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A phase Ⅱ trial of erlotinib in combination with gemcitabine and capecitabine in previously untreated metastatic/ recurrent pancreatic cancer: combined analysis with translational research

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Author(s)
Do-Youn OhKeun Wook LeeKyung-Hee LeeChang-Hak SohnYoung Suk ParkDae Young ZangHun-Mo RyooHong-Suk SongJin-Soo KimHye-Jin KangBong-Seog KimYung-Jue Bang
Keimyung Author(s)
Song, Hong Suk
Department
Dept. of Internal Medicine (내과학)
Journal Title
Investigational New Drugs
Issued Date
2012
Volume
30
Issue
3
Abstract
Summary

Background To confirm the efficacy and toxicity of Erlotinib in combination with Gemcitabine and Capecitabine when used as a first-line therapy in metastatic/recurrent pancreatic cancer (PC). Methods Locally advanced PC was excluded. Erlotinib was given at a dose of 100 mg daily from D1 to D28. 1000 mg/m2 of gemcitabine was given on D1,8,15 and 1660 mg/m2/day of capecitabine was given from D1 to 21, repeated every 4 weeks. Response was assessed every 8 weeks. Results A total of 47 patients were enrolled. Response rate and disease control rate was 32.6% (95% CI, 18.6–46.6%) and 83.7% (95% CI, 72.7–94.7%) respectively. The PFS was 6.5 months (95% CI, 3.4–9.7) and OS was 12.0 months (95% CI, 8.6–15.9). The Gr 3/4 toxicities were: neutropenia (6.8%), thrombocytopenia (3.2%), anemia (1.6%). nausea (1.6%), vomiting (1.6%), anorexia (5.3%), rash (2.4%). The EGFR expression was associated with shorter OS and ERCC2 expression was associated with longer PFS and OS. PFS and OS were not different according to K-RAS mutation or polymorphism of RRM1 and CDA. Conclusions Erlotinib, gemcitabine and capecitabine combination showed promising efficacy and good tolerability in metastatic PC. This efficacy was observed irrespective of K-RAS mutation, and EGFR expression was poor prognostic factor for OS.
Keimyung Author(s)(Kor)
송홍석
Publisher
School of Medicine
Citation
Do-Youn Oh et al. (2012). A phase Ⅱ trial of erlotinib in combination with gemcitabine
and capecitabine in previously untreated metastatic/
recurrent pancreatic cancer: combined analysis
with translational research. Investigational New Drugs, 30(3), 1164–1174. doi: 10.1007/s10637-011-9651-3
Type
Article
ISSN
0167-6997
Source
https://link.springer.com/article/10.1007%2Fs10637-011-9651-3
DOI
10.1007/s10637-011-9651-3
URI
https://kumel.medlib.dsmc.or.kr/handle/2015.oak/36029
Appears in Collections:
1. School of Medicine (의과대학) > Dept. of Internal Medicine (내과학)
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