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China is a country with a high incidence of esophageal cancer, and clinically, about 2/3 of esophageal cancer patients are locally advanced, making the incidence and death of esophageal cancer in China exceed the world 50%[1]
。 Surgery is one of the main treatment methods, but the cure rate of patients with locally advanced esophageal cancer after surgery alone is only 35%, and the 5-year survival rate of patients needs to be improved
.
In the past decade, with the addition of radiotherapy to the neoadjuvant therapy echelon and the progress of immunotherapy in the adjuvant and first-line treatment of esophageal cancer, the medical treatment of esophageal cancer has been revitalized
.
The progress of neoadjuvant and immunotherapy in the field of adjuvant therapy and first-line treatment of advanced patients has also made a further leap
in the survival of patients with esophageal cancer.
Professor Yu Zhentao, Director of the Department of Thoracic Surgery, Shenzhen Hospital, Cancer Hospital of the Chinese Academy of Medical Sciences, was invited by Doctor Daily to explain the advanced survival of
esophageal cancer patients.
Challenge distant recurrent metastases
Immunoadjuvant therapy targets the pain points of esophageal cancer treatment
"Esophageal cancer is not sensitive to chemotherapy, so in the era when there was no preoperative concurrent chemoradiotherapy (CRT) and immunotherapy, chemotherapy departments almost withdrew from the treatment
of esophageal cancer.
" Professor Yu Zhentao described the encounter
of physicians in the field of advanced esophageal cancer treatment more than a decade ago.
He said that preoperative chemotherapy was level II.
a evidence at that time, until around 2012, led by the Dutch CROSS study [2] and Professor Fu Jianhua's research group of Sun Yat-sen University Cancer Prevention and Treatment Center NEOCRTEC5010 STUDY [3], all confirmed by phase III RCTs, CRT+ Surgery improves survival
in patients with resectable advanced esophageal cancer compared to surgery alone.
The 5-year overall survival rate of the neo-adjuvant CRT group in the NEOCRTEC5010 study even reached 60%.
。 It can be seen in the study that preoperative neoadjuvant CRT has advantages in tumor reduction, R0 resection rate and overall survival, so preoperative neoadjuvant CRT has become the standard treatment recommended
by domestic and foreign guidelines for patients with potentially resectable locally advanced esophageal cancer.
Professor Yu Zhentao introduced: "Due to the biological characteristics of esophageal cancer, it is very easy to metastasize and recur, and in recent years, follow-up has found that neoadjuvant CRT can reduce the metastasis of lymph nodes, so that the perigastric and abdominal lymph node metastases are significantly reduced, but distant metastasis is still the main problem
faced by patients.
On the other hand, after neoadjuvant CRT therapy, non-pCR is relative to patients with pathological complete response (pCR).
Patients are at higher risk of postoperative recurrence and death [4].
In the NEOCRTEC5010 study[3], after neo-assisted CRT, the pCR rate was 43.
2% More than half of patients did not achieve pCR.
Distant recurrence and distant metastases have become "stumbling blocks" that plague esophageal cancer patients to obtain long-term survival, so postoperative adjuvant therapy has received more and more attention, but in 2020 CSCO and NCCN The guidelines recommend observation for adjuvant therapy for esophageal squamous cell carcinoma, is there no more active treatment for such patients than watching them recur? In 2021, the Checkmate577 study, published in the New England Journal of Medicine [ 5] Impressive data from immunoadjuvant therapy answered this question
.
The study included patients
with residual lesions after neoadjuvant + surgical resection.
Studies have shown significant benefits of nivolumab as a monotherapy adjuvant to disease-free survival (DFS), with long-term follow-up data showing that nivolumab reduces the risk of recurrence or death by 33% and mDFS by 22.
4 months, compared with the control group (10 4 months) doubled, with a trend of
higher benefit in patients with squamous cell carcinoma.
In addition, adjuvant nivolumab reduced the risk of distant metastases or death by 29% compared with placebo, with a median survival time without distant metastases (DMFS) of 29.
4 months
.
The CheckMate 577 study became the world's first phase III clinical study to prove the efficacy of immunotherapy in adjuvant therapy for esophageal cancer/gastroesophageal junction cancer.
Based on this study, 2022 NCCN [6] and CSCO Guide [7] Nivolumab is recommended for adjuvant therapy
after esophageal cancer.
Nivolumab has become the first and only immunotherapy drug approved for adjuvant therapy for esophageal cancer, and the only immunotherapy drug that has been recommended by NCCN and CSCO guidelines for postoperative adjuvant therapy for esophageal cancer.
Rewrite the guide
Immunotherapy is a brave challenge for the treatment of advanced esophageal cancer
"2022 edition of NCCN [6] and CSCO Guide [ 7] The biggest change is that postoperative adjuvant and first-line treatment of advanced esophageal cancer have been added to immunotherapy, bringing new hope
for the treatment of esophageal cancer.
Professor Yu Zhentao said
.
China has a high incidence of esophageal squamous cell carcinoma and a heavy disease burden, which requires better treatment options
.
In terms of advanced first-line treatment, the world's largest phase III clinical study of unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma - CheckMate 648 study [8]2 022 published in the New England Journal of Medicine
.
The results of the study showed that nivolumab combined with chemotherapy achieved longer survival in advanced esophageal squamous cell carcinoma in the first-line treatment (mOS: 13.
