Esophageal cancer is one of the top ten high-incidence cancers in China, according to the World Health Organization, nearly half of the world's new cases and deaths of esophageal cancer in 2018 came from China! What is more serious is that because the early symptoms are not obvious, about 75% of esophageal cancer patients in China have entered the advanced stage at the time of diagnosis, and the treatment methods and effects are very limited.
For advanced esophageal cancer, the current standard treatment plan is mainly chemotherapy, but chemotherapy is not only inefficient, but also brings many side effects such as anemia, decreased white blood cells, hair loss, vomiting, etc., which make patients very painful, and some patients even choose to give up treatment because they cannot tolerate the side effects of chemotherapy. Advanced esophageal cancer is in urgent need of new treatment drugs!
This good news brings new hope to patients with esophageal cancer: "The PD-1 inhibitor perborizumab (trade name: Correda ®, commonly known as "K drug" in China) has been approved by the State Drug Administration (NMPA) to combine platinum and fluorouracil chemotherapy drugs for first-line treatment of patients with locally advanced unresectable or metastatic esophageal or gastroesophageal conjugate cancer. ”
K drug became the first and currently the only PD-1 monoclonal antibody approved in China for the first-line treatment of the entire population of esophageal cancer.
K medicine broke the ice on the first line and achieved the only one in China
The approval of the first-line indication for the treatment of esophageal cancer is also the second indication approved by K drug in the field of esophageal cancer treatment. In June 2020, K drug was approved in China for the treatment of single-agent PD-1 expression positive, previous first-line systemic therapy failure, locally advanced or metastatic esophageal squamous cell carcinoma.
At the same time, K drug is also the only PD-(L)1 monoclonal antibody in China that has both first- and second-line treatment indications in the same advanced solid tumor.
The indications for the approval of the first-line treatment of K drug are based on a more than 10-month phase III clinical study analysis, and the results show that the K-drug combination chemotherapy first-line treatment regimen has significantly improved overall survival compared with platinum-containing chemotherapy in both the intended treatment (ITT) population, or the ITT and ESCC populations in the esophageal squamous cell carcinoma (ESCC), or PD-L1 CPS≥10.
This is also the world's first clinical study showing that the first-line treatment of advanced esophageal cancer with immune checkpoint inhibitors can bring significant overall survival benefits, bringing a new breakthrough to the first-line treatment of advanced esophageal cancer that has been almost stagnant for nearly half a century and is dominated by chemotherapy.
In this clinical study, the results of the Chinese subgroup population data analysis showed that the median overall survival of the first-line treatment regimen of K drug combined with platinum-containing chemotherapy was extended by 2.5 months compared with the chemotherapy control group, reducing the risk of death by 49%, which was consistent with the global data results.
At the same time, according to the K-drug single-drug first-line treatment "crushing" chemotherapy ± bevacizumab or cetuximab control group announced at the American Society of Clinical Oncology Gastrointestinal Tumor Conference this year.
According to the results of this study, some advanced patients can obtain the possibility of surgical resection through K drug combined with platinum-containing chemotherapy, and surgical resection is still one of the most important means for current esophageal cancer patients to obtain long-term survival benefits or even cure.
K-drug combination chemotherapy has the potential to be applied to preoperative neoadjuvant therapy for surgically progressive esophageal cancer, reducing postoperative recurrence rates, particularly in patients with locally advanced esophageal cancer who have developed multi-station lymph node metastasis.
A new standard for the treatment of esophageal cancer
In the past few decades, the first-line treatment for metastatic esophageal cancer has been dominated by 5-FU or paclitaxel plus platinum-containing chemotherapy. Regardless of the chemotherapy regimen, patients have a poor prognosis, with an overall survival of no more than 12 months.
The first-line treatment plan of K drug combined with platinum-containing chemotherapy has brought a new choice for the treatment of esophageal cancer in China with locally advanced unresectable and distal metastases, and is bound to become a new standard for the treatment of advanced esophageal cancer.
The 2021 CSCO Immune Checkpoint Inhibitor Clinical Application Guidelines administer (and only administer) K drug plus platinum-containing chemotherapy regimens are recommended by Class I experts for the first-line treatment of metastatic esophageal carcinoma (evidence level 1A).
Figure: Recommendations and level of evidence for immunotherapy for esophageal cancer in the 2021 CSCO Immune Checkpoint Inhibitor Clinical Application Guide
It is worth noting that the indications for the approval of K drug do not limit the pathological typing, PD-L1 expression, and esophageal cancer site of the population, so the first-line treatment of K drug combined with platinum-containing chemotherapy can be used for the first-line treatment of all locally advanced or metastatic esophageal cancer, regardless of PD-L1 expression, whether it is esophageal squamous cell carcinoma or adenocarcinoma, and also includes gastroesophageal junction cancer.
This expands the potential beneficiaries of the regimen while facilitating the clinical practice of the regimen.
There is no doubt that the approval of the K drug combined with the first-line treatment of platinum-containing chemotherapy for locally advanced unresectable and metastatic esophageal cancer has made K drug a well-deserved "king of precision immunity" in China, not only is esophageal cancer a possibility of long-term survival, but also a high-quality survival of "de-chemotherapy". It is expected that K medicine will bring long-term survival and even clinical cure to more Chinese esophageal cancer patients!