Professor Yuan Xianglin: "CSCO Gastric Cancer Diagnosis and Treatment Guidelines" immunotherapy update shows cutting-edge evidence-based

Recently, the 2020 China Society of Clinical Oncology (CSCO) Gastric Cancer Diagnosis and Treatment Guide (hereinafter referred to as the "Guidelines") was officially released to the public, the focus of this year's guidelines update will become the future of clinical treatment.
this, the medical community has the honor to invite Professor Yuan Zhonglin of Tongji Hospital, affiliated with Tongji Medical College of Huahua University of Science and Technology, to analyze and look forward to the highlights of the immunotherapy of stomach cancer in this guide update.
immunotherapy recommendations strive to be accurate as a whole, the guidelines update on molecular pathology testing, radiotherapy, chemotherapy, immunotherapy and other major content have been adjusted.
Among them, the immunotherapy part of advanced metastatic gastric cancer will be China's only approved late-stage gastric cancer adaptation immuno-tumor drug Navuliyu monoantigen as a single drug recommended, and the recommended grade compared to the previous single drug PD-1 single anti-further promotion, is listed as A-level recommendation, 1A evidence, for advanced metastatic gastric cancer three-line treatment, become one of the focus of attention.
Previously, the 2018 guidelines included PD-1 monoantitons as Class III recommendations, Category 1A evidence for the first time, upgraded to Level II recommendations, Category 1B evidence in 2019, and this year's guidelines were more detailed in recommending immunotherapy, with immunotherapy replacing the entire category with specific drugs for the first time.
fact, accurate recommendation is one way to further regulate clinical treatment.
considering the wide variety of PD-1 monoanto-drugs, there are differences in efficacy and approved adaptations between drugs, and therefore, the recommendations of the guidelines will also focus on the requirements of clinically reasonable drug use.
Yuan Linglin, also stressed in his interpretation that drugs should be selected in practice as far as possible on the basis of approved adaptive disorders.
at ATTRACTION-2, said that third-line treatment of stomach cancer is important in clinical practice, but drugs are still scarce.
previous I-level recommendations were only Apatini.
, the addition of Navuliyu monotherapy as a grade I recommendation that is not subject to CPS ratings could revolutionized the pattern of third-line treatment for stomach cancer.
is also one of the most important changes to this guide update.
noted that the recommendation was based primarily on the results of the ATTRACTION-2 study.
ATTRACTION-2 study is the world's first clinical trial of gastric cancer immunotherapy.
study included 493 patients with advanced stomach cancer in East Asia (Japan, Korea and Taiwan, China) who received Navuliyu monoanti or placebo for third-line and above treatment.
3-year follow-up results showed a 38% reduction in the risk of death (HR 0.62, P 0.0001).
the survival curve of the study, the Navuliyu monoantigroup: - 1 year OS rate reached 27.3% (11.6% in placebo group) - 2 years OS rate of 10.6% (comfort) The overall survival rate of the dose group was 3.2%)- 3 years OS rate of 5.6% (1.9% in the placebo group) was 2-3 times higher than that of the placebo group, and the "survival tail" of immunotherapy was clearly visible.
3 years of OS results from the 1 ATTRACTION-2 study, subgroup analysis showed that 9.7 percent of patients in the Navuliyu monoantigen group achieved complete remission (CR)/partial remission (PR), and the mesos in these patients reached 26.68 months, more than two years.
, no patients in the control group obtained CR/PR.
Chinese group clearly benefited in China, about 80% of gastric cancer patients were diagnosed with progress phase 3, the prognostic period is not ideal.
although the treatment of advanced stomach cancer, especially late-stage backline treatment, is extremely difficult, effective treatment is very important for a large number of patients.
results from the ATTRACTION-2 study in Taiwan, China, showed that Navuliyu monoantigen could bring significant survival benefits to patients with advanced stomach cancer in China treated with third- and post-line treatment.
reduced the risk of death by 51% in the Navuliyu monoantigroup (HR 0.49 in OS), 20% in 1 year OS, 10% in 2 years, and 0% in the placebo group.
, based on ATTRACTION-2 research data, the results of the Taiwan subgroup OS in the 2 ATTRACTION-2 study were officially approved by China's State Drug Administration (NMPA) in March this year for treatment of two or more systemic treatment options. Patients with advanced or relapsed gastric or gastroesophageal adenocarcinoma became the first immuno-oncology drug approved for advanced gastric cancer treatment in China and the first and so far the only PD-1 inhibitor proven by Phase III.clinical studies to bring significant survival benefits to patients with advanced gastric cancer in China.
Yuan Linglin believes that the ATTRACTION-2 results are a very important result.
this ample evidence-based evidence to make Navuliyu monoantimmune stand out in this update to the guidelines for immunotherapy.
first-line "gastric" to the "gastric cancer direction of exploratory research is emerging, I am personally full of expectations."
that although no guidelines have been written yet, I believe that in the near future, immunotherapy for first-line treatment of stomach cancer is likely to become a reality.
" Professor Yuan Linglin said, "precise screening of patients and immunotherapy are two major directions currently being explored."
" on the one hand, the preferred population is more likely to benefit from immune first-line treatment.
professor Yuan Linglin mentioned that the misalignment of repair defects (dMMR) patients in the treatment of bowel cancer or other tumors, immunotherapy has achieved better results, the immunotherapy of stomach cancer is also of guiding significance.
, patients with EB virus infection may also consider adding immunotherapy to the basis of chemotherapy.
for the remaining HER2-negative or weakly positive patients, immunotherapy patients with higher PD-L1 CPS scores are also expected to come to the fore.
, on the other hand, the exploration of immunotherapy combined chemotherapy has begun to take shape.
IST-4 study of the first-line treatment of gastric cancer by Narvulyu monoantigen chemotherapy is one of them, according to its current Phase II study, the objective mitigation rate (ORR) of the Navuliyu single anti-combination SOX program is 57.1%, the combined CapeOX program is 76.5%, significantly higher than the results of the simple chemotherapy program of about 40%.
the exciting therapeutic advantages of the industry's expectations for its follow-up Phase III results.
unique, the preliminary results of the recent Phase III clinical study CheckMate-649 for first-line treatment of stomach and esophageal cancer have also been released.
Compared with individual chemotherapy, The Phase III clinical study of the first-line therapeutic effect of Navulyu monoantigen chemotherapy for patients with PD-L1 expression-positive i.e. combined positive score (CPS) of 5 was achieved in phase III clinical studies with total end-of-life (OS) and non-progressive survival (PFS).
, this analysis OS is a pre-set interim analysis and PFS is the final analysis.
OS benefits were also observed in all random populations.
this point, Navuliyu monoantigen became the first and current immuno-oncology drug to be clinically positive in combination with chemotherapy for first-line treatment of stomach and esophageal cancer.
believe that in the future, as Professor Yuan Linglin has said, immunotherapy will change the pattern of gastric cancer treatment and bring survival benefits to more patients with advanced stomach cancer.
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