title: Efficacy of letrozole in the treatment of recurrent platinum- and taxane-resistant high-grade cancer of the ovary or peritoneum.
abstract: OBJECTIVE
  To evaluate the efficacy and safety of letrozole in patients with recurrent platinum- and taxane-resistant estrogen receptor-positive (ER+) high-grade cancer of the ovary or peritoneum.
  
  
  METHODS
  A single-institution, phase II study was performed in women with recurrent ER+ epithelial carcinoma of the ovary or peritoneum. All patients had measurable disease. Letrozole was administered at a dose of 2.5 mg orally once daily until disease progression or toxicity occurred.
  
  
  RESULTS
  Thirty-three patients were enrolled. The median age was 63 years (range, 38 to 83 years). Twenty-three patients (74%) had received three or more prior chemotherapy regimens. The 31 patients evaluable for response received a total of 81 cycles (4 weeks/cycle) of therapy (range, 1 to 14 cycles/patient). The median treatment duration was 8 weeks (range, 4 to 52 weeks). None of the patients had a complete response (CR), 1 (3%) had a partial response (PR), and 7 (23%) had stable disease (SD). The median duration of clinical benefit (SD and PR) was 9 weeks (range, 7 to 46 weeks). The median follow-up for all patients was 25 weeks. All patients were evaluable for toxicity. The most common adverse effects were fatigue (36%) and diaphoresis (21%). No grade 3 or 4 toxicities were reported, and no patients discontinued treatment owing to adverse effects. Eighteen patients (58%) went on to receive additional therapy with other agents.
  
  
  CONCLUSIONS
  In patients with ER-positive, platinum- and taxane-resistant high-grade ovarian and primary peritoneal cancer treated with letrozole, 26% derived a clinical benefit (SD and PR).
authors.affiliation: Department of Gynecologic Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, TX 77230-1439, USA. peramire@mdanderson.org
authors.forename: Pedro T
authors.initials: PT
authors.lastname: Ramirez
authors.forename: Kathleen M
authors.initials: KM
authors.lastname: Schmeler
authors.forename: Michael R
authors.initials: MR
authors.lastname: Milam
authors.forename: Brian M
authors.initials: BM
authors.lastname: Slomovitz
authors.forename: Judith A
authors.initials: JA
authors.lastname: Smith
authors.forename: John J
authors.initials: JJ
authors.lastname: Kavanagh
authors.forename: Michael
authors.initials: M
authors.lastname: Deavers
authors.forename: Charles
authors.initials: C
authors.lastname: Levenback
authors.forename: Robert L
authors.initials: RL
authors.lastname: Coleman
authors.forename: David M
authors.initials: DM
authors.lastname: Gershenson
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000627:therapeutic use* / Q000633:toxicity; D002945:Cisplatin / Q000627:therapeutic use; D018450:Disease Progression; D019008:Drug Resistance, Neoplasm / Q000187:drug effects; D005260:Female; D006801:Humans; D000077289:Letrozole; D008875:Middle Aged; D009570:Nitriles / Q000627:therapeutic use* / Q000633:toxicity; D010051:Ovarian Neoplasms / Q000188:drug therapy* / Q000473:pathology*; D010534:Peritoneal Neoplasms / Q000188:drug therapy* / Q000473:pathology*; D012008:Recurrence; D043823:Taxoids / Q000627:therapeutic use; D016896:Treatment Outcome; D014230:Triazoles / Q000627:therapeutic use* / Q000633:toxicity
chemical_list: D000970:Antineoplastic Agents; D009570:Nitriles; D043823:Taxoids; D014230:Triazoles; D000077289:Letrozole; D002945:Cisplatin