Author: Ma Fei, Department of Internal Medicine Treatment Center, National Cancer Center/Chinese Academy of Medical Sciences
Professor Fei Ma
Nearly 70 breast cancer diagnosis and treatment experts across the country were jointly organized by the Breast Cancer Expert Committee of the National Center for Cancer Quality Control, the Breast Cancer Expert Committee of the Chinese Anti-Cancer Association, and the Clinical Research Expert Committee of Tumor Drugs of the Chinese Anti-Cancer Association to carefully analyze, discuss and summarize according to the progress of breast cancer research at home and abroad and the update of real-world clinical data, update on the basis of the 2018 edition, and formulate the "Guidelines for the Standardized Diagnosis and Treatment of Advanced Breast Cancer in China (2020 Edition)".
The compilation of the guide lasted one year, has been officially released in Beijing on August 15, breast cancer experts from Beijing, Shanghai, Tianjin, Guangzhou and other places also on behalf of the guide writing team also made the first guide presentation, the future guide writing team experts will also through the tour, exchange, guidance, consultation and other forms, jointly promote the implementation of the guideline, jointly promote the process of standardized diagnosis and treatment of advanced breast cancer in China, and help Healthy China 2030.
The official Chinese print version of the guideline will be published in the Chinese Journal of Oncology in October 2020, and only the updated points of this edition of the guide and the 2018 edition will be briefly reported to you.
<h1 class="pgc-h-arrow-right" >01, change the name, add the guide organization</h1>
In order to emphasize the standardization of advanced diagnosis and treatment and increase the binding force of the guidelines, the name was revised from the previous "Expert Consensus on Clinical Diagnosis and Treatment of Advanced Breast Cancer in China" to the "Guidelines for the Standardized Diagnosis and Treatment of Advanced Breast Cancer in China", and the organization was added to the Breast Cancer Expert Committee of the National Center for Cancer Quality Control on the basis of the breast cancer expert committee of the original industry association China Anti-Cancer Association. At the same time, in order to emphasize the vital value of innovative drug research for advanced diagnosis and treatment, the organization has also added the Expert Committee on Clinical Research of Oncology Drugs of the Chinese Anti-Cancer Association.
< h1 class="pgc-h-arrow-right" >02, increasing the definition of advanced breast cancer</h1>
Advanced breast cancer includes locally advanced and recurrent or metastatic (stage IV) breast cancer. Locally advanced breast cancer typically includes radically invasive partial II.B (T3N0M0), stage III.A primary breast cancer, and stage III.B, and stage III .C breast cancer with skin, chest wall, or extensive lymph node involvement in difficult-to-radical surgery. Locally advanced breast cancer in this guideline is only for locally advanced breast cancers that are initially inoperable and have not yet spread to distant distances (stages III.B, III.C).
< h1 class="pgc-h-arrow-right" >03, add the recommended evidence level standard</h1>
To strengthen the normative nature of the guidelines, recommendations with corresponding evidence-based medical evidence (especially first- or second-line treatments) have been added to the corresponding levels of recommended evidence, mainly divided into the following four levels:
IA: evidence from at least one high-quality large randomized, controlled clinical study, or high-quality meta-analysis, with clear clinical benefit and is highly recommended;
IB: Evidence from at least one high-quality, large randomized, controlled clinical study with clinical benefit and recommended first;
IIA: evidence from randomized controlled clinical studies or meta-analyses with limitations, with some clinical benefit, generally recommended;
IIB: evidence from randomized controlled clinical studies or meta-analyses with limitations, limited clinical benefit, can be recommended.
< h1 class= "pgc-h-arrow-right" >04, revise the basic principles of advanced breast cancer treatment</h1>
Based on current advances in molecular detection and targeted drugs, it has been added that for advanced patients "it is recommended to clarify PI3K, PD-L1 and BRCA status to guide treatment when relevant targeted drugs are clinically available" has been added. Revise the "Principles of Treatment for Relatively Limited Locally Recurrent Advanced Breast Cancer": Patients who achieve radical treatment should actively carry out systemic therapy strategies, and the specific regimen can refer to adjuvant or neoadjuvant treatment strategies based on the previous treatment history. In patients who cannot achieve radical treatment, systemic therapy should still be used as the main treatment, and on the basis of systemic therapy, local therapy can be combined with patients who urgently need to relieve symptoms or relieve complications.
< h1 class="pgc-h-arrow-right" >05, refine the treatment principles for patients with locally advanced disease</h1>
This group of patients is divided into patients who may be converted to radical surgery and those who are not able to achieve radical treatment even after evaluation of neoadjuvant therapy, based on the outcome of aggressive systemic therapy. Neoadjuvant therapy strategies should be actively used in patients with locally advanced stages that may translate to radical surgery. Patients who are evaluated for radical treatment even after neoadjuvant therapy are referred to systemic treatment strategies for metastatic breast cancer.
