PMID- 17161453
OWN - NLM
STAT- MEDLINE
DCOM- 20070522
LR  - 20181201
IS  - 0090-8258 (Print)
IS  - 0090-8258 (Linking)
VI  - 105
IP  - 1
DP  - 2007 Apr
TI  - Gefitinib in combination with tamoxifen in patients with ovarian cancer 
      refractory or resistant to platinum-taxane based therapy--a phase II trial of the 
      AGO Ovarian Cancer Study Group (AGO-OVAR 2.6).
PG  - 132-7
AB  - BACKGROUND: Tamoxifen and gefitinib (IRESSA) combination therapy was studied in 
      patients with ovarian cancer refractory or resistant to platinum- and 
      taxane-based therapy. PATIENTS AND METHODS: In this phase II study, 56 patients 
      with epithelial ovarian carcinoma or cancer of the fallopian tube or peritoneum 
      received oral tamoxifen 40 mg/day and gefitinib 500 mg/day until progression or 
      unacceptable toxicity. RESULTS: Seventeen patients (mean age: 59.6 years) had 
      previously received first-line platinum/taxane treatment only, while 39 had 
      received 2-8 (median 2) prior chemotherapy regimens. Gefitinib dose reduction to 
      250 mg/day was performed in 10 patients (14.9%), predominantly due to diarrhea (6 
      patients [10.7%]). Trial medication was discontinued in 6 patients (10.7%) due to 
      adverse events (AEs). The most frequent drug-related AEs were diarrhea and 
      acne-like skin rash. There were no tumor responses, but 16 patients had stable 
      disease. Median time-to-progression was 58 days (95% CI, 55-71 days) and median 
      survival was 253 days (95% CI, 137-355 days). CONCLUSION: Gefitinib plus 
      tamoxifen did not appear to be efficacious in the treatment of patients with 
      refractory/resistant ovarian cancer. The addition of tamoxifen did not worsen the 
      known side effects of gefitinib, or induce additional side effects.
FAU - Wagner, Uwe
AU  - Wagner U
AD  - Department of Gynecology, Gynecologic Endocrinology and Oncology, 
      Philipps-University Marburg, Baldingerstrasse, D-35043 Marburg, Germany. 
      uwe.wagner@med.uni-marburg.de
FAU - du Bois, Andreas
AU  - du Bois A
FAU - Pfisterer, Jacobus
AU  - Pfisterer J
FAU - Huober, Jens
AU  - Huober J
FAU - Loibl, Sybille
AU  - Loibl S
FAU - Luck, Hans-Joachim
AU  - Luck HJ
FAU - Sehouli, Jalid
AU  - Sehouli J
FAU - Gropp, Martina
AU  - Gropp M
FAU - Stahle, Anne
AU  - Stahle A
FAU - Schmalfeldt, Barbara
AU  - Schmalfeldt B
FAU - Meier, Werner
AU  - Meier W
FAU - Jackisch, Christian
AU  - Jackisch C
CN  - AGO Ovarian Cancer Study Group
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20061211
PL  - United States
TA  - Gynecol Oncol
JT  - Gynecologic oncology
JID - 0365304
RN  - 0 (Bridged-Ring Compounds)
RN  - 0 (Organoplatinum Compounds)
RN  - 0 (Quinazolines)
RN  - 0 (Taxoids)
RN  - 094ZI81Y45 (Tamoxifen)
RN  - 1605-68-1 (taxane)
RN  - S65743JHBS (Gefitinib)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Antineoplastic Combined Chemotherapy Protocols/adverse 
      effects/pharmacology/*therapeutic use
MH  - Bridged-Ring Compounds/administration & dosage/pharmacology
MH  - Drug Resistance, Neoplasm
MH  - Epithelial Cells/pathology
MH  - Female
MH  - Gefitinib
MH  - Humans
MH  - Middle Aged
MH  - Organoplatinum Compounds/administration & dosage/pharmacology
MH  - Ovarian Neoplasms/*drug therapy
MH  - Patient Compliance
MH  - Quinazolines/administration & dosage/adverse effects
MH  - Tamoxifen/administration & dosage/adverse effects
MH  - Taxoids/administration & dosage/pharmacology
EDAT- 2006/12/13 09:00
MHDA- 2007/05/23 09:00
CRDT- 2006/12/13 09:00
PHST- 2006/06/30 00:00 [received]
PHST- 2006/10/28 00:00 [revised]
PHST- 2006/10/31 00:00 [accepted]
PHST- 2006/12/13 09:00 [pubmed]
PHST- 2007/05/23 09:00 [medline]
PHST- 2006/12/13 09:00 [entrez]
AID - S0090-8258(06)00898-5 [pii]
AID - 10.1016/j.ygyno.2006.10.053 [doi]
PST - ppublish
SO  - Gynecol Oncol. 2007 Apr;105(1):132-7. doi: 10.1016/j.ygyno.2006.10.053. Epub 2006 
      Dec 11.