*For medical professionals for reference
Immunoma combined chemotherapy-advanced gallbladder New standards for first -line treatment.
In November 2023, based on TOPAZ-1 research [1], the National Drug Administration (NMPA) approval of the new indicator of the Mipidabi, that is,It is suitable for the first -line treatment of adult patients in the advanced or metastatic biliary cancer (BTC) adult patients with Jesitabin and cisplatin.This means that Chinese BTC patients have finally ushered in the first -line treatment plan for immunochemical chemotherapy that can be used, providing new options for BTC clinical treatment practice.Liver International Magazine released a real world research that explores the effectiveness and security of the moderate world in real world.Data from PFS), objective relief rate (ORR) and security have been verified [2].
BTC treatment urgent need for new solutions, research confirming the efficacy of the combined chemotherapy in the real world
BTC is a set of heterogeneous diseases with poor prognosis. Surgical and chemotherapy is currently the only treatment method, but only 1/5 patients have the opportunity to receive surgical intervention after diagnosis of BTC.For patients with diagnosis of local advanced and metastatic BTCs, the treatment methods have always been complacent chemotherapy.RecentsBased on TOPAZ-1 research, the US Food and Drug Administration (FDA), the European Drug Administration (EMA), and the China National Drug Administration (NMPA) approval of Raoli Mippitaria combined with Shi Platinum+Jesitabin as the previous unborn treatmentThe first -line treatment of non -removed or metastatic BTC patients.
A real -world research forward -looking collection of data from 17 centers in Italy, including non -removal, advanced or metastatic biliary glandular cancer patients, including intrahepatic or extraprooperlasia bile ductsCancer and gallbladder cancer, patients with the test group give Duvaruyabe (1500 mg, first administration on the first day of each cycle) and Gessabin (1000 mg/m2)+cisplatin treatment1 day and 8 days), each cycle is 21 days.After the patient completes 8 cycles of treatment, it is given Dueruyou single anti -single drug (1500 mg) every 4 weeks, until clinical or imaging manifestations are progressive or unacceptable toxicity.The main and secondary points of the study are the PFS in the patient queue of patients treated with Crown Platinum and Garcitabin in the non -clinical trial environment, as well as the total survival period (OS), total orr, and safetyEssence
The research results show that a total of 145 patients in 17 medical institutions in Italy from February 2022 to November 2022.As of April 28, 2023, the median of the follow -up time was 8.5 months.76 patients (52.4%) stopped treatment and 36 patients (24.8%) died.The median PFS is 8.9 months and the mid -bit OS is 12.9 months.
Figure 1. The Kaplan-Meier curve of OS and PFS
ORR is 34.5%,Patients with a complete relief (CR) accounted for 4.8%, the partial relief (PR) rate was 29.6%, and the disease control rate (DCR) was 87.6%.
Figure 2. The treatment response in the research queue
In terms of security, there are 137In example, patients (94.5%) had adverse events (AE), of which 51 patients (35.2%) appeared 3 or level 4 AE.The most common AE is fatigue (59.2%), neutral granulocytes (46.2%), anemia (43.2%), and platelet reduction (34.3%).
Real World Research and TOPAZ-1 research complement each
In the tide tide of tumor immunotherapy, immune combined therapy brings new hope to tumor patients.Phase III Keynote-966 clinical trial confirmed the benefits of immunotherapy combined with chemotherapy for BTC treatment [3].TOPAZ-1 Studies combined with the combination of Permutsukaguya on the basis of previous standard chemotherapy to further improve the survival benefits of patients. The results of global data show that compared with individual chemotherapy, the combined standard chemotherapy team of Diagaruyuke will patients.The risk of death was reduced by 24% (HR = 0.76; 95% CI, 0.64-0.91), and the median OS was 12.9 months, which was better than the individual chemotherapy group for 11.3 months [1].
2023 ESMO conference reported that Topaz-studies of Asian group data for Chinese patients [4], further supporting the first-line standard treatment of Du Diabulu combined chemotherapy as a Chinese BTC patient.Overall, compared with the global queue, the patients baseline levels in the group of China are worse and the treatment is more difficult.When the maturity of data in mainland China is similar to global data, OSs HR reaches 0.79 (P = 0.009). The result further confirmed the positive results of Topaz-1 research, and the benefits of people in different countries in the world are consistent.
Topaz-1 study laid the first-line therapeutic position of immunochemical combined chemotherapy in advanced BTC. The real world research released by Liver International magazine basically confirmed the results of Topaz-1 research.Among them, the median PFS of Du Diartabi combined with standard chemotherapy is 8.9 months, which is consistent with the median PFS of the TOPAZ-1 test.The report of the report was consistent with 12.9 months; the Orr and DCR in the real world were 34.5%and 87.6%, respectively, and the ORR and DCR in Topaz-1 studies were 26.7%and 85.3%, respectively.
The research still has some limitations. For example, the tumor evaluation mode and time point are not pre -defined solutions, but by each doctor themselves. This difference may be PFS.The assessment has an impact.In addition, the median follow -up time of the study is short, and the longer follow -up time will be verified in the future.
In general, this research is the first real world study that uses Garcapi with Gascibbine and Cisplatin for BTC first-line therapy. The research results are topaz-1 Research on the results obtained by PFS, ORR and security.It is believed that with the continuous deepening of exploration and further deepening the understanding of the biological characteristics of various types of biliary tumor, the new breakthrough is just around the corner, which will benefit more BTC patients.
References:
[1] oh dy, ruth he a, qin s, et al. et al.Durvalumab Plus Gemcitabine and Cisplatin in Advanced Bilily Tract Cancer. Nejm Evid. 2022; 1 (8): Evidoa2200015.
[2] Rimini M, For for naro l, longi s, et al.Durvalumab Plus Gemcitabine and Cisplatin in Advanced Bilily Tract Cancer: An Early Explrative Analysis of Reald Data. 2023; 43 (8): 1803-1812.
[3]Kelley RK, Ueno M, YOOO C, Et Al. PEMBROLIZUMAB in Combination with Gemcitabine and Cisplatin with Gemcitabine and Cisplatin Alone with Advanced Biliary Tract Cancer3 TRIAL. Lancet. 2023; 401 (10391): 1853-1865.
[4] qin S, et al. 98p -effical and Safety of Durvalumab Plus Gemcitabine and CISP CISP CISP CISP CISP CISP CISP CISP Latin in ChineseParticipants with Advanced Billy Tract Cancer: Extension Cohort of the Phase III, Randomised, Double-Blind, Placeboard, Global Topaz-Study. ESMO 202 3.
Approval Number: CN-145590 Date: 2025-03-31
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