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*Only for medical professionals to read and refer to Ramucirumab (Ramucirumab) has been approved by the FDA for second-line treatment of gastric cancer
.
Subsequently, the RAINBOW-Asia study confirmed the effectiveness and safety of Ramucirumab in Asian populations
.
China is a big country with gastric cancer
.
In 2020, the number of new cases of gastric cancer in China is 480,000, accounting for 43.
9% of the world; the death toll is 370,000, accounting for 48.
5% of the world
.
Therefore, the diagnosis and treatment of gastric cancer is very important
.
Most Chinese gastric cancer patients are already at an advanced stage when they are diagnosed, and they have missed opportunities for surgical treatment
.
The first-line treatment for advanced gastric cancer is based on chemotherapy, but it is prone to recurrence and metastasis
.
At the 2021 Chinese Society of Clinical Oncology (CSCO) annual meeting, the results of the RAINBOW-Asia Chinese population study were announced, adding new medical evidence for the treatment of advanced gastric cancer in China
.
What is the current status of second-line treatment for gastric cancer? How are the new developments? What is the future development direction? This "Medical Oncology Channel" invited Professor Zhang Yanqiao from the Cancer Hospital of Harbin Medical University and Professor Pan Hongming from the Run Run Run Run Shaw Hospital of Zhejiang University School of Medicine to discuss issues related to the second-line treatment of gastric cancer
.
What is the current status of second-line treatment for advanced gastric cancer? The curative effect of comprehensive treatment for advanced gastric cancer is limited.
At present, platinum and fluorouracils are used as the conventional first-line chemotherapy for gastric cancer, and there is no effective later-line treatment after failure
.
The principle of second-line treatment in the National Comprehensive Cancer Network (NCCN) guidelines is to refer to the first-line treatment plan and give priority to the first-line drugs that have not been used.
This also makes the second-line chemotherapy drugs have a variety of options
.
Professor Pan Hongming believes that the main second-line treatment for advanced gastric cancer/gastroesophageal junction adenocarcinoma is single-agent chemotherapy with paclitaxel, docetaxel, irinotecan and other drugs, or a combination of two-drug chemotherapy based on the choice of drugs in the first-line treatment.
However, the overall treatment effect is not ideal, and the patient's median overall survival (OS) is less than one year
.
Anti-angiogenic drugs, immunotherapy and other new treatment methods have not yet fully established their status in the second-line treatment of gastric cancer.
The Chinese Society of Clinical Oncology (CSCO) guidelines only recommend single-agent taxanes and irinotecan for second-line treatment.
Immunotherapy is not recommended.
It is only used for patients with high microsatellite instability (MSI-H) or mismatch repair function defects (dMMR), and it is temporarily unable to guide precise selection of programs by molecular typing.
Patients have a low-toxicity and high-efficiency program.
Urgent need
.
What are the research advances in the second-line treatment of advanced gastric cancer in China? Cytotoxic drugs represented by irinotecan and taxanes are still the cornerstones of second-line therapy, but recent studies have confirmed that targeted drugs with different targets can also be used as one of the options for second-line therapy
.
The hot spots for targeted drugs for gastric cancer are anti-human epidermal growth factor receptor-2 (HER-2) antibodies and anti-angiogenic drugs
.
A few years ago, the clinical research of bevacizumab in gastric cancer was smashed, and the clinical research of other target drugs in the second-line treatment of gastric cancer had no positive results, such as everolimus, sunitinib, etc.
The second-line treatment of gastric cancer requires more effective drugs to solve the dilemma of clinical treatment
.
Professor Zhang Yanqiao said that Ramucirumab (Ramucirumab) is a human IgG1 monoclonal antibody that specifically binds to vascular endothelial growth factor receptor 2 (VEGFR-2) to inhibit VEGFR-2 activation, thereby inhibiting ligand induction The proliferation and migration of endothelial cells eventually inhibit tumor angiogenesis
.
Ramucirumab (Ramucirumab) has been approved by the FDA for the second-line treatment of gastric cancer.
The classic test is the RAINBOW study
.
The RAINBOW-Asia study is the bridging test of the study, which mainly evaluates the combination of Ramucirumab (Ramucirumab) and paclitaxel compared with placebo + paclitaxel in a population of patients with gastric cancer or gastroesophageal junction adenocarcinoma, which is dominated by Chinese patients.
For the effectiveness of second-line treatment, the primary endpoints are progression-free survival (PFS) and overall survival (OS)
.