< h1 class="pgc-h-arrow-right" >06, renewal HR-positive HER2-negative advanced breast cancer treatment</h1>
Clarify the order of first- and second-line priority protocols and the specific recommended levels, so that reference doctors can choose a more suitable protocol for patients based on the recommended level and description of research progress. First-line therapy recommends a treatment regimen of CDK4/6 inhibitors plus endocrine drugs. Patients who have progressed after first-line endocrine therapy can choose CDK4/6 inhibitors combined with fulvestrant or aromatase inhibitors based on the progress of targeted therapy for advanced breast cancer in recent years and the availability of drugs in China. As in the past, fulvestrant can also be selected without treatment with fulvestrant. Other treatment options include everolimus plus aromatase inhibitors, everolimus plus tamoxifen, everolimus plus fulvestrant, cedaraniline plus exemestane, tamoxifen, torremifine, aromatase inhibitors, and progesterones.
< h1 class= "pgc-h-arrow-right" >07, renewal HER2-positive treatment of advanced breast cancer</h1>
First-line anti-HER2 treatment regimens are preferred with trastuzumab and paltuzumab plus yew drugs, or in combination with other chemotherapy agents such as capecitabine, gemcitabine, and vinorelbine. The second line has increased the number of new drugs in anti-HER-2 treatment for nearly 2 years, including innovative drugs in China. Pirrolidinib plus capecitabine is the treatment option after failure of trastuzumab therapy. Trastuzumab-metaninconotic therapy may also be available. Other second-line treatment options, expert opinion is that trastuzumab plus another chemotherapy agent can continue; lapatinib plus capecitabine and trastuzumab plus lapatinib dual targeting are optional.
< h1 class ="pgc-h-arrow-right" >08, update the treatment of triple-negative advanced breast cancer</h1>
In the past 2 years, there has been more progress in immunotherapy for triple-negative breast cancer, but there are no indications for the approval of immune checkpoint inhibitors for advanced triple-negative breast cancer in China, and there is currently no high-level recommended immunotherapy program in the guidelines. The platinum-containing combination regimen for first-line treatment of patients with triple-negative advanced breast cancer remains the main recommended regimen.
< h1 class = "pgc-h-arrow-right" >09, renewal of the treatment of hereditary breast cancer</h1>
The poly ADP-ribose polymerase (PARP) inhibitor Olaparib is one of the reasonable choices for patients with brCA germline mutations who have previously received chemotherapy for triple-negative or Luminal (not suitable for further endocrine therapy) advanced breast cancer. Progress in parp inhibitor therapy was also updated.
<h1 class="pgc-h-arrow-right" >10, chemical drug therapy has been updated and refined</h1>
Chemotherapy is still indispensable in the treatment of patients with advanced breast cancer, and there has been no standard treatment plan for advanced chemotherapy. The guidelines are updated here with reference to the Guidelines for rational use of drugs for breast cancer to give common chemotherapy regimens and increase the progress of chemotherapy.
<h1 class="pgc-h-arrow-right" >11, update the transfer stove management</h1>
There is no new progress in local treatment of bone metastases, brain metastases and liver metastases, but in recent years, with the development of new drugs and systemic treatment, the lesions of bone, brain and liver metastasis have also been well controlled. The guidelines cite relevant subgroup data reported in important studies.
<h1 class= "pgc-h-arrow-right" >12, update the treatment of male breast cancer</h1>
The U.S. FDA has approved piperacill in combination with aromatase inhibitors or fulvestrant for treatment, which is mainly based on real-world research data and the efficacy of piperacilly in PALOMA-2, PALOMA-3, suggesting that piperoxil in combination with aromatase inhibitors or fulvestrant can benefit male patients and have a good safety profile. This therapy is an important treatment option for current HR-positive HER2-negative male patients with advanced breast cancer, and requires treatment with a combination of luteinizing hormone-releasing hormone agonists or or orchiectomy.
<h1 class="pgc-h-arrow-right" > the current status of advanced breast cancer</h1>
Breast cancer is the most common malignant tumor in women around the world, with about 304,000 new cases of breast cancer in Chinese women in 2015, and more than 70,000 deaths due to advanced disease progression, and China accounts for the first number of breast cancer deaths in the world.
In each year's new breast cancer cases, about 3% to 10% of patients have distant metastases at the time of diagnosis, about 30% of early patients can develop advanced breast cancer, the 5-year survival rate of advanced patients is only 20%, and the overall median survival time is 2 to 3 years.
Although advanced breast cancer is difficult to cure, it can alleviate the clinical symptoms of patients, improve the quality of life of patients, and further extend the survival time of patients through the development of new treatment drugs and optimization of treatment models, so as to achieve the purpose of long-term survival with tumors.
Advanced breast cancer is more complex in its treatment due to its significant heterogeneity, wide range of metastasis sites, diverse treatment options, and complex disease characteristics, and the lack of standard treatment options after first- and second-line rescue makes it particularly difficult to standardize diagnosis and treatment.
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