On May 8th, Shanghai Proton Heavy Ion Hospital and Fudan University Affiliated Tumor Hospital Proton Heavy Ion Center (hereinafter referred to as “Heavy Ion Hospital”) ushered in the “three-year-old” birthday. After three years of unremitting efforts, the number of particle treatments in the heavy ion hospital has exceeded 500 cases (lasting 19 months) and 1000 cases (lasting 30 months).

Treated 1263 patients with nearly 40 tumor diseases

As a radiotherapy technique that uses precise proton or heavy ion radiation to accurately irradiate and kill tumors, proton heavy ion radiotherapy is considered to be the most advanced tumor radiotherapy technology in the world. Since 2003, Shanghai has officially launched the introduction of proton heavy ion system equipment. From June to December 2014, the Heavy Ion Hospital carried out clinical trials of 35 patients in China's first particle therapy equipment . After obtaining the first medical certificate registration certificate for proton heavy ion system equipment in China, the hospital officially opened in May 2015. It has been 3 years since then.

In the past three years, among the 1263 patients admitted to the heavy ion hospital, 654 cases of head and neck cancer, including 241 cases of nasopharyngeal carcinoma, 161 cases of intracranial skull base tumor (meningioma, glioma, chordoma, etc.), adenoid 75 cases of cystic carcinoma, 35 cases of sarcoma and chondrosarcoma, 142 other cases (beladal adenoma, melanoma, oropharyngeal cancer, lacrimal gland and lacrimal sac tumor, ocular tumor, etc.); 205 cases of chest tumor, including 159 cases of lung tumor 10 cases of esophageal cancer, 36 cases (thymoma, tracheal adenoid cystic carcinoma, etc.); 404 cases of abdominal pelvic and other parts of the tumor, including 124 cases of prostate cancer, 45 cases of liver tumor, 51 cases of pancreatic cancer, cervical cancer 32 cases, 10 cases of biliary tumor, 19 cases of recurrent rectal cancer, 20 cases of breast cancer, and other 103 cases (chord chordoma, renal cancer, lymphoma, bone and soft tissue tumors, etc.).

Of the 1263 patients, 1154 were treated with heavy ions or with heavy ions combined with protons, accounting for 91.4%, which fully utilized and exerted the advantages of the hospital's international advanced radiotherapy technology. The median age of all patients was 54 years old, and 25.5% of patients aged 65-80 years. Since the opening of the heavy ion hospital, the number of patients admitted to the first 500 cases (December 2016) lasted 19 months, and the second 500 cases (November 2017) lasted 11 months. The number of patients admitted to the hospital in the year is close to the level of similar particle treatment institutions that have been in operation for more than five years. At present, the heavy ion hospital has treated nearly 40 kinds of tumor diseases, and the clinical standard of particle therapy SOP has been expanded to 56, which basically covers the top 10 diseases in China.

Radiotherapy doctors and therapists are paying close attention to the patient particle treatment process (Source: Heavy Ion Hospital)

Focus on key diseases, focusing on clinical efficacy and service improvement

The heavy ion hospital mainly focuses on clinical treatment of five key diseases such as nasopharyngeal carcinoma, intracranial skull base tumor, lung cancer, liver cancer and prostate cancer, and carries out key clinical research on pancreatic cancer ("5+1" key disease). At present, the number of “5+1” key diseases in the heavy ion hospital accounted for 61.8% of the total number of treatments.

According to statistics, among the 241 patients with nasopharyngeal carcinoma admitted to the Heavy Ion Hospital, recurrent nasopharyngeal carcinoma accounted for 64%, and advanced patients accounted for 75%. Both of them achieved good results after heavy ion treatment. Especially for recurrent radiotherapy for recurrent nasopharyngeal carcinoma, clinical studies have shown that 75 patients with recurrent nasopharyngeal carcinoma treated with simple heavy ion therapy have a 1-year overall survival rate of 98.1% and a 1-year progression-free tumor control rate. The 82.2%, local progression-free survival rate was 86.6%, and the distant metastasis survival rate was 96.2%, which was higher than the efficacy data of conventional radiotherapy. The particle therapy specification of carbon-ion ray re-radiation therapy for local recurrent nasopharyngeal carcinoma summarized by the hospital on the basis of clinical practice has become an international standard recognized in the field of radiotherapy for nasopharyngeal carcinoma.

Among the 161 patients with intracranial skull base tumors, 61 patients with chordoma and chondrosarcoma treated with proton heavy ion therapy as the first-pass radiotherapy were treated with simple heavy ion or heavy ion combined with proton therapy without any serious acute side effects. The 2-year overall survival rate was 100%, and the 2-year tumor progression-free survival rate was 91.2%.

