2022ESMO ｜ Professor Longjiang: Fantastic Thorfinib Real World Study, adding efficacy to the effect

*For medical professionals for reading reference

Professor Longjiang takes you to understand the real world research of Soffinib the treatment of Nen patients.

Neurological endocrine tumor (Nen) is a rare tumor that originated from the systemic nerve endocrine cells distributed, and the tumor shows a high heterogeneity [1]. In recent years, the incidence of Nen in my country has continued to rise. Unfortunately, because the early symptoms of neuromusculosis (NET) are difficult to find, and many grass -roots hospital tumor doctors have insufficient understanding of NET, patients have occurred when they misdiagnose. Most patients have metastasized during the diagnosis and losing opportunities for surgical treatment. The difference in nerve endocrine cancer (NEC), which has a poor degree of differentiation and a higher degree of malignant degree, is known for its poor treatment effect and short survival cycle of patients. It has become a problem that needs to be overcome in the field of treatment.

The European Cancer Internal Science Society (ESMO) is a major event in the field of tumor. At this year's ESMO Annual Conference, a forward -looking, multi -center of which is led by Professor Longjiang to explore the safety and effectiveness of NEN in the treatment of Nen in the treatment of Nen Real world research was successfully shortlisted. In order to further understand the real world data of Sovinib for treating NEN's efficacy and security, the "Medical Circular Cancer Channel" invites this heavy study Leading Pi to the first People's Hospital of Shanghai Jiaotong University School of Medical College. The professor gives interpretation and shared its academic insights.

Soffinib emerged in the Net field

Earlier, there were two double-blind-stage III random control research (SANET-P Study [2] and SANET-EP Studies [3]), which explored the patients and patients and advanced pancreatic NET (PNET) patients and advanced stages. The efficacy and safety of patients with non -pancreatic NET (EPNET) show excellent effects.

SaNet-P Study: The ORR of the Sovinib group was 19.2%, and the mid-bit PFS was 10.9 months (95%CI: 7.5-13.8), which was significantly higher than the placebo group (3.7 months, 95%CI: 2.8- 5.6) (HR = 0.49, 95%CI: 0.32-0.76, P = 0.0011). Orrr

SANET-EP research: Sovinib showed the same benefit. The ORR of the Sovininib group was 10.3%, and the median PFS of the placebo group was 9.2 months and 3.8 months (HR = 0.33, 95 95 %CI: 0.22-0.50, P <0.0001).

The results of the above two studies show that Soffinib has prominent effects among patients with advanced PNET and advanced EPNET, becoming the only domestic neurological endocrine tumor drug covering all sources in China, and has been approved to be listed in China.

Professor Longjiang highly evaluated the extraordinary efficacy and safety of Sofinib in the Randoming Research Study of the III phase III. He said that traditional random control studies have strict enrollment standards and have multiple restrictions. Real world research can reduce this restriction and reflect the clinical efficacy of the treatment of drugs. Data in SANET research in SANET is also enriched from a clinical perspective to the evidence -based medical evidence used by Sovinib to treat Nen, bringing hope for more patients. A forward -looking, multi -center, and real world study that is used to explore the safety and effectiveness of Nen in the treatment of Nen in the treatment of Nen in the treatment of Nen. [4] came into being.

Soffinib has been broken again in the real world, PFS exceeds 10 months!

The real world research was included in 23 irregularities (including 20 NET patients and 3 NEC patients) in advanced Nen patients, and was treated in the multi -disciplinary diagnosis (MDT) model. During the period during the research and development process, the real world research used a remote medical platform that could use all patients to minimize interference caused by the impact of the epidemic. Figure 1. Research design

Professor Longjiang has some special considerations on the group who joined the group. He talked: "In the real world research, we boldly made some breakthroughs and incorporated 3 patients with NEC. Poor control over NEC, so we explored 3 cases of NEC patients. In addition, the research data of Thorfinib in bile duct cell carcinoma has also been announced, and it has shown a good effect. It is meaningful to include a part of NEC patients. "

At the time of the data deadline on July 30, 2022, a total of 21 patients had a tumor reaction evaluation after at least one baseline. Of all 21 patients, the objective relief rate (ORR) was 14.3%(95%CI: 3.0%-36.3%), and the disease control rate (DCR) reached 95.2%(95%CI: 76.2%-99.99%); Among the patients, a total of 18 patients conducted at least one tumor reaction evaluation, and ORR was 16.7%(95%CI: 3.6%-41.1%), and DCR was as high as 100%(95%CI: 81.5%-100%); and at NEC NEC Of the patients, all three patients conducted a tumor reaction evaluation. Although the ORR was 0, the DCR could reach 66.7%(95%CI: 9.4%-99.2%).

Table 1. 21 patient tumor reactions evaluation

In the analysis of the treatment results of all patients, it was found that a patient (NO.010003) was discontinued due to adverse events (AE). There are still PFS2 in Fanitinib treatment; a patient with PNET patients (NO.010007) was interrupted by the new crown infection of the asymptomatic in 9 months. The PFS was 7.46 months, and the target lesion was removed during its baseline and was not evaluated.

