Editor's note:
In order to better standardize the clinical rational diagnosis and treatment of HER2-positive breast cancer and achieve "suitable population, reasonable timing, and appropriate plan", the Breast Cancer Expert Committee of the Chinese Society of Clinical Oncology and the Breast Cancer Professional Committee of the Chinese Anti-Cancer Association have updated the "China Guidelines for Targeting HER2 Breast Cancer Diagnosis and Treatment of Targeted HER2 Breast Cancer (2023 Edition)" (hereinafter referred to as the "New Version of Consensus"). It is understood that this new version of the consensus is based on the "HER2-positive Breast Cancer Clinical Diagnosis and Treatment Expert Consensus (2021 Edition)" that absorbs a wider diagnosis and treatment concept and covers more innovative diagnosis and treatment strategies, and is a new life.
In recent years, the research results with the drug pyrrolitinib, independently developed by my country, have been stunningly made at international conferences. One of the highlights of this new version of the consensus is to refer to these medical evidence-based and make relevant clinical guidance suggestions. We specially invited Professor Jiang Zefei, Vice Chairman and Secretary-General of the Chinese Society of Clinical Oncology (CSCO), one of the editors, to introduce the development history of the consensus and the key points of the update of this consensus.
Expert Profile
Jiang Zefei Professor
Beijing Medical Association of Breast Gland Diseases Branch Chairman
Chinese Society of Clinical Oncology (CSCO) Vice Chairman and Secretary General
Chinese Anti-Cancer Association (CACA) Breast Cancer Committee Director-elect Member
Former Chairman of the Breast Cancer Committee of the Chinese Society of Clinical Oncology (CSCO)
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Yimaitong:
Hello Professor Jiang. The CSCO Guide is one of the most authoritative guides in the field of tumor diagnosis and treatment in China, and the "China Guidelines for Targeting HER2 Breast Cancer Diagnosis and Treatment in this CSCO Conference has also attracted much attention. In your opinion, clinicians should How to understand and reasonably apply the two guiding documents: guidelines and consensus?
Professor Jiang Zefei
In recent years, clinical research in the field of breast cancer has achieved fruitful results, and there are countless related evaluation articles. With the continuous improvement of national medical standardization and scientific requirements for clinical decision-making, the importance of guidelines and consensus in clinical practice is becoming increasingly prominent.Clinical Practice Guide is a material formed by balancing the pros and cons of different interventions under sufficient evidence-based medical evidence and accessible products, which can provide patients with the best medical services recommendations. However, the evidence is not sufficient, but clinically In the case of urgent need for reference plans, we can coordinate the views and disputes of relevant experts by formulating consensus to reach general opinions.
It can be seen that the consistency between the guidelines and consensus is that they can provide doctors with standardized clinical decision-making suggestions; but the difference is that the evidence included in the guidelines is higher quality and more guiding, and similar to this new version of the consensus, the opinions in them are generally recognized by experts in relevant fields and are an integration of the experience, suggestions and opinions of authoritative experts.
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Yimaitong:
Please tell me what progress has existed in the treatment strategies of HER2-positive breast cancer at home and abroad? What are the differences?
Professor Jiang Zefei
Recalling in 1998, when China was still in the stage of using chemotherapy drugs to treat HER2-positive breast cancer, it had achieved remarkable results in the field of targeted therapy in the international field. Looking back on the past 20 years, domestic and foreign therapeutic strategies in the field of anti-HER2 have been constantly innovating. From the era of single-target treatment with trastuzumab initially, it has entered the era of dual-target treatment with trastuzumab combined with peduzumab . To this day, a variety of new drugs such as small molecule tyrosine kinase inhibitors (TKI), antibody-conjugated drugs (ADCs), etc. have emerged. The treatment of HER2-positive breast cancer has made progress together; during this period, my country's original innovative products have also made rapid progress.As for the current differences in HER2-positive breast cancer treatment strategies at home and abroad, for example:
internationally tends to use enmetrastuzumab (T-DM1) as an adjuvant treatment for HER2-positive breast cancer patients who have failed to treat trastuzumab;
and the emergence of the domestic small molecule TKI drug pyrrolitinib has given domestic patients a "Chinese standard". Previously, the PHENIX study and the PHOEBE study have demonstrated the advantages of pyrrolitinib in the population of trastuzumab failed in the treatment of trastuzumab; the PHEDRA study has confirmed that the neoadjuvant regimen of pyrrolitinib combined with trastuzumab can bring clear benefits to patients with HER2-positive early breast cancer ; the recent PHILA study has also achieved amazing results, proving that pyrrolitinib combined with trastuzumab and docetaxel can be used as the first-line treatment plan for HER2-positive advanced breast cancer.
The development of domestic anti-HER2 is constantly expanding and has gradually adapted to the international level - changing the original situation of patients "only hearing and not using it" to the current situation of "hearing and being able to use it"; after pyrrotinib was included in medical insurance, domestic patients not only "use it" but also "affordable". China's original research strength has emerged, allowing the world to see "Chinese wisdom".
