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A Phase II Biomarker-Embedded Study of Lapatinib plus Capecitabine as First-line Therapy in Patients with Advanced or Metastatic Gastric Cancer
Molecular cancer therapeutics, 2016-09, Vol.15 (9), p.2251-2258
LaBonte, Melissa J
Yang, Dongyun
Zhang, Wu
Wilson, Peter M
Nagarwala, Yasir M
Koch, Kevin M
Briner, Colleen
Kaneko, Tomomi
Rha, Sun-Young
Gladkov, Oleg
Urba, Susan G
Sakaeva, Dina
Pishvaian, Michael J
Hsieh, Ruey-Kuen
Lee, Wei-Ping
Lenz, Heinz-Josef
2016
Details
Autor(en) / Beteiligte
LaBonte, Melissa J
Yang, Dongyun
Zhang, Wu
Wilson, Peter M
Nagarwala, Yasir M
Koch, Kevin M
Briner, Colleen
Kaneko, Tomomi
Rha, Sun-Young
Gladkov, Oleg
Urba, Susan G
Sakaeva, Dina
Pishvaian, Michael J
Hsieh, Ruey-Kuen
Lee, Wei-Ping
Lenz, Heinz-Josef
Titel
A Phase II Biomarker-Embedded Study of Lapatinib plus Capecitabine as First-line Therapy in Patients with Advanced or Metastatic Gastric Cancer
Ist Teil von
Molecular cancer therapeutics, 2016-09, Vol.15 (9), p.2251-2258
Ort / Verlag
United States
Erscheinungsjahr
2016
Link zum Volltext
Quelle
MEDLINE
Beschreibungen/Notizen
An exploratory phase II biomarker-embedded trial (LPT109747; NCT00526669) designed to determine the association of lapatinib-induced fluoropyrimidine gene changes with efficacy of lapatinib plus capecitabine as first-line treatment for advanced gastric cancer or gastroesophageal junction adenocarcinoma independent of tumor HER2 status. Tumor biopsies obtained before and after 7-day lapatinib (1,250 mg) to analyze changes in gene expression, followed by a 14-day course of capecitabine (1,000 mg/m(2) twice daily, 14/21 days) plus lapatinib 1,250 mg daily. Blood samples were acquired for pharmacokinetic analysis. Primary clinical objectives were response rate (RR) and 5-month progression-free survival (PFS). Secondary objectives were overall survival (OS), PFS, time to response, duration of response, toxicity, and identification of associations between lapatinib pharmacokinetics and biomarker endpoints. Primary biomarker objectives were modulation of 5-FU-pathway genes by lapatinib, effects of germline SNPs on treatment outcome, and trough steady-state plasma lapatinib concentrations. Sixty-eight patients were enrolled; (75% gastric cancer, 25% gastroesophageal junction). Twelve patients (17.9%) had confirmed partial response, 31 (46.3%) had stable disease, and 16 (23.9%) had progressive disease. Median PFS and OS were 3.3 and 6.3 months, respectively. Frequent adverse events included diarrhea (45%), decreased appetite (39%), nausea (36%), and fatigue (36%). Lapatinib induced no changes in gene expression from baseline and no significant associations were found for SNPs analyzed. Elevated baseline HER3 mRNA expression was associated with a higher RR (33% vs. 0%; P = 0.008). Lapatinib plus capecitabine was well tolerated, demonstrating modest antitumor activity in patients with advanced gastric cancer. The association of elevated HER3 and RR warrants further investigation as an important player for HER-targeted regimens in combination with capecitabine. Mol Cancer Ther; 15(9); 2251-8. ©2016 AACR.
Sprache
Englisch
Identifikatoren
ISSN: 1535-7163
eISSN: 1538-8514
DOI: 10.1158/1535-7163.MCT-15-0908
Titel-ID: cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_7496218
Format
–
Schlagworte
Antineoplastic Combined Chemotherapy Protocols - adverse effects
,
Antineoplastic Combined Chemotherapy Protocols - therapeutic use
,
Biomarkers
,
Capecitabine - administration & dosage
,
Disease Progression
,
Gene Amplification
,
Humans
,
Neoplasm Staging
,
Polymorphism, Single Nucleotide
,
Quinazolines - administration & dosage
,
Receptor, Epidermal Growth Factor - genetics
,
Receptor, Epidermal Growth Factor - metabolism
,
Receptor, ErbB-2 - genetics
,
Receptor, ErbB-2 - metabolism
,
Signal Transduction
,
Stomach Neoplasms - drug therapy
,
Stomach Neoplasms - metabolism
,
Stomach Neoplasms - mortality
,
Stomach Neoplasms - pathology
,
Treatment Outcome
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