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*Only for medical professionals to read and refer to the 2021 CSCO Guidelines for Diagnosis and Treatment of Biliary Tract Malignancies.
The update mainly focuses on the radiotherapy part and system treatment part.
The CSCO Guidelines Conference held in Beijing on April 23-24 is one of the most important conferences in the field of oncology in China.
At the conference on the 24th, Professor Zhou Jun from Peking University Cancer Hospital shared with you the updated points of the guidelines for the diagnosis and treatment of biliary tract carcinoma (BTC).
BTC mainly includes gallbladder cancer and cholangiocarcinoma, accounting for about 3% of all digestive system tumors, most of which are adenocarcinomas, which are aggressive and have a very poor prognosis, with a 5-year survival rate of <5%.
And the diagnosis and treatment of BTC is obviously different from that of hepatocellular carcinoma.
This year, the Chinese Society of Clinical Oncology (CSCO) has updated the BTC diagnosis and treatment guidelines, the main update content is the radiotherapy part and the system treatment part.
Radiotherapy: Overcoming doubts and finally approved.
■ Update 1: Postoperative adjuvant radiotherapy is finally approved.
For intrahepatic and extrahepatic bile duct malignancies with positive margins after surgery (R2 resection), postoperative adjuvant radiotherapy is recommended.
(Recommended by Level I Experts, Evidence Type 2A) For patients with intrahepatic and extrahepatic bile duct malignant tumors R0 after N+, postoperative adjuvant radiotherapy is recommended.
(Recommended by Level II experts, Type 2A evidence) Whether adjuvant radiotherapy for biliary malignancies can benefit patients has always been a topic of debate in the past.
Therefore, Level I experts recommend in the previous CSCO guidelines for diagnosis and treatment of biliary malignancies.
The option is to participate in clinical trials, and adjuvant radiotherapy has not been recommended and approved by the highest-level experts.A MATE analysis published in 2020, the study of the benefit of extrahepatic cholangiocarcinoma and gallbladder cancer in radiotherapy, combined with the original 0809 prospective phase II study, supports postoperative adjuvant radiotherapy for BTC with positive resection margins.
Therefore, in this guideline update, adjuvant radiotherapy with positive margins after surgery is listed as recommended by level I experts.
■ Update 2: Stereotactic body radiotherapy (SBRT) is emerging in palliative radiotherapy.
For inoperable but more limited intrahepatic cholangiocarcinoma, SBRT can be considered.
(Recommended by Level II Experts, Evidence Type 2A) Due to the current advancement in radiotherapy technology and the gradual development of SBRT, precision radiotherapy represented by SBRT has been proven in the unresectable BTC that protects normal liver tissue and controls tumors.
Based on the results of some prospective studies, retrospective studies, and MATE analysis, for inoperable but more limited intrahepatic cholangiocarcinoma, SBRT treatment is included in the recommendation of level II experts.
Systematic treatment: precision treatment, the 2021 version of CSCO biliary malignant tumor diagnosis and treatment guidelines have been updated more in the system treatment part, mainly focusing on the targeted and immunotherapy of precision treatment.
■ Update 1: Advanced second-line therapy adds another treatment option.
Advanced BTC second-line therapy adds BRAF V600E mutant tumors and recommends dabrafenib + trametinib.
(Recommended by Level II experts, Type 2A evidence) A small sample study published in 2020 shows that the effective rate of dabrafenib + trametinib for the treatment of BRAF V600E mutant tumors reached 47%, far exceeding the effective rate of second-line chemotherapy5 %.
Although BRAF V600E mutation accounts for only about 3% of all biliary tract tumors, in the past, BRAF V600E mutation was considered to be an indicator of poor prognosis.
Under the guidance of precision treatment, relatively good therapeutic effects can be obtained, and patients with dabrafenib and trametinib can be bought and used in China.
Taking into account the efficacy and availability of drugs, it is listed as a level II expert recommendation.
■ Update 2: The first successful targeted therapy for biliary tumors.
