emphasizing multidisciplinary comprehensive treatment throughout the treatment process.
In the process of anti-tumor therapy, special attention should be paid to the maintenance of the patient's nutritional status and the active prevention and treatment of complications.
Update points: Drug therapy for metastatic gastric cancer is the first-line treatment of HER2-negative gastric cancer.
Class I recommendation is newly added: "PD-L1 CPS≥5 can be treated with chemotherapy (FOLFOX/XELOX) combined with nivolumab (Class IA evidence)" ; Level III recommendation added: "Pembrolizumab monotherapy can be used for people with PD-L1 CPS≥1 (Class IB evidence)" Note added: ATTRCTION-04, CheckMate 649 study results description.
The status of immune checkpoint inhibitors as a single agent in the first-line treatment of late has not been established, and patients are encouraged to participate in relevant clinical studies.
The CheckMate 649 study is a clinical study that has the significance of changing clinical practice.
It establishes a new standard for the first-line treatment of PD-L1 CPS ≥ 5 HER2-negative metastatic gastric cancer with immune checkpoint inhibitors.
The study evaluated the efficacy and safety of nivolumumab + chemotherapy or nivolumumab + ipilimumab versus chemotherapy for the first-line treatment of HER2-negative metastatic gastric cancer.
Preliminary analysis results show that compared with chemotherapy (11.
1 months), nivolumab plus chemotherapy (14.
4 months) can significantly improve the median overall survival (OS) of patients with PD-L1 CPS≥5.
The Chinese population data released by AACR in 2021 showed that in patients with PD-L1 CPS≥5, CPS≥1 and ITT, the OS, progression-free survival (PFS) and objective response rate (ORR) of nivolumab combined with chemotherapy were all Significantly better than chemotherapy.
In the population with PD-L1 CPS ≥ 5, the median OS of the nivolumab + chemotherapy group and the chemotherapy group were 15.
5 months and 9.
6 months (HR=0.
54); the median PFS of the two groups was 8.
5 Months and 4.
3 months (HR=0.
52); the ORRs of the two groups were 68% and 48%, respectively.
The ATTRACTION-04 study aims to evaluate the efficacy of nivolumab + chemotherapy versus chemotherapy for the first-line treatment of unresectable or recurrent gastroesophageal junction adenocarcinoma.
Interim analysis showed that the median PFS of the nivolumab+chemotherapy group and the chemotherapy group were 10.
45 months and 8.
34 months, respectively (HR=0.
68, P=0.
0007); the median OS results of the two groups were similar.
The difference in the results of CheckMate 649 and ATTRACTION-4 OS may be affected by subsequent treatment.
The KEYNOTE-062 study explored the efficacy and safety of pembrolizumab±chemotherapy versus chemotherapy for the first-line treatment of adenocarcinoma at the gastric or gastroesophageal junction with PD-L1 CPS≥1.
The results showed that in people with PD-L1 CPS ≥ 1 or 10, pembrolizumab + chemotherapy is not better than chemotherapy alone in improving OS, and PFS and ORR have moderate benefits.
In the population with PD-L1 CPS≥1, the OS of pembrolizumab monotherapy is not inferior to chemotherapy.
A subgroup analysis showed that the risk of death in the subgroup of people who received pembrolizumab was reduced by 46%; Among people with PD-L1 CPS≥10, the OS of pembrolizumab as a single agent (17.
4 months) was better than chemotherapy (10.
8 months).
Second-line treatment of metastatic gastric cancer For the second-line treatment of metastatic gastric cancer, the stratification is divided into two parts: HER2 positive and HER2 negative.
Level II recommendation increased: For patients with high microsatellite instability (MSI-H), pembrolizumab can be used for treatment (class 2A evidence).
” 2020 ASCO GI announced a comparison of pembrolizumab with chemotherapy in MSI-H Comprehensive analysis of advanced gastric cancer/gastroesophageal junction adenocarcinoma (KEYNOTE-059, KEYNOTE-061, KEYNOTE-062).
The
results showed that in MSI-H patients, compared with chemotherapy, the OS and PFS of Pembrolizumab Better; the ORR of the pembrolizumab group was higher, the ORRs of the first-line, second-line, and third-line treatment were 57.
1%, 46.