Among the 205 patients with chest tumors, 39 patients with early-stage non-small cell lung cancer who completed complete follow-up and were followed up regularly (28 patients were treated with simple heavy ion or heavy ion combined with proton therapy), 1 year and 2 years overall survival rate 95% and 87.7%, respectively, the 2-year disease-free survival rate was 81.6%, and the 2-year local control rate was 95.2%.

The incidence of liver cancer in China is high. Among the 45 patients with liver cancer who have been admitted to the hospital, there are 18 cases of hepatocellular carcinoma with tumor lesions more than 1 cm away from the digestive tract. After 10 times of simple heavy ion fragmentation, there is no gastrointestinal toxicity, liver function damage and radiation liver disease. Severe toxic and side effects, the 2-year overall survival rate was 93.8%, and the 2-year local tumor control rate was 100%.

124 patients with prostate cancer (including limited period, limited progressive prostate cancer and oligometastasis prostate cancer) have been treated. All patients were treated with heavy ion or heavy ion combined with proton therapy. The 2-year overall survival rate was 98.4%. Among them, 95 cases of limited prostate cancer, the 2-year overall survival rate reached 100%, and the 2-year biochemical recurrence-free survival rate also reached 100%.

At the same time as clinical treatment, the team of experts in the heavy ion hospital continued to conduct regular follow-up work on 35 clinical trial patients (participating in the registration of clinical trials of particle system equipment in June 2014), and since receiving proton heavy ion therapy from these patients, According to the follow-up data of the past 4 years, in the safety evaluation, most of the patients' mild adverse reactions have completely disappeared. In terms of effectiveness evaluation, except for one patient who died of a sudden cerebrovascular accident last year, the other 34 cases The patient's follow-up rate was 97.1% in the past 4 years, and the local control rate of the patients in all clinical trials reached 91.4%.

In the past three years, Heavy Ion Hospital has been focusing on the dual improvement of particle treatment quality and service. In September 2017, the hospital successfully passed the JCI (International Medical Accreditation Joint Commission) review, becoming the only proton heavy ion center in the world to pass JCI certification. Hospital outpatient clinics have always implemented full appointments, and 11857 ​​patients have been admitted. Each patient admitted to the hospital must undergo a multidisciplinary multidisciplinary discussion (MDT) before the treatment of particles. A total of 1457 MDT cases were performed. In order to prevent patients, especially those from other places, from going to and from the hospital, the hospital opened the “Proton and Heavy Ion Patient Consultation Service Platform” with the help of “Internet +” means, providing free remote guidance and consultation services for 5,335 people at home and abroad. Sixty-four patients were evaluated by strict screening to enter the treatment after meeting the indications. In order to further facilitate the medical treatment environment and provide humanized services, the hospital has comprehensively upgraded the relevant clinics and facilities of the outpatient department and the inpatient department, optimized and adjusted the relevant service procedures, and combined with the patient's disease course and treatment characteristics to carry out various inpatient services, such as : TCM Health Exercise (Ba Duan Jin), Hand Workshop, Psychological Counseling, Rehabilitation Forum, also provides personalized personalized food service and bedside iPad multimedia internet service terminal for patients. The clinical quality and service concept of the heavy ion hospital have been widely recognized. 21 foreign and Hong Kong, Macao and Taiwan patients have come to the hospital for treatment.

Focus on clinical research and innovation, and improve the efficacy and quality of diagnosis

On the basis of continuously accumulating the number of cases and improving the curative effect, the heavy ion hospital team actively carries out clinical research and innovation. According to the clinical condition accumulation, under the premise of ensuring safety, the application of respiratory gating technology around the target area and different tumors The clinical key issues such as the dose-administering method and the best treatment model for disease particle therapy, combined with domestic and international related treatment and research institutions, carried out a number of prospective clinical studies, exploring the establishment of China's “native” to reduce the number of particle treatments and increase the proportion of heavy ion treatment. "medical treatment program. At present, the number of heavy ion treatments for prostate cancer has been reduced from 23 to 16 times, and the third phase of dose escalation is being actively carried out. The treatment of recurrent head and neck malignant tumors has been optimized from the original proton therapy 28-33 times to 18-24 times with heavy ion therapy. In addition, in view of the advantages of particle treatment for lung cancer and breast cancer in “non-invasive” and greatly reducing post-radiation damage, the hospital clinical team has focused on the technical research of particle therapy for micro-solid nodular lung cancer and breast cancer, and has successfully treated small There were 22 cases of lung cancer (the smallest lesion was 0.6 cm) and 20 cases of breast cancer.

