Professor Shen Lin: CSCO gastrointestinal mesoma diagnosis guidelines issued, based on genotype recommended treatment options.

Recently, the 2020 edition of the Chinese Society of Clinical Oncology (CSCO) Gastroenteromema Diagnosis and Treatment Guide" was released, which is the first gastrointestinal mesoma (GIST) guide prepared by the CSCO Gastroenterometomas Specialist Committee, which is of great significance and value for guiding and standardizing the clinical practice of GIST in China.
it is worth noting that this edition of the CSCO Gastroenteromelioma Diagnosis And Treatment Guidelines, based on the follow-up drug recommendations based on the number of treatment lines, recommendpatients with first-line treatment according to the genotyt sub-section, choose more accurate targeted treatment: if carrying PDGFRA exon 18 mutation, especially D842V mutation patients, recommended apostinib treatment.
Shen Lin, Director physician, professor, doctoral tutor, 2019 Beijing scholar, vice president of Beijing Cancer Hospital, deputy director of Beijing Cancer Prevention and Control Institute, director of digestive oncology surgery, director of phase I clinical trial ward, Asian gastric cancer diagnosis and treatment guide China drafter, National Health and Health Commission gastric cancer / colorectal cancer treatment standards, the secretary-general of the Chinese Association of Cancer Association Members, China Anti-Cancer Association Cancer Drug Clinical Research Professional Committee, and other positions, as the Ministry of Science and Technology national key research and development program "gastric cancer targeted treatment of new technology research" project chief expert, undertake national or provincial-level topics nearly 10, international cooperation and horizontal topics more than 30, published more than 120 SCI papers, won the second prize of national scientific and technological progress, the Ministry of Education science and technology progress first prize, The first prize of Chinese medical science and technology award, china medical science and technology award first/ second prize, in 2016 was praised as the national outstanding science and technology workers.
CSCO first launched the GIST clinical consultation guide, for China's GIST diagnosis and treatment to provide an authoritative basis in recent years, with the development of new drugs and the renewal of treatment concepts, GIST treatment model has undergone great changes, especially in patients with advanced GIST, has been approved a number of TKI drugs, providing a new treatment option for prolonging the survival of patients.
in order to better guide the clinical standardization of giST diagnosis and treatment in China, CSCO Gastroenteromelioma Expert Committee based on the general guidelines on solid tumor diagnosis and treatment guidelines, combined with the latest research progress at home and abroad in the field of GIST and the status quo of China's diagnosis and treatment, by the CSCO Gastroenteromelioma Committee, including oncology surgery, oncology, imaging diagnostics, pathology, digestive surgery and other disciplines of experts jointly formulated this version of the "CSCO gastroenteroplasma diagnosis and treatment."
this is the first time that the CSCO Clinical Guidelines system has published guidelines for GIST, and it shows the importance Chinese researchers attach to GIST, a small tumor species.
the publication of the guidelines is significant, so that China's GIST patients clinical treatment can be justified.
recommending more accurate treatment of GIST for patients based on genotyts is a relatively clear disease caused by the driver's mutation.
study found that more than 80% of GIST patients had the kit gene progenitor mutation, the most common mutation occurred in the KIT gene No. 11 exon (70% of cases), followed by the 9th exon (10% to 15%).
in addition to the KIT gene, the PDGFRA gene mutation is also one of the drivers of GIST.
is one of the pioneers in the development of precision tumor therapy, and the first to be used in GIST treatment is imatinib, which led to a major change in advanced GIST therapy and was the first time that targeted therapy has been successful in patients with solid tumors.
Although the target treatment of GIST has a long history, but in the past 20 years, regarding the treatment of late-stage GIST, Chinese and Western clinical practice is based on the treatment line number rather than the gene type selection of drug model: the first-line standard treatment for imatinib, the second line for shonetini, the third line for rigofenib.
