Half of the world's esophageal cancer is in China, and the standard diagnosis and treatment points are here!

*Only for medical professionals to read and refer to the exciting content of the punch-in learning conference! Esophageal cancer is one of the most common cancers of the digestive system
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According to the data released by the World Health Organization's International Agency for Research on Cancer in 2020, the incidence of esophageal cancer in the world ranks among the top ten, and more than half of the cases occur in China
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On April 23-24, 2022, the annual "Chinese Society of Clinical Oncology (CSCO) Guidelines Conference" will be held online and offline
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In the special session of esophageal cancer, Professor Huang Jing from Cancer Hospital of Chinese Academy of Medical Sciences brought a wonderful report of "2022 CSCO Guidelines for Diagnosis and Treatment of Esophageal Cancer Update Internal Medicine".
The medical tumor channel will now organize the content for readers
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Update Point 1 of Neoadjuvant Therapy for Locally Advanced Esophageal Cancer
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Update based on research: The JCOG 1109NExT study is a randomized controlled phase III clinical study exploring the efficacy and safety of two-drug chemotherapy, three-drug chemotherapy, and chemoradiotherapy as neoadjuvant therapy for locally advanced esophageal cancer
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The study was divided into three arms to demonstrate the overall survival (OS) of docetaxel + fluorouracil + cisplatin (DCF) regimen and fluorouracil + cisplatin (CF) concurrent radiotherapy (CF-RT) versus CF regimen Has superiority
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The results of the study showed that: in terms of OS, the median OS in the DCF group had not yet reached, the median OS in the CF group was 5.
6 years, and the median OS in the CF-RT group was 7 years
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The 3-year OS rates of CF group, DCF group and CF-RT group were 62.
6%, 72.
1% and 68.
3%, respectively
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Left: 3-year OS rate in CF group vs DCF group Right: 3-year OS rate in CF group vs CF-RT group In terms of progression-free survival (PFS), the median PFS in DCF group has not yet reached, and the median PFS in CF group is 2.
7 years.
The median PFS in the CF-RT group was 5.
3 years
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The 3-year PFS rates of the CF, DCF and CF-RT groups were 47.
7%, 61.
8% and 58.
5%, respectively
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Left: CF group vs DCF group median PFS Right: CF group vs CF-RT group median PFS pathological complete remission (pCR) rate, CF group, DCF group and CF-RT group R0 resection rates were 168 cases (90.
3%) %), 173 (94.
5%) and 175 (98.
9%)
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The pCR remission rates in the three groups were 4 (2.
2%), 34 (18.
6%) and 65 (36.
7%) cases, respectively
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This study showed that the DCF three-drug three-cycle neoadjuvant therapy regimen significantly improved the OS of patients with locally advanced esophageal squamous cell carcinoma (ESCC) compared with the two-cycle CF regimen, with controllable safety
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There was no significant difference in OS between the CF-RT group and the CF group
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The DCF three-drug three-cycle regimen may become a new standard treatment regimen for the neoadjuvant treatment of ESCC patients
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Update point 2: In the "treatment of resectable esophageal cancer", the level III recommendation of "cT1b-cT2N+ or cT3-cT4a any N (thoracic esophageal cancer)" was added "preferentially recommend participating in clinical research" and "neoadjuvant chemotherapy combined with immunization" Treatment (camrelizumab or pembrolizumab) + esophagectomy (category 3)”
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Update point 1 for first-line treatment of metastatic/recurrent esophagogastric and esophagogastric junction cancer: Added "esophagogastric junction cancer" to the title to more accurately reflect the tumor sites included in this guideline
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A note was added to explain the principles of the guideline update: In multiple phase III randomized controlled clinical trials of PD-1 antibody combined with chemotherapy versus chemotherapy alone for first-line treatment of advanced esophageal and/or gastroesophageal junction cancer, for reported positive results, and It has been approved by the National Medical Products Administration (NMPA) of China for the first-line treatment of advanced esophageal and/or gastroesophageal junction cancer, and is listed as a level I recommendation; for positive results that have been reported in academic journals or international conferences, but Treatment regimens not approved by NMPA are listed as class II recommendations
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Update point 2: In the class II recommendation of "HER2-positive adenocarcinoma", add "trastuzumab + pembrolizumab + cisplatin or oxaliplatin + fluorouracil (category 1A)"
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Update based on study: The KEYNOTE-811 study is a double-blind phase III study to compare pembrolizumab + trastuzumab plus chemotherapy versus placebo + trastuzumab plus chemotherapy in patients with HER2-positive Efficacy and safety in patients with resected or metastatic gastric/gastroesophageal junction adenocarcinoma
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The first interim analysis set by the protocol was performed at a follow-up of >8.
