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The "Progress in Multidisciplinary Treatment of Liver Cancer" conference co-sponsored by the Beijing Xisk Clinical Oncology Research Foundation and Eastern Cancer Center (ECCO) was successfully held online on March 3, 2021.
During the meeting, Professor Wang Liwei from Renji Hospital, Shanghai Jiaotong University School of Medicine, shared the progress of liver cancer medical treatment.
Current status of diagnosis and treatment of liver cancer 01 Liver cancer epidemiology The latest WHO forecast data in 2020 shows that in 2020, new cases of liver cancer worldwide (905,700) rank sixth among all malignant tumors, and new death cases (830,200) rank third.
In 2020, the new cases of liver cancer in China (410,000) ranked 5th among all malignant tumors, and the new deaths (391,100) ranked 2nd.
02 Systemic chemotherapy is more limited.
Research before 2011 showed that patients with hepatocellular carcinoma (HCC) could hardly get survival benefit from chemotherapy.
Until 2011, research led by Chinese scholars ushered in a new era of chemotherapy for liver cancer.
The EACH study shows that the FOLFOX4 regimen can bring survival benefits to the Asian population.
03 History of drug treatment for liver cancer Before the etiology and pathogenesis of tumors have not been fully explained, multidisciplinary comprehensive treatment is one of the most effective means to improve patient survival and improve the quality of life of patients.
In 2007, sorafenib ushered in a new era of targeted therapy for liver cancer.
For the first-line treatment of liver cancer, there are currently 6 important research advances on targeted or immunotherapy.
In the future, in the field of anti-angiogenesis drug therapy, "precise" targeting of the tumor microenvironment may be an important development direction.
In 2017, researchers began to explore the application of targeted or immunotherapy drugs in the second-line treatment of liver cancer.
Regorafenib was the first to obtain indications for the second-line treatment of liver cancer.042020 CSCO Guidelines: Treatment Strategies for Advanced HCC First-line Treatment Strategies for Advanced HCC Second-line Treatment Strategies for Advanced HCC Second-line Treatment Strategies for Advanced HCC 2020 Progress in Medical Treatment of Liver Cancer 01 First-line Targeted Therapy During the 2020 ASCO Conference, Phase II/III co-led by Professor Shukui Qin and Professor Feng Bi The results of the ZGDH3 study were announced.
The study aims to evaluate the efficacy and safety of Donafenib versus Sorafenib in the first-line treatment of advanced HCC.
A total of 668 Chinese patients with advanced HCC were included in the study.
The median overall survival (OS) of Donafenib and Sorafenib were 12.
1 months and 10.
3 months (HR=0.
83, P=0.
0363).
There were no significant differences in the median progression-free survival (PFS), objective response rate (ORR) and disease control rate (DCR) between the two groups.
The IMbrave150 study of targeted combined immunotherapy is based on the results of the IMbrave150 study.
In October 2020, the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China approved atilizumab + bevacizumab for previously unacceptable use First-line treatment for patients with unresectable HCC who have undergone systemic treatment.
So far, the first first-line immune combination therapy in the field of unresectable HCC was born.
In June 2020, the results of the IMbrave150 study were published in the Lancet Oncology.
According to the latest data released by ASCO GI in 2021, at a median follow-up of 15.
6 months, compared with sorafenib, atilizumab + bevacizumab can significantly prolong the OS and PFS of patients.
The median OS was 19.
2 months and 13.
4 months (HR=0.
66, P=0.
0009), and the median PFS was 6.
9 months and 4.
3 months (HR=0.
65, P=0.
0001).
Subgroup analysis showed that in the Chinese population, the median OS of the combination therapy group was as long as 24 months, and that of the sorafenib group was 11.
4 months (HR=0.
53).
Combined immunotherapy reduced the risk of death in Chinese patients by 47%. KEYNOTE-524 Study During the 2020 ASCO conference, the results of the Phase Ib KEYNOTE-524 study were announced.
The study aims to evaluate the efficacy and safety of lenvatinib + pembrolizumab in the treatment of patients with unresectable liver cancer.
The results showed that the median OS of lenvatinib + pembrolizumab was 22 months, and the median PFS was 9.
3 months.
Surprisingly, the ORR was as high as 46%.
The Phase III clinical study (LEAP 002) of this joint program is currently underway.
RESCUE Research During the 2020 ESMO conference, RESCUE research made a stunning appearance.
In October 2020, the full text of the study was published in the journal Clinical Cancer Research.
RESCUE is a non-randomized, open-label Phase II clinical study conducted in 25 centers in China to evaluate the efficacy and safety of carrelizumab + apatinib for first-line and second-line treatment of advanced liver cancer.
70 and 120 patients were enrolled in the first-line treatment and second-line treatment cohorts, respectively.
The results showed that the ORRs of the first-line and second-line treatment cohorts evaluated by the Independent Review Committee (IRC) were 34.
3% and 22.
5%, respectively, and the median duration of response (DOR) of the two cohorts were 14.
8 months and not reached, respectively.
