Gemcitabine plus sorafenib versus gemcitabine alone in advanced biliary tract cancer: a double-blind placebo-controlled multicentre phase II AIO study with biomarker and serum programme.
Abstract | BACKGROUND: PATIENTS AND METHODS: RESULTS:
Gemcitabine plus sorafenib was generally well tolerated. Four and three patients achieved partial responses in the sorafenib and placebo groups, respectively. There was no difference in the primary end-point, median progression-free survival (PFS) for gemcitabine plus sorafenib versus gemcitabine plus placebo (3.0 versus 4.9 months, P=0.859), and no difference for median overall survival (OS) (8.4 versus 11.2 months, P=0.775). Patients with liver metastasis after resection of primary BTC survived longer with sorafenib (P=0.019) compared to placebo. Patients who developed hand-foot syndrome (HFS) showed longer PFS and OS than patients without HFS. Two sorafenib targets, VEGFR-2 and c-kit, were not expressed in BTC samples. VEGFR-3 and Hif1α were associated with lymph node metastases and T stage. Absence of PDGFRβ expression correlated with longer PFS. CONCLUSION: The addition of sorafenib to gemcitabine did not demonstrate improved efficacy in advanced BTC patients. Biomarker subgroup analysis suggested that some patients might benefit from combined treatment.
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Authors | M Moehler, A Maderer, C Schimanski, S Kanzler, U Denzer, F T Kolligs, M P Ebert, A Distelrath, M Geissler, J Trojan, M Schütz, L Berie, C Sauvigny, F Lammert, A Lohse, M M Dollinger, U Lindig, E M Duerr, N Lubomierski, S Zimmermann, D Wachtlin, A-K Kaiser, S Schadmand-Fischer, P R Galle, M Woerns, Working Group of Internal Oncology |
Journal | European journal of cancer (Oxford, England : 1990)
(Eur J Cancer)
Vol. 50
Issue 18
Pg. 3125-35
(Dec 2014)
ISSN: 1879-0852 [Electronic] England |
PMID | 25446376
(Publication Type: Clinical Trial, Phase II, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | Copyright © 2014 The Authors. Published by Elsevier Ltd.. All rights reserved. |
Chemical References |
- Biomarkers, Tumor
- Chemokine CXCL12
- Phenylurea Compounds
- Vascular Endothelial Growth Factors
- Deoxycytidine
- Niacinamide
- Sorafenib
- Vascular Endothelial Growth Factor Receptor-2
- Gemcitabine
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Topics |
- Adult
- Aged
- Aged, 80 and over
- Antineoplastic Combined Chemotherapy Protocols
(therapeutic use)
- Bile Duct Neoplasms
(drug therapy, metabolism, pathology)
- Bile Ducts, Intrahepatic
- Biliary Tract Neoplasms
(drug therapy, metabolism, pathology)
- Biomarkers, Tumor
(metabolism)
- Chemokine CXCL12
(metabolism)
- Deoxycytidine
(administration & dosage, adverse effects, analogs & derivatives)
- Disease-Free Survival
- Double-Blind Method
- Drug Administration Schedule
- Female
- Gallbladder Neoplasms
(drug therapy, metabolism, pathology)
- Hand-Foot Syndrome
(etiology)
- Humans
- Kaplan-Meier Estimate
- Male
- Middle Aged
- Niacinamide
(administration & dosage, adverse effects, analogs & derivatives)
- Phenylurea Compounds
(administration & dosage, adverse effects)
- Prospective Studies
- Quality of Life
- Sorafenib
- Treatment Outcome
- Vascular Endothelial Growth Factor Receptor-2
(metabolism)
- Vascular Endothelial Growth Factors
(metabolism)
- Gemcitabine
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