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A few days ago, the "Guidelines for the Standardized Diagnosis and Treatment of Advanced Breast Cancer in China (2022 Edition)" (hereinafter referred to as the "Guidelines") jointly compiled by the Breast Cancer Expert Committee of the National Cancer Quality Control Center, the Breast Cancer Professional Committee of the Chinese Anti-Cancer Association, and the Oncology Drug Clinical Research Professional Committee of the Chinese Anti-Cancer Association was released
in Beijing.
The guidelines are upgraded from the 2020 version, and there are many highlights while inheriting, such as the addition of clinical evidence-based evidence of the original domestic innovative product pyrrotinib, and the formulation of recommended diagnosis and treatment paths and treatment plans
that are more suitable for Chinese groups.
We invited Professor Ma Fei, Cancer Hospital of the Chinese Academy of Medical Sciences, as one of the compilers of the guidelines, to introduce
the development history of the guidelines and the highlights of this guideline update.
Hello Professor Ma Fei, it is a pleasure to interview you
.
Could you please introduce the features of the guide, based on the development of the guideline/consensus?
Breast cancer is the most common malignant tumor in women around the world, and advanced breast cancer has seriously affected the life and quality of
life of patients.
In order to change this situation, Chinese experts in the field of breast cancer have formulated the first Expert Consensus on the Diagnosis and Treatment of Advanced Breast Cancer in China (2015 Edition) (ABC-China) since 2014, combining the progress of clinical research and real-world research data at home and abroad, filling the gap
in clinical diagnosis and treatment guidance for advanced breast cancer in China 。 The consensus was updated twice in 2016 and 2018, and in 2020, under the leadership of Academician Xu Binghe and other experts, it underwent a change from a consensus document to an authoritative guidance document that was upgraded to a standard.
This updated version of the guide is adjusted on the basis of the 2020 version, and there are many features in the inheritance:
First, binding force: From the perspective of the organizers, compared with the consensus, the guidelines have a certain administrative binding force, from the original industry society led to the National Cancer Quality Control Center Breast Cancer Expert Committee, the Chinese Anti-Cancer Association Breast Cancer Professional Committee, the Chinese Anti-Cancer Association Oncology Drug Clinical Research Professional Committee;
Second, innovation: the guidelines update the new progress in the treatment of advanced tumors at home and abroad in real time, especially the evidence-based medical evidence for the first- and second-line treatment of advanced breast cancer and the absorption of original domestic research to serve Chinese patients;
Third, standardization: nationwide, the degree of standardization of the diagnosis and treatment of advanced breast cancer needs to be further improved, and the updated version of the guidelines will ensure a high degree of unity with the "Breast Cancer Diagnosis and Treatment Guidelines" and "Breast Cancer Rational Drug Use Guidelines" in terms of evidence recommendation level, clinical guidelines and medical insurance management plans, ensuring the correct understanding and reasonable use of the content by grassroots doctors in the process of using various guidelines
。
What are the recommended treatment options added to this guideline? On what considerations are the expert groups giving such clinical guidance?
A highlight of this updated guideline is the update in terms of recommended levels of diagnosis and treatment recommendations and the grading of evidence-based medical evidence, which are based on evidence aggregation and give concise, clear, and readable practical recommendations, so that clinicians can clearly understand the persuasiveness of evidence-based evidence and the ultimate benefit
of patients under strategic guidance.
In addition, we know that the diagnosis and treatment of advanced cancer patients is urgent, but the accessibility of domestic innovative drugs is not high
.
Based on this actual needs of patients, another highlight of the updated guidelines is the rapid absorption of the latest research data for clinical guidance
.
For example, at the ESMO conference in September this year, Academician Xu Binghe announced for the first time the data of the PHILA study, a large-scale phase III clinical study of China's original innovative drug pyrrotinib; Just over a month later, pyrrotinib (+trastuzumab + docetaxel) was included in this new version of the guidelines as an expert priority for HER2-positive advanced first-line treatment
.
