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*Only for medical professionals to read and reference, Professor Bei Zhong, Professor Lu Zhihao, will take you to interpret the 2021 ESMO esophageal squamous cell carcinoma related hot research and discuss the latest progress of the immune combined chemotherapy regimen.
2021 European Society of Medical Oncology (ESMO) Annual Meeting, September 2021 It was grandly held in the form of an online conference from the 16th to the 21st
.
As the world's leading academic annual meeting in the field of oncology, every year the ESMO annual meeting is held, a large number of blockbuster studies are announced, bringing changes to the field of clinical diagnosis and treatment
.
At the same time, it also attracts the attention of top experts in the field of global cancer diagnosis and treatment
.
At this year's ESMO annual meeting, what are the important research announcements about esophageal cancer? What enlightenment does related research bring us? The medical profession specially invited Professor Lu Zhihao from the Department of Digestive Oncology, Beijing Cancer Hospital, to interpret the important research results in the field of esophageal cancer treatment for us, and to discuss the latest developments in immune combined chemotherapy
.
Professor Lu Zhihao's interpretation of the video The dilemma of diagnosis and treatment of esophageal squamous cell carcinoma in China is urgently needed to effectively break through.
Esophageal cancer has become a malignant tumor that seriously threatens human life and health.
It is also one of the most common malignant tumors in China.
At present, esophageal cancer has become the sixth most common malignant tumor in China.
The tumor and the fourth dead tumor
.
According to statistics, the number of new cases of esophageal cancer in China in 2020 will exceed 300,000, accounting for more than 53% of the world.
Among them, about 80% of the patients died the year they were diagnosed, and the number of deaths accounted for more than 55% of the world
.
Although the incidence of esophageal cancer is not optimistic, the overall progress in the treatment of esophageal cancer is slow.
The 5-year survival rate for esophageal cancer is only about 20%.
China is slightly better than the international level, but the overall 5-year survival rate is only 30%
.
Therefore, improving the survival time and quality of life of patients with esophageal cancer is an urgent clinical problem to be solved.
.
In the treatment of esophageal cancer, for a long time, the treatment has mainly relied on chemotherapy and radiotherapy.
The patients suffered from serious adverse reactions but failed to completely improve the prognosis.
There is an urgent need to find new strategies to improve the efficacy in clinical practice
.
In recent years, as malignant tumors have entered the age of immunotherapy, immunotherapy has also made great breakthroughs in esophageal cancer.
A number of studies at home and abroad have established the status of immunotherapy in the second-line treatment of advanced esophageal cancer, prompting us to further explore the role of immunotherapy in the treatment of advanced esophageal cancer.
The role of first-line treatment of esophageal cancer and perioperative period
.
ORIENT-15 study Sintilizumab combined with chemotherapy: a new strategy for the first-line treatment of advanced esophageal cancer At this year’s ESMO annual meeting, a report on Sintilizumab combined with chemotherapy led by Professor Shen Lin from the Department of Digestive Oncology, Beijing Cancer Hospital The phase III clinical study (ORIENT-15 study [1] NCT03748134) comparing placebo combined with chemotherapy in the first-line treatment of patients with advanced or metastatic esophageal squamous cell carcinoma (ESCC) is particularly interesting
.
Professor Lu Zhihao said that the incidence of esophageal squamous cell carcinoma in Asian countries is much higher than that in Western countries.
In addition to chemotherapy and radiotherapy, patients have no other treatment options
.
Immune checkpoint inhibitors have brought new hope to this field
.
The ORIENT-15 study verified the outstanding value of sintilimab combined with chemotherapy in patients with advanced esophageal squamous cell carcinoma
.
A total of 659 patients with unresectable locally advanced or metastatic ESCC were included in the study, and they were assigned 1:1 to the sintilimab + chemotherapy group and placebo combined chemotherapy group for treatment
.
The primary endpoint of the study is the overall survival (OS) of patients with a combined positive score (CPS) ≥10 and all randomized patients.
The secondary endpoints include progression-free survival (PFS), objective response rate (ORR), disease control rate (DCR) ) And duration of remission (DoR)
.
When designing the study, the investigator did not specify which chemotherapy regimen should be combined with Sintilimab.
Instead, it requested that the combination of paclitaxel and cisplatin (TP) and 5-fluorouracil combined with cisplatin (CF ) Choose among the schemes to make the research conclusions closer to the real world situation
.