Professor Longjiang specially emphasized that NEC patients can also get 7.46 months of PFS. It is unexpected. In the traditional sense, NEC is difficult to control, and this time the real -world research implementation stage happens to meet the epidemic situation. There are some difficulties. So whether it is a moderate expansion in the range of medication, or letting patients spend this special period safely, it is very valuable. "

Figure 2. PFS and treatment results of all patients

When the median follow-up time was 9.030 months (95%CI: 6.284-11.776), the median PFS has reached 10.380 months (95%CI: 9.615-11.145) (excluded NO.010003's PFS2). OS. Professor Longjiang once again highly affirmed the PFS data in the real world in the real world, and said that it was very close to the PFS (10.9 months) in the SANET-P research. The effect of the middle.

Figure 3. The KM curve of PFS

In the post -epidemic era, clinical research has challenges and opportunities

Professor Longjiang talked: "During the implementation of the real world research, the outbreak of the Shanghai epidemic broke out, bringing many problems to the progress of research. In order to maximize the interference caused by the epidemic, we were in the real world research. Use remote medical platforms that can provide services to all patients, including online consultation, subsequent drug distribution and health management services. "

Patients can contact the patient directly through the remote medical platform when they go home or when they go home or isolate due to the epidemic. In order to solve the various needs of patients in the medication, some plans have been set up in the platform to facilitate the treatment of patients to stop drugs and side reactions, so that patients can feel safe and secure no matter where they are.

Professor Longjiang recalled the situation of patients who entered the cabin isolation in the real world research. He said: "In the environment of the epidemic, we must not only work hard to make research continue to be carried out, but also have a temperature in the management of patients. There are more or less panic in patients with cabin isolation. In addition to the fear of the new crown, there are also concerns about whether the study can be successfully carried out. This is a test of our MDT team. Communicate closely, soothe their tension, record the common side effects of patients in the process of medication, as well as new crown related performance such as fever and respiratory symptoms, and deal with problems in time. Fortunately, these patients have successfully spent observation in the square cabin smoothly. Period and continue to receive the treatment of Sovinib. In the epidemic, we adopt an online joint management model, plus the team's concern, so that patients can have a sense of security and trust us. This is something we have made. Breakthrough. "

Soffinib has conducted corresponding clinical research in the field of Net treatment, showing excellent results. Not only that, in the real world research, researchers have included NEC patients, and they have also received significant benefits. This not only strongly verifies the significant effect of Sovininib in the Nen field, but also for the NEC field for Soffinib in the NEC field. Exploration provides possibilities, looking forward to the further exploration results of Soffinib in the future. The sudden outbreak of the epidemic was caught off guard, and the development and implementation of various clinical studies were greatly affected. However, in the post -epidemic era, many problems in clinical research were resolved after the joint efforts of many parties. Professor Longjiang is paying attention to the psychological conditions of the patient outside the diagnosis and treatment, so that clinical research has temperature, which is also the direction of future clinical researchers' efforts.

Expert Introduction

Professor Longjiang

Professor Longjiang, Pan -Surgery, First People's Hospital of Shanghai Jiaotong University Medical College

Vice Chairman of the Youth Council of the China Anti -Cancer Association

Vice Chairman of the Youth Council of the Shanghai Anti -Cancer Association

Deputy Chairman of the Shanghai Anti -Cancer Association's physical tumor focusing on diagnosis and treatment committee

The leader of the Shanghai Anti -Cancer Association Neurological Endocrine Tumor Youth Learning Group

Member of the Pancreatic Studies Group of the Shanghai Medical Association's General Branch

Standing Committee of the Chinese Anti -Cancer Association Big Data and Real World Research Committee

Member of the Artificial Intelligence Special Committee of the China Anti -Cancer Association

Standing Committee Member of the Chinese Anti -Cancer Association Popularization Professional Committee

Professor Ni Quanxing, a well -known expert in pancreatic surgery in my country

Good at scammer surgery and comprehensive treatment of pancreatic cancer, duodenum tumors, neuro endocrine tumors, post -peritonal tumors and other tumors

It is mainly engaged in the clinical and basic transformation of pancreatic tumors. It is especially dedicated to the research of heterogeneous biology watches of pancreatic cancer. As a project leader, it takes the project in charge of the National Natural Science Foundation of China, the key project of the Ministry of Health's clinical discipline, and Shanghai. Key projects of the Science and Technology Commission, Fudan University "985" project youth project and other projects

Won the Young Scholar Award of the American Pancreatic Society during the United States Study Abroad

In 2012, he won the "Golden Finger" award of the Surgery Speaking Award of the Chinese Medical Association.

Published more than 20 SCI papers

references:

[1] The Professional Committee of the China Anti -Cancer Association Neuroma Endocrine Tumor. The China Anti -Cancer Association Neurological Endocrine Tumor Diagnosis and Treatment Guide (2022). "China Cancer Magazine" 2022 VOL.32 No.6.

[2] XU J, SHEN L, BAI C, Et Al. Surufatinib in Advanced Pancreatic NeuroCrine Tumours (SANET-P): A Randomised, Double-Blind, PlaceBo-Controlled, Phase 3 Study. 11): 1489-1499.

[3]Xu J, Shen L, Zhou Z, et al. Surufatinib in advanced extrapancreatic neuroendocrine tumours (SANET-ep): a randomised, double-blind, placebo-controlled, phase 3 study. Lancet Oncol. 2020 Nov;21( 11): 1500-1512.

[4]Jiang Long, Chuntao Wu, Beiyuan Hu, et al. The safety and efficacy of surufatinib for the treatment of advanced neuroendocrine tumors: A prospective, multicenter, real-world study. 2022 ESMO 898P.

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