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Yimaitong:
The PHENIX study you led in 2019 was awarded the report of the ASCO conference and was highly praised by domestic and foreign scholars; a series of studies since then are also considerable. How do you view the value and influence of pyrrolitinib in the field of HER2-positive breast cancer treatment?
Jiang Zefei Professor
The role of the domestic team in previous international clinical research is relatively limited. In the original clinical research of Chinese original drugs such as pyrrolitinib, we have more dominance and can design research plans according to local conditions and timely conditions. The initial design of
PHENIX was in the Tianjin port accident, and the domestic lapatinib storage was insufficient, so it was impossible to use lapatinib to set up a control group. Therefore, , combined with the domestic treatment environment at that time, we chose the treatment plan of pyrrolitinib combined with capecitabine vs capecitabine; and then, considering the treatment interests of the patients, the control group was allowed to use pyrrolitinib single-agent sequential treatment.
was designed in this way: in patients with HER2-positive advanced breast cancer who had received talc and trastuzumab, The treatment of roctinib combined with capecitabine can show excellent objective response rate (ORR) and median progression-free survival (mPFS);
On the other hand, pyrrolitinib was used sequentially after the failure of capecitabine monotherapy, which further confirmed that pyrrolitinib alone has significant anti-tumor effects.
PHENIX study was fortunate to be selected in 2019 due to its results. The oral report of the ASCO International Conference has become the recommended evidence of the "CSCO Breast Cancer Diagnosis and Treatment Guidelines (2020 Edition)" and proves the strong strength contained in China's original research strength. At present, pyrrolitinib has entered medical insurance, which has greatly alleviated the lack of clinical drugs for HER2-positive advanced breast cancer patients in China; and looking around the world, pyrrolitinib will also be expected to enter the international market in the future, allowing more patients to benefit from it.
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Yimaitong:
What significance do you think the excellent performance of pyrrolitinib in PHEDRA research will have in the exploration of the direction of accurate diagnosis and treatment for HER2-positive breast cancer in the future?
Professor Jiang Zefei
pyrrolitinib has shown amazing efficacy in HER2-positive advanced breast cancer, and it continues to make efforts in the field of HER2-positive early breast cancer. PHEDRA research has demonstrated the unique position of pyrrolitinib in the neoadjuvant of HER2-positive breast cancer. The results have an important impact on clinical practice. The new dual-target solution of trastuzumab combined with pyrrolitinib is also expected to serve more Chinese HER2-positive early breast cancer patients, achieving the purpose of controlling tumors, reducing symptoms, prolonging survival, and improving quality of life.
At the same time, we also look forward to more complete and long-term research results in the future. In addition to improving the pCR rate, it can also prolong the disease-free survival of patients and bring hope to patients with HER2-positive early breast cancer.
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Yimaitong : What are the characteristics of this updated version of the consensus? How can China's original research innovation and international progress learn from each other and communicate with each other?
Professor Jiang Zefei
"CSCO The Breast Cancer Diagnosis and Treatment Guide (2021 Edition)" describes the content of low expression of HER2 for the first time. According to the HER2 expression, the patient classification is changed from "two-part method" to "three-part method", namely "HER2 high expression", "HER2 low expression" and "HER2 non-expression". The new version of
consensus is closer to clinical practice, and on the basis of the original version, it emphasizes the importance of standardized HER2 detection and result judgment, and at the same time provides standardized diagnosis and treatment suggestions for "new populations" such as "low expression of HER2", and further promotes the selection of "reasonable opportunity" in "suitable populations" The concept of choosing a "suitable plan"; therefore, the naming of the new version of the consensus was adjusted from the original "HER2-positive Breast Cancer Clinical Diagnosis and Treatment Expert Consensus" to "China Guidelines for Targeting HER2 Breast Cancer Diagnosis and Treatment".
As Chinese doctors, we have the responsibility and obligation to summarize our valuable clinical experience and excellent research data through guidelines and consensus, providing more diagnostic and treatment paths for domestic patients, and singing China's voice on the international stage: Recently, the English version of the new version of the consensus has also been on Translational Breast Cancer Published in the journal Research (TBCR) , it has become the first consensus in the world to include "HER2 low expression" and lead international breast cancer experts to understand new fields together.
On the other hand, in the process of consensus formulation, the expert group also needs to use international guidelines and consensus as reference backgrounds to absorb international cutting-edge progress, be eclectic, learn from strengths and weaknesses, form guiding opinions with Chinese characteristics, and provide appropriate and feasible reference information for clinicians.
With the rapid development of the anti-HER2 field, the prognosis of HER2 positive breast cancer patients has been significantly improved, and the emergence and application of new anti-HER2 drugs such as pyrrolitinib has become It is a powerful weapon for anti-HER2 treatment. The new version of the consensus focuses on clinical evidence-based basis and keeps pace with the times. It further supplements and improves the diagnosis and treatment plans for HER2-positive breast cancer, and contributes the backbone of my country's breast cancer prevention and treatment.
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