Preface
Breast cancer is the most common malignant tumor in women in China, and patients with human epidermal growth factor receptor 2 (HER2)-positive breast cancer face more severe treatment challenges due to HER2 gene amplification or overexpression. At present, traditional anti-HER2 targeted drugs such as trastuzumab and pertuzumab have significantly improved the survival of patients, but the complex and cumbersome treatment process and inconvenience in the treatment process are still problems that need to be solved urgently. Fortunately, in October 2022, the launch of the subcutaneous formulation of trastuzumab provides a more flexible and convenient treatment option for HER2-positive breast cancer patients in China. What's even more exciting is that in December 2023, the approval of the dual-target subcutaneous formulation of tripag has further promoted the direction of "dimensionally elevated therapy and dimensional-reduced implementation" in the field of breast cancer treatment in China. In this context, Yimaitong invited Professor Zhang Hui from Fujian Provincial Hospital to share the current treatment status of HER2-positive breast cancer in mainland China, and discuss how to build a flexible and convenient anti-HER2 treatment model that conforms to Chinese characteristics.
Expert Profile
Professor Zhang Hui
- Deputy Chief Physician of the Department of Breast Surgery, Fujian Provincial Hospital
- Doctor of Medicine, Master Supervisor
- Member of the Young Expert Committee of the Chinese Society of Clinical Oncology (CSCO).
- Member of the Breast Cancer Committee of the Chinese Geriatric Health Care Association
- Executive Director of Breast Cancer Prevention and Treatment Branch of Fujian Strait Cancer Prevention and Treatment Association, Vice Chairman of Youth Committee
- He is a member of the Standing Committee of the Oncology and Plastic Surgery Committee of Fujian Anti-Cancer Association
- Member of the Breast Disease Branch of Fujian Medical Association
- Fourth place in the finals of the 9th "Art on the Fingertips" National Young and Middle-aged Surgery Competition (Laparoscopic Group)
"Dimensionality enhancement therapy is off to a good start, and dimensionality reduction is a good step. The treatment of HER2-positive breast cancer has been introducing new methods and drugs, which has greatly improved the treatment effect of patients, but at the same time, we need to simplify the treatment operation as much as possible and improve the convenience of treatment. The advent of subcutaneous preparations has organically combined 'dimensionality enhancement therapy' with 'dimensionality reduction implementation', opening a new treatment blueprint for HER2-positive breast cancer. ”
——Professor Zhang Hui
Treatment is advancing rapidly, and the treatment of HER2-positive breast cancer still needs to be "reduced in dimensionality"
Since the discovery of HER2 targets, anti-HER2 therapeutic drugs have emerged one after another, and significant breakthroughs have been made in the treatment of HER2-positive breast cancer. However, with the continuous prolongation of survival, patients have higher requirements for treatment convenience and quality of life.
Policies such as the "Healthy China 2030" Planning Outline and the "Theme Activity Plan for Improving Medical Experience and Enhancing Patient Experience (2023-2025)" also put forward the need to effectively improve people's medical experience, integrate "patient-centered" into all aspects of medical services, and pay attention to bringing convenient treatment methods to patients and improving their quality of life while improving patients' survival.
At present, the treatment principle of "ascending the dimension of therapy and implementing the reduction of dimensionality" is corresponding to the transformation of the above treatment modes. Among them, "ascending therapy" means the introduction of new treatment concepts and technologies to improve the treatment effect and the quality of life of patients. The "implementation of dimensionality reduction" emphasizes the transformation of these advanced treatment methods into practical operation, simplifying the treatment procedure, and making it easy to implement and popularize in clinical practice. For example, the emergence of anti-HER2 subcutaneous preparations has shortened the treatment time from several hours to a few minutes, reduced the time of patients in hospital treatment and waiting in line, and improved the treatment experience of patients with flexible and convenient treatment methods while ensuring the treatment efficacy, and also improved patients' satisfaction with medical services, which is a vivid embodiment of "dimensionality enhancement treatment, dimensionality reduction implementation".
Innovative dosage forms have been implemented to achieve a double harvest of efficacy and clinical reputation
In clinical practice, we have been deeply impressed by the use of trastuzumab subcutaneous preparations. In the past, patients received trastuzumab targeted therapy for a long time, and a lot of time was wasted in going through the admission and discharge procedures, which caused great inconvenience to patients. In contrast, trastuzumab is administered subcutaneously in a simple and convenient way, requiring only a few minutes of subcutaneous injection into the thigh, and its treatment convenience is self-evident. In addition, this method of administration not only significantly shortens the patient's stay in the hospital, effectively reduces their physical and mental burden, but also reduces the burden of care for the patient's family, further improves the patient's acceptance and compliance with the treatment, and optimizes the overall treatment effect. Over the course of a year-long clinical application, we have found that many breast cancer patients have shown a preference for subcutaneous injections. After receiving the treatment, patients generally reported that the treatment experience was good, they felt very comfortable, and their quality of life improved.
Because the subcutaneous preparation of trastuzumab is a fixed dose, the medical staff not only eliminates the step of calculating and configuring the dose according to weight, avoids the wrong drug configuration, but also reduces the time of explanation and communication with the patient, and greatly simplifies the treatment process. Such changes not only improve the work efficiency of medical staff, but also make effective use and saving of medical resources. In addition, the subcutaneous preparation of trastuzumab has been included in the national medical insurance list this year, which greatly reduces the financial pressure on patients and improves the accessibility of the drug. In conclusion, the subcutaneous formulation of trastuzumab is a drug worth looking forward to, and we are full of confidence in its further promotion and application.
