1. Initial Use Experience of Durvalumab Plus Gemcitabine and Cisplatin for Advanced Biliary Tract Cancer in a Japanese Territory Center.
- Author
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Shionoya, Kento, Sofuni, Atsushi, Mukai, Shuntaro, Yamauchi, Yoshiya, Tsuchiya, Takayoshi, Tanaka, Reina, Tonozuka, Ryosuke, Yamamoto, Kenjiro, Nagai, Kazumasa, Matsunami, Yukitoshi, Kojima, Hiroyuki, Minami, Hirohito, Hirakawa, Noriyuki, Zhan, Qiang, and Itoi, Takao
- Subjects
THERAPEUTIC use of antineoplastic agents ,THERAPEUTIC use of monoclonal antibodies ,BILE duct tumors ,CISPLATIN ,ANTINEOPLASTIC agents ,TREATMENT effectiveness ,RETROSPECTIVE studies ,CANCER chemotherapy ,GEMCITABINE ,DRUG efficacy ,MEDICAL records ,ACQUISITION of data ,MEDICAL drainage ,SURVIVAL analysis (Biometry) ,PROGRESSION-free survival ,OVERALL survival - Abstract
Simple Summary: Biliary tract cancers (BTCs) present a challenging prognosis. However, advancements in chemotherapy, particularly the use of targeted therapies for specific gene mutations, have led to improved patient outcomes. This retrospective single-center study evaluated 44 patients who received gemcitabine and cisplatin, combined with durvalumab (GCD) chemotherapy, from January 2023 to March 2024, with a median follow-up of 10 months. This study assessed overall survival (OS), progression-free survival (PFS), response rates, and adverse events (AEs). Results indicate an overall response rate of 23% and a disease control rate of 82%. Median OS and PFS were 15.3 and 8.0 months, respectively. Patients receiving primary chemotherapy exhibited prolonged survival, while bile duct drainage was associated with improved outcomes. Notably, Grade 3 or higher AEs occurred in 54.5% of patients. Overall, GCD chemotherapy demonstrates significant potential for BTC treatment, underscoring the importance of bile duct management in enhancing patient outcomes. Background: Biliary tract cancers (BTCs), including gallbladder and bile duct cancers, have a poor prognosis. Recent advances in chemotherapy, such as using targeted drugs for specific gene mutations, have improved outcomes. Gemcitabine plus cisplatin chemotherapy has been the standard of care for the primary treatment of BTCs, but secondary treatment had not been established until recently. In recent years, durvalumab plus gemcitabine and cisplatin (GCD) chemotherapy is emerging as a promising regimen, although more evidence is needed for its effectiveness. Methods: This retrospective single-center study involved 44 patients receiving GCD treatment between January 2023 and March 2024 with a median follow-up of 10 months. Outcomes focused on overall survival (OS), progression-free survival (PFS), response rates, and adverse events (AEs). Results: The overall response rate (ORR) was 23%, and the disease control rate (DCR) was 82%. The overall median OS and PFS were 15.3 and 8.0 months, respectively, with patients receiving primary chemotherapy experiencing longer survival compared to a control group. Patients who did not undergo bile duct drainage had statistically different better OS and PFS. Grade 3 or higher AEs occurred in 54.5% of patients, with neutropenia and biliary infections being common. Conclusions: GCD chemotherapy shows potential as an effective treatment for BTCs. The favorable treatment outcome was the response rate, particularly in primary therapy or those cases with no metastasis. Bile duct management is crucial for improving patient outcomes. GCD chemotherapy has a high response rate, PFS, and OS compared to other forms of chemotherapy. [ABSTRACT FROM AUTHOR]
- Published
- 2025
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