7%, and 57.
1%, respectively; MSI-H status can be used as a biomarker to predict the efficacy of pembrolizumab . It can be seen that since immunotherapy has been added to the layout of gastric cancer treatment, since 2018, from third-line treatment to first-line and second-line treatment, from level III recommendation to level I and level II recommendation, the recommendation level of gastric cancer immunotherapy has continued to move forward, changing the risk of gastric cancer.
Treatment layout.
Annotations for the first-line treatment of HER2-positive gastric cancer have been added: description of anti-HER2 biosimilar drugs, description of ADC drugs.
Both NCCN and ESMO guidelines support that biosimilar drugs can reasonably replace trastuzumab.
The 2020 "Chinese Expert Consensus on Biosimilars" also recognizes the clinical substitution of biosimilars.
Although the biosimilar drug has only carried out clinical trials in one indication in the research and development stage, according to the principle of "indication extrapolation", all other indications with the same mechanism of action of the reference drug can be obtained.
In 2020, Hanquyou will simultaneously obtain three indications for metastatic breast cancer, early breast cancer and metastatic gastric cancer in China.
This brings more treatment options for patients with HER2-positive metastatic gastric cancer.
ADC drugs targeting HER2 are currently a research hotspot, and the research results are worthy of attention.
The DESTINY-Gastric01 study is a multi-center, phase II open-label study to evaluate the efficacy and safety of DS-8201 versus chemotherapy in patients with HER2-positive advanced gastric cancer who have progressed through at least two treatments.
The results showed that the ORR of the DS-8201 group was significantly higher, 51% and 14% in the two groups (P<0.
001).
More than 80% and about half of the patients in the DS-8201 group and the chemotherapy group shrank tumors.
The median duration of remission in the two groups was 11.
3 months and 3.
9 months, respectively.
The disease control rates (DCR) of the two groups were 86%, respectively.
And 62%, the median OS of the two groups was 12.
5 months and 8.
4 months, respectively (P=0.
01).
The RC48-C008 study explored the efficacy of RC48 in metastatic gastric cancer/gastroesophageal junction adenocarcinoma after at least two lines of chemotherapy and HER overexpression in the past.
The results showed that the ORR of RC48 was 24.
4%, and the DCR was 41.
7%. Subgroup analysis showed that the ORR of RC48 treatment who had previously received trastuzumab treatment was 27%.
Conclusion Based on the 2020 version of the CSCO guidelines for gastric cancer, the 2021 version of the gastric cancer CSCO guidelines will more quickly integrate the latest clinical research progress at home and abroad, pay more attention to the research data of the Chinese population, and be closer to clinical practice.
Anti-HER2 targeted therapy is remarkable, and patients have more treatment options.
Following the establishment of PD-1 monoclonal antibody in the treatment of advanced gastric cancer, with the recommendation of the guidelines and the approval of the indications, the first-line treatment of advanced gastric cancer will enter the era of immune combined chemotherapy in 2021.
The following issues need to be paid attention to:-Navulio The combination of monoclonal antibody and chemotherapy is better than chemotherapy, but most patients have not achieved the desired long-term effective state.
It is necessary to further think and explore the patient population and new immune combination strategies that can benefit more in the future; -Based on evidence-based selection Appropriate immunotherapy plan; -Based on evidence-based, rational layout of the whole course of treatment and immunotherapy; -Encourage patients to participate in clinical research to accumulate Chinese data, reflect Chinese voices and more suitable treatment methods for Chinese patients.
In the digestive tract tumor special session on the morning of the 24th, Professor Wang Fenghua from the Cancer Center of Sun Yat-sen University interpreted the updated part of the CSCO gastric cancer diagnosis and treatment guidelines in the 2021 edition of the CSCO gastric cancer diagnosis and treatment guidelines.
General Principles of Medical Treatment For patients with no chance of radical surgery or metastatic gastric cancer, it is currently recognized that comprehensive treatment based on systemic drug therapy should be adopted.
Anti-tumor drugs include: chemotherapy drugs, molecular targeted drugs, immune checkpoint inhibitors.
Chemotherapy drugs: relatively sufficient evidence-based medicine evidence and rich clinical practice experience.
Targeted drugs: There are many studies.
