PMID- 16052341
OWN - NLM
STAT- MEDLINE
DCOM- 20060316
LR  - 20181203
IS  - 0344-5704 (Print)
IS  - 0344-5704 (Linking)
VI  - 57
IP  - 4
DP  - 2006 Apr
TI  - A phase II, open-label study of gefitinib (IRESSA) in patients with locally 
      advanced, metastatic, or relapsed renal-cell carcinoma.
PG  - 533-9
AB  - 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 500 mg/day. 
      Objective responses (ORs) were assessed every 2 months 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 110 days (95% confidence interval [CI]: 55, 117); median overall survival was 
      303 days (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 > or =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.
FAU - Jermann, Monika
AU  - Jermann M
AD  - Clinic and Policlinic of Oncology, University Hospital, Zurich, Switzerland. 
      monika.jermann@ksbh.ch
FAU - Stahel, Rolf A
AU  - Stahel RA
FAU - Salzberg, Marc
AU  - Salzberg M
FAU - Cerny, Thomas
AU  - Cerny T
FAU - Joerger, Markus
AU  - Joerger M
FAU - Gillessen, Silke
AU  - Gillessen S
FAU - Morant, Rudolf
AU  - Morant R
FAU - Egli, Fritz
AU  - Egli F
FAU - Rhyner, Kaspar
AU  - Rhyner K
FAU - Bauer, Jean A
AU  - Bauer JA
FAU - Pless, Miklos
AU  - Pless M
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20050729
PL  - Germany
TA  - Cancer Chemother Pharmacol
JT  - Cancer chemotherapy and pharmacology
JID - 7806519
RN  - 0 (Antineoplastic Agents)
RN  - 0 (Quinazolines)
RN  - EC 2.7.10.1 (ErbB Receptors)
RN  - S65743JHBS (Gefitinib)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Antineoplastic Agents/adverse effects/*therapeutic use
MH  - Carcinoma, Renal Cell/*drug therapy/metabolism/pathology
MH  - ErbB Receptors/biosynthesis/genetics
MH  - Female
MH  - Gefitinib
MH  - Humans
MH  - Kidney Neoplasms/*drug therapy/metabolism/pathology
MH  - Male
MH  - Middle Aged
MH  - Neoplasm Metastasis
MH  - Quinazolines/adverse effects/*therapeutic use
MH  - Recurrence
MH  - Tomography, X-Ray Computed
EDAT- 2005/07/30 09:00
MHDA- 2006/03/17 09:00
CRDT- 2005/07/30 09:00
PHST- 2005/04/14 00:00 [received]
PHST- 2005/06/22 00:00 [accepted]
PHST- 2005/07/30 09:00 [pubmed]
PHST- 2006/03/17 09:00 [medline]
PHST- 2005/07/30 09:00 [entrez]
AID - 10.1007/s00280-005-0070-z [doi]
PST - ppublish
SO  - Cancer Chemother Pharmacol. 2006 Apr;57(4):533-9. doi: 10.1007/s00280-005-0070-z. 
      Epub 2005 Jul 29.