Figure 1 The results of the ORINET-15 study design showed that the primary end point of the study was OS in patients with CPS ≥10.
The median OS in the sintilimab+chemotherapy group was 17.
2 months, which was significantly higher than that of the placebo+chemotherapy group 13.
6 months
.
Among all patients, the median OS of sintilimab+chemotherapy patients was 16.
7 months, which was greater than 12.
5 months in the placebo+chemotherapy group
.
In the OS subgroup analysis of all patients, in almost all subgroups, sintilimab combined with chemotherapy showed more obvious survival benefits
.
Figure 2 OS results of the ORINET-15 study Figure 3 OS subgroup analysis of all patients in the ORINET-15 study In terms of PFS, the median PFS of the CITIC Dilimumab + chemotherapy group was 8.
3 months in patients with CPS ≥ 10, which was significantly higher than that of placebo 6.
4 months for the drug + chemotherapy group
.
Among all patients, the median PFS of sintilimab+chemotherapy patients was 7.
2 months, which was greater than that of the placebo+chemotherapy group of 5.
7 months
.
Figure 4 Results of PFS in the ORINET-15 study.
Compared with chemotherapy alone, Sintilimab + chemotherapy has better benefits for OS and PFS in patients with CPS ≥ 10 points or in all randomized patients
.
At the same time, the objective tumor remission rate of the sintilimab+chemotherapy group was 20% higher than that of the chemotherapy group, reaching 66.
1%, and the DoR was up to 9.
7 months, which was up to 2.
8 months longer than that of the chemotherapy group
.
Figure 5 ORINET-15 study tumor remission and sustained remission time.
In terms of safety, the incidence of adverse reactions ≥ grade 3 in the Sintilimab+chemotherapy group is similar to the placebo+chemotherapy group, and the Sintilizumab monoclonal antibody shows good results Security
.
Figure 6 Adverse events (AEs) of all patients treated in the ORINET-15 study Professor Lu Zhihao said that the ORIENT-15 study is the first international multi-center clinical study led by a Chinese researcher to treat esophageal squamous cell carcinoma as a first-line immunotherapy, mainly in the Chinese population , To adapt to the differences in clinical practice in various regions
.
In the study design, the choice of chemotherapeutic drugs combined with Sindilizumab is determined by the investigator and is closer to the real-world situation; in addition, in terms of design details, the ORIENT-15 study adopts a weekly divided dose strategy to reduce chemotherapeutic drugs The probability of bleeding and perforation brought to the patient ensures the safety of the patient's medication
.
The results of the study confirmed that in the first-line treatment of patients with unresectable locally advanced, recurrent or metastatic esophageal squamous cell carcinoma, Sintilimab combined with chemotherapy significantly improved OS, PFS and regardless of the expression of PD-L1.
DOR
.
Sintilimab combined with chemotherapy will provide a better choice for the first-line treatment of advanced esophageal cancer! Immunization combined with chemotherapy is among the first-line treatments for advanced esophageal cancer.
How the new strategy can go further.
After interpreting and sharing the above-mentioned research, Professor Lu Zhihao expressed his views on how to optimize the treatment strategy for esophageal cancer in the immunotherapy era
.
Professor Lu Zhihao said that in the process of applying immune combination therapy strategies, the selection of benefiting groups is the key
.
In addition to focusing on the effect of immunotherapy on the overall population, the ORIENT-15 study also explored the effect of PD-L1 expression on clinical outcomes
.
The research results seem to have the phenomenon that the higher the expression of PD-L1, the more obvious the benefit of immunotherapy
.
But only relying on PD-L1 to screen the benefiting population is unreliable according to related studies published in the past
.
In the future, it is still necessary to explore more immunotherapy-related targets to accurately screen the benefiting population so that clinical patients can benefit more fully
.
Secondly, we see that there is insufficient knowledge about the immune microenvironment of esophageal cancer.
The immune microenvironment is not only related to immunotherapy, but also plays a vital role in many combined treatment options
.
How to transform the so-called "immune desert" tumors into "immune sensitivity" will be an important direction for future exploration
.
At present, relevant clinical research has been carried out, and the research on the expression of PD-L1 and TMB (tumor mutation burden) has achieved certain results
.
