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Foreword For resectable locally advanced esophageal cancer (EC) and gastroesophageal junction cancer (GEJC), sequential neoadjuvant chemoradiotherapy (nCRT) surgery is currently the standard treatment plan recommended by the guideline
.
However, after receiving this type of treatment, there are still a considerable number of patients who cannot achieve complete pathological remission (pCR) after surgery, have a higher risk of recurrence and metastasis, and lack clinically clear adjuvant treatment options with clear evidence of benefit
.
In recent years, immunotherapy has achieved fruitful results in this field.
Starting from the posterior stage of esophageal cancer, gradually advancing to the front line, and finally successfully gaining a foothold in the field of perioperative treatment-the breakthrough CheckMate -577 study clarified immunotherapy for the first time In the value of adjuvant treatment of esophageal cancer after surgery, nivolumab has also been approved in the United States in May this year and has become the world's first immune adjuvant therapy for esophageal cancer, filling a major gap in clinical guidelines
.
Recently, Yimaitong invited Professor Chen Qixun, Director of Thoracic Surgery of Zhejiang Cancer Hospital, to deeply interpret the experimental design and latest data of CheckMate-577 research and its influence on the development of perioperative treatment of esophageal cancer in China
.
Expert profile Professor Chen Qixun, director and chief physician of the Department of Thoracic Surgery, Affiliated Tumor Hospital of the Chinese Academy of Sciences (Zhejiang Tumor Hospital), Chairman-designate of the Thoracic Surgery Branch of Zhejiang Medical Association, Chairman-designate of the Esophageal Cancer Professional Committee of Zhejiang Anticancer Association Member of the Thoracic Surgery Branch, Member of the Standing Committee of the Cardiothoracic Surgery Branch of the Zhejiang Medical Association.
Clinical practice, focusing on patients' unmet needs CheckMate-5771 is a phase III, randomized, multi-center, double-blind clinical study designed to evaluate nivolumab as an adjuvant therapy for neoadjuvant concurrent chemoradiation (CRT) follow-up The efficacy and safety of resectable locally advanced EC/GEJC patients who have not reached pCR after surgery
.
A total of 794 patients were enrolled in the study, who were randomly assigned 2:1 to receive nivolumab or placebo treatment, and the total treatment duration was 1 year
.
Stratification factors include histological type (adenocarcinoma or squamous cell carcinoma), pathological lymph node status (≥ypN1 or ypN0), and tumor cell PD-L1 expression (≥1% or <1%)
.
The primary endpoint of the study is disease-free survival (DFS), the secondary endpoints are overall survival (OS) and the 1, 2, and 3-year OS rate, and the exploratory endpoints are distant metastasis-free survival (DMFS) and safety ( Figure 1)
.
Figure 1: CheckMate-577 trial design Professor Chen Qixun commented that based on the results of the two phase III clinical studies of NEOCRTEC50103 led by the CROSS2 study from the Netherlands and Chinese experts, preoperative neoadjuvant CRT and sequential surgical treatment are currently resectable locally late The recommended treatment plan with the strongest evidence of benefit from esophageal cancer
.
Although CRT makes local recurrence controllable, patients still have a certain chance of recurrence after surgery, especially the control effect of distant metastasis is still not ideal
.
High-risk factors for recurrence and metastasis include more than 4 lymph node metastases, and failure to reach pCR after radiotherapy and chemotherapy
.
At the same time, postoperative patients are poorly tolerated by existing adjuvant treatments, such as adjuvant radiotherapy and chemotherapy, and their benefits for different groups of people are still unclear
.
The design of the CheckMate-577 study is based on clinical needs.
The included patients are patients who have undergone neoadjuvant CRT sequential surgery and achieved R0 resection, but have pathological residues after surgery.
For this type of patients, there is currently no control of distant metastasis after surgery.
Good pain point, hope that by choosing a well-tolerated immunotherapy drug nivolumab as a systemic treatment after surgery, eliminate potential micrometastasis, achieve long-term benefits for patients, and achieve surprising results
.
"Food" is unlimited: Nivolumab adjuvant treatment of DFS doubles, DMFS up to 29.
4 months, safety is controllable! The results of the first round of CheckMate-577 study announced at the ESMO Conference in 20204 showed that at least 6.