5 months in the initially enrolled 260 patients to explore whether the addition of pembrolizumab to trastuzumab + chemotherapy significantly improved the objective response rate (ORR)
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The results of the analysis showed that the ORR of patients in the placebo + trastuzumab combination chemotherapy group was 51.
9%, and the ORR of patients in the pembrolizumab + trastuzumab combination chemotherapy group was 74.
4%.
These findings suggest that pembrolizumab + trastuzumab + chemotherapy is a potential new treatment option for patients with previously untreated, unresectable or metastatic HER2-positive gastric or gastroesophageal junction cancer
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Update point 3: In the stratification of "HER2-negative adenocarcinoma" and "squamous cell carcinoma": "Pembrolizumab + cisplatin + fluorouracil (5-FU or capecitabine) (category 1A)" from II The grade recommendation was changed to a grade I recommendation; and the restriction on PD-L1 expression was removed based on the NMPA-approved indications
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Changed "Camrelizumab + Cisplatin + Paclitaxel (Class 1A)" from Class II recommendation to Class I recommendation
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In the class II recommendation, "nivolumab + cisplatin + fluorouracil (squamous cell carcinoma) (category 1A)", "nivolumab + ipilimumab (for chemotherapy contraindications or refusal of chemotherapy)" were added.
, and PD-L1 CPS≥1) (category 1A)”, “Toripalimab + cisplatin + paclitaxel (squamous cell carcinoma) (category 1A)” and “sintilimab + cisplatin + paclitaxel” or 5-FU (Class 1A)”
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Update based on research: Immunocombination chemotherapy becomes standard regimen for first-line treatment of advanced esophageal squamous cell carcinoma
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The KEYNOTE-590 study is a global multicenter, randomized, double-blind controlled phase III clinical study comparing the efficacy and safety of cisplatin and 5-FU in the first-line treatment of unresectable locally advanced or metastatic esophageal cancer
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The results showed that the first-line treatment of pembrolizumab combined with chemotherapy was effective in the intention-to-treat analysis (ITT) population, the advanced esophageal squamous cell carcinoma population, the PD-L1 CPS ≥10 population, and the advanced ESCC population with a CPS ≥10.
OS, PFS, ORR, and duration of response (DoR) data showed significant superiority to first-line chemotherapy alone, while safety data were comparable to standard chemotherapy
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The ESCORT-1st study is a randomized, double-blind, placebo-controlled Phase III study to evaluate camrelizumab plus paclitaxel and cisplatin versus placebo plus paclitaxel and cisplatin for first-line treatment of advanced esophageal cancer Efficacy and Safety
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This study is the first phase III clinical study of first-line immunotherapy combined with chemotherapy for advanced ESCC, confirming that immunotherapy combined with chemotherapy can significantly prolong the OS and PFS of patients, and promotes immune (carrelizumab) combined chemotherapy to become the first-line treatment of advanced ESCC.
Standard scheme
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The CheckMate-648 study, ORIENT-15 study and JUPITER-06 study all achieved the primary endpoint in the exploration of immunocombination chemotherapy versus chemotherapy.