Coincidentally, as early as 2018, pyrrotinib became the first innovative drug in China to be conditionally approved by CFDA for the treatment of solid tumors with its performance in a series of studies, and the "Expert Consensus on Clinical Diagnosis and Treatment of Advanced Breast Cancer in China (2018 Edition)" also followed up in a timely manner, recommending pyrrotinib combined with capecitabine, everolimus combined with trastuzumab and chemotherapy as second-line therapy
。 These initiatives provide new options for clinical diagnosis and treatment, and improve the accessibility of innovative clinical drugs; According to rough statistics, clinical practice can save the lives
of 27,000 more patients with advanced breast cancer every year.
The updated guidelines also use the single-target regimen of pyrrotinib combined with capecitabine as a late-stage first-line recommended regimen, what are the in-depth considerations for making the recommendation of such single-target regimens?
The single-target regimen of pyrrotinib plus capecitabine was included in the guidelines for two reasons:
On the one hand, through real-world research in China, we found that for HER2-positive patients, there is a certain gap between the current clinical practice and guideline recommendations, such as limited by local conditions, patients still receive single-target therapy strategies, and even patients in some areas have not been exposed to targeted drugs, which is different
from the international perception of tropa dual target as the standard treatment plan.
Compared with dual-target therapy regimens that can produce more clinical benefits, single-target therapy still needs to refer to evidence-based medical evidence to give more objective and standardized guidance in practical work
.
On the other hand, the results of PHOEBE studies also showed that pyrrotinib + capecitabine can also significantly prolong PFS (12.
5 vs.
6.
8 months)
compared with lapatinib + capecitabine.
Therefore, for the common trastuzumab primary resistance encountered clinically, when using second-line regimens for first-line rescue, the recommended option
of giving pyrrotinib in combination with chemotherapy can also be considered.
We understand that more and more Chinese independent original research and innovative products occupy an important recommended position in Chinese guidelines, which is obviously different from international guidelines, how do you think China's primary doctors should more rationally understand and use Chinese guidelines and international guidelines?
In recent years, original research and innovative research in China's pharmaceutical field have sprung up, and China's independently developed original innovative drugs have also been at the forefront
of the world.
In fact, the continuous acceleration of innovation and development of the pharmaceutical industry in China can not only quickly meet unmet clinical needs, but also have the opportunity to create products
that are more suitable for the disease characteristics and epidemiological trends of Chinese patients 。 In this process, Chinese medical scientists are bound to accumulate valuable clinical experience, and Chinese guidelines are to summarize these valuable experiences to guide clinical trials quickly, scientifically and reasonably, and bring more clinical benefits to patients, while international guidelines are relatively slow to absorb evidence; More importantly, the Chinese guidelines take into account China's drug accessibility, pharmacoeconomics and other issues, so they have more Chinese characteristics
than international guidelines.
However, in the process of formulating Chinese guidelines, the expert group also needs to use international guidelines as a reference background and draw on the evidence-based evidence of international guidelines, so there is no contradiction between the two, but an inclusive and complementary relationship
.
Expert profiles
Professor Ma Fei
National Cancer Center/Cancer Hospital of Chinese Academy of Medical Sciences
Director of the Internal Medicine Treatment Center, chief physician, doctoral supervisor
"Changjiang Scholar" Distinguished Professor of the Ministry of Education
Tenured Professor, Peking Union Medical College / Chinese Academy of Medical Sciences
Chief Scientist of the National Key R&D Program
National Natural Science Foundation of China Key Project Leader
Editor-in-Chief of Cancer Innovation, Associate Editor of Chinese Journal of Medical Frontiers
Vice Chairman and Secretary-General of the Breast Cancer Committee of the National Cancer Quality Control Center
Secretary-General of China Breast Cancer Screening and Early Diagnosis and Early Treatment Standardization Committee
Secretary-General of the National Antitumor Drug Clinical Application Monitoring Committee
Vice Chairman of the Integrated Oncology and Cardiology Branch of the Chinese Anti-Cancer Association
Secretary General of the Oncology Drug Clinical Research Committee of the Chinese Anti-Cancer Association
Vice Chairman of the Oncology Specialist Pharmacist Branch of the Chinese Pharmacists Association
Editor: DKK
Review: DKK
Typesetting: Youshi
Execution: Uni
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