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Today (April 24, 2021), the Chinese Society of Clinical Oncology (CSCO) released the "2021 Edition of Guidelines for Diagnosis and Treatment of Esophageal Cancer" (hereinafter referred to as the "CSCO Guidelines"), recommending PD-1 immune checkpoint inhibitors for advanced metastasis for the first time First-line treatment for esophageal cancer.
CSCO guidelines give PD-1 immune checkpoint inhibitor pembrolizumab (commonly known as "K drug" in China) combined with platinum-containing chemotherapy regimens for first-line treatment of PD-L1 comprehensive positive score (CPS) ≥ 10, ECOG PS score 0 -2 level II expert recommendation for esophageal cancer with distant metastasis, level of evidence 1A.
The recommendation of the CSCO guidelines is based on the results of a global multi-center, randomized, double-blind controlled Phase III clinical study (KEYNOTE-590).
The analysis results of the study with a median follow-up of 10.
8 months were announced at the 2020 European Medical Oncology (ESMO) Congress.
The results showed that whether it is in intention-to-treat (ITT), esophageal squamous cell carcinoma (ESCC), or ITT and ESCC population with PD-L1 CPS ≥ 10, drug K combined with platinum-based chemotherapy (cisplatin and 5-fluorouracil) The overall survival (OS), disease progression-free survival (PFS), objective tumor response rate (ORR) and duration of response (DOR) data of first-line treatment show significant superiority compared with the first-line treatment of platinum-containing chemotherapy.
Safety data It is equivalent to standard chemotherapy.
KEYNOTE-590: OSKEYNOTE-590 for the overall population and subgroup populations is a landmark clinical study in the treatment of esophageal cancer, rewriting the guidelines for the first-line treatment of metastatic esophageal cancer and changing clinical practice.
The recommended update of the CSCO guidelines for pembrolizumab combined with chemotherapy is in line with the 2021 V2 guidelines for esophageal cancer and gastroesophageal junction cancer issued by the National Comprehensive Cancer Network (NCCN) on March 9 this year.
The 2020V5 version of the NCCN guidelines has given priority to recommend pembrolizumab combined with platinum (oxaliplatin or cisplatin) chemotherapy for the first-line treatment of unresectable locally advanced, locally recurring or metastatic HER2 expression with PD-L1 CPS ≥ 10 Negative esophageal cancer.
The NCCN 2020 V5 version is worth mentioning that on March 24 this year, based on the results of the KEYNOTE-590 study, the U.
S.
Food and Drug Administration (FDA) has approved pembrolizumab combined with platinum-containing chemotherapy as the first-line treatment to be unresectable or unsuitable Locally advanced or metastatic esophageal cancer or gastroesophageal junction cancer with radical radiotherapy and chemotherapy, regardless of PD-L1 expression.
Pembrolizumab has therefore become the world's first and currently the only PD-1 immune checkpoint inhibitor approved as a first-line treatment for esophageal cancer.
In view of the fact that the US FDA has approved pembrolizumab combined with platinum-containing chemotherapy for the first-line treatment of the "whole population", regardless of the expression of PD-L1, the 2021 NCCN V3 guidelines may be expected to change the population limit, and recommend that the program is suitable for The whole crowd.
In China, the indication of pembrolizumab combined with platinum-containing chemotherapy for the first-line treatment of unresectable locally advanced or metastatic esophageal cancer has been submitted to the National Medical Products Administration (NMPA) of my country and accepted in November 2020, and is expected to be approved this year Approved, the treatment plan will become the new standard for the first-line treatment of advanced esophageal cancer.
The 2021 version of the CSCO Esophageal Cancer Guidelines also recommends two PD-1 immune checkpoint inhibitors combined with chemotherapy as a first-line treatment plan II level expert recommendation for the treatment of esophageal cancer of different tissue types.
Based on the results of the Phase III clinical study CheckMate-649 announced by the European Society of Medical Oncology (ESMO) conference in 2020, nivolumab combined with platinum-containing chemotherapy for the first-line treatment of PD-L1 CPS≥5 esophageal adenocarcinoma was recommended by Level II experts (evidence Level 1A).
The Phase III clinical study (ESCORT 1st) of carrelizumab combined with platinum-containing chemotherapy for the first-line treatment of esophageal cancer squamous cell carcinoma was announced as positive in December last year, but the specific data has not yet been announced.
