The CSCO gastric cancer guideline received the special "acceptance" of nivolumab, which is recommended by the whole population, leading a new journey in the treatment of upper gastrointestinal tumors

On April 23-24, the 2022 Chinese Society of Clinical Oncology (CSCO) Guidelines Conference was held online
.

At the meeting, the 2022 version of the CSCO Guidelines for the Diagnosis and Treatment of Gastric Cancer was officially released, and the new version of the guidelines was updated several times
.

Among them, the update of gastric cancer immunotherapy is one of the biggest highlights
.

Last year, based on the CheckMate-649 study¹, the National Medical Products Administration (NMPA) approved nivolumab in combination with chemotherapy for first-line treatment of patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer and esophageal adenocarcinoma, the first in China.
It is the only and currently the only immunotherapy approved for first-line indications for gastric cancer, which has revolutionized the treatment landscape of gastric cancer
.

In the updated CSCO guidelines for the diagnosis and treatment of gastric cancer this year, nivolumab combined with chemotherapy is also recommended for the first-line treatment of the whole population of advanced gastric cancer
.

 In the field of upper gastrointestinal tumors, researches such as CheckMate-6482 and CheckMate-5773 have also made breakthroughs
.

At present, nivolumab has gradually conquered gastric cancer, gastroesophageal junction cancer, esophageal adenocarcinoma, and esophageal squamous cell carcinoma, and has achieved full coverage from late-stage posterior line, late-stage first-line to early stage
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Overall, immunotherapy has become a focus in the field of gastric cancer and other upper gastrointestinal tumors
.

On the occasion of the CSCO guideline meeting, Yimaitong analyzed and produced a special edition of immunotherapy for the new edition of gastric cancer diagnosis and treatment guidelines, with nivolumab as a beacon, to explore the value of immunotherapy in the full-line application of upper gastrointestinal tumors
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Whole population recommendation - Nivolumab combined with chemotherapy CSCO guidelines recommend that the changes in the 2022 version of the guidelines focus on the treatment of advanced gastric cancer
.

The large-scale phase III clinical study data has confirmed the application value of nivolumab.
In the first-line treatment of advanced gastric cancer, the recommended settings for the nivolumab regimen in the new guideline set the CPS ≥ 5 population as a class I recommendation.
CPS<5 is recommended as level II
.

For the treatment of HER-2-positive gastric cancer, the new guideline regards anti-HER-2 therapy combined with immunotherapy and chemotherapy as a class III recommendation
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In addition, because of the unique biological behaviors of microsatellite instability (MSI) or mismatch repair deficient (dMMR) populations, these populations are listed separately in both first- and second-line treatment of advanced gastric cancer
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However, due to the low proportion of the MSI or dMMR population, there is still a lack of clinical research evidence with a large sample size.
Therefore, it is necessary to balance the treatment concept of clinicians and the existing clinical evidence when making treatment decisions
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An immunotherapy-based strategy is currently recommended for MSI-H or dMMR populations
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regardless of HER-2 status
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Chemotherapy alone should be considered only if the patient is not suitable for immunotherapy
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Some other updates include: the video gastroscope section is updated according to the templated report; the pathological diagnosis section requires that all newly diagnosed gastric cancers should be tested for MSI and dMMR; the perioperative treatment section updates the surgical specifications for esophagogastric junction cancer, according to tumor invasion The range of the length of the esophagus is used to guide the range of lymph node dissection
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Comprehensive benefits - CheckMate-649 creates a new era of gastric cancer immunotherapy Currently, nivolumab combined with chemotherapy has been approved in China for the first-line whole population treatment of advanced gastric cancer
.

The approval of the nivolumab regimen was mainly due to the excellent overall survival (OS) data in the CheckMate-649 study.
The overall OS of Chinese patients was 4 months longer than chemotherapy, and the risk of death was reduced by 39%
.

In addition to the overall benefit of median OS, in the CheckMate-649 Chinese subgroup study, we can also see that the median progression-free survival (mPFS) of the patient population with CPS ≥ 5 doubled, and the objective response rate (ORR) was nearly 70%.
%, the duration of response (DOR) was doubled in all Chinese subgroups and there were no immunotherapy-related deaths
.

In the CheckMate-649 study, the mortality risk reduction in the Chinese population was nearly 20 percentage points greater than that in the global population, a clearer advantage that was also reflected in previous studies
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Combined with the analysis of previous expert opinions, the main reason for this phenomenon may be that Chinese patients have a later disease, which also means that for people with a large tumor burden and difficult second- and third-line treatment, it is especially necessary to start immunotherapy in the first line.

.

Of course, the dietary structure of the Chinese population, the infection of other flora such as Helicobacter pylori, and the particularity of the eastern population may also be influencing factors
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Click to view the detailed explanation of CheckMate -649 research results Harvest and exploration - Nivolumab leads upper gastrointestinal tumor immunotherapy In recent years, nivolumab-based therapy has continuously made breakthroughs in the treatment of esophageal cancer
.

Several clinical studies have confirmed that the benefit of immunotherapy for squamous cell carcinoma is greater than that of adenocarcinoma
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In the CheckMate-648 study, patients with esophageal squamous cell carcinoma received significant benefit from nivolumab combined with chemotherapy
.

The CheckMate-649 study also included a subset of patients with esophageal adenocarcinoma.
Based on these two studies, nivolumab has become the world's first and currently only proven combination chemotherapy for first-line treatment of various tumor sites and histological types of the upper gastrointestinal tract Cancer, immune checkpoint inhibitors that can bring significant OS benefits
.

Click to view the results of the CheckMate -648 study for details.
The CheckMate-577 study explored the efficacy and safety of nivolumab as adjuvant therapy for esophageal cancer.
Adjuvant immunotherapy delivered significant clinical benefit, doubling the median DFS (22.
4 months vs.
10.
4 months in the control group)
.

In May 2021, based on the results of CheckMate-577, nivolumab was approved by the FDA, becoming the world's first immunotherapy for the adjuvant treatment of esophageal cancer
.

In the past, there was no clear clinical consensus or recommendation for postoperative adjuvant therapy for locally advanced esophageal cancer
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CheckMate-577 not only achieved the first important results of immunotherapy in this field, but also provided new high-level evidence for the adjuvant treatment of locally advanced esophageal cancer
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Click to view the detailed explanation of CheckMate -577 study results In the field of advanced gastric cancer treatment, nivolumab is the first and currently the only immunotherapy drug approved for first-line indications for gastric cancer in China
.

The CheckMate-649 study has changed the entire gastric cancer treatment landscape and made a big step forward in the treatment of gastric cancer
.

In the field of perioperative treatment of gastric cancer, the existing clinical data show that nivolumab has good efficacy and safety, and the future can be expected
.

References: 1.
Yelena Y Janjigian, Kohei Shitara, Markus Moehler, et al.
First-line nivolumab plus chemotherapy versus chemotherapy alone for advanced gastric, gastro-oesophageal junction, and oesophageal adenocarcinoma (CheckMate 649): a randomised, open-label , phase 3 trial [J].
Lancet.
2021 Jul 3;398(10294):27-40.
2.
Doki Yuichiro,Ajani Jaffer A,Kato Ken et al.
Nivolumab Combination Therapy in Advanced Esophageal Squamous-Cell Carcinoma [J].
N Engl J Med, 2022, 386:449-462.
3.
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 Apr 1; 384(13):1191-1203.
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