It is believed that with the further in-depth understanding and grasp of the immune microenvironment of esophageal cancer, we will achieve better development in accurately screening the beneficiaries and accurately formulating combined treatment strategies
.
Finally, Professor Lu Zhihao summarized the interpretation of this research
.
He said that the ORIENT-15 study has achieved such excellent results, which shows that Sintilimab is very trustworthy
.
The benefits of Sintilizumab combined with chemotherapy in PFS and OS are significantly better than other first-line immunotherapy studies on esophageal cancer.
This shows that Sintilizumab significantly improves the disease outcome of patients regardless of short-term or long-term efficacy.
, Prolong the survival of patients, and provide a better choice for the first-line treatment of advanced esophageal cancer
.
Expert profile Prof.
Zhihao Lu, PhD in Oncology, Peking University Postdoctoral in Oncology, Johns Hopkins Hospital, United States Associate Chief Physician, Associate Professor, and Postgraduate Tutor of the Department of Digestive Oncology, Peking University Project Outstanding Contribution Award (in the field of esophageal cancer) 2019 Beijing Municipal Hospital Administration “Young Miao” Talent Program, Deputy Chairman, Esophageal Cancer Special Committee, Beijing Cancer Prevention and Treatment Society, Chairman, Esophageal Cancer Youth Committee, Beijing Cancer Prevention and Treatment Society, Chinese Anti-Cancer Association Tumor Accuracy The young member of the Treatment Committee The young member of the Esophageal Cancer Professional Committee of the Chinese Anti-Cancer Association is mainly engaged in the drug treatment and comprehensive treatment of malignant tumors of the digestive tract, including chemotherapy and molecular targets for advanced esophageal cancer, gastric cancer, colorectal cancer, pancreatic cancer and neuroendocrine tumors to therapy and immune therapy
.
As the main researcher and participant, he has participated in dozens of international and domestic multi-center clinical research on new drugs
.
References[1] L.
Shen, ZH.
Lu, JY.
Wang.
Sintilimab plus chemotherapy versus chemotherapy as first- line therapy in patients with advanced or metastatic esophageal squamous cell cancer: First results of the phase III ORIENT-15 study https: //doi.
org/10.
1016/j.
annonc.
2021.
08.
2132*This article is only used to provide scientific information to medical professionals and does not represent the views of this platform
2021 European Society of Medical Oncology (ESMO) Annual Meeting, September 2021 It was grandly held in the form of an online conference from the 16th to the 21st
.
As the world's leading academic annual meeting in the field of oncology, every year the ESMO annual meeting is held, a large number of blockbuster studies are announced, bringing changes to the field of clinical diagnosis and treatment
.
At the same time, it also attracts the attention of top experts in the field of global cancer diagnosis and treatment
.
At this year's ESMO annual meeting, what are the important research announcements about esophageal cancer? What enlightenment does related research bring us? The medical profession specially invited Professor Lu Zhihao from the Department of Digestive Oncology, Beijing Cancer Hospital, to interpret the important research results in the field of esophageal cancer treatment for us, and to discuss the latest developments in immune combined chemotherapy
.
Professor Lu Zhihao's interpretation of the video The dilemma of diagnosis and treatment of esophageal squamous cell carcinoma in China is urgently needed to effectively break through.
Esophageal cancer has become a malignant tumor that seriously threatens human life and health.
It is also one of the most common malignant tumors in China.
At present, esophageal cancer has become the sixth most common malignant tumor in China.
The tumor and the fourth dead tumor
.
According to statistics, the number of new cases of esophageal cancer in China in 2020 will exceed 300,000, accounting for more than 53% of the world.
Among them, about 80% of the patients died the year they were diagnosed, and the number of deaths accounted for more than 55% of the world
.
Although the incidence of esophageal cancer is not optimistic, the overall progress in the treatment of esophageal cancer is slow.
The 5-year survival rate for esophageal cancer is only about 20%.
China is slightly better than the international level, but the overall 5-year survival rate is only 30%
.
Therefore, improving the survival time and quality of life of patients with esophageal cancer is an urgent clinical problem to be solved.
.
In the treatment of esophageal cancer, for a long time, the treatment has mainly relied on chemotherapy and radiotherapy.
The patients suffered from serious adverse reactions but failed to completely improve the prognosis.
There is an urgent need to find new strategies to improve the efficacy in clinical practice
.