This time it was also recommended by level II experts in the CSCO guidelines , Evidence level 1A category.
CSCO guidelines give PD-1 immune checkpoint inhibitor pembrolizumab (commonly known as "K drug" in China) combined with platinum-containing chemotherapy regimens for first-line treatment of PD-L1 comprehensive positive score (CPS) ≥ 10, ECOG PS score 0 -2 level II expert recommendation for esophageal cancer with distant metastasis, level of evidence 1A.
The recommendation of the CSCO guidelines is based on the results of a global multi-center, randomized, double-blind controlled Phase III clinical study (KEYNOTE-590).
The analysis results of the study with a median follow-up of 10.
8 months were announced at the 2020 European Medical Oncology (ESMO) Congress.
The results showed that whether it is in intention-to-treat (ITT), esophageal squamous cell carcinoma (ESCC), or ITT and ESCC population with PD-L1 CPS ≥ 10, drug K combined with platinum-based chemotherapy (cisplatin and 5-fluorouracil) The overall survival (OS), disease progression-free survival (PFS), objective tumor response rate (ORR) and duration of response (DOR) data of first-line treatment show significant superiority compared with the first-line treatment of platinum-containing chemotherapy.
Safety data It is equivalent to standard chemotherapy.
KEYNOTE-590: OSKEYNOTE-590 for the overall population and subgroup populations is a landmark clinical study in the treatment of esophageal cancer, rewriting the guidelines for the first-line treatment of metastatic esophageal cancer and changing clinical practice.
The recommended update of the CSCO guidelines for pembrolizumab combined with chemotherapy is in line with the 2021 V2 guidelines for esophageal cancer and gastroesophageal junction cancer issued by the National Comprehensive Cancer Network (NCCN) on March 9 this year.
The 2020V5 version of the NCCN guidelines has given priority to recommend pembrolizumab combined with platinum (oxaliplatin or cisplatin) chemotherapy for the first-line treatment of unresectable locally advanced, locally recurring or metastatic HER2 expression with PD-L1 CPS ≥ 10 Negative esophageal cancer.
The NCCN 2020 V5 version is worth mentioning that on March 24 this year, based on the results of the KEYNOTE-590 study, the U.
S.
Food and Drug Administration (FDA) has approved pembrolizumab combined with platinum-containing chemotherapy as the first-line treatment to be unresectable or unsuitable Locally advanced or metastatic esophageal cancer or gastroesophageal junction cancer with radical radiotherapy and chemotherapy, regardless of PD-L1 expression.
Pembrolizumab has therefore become the world's first and currently the only PD-1 immune checkpoint inhibitor approved as a first-line treatment for esophageal cancer.
In view of the fact that the US FDA has approved pembrolizumab combined with platinum-containing chemotherapy for the first-line treatment of the "whole population", regardless of the expression of PD-L1, the 2021 NCCN V3 guidelines may be expected to change the population limit, and recommend that the program is suitable for The whole crowd.
In China, the indication of pembrolizumab combined with platinum-containing chemotherapy for the first-line treatment of unresectable locally advanced or metastatic esophageal cancer has been submitted to the National Medical Products Administration (NMPA) of my country and accepted in November 2020, and is expected to be approved this year Approved, the treatment plan will become the new standard for the first-line treatment of advanced esophageal cancer.
The 2021 version of the CSCO Esophageal Cancer Guidelines also recommends two PD-1 immune checkpoint inhibitors combined with chemotherapy as a first-line treatment plan II level expert recommendation for the treatment of esophageal cancer of different tissue types.
Based on the results of the Phase III clinical study CheckMate-649 announced by the European Society of Medical Oncology (ESMO) conference in 2020, nivolumab combined with platinum-containing chemotherapy for the first-line treatment of PD-L1 CPS≥5 esophageal adenocarcinoma was recommended by Level II experts (evidence Level 1A).
The Phase III clinical study (ESCORT 1st) of carrelizumab combined with platinum-containing chemotherapy for the first-line treatment of esophageal cancer squamous cell carcinoma was announced as positive in December last year, but the specific data has not yet been announced.
This time it was also recommended by level II experts in the CSCO guidelines , Evidence level 1A category.