Because the corresponding indications have not yet been approved, they are listed as class II recommendations in this version of the guideline
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Update point 4: In "HER2-negative adenocarcinoma", "nivolumab + oxaliplatin + fluorouracil (5-FU or capecitabine) (PD-L1 CPS ≥ 5)" (category 1A) "Included in the Class I recommendation
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"Nivolumab + oxaliplatin + fluorouracil (5-FU or capecitabine) (category 1A)" is listed as a class II recommendation
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Added a note explaining the reasons for the above recommendation: In the CheckMate-649 study, nivolumab plus chemotherapy significantly prolonged OS and PFS in patients with PD-L1 CPS ≥5 compared with chemotherapy alone, meeting both primary endpoints of the study Therefore, for patients with PD-L1 CPS ≥ 5, nivolumab in combination with chemotherapy is recommended as category 1; in the CheckMate-649 study, nivolumab in combination with chemotherapy also showed significant statistical significance in all randomized populations The NMPA approved nivolumab in combination with a fluorouracil- and platinum-based chemotherapy regimen for the first-line treatment of advanced or metastatic gastric cancer, gastroesophageal junction cancer, or esophageal adenocarcinoma
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Taking into account the survival results of the CPS <5 subgroup in this study and the currently approved indications, this regimen is listed as a level II recommendation in the entire population that does not distinguish CPS levels
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Update based on study: The CheckMate-649 study is a randomized, open-label, global, phase III study evaluating nivolumab in combination with chemotherapy versus chemotherapy alone in advanced or metastatic gastric cancer, gastroesophageal junction Efficacy and safety of first-line treatment of carcinoma and esophageal adenocarcinoma in the global population
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CONCLUSIONS: In all randomized patients, nivolumab plus chemotherapy had superior OS benefit and clinically meaningful improvement in PFS compared with chemotherapy
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Among patients with PD-L1 CPS ≥5, the median OS of nivolumab plus chemotherapy versus chemotherapy was 14.
4 months vs 11.
1 months, and median PFS was 7.
7 months vs 6.
0 months, respectively
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OS and PFS update point 6 for all randomized patients: In the class III recommendation, "anlotinib + cisplatin + paclitaxel (squamous cell carcinoma) (category 3A)" was added, and note c was added, bleeding is not recommended At-risk patients use this regimen
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Update based on research: The ALTER-E002 study is a domestic multi-center phase II clinical study exploring paclitaxel + cisplatin combined with anlotinib in the first-line treatment of advanced ESCC
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The results of the study showed that among the 46 ESCC patients who were evaluated for efficacy, 1 confirmed complete remission (CR), 35 partial remission (PR), 7 stable disease (SD), and 3 NE
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The ORR of the current study was 78.
3% and the disease control rate (DCR) was 93.
5%
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Update point 1 for second-line treatment of metastatic/recurrent esophagus and esophagogastric junction cancer: In the class II recommendation, "Tislelizumab (squamous cell carcinoma) (category 1A)" has been added
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Update point 2 of 4 randomized controlled studies comparing chemotherapy in second-line treatment of metastatic/recurrent esophagus and esophagogastric junction cancer: Added "Veldicitumab (HER2-positive adenocarcinoma, third-line and above, category 3)"
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Added a corresponding note: The clinical study of vildicitumab in patients with HER2-overexpressing locally advanced or metastatic gastric and gastroesophageal junction cancer who have received at least 2 kinds of systemic chemotherapy is a phase II single-arm design.
Class 3 evidence, but considering that the NMPA has approved the corresponding indications and the treatment options for such patients are very limited, it is listed as a class II recommendation
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The inclusion criteria for this study were defined as HER2 overexpression (positive): HER2 immunohistochemical examination showed 2+ or 3+
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Update based on the study: The C008 study is a phase II clinical study exploring RC48 in the treatment of HER2 overexpression (IHC 2+ or 3+), the study included 127 patients with locally advanced or metastatic gastric cancer (including ≥2 previous systemic chemotherapy) gastroesophageal junction adenocarcinoma)
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The results showed that the ORR was 24.
4%
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