Based on this, the combination treatment plan is recommended by the 2020 CSCO guidelines to be included in the first-line treatment level III expert recommendation and the second-line treatment level II expert recommendation (for those who have used oxaliplatin-based programs in the past), Carrelizol Monoclonal antibody + apatinib enriches the first-line and second-line treatment options for patients with advanced liver cancer.
02 During the 2020 ASCO conference, a phase III study of apatinib versus placebo in the second-line treatment of Chinese patients with advanced liver cancer was announced.
The results showed that the efficacy of apatinib was significantly better than that of placebo.
The median OS of the two groups was 8.
7 months and 6.
8 months (HR=0.
785, P=0.
0476), and the median PFS was 4.
5 months and 1.
9 months, respectively.
Month (HR=0.
471, P˂0.
0001), the ORRs of the two groups were 10.
7% and 1.
5%, respectively.
Apatinib can significantly prolong the OS and PFS of patients after the first-line treatment progresses, and it is well tolerated and its safety is controllable.
Immunotherapy A Phase II study led by Professor Qin Shukui and Professor Ren Zhenggang was published in The Lancet Oncology in February 2020.
This study aims to evaluate the effectiveness and safety of carrelizumab in the second-line treatment of advanced liver cancer in China.
A total of 220 Chinese liver cancer patients who failed first-line treatment were included.
The results showed that carrelizumab was safe and effective in the treatment of advanced liver cancer.
The ORR of all patients was 14.
7%, the 12-month OS rate was 55.
9%, and the median OS was 13.
8 months.
Based on this, in March 2020, carrelizumab was approved by the NMPA for the treatment of advanced HCC patients who have received sorafenib treatment and/or oxaliplatin-containing system chemotherapy.
Precise treatment of liver cancer to explore the current molecular targeted therapy drugs for liver cancer involve multiple signal pathways in the pathogenesis of hepatocellular carcinoma, including EGR/EGFR, VEGR/VEGFR, PDGF/PDGFR, etc.
It mainly includes four aspects: precise targeted immunotherapy for liver cancer based on molecular pathological classification; full use of preclinical research/clinical research to carry out efficient drug target verification; use of biomarkers such as AFP and PD-L1 to screen for potential benefits Population; combined immunotherapy to increase the expression of tumor-associated antigens and enhance the effect of immunotherapy.
Summarize the progress of medical treatment of liver cancer with targeted combined immunotherapy, start the era of immunotherapy, focus on the characteristics of liver cancer in the Chinese population, expand second-line options, prolong patient survival, and improve the molecular pathological classification of liver cancer through continuous exploration and improvement of new targets and multiple targets The efficiency of drug verification, the preliminary verification of the safety of screening biomarker cell therapy, and the further efficacy verification.
Focus on the immune microenvironment, and explore joint strategies to reduce immune suppression
During the meeting, Professor Wang Liwei from Renji Hospital, Shanghai Jiaotong University School of Medicine, shared the progress of liver cancer medical treatment.
Current status of diagnosis and treatment of liver cancer 01 Liver cancer epidemiology The latest WHO forecast data in 2020 shows that in 2020, new cases of liver cancer worldwide (905,700) rank sixth among all malignant tumors, and new death cases (830,200) rank third.
In 2020, the new cases of liver cancer in China (410,000) ranked 5th among all malignant tumors, and the new deaths (391,100) ranked 2nd.
02 Systemic chemotherapy is more limited.
Research before 2011 showed that patients with hepatocellular carcinoma (HCC) could hardly get survival benefit from chemotherapy.
Until 2011, research led by Chinese scholars ushered in a new era of chemotherapy for liver cancer.
The EACH study shows that the FOLFOX4 regimen can bring survival benefits to the Asian population.
03 History of drug treatment for liver cancer Before the etiology and pathogenesis of tumors have not been fully explained, multidisciplinary comprehensive treatment is one of the most effective means to improve patient survival and improve the quality of life of patients.
In 2007, sorafenib ushered in a new era of targeted therapy for liver cancer.
For the first-line treatment of liver cancer, there are currently 6 important research advances on targeted or immunotherapy.
In the future, in the field of anti-angiogenesis drug therapy, "precise" targeting of the tumor microenvironment may be an important development direction.
In 2017, researchers began to explore the application of targeted or immunotherapy drugs in the second-line treatment of liver cancer.
Regorafenib was the first to obtain indications for the second-line treatment of liver cancer.042020 CSCO Guidelines: Treatment Strategies for Advanced HCC First-line Treatment Strategies for Advanced HCC Second-line Treatment Strategies for Advanced HCC Second-line Treatment Strategies for Advanced HCC 2020 Progress in Medical Treatment of Liver Cancer 01 First-line Targeted Therapy During the 2020 ASCO Conference, Phase II/III co-led by Professor Shukui Qin and Professor Feng Bi The results of the ZGDH3 study were announced.
The study aims to evaluate the efficacy and safety of Donafenib versus Sorafenib in the first-line treatment of advanced HCC.
A total of 668 Chinese patients with advanced HCC were included in the study.
The median overall survival (OS) of Donafenib and Sorafenib were 12.
1 months and 10.
3 months (HR=0.
83, P=0.
0363).