2 months of follow-up, adjuvant nivolumab doubled the patient’s median DFS to 22.
4 months, reducing disease recurrence by 31% Or risk of death (11.
0 months in the control group, HR=0.
69, p=0.
003).
This is the first time that immunotherapy has been proven to bring significant clinical benefits in the adjuvant treatment of esophageal cancer patients (Figure 2)
.
Figure 2: The first DFS result of the CheckMate-577 trial At the 2021 ESMO annual meeting, the updated results of the CheckMate-577 study 5 showed that at least 14 months of follow-up, the median DFS of the nivolumab group was maintained for 22.
4 months, a 33% decrease The risk of disease recurrence or death (control group 10.
4 months, HR=0.
67)
.
Moreover, the median DMFS of the nivolumab group was 29.
4 months and that of the control group was 16.
6 months, which reduced the risk of distant metastasis or death by 29% (HR=0.
71)
.
In addition, the benefit of the nivolumab group was observed in the preset subgroups, regardless of PD-L1 expression (≥1% or <1%) and histological type (squamous cell carcinoma patients tended to benefit more)
.
In terms of safety, the safety of nivolumab treatment is controllable and tolerable, and no new signals of adverse reactions have been found.
The vast majority of treatment-related adverse events (TRAEs) are grade 1 or 2, and the incidence of severe TRAEs of any grade is 8 % (Table 1)
.
Table 1: Efficacy and safety data of the CheckMate-577 trial after 14 months of follow-up.
The descriptive analysis of the CheckMate-577 study published by the 2021 ASCO GI Conference6 shows that adjuvant nivolumab does not affect the quality of life of patients after surgery
.
From baseline to 53 weeks, the total score of FACT-E, ECS, EQ-5D-3L VAS, and EQ-5D-3L utility index of the nivolumab and placebo treatment groups were more significant than baseline at most time points Increasing trend, and there is no significant difference between the two groups
.
Professor Chen Qixun commented that in the past, there was no clear clinical consensus or recommendation for postoperative adjuvant treatment of advanced esophageal cancer
.
The Phase III study, CheckMate -577, not only achieved the first important result of immunotherapy in this field, but also provided new high-level evidence for adjuvant treatment of locally advanced esophageal cancer
.
The adjuvant treatment of nivolumab has shown good efficacy data.
The median DFS of patients has doubled compared with placebo, and the median DMFS in the past 30 months is also very impressive, especially for patients with high-incidence squamous cell carcinoma in China
.
Not only that, the minimum 14-month follow-up results of this update did not show the phenomenon of “split first, then approach” in the previous similar studies.
The transfer of cases led to a weakening of the overall benefit trend of the study
.
In addition, thanks to the controllable safety of the program, the incidence, type, and degree of adverse reactions are acceptable, and the overall quality of life of patients is not reduced
.
Create a "food" generation: Nivolumab adjuvant therapy rewrites clinical guidelines, and explores not only to advance to the front line.
Based on the results of CheckMate -577, nivolumab has been approved in the United States this year, becoming the world's first adjuvant immune system for esophageal cancer Therapy; 2021 CSCO guidelines have also included nivolumab in the recommendation for adjuvant treatment after esophageal cancer surgery for the first time (Class IA evidence) (Table 2)
.
Table 2: CSCO Guidelines for Diagnosis and Treatment of Esophageal Cancer 2021-Postoperative Adjuvant Treatment Prof.
Qixun Chen commented that CheckMate-577 is a milestone study of perioperative immunotherapy for esophageal cancer, filling the gap in this field, and is expected to rewrite clinical practice
.
In addition to the field of adjuvant therapy, the clinic is also actively exploring the advancement of immunotherapy combined with chemotherapy to the field of neoadjuvant therapy before surgery for esophageal cancer
.
Theoretically speaking, immunotherapy can fight tumor cells by strengthening the lymphocytes in the patient's body and activating the immune system.
The patient's physical condition before surgery is relatively good, not only can tolerate chemotherapy better, but also get more immune Benefit from treatment
.
The exploration in this field is currently mostly single-arm research, and it is expected that large-scale randomized controlled studies that challenge the status of CRT standards can be carried out in the future
.
In general, with the continuous exploration and harvest of perioperative immunotherapy, patients with resectable locally advanced EC/GEJC are expected to be reborn
.