At the same time, the radiation physics team of the Heavy Ion Hospital combined with the actual situation of clinical diagnosis and treatment, independently developed a rotating treatment bed, isocenter rotating treatment chair, particle therapy limiting equipment and other particle therapy auxiliary equipment. The clinical use of the rotating treatment bed and the isocenter rotating treatment chair increases the choice of the radiotherapy doctor's angle of incidence of the particle beam, meets the needs of multi-angle particle irradiation, expands the indication range of the treatment system, and further improves the treatment efficiency and equipment utilization. Rate; the application of particle therapy limiting device makes proton heavy ion ray more precise and sharp, and is more suitable for proton heavy ion therapy of eye tumors.

In the information system update research and development of particle therapy system equipment, the hospital has independently researched and developed the first set of therapeutic process management information system (TIMPS), which is more suitable for proton heavy ions, and has been officially put into clinical use. This system replaces the foreign version originally used by the hospital, greatly improving the matching with the hospital proton heavy ion system equipment. This is also the first software system for the proton heavy ion treatment process independently developed by China.

The patient is undergoing CT examination (Source: Heavy Ion Hospital)

Pay attention to the construction of equipment and hardware and create a "model" for equipment operation guarantee and talent training

For heavy ion hospitals, the normal operation of particle therapy system equipment is the "lifeline" of heavy ion hospitals. In the past three years, the heavy ion hospital teamed up with the German Siemens company maintenance team to continuously improve the equipment maintenance level, continuously improve the quality management process and ensure the timely supply of spare parts, and maintain the high operating rate and stable operation of the system equipment. More than 1,000 days and nights since its opening, staff are monitoring the operation of the entire particle therapy system.

In order to further improve the operation and maintenance efficiency of system equipment, the Heavy Ion Hospital and the relevant universities have developed China's first intelligent management platform for the operation and maintenance of proton heavy ion system equipment, namely “monitoring system + management system + data decision + information model (BIM) )), the platform monitors and manages about 15,000 data collection points, more than 400 maintenance projects, and 170 core parameters of the complete set of equipment, and supports real-time messaging through multiple platforms such as PC and mobile phones. To realize online management, disposal, statistics and analysis of proton heavy ion system equipment, and to create the first “prototype” of operation and maintenance guarantee for proton heavy ion system equipment in China. In the past three years, the operating rate of proton heavy ion system equipment has been steadily increasing year by year and maintained at a high level of 96.6%. The auxiliary system operating rate has remained at 99.9% per year.

In addition to the normal operation of the equipment, talent cultivation and echelon construction are also the key to the successful operation of the heavy ion hospital. With the popularization of radiotherapy technology, and about 60% of cancer patients need to receive radiotherapy, the consequent radiation physicist talent gap is highlighted. Normally, every two radiotherapists in the clinic need to work with at least one radiophysicist. Nowadays, the ratio of radiotherapy doctors and radiophysicists in some developed countries generally reaches 1:1. But at present, the ratio of Chinese radiotherapists and physicists is generally 4:1, and some areas are even lower. At the same time, the existing physicist team in China has different sources and specialties, which cannot meet the requirements of new radiotherapy technology development, especially for proton heavy ion, an internationally advanced tumor radiotherapy technology.

In 2013, the Heavy Ion Hospital and Fudan University launched the Master of Biomedical Engineering (Medical Physics) training program. Different from the training mode of other colleges and universities related to theoretical courses, the project combines short-term course teaching and long-term hospital practice rotation, which is the first attempt of domestic universities and hospitals to cooperate and systematically train applied medical physicists. This is a "model" for the deep integration of interdisciplinary and cross-border education. The education and training of medical physicist talents also ushered in the opportunity of development. So far, the master's class has enrolled 35 students (4 sessions), and will continue to provide a new stream of force for the field of particle therapy in China, and cultivate a large number of particles including the “localized” chief physicist. Healing talent.

Heavy Ion Hospital stated that it will continue to meet the requirements of Shanghai to accelerate the establishment of a globally influential science and technology innovation center, and actively participate in the construction of Zhangjiang Comprehensive National Science Center, giving full play to the cutting-edge medical equipment , personalized medical services and international standards of Heavy Ion Hospital. The team of tumor particle treatment experts and other advantages, to create an internationally influential "Shanghai Heavy Ion" high-end medical service brand.

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