There were no significant differences in the median progression-free survival (PFS), objective response rate (ORR) and disease control rate (DCR) between the two groups.
The IMbrave150 study of targeted combined immunotherapy is based on the results of the IMbrave150 study.
In October 2020, the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China approved atilizumab + bevacizumab for previously unacceptable use First-line treatment for patients with unresectable HCC who have undergone systemic treatment.
So far, the first first-line immune combination therapy in the field of unresectable HCC was born.
In June 2020, the results of the IMbrave150 study were published in the Lancet Oncology.
According to the latest data released by ASCO GI in 2021, at a median follow-up of 15.
6 months, compared with sorafenib, atilizumab + bevacizumab can significantly prolong the OS and PFS of patients.
The median OS was 19.
2 months and 13.
4 months (HR=0.
66, P=0.
0009), and the median PFS was 6.
9 months and 4.
3 months (HR=0.
65, P=0.
0001).
Subgroup analysis showed that in the Chinese population, the median OS of the combination therapy group was as long as 24 months, and that of the sorafenib group was 11.
4 months (HR=0.
53).
Combined immunotherapy reduced the risk of death in Chinese patients by 47%. KEYNOTE-524 Study During the 2020 ASCO conference, the results of the Phase Ib KEYNOTE-524 study were announced.
The study aims to evaluate the efficacy and safety of lenvatinib + pembrolizumab in the treatment of patients with unresectable liver cancer.
The results showed that the median OS of lenvatinib + pembrolizumab was 22 months, and the median PFS was 9.
3 months.
Surprisingly, the ORR was as high as 46%.
The Phase III clinical study (LEAP 002) of this joint program is currently underway.
RESCUE Research During the 2020 ESMO conference, RESCUE research made a stunning appearance.
In October 2020, the full text of the study was published in the journal Clinical Cancer Research.
RESCUE is a non-randomized, open-label Phase II clinical study conducted in 25 centers in China to evaluate the efficacy and safety of carrelizumab + apatinib for first-line and second-line treatment of advanced liver cancer.
70 and 120 patients were enrolled in the first-line treatment and second-line treatment cohorts, respectively.
The results showed that the ORRs of the first-line and second-line treatment cohorts evaluated by the Independent Review Committee (IRC) were 34.
3% and 22.
5%, respectively, and the median duration of response (DOR) of the two cohorts were 14.
8 months and not reached, respectively.
Based on this, the combination treatment plan is recommended by the 2020 CSCO guidelines to be included in the first-line treatment level III expert recommendation and the second-line treatment level II expert recommendation (for those who have used oxaliplatin-based programs in the past), Carrelizol Monoclonal antibody + apatinib enriches the first-line and second-line treatment options for patients with advanced liver cancer.
02 During the 2020 ASCO conference, a phase III study of apatinib versus placebo in the second-line treatment of Chinese patients with advanced liver cancer was announced.
The results showed that the efficacy of apatinib was significantly better than that of placebo.
The median OS of the two groups was 8.
7 months and 6.
8 months (HR=0.
785, P=0.
0476), and the median PFS was 4.
5 months and 1.
9 months, respectively.
Month (HR=0.
471, P˂0.
0001), the ORRs of the two groups were 10.
7% and 1.
5%, respectively.
Apatinib can significantly prolong the OS and PFS of patients after the first-line treatment progresses, and it is well tolerated and its safety is controllable.
Immunotherapy A Phase II study led by Professor Qin Shukui and Professor Ren Zhenggang was published in The Lancet Oncology in February 2020.
This study aims to evaluate the effectiveness and safety of carrelizumab in the second-line treatment of advanced liver cancer in China.
A total of 220 Chinese liver cancer patients who failed first-line treatment were included.
The results showed that carrelizumab was safe and effective in the treatment of advanced liver cancer.
The ORR of all patients was 14.
7%, the 12-month OS rate was 55.
9%, and the median OS was 13.
8 months.
Based on this, in March 2020, carrelizumab was approved by the NMPA for the treatment of advanced HCC patients who have received sorafenib treatment and/or oxaliplatin-containing system chemotherapy.
Precise treatment of liver cancer to explore the current molecular targeted therapy drugs for liver cancer involve multiple signal pathways in the pathogenesis of hepatocellular carcinoma, including EGR/EGFR, VEGR/VEGFR, PDGF/PDGFR, etc.
It mainly includes four aspects: precise targeted immunotherapy for liver cancer based on molecular pathological classification; full use of preclinical research/clinical research to carry out efficient drug target verification; use of biomarkers such as AFP and PD-L1 to screen for potential benefits Population; combined immunotherapy to increase the expression of tumor-associated antigens and enhance the effect of immunotherapy.
Summarize the progress of medical treatment of liver cancer with targeted combined immunotherapy, start the era of immunotherapy, focus on the characteristics of liver cancer in the Chinese population, expand second-line options, prolong patient survival, and improve the molecular pathological classification of liver cancer through continuous exploration and improvement of new targets and multiple targets The efficiency of drug verification, the preliminary verification of the safety of screening biomarker cell therapy, and the further efficacy verification.
Focus on the immune microenvironment, and explore joint strategies to reduce immune suppression