References: 1.
Ronan J.
Kelly, Jaffer A.
Ajani, Jaroslaw Kuzdzal, et al.
Adjuvant Nivolumab in Resected Esophageal or Gastroesophageal Junction Cancer[J].
N Engl J Med 2021; 384:1191-12032.
M van Heijl, JJB van Lanschot, LB Koppert, et al.
Neoadjuvant chemoradiation followed by surgery versus surgery alone for patients with adenocarcinoma or squamous cell carcinoma of the esophagus (CROSS) [J].
BMC Surg.
2008 Nov 26;8:21.
3.
Hong Yang, Hui Liu, Yuping Chen ,et al.
Neoadjuvant Chemoradiotherapy Followed by Surgery Versus Surgery Alone for Locally Advanced Squamous Cell Carcinoma of the Esophagus (NEOCRTEC5010): A Phase III Multicenter, Randomized, Open-Label Clinical Trial[J].
J Clin Oncol.
2018 Sep 20;36(27):2796-2803.
4.
2020 ESMO.
LBA9-Adjuvant nivolumab in resected esophageal or gastroesophageal junction cancer following neoadjuvant chemoradiation therapy: first results of the CheckMate 577 study.
5.
2021 ESMO.
1381P-Adjuvant nivolumab in resected esophageal or gastroesophageal junction cancer following neoadjuvant cancer (C/GEJCRT) ): 14-month follow-up of CheckMate 577.
6.
Ronan Joseph Kelly, Jaffer A.
Ajani, Jaroslaw Kuzdzal, et al.
Adjuvant nivolumab (NIVO) in resected esophageal or gastroesophageal junction cancer (EC/GEJC) following neoadjuvant chemoradiotherapy (CRT) : Expanded efficacy and safety analyses from CheckMate 577[J].
DOI: 10.
1200/JCO.
2021.
39.
15_suppl.
4003 Journal of Clinical Oncology 39, no.
15_suppl (May 20, 2021) 4003-4003.
1381P-Adjuvant nivolumab in resected esophageal or gastroesophageal junction cancer (EC/GEJC) following neoadjuvant chemoradiotherapy (CRT): 14-month follow-up of CheckMate 577.
6.
Ronan Joseph Kelly, Jaffer A.
Ajani, Jaroslaw Kuzdzal, etlumab Adjuvant nivoal.
(NIVO) in resected esophageal or gastroesophageal junction cancer (EC/GEJC) following neoadjuvant chemoradiotherapy (CRT): Expanded efficacy and safety analyses from CheckMate 577[J].
DOI: 10.
1200/JCO.
2021.
39.
15_suppl.
4003 Journal of Clinical Oncology 39 , no.
15_suppl (May 20, 2021) 4003-4003.
1381P-Adjuvant nivolumab in resected esophageal or gastroesophageal junction cancer (EC/GEJC) following neoadjuvant chemoradiotherapy (CRT): 14-month follow-up of CheckMate 577.
6.
Ronan Joseph Kelly, Jaffer A.
Ajani, Jaroslaw Kuzdzal, etlumab Adjuvant nivoal.
(NIVO) in resected esophageal or gastroesophageal junction cancer (EC/GEJC) following neoadjuvant chemoradiotherapy (CRT): Expanded efficacy and safety analyses from CheckMate 577[J].
DOI: 10.
1200/JCO.
2021.
39.
15_suppl.
4003 Journal of Clinical Oncology 39 , no.
15_suppl (May 20, 2021) 4003-4003.
Adjuvant nivolumab (NIVO) in resected esophageal or gastroesophageal junction cancer (EC/GEJC) following neoadjuvant chemoradiotherapy (CRT): Expanded efficacy and safety analyses from CheckMate 577[J].
DOI: 10.
1200/JCO.
2021.
39.
15_suppl.
4003 Journal of Clinical Oncology 39, no.
15_suppl (May 20, 2021) 4003-4003.
Adjuvant nivolumab (NIVO) in resected esophageal or gastroesophageal junction cancer (EC/GEJC) following neoadjuvant chemoradiotherapy (CRT): Expanded efficacy and safety analyses from CheckMate 577[J].
DOI: 10.
1200/JCO.
2021.
39.
15_suppl.