Patients with intrahepatic cholangiocarcinoma who carry isocitrate dehydrogenase (IDH1) mutation inhibitors are recommended to Ivosidenib (AG-120).
(Recommended by level III experts, evidence of category 1A) According to domestic research data, approximately 8%-11% of patients with intrahepatic cholangiocarcinoma have IDH1 mutations.
The results of the ClarDhy trial in a phase III clinical study showed that 15% of patients with IDH1 mutations (25 cases) who were treated with IDH1 inhibitors were treated for more than 1 year, with progression-free survival (PFS) and adjusted overall survival (OS) All got positive results.
Although the efficacy of the drug is gratifying, due to the current unavailability of the drug in China and the high cost of the drug (nearly 30,000 US dollars/month), the expert recommends level III.
Figure 1.
The PFS of patients using IDH1 inhibitors was significantly better than the placebo group.
■ Update 3: New Dawn Fibroblast Growth Factor Receptor 2 (FGFR2) gene fusion/rearrangement for biliary malignancies targeted therapy for TBC patients It is recommended to treat pemigatinib or Infigratinib (BGJ389).
(Recommended by Level III experts, evidence of Class 2A) FGFR is a typical type of receptor tyrosine kinase.
The high expression and mutation of FGFR lead to abnormal activation of its signal pathway, which is closely related to the occurrence and development of a variety of malignant tumors.
About 5% of the domestic population has FGFR2 gene fusion/rearrangement.
Two foreign FGFR inhibitors pemigatinib and Infigratinib (BGJ389) have achieved better objective response rates (ORR) than second-line chemotherapeutics in the treatment of FGFR2 gene fusion/rearrangement.
And studies have shown that the earlier the FGFR2 inhibitor is used, the higher the effective rate of the drug.
Therefore, many units are currently carrying out clinical studies on the first-line treatment of FGFR2 inhibitors versus GC chemotherapy regimens, and there may be breakthrough developments that are unknown.
At present, due to the low level of evidence and the inaccessibility of domestic drugs, only FGFR2 inhibitor level III expert recommendation is given.
■ Update 4: The effective rate of targeted combined immunization research still needs to be further explored for lenvatinib + pembrolizumab for second-line treatment of TBC.
(Recommendation by level III experts, evidence of type 2B) The reason why lenvatinib+pembrolizumab is only recommended by level III experts in the treatment of second-line biliary tract malignancies is because lenvatinib+ Pembrolizumab's treatment results published in various units are relatively uneven: the highest treatment effective rate is reported to be nearly 40%, while some units have reported a rate of only 10%.
Since lenvatinib + pembrolizumab are currently studied with a small sample size and the level of evidence is low, only level III expert recommendation has been obtained.
■ Update 5: First-line treatment newly added option GEMOX+lenvatinib+teriprolizumab in the first-line treatment of advanced biliary malignant tumors.
(Recommended by level III experts, evidence of category 2B) There is a small sample size study in China that shows the treatment of GEMOX+lenvatinib+teriprizumab.
Although the sample size of the study is small (only 30 patients), it is objective The efficiency (ORR) is as high as 80%, and the disease control rate is 93.
3%.
It is the first domestic treatment plan of immunity + targeting + chemotherapy.
Therefore, it is listed as the first-line treatment for advanced biliary tract tumors and recommended by level III experts.
Figure 2 Summary of the good experimental results of GEMOX+lenvatinib+teriprolizumab The update of the CSCO guidelines for diagnosis and treatment of biliary malignancies in 2021 mainly focuses on radiotherapy and systemic treatment.
In terms of radiotherapy: The benefits of postoperative adjuvant radiotherapy for TBC patients have been recognized by more and more experts, and patients with advanced unresectable TBC are also recommended for SBRT.
This year’s guideline system treatment update brings you more choices for treatment decisions.
Under the precision treatment concept, after high-throughput sequencing, TBC patients have more and better drugs to choose from, including targeting, immunity, A series of anti-angiogenesis and other drug combinations, new drugs and new research may bring more exciting good news to TBC patients.
