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"O drug" adjuvant treatment of gastric cancer and esophageal cancer disease-free survival doubles

 Last Update: 2021-06-03
 Source: Internet
 Author: User

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Recently, the US FDA announced that it has approved an extended indication for PD-1 inhibitor “O drug” nivolumab as an adjuvant therapy for the treatment of esophageal cancer or gastroesophageal junction (GEJ) cancer undergoing complete resection patient.

Esophageal cancer is the seventh most common cancer in the world and the sixth leading cause of cancer death.
The five-year relative survival rate of patients with metastatic esophageal cancer is less than 5%.

The two most common types of esophageal cancer are squamous cell carcinoma and adenocarcinoma, which account for approximately 85% and 15% of all esophageal cancers, respectively.
Most patients with esophageal cancer are already at an advanced stage when they are diagnosed, and their daily life, including their diet, will be affected.

Stomach cancer is the fifth most common cancer in the world and the third leading cause of cancer deaths.
In China, gastric cancer is the second largest type of cancer after lung cancer, with more than 370,000 deaths.
Among them, about 80% of patients are already at an advanced stage at the time of diagnosis.

There is a special type of gastric cancer-gastroesophageal junction (GEJ) cancer formed at the junction of the stomach and esophagus.
Although the prevalence is lower than that of gastric cancer, it is showing a continuous increase.

Currently, for patients with resectable, locally advanced esophageal cancer or gastroesophageal junction cancer, the standard treatment is neoadjuvant chemoradiation combined with surgery.

However, patients who have received standard therapies are still at a higher risk of recurrence, especially those who have not achieved complete pathological remission.
The risk of recurrence is higher.
A good adjuvant therapy is urgently needed to help patients improve their prognosis.

▌"O medicine" has another success!

Last month, the “O drug” nivolumab has just obtained an indication from the FDA.
It is used in combination with chemotherapy to treat patients with advanced or metastatic gastric cancer, gastroesophageal junction (GEJ) cancer and esophageal adenocarcinoma, regardless of What is the expression status of PD-L1?

In recent years, with the launch of immunotherapies such as nivolumab and pembrolizumab, it has greatly benefited patients with gastric cancer and esophageal cancer worldwide.

Nivolumab received its first batch as early as 2014, and is now marketed in more than 60 countries/regions around the world for the treatment of various cancers including melanoma and non-small cell lung cancer.

Last year, both nivolumab and pembrolizumab were approved by the China Food and Drug Administration for the treatment of patients with gastric cancer and esophageal cancer, respectively.
However, currently O drugs and K drugs have not many indications approved in China, and some patients cannot benefit.

▌Disease-free survival is doubled!

CheckMate -577 is a phase 3 randomized, double-blind, placebo-controlled, multicenter clinical trial that evaluates nivolumab as an adjuvant therapy.
After receiving adjuvant chemotherapy and surgical treatment, there are still residual pathological diseases.
Efficacy and safety in patients with esophageal cancer or gastroesophageal junction cancer.

A total of 794 patients were enrolled in the trial and were randomly assigned to receive nivolumab 240 mg (n = 532) or placebo.
The primary endpoint is disease-free survival (DFS).

The results show that:

Among patients treated with nivolumab, disease-free survival (DFS) was twice that of patients in the placebo group (22.
4 months VS 11.
0 months).
Regardless of the tumor PD-L1 expression and histological classification, DFS benefits can be observed.

Compared with placebo, nivolumab reduced the patient's risk of disease recurrence or death by 31%.

In an exploratory analysis, among adenocarcinoma patients (70.
9%), the mDFS of patients in the nivolumab group was 19.
4 months, and that of patients with placebo was 11.
1 months.

Among patients with squamous cell carcinoma (29%), the mDFS of patients in the nivolumab group was 29.
7 months and that of placebo was 11.
0 months.

Locally advanced esophageal and gastroesophageal junction cancers are aggressive tumor types and usually require multiple methods to treat them, including chemotherapy, radiotherapy, and surgery.
Even after neoadjuvant chemotherapy or even complete resection, the risk of recurrence is high for patients who have not achieved complete pathological remission.

In this trial, nivolumab treatment doubled the patient's median disease-free survival and reduced the patient's risk of recurrence in the early stage, which is expected to become the new standard of treatment for these patients.

However, the new indication has not yet been approved in China, and patients should not try it rashly.

Reference materials:

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