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.

CONCLUSION:

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: Pedro T Ramirez, Kathleen M Schmeler, Michael R Milam, Brian M Slomovitz, Judith A Smith, John J Kavanagh, Michael Deavers, Charles Levenback, Robert L Coleman, David M Gershenson
• Journal: Gynecologic oncology (Gynecol Oncol) Vol. 110 Issue 1 Pg. 56-9 (Jul 2008) ISSN: 1095-6859 [Electronic] United States
• PMID: 18457865 (Publication Type: Clinical Trial, Phase II, Journal Article, Research Support, Non-U.S. Gov't)

Chemical References

• Antineoplastic Agents
• Nitriles
• Taxoids
• Triazoles
• Letrozole
• Cisplatin

Topics

• Adult
• Aged
• Aged, 80 and over
• Antineoplastic Agents (therapeutic use, toxicity)
• Cisplatin (therapeutic use)
• Disease Progression
• Drug Resistance, Neoplasm (drug effects)
• Female
• Humans
• Letrozole
• Middle Aged
• Nitriles (therapeutic use, toxicity)
• Ovarian Neoplasms (drug therapy, pathology)
• Peritoneal Neoplasms (drug therapy, pathology)
• Recurrence
• Taxoids (therapeutic use)
• Treatment Outcome
• Triazoles (therapeutic use, toxicity)