A total of 440 patients from China, Malaysia, Thailand, and the Philippines were enrolled in the RAINBOW-Asia study.
They were divided into the Ramucirumab + paclitaxel group or placebo + paclitaxel group at a ratio of 2:1, and were included in the study.
There are a total of 392 Chinese patients, accounting for nearly 90% of all patients.
Therefore, this study has a very good reference value for guiding the application of Ramucirumab (Ramucirumab) in clinical practice in China
.
Professor Pan Hongming said that the RAINBOW-Asia study included a total of 392 Chinese patients.
The data released by the CSCO conference this year showed that the median PFS of the ramucirumab + paclitaxel group in the treatment of the Chinese population was 4.
17 months, which was significantly better.
In the placebo + paclitaxel group for 3.
15 months (HR=0.
751, P=0.
0169), the objective response rates (ORR) of the two groups were 29.
2% and 23.
0%, respectively, and the median OS was 9.
03 months and 8.
08 months ( HR=0.
942), the median OS benefit was consistent with the results of the RAINBOW study, reaching the main study endpoint
.
Chinese patients generally tolerated the regimen well, consistent with the known safety features of Ramucirumab (Ramucirumab), and no new safety signals were observed
.
The results of the RAINBOW study showed that the median PFS of the ramucirumab + paclitaxel group was 4.
4 months, which was better than the control group's 2.
9 months (HR 0.
64, P＜0.
001).
The median OS of the two groups were respectively It was 9.
6 months and 7.
4 months (HR 0.
81, P＜0.
017)
.
What is the impact of the RAINBOW-Asia study on the clinical practice of gastric cancer in my country? So far, there is no standard plan for the second-line treatment of advanced gastric cancer in China.
In the past, the main plan was single-drug or dual-drug chemotherapy.
Patients lacked low-toxic and efficient treatment options.
The RAINBOW-Asia study is the first and currently only Chinese patient in China.
A phase III study that confirms the clinical benefit of anti-angiogenesis therapy in the second-line population of advanced gastric cancer
.
Professor Zhang Yanqiao pointed out that Ramucirumab combined with paclitaxel has been approved for the second-line treatment of gastric cancer in many foreign countries.
Although it has not yet been approved in China, it has brought new ideas to Chinese patients suffering from advanced gastric cancer.
Treatment options and hope for survival
.
It is believed that for the treatment of advanced gastric cancer in the future, researchers will explore more Ramucirumab (Ramucirumab) combined treatment models
.
What is the future development direction of advanced gastric cancer treatment? Umbrella trial for second-line treatment of gastric cancer-South Korea’s VIKTORY trial showed that 105 patients who received biomarker-guided drug therapy had better treatment response and significantly improved survival outcomes.
In the future, clinical trials of molecular targeted drugs will be more important.
Focus on specific patient subgroups
.
Professor Pan Hongming proposed that in recent years, the Cancer Genome Atlas (TCGA) project and the Asian Cancer Research Group (ACRG) have proposed some new molecular typing models for gastric cancer, including chromosomal instability and microsatellite instability (MSI).
Obvious characteristics, suitable for the development of new targeted or immunotherapy strategies, and precise selection of patients and programs are the key to improving the prognosis of patients
.
In recent years, what has made great progress in second-line treatment is the advent of Ramucirumab (Ramucirumab), which has added a clinically available drug for Chinese patients.
If Ramucirumab (Ramucirumab) can enter the market in the future National health insurance, its application will be more extensive, and the future application of Ramucirumab (Ramucirumab) can also be explored in the direction of combining new targeted or immunotherapeutic drugs
.
Existing trials have confirmed that the efficacy of single-agent immunotherapy for gastric cancer is limited.
What kind of population can benefit and how to combine with other treatments are also questions that must be clarified in future research
.