In recent years, as malignant tumors have entered the age of immunotherapy, immunotherapy has also made great breakthroughs in esophageal cancer.
A number of studies at home and abroad have established the status of immunotherapy in the second-line treatment of advanced esophageal cancer, prompting us to further explore the role of immunotherapy in the treatment of advanced esophageal cancer.
The role of first-line treatment of esophageal cancer and perioperative period
.
ORIENT-15 study Sintilizumab combined with chemotherapy: a new strategy for the first-line treatment of advanced esophageal cancer At this year’s ESMO annual meeting, a report on Sintilizumab combined with chemotherapy led by Professor Shen Lin from the Department of Digestive Oncology, Beijing Cancer Hospital The phase III clinical study (ORIENT-15 study [1] NCT03748134) comparing placebo combined with chemotherapy in the first-line treatment of patients with advanced or metastatic esophageal squamous cell carcinoma (ESCC) is particularly interesting
.
Professor Lu Zhihao said that the incidence of esophageal squamous cell carcinoma in Asian countries is much higher than that in Western countries.
In addition to chemotherapy and radiotherapy, patients have no other treatment options
.
Immune checkpoint inhibitors have brought new hope to this field
.
The ORIENT-15 study verified the outstanding value of sintilimab combined with chemotherapy in patients with advanced esophageal squamous cell carcinoma
.
A total of 659 patients with unresectable locally advanced or metastatic ESCC were included in the study, and they were assigned 1:1 to the sintilimab + chemotherapy group and placebo combined chemotherapy group for treatment
.
The primary endpoint of the study is the overall survival (OS) of patients with a combined positive score (CPS) ≥10 and all randomized patients.
The secondary endpoints include progression-free survival (PFS), objective response rate (ORR), disease control rate (DCR) ) And duration of remission (DoR)
.
When designing the study, the investigator did not specify which chemotherapy regimen should be combined with Sintilimab.
Instead, it requested that the combination of paclitaxel and cisplatin (TP) and 5-fluorouracil combined with cisplatin (CF ) Choose among the schemes to make the research conclusions closer to the real world situation
.
Figure 1 The results of the ORINET-15 study design showed that the primary end point of the study was OS in patients with CPS ≥10.
The median OS in the sintilimab+chemotherapy group was 17.
2 months, which was significantly higher than that of the placebo+chemotherapy group 13.
6 months
.
Among all patients, the median OS of sintilimab+chemotherapy patients was 16.
7 months, which was greater than 12.
5 months in the placebo+chemotherapy group
.
In the OS subgroup analysis of all patients, in almost all subgroups, sintilimab combined with chemotherapy showed more obvious survival benefits
.
Figure 2 OS results of the ORINET-15 study Figure 3 OS subgroup analysis of all patients in the ORINET-15 study In terms of PFS, the median PFS of the CITIC Dilimumab + chemotherapy group was 8.
3 months in patients with CPS ≥ 10, which was significantly higher than that of placebo 6.
4 months for the drug + chemotherapy group
.
Among all patients, the median PFS of sintilimab+chemotherapy patients was 7.
2 months, which was greater than that of the placebo+chemotherapy group of 5.
7 months
.
Figure 4 Results of PFS in the ORINET-15 study.
Compared with chemotherapy alone, Sintilimab + chemotherapy has better benefits for OS and PFS in patients with CPS ≥ 10 points or in all randomized patients
.
At the same time, the objective tumor remission rate of the sintilimab+chemotherapy group was 20% higher than that of the chemotherapy group, reaching 66.
1%, and the DoR was up to 9.
7 months, which was up to 2.
8 months longer than that of the chemotherapy group
.
Figure 5 ORINET-15 study tumor remission and sustained remission time.
In terms of safety, the incidence of adverse reactions ≥ grade 3 in the Sintilimab+chemotherapy group is similar to the placebo+chemotherapy group, and the Sintilizumab monoclonal antibody shows good results Security
.
Figure 6 Adverse events (AEs) of all patients treated in the ORINET-15 study Professor Lu Zhihao said that the ORIENT-15 study is the first international multi-center clinical study led by a Chinese researcher to treat esophageal squamous cell carcinoma as a first-line immunotherapy, mainly in the Chinese population , To adapt to the differences in clinical practice in various regions
.
