Editorial Note: Quality control has become an increasingly critical focus in breast cancer diagnosis and treatment. As China enhances its cancer prevention and control framework, the standardization of breast cancer care is receiving growing attention. At the 2024 Conference on Standardized Diagnosis and Quality Control in Breast Cancer, Dr. Jin Yang from The First Affiliated Hospital Xi'an Jiao Tong University presented a comprehensive report titled Quality Control in Breast Cancer Care and National Performance Indicators. In an exclusive interview with Oncology Frontier, Professor Yang provided in-depth insights into the content, significance, and implementation challenges of these quality control measures, illuminating the path forward for breast cancer diagnosis and treatment in China.

Oncology Frontier: During the conference, you presented on “Quality Control in Breast Cancer Care and National Performance Indicators.” Could you outline the key components of these indicators and their role in enhancing standardized breast cancer care in China?

Dr. Jin Yang: Breast cancer was the first cancer type to initiate quality control as a single-disease program in China. Under the leadership of Academician Binghe Xu and Professor Fei Ma, the National Cancer Quality Control Center’s Breast Cancer Expert Committee released the 2022 Guidelines for Standardized Diagnosis and Quality Control in Breast Cancer. This system included 20 quality control indicators and four quality management metrics, covering every aspect of breast cancer care, including diagnosis, surgery, medical therapy, radiation therapy, and multidisciplinary team (MDT) management. These indicators became the foundation for evaluating hospitals designated as pilot units for breast cancer quality control.

In March 2023, the National Health Commission (NHC) refined these indicators, identifying the 12 most critical metrics for inclusion in the 2023 Oncology Specialty Quality Control Indicators. By 2024, the NHC further emphasized six key indicators in the National Tertiary Public Hospital Performance Assessment Manual (2024 Edition), five of which are specific to breast cancer. These include:

• Pre-Treatment Clinical Staging Assessment Rate: Ensuring that all patients undergo TNM staging before their first treatment.
• Pathological Diagnosis Before Non-Surgical Treatment: Confirming accurate diagnosis before initiating systemic therapies.
• Post-Surgical Pathological TNM Staging Rate: A crucial metric for guiding further treatment decisions.
• Pre-Targeted/Immunotherapy Molecular Testing Rate: Ensuring all patients receive molecular diagnostics before starting targeted or immune therapies.
• Intraoperative Lymph Node Dissection Compliance Rate: Guaranteeing thorough lymph node management during surgery.

The evolution of these indicators from 24 metrics in 2022 to 12 in 2023, and now to six national-level performance metrics in 2024, underscores the growing emphasis on quality control in breast cancer care. These metrics are no longer limited to expert committees but have been incorporated into the national public hospital performance evaluation framework, reflecting their critical role in shaping the future of breast cancer care in China.

Oncology Frontier: One key metric is the “Pre-Targeted/Immunotherapy Molecular Testing Rate.” Why is molecular testing so critical for targeted and immunotherapy? How would you assess the current state of pathology and genetic testing for breast cancer in China?

Dr. Jin Yang: Modern oncology has entered the era of personalized and precision medicine, and breast cancer has led the way in applying molecular subtyping to individualize treatment strategies. HER2-positive breast cancer, for example, requires comprehensive HER2-targeted therapy, while triple-negative breast cancer (TNBC) patients may benefit from immunotherapy during neoadjuvant or advanced-stage treatments.

Emerging areas such as HER2-low expression, PI3K/AKT, and ESR1 pathway mutations are also gaining attention, guided by evidence-based medicine to explore more effective, less toxic therapeutic options. Accurate molecular testing is the cornerstone of these advancements, enabling the identification of specific patient subgroups that can benefit most from targeted or immunotherapies.

