The Lancet-Oncology：New breakthrough in treatment of “most toxic breast cancer”

Recently, “The Lancet-Oncology” published the results of a randomized controlled umbrella phase II clinical study from China called “FUTURE-SUPER” for the first-line treatment of metastatic triple-negative breast cancer. The results of this study reveal that a new precision treatment method using chemotherapy combined with targeting or immunity based on patient molecular subtypes and genomic markers can significantly extend the progression-free survival of patients with metastatic triple-negative breast cancer, and the toxicity can be reduced. control. This changes the clinical problem of single treatment method and poor efficacy in the past.

The research results were led by the clinical research team of Professor Shao Zhimin, Professor Wang Zhonghua, Professor Jiang Yizhou, and Professor Fan Lei from Fudan University Cancer Hospital. This is another landmark achievement of the integrated development of industry and medicine at Fudan University Cancer Hospital.

Triple-negative breast cancer accounts for about 15% of the total number of breast cancers. It is known as the “most toxic breast cancer” because of its high malignancy, easy recurrence and metastasis, single treatment method, and lack of effective treatment targets. In 2019, Professors Shao Zhimin and Jiang Yizhou drew a genetic map based on the different molecular characteristics and treatment targets of the Chinese population, and drew the “Fudan Classification” of triple-negative breast cancer for the first time in the world, namely, luminal androgen receptor type, immunoregulatory type, Basal-like immunosuppressive type, stromal type (MES), which provides clinical and theoretical guidance for the precise treatment of triple-negative breast cancer.

“In recent years, based on the ‘Fudan Classification’, our clinical research team has launched a series of prospective clinical research projects called ‘FUTURE’ in order to further verify the clinical value of the ‘Fudan Classification’ and explore potential treatment targets,” Shao Zhimin said. . Jiang Yizhou further said that the “FUTURE” series of blockbuster research results based on the “Fudan Classification” have come out one after another. A study called “FUTURE-C-PLUS” achieved an objective response rate of up to 81.3% in first-line immunomodulatory patients. To this end, Shao Zhimin led the translation and clinical team to start a clinical trial called “FUTURE-SUPER” in 2020. Wang Zhonghua said that the “FUTURE-SUPER” clinical trial project was jointly carried out by the hospital’s Breast Surgery Department and Hengrui Pharmaceuticals. Clinical research teams do a good job in trial design and potential treatment targets. Pharmaceutical companies rely on drug research and development teams to continue to provide innovative drugs for the research platform. This is a useful exploration of the integration of medicine and industry.

After more than two years, the team completed the clinical trial and enrolled 139 patients. Patients enrolled were patients with metastatic triple-negative breast cancer or triple-negative breast cancer who were inoperable. The research team divided them into 5 treatment arms based on their subtypes and genomic biomarker test results, and randomly divided the enrolled patients into the “nab-paclitaxel” standard chemotherapy group and the precise combination of traditional targeted or immune drugs. therapy group.

The study showed that during a median follow-up period of 22.5 months, the median progression-free survival of patients in the precision therapy group was 11.3 months, which was 5.5 months longer than the 5.8 months in the traditional chemotherapy group. It should be pointed out that the immunomodulatory patients are the group of patients with the largest increase in disease progression-free survival in the precision treatment plan. Among them, the disease progression-free survival time reached 15.1 months, which is 8.6 months longer than that of traditional chemotherapy. This is currently the best survival benefit in the world.

In addition, patients with basal-like immunosuppressive type and interstitial type survived by 5.2 months longer than those with traditional chemotherapy after receiving precise treatment. “This result breaks the ‘bottleneck’ and limitations of targeted therapy in the treatment of triple-negative breast cancer.” Professor Fan Lei of the Hospital’s Breast Surgery Department said that the research results are very exciting. The objective response rate of the precise treatment group was as high as 80%, significantly higher than the 44.8% of the traditional chemotherapy group, with controllable toxicity and no serious adverse reactions.