Currently, only the anti-HER2 drug trastuzumab and the anti-angiogenesis pathway drug apatinib are currently in clinical practice.
Other effective molecular targeted drugs are still lacking.
Immune checkpoint inhibitor: PD-1 monoclonal antibody has made breakthrough progress in the treatment of advanced gastric cancer.
Gastric cancer has strong temporal and spatial heterogeneity, and the tumor microenvironment is complex.
There are differences in epidemiological characteristics, clinicopathological characteristics, treatment modes, and drug choices between Eastern and Western populations.
Chinese patients are encouraged to actively participate in clinical research.
The value and timing of local treatment methods such as palliative surgery, radiotherapy, and intraperitoneal perfusion interventional therapy.
If the population is properly selected, it will help prolong survival and improve the quality of life; emphasizing multidisciplinary comprehensive treatment throughout the treatment process.
In the process of anti-tumor therapy, special attention should be paid to the maintenance of the patient's nutritional status and the active prevention and treatment of complications.
Update points: Drug therapy for metastatic gastric cancer is the first-line treatment of HER2-negative gastric cancer.
Class I recommendation is newly added: "PD-L1 CPS≥5 can be treated with chemotherapy (FOLFOX/XELOX) combined with nivolumab (Class IA evidence)" ; Level III recommendation added: "Pembrolizumab monotherapy can be used for people with PD-L1 CPS≥1 (Class IB evidence)" Note added: ATTRCTION-04, CheckMate 649 study results description.
The status of immune checkpoint inhibitors as a single agent in the first-line treatment of late has not been established, and patients are encouraged to participate in relevant clinical studies.
The CheckMate 649 study is a clinical study that has the significance of changing clinical practice.
It establishes a new standard for the first-line treatment of PD-L1 CPS ≥ 5 HER2-negative metastatic gastric cancer with immune checkpoint inhibitors.
The study evaluated the efficacy and safety of nivolumumab + chemotherapy or nivolumumab + ipilimumab versus chemotherapy for the first-line treatment of HER2-negative metastatic gastric cancer.
Preliminary analysis results show that compared with chemotherapy (11.
1 months), nivolumab plus chemotherapy (14.
4 months) can significantly improve the median overall survival (OS) of patients with PD-L1 CPS≥5.
The Chinese population data released by AACR in 2021 showed that in patients with PD-L1 CPS≥5, CPS≥1 and ITT, the OS, progression-free survival (PFS) and objective response rate (ORR) of nivolumab combined with chemotherapy were all Significantly better than chemotherapy.
In the population with PD-L1 CPS ≥ 5, the median OS of the nivolumab + chemotherapy group and the chemotherapy group were 15.
5 months and 9.
6 months (HR=0.
54); the median PFS of the two groups was 8.
5 Months and 4.
3 months (HR=0.
52); the ORRs of the two groups were 68% and 48%, respectively.
The ATTRACTION-04 study aims to evaluate the efficacy of nivolumab + chemotherapy versus chemotherapy for the first-line treatment of unresectable or recurrent gastroesophageal junction adenocarcinoma.
Interim analysis showed that the median PFS of the nivolumab+chemotherapy group and the chemotherapy group were 10.
45 months and 8.
34 months, respectively (HR=0.
68, P=0.
0007); the median OS results of the two groups were similar.
The difference in the results of CheckMate 649 and ATTRACTION-4 OS may be affected by subsequent treatment.
The KEYNOTE-062 study explored the efficacy and safety of pembrolizumab±chemotherapy versus chemotherapy for the first-line treatment of adenocarcinoma at the gastric or gastroesophageal junction with PD-L1 CPS≥1.
The results showed that in people with PD-L1 CPS ≥ 1 or 10, pembrolizumab + chemotherapy is not better than chemotherapy alone in improving OS, and PFS and ORR have moderate benefits.
In the population with PD-L1 CPS≥1, the OS of pembrolizumab monotherapy is not inferior to chemotherapy.
A subgroup analysis showed that the risk of death in the subgroup of people who received pembrolizumab was reduced by 46%; Among people with PD-L1 CPS≥10, the OS of pembrolizumab as a single agent (17.
4 months) was better than chemotherapy (10.
8 months).
