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This article takes you into the 2024 CSCO Guide
Written by | Pu Yue
From April 26 to 27, 2024, at the Chinese Society of Clinical Oncology (CSCO) guidelines meeting held in Jinan, experts and scholars in the field of oncology from all over the country gathered together to discuss the "CSCO Breast Cancer Diagnosis and Treatment Guidelines 2024 Edition" (hereinafter referred to as the "Guidelines").
After the meeting, in order to allow more oncology colleagues who were unable to attend the conference to share the essence of the conference, the medical community's "Author Says" column also had the honor to invite Professor Zhang Jian from Fudan University Cancer Hospital and Professor Wang Kun from Guangdong Provincial People's Hospital to conduct detailed interviews on the updated points in the 2024 version of the Guidelines.
Current status of breast cancer diagnosis and treatment and the characteristics of the Guidelines
Breast cancer is one of the most common malignant tumors in women, and in the advanced stage, due to distant metastasis of cancer cells, multi-organ lesions often appear, which directly threatens the lives of patients.
The number of new cases of breast cancer in mainland China has reached 420,000 and is increasing year by year. There are undoubtedly serious challenges in the diagnosis and treatment of breast cancer.
Talking about the current status of breast cancer diagnosis and treatment in mainland China, Professor Zhang Jian said: "The incidence of breast cancer in mainland China has its important characteristics, that is, the age of onset is early, and most patients have premenopausal onset. Vertically, thanks to the inclusiveness of relevant policies, the continuous updating of relevant diagnosis and treatment guidelines, and the joint efforts of doctors and patients to fully popularize 'early diagnosis and early treatment', the radical breast cancer cure rate of the overall population is getting higher and higher. In addition, with the popularization of new treatment strategies and methods, the updating of neoadjuvant concepts, and the addition of more and more new drugs with sufficient evidence-based medical evidence, the survival rate of patients with advanced breast cancer has also been greatly improved, and there is even a potential cure. At present, the overall treatment level of breast cancer in China has been comparable to that of Europe and the United States, and it is expected that China's original clinical studies will be recommended by guidelines in the future, which will eventually bring new opportunities for more patients to benefit. ”
At the same time, compared with foreign guidelines, Professor Zhang Jian also summarized the characteristics of the Guidelines:
- Chinese characteristics: It has been six years since the first edition of the CSCO Breast Cancer Diagnosis and Treatment Guidelines was released in 2017, and in this process, the expert group has learned from the authoritative guidelines in Europe and the United States, and has also incorporated Chinese wisdom and innovation based on the actual situation in China, reflecting Chinese characteristics.
- Practical pocket book: According to the specific situation, different auxiliary treatment plans are recommended, and they are presented in the form of a table, so that practitioners can easily adopt and refer to them in the actual work process. Published in the form of a pocket book, it is very popular among experts working at the grassroots level.
- Coexistence of advancement and accessibility: The CSCO guidelines insist on formulating diagnosis and treatment recommendations based on the latest evidence-based medical evidence, and also incorporate the views of experts and scholars, and have corresponding considerations in the corresponding recommendation level, while also taking into account the availability of therapeutic drugs in China, and make corresponding adjustments to treatment options that lack availability. If the clinical data of the drug has been reported in an authoritative academic conference but has not yet been approved in China, the CSCO guidelines will be elaborated in the form of text, so that experts and patients can easily understand and adopt.
- Localization: The CSCO Guidelines panel also pays special attention to local research in China. Professor Zhang Jian mentioned that a phase III TORCHLIGHT clinical study led by Professor Jiang Zefei's team from the Chinese People's Liberation Army General Hospital explored the efficacy and safety of toripalimab combined with nab-paclitaxel (nab-P) in the first-line treatment of metastatic or recurrent triple-negative breast cancer (TNBC), and the new indication of toripalimab combined with nab-P for the treatment of PD-L1-positive (CPS≥1) metastatic or recurrent metastatic TNBC is also expected to be approved this year. At the same time, when there is no approved drug for advanced TNBC, the data of domestic clinical studies are particularly valuable, so that it can be reasonably applied within a certain range of conditions.
