Header

UZH-Logo

Maintenance Infos

A phase II, open-label study of gefitinib (IRESSA) in patients with locally advanced, metastatic, or relapsed renal-cell carcinoma


Jermann, Monika; Stahel, Rolf A; Salzberg, Marc; Cerny, Thomas; Joerger, Markus; Gillessen, Silke; Morant, Rudolf; Egli, Fritz; Rhyner, Kaspar; Bauer, Jean A; Pless, Miklos (2006). A phase II, open-label study of gefitinib (IRESSA) in patients with locally advanced, metastatic, or relapsed renal-cell carcinoma. Cancer Chemotherapy and Pharmacology, 57(4):533-539.

Abstract

Epidermal growth factor receptor (EGFR) expression has been associated with clinical outcome in some studies of renal-cell carcinoma (RCC). We investigated the efficacy and safety of gefitinib (IRESSA), an EGFR tyrosine kinase inhibitor, in RCC patients. This phase II trial recruited 28 patients with advanced, metastatic, or relapsed RCC. Patients received oral gefitinib 500mg/day. Objective responses (ORs) were assessed every 2months according to RECIST. Baseline tumor biopsies were analyzed immunohistochemically for EGFR expression. At trial closure (March 2003), no ORs were seen but 14 patients (53.8%) had stable disease. At extended analysis (August 2004), median time to progression was 110days (95% confidence interval [CI]: 55, 117); median overall survival was 303days (95% CI 180, 444). Gefitinib was generally well tolerated. Skin rash and diarrhea were the most common drug-related adverse events (AEs) [54 and 39% of patients, respectively] and the most common drug-related grade 3/4 AEs (both 11%). The majority of tumor biopsies (91%) had ≥70% of tumor cells expressing membrane EGFR. Despite the lack of ORs in this study, disease control was observed in 53.8% of patients. Gefitinib was generally well tolerated and no unexpected drug-related AEs were observed

Abstract

Epidermal growth factor receptor (EGFR) expression has been associated with clinical outcome in some studies of renal-cell carcinoma (RCC). We investigated the efficacy and safety of gefitinib (IRESSA), an EGFR tyrosine kinase inhibitor, in RCC patients. This phase II trial recruited 28 patients with advanced, metastatic, or relapsed RCC. Patients received oral gefitinib 500mg/day. Objective responses (ORs) were assessed every 2months according to RECIST. Baseline tumor biopsies were analyzed immunohistochemically for EGFR expression. At trial closure (March 2003), no ORs were seen but 14 patients (53.8%) had stable disease. At extended analysis (August 2004), median time to progression was 110days (95% confidence interval [CI]: 55, 117); median overall survival was 303days (95% CI 180, 444). Gefitinib was generally well tolerated. Skin rash and diarrhea were the most common drug-related adverse events (AEs) [54 and 39% of patients, respectively] and the most common drug-related grade 3/4 AEs (both 11%). The majority of tumor biopsies (91%) had ≥70% of tumor cells expressing membrane EGFR. Despite the lack of ORs in this study, disease control was observed in 53.8% of patients. Gefitinib was generally well tolerated and no unexpected drug-related AEs were observed

Statistics

Citations

Dimensions.ai Metrics
42 citations in Web of Science®
51 citations in Scopus®
Google Scholar™

Altmetrics

Downloads

20 downloads since deposited on 03 Jul 2019
11 downloads since 12 months
Detailed statistics

Additional indexing

Item Type:Journal Article, refereed, original work
Communities & Collections:National licences > 142-005
Dewey Decimal Classification:570 Life sciences; biology
610 Medicine & health
Scopus Subject Areas:Health Sciences > Oncology
Life Sciences > Toxicology
Life Sciences > Pharmacology
Life Sciences > Cancer Research
Health Sciences > Pharmacology (medical)
Language:English
Date:1 April 2006
Deposited On:03 Jul 2019 13:10
Last Modified:15 Apr 2021 14:54
Publisher:Springer
ISSN:0344-5704
OA Status:Green
Publisher DOI:https://doi.org/10.1007/s00280-005-0070-z
PubMed ID:16052341

Download

Green Open Access

Download PDF  'A phase II, open-label study of gefitinib (IRESSA) in patients with locally advanced, metastatic, or relapsed renal-cell carcinoma'.
Preview
Content: Published Version
Language: English
Filetype: PDF (Nationallizenz 142-005)
Size: 231kB
View at publisher