Expert profile Professor Zhang Yanqiao, chief physician, doctoral supervisor, deputy dean of Heilongjiang Cancer Center, Heilongjiang Cancer Center, deputy director of Heilongjiang Cancer Center, Director of Heilongjiang Gastrointestinal Cancer Center, Chinese Anti-Cancer Association, Chairman of Cancer Big Data and Real World Research Committee, China Anti-Cancer Vice Chairman of CSCO Colorectal Cancer Professional Committee Vice Chairman of CSCO Gastric Cancer Professional Committee Vice Chairman of CSCO Clinical Research Professional Committee Vice Chairman of Chinese Medical Doctor Association Surgery Branch Vice Chairman of MDT Steering Committee International Hepatobiliary and Pancreatic Association China Subcommittee, Metastatic Liver Cancer Professional Committee, Deputy Chairman, Chinese Anti-Cancer Association, Gastric Cancer Professional Committee, Standing Committee, Chinese Anti-Cancer Association, Tumor Clinical Chemotherapy Professional Committee, Standing Committee, Chinese Anti-Cancer Association, Tumor Targeted Therapy Professional Committee, Standing Committee, Chinese Anti-Cancer Association, Tumor Marker Professional Committee, Standing Committee, China Anti-Cancer Association Member of the Standing Committee of the Accurate Medicine Professional Committee of the Cancer Association, China Anti-Cancer Association, Professor Pan Hongming, Deputy Dean of Run Run Run Shaw Hospital, Zhejiang University School of Medicine, Zhejiang University Qiushi Distinguished Physician, Doctoral Tutor, Leader of the Department of Oncology, Member of the National Committee of Experts on Rational Use of Medicines Head of the Comprehensive Oncology Group of the Reeducation Center of the National Health Commission; Designated Director of the Chinese Anti-Cancer Association Targeted Tumor Therapy Committee; Standing Director of the Chinese Society of Clinical Oncology; CSCO Cancer Nutrition Therapy Expert Committee; CSCO Support and Rehabilitation Expert Committee Designated Director Commissioner The director of Zhejiang Cancer Targeted Therapy Technical Guidance Center has published more than 120 Chinese and English papers, presided over and participated in more than 260 clinical trials, and edited "Toxic and Side Effects and Prevention of Cancer Chemotherapy", "Diagnosis and Treatment Strategies in Oncology" and "Internal Oncology" Reasonable Treatment and Medication Skills, etc.
, presided over the formulation of "Guidelines for the Nutritional Treatment of Chinese Cancer Patients", "Guidelines for the Rational Use of Gastrointestinal Tumors", etc.
, presided over the national major new drug creation special projects, the National Natural Science Foundation of China, and the Zhejiang Provincial Major Science and Technology Projects at provincial and ministerial levels More than 10 topics above
.
*This article is only used to provide scientific information to medical professionals, and does not represent the views of this platform
.
Subsequently, the RAINBOW-Asia study confirmed the effectiveness and safety of Ramucirumab in Asian populations
.
China is a big country with gastric cancer
.
In 2020, the number of new cases of gastric cancer in China is 480,000, accounting for 43.
9% of the world; the death toll is 370,000, accounting for 48.
5% of the world
.
Therefore, the diagnosis and treatment of gastric cancer is very important
.
Most Chinese gastric cancer patients are already at an advanced stage when they are diagnosed, and they have missed opportunities for surgical treatment
.
The first-line treatment for advanced gastric cancer is based on chemotherapy, but it is prone to recurrence and metastasis
.
At the 2021 Chinese Society of Clinical Oncology (CSCO) annual meeting, the results of the RAINBOW-Asia Chinese population study were announced, adding new medical evidence for the treatment of advanced gastric cancer in China
.
What is the current status of second-line treatment for gastric cancer? How are the new developments? What is the future development direction? This "Medical Oncology Channel" invited Professor Zhang Yanqiao from the Cancer Hospital of Harbin Medical University and Professor Pan Hongming from the Run Run Run Run Shaw Hospital of Zhejiang University School of Medicine to discuss issues related to the second-line treatment of gastric cancer
.
What is the current status of second-line treatment for advanced gastric cancer? The curative effect of comprehensive treatment for advanced gastric cancer is limited.
At present, platinum and fluorouracils are used as the conventional first-line chemotherapy for gastric cancer, and there is no effective later-line treatment after failure
.
The principle of second-line treatment in the National Comprehensive Cancer Network (NCCN) guidelines is to refer to the first-line treatment plan and give priority to the first-line drugs that have not been used.
This also makes the second-line chemotherapy drugs have a variety of options
.
Professor Pan Hongming believes that the main second-line treatment for advanced gastric cancer/gastroesophageal junction adenocarcinoma is single-agent chemotherapy with paclitaxel, docetaxel, irinotecan and other drugs, or a combination of two-drug chemotherapy based on the choice of drugs in the first-line treatment.
However, the overall treatment effect is not ideal, and the patient's median overall survival (OS) is less than one year
.
