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

Title
A phase II trial of erlotinib in combination with gemcitabine and capecitabine in previously untreated metastatic/recurrent pancreatic cancer: combined analysis with translational research
Author(s)
이경희Oh do youn[Oh do youn]Lee keun wook[Lee keun wook]Sohn chang hak[Sohn chang hak]Park young suk[Park young suk]Zang dae young[Zang dae young]Ryoo hun mo[Ryoo hun mo]Song hong suk[Song hong suk]Kim jin soo[Kim jin soo]Kang hye jin[Kang hye jin]Kim bong seog[Kim bong seog]Bang yung jue[Bang yung jue]
Keywords
RECEPTOR INTRON-1 POLYMORPHISM; COOPERATIVE-ONCOLOGY-GROUP; RIBONUCLEOTIDE REDUCTASE; PLUS GEMCITABINE; SURVIVAL; EXPRESSION; PHARMACOGENETICS; OVEREXPRESSION; ADENOCARCINOMA; TRANSCRIPTION
Issue Date
201206
Publisher
SPRINGER
Citation
INVESTIGATIONAL NEW DRUGS, v.30, no.3, pp.1164 - 1174
Abstract
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/m(2) of gemcitabine was given on D1,8,15 and 1660 mg/m(2)/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.
URI
http://hdl.handle.net/YU.REPOSITORY/28051http://dx.doi.org/10.1007/s10637-011-9651-3
ISSN
0167-6997
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의과대학 > 내과학교실 > Articles
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