4003 Journal of Clinical Oncology 39, no.
15_suppl (May 20, 2021) 4003-4003.
.
However, after receiving this type of treatment, there are still a considerable number of patients who cannot achieve complete pathological remission (pCR) after surgery, have a higher risk of recurrence and metastasis, and lack clinically clear adjuvant treatment options with clear evidence of benefit
.
In recent years, immunotherapy has achieved fruitful results in this field.
Starting from the posterior stage of esophageal cancer, gradually advancing to the front line, and finally successfully gaining a foothold in the field of perioperative treatment-the breakthrough CheckMate -577 study clarified immunotherapy for the first time In the value of adjuvant treatment of esophageal cancer after surgery, nivolumab has also been approved in the United States in May this year and has become the world's first immune adjuvant therapy for esophageal cancer, filling a major gap in clinical guidelines
.
Recently, Yimaitong invited Professor Chen Qixun, Director of Thoracic Surgery of Zhejiang Cancer Hospital, to deeply interpret the experimental design and latest data of CheckMate-577 research and its influence on the development of perioperative treatment of esophageal cancer in China
.
Expert profile Professor Chen Qixun, director and chief physician of the Department of Thoracic Surgery, Affiliated Tumor Hospital of the Chinese Academy of Sciences (Zhejiang Tumor Hospital), Chairman-designate of the Thoracic Surgery Branch of Zhejiang Medical Association, Chairman-designate of the Esophageal Cancer Professional Committee of Zhejiang Anticancer Association Member of the Thoracic Surgery Branch, Member of the Standing Committee of the Cardiothoracic Surgery Branch of the Zhejiang Medical Association.
Clinical practice, focusing on patients' unmet needs CheckMate-5771 is a phase III, randomized, multi-center, double-blind clinical study designed to evaluate nivolumab as an adjuvant therapy for neoadjuvant concurrent chemoradiation (CRT) follow-up The efficacy and safety of resectable locally advanced EC/GEJC patients who have not reached pCR after surgery
.
A total of 794 patients were enrolled in the study, who were randomly assigned 2:1 to receive nivolumab or placebo treatment, and the total treatment duration was 1 year
.
Stratification factors include histological type (adenocarcinoma or squamous cell carcinoma), pathological lymph node status (≥ypN1 or ypN0), and tumor cell PD-L1 expression (≥1% or <1%)
.
The primary endpoint of the study is disease-free survival (DFS), the secondary endpoints are overall survival (OS) and the 1, 2, and 3-year OS rate, and the exploratory endpoints are distant metastasis-free survival (DMFS) and safety ( Figure 1)
.
Figure 1: CheckMate-577 trial design Professor Chen Qixun commented that based on the results of the two phase III clinical studies of NEOCRTEC50103 led by the CROSS2 study from the Netherlands and Chinese experts, preoperative neoadjuvant CRT and sequential surgical treatment are currently resectable locally late The recommended treatment plan with the strongest evidence of benefit from esophageal cancer
.
Although CRT makes local recurrence controllable, patients still have a certain chance of recurrence after surgery, especially the control effect of distant metastasis is still not ideal
.
High-risk factors for recurrence and metastasis include more than 4 lymph node metastases, and failure to reach pCR after radiotherapy and chemotherapy
.
At the same time, postoperative patients are poorly tolerated by existing adjuvant treatments, such as adjuvant radiotherapy and chemotherapy, and their benefits for different groups of people are still unclear
.
The design of the CheckMate-577 study is based on clinical needs.
The included patients are patients who have undergone neoadjuvant CRT sequential surgery and achieved R0 resection, but have pathological residues after surgery.
For this type of patients, there is currently no control of distant metastasis after surgery.
Good pain point, hope that by choosing a well-tolerated immunotherapy drug nivolumab as a systemic treatment after surgery, eliminate potential micrometastasis, achieve long-term benefits for patients, and achieve surprising results
.
"Food" is unlimited: Nivolumab adjuvant treatment of DFS doubles, DMFS up to 29.
4 months, safety is controllable! The results of the first round of CheckMate-577 study announced at the ESMO Conference in 20204 showed that at least 6.
2 months of follow-up, adjuvant nivolumab doubled the patient’s median DFS to 22.