Highlights of the Guide
At present, the CSCO guidelines are updated once a year, and the guidelines will be held every year to give lectures to experts and scholars from all over the world. Professor Zhang Jian also introduced and shared his views on the update of the Guidelines in 2024:
- First, for HER2-positive early-stage breast cancer, the recommendation level of the four-cycle regimen of traspa dual-target plus taxane (THP) was reduced, but based on the excellent results of the PHILA trial, trastuzumab plus pyrotinib and taxane (TH + pyrotinib) was adjusted to the level I recommendation, and the evidence category was 1A. Due to the improvement of drug accessibility in China, the new ADC drug T-DXd has become an important choice for patients who have failed trastuzumab treatment, after capecitabine + pyrotinib, making it break T-DM1 and become the only ADC drug recommended for the second-line treatment of HER2-positive advanced breast cancer (evidence category 1A).
- Secondly, for hormone receptor (HR)-positive breast cancer, the new version of the guideline update mainly focuses on the combination therapy of CDK4/6 inhibitors. The level I recommendation in each stratum basically includes all CDK4/6 inhibitors, and no longer makes separate drug distinctions, and this update is mainly based on a series of clinical study data of the four CDK4/6 inhibitors, such as the advantages of the MONALEESA, MONARCH, PALOMA, DAWNA studies. In addition, although there are differences in the level of evidence between different CDK4/6 inhibitor combinations, and there is no significant difference in treatment effect between them, the same level of recommendation is given, which also provides more practical guidance for clinicians in the actual diagnosis and treatment process.
- At the same time, for TNBC patients, the biggest highlight is that the independent opening of immunotherapy chapter, TP-AC sequential therapy combined with immunotherapy has a significant effect on early patients, and immunotherapy combined with chemotherapy has also significantly prolonged the survival of advanced TNBC patients.
- Finally, this update of the Guidelines also pays attention to the identification of HER2-low expression populations, and elaborates HER2 low expression as a separate chapter, which further highlights the therapeutic status of T-DXd in HER2-low advanced breast cancer.
In response to the blockbuster update in the field of neoadjuvant therapy in the Guidelines, Professor Wang Kun brought a more detailed explanation:
- The guidelines emphasise the importance of using a 6-cycle THP (docetaxel + trastuzumab + pertuzumab) regimen (level I recommendation, category 2A evidence). Based on the NeoSphere and PHEDRA studies, dual-target therapy has become an available option, and single-target combination regimens are no longer recommended. The new version of the guidelines recommends that all 6 cycles of THP be completed in the neoadjuvant phase, and is also listed as a Level I recommendation for patients who cannot tolerate TCHP or who are medically ill.
- Secondly, the new version of the guidelines emphasizes that the use of subcutaneous preparations can replace traditional intravenous injections, especially trastuzumab or pertuzumab can use the same biologics or subcutaneous preparations that have been marketed in China.
- For TNBC, neoadjuvant chemotherapy plus immunotherapy has a wider range of applications and is becoming more and more important. One is the classic TP-AC plus pembrolizumab (1A), from the KEYNOTE-522 study. The other category is TP+PD-1 inhibitors (1A), which are derived from the cTRIO study.
- For HR-positive and HER2-negative breast cancer, neoadjuvant endocrine therapy includes a new population, i.e., HR-positive breast cancer patients who are not sensitive to neoadjuvant chemotherapy, in addition to traditional patients who cannot tolerate chemotherapy or are temporarily inoperable. These patients can be treated with neoadjuvant aromatase inhibitors (AI) or AI in combination with CDK4/6 inhibitors. It should be noted that based on the data of two studies, MonarchE and NATALEE, for patients with intermediate- or high-risk HR-positive breast cancer, the addition of CDK4/6 inhibitors to traditional endocrine therapy can further reduce the risk of recurrence and metastasis, and the risk of both can be reduced by about 25%. Therefore, neoadjuvant endocrine therapy in combination with CDK4/6 inhibitors may be considered in the neoadjuvant therapy phase for this group of patients.
Neoadjuvant therapy for breast cancer: hot spots and challenges
Neoadjuvant therapy is currently an important treatment strategy for HER2-positive or locally advanced TNBC, and its efficacy in improving disease remission and tumor regression in patients has been clinically recognized. After neoadjuvant therapy, patients undergo pathological evaluation by surgical resection, and the prognosis of patients who achieve pathologic complete response (pCR) is generally better, while patients who do not achieve pCR require intensive therapy in subsequent adjuvant therapy.
