Loading...
|
Please use this identifier to cite or link to this item:
http://ir.nhri.org.tw/handle/3990099045/8528
|
| Title: | A KRAS mutation status-stratified randomized phase II trial of gemcitabine and oxaliplatin alone or in combination with cetuximab in advanced biliary tract cancer |
| Authors: | Chen, JS;Hsu, C;Chiang, NJ;Tsai, CS;Tsou, HH;Huang, SF;Bai, LY;Chang, IC;Shiah, HS;Ho, CL;Yen, CJ;Lee, KD;Chiu, CF;Rau, KM;Yu, MS;Yang, Y;Hsieh, RK;Chang, JY;Shan, YS;Chao, Y;Chen, LT |
| Contributors: | National Institute of Cancer Research;Division of Biostatistics and Bioinformatics;Institute of Molecular and Genomic Medicine |
| Abstract: | BACKGROUND: Previous clinical trials have not proved that adding epidermal growth factor receptor inhibitors to chemotherapy confers a survival benefit for patients with advanced biliary tract cancer (ABTC). Whether the KRAS mutation status of tumor cells confounded the results of past studies is unknown. PATIENTS AND METHODS: ABTC patients stratified by KRAS status, Eastern Cooperative Oncology Group performance status, and primary tumor location were randomized 1:1 to receive GEMOX (800 mg/m2 gemcitabine and 85 mg/m2 oxaliplatin) or C-GEMOX (500 mg/m2 cetuximab plus GEMOX) every 2 weeks. The primary endpoint was objective response rate (ORR). RESULTS: The study enrolled 122 patients between December 2010 and May 2012 (62 treated with C-GEMOX and 60 with GEMOX). Compared to GEMOX alone, C-GEMOX was associated with trend to better ORR (27% vs. 15%; p=0.12) and progression-free survival (PFS, 6.7 vs. 4.1 months; p=0.05), but not overall survival (OS, 10.6 vs. 9.8 months; p=0.91). KRAS mutations, which were detected in 36% of tumor samples, did not affect the trends of difference in ORR and PFS between C-GEMOX and GEMOX. The two treatment arms had similar adverse events, except that more patients had skin rashes, allergic reactions, and neutropenia in the C-GEMOX arm. Of patients with C-GEMOX, the presence of a grade 2 or 3 skin rash was associated with significantly better ORR, PFS, and OS. CONCLUSIONS: Addition of cetuximab did not significantly improve the ORR of GEMOX chemotherapy in ABTC, although a trend of PFS improvement was observed. The trend of improvement did not correlate with KRAS mutation status. |
| Date: | 2015-05 |
| Relation: | Annals of Oncology. 2015 May;26(5):943-949. |
| Link to: | http://dx.doi.org/10.1093/annonc/mdv035 |
| JIF/Ranking 2023: | http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcAuth=NHRI&SrcApp=NHRI_IR&KeyISSN=0923-7534&DestApp=IC2JCR |
| Cited Times(WOS): | https://www.webofscience.com/wos/woscc/full-record/WOS:000353830000017 |
| Cited Times(Scopus): | http://www.scopus.com/inward/record.url?partnerID=HzOxMe3b&scp=84929091392 |
| Appears in Collections: | [陳立宗] 期刊論文
[張俊彥] 期刊論文
[姜乃榕] 期刊論文
[鄒小蕙] 期刊論文
[黃秀芬] 期刊論文
|
Files in This Item:
| File |
Description |
Size | Format | |
|---|
| PUB25632066.pdf | | 323Kb | Adobe PDF | 626 | View/Open |
|
All items in NHRI are protected by copyright, with all rights reserved.
|