4 months, reducing disease recurrence by 31% Or risk of death (11.
0 months in the control group, HR=0.
69, p=0.
003).
This is the first time that immunotherapy has been proven to bring significant clinical benefits in the adjuvant treatment of esophageal cancer patients (Figure 2)
.
Figure 2: The first DFS result of the CheckMate-577 trial At the 2021 ESMO annual meeting, the updated results of the CheckMate-577 study 5 showed that at least 14 months of follow-up, the median DFS of the nivolumab group was maintained for 22.
4 months, a 33% decrease The risk of disease recurrence or death (control group 10.
4 months, HR=0.
67)
.
Moreover, the median DMFS of the nivolumab group was 29.
4 months and that of the control group was 16.
6 months, which reduced the risk of distant metastasis or death by 29% (HR=0.
71)
.
In addition, the benefit of the nivolumab group was observed in the preset subgroups, regardless of PD-L1 expression (≥1% or <1%) and histological type (squamous cell carcinoma patients tended to benefit more)
.
In terms of safety, the safety of nivolumab treatment is controllable and tolerable, and no new signals of adverse reactions have been found.
The vast majority of treatment-related adverse events (TRAEs) are grade 1 or 2, and the incidence of severe TRAEs of any grade is 8 % (Table 1)
.
Table 1: Efficacy and safety data of the CheckMate-577 trial after 14 months of follow-up.
The descriptive analysis of the CheckMate-577 study published by the 2021 ASCO GI Conference6 shows that adjuvant nivolumab does not affect the quality of life of patients after surgery
.
From baseline to 53 weeks, the total score of FACT-E, ECS, EQ-5D-3L VAS, and EQ-5D-3L utility index of the nivolumab and placebo treatment groups were more significant than baseline at most time points Increasing trend, and there is no significant difference between the two groups
.
Professor Chen Qixun commented that in the past, there was no clear clinical consensus or recommendation for postoperative adjuvant treatment of advanced esophageal cancer
.
The Phase III study, CheckMate -577, not only achieved the first important result of immunotherapy in this field, but also provided new high-level evidence for adjuvant treatment of locally advanced esophageal cancer
.
The adjuvant treatment of nivolumab has shown good efficacy data.
The median DFS of patients has doubled compared with placebo, and the median DMFS in the past 30 months is also very impressive, especially for patients with high-incidence squamous cell carcinoma in China
.
Not only that, the minimum 14-month follow-up results of this update did not show the phenomenon of “split first, then approach” in the previous similar studies.
The transfer of cases led to a weakening of the overall benefit trend of the study
.
In addition, thanks to the controllable safety of the program, the incidence, type, and degree of adverse reactions are acceptable, and the overall quality of life of patients is not reduced
.
Create a "food" generation: Nivolumab adjuvant therapy rewrites clinical guidelines, and explores not only to advance to the front line.
Based on the results of CheckMate -577, nivolumab has been approved in the United States this year, becoming the world's first adjuvant immune system for esophageal cancer Therapy; 2021 CSCO guidelines have also included nivolumab in the recommendation for adjuvant treatment after esophageal cancer surgery for the first time (Class IA evidence) (Table 2)
.
Table 2: CSCO Guidelines for Diagnosis and Treatment of Esophageal Cancer 2021-Postoperative Adjuvant Treatment Prof.
Qixun Chen commented that CheckMate-577 is a milestone study of perioperative immunotherapy for esophageal cancer, filling the gap in this field, and is expected to rewrite clinical practice
.
In addition to the field of adjuvant therapy, the clinic is also actively exploring the advancement of immunotherapy combined with chemotherapy to the field of neoadjuvant therapy before surgery for esophageal cancer
.
Theoretically speaking, immunotherapy can fight tumor cells by strengthening the lymphocytes in the patient's body and activating the immune system.
The patient's physical condition before surgery is relatively good, not only can tolerate chemotherapy better, but also get more immune Benefit from treatment
.
The exploration in this field is currently mostly single-arm research, and it is expected that large-scale randomized controlled studies that challenge the status of CRT standards can be carried out in the future
.
In general, with the continuous exploration and harvest of perioperative immunotherapy, patients with resectable locally advanced EC/GEJC are expected to be reborn
.
References: 1.
Ronan J.
Kelly, Jaffer A.