In view of the current hotspots and future exploration directions of neoadjuvant therapy for breast cancer, Professor Wang Kun shared: "At present, the pCR rate of patients with HER2-positive or locally advanced TNBC under neoadjuvant therapy can reach about 65%, which means that these two types of breast cancer patients can benefit more and more from neoadjuvant therapy. The difficulty of the current treatment strategy lies in how to reduce the toxic side effects of drugs and reduce the adverse reactions of patients on the premise of ensuring efficacy, and at the same time allow patients to achieve the same effect in a more comfortable situation by using more precise targeted therapy, reducing chemotherapy or using simpler targeted therapy such as subcutaneous preparations, which are the future development directions.
For TNBC patients, the classical neoadjuvant regimen is 4 cycles of chemotherapy combined with immunotherapy, so whether the same effect can be achieved with only 2 cycles of chemotherapy combined with immunotherapy in the future is also a direction that can be explored.
After neoadjuvant therapy, patients underwent pathological evaluation by surgical resection, and the prognosis of patients who achieved pCR was generally better, which could achieve downstaging, reduce patients' adverse reactions, and improve efficacy. For patients who do not reach pCR, they will be treated with an upgraded stage and given new targeted therapy or new drugs to achieve the purpose of improving the efficacy, which are also the two major directions of exploration in the future. ”
The 2024 CSCO guidelines have come to an end, but the development of cancer diagnosis and treatment in mainland China will always be on the way. The medical community will also work together with colleagues to devote themselves to the development and progress of medicine and witness the broad future of cancer treatment in China.
Expert Profile
Prof. Jian Zhang
- Chief physician of the Department of Medical Oncology of Fudan University Affiliated Hospital, Ph.D. supervisor, and medical director of Phase I Clinical Research Ward
- Director of the Clinical Research Center of Fujian Hospital, Fudan University Cancer Hospital, and Executive Deputy Director of the Department of Medical Oncology
- Chairman of the Cancer Prevention and Clinical Research Committee of the Chinese Geriatric Health Care Association
- Chairman of YBCSG, Yangtze River Academic Belt Breast Alliance
- He is the chairman-elect of the Oncology Drug Clinical Research Committee of Shanghai Anti-Cancer Association
- Member of the Standing Committee of the Breast Cancer Professional Committee of the Chinese Anti-Cancer Association
- Deputy Convener of the Youth Committee of the Breast Cancer Professional Committee of the Chinese Anti-Cancer Association
- Vice Chairman of the Youth Committee of the Breast Professional Committee of the Chinese Research Hospital Association
- Vice Chairman of the Oncology and Cardiology Committee of Shanghai Anti-Cancer Association
- Member of the Standing Committee of the CSCO Expert Committee on Tumor Support and Rehabilitation
- Member of the Standing Committee of the Cancer Rehabilitation Professional Committee of the Chinese Association of Rehabilitation Medicine
- Member of the Standing Committee of the CSCO Youth Expert Committee
- Member of the CSCO Breast Cancer Expert Committee
- He is a member of the Cancer Clinical Research Management Committee of the Chinese Anti-Cancer Association
- Winner of Shanghai "Medical Garden Rising Star" Outstanding Young Talent
- The first batch of part-time reviewers of chemical drugs clinical in the CDE of the International Food and Drug Administration
- He won the 2023 Top Ten Medical Pioneer Experts and the 2023 "People's Good Doctor" Outstanding Contribution Award
Expert Profile
Prof. Kun Wang
- Vice President of Cancer Hospital of Guangdong Provincial People's Hospital
- Doctoral supervisor
- Director of CSCO, member of the Standing Committee of the Breast Cancer Committee
- 2019 National Famous Doctor Awardee
- In 2021, the NeoCART study was selected into the NCNN breast cancer guidelines in the United States
- Winner of the 2023 People's Good Doctor - Contact Contribution Award in the Field of Breast Cancer
Exciting information is waiting for you
Editor in charge: Sheep
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