Single- and dual-target subcutaneous formulations are working together to open up a new paradigm in the treatment of HER2-positive breast cancer
At present, the treatment of HER2-positive breast cancer has entered the era of traspa dual-target therapy, and compared with trastuzumab single-target therapy, trapa dual-target is more widely used and can cover more breast cancer patient groups, so there is great clinical expectation for the arrival of trapa dual-target subcutaneous preparations.
A dual-target subcutaneous formulation of trastuzumab is a fixed-dose subcutaneous formulation that combines two monoclonal antibodies, trastuzumab and pertuzumab, into a single dose. Both previous FeDeriCa and FDChina studies1,2 demonstrated similar efficacy and safety to the intravenous formulation of the dual-target subcutaneous formulation of tropa. In addition, the PHranceSCa study3 showed a strong preference for dual-target subcutaneous formulations of traspag in patients with HER2-positive breast cancer, and the switching between subcutaneous and intravenous formulations did not affect the known safety profile of the drug. Based on the above research results, the latest edition of the Guidelines and Norms for the Diagnosis and Treatment of Breast Cancer of the Chinese Anti-Cancer Association (2024 Edition) recommends that the dual-target subcutaneous preparation of tripaga can be used as an alternative to the dual-target intravenous preparation in early neoadjuvant therapy, adjuvant therapy, and metastatic breast cancer treatment4.
In terms of use, the dual-target subcutaneous preparation of tripa can complete the two-drug treatment through a single subcutaneous injection of a fixed dose. Compared with the traditional intravenous infusion, which takes several hours, the subcutaneous preparation of tripaz dual-target only takes 5~8 minutes to administer, and the observation time is shorter, which greatly shortens the patient's time in the hospital and improves the treatment experience of the patient. In addition, the dual-target subcutaneous preparation of tripaga also further shortens the overall treatment process, eliminates the tedious dosage calculation, dispensing, residual fluid management, inspection and other work, greatly saves labor and time costs, and reduces the burden of medical care.
In fact, compared with traditional intravenous preparations, the simple operation mode and fast administration time of trastuzumab subcutaneous preparations and trapazumab dual-target subcutaneous preparations are more convenient for the implementation of primary hospitals, which is helpful for patients in remote areas to enjoy high-level treatment. More importantly, the use of subcutaneous preparations facilitates the long-term treatment and chronic disease management of patients, helps patients better balance treatment and life, and allows them to return to family and social life more quickly. In other words, the addition of the dual-target subcutaneous preparation of tripag is expected to promote the further implementation of the concept of breast cancer treatment, and realize the combination of "dimensionality enhancement therapy" and "dimensionality reduction implementation", so as to better serve patients and improve the treatment effect.
Efforts should be made to build a flexible and convenient anti-HER2 treatment model that conforms to Chinese characteristics
In fact, in the process of further implementing and promoting the anti-HER2 subcutaneous treatment model in China, there are still the following challenges: First, the uneven distribution of medical resources. In many areas, especially in remote or impoverished areas, the level of medical care and the number of specialized doctors may not be able to meet the needs of patients, and although the application of anti-HER2 subcutaneous preparations is more flexible and convenient, there will be some difficulties in the early promotion and use. Second, patients and healthcare professionals may lack knowledge and awareness of anti-HER2 subcutaneous formulations, which may lead to misunderstandings and concerns about new formulations, which can affect their promotion and use. Third, the economic burden of new preparations. New formulations tend to be expensive to develop and manufacture, which can make the price of new formulations unaffordable for many patients. Fourth, hospitals and health systems may need to adapt existing processes and facilities to accommodate new subcutaneous treatment modalities. These changes may require time and resources to ensure that the new formulation can be used correctly and effectively.
In order to meet these challenges, we can make improvements in the following aspects: First, we need to improve the medical level of primary care institutions and the professional skills of medical staff. This can be done by providing professional training to guide and encourage healthcare professionals to continuously learn and improve so that they can better understand and use anti-HER2 subcutaneous preparations. Second, there is a need to increase patient education and awareness of the disease and treatments. This can be done by providing easy-to-understand scientific information, or through community events, to make patients and the community more aware of and accept anti-HER2 subcutaneous agents. Thirdly, it is hoped that the dual-target subcutaneous preparation of tripag can also be included in the medical insurance system as soon as possible to help reduce the financial pressure of patients and allow more patients to use this flexible and convenient drug. Finally, in the process of long-term chronic management of breast cancer, we can also use modern Internet technology, such as telemedicine and mobile health applications, to help hierarchical diagnosis and treatment, and provide patients with more convenient and personalized services. These technologies can not only help breast cancer patients better manage their disease in primary care settings and even at home, but also provide real-time guidance and feedback to healthcare professionals to improve treatment outcomes.
It is hoped that with the concerted efforts of all parties, a more flexible and convenient treatment path can be opened up for HER2-positive breast cancer patients. It is expected that patients can enjoy more freedom and happiness during the treatment process, significantly improve their quality of life, and finally be able to better return to society.
Bibliography:
1. Tan AR, et al. Lancet Oncol. 2021 Jan; 22(1):85-97.
2. Zhimin Shao, et al. ESMO ASIA 2022. Abstract #929.
3. O'Shaughnessy J, et al. Eur J Cancer. 2021 Jul;152:223-232.
4. Breast Cancer Committee of Chinese Anti-Cancer Association, Breast Oncology Group of Chinese Society of Oncology. China Oncology . 2023, (12): 1092 -1187 .
Editor: Tina
Reviewer: Max
Typography: Uni
Execution: Uni
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