The update mainly focuses on the radiotherapy part and system treatment part.
The CSCO Guidelines Conference held in Beijing on April 23-24 is one of the most important conferences in the field of oncology in China.
At the conference on the 24th, Professor Zhou Jun from Peking University Cancer Hospital shared with you the updated points of the guidelines for the diagnosis and treatment of biliary tract carcinoma (BTC).
BTC mainly includes gallbladder cancer and cholangiocarcinoma, accounting for about 3% of all digestive system tumors, most of which are adenocarcinomas, which are aggressive and have a very poor prognosis, with a 5-year survival rate of <5%.
And the diagnosis and treatment of BTC is obviously different from that of hepatocellular carcinoma.
This year, the Chinese Society of Clinical Oncology (CSCO) has updated the BTC diagnosis and treatment guidelines, the main update content is the radiotherapy part and the system treatment part.
Radiotherapy: Overcoming doubts and finally approved.
■ Update 1: Postoperative adjuvant radiotherapy is finally approved.
For intrahepatic and extrahepatic bile duct malignancies with positive margins after surgery (R2 resection), postoperative adjuvant radiotherapy is recommended.
(Recommended by Level I Experts, Evidence Type 2A) For patients with intrahepatic and extrahepatic bile duct malignant tumors R0 after N+, postoperative adjuvant radiotherapy is recommended.
(Recommended by Level II experts, Type 2A evidence) Whether adjuvant radiotherapy for biliary malignancies can benefit patients has always been a topic of debate in the past.
Therefore, Level I experts recommend in the previous CSCO guidelines for diagnosis and treatment of biliary malignancies.
The option is to participate in clinical trials, and adjuvant radiotherapy has not been recommended and approved by the highest-level experts.A MATE analysis published in 2020, the study of the benefit of extrahepatic cholangiocarcinoma and gallbladder cancer in radiotherapy, combined with the original 0809 prospective phase II study, supports postoperative adjuvant radiotherapy for BTC with positive resection margins.
Therefore, in this guideline update, adjuvant radiotherapy with positive margins after surgery is listed as recommended by level I experts.
■ Update 2: Stereotactic body radiotherapy (SBRT) is emerging in palliative radiotherapy.
For inoperable but more limited intrahepatic cholangiocarcinoma, SBRT can be considered.
(Recommended by Level II Experts, Evidence Type 2A) Due to the current advancement in radiotherapy technology and the gradual development of SBRT, precision radiotherapy represented by SBRT has been proven in the unresectable BTC that protects normal liver tissue and controls tumors.
Based on the results of some prospective studies, retrospective studies, and MATE analysis, for inoperable but more limited intrahepatic cholangiocarcinoma, SBRT treatment is included in the recommendation of level II experts.
Systematic treatment: precision treatment, the 2021 version of CSCO biliary malignant tumor diagnosis and treatment guidelines have been updated more in the system treatment part, mainly focusing on the targeted and immunotherapy of precision treatment.
■ Update 1: Advanced second-line therapy adds another treatment option.
Advanced BTC second-line therapy adds BRAF V600E mutant tumors and recommends dabrafenib + trametinib.
(Recommended by Level II experts, Type 2A evidence) A small sample study published in 2020 shows that the effective rate of dabrafenib + trametinib for the treatment of BRAF V600E mutant tumors reached 47%, far exceeding the effective rate of second-line chemotherapy5 %.
Although BRAF V600E mutation accounts for only about 3% of all biliary tract tumors, in the past, BRAF V600E mutation was considered to be an indicator of poor prognosis.
Under the guidance of precision treatment, relatively good therapeutic effects can be obtained, and patients with dabrafenib and trametinib can be bought and used in China.
Taking into account the efficacy and availability of drugs, it is listed as a level II expert recommendation.
■ Update 2: The first successful targeted therapy for biliary tumors.