Anti-angiogenic drugs, immunotherapy and other new treatment methods have not yet fully established their status in the second-line treatment of gastric cancer.
The Chinese Society of Clinical Oncology (CSCO) guidelines only recommend single-agent taxanes and irinotecan for second-line treatment.
Immunotherapy is not recommended.
It is only used for patients with high microsatellite instability (MSI-H) or mismatch repair function defects (dMMR), and it is temporarily unable to guide precise selection of programs by molecular typing.
Patients have a low-toxicity and high-efficiency program.
Urgent need
.
What are the research advances in the second-line treatment of advanced gastric cancer in China? Cytotoxic drugs represented by irinotecan and taxanes are still the cornerstones of second-line therapy, but recent studies have confirmed that targeted drugs with different targets can also be used as one of the options for second-line therapy
.
The hot spots for targeted drugs for gastric cancer are anti-human epidermal growth factor receptor-2 (HER-2) antibodies and anti-angiogenic drugs
.
A few years ago, the clinical research of bevacizumab in gastric cancer was smashed, and the clinical research of other target drugs in the second-line treatment of gastric cancer had no positive results, such as everolimus, sunitinib, etc.
The second-line treatment of gastric cancer requires more effective drugs to solve the dilemma of clinical treatment
.
Professor Zhang Yanqiao said that Ramucirumab (Ramucirumab) is a human IgG1 monoclonal antibody that specifically binds to vascular endothelial growth factor receptor 2 (VEGFR-2) to inhibit VEGFR-2 activation, thereby inhibiting ligand induction The proliferation and migration of endothelial cells eventually inhibit tumor angiogenesis
.
Ramucirumab (Ramucirumab) has been approved by the FDA for the second-line treatment of gastric cancer.
The classic test is the RAINBOW study
.
The RAINBOW-Asia study is the bridging test of the study, which mainly evaluates the combination of Ramucirumab (Ramucirumab) and paclitaxel compared with placebo + paclitaxel in a population of patients with gastric cancer or gastroesophageal junction adenocarcinoma, which is dominated by Chinese patients.
For the effectiveness of second-line treatment, the primary endpoints are progression-free survival (PFS) and overall survival (OS)
.
A total of 440 patients from China, Malaysia, Thailand, and the Philippines were enrolled in the RAINBOW-Asia study.
They were divided into the Ramucirumab + paclitaxel group or placebo + paclitaxel group at a ratio of 2:1, and were included in the study.
There are a total of 392 Chinese patients, accounting for nearly 90% of all patients.
Therefore, this study has a very good reference value for guiding the application of Ramucirumab (Ramucirumab) in clinical practice in China
.
Professor Pan Hongming said that the RAINBOW-Asia study included a total of 392 Chinese patients.
The data released by the CSCO conference this year showed that the median PFS of the ramucirumab + paclitaxel group in the treatment of the Chinese population was 4.
17 months, which was significantly better.
In the placebo + paclitaxel group for 3.
15 months (HR=0.
751, P=0.
0169), the objective response rates (ORR) of the two groups were 29.
2% and 23.
0%, respectively, and the median OS was 9.
03 months and 8.
08 months ( HR=0.
942), the median OS benefit was consistent with the results of the RAINBOW study, reaching the main study endpoint
.
Chinese patients generally tolerated the regimen well, consistent with the known safety features of Ramucirumab (Ramucirumab), and no new safety signals were observed
.
The results of the RAINBOW study showed that the median PFS of the ramucirumab + paclitaxel group was 4.
4 months, which was better than the control group's 2.
9 months (HR 0.
64, P＜0.
001).
The median OS of the two groups were respectively It was 9.
6 months and 7.
4 months (HR 0.
81, P＜0.
017)
.
What is the impact of the RAINBOW-Asia study on the clinical practice of gastric cancer in my country? So far, there is no standard plan for the second-line treatment of advanced gastric cancer in China.
In the past, the main plan was single-drug or dual-drug chemotherapy.
Patients lacked low-toxic and efficient treatment options.
The RAINBOW-Asia study is the first and currently only Chinese patient in China.
A phase III study that confirms the clinical benefit of anti-angiogenesis therapy in the second-line population of advanced gastric cancer
.
Professor Zhang Yanqiao pointed out that Ramucirumab combined with paclitaxel has been approved for the second-line treatment of gastric cancer in many foreign countries.