In the study design, the choice of chemotherapeutic drugs combined with Sindilizumab is determined by the investigator and is closer to the real-world situation; in addition, in terms of design details, the ORIENT-15 study adopts a weekly divided dose strategy to reduce chemotherapeutic drugs The probability of bleeding and perforation brought to the patient ensures the safety of the patient's medication
.
The results of the study confirmed that in the first-line treatment of patients with unresectable locally advanced, recurrent or metastatic esophageal squamous cell carcinoma, Sintilimab combined with chemotherapy significantly improved OS, PFS and regardless of the expression of PD-L1.
DOR
.
Sintilimab combined with chemotherapy will provide a better choice for the first-line treatment of advanced esophageal cancer! Immunization combined with chemotherapy is among the first-line treatments for advanced esophageal cancer.
How the new strategy can go further.
After interpreting and sharing the above-mentioned research, Professor Lu Zhihao expressed his views on how to optimize the treatment strategy for esophageal cancer in the immunotherapy era
.
Professor Lu Zhihao said that in the process of applying immune combination therapy strategies, the selection of benefiting groups is the key
.
In addition to focusing on the effect of immunotherapy on the overall population, the ORIENT-15 study also explored the effect of PD-L1 expression on clinical outcomes
.
The research results seem to have the phenomenon that the higher the expression of PD-L1, the more obvious the benefit of immunotherapy
.
But only relying on PD-L1 to screen the benefiting population is unreliable according to related studies published in the past
.
In the future, it is still necessary to explore more immunotherapy-related targets to accurately screen the benefiting population so that clinical patients can benefit more fully
.
Secondly, we see that there is insufficient knowledge about the immune microenvironment of esophageal cancer.
The immune microenvironment is not only related to immunotherapy, but also plays a vital role in many combined treatment options
.
How to transform the so-called "immune desert" tumors into "immune sensitivity" will be an important direction for future exploration
.
At present, relevant clinical research has been carried out, and the research on the expression of PD-L1 and TMB (tumor mutation burden) has achieved certain results
.
It is believed that with the further in-depth understanding and grasp of the immune microenvironment of esophageal cancer, we will achieve better development in accurately screening the beneficiaries and accurately formulating combined treatment strategies
.
Finally, Professor Lu Zhihao summarized the interpretation of this research
.
He said that the ORIENT-15 study has achieved such excellent results, which shows that Sintilimab is very trustworthy
.
The benefits of Sintilizumab combined with chemotherapy in PFS and OS are significantly better than other first-line immunotherapy studies on esophageal cancer.
This shows that Sintilizumab significantly improves the disease outcome of patients regardless of short-term or long-term efficacy.
, Prolong the survival of patients, and provide a better choice for the first-line treatment of advanced esophageal cancer
.
Expert profile Prof.
Zhihao Lu, PhD in Oncology, Peking University Postdoctoral in Oncology, Johns Hopkins Hospital, United States Associate Chief Physician, Associate Professor, and Postgraduate Tutor of the Department of Digestive Oncology, Peking University Project Outstanding Contribution Award (in the field of esophageal cancer) 2019 Beijing Municipal Hospital Administration “Young Miao” Talent Program, Deputy Chairman, Esophageal Cancer Special Committee, Beijing Cancer Prevention and Treatment Society, Chairman, Esophageal Cancer Youth Committee, Beijing Cancer Prevention and Treatment Society, Chinese Anti-Cancer Association Tumor Accuracy The young member of the Treatment Committee The young member of the Esophageal Cancer Professional Committee of the Chinese Anti-Cancer Association is mainly engaged in the drug treatment and comprehensive treatment of malignant tumors of the digestive tract, including chemotherapy and molecular targets for advanced esophageal cancer, gastric cancer, colorectal cancer, pancreatic cancer and neuroendocrine tumors to therapy and immune therapy
.
As the main researcher and participant, he has participated in dozens of international and domestic multi-center clinical research on new drugs
.
References[1] L.
Shen, ZH.
Lu, JY.
Wang.
Sintilimab plus chemotherapy versus chemotherapy as first- line therapy in patients with advanced or metastatic esophageal squamous cell cancer: First results of the phase III ORIENT-15 study https: //doi.
org/10.
1016/j.
annonc.
2021.
08.
2132*This article is only used to provide scientific information to medical professionals and does not represent the views of this platform