At this conference, Dr. Wenjing Yang from the Cancer Hospital of the Chinese Academy of Medical Sciences presented data demonstrating China’s leading position in pathology and targeted therapy standardization for breast cancer, with detection rates among the highest globally. HER2 amplification testing, for instance, is mandatory before initiating treatments like monoclonal antibodies, small-molecule TKIs, or ADCs. With the advent of HER2-low subgroups and new evidence such as the DB-06 trial results, pathologists face higher demands to refine testing methods. Clinicians rely on precise detection to tailor therapies effectively.

Similarly, immunotherapy has entered breast cancer clinical practice, particularly for PD-L1-positive TNBC patients, where evidence supports immunotherapy combined with chemotherapy in early and advanced settings. Standardized PD-L1 testing is now essential for TNBC patients. Additionally, genomic tests like PAM pathway analysis and ESR1 mutation detection are becoming critical for patients resistant to CDK4/6 inhibitors or post-surgical endocrine therapies.

The continued implementation of quality control measures and standardized testing across regions will further enhance treatment precision and promote equitable access to advanced care.

Oncology Frontier: What challenges remain in implementing quality control measures and national performance indicators for breast cancer? Could you share your hospital’s experience in addressing these challenges?

Dr. Jin Yang: This is a practical and crucial question. Implementing national performance indicators requires the collective efforts of healthcare leaders across China’s tertiary public hospitals, as it plays a pivotal role in advancing cancer quality control. All stakeholders—from clinicians to administrators—must adhere to standardized indicators across specialties, including medical oncology, surgery, pathology, imaging, and radiation therapy.

For hospital administrators, challenges differ between specialized cancer centers and general tertiary hospitals. Specialized cancer centers often have concentrated expertise and dedicated teams, making quality control relatively easier. In contrast, general hospitals must coordinate across multiple departments to implement single-disease quality control metrics effectively.

At The First Affiliated Hospital Xi’an Jiao Tong University, we’ve prioritized building a robust digital infrastructure to tackle these challenges. In 2023, we launched a standardized oncology quality control platform in collaboration with the National Cancer Center. This platform encompasses quality metrics for ten major cancer types, allowing real-time monitoring and dynamic management.

By extracting and analyzing these metrics, we provide timely feedback to our hospital’s quality control office and clinical departments. Using a PDCA (Plan-Do-Check-Act) cycle, we continuously refine practices such as medical record documentation, surgical procedures, medication use, pathology reporting, imaging analysis, and radiotherapy techniques. For example, improving the standardization of medical records has significantly enhanced compliance with quality metrics.

The PDCA cycle has proven invaluable in translating quality control indicators into standardized clinical practices. This is particularly important given China’s vast geographical diversity and disparities in healthcare delivery. The inclusion of national performance indicators in public hospital assessments has been a powerful catalyst, driving widespread efforts to improve cancer care quality across the country.

About Dr. Jin Yang

• Director, Cancer Center, Xi’an Jiaotong University First Affiliated Hospital
• Director, Precision Oncology Research Center, Xi’an Jiaotong University
• Chief Physician, Professor, and PhD Supervisor
• Deputy Chair, Oncology Drug Clinical Research Committee, China Medical Education Association
• Standing Member, Breast Cancer Committee, Chinese Research Hospital Association
• Member, Breast Cancer Committee, National Cancer Quality Control Center
• Member, Breast Cancer Committee, Chinese Society of Clinical Oncology (CSCO)
• Member, Breast Cancer Committee, Chinese Anti-Cancer Association
• Deputy Chair, Breast Cancer Group, Tumor Biomarkers Committee, Chinese Anti-Cancer Association
• Standing Member, Oncology Internal Medicine Committee, Shaanxi Medical Association
• Chair, Anti-Cancer Drug Committee, Shaanxi Anti-Cancer Association
• Chair, Precision Oncology Committee, Xi’an Cancer Rehabilitation Association
• Recipient of numerous awards, including the Shaanxi Province May Day Women’s Pacesetter Award
• Published over 50 papers, including 47 indexed by SCI
• Principal Investigator for five National Natural Science Foundation projects
• Recipient of two Shaanxi Provincial Science and Technology Progress Awards and two Higher Education Science and Technology Progress Awards