title: 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).
abstract: BACKGROUND
  Tamoxifen and gefitinib (IRESSA) combination therapy was studied in patients with ovarian cancer refractory or resistant to platinum- and taxane-based therapy.
  
  
  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).
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Gynecology, Gynecologic Endocrinology and Oncology, Philipps-University Marburg, Baldingerstrasse, D-35043 Marburg, Germany. uwe.wagner@med.uni-marburg.de
authors.forename: Uwe
authors.initials: U
authors.lastname: Wagner
authors.forename: Andreas
authors.initials: A
authors.lastname: du Bois
authors.forename: Jacobus
authors.initials: J
authors.lastname: Pfisterer
authors.forename: Jens
authors.initials: J
authors.lastname: Huober
authors.forename: Sybille
authors.initials: S
authors.lastname: Loibl
authors.forename: Hans-Joachim
authors.initials: HJ
authors.lastname: Lück
authors.forename: Jalid
authors.initials: J
authors.lastname: Sehouli
authors.forename: Martina
authors.initials: M
authors.lastname: Gropp
authors.forename: Anne
authors.initials: A
authors.lastname: Stähle
authors.forename: Barbara
authors.initials: B
authors.lastname: Schmalfeldt
authors.forename: Werner
authors.initials: W
authors.lastname: Meier
authors.forename: Christian
authors.initials: C
authors.lastname: Jackisch
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D001952:Bridged-Ring Compounds / Q000008:administration & dosage / Q000494:pharmacology; D019008:Drug Resistance, Neoplasm; D004847:Epithelial Cells / Q000473:pathology; D005260:Female; D000077156:Gefitinib; D006801:Humans; D008875:Middle Aged; D009944:Organoplatinum Compounds / Q000008:administration & dosage / Q000494:pharmacology; D010051:Ovarian Neoplasms / Q000188:drug therapy*; D010349:Patient Compliance; D011799:Quinazolines / Q000008:administration & dosage / Q000009:adverse effects; D013629:Tamoxifen / Q000008:administration & dosage / Q000009:adverse effects; D043823:Taxoids / Q000008:administration & dosage / Q000494:pharmacology
chemical_list: D001952:Bridged-Ring Compounds; D009944:Organoplatinum Compounds; D011799:Quinazolines; D043823:Taxoids; D013629:Tamoxifen; C080625:taxane; D000077156:Gefitinib