Although it has not yet been approved in China, it has brought new ideas to Chinese patients suffering from advanced gastric cancer.
Treatment options and hope for survival
.
It is believed that for the treatment of advanced gastric cancer in the future, researchers will explore more Ramucirumab (Ramucirumab) combined treatment models
.
What is the future development direction of advanced gastric cancer treatment? Umbrella trial for second-line treatment of gastric cancer-South Korea’s VIKTORY trial showed that 105 patients who received biomarker-guided drug therapy had better treatment response and significantly improved survival outcomes.
In the future, clinical trials of molecular targeted drugs will be more important.
Focus on specific patient subgroups
.
Professor Pan Hongming proposed that in recent years, the Cancer Genome Atlas (TCGA) project and the Asian Cancer Research Group (ACRG) have proposed some new molecular typing models for gastric cancer, including chromosomal instability and microsatellite instability (MSI).
Obvious characteristics, suitable for the development of new targeted or immunotherapy strategies, and precise selection of patients and programs are the key to improving the prognosis of patients
.
In recent years, what has made great progress in second-line treatment is the advent of Ramucirumab (Ramucirumab), which has added a clinically available drug for Chinese patients.
If Ramucirumab (Ramucirumab) can enter the market in the future National health insurance, its application will be more extensive, and the future application of Ramucirumab (Ramucirumab) can also be explored in the direction of combining new targeted or immunotherapeutic drugs
.
Existing trials have confirmed that the efficacy of single-agent immunotherapy for gastric cancer is limited.
What kind of population can benefit and how to combine with other treatments are also questions that must be clarified in future research
.
Expert profile Professor Zhang Yanqiao, chief physician, doctoral supervisor, deputy dean of Heilongjiang Cancer Center, Heilongjiang Cancer Center, deputy director of Heilongjiang Cancer Center, Director of Heilongjiang Gastrointestinal Cancer Center, Chinese Anti-Cancer Association, Chairman of Cancer Big Data and Real World Research Committee, China Anti-Cancer Vice Chairman of CSCO Colorectal Cancer Professional Committee Vice Chairman of CSCO Gastric Cancer Professional Committee Vice Chairman of CSCO Clinical Research Professional Committee Vice Chairman of Chinese Medical Doctor Association Surgery Branch Vice Chairman of MDT Steering Committee International Hepatobiliary and Pancreatic Association China Subcommittee, Metastatic Liver Cancer Professional Committee, Deputy Chairman, Chinese Anti-Cancer Association, Gastric Cancer Professional Committee, Standing Committee, Chinese Anti-Cancer Association, Tumor Clinical Chemotherapy Professional Committee, Standing Committee, Chinese Anti-Cancer Association, Tumor Targeted Therapy Professional Committee, Standing Committee, Chinese Anti-Cancer Association, Tumor Marker Professional Committee, Standing Committee, China Anti-Cancer Association Member of the Standing Committee of the Accurate Medicine Professional Committee of the Cancer Association, China Anti-Cancer Association, Professor Pan Hongming, Deputy Dean of Run Run Run Shaw Hospital, Zhejiang University School of Medicine, Zhejiang University Qiushi Distinguished Physician, Doctoral Tutor, Leader of the Department of Oncology, Member of the National Committee of Experts on Rational Use of Medicines Head of the Comprehensive Oncology Group of the Reeducation Center of the National Health Commission; Designated Director of the Chinese Anti-Cancer Association Targeted Tumor Therapy Committee; Standing Director of the Chinese Society of Clinical Oncology; CSCO Cancer Nutrition Therapy Expert Committee; CSCO Support and Rehabilitation Expert Committee Designated Director Commissioner The director of Zhejiang Cancer Targeted Therapy Technical Guidance Center has published more than 120 Chinese and English papers, presided over and participated in more than 260 clinical trials, and edited "Toxic and Side Effects and Prevention of Cancer Chemotherapy", "Diagnosis and Treatment Strategies in Oncology" and "Internal Oncology" Reasonable Treatment and Medication Skills, etc.
, presided over the formulation of "Guidelines for the Nutritional Treatment of Chinese Cancer Patients", "Guidelines for the Rational Use of Gastrointestinal Tumors", etc.
, presided over the national major new drug creation special projects, the National Natural Science Foundation of China, and the Zhejiang Provincial Major Science and Technology Projects at provincial and ministerial levels More than 10 topics above
.
*This article is only used to provide scientific information to medical professionals, and does not represent the views of this platform
