Loading...
|
Please use this identifier to cite or link to this item:
http://ir.nhri.org.tw/handle/3990099045/14447
|
| Title: | Impaired chromatin remodeling predicts better survival to modified gemcitabine and S-1 plus nivolumab in advanced biliary tract Cancer: A phase II T1219 study |
| Authors: | Chiang, NJ;Tan, KT;Bai, LY;Hsiao, CF;Huang, CY;Hung, YP;Huang, CJ;Chen, SC;Shan, YS;Chao, Y;Huang, YH;Lee, IC;Lee, PC;Su, YY;Chen, SJ;Yeh, CN;Chen, LT;Chen, MH |
| Contributors: | National Institute of Cancer Research;Institute of Population Health Sciences |
| Abstract: | PURPOSE: Modified Gemcitabine and S-1 is an active regimen for patients with advanced biliary tract cancer (ABTC) in our previous study. Herein, we report the results of a single-arm phase II of Nivolumab plus modified GS (NGS) as first-line treatment in ABTC. PATIENTS AND METHODS: Patients received Nivolumab 240 mg and 800 mg/m2 Gemcitabine on day 1 plus daily 80/100/120 mg of S-1 (based on body surface area) on days 1-10, in a 2-week cycle. The primary endpoint was the objective response rate (ORR). The correlation between therapeutic efficacy and genetic alterations with signatures identified by targeted next-generation sequencing panels was explored. RESULTS: Between December 2019 and December 2020, 48 eligible patients were enrolled. After a median of 17.6 months of follow-up, the ORR was 45.9% (95% confidence interval [CI], 31.4%-60.8%). The median progression-free survival (PFS) and overall survival (OS) was 9.1 (95% CI, 5.8-9.6) and 19.2 (95% CI, 11.6-not reached) months, respectively. All grade 3/4 treatment-related adverse events (AEs) were less than 10%, except fatigue (14.6%) and skin rash (10.4%). Eighteen patients (35.4%) experienced immune-related AEs without treatment-related death. TMB-H (top 20%; ≥7.1 mut/Mb) only predicted prolonged median PFS but not OS. Up to 28.9% of patients who harbored loss-of-function mutations in chromatin remodeling genes demonstrated significantly longer median PFS and OS than those without alterations. CONCLUSIONS: NGS is a safe and promising regimen in ABTC. Impaired functions of chromatin remodeling genes may be a potential surrogate biomarker with predictive value in the current study. |
| Date: | 2022-10 |
| Relation: | Clinical Cancer Research. 2022 Oct 3;28(19):4248-4257. |
| Link to: | http://dx.doi.org/10.1158/1078-0432.Ccr-22-1152 |
| JIF/Ranking 2023: | http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcAuth=NHRI&SrcApp=NHRI_IR&KeyISSN=1078-0432&DestApp=IC2JCR |
| Cited Times(WOS): | https://www.webofscience.com/wos/woscc/full-record/WOS:000866452900001 |
| Cited Times(Scopus): | https://www.scopus.com/inward/record.url?partnerID=HzOxMe3b&scp=85139535605 |
| Appears in Collections: | [陳立宗] 期刊論文
[姜乃榕] 期刊論文
[蘇勇曄] 期刊論文
[蕭金福] 期刊論文
|
Files in This Item:
| File |
Description |
Size | Format | |
|---|
| PUB35849151.pdf | | 2021Kb | Adobe PDF | 174 | View/Open |
|
All items in NHRI are protected by copyright, with all rights reserved.
|
