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1.
Anticancer Drugs ; 18(5): 581-6, 2007 Jun.
Article in English | MEDLINE | ID: mdl-17414627

ABSTRACT

The purpose of this study was to evaluate the efficacy and safety of an epirubicin, oxaliplatin and infusional 5-fluorouracil combination in patients with advanced gastric cancer. Patients with previously untreated advanced measurable gastric cancer received epirubicin (50 mg/m2, day 1), oxaliplatin (130 mg/m2 2-h infusion, day 1) and 5-fluorouracil (750 mg/m2, 24-h infusion, day 1-3) every 3 weeks. The primary endpoint of this phase II study was the response rate according to Response Evaluation Criteria in Solid Tumors. Out of 48 patients, 46 were evaluable for efficacy and 48 for toxicity. A median of five cycles (range 1-6) was administered. The overall best response rate was 47.8% (95% confidence interval 33-63%) including 2.2% complete responses and 45.6% partial responses. The median time for progression and median overall survival was 5 (95% confidence interval 4.1-5.9) and 11 months (95% confidence interval 8.1-13.9), respectively. Grade 3/4 neutropenia and leukocytopenia were observed in 25 and 12.5% of patients, respectively. Grade 3/4 nonhematological toxicities included nausea (6.3%), vomiting (14.6%), neurological toxicity (10.4%) and mucositis (2.1%). The epirubicin, oxaliplatin and infusional 5-fluorouracil regimen was effective and well tolerated as a front-line chemotherapy for patients with metastatic or advanced gastric cancer, and should be evaluated further.


Subject(s)
Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Stomach Neoplasms/drug therapy , Adult , Aged , Antibiotics, Antineoplastic/administration & dosage , Antimetabolites, Antineoplastic/administration & dosage , Antineoplastic Agents/administration & dosage , Antineoplastic Combined Chemotherapy Protocols/administration & dosage , Antineoplastic Combined Chemotherapy Protocols/adverse effects , Disease Progression , Endpoint Determination , Epirubicin/administration & dosage , Female , Fluorouracil/administration & dosage , Follow-Up Studies , Humans , Infusions, Intravenous , Male , Middle Aged , Neoplasm Metastasis/drug therapy , Neoplasm Metastasis/pathology , Organoplatinum Compounds/administration & dosage , Oxaliplatin , Stomach Neoplasms/pathology , Survival Analysis
2.
J Immunol ; 177(2): 1197-207, 2006 Jul 15.
Article in English | MEDLINE | ID: mdl-16818778

ABSTRACT

Intradermal (i.d.) immunization is a promising route of vaccine administration. Suitable i.d. adjuvants are important to increase vaccine efficacy in poorly responding populations such as the elderly or for dose-sparing strategies in the face of vaccine shortages. Bacterial exotoxins, such as Escherichia coli heat-labile enterotoxin (LT), exert strong immunostimulatory effects through binding to monosialoganglioside (GM1) cell surface receptors; however, injection is hampered by local inflammation. We demonstrate that the injection of LT formulations deficient in GM1 binding by mutation (LT(G33D)) or in vitro ligand coupling does not cause localized edema and inflammation in mice, yet these formulations retain potent adjuvant activity by enhancing functional Ab and cellular immune responses to coadministered Ags. Complete protection against in vivo lethal tetanus toxin challenge and the induction of Ag-specific CTL responses capable of killing target cells in vivo indicated in vivo efficacy of the induced immune responses. LT(G33D) proved superior to standard alum adjuvant regarding the magnitude and breadth of the induced immune responses. Immunizations in complex ganglioside knockout mice revealed a GM1-independent pathway of LT adjuvanticity. Immunostimulation by i.d. LT(G33D) is explained by its ability to induce migration of activated APCs to the proximal draining lymph nodes. LT(G33D) is a promising candidate adjuvant for human trials of parenteral vaccines in general and for current i.d. vaccine development in particular.


Subject(s)
Adjuvants, Immunologic/administration & dosage , Exotoxins/administration & dosage , G(M1) Ganglioside , Adjuvants, Immunologic/metabolism , Alum Compounds/administration & dosage , Alum Compounds/metabolism , Animals , Antibodies, Bacterial/biosynthesis , Antibodies, Bacterial/blood , Antigen-Presenting Cells/cytology , Antigen-Presenting Cells/immunology , Bacterial Toxins/administration & dosage , Cell Line, Tumor , Cell Movement/immunology , Cytotoxicity, Immunologic/genetics , Enterotoxins/administration & dosage , Escherichia coli Proteins/administration & dosage , Exotoxins/metabolism , Female , G(M1) Ganglioside/metabolism , Inflammation/immunology , Inflammation/prevention & control , Injections, Intradermal , Lymph Nodes/cytology , Lymph Nodes/immunology , Melanoma, Experimental , Mice , Mice, Inbred C3H , Mice, Inbred C57BL , Mice, Knockout , N-Acetylgalactosaminyltransferases/deficiency , N-Acetylgalactosaminyltransferases/genetics , Protein Binding/genetics , Protein Binding/immunology , T-Lymphocytes, Cytotoxic/immunology , Tetanus/genetics , Tetanus/immunology , Tetanus/prevention & control , Tetanus Toxoid/administration & dosage , Tetanus Toxoid/immunology , Tetanus Toxoid/metabolism
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