Ajani, Jaroslaw Kuzdzal, et al.
Adjuvant Nivolumab in Resected Esophageal or Gastroesophageal Junction Cancer[J].
N Engl J Med 2021; 384:1191-12032.
M van Heijl, JJB van Lanschot, LB Koppert, et al.
Neoadjuvant chemoradiation followed by surgery versus surgery alone for patients with adenocarcinoma or squamous cell carcinoma of the esophagus (CROSS) [J].
BMC Surg.
2008 Nov 26;8:21.
3.
Hong Yang, Hui Liu, Yuping Chen ,et al.
Neoadjuvant Chemoradiotherapy Followed by Surgery Versus Surgery Alone for Locally Advanced Squamous Cell Carcinoma of the Esophagus (NEOCRTEC5010): A Phase III Multicenter, Randomized, Open-Label Clinical Trial[J].
J Clin Oncol.
2018 Sep 20;36(27):2796-2803.
4.
2020 ESMO.
LBA9-Adjuvant nivolumab in resected esophageal or gastroesophageal junction cancer following neoadjuvant chemoradiation therapy: first results of the CheckMate 577 study.
5.
2021 ESMO.
1381P-Adjuvant nivolumab in resected esophageal or gastroesophageal junction cancer following neoadjuvant cancer (C/GEJCRT) ): 14-month follow-up of CheckMate 577.
6.
Ronan Joseph Kelly, Jaffer A.
Ajani, Jaroslaw Kuzdzal, et al.
Adjuvant nivolumab (NIVO) in resected esophageal or gastroesophageal junction cancer (EC/GEJC) following neoadjuvant chemoradiotherapy (CRT) : Expanded efficacy and safety analyses from CheckMate 577[J].
DOI: 10.
1200/JCO.
2021.
39.
15_suppl.
4003 Journal of Clinical Oncology 39, no.
15_suppl (May 20, 2021) 4003-4003.
1381P-Adjuvant nivolumab in resected esophageal or gastroesophageal junction cancer (EC/GEJC) following neoadjuvant chemoradiotherapy (CRT): 14-month follow-up of CheckMate 577.
6.
Ronan Joseph Kelly, Jaffer A.
Ajani, Jaroslaw Kuzdzal, etlumab Adjuvant nivoal.
(NIVO) in resected esophageal or gastroesophageal junction cancer (EC/GEJC) following neoadjuvant chemoradiotherapy (CRT): Expanded efficacy and safety analyses from CheckMate 577[J].
DOI: 10.
1200/JCO.
2021.
39.
15_suppl.
4003 Journal of Clinical Oncology 39 , no.
15_suppl (May 20, 2021) 4003-4003.
1381P-Adjuvant nivolumab in resected esophageal or gastroesophageal junction cancer (EC/GEJC) following neoadjuvant chemoradiotherapy (CRT): 14-month follow-up of CheckMate 577.
6.
Ronan Joseph Kelly, Jaffer A.
Ajani, Jaroslaw Kuzdzal, etlumab Adjuvant nivoal.
(NIVO) in resected esophageal or gastroesophageal junction cancer (EC/GEJC) following neoadjuvant chemoradiotherapy (CRT): Expanded efficacy and safety analyses from CheckMate 577[J].
DOI: 10.
1200/JCO.
2021.
39.
15_suppl.
4003 Journal of Clinical Oncology 39 , no.
15_suppl (May 20, 2021) 4003-4003.
Adjuvant nivolumab (NIVO) in resected esophageal or gastroesophageal junction cancer (EC/GEJC) following neoadjuvant chemoradiotherapy (CRT): Expanded efficacy and safety analyses from CheckMate 577[J].
DOI: 10.
1200/JCO.
2021.
39.
15_suppl.
4003 Journal of Clinical Oncology 39, no.
15_suppl (May 20, 2021) 4003-4003.
Adjuvant nivolumab (NIVO) in resected esophageal or gastroesophageal junction cancer (EC/GEJC) following neoadjuvant chemoradiotherapy (CRT): Expanded efficacy and safety analyses from CheckMate 577[J].
DOI: 10.
1200/JCO.
2021.
39.
15_suppl.
4003 Journal of Clinical Oncology 39, no.
15_suppl (May 20, 2021) 4003-4003.
