The incidence and mortality of esophageal cancer separately rank 7th and 6th among cancers in the world. China is a country with a high incidence of esophageal cancer, with incidence and mortality accounting for more than half of global incidence and mortality. Unlike the pathological types of esophageal cancer in Europe and North America, which are mostly adenocarcinomas, more than 90% of the pathological types of esophageal cancer in China are squamous cell carcinomas. Current clinical treatments mainly include surgery, chemotherapy, radiation therapy, and targeted therapy. Chemoradiotherapy has become the standard treatment for advanced esophageal cancer as about half of patients have distant metastasis at the time of clinical diagnosis. However, both esophageal squamous cell carcinoma (ESCC) and esophageal adenocarcinoma are intrinsically resistant to traditional treatment, with limited treatment response to first-line chemotherapy, and the application of targeted drugs in esophageal cancer treatment is very limited, therefore, new therapeutic methods are urgently needed to improve esophageal cancer prognosis. Immunotherapy has brought revolutionary therapeutic changes to other tumor types, and although esophageal cancer immunotherapy started relatively late, it has made some achievements.
Pembrolizumab, camrelizumab, and nivolumab are recommended in the current CSCO Guidelines as second-line immunotherapies for esophageal cancer and constitute the “iron triangle” of immunotherapy for esophageal cancer. A clinical trial has been conducted to use the Chinese-produced sintilimab as a second-line therapy for advanced ESCC and has achieved positive results. As a result, sintilimab is expected to become the fourth major immunotherapy for esophagus cancer in China. Let’s see the new recommendations for immunotherapy for esophageal cancer below.
Pembrolizumab (squamous cell carcinoma, PD-L1 CPS≥10, Level 1A evidence)
Pembrolizumab, one of the two major anti-PD-1 monoclonal antibodies, has received Level I recommendation (Level 1A evidence) as a second-line therapy for patients with advanced ESCC (CPS ≥ 10). Its approval was based on phase 3 KEYNOTE-181 clinical study. As an international multicenter, randomized, controlled phase 3 clinical study, KEYNOTE-181 enrolled 123 patients with recurrent, locally advanced, or metastatic esophageal cancer in the Chinese subgroup to randomly receive pembrolizumab (62 cases) or chemotherapy (61 cases).
According to the results, the OS benefits of Chinese patients with ESCC who received pembrolizumab were more significant, with death risk reduced by 45%, 3 times the death risk of the overall study population (45% vs 15%, with HR separately of 0.55 and 0.85).
Recommendation level: Squamous cell carcinoma patients with CPS≥10. The Level III recommendation by experts in the old Guidelines has been “promoted” to Level I recommendation, and the level of evidence has been adjusted from 2B to 1A.
Camrelizumab (squamous cell carcinoma, Level 1A evidence)
Camrelizumab is the first Chinese-produced immune drug approved for advanced esophageal cancer in China. The recommendation was mainly based on the results of the randomized, open, chemotherapeutic-controlled, multicenter phase III ESCORT clinical study. ESCORT study, the first study with the largest sample size on immune checkpoint inhibitors conducted in patients with advanced ESCC in China, enrolled a total of 457 patients with advanced or metastatic ESCC who failed first-line chemotherapy (camrelizumab group and chemotherapy group separately having 228 and 220). According to the results, the median OS of the two groups was separately 8.3 months vs 6.2 months, and camrelizumab reduced the death risk by about 30%; the ORR was separately 20.2% vs 6.4%, DOR was separately 7.4 months vs 3.4 months, and patients could benefit from camrelizumab treatment regardless of the PD-L1 expression state; in terms of safet...
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