Second-line treatment of metastatic gastric cancer For the second-line treatment of metastatic gastric cancer, the stratification is divided into two parts: HER2 positive and HER2 negative.
Level II recommendation increased: For patients with high microsatellite instability (MSI-H), pembrolizumab can be used for treatment (class 2A evidence).
” 2020 ASCO GI announced a comparison of pembrolizumab with chemotherapy in MSI-H Comprehensive analysis of advanced gastric cancer/gastroesophageal junction adenocarcinoma (KEYNOTE-059, KEYNOTE-061, KEYNOTE-062).
The
results showed that in MSI-H patients, compared with chemotherapy, the OS and PFS of Pembrolizumab Better; the ORR of the pembrolizumab group was higher, the ORRs of the first-line, second-line, and third-line treatment were 57.
1%, 46.
7%, and 57.
1%, respectively; MSI-H status can be used as a biomarker to predict the efficacy of pembrolizumab . It can be seen that since immunotherapy has been added to the layout of gastric cancer treatment, since 2018, from third-line treatment to first-line and second-line treatment, from level III recommendation to level I and level II recommendation, the recommendation level of gastric cancer immunotherapy has continued to move forward, changing the risk of gastric cancer.
Treatment layout.
Annotations for the first-line treatment of HER2-positive gastric cancer have been added: description of anti-HER2 biosimilar drugs, description of ADC drugs.
Both NCCN and ESMO guidelines support that biosimilar drugs can reasonably replace trastuzumab.
The 2020 "Chinese Expert Consensus on Biosimilars" also recognizes the clinical substitution of biosimilars.
Although the biosimilar drug has only carried out clinical trials in one indication in the research and development stage, according to the principle of "indication extrapolation", all other indications with the same mechanism of action of the reference drug can be obtained.
In 2020, Hanquyou will simultaneously obtain three indications for metastatic breast cancer, early breast cancer and metastatic gastric cancer in China.
This brings more treatment options for patients with HER2-positive metastatic gastric cancer.
ADC drugs targeting HER2 are currently a research hotspot, and the research results are worthy of attention.
The DESTINY-Gastric01 study is a multi-center, phase II open-label study to evaluate the efficacy and safety of DS-8201 versus chemotherapy in patients with HER2-positive advanced gastric cancer who have progressed through at least two treatments.
The results showed that the ORR of the DS-8201 group was significantly higher, 51% and 14% in the two groups (P<0.
001).
More than 80% and about half of the patients in the DS-8201 group and the chemotherapy group shrank tumors.
The median duration of remission in the two groups was 11.
3 months and 3.
9 months, respectively.
The disease control rates (DCR) of the two groups were 86%, respectively.
And 62%, the median OS of the two groups was 12.
5 months and 8.
4 months, respectively (P=0.
01).
The RC48-C008 study explored the efficacy of RC48 in metastatic gastric cancer/gastroesophageal junction adenocarcinoma after at least two lines of chemotherapy and HER overexpression in the past.
The results showed that the ORR of RC48 was 24.
4%, and the DCR was 41.
7%. Subgroup analysis showed that the ORR of RC48 treatment who had previously received trastuzumab treatment was 27%.
Conclusion Based on the 2020 version of the CSCO guidelines for gastric cancer, the 2021 version of the gastric cancer CSCO guidelines will more quickly integrate the latest clinical research progress at home and abroad, pay more attention to the research data of the Chinese population, and be closer to clinical practice.
Anti-HER2 targeted therapy is remarkable, and patients have more treatment options.
Following the establishment of PD-1 monoclonal antibody in the treatment of advanced gastric cancer, with the recommendation of the guidelines and the approval of the indications, the first-line treatment of advanced gastric cancer will enter the era of immune combined chemotherapy in 2021.
The following issues need to be paid attention to:-Navulio The combination of monoclonal antibody and chemotherapy is better than chemotherapy, but most patients have not achieved the desired long-term effective state.
It is necessary to further think and explore the patient population and new immune combination strategies that can benefit more in the future; -Based on evidence-based selection Appropriate immunotherapy plan; -Based on evidence-based, rational layout of the whole course of treatment and immunotherapy; -Encourage patients to participate in clinical research to accumulate Chinese data, reflect Chinese voices and more suitable treatment methods for Chinese patients.
