التفاصيل البيبلوغرافية
| العنوان: |
Bortezomib in previously treated phosphatase and tension homology‐deficient patients with advanced intrahepatic cholangiocarcinoma: An open‐label, prospective and single‐centre phase II trial |
| المؤلفون: |
Zeng, Tian‐mei, Jiang, Tian‐yi, Yang, Guang, Cheng, Zhuo, Lou, Cheng, Wei, Wei, Tao, Chen‐jie, Hu, Shouzi, Wang, Hui, Cui, Xiao‐wen, Tan, Ye‐xiong, Dong, Li‐wei, Wang, Hong‐yang, Yuan, Zhen‐gang |
| المساهمون: |
National Natural Science Foundation of China |
| المصدر: |
Clinical and Translational Medicine ; volume 14, issue 5 ; ISSN 2001-1326 2001-1326 |
| بيانات النشر: |
Wiley |
| سنة النشر: |
2024 |
| المجموعة: |
Wiley Online Library (Open Access Articles via Crossref) |
| الوصف: |
Introduction Intrahepatic cholangiocarcinoma (ICC) is characterized by a dismal prognosis with limited therapeutic alternatives. To explore phosphatase and tension homolog (PTEN) as a biomarker for proteasome inhibition in ICC, we conducted a phase II trial to assess the second‐line efficacy of bortezomib in PTEN‐deficient advanced ICC patients. Methods A total of 130 patients with advanced ICC in our centre were screened by PTEN immunohistochemical staining between 1 July 2017, and 31 December 2021, and 16 patients were ultimately enrolled and treated with single‐agent bortezomib 1.3 mg/m 2 on days 1, 4, 8 and 11 of a 21‐day cycle. The primary endpoint was the objective response rate (ORR) according to Response Evaluation Criteria in Solid Tumors v1.1. Results The median follow‐up was 6.55 months (95% confidence interval [CI]: 0.7–19.9 months). Among the 16 enrolled patients, the ORR was 18.75% (3/16) and the disease control rate was 43.75% (7/16). The median progress‐free survival was 2.95 months (95% CI: 2.1–5.1 months) and the median overall survival (mOS) was 7.2 months (95% CI: 0.7–21.6 months) in the intent‐to‐treat‐patients. Treatment‐related adverse events of any grade were reported in 16 patients, with thrombopenia being the most common toxicity. Patients with PTEN staining scores of 0 were more likely to benefit from bortezomib than those with staining scores > 0. Conclusions Bortezomib yielded an encouraging objective response and a favourable OS as a second‐line agent in PTEN‐deficient ICC patients. Our findings suggest bortezomib as a promising therapeutic option for patients with PTEN‐deficient ICC. Highlights There is a limited strategy for the second‐line option of intrahepatic cholangiocarcinoma (ICC). This investigator‐initiated phase 2 study evaluated bortezomib in ICC patients with phosphatase and tension homology deficiency. The overall response rate was 18.75% and the overall survival was 7.2 months in the intent‐to‐treat cohort. These results justify further developing ... |
| نوع الوثيقة: |
article in journal/newspaper |
| اللغة: |
English |
| DOI: |
10.1002/ctm2.1675 |
| الإتاحة: |
https://doi.org/10.1002/ctm2.1675Test |
| حقوق: |
http://creativecommons.org/licenses/by/4.0Test/ |
| رقم الانضمام: |
edsbas.5D54F799 |
| قاعدة البيانات: |
BASE |