Patients with intrahepatic cholangiocarcinoma who carry isocitrate dehydrogenase (IDH1) mutation inhibitors are recommended to Ivosidenib (AG-120).
(Recommended by level III experts, evidence of category 1A) According to domestic research data, approximately 8%-11% of patients with intrahepatic cholangiocarcinoma have IDH1 mutations.
The results of the ClarDhy trial in a phase III clinical study showed that 15% of patients with IDH1 mutations (25 cases) who were treated with IDH1 inhibitors were treated for more than 1 year, with progression-free survival (PFS) and adjusted overall survival (OS) All got positive results.
Although the efficacy of the drug is gratifying, due to the current unavailability of the drug in China and the high cost of the drug (nearly 30,000 US dollars/month), the expert recommends level III.
Figure 1.
The PFS of patients using IDH1 inhibitors was significantly better than the placebo group.
■ Update 3: New Dawn Fibroblast Growth Factor Receptor 2 (FGFR2) gene fusion/rearrangement for biliary malignancies targeted therapy for TBC patients It is recommended to treat pemigatinib or Infigratinib (BGJ389).
(Recommended by Level III experts, evidence of Class 2A) FGFR is a typical type of receptor tyrosine kinase.
The high expression and mutation of FGFR lead to abnormal activation of its signal pathway, which is closely related to the occurrence and development of a variety of malignant tumors.
About 5% of the domestic population has FGFR2 gene fusion/rearrangement.
Two foreign FGFR inhibitors pemigatinib and Infigratinib (BGJ389) have achieved better objective response rates (ORR) than second-line chemotherapeutics in the treatment of FGFR2 gene fusion/rearrangement.
And studies have shown that the earlier the FGFR2 inhibitor is used, the higher the effective rate of the drug.
Therefore, many units are currently carrying out clinical studies on the first-line treatment of FGFR2 inhibitors versus GC chemotherapy regimens, and there may be breakthrough developments that are unknown.
At present, due to the low level of evidence and the inaccessibility of domestic drugs, only FGFR2 inhibitor level III expert recommendation is given.
■ Update 4: The effective rate of targeted combined immunization research still needs to be further explored for lenvatinib + pembrolizumab for second-line treatment of TBC.
(Recommendation by level III experts, evidence of type 2B) The reason why lenvatinib+pembrolizumab is only recommended by level III experts in the treatment of second-line biliary tract malignancies is because lenvatinib+ Pembrolizumab's treatment results published in various units are relatively uneven: the highest treatment effective rate is reported to be nearly 40%, while some units have reported a rate of only 10%.
Since lenvatinib + pembrolizumab are currently studied with a small sample size and the level of evidence is low, only level III expert recommendation has been obtained.
■ Update 5: First-line treatment newly added option GEMOX+lenvatinib+teriprolizumab in the first-line treatment of advanced biliary malignant tumors.
(Recommended by level III experts, evidence of category 2B) There is a small sample size study in China that shows the treatment of GEMOX+lenvatinib+teriprizumab.
Although the sample size of the study is small (only 30 patients), it is objective The efficiency (ORR) is as high as 80%, and the disease control rate is 93.
3%.
It is the first domestic treatment plan of immunity + targeting + chemotherapy.
Therefore, it is listed as the first-line treatment for advanced biliary tract tumors and recommended by level III experts.
Figure 2 Summary of the good experimental results of GEMOX+lenvatinib+teriprolizumab The update of the CSCO guidelines for diagnosis and treatment of biliary malignancies in 2021 mainly focuses on radiotherapy and systemic treatment.
In terms of radiotherapy: The benefits of postoperative adjuvant radiotherapy for TBC patients have been recognized by more and more experts, and patients with advanced unresectable TBC are also recommended for SBRT.
This year’s guideline system treatment update brings you more choices for treatment decisions.
Under the precision treatment concept, after high-throughput sequencing, TBC patients have more and better drugs to choose from, including targeting, immunity, A series of anti-angiogenesis and other drug combinations, new drugs and new research may bring more exciting good news to TBC patients.