2 months vs.
10.
7 months), higher response rate (ORR: 47% vs.
27%), PD-L1 The positive population benefits are particularly significant (mOS: 15.
4 months vs.
9.
1 months; ORR：53%vs.
33%）
。 And the results of the study showed that the quality of life of patients with esophageal squamous cell carcinoma in the nivolumab combined with chemotherapy group was stable
.
Nivolumab in combination with chemotherapy is recommended by the 2022 CSCO and NCCN guidelines for the first-line treatment of patients with
advanced esophageal squamous cell carcinoma.
Professor Yu Zhentao also emphasized that while paying attention to the changes in guidelines, it should also be noted that the population of immunoadjuvant therapy does not include all esophageal cancer patients
undergoing surgery.
People who can undergo immunoadjuvant therapy should include patients who have undergone standardized neoadjuvant CRT before surgery, and patients with non-pCR who have residual lesions after neoadjuvant CRT therapy, and have direct surgery or menstruation Patients who achieve PCR after neoadjuvant therapy for CRT are not suitable for
immunoadjuvant therapy.
"The better news for Chinese patients is that both the Checkmate 577 study and the Checkmate648 study, Immunotherapy works better
in squamous cell carcinoma than adenocarcinoma.
Professor Yu Zhentao said
.
Look to the future
Immunotherapy is promising
"China's esophageal cancer incidence and mortality are both high, in the past 10~20 years, China has made remarkable achievements
in surgery, internal medicine and radiotherapy.
China's esophageal cancer patients after standardized diagnosis and treatment, the 5-year survival rate is about 10% higher than that of European and American countries, which is inseparable from the joint efforts of domestic counterparts, but also thanks to the establishment of more and more esophageal cancer diagnosis and treatment centers in China, doctors of various specialties cooperate with each other to bring patients the best treatment decisions with MDT
。 Professor Yu Zhentao introduced
.
In recent years, the understanding of immunotherapy has also allowed us to save more patients
.
Whether it is the CheckMate series of studies or the Keynote series of studies, we have seen the superiority of immunotherapy in the field of upper gastrointestinal tumor treatment, especially for the high incidence of esophageal squamous cell carcinoma in China, immunotherapy is more effective [5,8]
。 In patients with potentially operable locally advanced or esophageal cancer with lymph node metastases, preoperative neoadjuvant CRT regimens recommended by domestic and foreign guidelines as the gold standard
.
At present, some immuno-related treatments, including neoadjuvant immunity, almost all studies are still in phase II.
~III research stage, and it will take some time to prove whether neoadjuvant immunotherapy is superior.
In the direction of future immunotherapy research, Professor Yu Zhentao also suggested that, first of all, drug research and development companies can be encouraged to develop new immunotherapy drugs
with different structures, high efficiency and low toxicity.
Secondly, different combinations of immunotherapy can be explored, such as the application of immunotherapy and chemotherapy in postoperative adjuvant therapy, and the three-drug or four-drug regimen of immunocombined chemotherapy plus anti-angiogenic drugs to solve the problem of recurrence and metastasis in
postoperative patients.
Third, the dose exploration
of immunotherapy.
Because immune enhancement is also a process of increasing the body's response and adverse reactions, then for tumor patients, what kind of homeostasis should be achieved by immunity is the best result
.
It is hoped that in the future, through the joint efforts of clinicians and drug research and development companies, the emergence of updated drugs and treatment regimens, improve efficacy, reduce the risk of death of tumor patients, and prolong their survival is the greatest wish
of clinicians.
➤ Expert profile
Professor Yu Zhentao
Director of Department of Thoracic Surgery, Shenzhen Hospital, Cancer Hospital of Chinese Academy of Medical Sciences
Fellow of the Royal College of Surgeons (FRCS) Chief Physician Professor, Ph.
D.
Doctoral supervisor
Honorary Chairman of the Esophageal Cancer Professional Committee of the Chinese Anti-Cancer Association
Vice Chairman of the Mediastinal Tumor Professional Committee of the Chinese Anti-Cancer Association
Member of the Standing Committee of the Cancer Nutrition Professional Committee of the Chinese Anti-Cancer Association
Director of Chinese Anti-Cancer Association
Member of the Standing Committee of the Thoracic Surgery Branch of the Chinese Medical Doctor Association
Vice Chairman of Thoracic Surgery Branch of Guangdong Medical Association
Member of the European Society of Thoracic Surgeons (ESTS).
Member of the International Lung Cancer Society (ITMIG).
References: (swipe to view)
[1] GLOBOCAN 2020.
https://gco.
iarc.
fr/today/home
[2]Shapiro J, et al.
Lancet Oncol.
2015; 16(9):1090-1098.
[3]Yang H, et al.
J Clin Oncol.
2018 Sep 20; 36(27):2796-2803.
[4]Singh P, et al.
2021 ASCO GI Abstract 360.
[5]Kelly RJ, et al.
N Engl J Med.
2021; 384(13):1191-1203.
[6]NCCN Guidelines Esophageal and Esophagogastric Junction Cancers 2022.
v1.
[7] 2022 CSCO Guidelines for the Diagnosis and Treatment of Esophageal Cancer
[8]Doki Y, et al.
N Engl J Med.
2022; 386(5):449-462.
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