, while more than 80% of GIST patients benefit from imatinib monodrug treatment, some patients are still resistant to imatinib.
patients with a 18 D842V mutation such as PDGFRA exon 18 D842V received imatinib and other targeted drugs available at 0, and the birth of Apertinib brought about a turning point for such patients.
aperinib is an oral, potent, highly selective Type I KIT and PDGFRA activated ring mutant inhibitor that inhibits the activity of KIT D816V and PDGFRA D842V kinase much higher than the type II inhibitors Imatinib, shonetinib and rigofin.
follow-up clinical study OF NAVIGATOR further confirmed the great potential of apothinib for PDGFRA D842V mutation patients.
the "CSCO Gastroenteromelioma Diagnosis and Treatment Guide" this time, not only follow the past according to the number of treatment lines of drug recommendations model, but also in the first-line treatment choice, according to the patient's genotype, the patient type segmentation, accurate recommendation of targeted treatment.
for patients with unidentified genotys, Grade I is recommended as Imatinib 400mg/d (1A evidence).
for patients with specific genotypes, they are accurately recommended according to the genotyt: for patients with KIT exon 9 mutations, i-grade recommended high doses of imatinib (1A evidence); Except for the GENE type other than the KIT exon 9 mutation and the PDGFRA D842V mutation, I grade recommended imartinib 400mg/d (1A evidence);
guidelines recommend the basis: Aperitinib used in PDGFRA exoon 18 mutation patients significant efficacy this Apertinib into the treatment recommendation, is based on a poatinib open, dose increment / dose expansion I. phase study NAVIGATOR study.
study edited 43 patients with PDGFRA exon 18 mutations, with a starting dose of 300/400 mg/d using Aperitinib.
results showed that in patients with PDGFRA exon 18 mutations, the objective remission rate (ORR) of aperinib therapy was as high as 86% and the clinical benefit rate (CBR) was as high as 95.3%. In addition, patients who were effective after treatment with aperitinib
observed lasting efficacy.
to data deadline November 16, 2018, when the median follow-up time was 10.9 months, 78% of PDGFRA exosome 18 mutationpatients continued to remission.
the study further analyzed according to the number of patients' treatment lines, Apothinib showed good efficacy in the first and after-line treatment of patients with PDGFRA exoon 18 mutation.
the ORR for first-line treatment of GIST patients is 100%, and the ORR for second-line and above treatment is more than 80%.
aperinib showed significant activity in giST patients with any type of PDGFRA exon 18 mutation, including the D842V mutation.
recently, NAVIGATOR research published data on patients with PDGFRA D842V mutations in Lancet Oncology: Aperitinib had a higher ORR of 88% among these patients, with a total remission (CR) rate of 9%, partial remission (PR) rate of 79%, one-year progression survival (PFS) rate 81% and 2-year total survival (OS) rate of 81%.
based on the results of the NAVIGATOR study, on January 9, 2020, the U.S. Food and Drug Administration (FDA) approved Aperinib for non-removable or metastatic GIST patients with PDGFRA exosome 18 mutations, including the D842 mutation, the first FDA-approved GIST-targeted treatment drug based on the driving gene.
it shows that for patients with metastatic GIST with PDGFRA exome 18 mutations, apothinib has the potential for full-line treatment.
at the same time, Apothinib for treatment of four lines and above in advanced GIST patients (regardless of genotype), also showed considerable clinical activity and good tolerance, the extended queue of the study included 111 patients with four-line or above treatment, ORR reached 22%, median PFS is 3.7 months, so in this version of the guidelines, Apothinib is also recommended as a treatment option for the failure of third-line treatment in patients with metastasis GIST (Table 3).
summary and prospect with the popularization and application of genetic testing, the treatment based on molecular type-type will be the trend of GIST treatment.
patients with PDGFRA D842V mutation sjiST, all of which are primary resistant to other existing molecular-targeted drugs.
apothinib is currently the only targeted drug that is effective in this class of patients, and the effect is very good.
, the ORR was as high as 86% in patients with PDGFRA exnomer18 mutation, and in patients with D842 mutations, the ORR was higher, at 88%, and the D842 mutation was the most common type of PDGFRA exon 18 mutation.
this time, Apothinib has written CSCO guidelines to provide patients in China with an efficient treatment option.
hopes that in the future, Aperinib will be able to explore more in assistive and new adjuvant therapy in patients with PDGFRA exosome 18 D842V mutations, filling gaps in the field of assisted and new adjuvant therapy for such patients.
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