Editor’s Note:The 27th National Clinical Oncology Conference and 2024 CSCO Annual Meeting, jointly hosted by the Chinese Society of Clinical Oncology (CSCO) and the Beijing Xisike Clinical Oncology Research Foundation, took place from September 25 to 29, 2024, in Xiamen. During this prestigious event, CSCO awarded Academician Binghe Xu with the “2024 Annual Achievement Award” in recognition of his leadership in the groundbreaking multi-center PHILA study, which has rewritten domestic and international breast cancer treatment guidelines. In an interview with Oncology Frontier at the conference, Professor Xu shared his reflections on the award and insights into China’s progress in clinical drug research.CSCO Award Citation:
“He led 40 research centers nationwide over nearly five years, introducing pyrotinib, a small-molecule targeted drug, for the first-line treatment of HER2-positive advanced breast cancer. This innovative dual HER2 therapy, combining small and large molecules, achieved the longest progression-free survival (PFS) in any global phase III trial for HER2-positive advanced breast cancer to date, altering treatment guidelines worldwide. The PHILA study, published in BMJ, marked the first Chinese breast cancer drug study to be featured in the journal’s 183-year history, paving the way for future Chinese clinical breast cancer research.”
Oncology Frontier: Congratulations on receiving the CSCO “2024 Annual Achievement Award”! Could you share your thoughts on winning this prestigious honor?
Academician Binghe Xu: I am deeply honored to receive the CSCO “2024 Annual Achievement Award.” This is the first project in the field of breast cancer research in China to be awarded the CSCO Annual Achievement Award. This accomplishment reflects the hard work of countless researchers from 40 hospitals nationwide, the selfless contributions of participants, and the invaluable involvement of patients. From the launch of the research to the eventual publication of the results, it has been a long and challenging journey. I am particularly proud that our findings were published in The BMJ (British Medical Journal), which, for the first time in its 183-year history, featured an original Chinese breast cancer drug research study. This breakthrough is a source of great pride for all of us.
The study marks significant progress in breast cancer treatment, as it successfully altered both domestic and international guidelines. Numerous leading guidelines have adopted our results, which is a remarkable achievement. What makes me most proud is that our research provides a tangible and effective treatment option for HER2-positive advanced breast cancer patients, offering new hope for their future.
Oncology Frontier: During the conference, you will be discussing the progress of clinical drug research in China, including novel agents like TROP-2 ADCs. Could you share your perspective on the current state and future of breast cancer drug innovation in China?
Academician Binghe Xu: China’s development of anti-cancer drugs has transitioned from imitation to original innovation. Initially, we actively participated in international multi-center studies, learning from global frontiers while honing our clinical research capabilities. Over time, we moved from “me too” and “me better” drugs to producing “first-in-class” original drugs. Today, China’s clinical research not only serves domestic patients but also contributes globally by offering more treatment options, a journey that has been long and filled with challenges.
In breast cancer, we’ve made significant advancements across all subtypes, driving breakthroughs in treatment strategies. For example, in HR-positive breast cancer, we’ve seen a shift from single-agent endocrine therapy to the introduction of CDK4/6 inhibitors, fundamentally changing the treatment landscape. We were among the first to conduct studies combining CDK4/6 inhibitors with endocrine therapies like fulvestrant and aromatase inhibitors (anastrozole and letrozole), and successfully established new first-line treatment standards (DAWNA-2 study), while also optimizing second-line treatment options (DAWNA-1 study). Furthermore, we led the phase III trial of a China-developed TROP-2 ADC (OptiTROP-Breast01 study), the positive results of which were presented at ASCO.
For HER2-positive breast cancer, we’ve made similar strides. From single-target to dual-target therapies, and now with the introduction of small-molecule targeted drugs, we’ve been continuously innovating. Our phase III trial (PHOEBE study) confirmed that pyrotinib combined with capecitabine significantly outperformed the internationally recognized lapatinib regimen in second-line treatment, establishing a new standard. In first-line treatment, combining large-molecule and small-molecule targeted therapies has shown superior efficacy, with the PHILA study results published in BMJ, contributing globally to breast cancer treatment.
In triple-negative breast cancer (TNBC), domestic research is also highly active. Chinese scholars have made significant progress in molecular subtyping of TNBC, exploring immunotherapy, chemotherapy, and targeted therapies based on these subtypes. Immunotherapy combined with chemotherapy has become a new standard, with significant contributions from Chinese researchers, reshaping the treatment landscape for TNBC.
Overall, breast cancer treatment has transformed dramatically over the past decades. These advancements have not only extended the survival of patients with advanced breast cancer but have also increased cure rates for early-stage patients. Looking ahead, we are committed to driving further innovation in breast cancer treatment and bringing more benefits to patients globally.
Oncology Frontier: You have worked in the field of clinical oncology for 40 years since starting your career at Peking Union Medical College in 1984. How do you reflect on the changes in clinical oncology in China over this period?
Academician Binghe Xu: When I first started in the 1980s, oncology, especially medical oncology, was not a highly sought-after field. Many preferred surgery or radiation oncology, as internal medicine had very few treatment options and primarily relied on a limited number of chemotherapy drugs. However, as medical research advanced, breast cancer began to be subdivided into different subtypes, such as HR-positive breast cancer, which spurred the development of endocrine therapies, including aromatase inhibitors (AIs) and selective estrogen receptor degraders (SERDs), offering new treatment options for patients.
Entering the 21st century, oncology witnessed transformative changes. The emergence of anti-HER2 therapies, particularly large-molecule drugs like trastuzumab, followed by small-molecule targeted drugs and antibody-drug conjugates (ADCs), formed a triad of therapies for treating HER2-positive breast cancer. These rapid developments greatly improved treatment outcomes and extended survival for HER2-positive breast cancer patients.
In 2011, at the St. Gallen Early Breast Cancer Consensus Conference, breast cancer was officially divided into four subtypes: luminal A, luminal B, triple-negative, and HER2 overexpression, with distinct treatment strategies for each. This classification marked the beginning of an era of individualized, precision treatment for breast cancer. Today, our research is often based on molecular subtypes, and this approach has driven the development of targeted therapies for other cancers as well, such as small-molecule drugs targeting EGFR mutations in non-small cell lung cancer (NSCLC).
Current research trends in oncology include molecular subtyping, immunotherapy, ADCs, cell therapy, and gene therapy. These innovative therapies, in combination with traditional chemotherapy, endocrine therapy, and targeted therapy, have accelerated the advancement of oncology. Many cancers are now becoming chronic diseases, and some patients are even reaching cure benchmarks.
Academician Binghe Xu
- Director, Oncology Center, Fudan University Cancer Hospital
- Chair, Breast Cancer Division, Chinese Society of Clinical Oncology (CSCO)
- Leading Chinese researcher in multi-center clinical trials for innovative breast cancer therapies, including HER2-positive and TNBC treatments
- Pioneer of pyrotinib’s clinical application for breast cancer
- Published in The BMJ, Nature Communications, The Lancet Oncology, and other high-impact journals
