He Liping, chief reporter of The Paper
"The premise of precision medicine is precision detection, before we reached some standardized consensus on second-generation sequencing (NGS), but how to interpret this report, domestic has not yet formed a unified standard." At the "Consensus on the Interpretation of Clinical Reports on Second Generation Of Tumor Sequencing" and the Second NGS National Research Project Press Conference held on April 8, Professor Wu Yilong, chairman of the Cancer Biomarker Expert Committee of the Chinese Society of Clinical Oncology (CSCO) and Guangdong Provincial People's Hospital, talked about one of the current bottlenecks in the development of precision medicine oncology.
The Consensus on the Interpretation of Clinical Reports on Second-Generation Sequencing of Tumors (hereinafter referred to as the "Consensus"), written by the CSCO Expert Committee on Tumor Biomarkers, will be officially released in the near future, and in 2021, the CSCO Expert Committee on Tumor Biomarkers organized and published the Guidelines for the Interpretation of Clinical Reports for Second-Generation Sequencing (hereinafter referred to as the "Guidelines"). Wu Yilong said that the latest Consensus is actually a further update and improvement of the Guidelines, "I hope that the promulgation of the Consensus can guide China to embark on a new path of precision medicine." ”
In fact, prior to the release of the Guidelines, the CSCO Expert Committee on Tumor Biomarkers also co-sponsored China's first large-scale study of tumor NGS. Professor Zhang Xuchao, the writing team leader of consensus and director of the Guangdong Lung Cancer Research Institute, said in an interview with the surging news (www.thepaper.cn) reporter, "In the past few years, especially in large top three hospitals, the understanding and application of NGS by oncology clinicians has indeed undergone great changes. ”
Zhang Xuchao said that many doctors have slowly become experts from not knowing what the content of NGS testing is. Previous large-scale research on tumor NGS shows that NGS has become a common detection tool for Chinese clinical oncologists, "more than 30% of oncologists have more than 5 NGS tests per month, which shows that NGS has become a part of clinical practice, and the amount of detection will be larger and larger in the future." But at the same time, the problem is that "more than 90% of clinicians in China need support in interpreting NGS reports." ”
The above situation also exists in developed countries in Europe and the United States. Zhang Xuchao mentioned that the data of the United States in the same period also shows that "about 51% of doctors also need support for the interpretation of NGS reports." Zhang Xuchao believes that today's medical sub-disciplines are becoming more and more detailed, so professional talents are needed to serve other professions. He repeatedly stressed, "NGS is not a simple biochemical test, it is a systematic tool, and its report covers a lot of clinical tumor and gene mutation related knowledge, so the interpretation support in this area is relatively large." ”
Based on the above status quo, the CSCO Expert Committee on Tumor Biomarkers has once again iteratively upgraded the Guidelines to the Consensus, aiming to further standardize the interpretation methods of NGS reports and improve the ability of clinical experts to interpret reports. According to reports, the Consensus regulates the interpretation of NGS clinical reports from three aspects: annotation and interpretation of somatic cell variations related to clinical targets or driving genes, interpretation of NGS reports, clinical decision-making, and reportable scope and quality control.
It is worth noting that with the continuous listing of targeted drugs and the continuous advancement of NGS detection technology, the use of DNA detection alone can no longer meet all clinical needs, and the Consensus has increased the recommendation of RNA sequencing, and included the clinical interpretation of mutations such as fusion variants and exon skipping, providing interpretation guidance for complex variant forms and helping clinical precision diagnosis and treatment.
In addition, closely following the clinical hotspot applications, the Consensus has added related interpretations such as homologous recombinant defects (HRD) and tiny residual lesions (MRD) to better cover the test content that can benefit patients.
For example, Zhang Xuchao said that the NGS report is a thick little book, "For clinicians, how to know whether the NGS test report is reliable in a short period of time, and how to quickly obtain the most critical information in the complicated content, it seems that everyone is most concerned about one of the issues." Secondly, whether the information obtained from the NGS report can be used in clinical practice is also a more questionable part of everyone. ”
In clinical practice, doctors may have to look at dozens of patients and dozens of NGS reports in a morning, "We just look at a report and carefully interpret it for a long time." Zhang Xuchao further said, "The original intention of our formulation of the NGS report is to help doctors quickly help clinicians sort out the logic of NGS report interpretation, quickly grasp key information, and help doctors implement NGS into clinical precision diagnosis and treatment more standardized, benefiting patients." ”
He told the surging news reporter that in recent years, clinical oncologists are also gradually changing, "the main key points of the change include that the factors considered by doctors are that the first technology is unreliable, and this aspect is now more concerned; it also pays attention to some of the specific parameters, such as how many genetic tests are there, how much sequencing depth, how much DNA is initially invested, and even how much the pathological tumor cell content is, the oncologist will go to see. Because he knows these are the key factors for them. "In general, clinicians in large hospitals in particular are becoming more and more aware of NGS.
On the other hand, "most of the hospital's NGS tests were originally delivered, and now many hospitals have their own platforms and teams doing NGS tests." Zhang Xuchao believes that this is a good phenomenon. The improvement of NGS capabilities in the hospital also reflects the close integration of this system tool and the clinical team. "It's very important to really integrate NGS platform testing into clinical practice and integrate it with other clinical oncology disciplines."
In addition, it is worth noting that the initial clinical application of NGS lies in the targeted diagnosis of patients with advanced tumors, and has basically covered the whole process of tumor management.
Han Yusheng, founder and CEO of Stone Burning Medicine, told the media including the surging news (www.thepaper.cn) reporter that NGS has expanded from the initial tissue-based companion diagnosis to blood-based companion diagnosis, and then to MRD and early screening and early examination, "These technologies have made rapid progress in the past few years." "The current status quo is that "NGS is relatively mature in concomitant diagnosis, and in first-tier and second-tier cities, everyone has seen more." Like MRD and early screening and early inspection, in fact, it is still in the relatively early commercialization period. ”
The so-called MRD refers to tiny residual lesions. Zhang Xuchao explained that when all imaging tools do not see that there are tumor lesions in the patient, in fact, there are a small number of tumor cells in the patient's circulating blood or tissue, "The new molecular level technology can be detected, and we detect this disease state called MRD." He mentioned that there are many technologies to analyze the existence of MRD, and one of the important technologies is the second-generation sequencing technology based on blood DNA.
For the role of MRD, Zhang Xuchao said, "In fact, it helps us to judge early in the patient population for the purpose of radical surgery that some patients may have relapse, and the early warning of this recurrence helps us to choose early intervention clinically, and it is possible to better improve the prognosis of patients." Of course, for this technology, which is very hot at home and abroad, Zhang Xuchao reminded, "You can't just apply MRD to a patient after surgery, we have to consider that MRD must bring clinical benefits to patients, which is why MRD is not applied to the clinic on a large scale, and more is in the process of clinical research." ”
Han Yusheng believes that NGS will also play a greater role in the early stages of patient life in the future, "Precision medicine is moving from advanced patients to early patients, and MRD can also help more early patients." Through the early detection of tumors, coupled with the two weapons of MRD, we hope to enable more tumor patients to be detected at an early stage and receive more accurate treatment, thereby extending the five-year survival rate." ”
Editor-in-Charge: Li Yuequn Photo Editor: Jiang Lidong