Phase II and III clinical trials of toremifene for metastatic breast cancer.

Abstract

Toremifene (Fareston) received FDA approval in 1997 for the first-line treatment of postmenopausal women with estrogen receptor (ER)-positive or -unknown metastatic breast cancer. Phase II and III trials have demonstrated that first-line therapy with toremifene, 60 mg/d, is as effective and as well tolerated as tamoxifen (Nolvadex), 20 or 40 mg/d, in such patients. To date, phase III trials have failed to show a statistically significant advantage of higher toremifene doses over standard doses of tamoxifen in these women. Studies appeared to indicate minimal efficacy of high toremifene doses in women with ER-negative tumors, but the number of patients studied was small. Although results of some trials of high-dose (240 mg/d) toremifene in tamoxifen-"refractory" patients were negative, other trials that included prolonged (> or = 6 months) stable disease as an indication of clinical benefit yielded positive results.

• Authors: C L Vogel
• Journal: Oncology (Williston Park, N.Y.) (Oncology (Williston Park)) Vol. 12 Issue 3 Suppl 5 Pg. 9-13 (Mar 1998) ISSN: 0890-9091 [Print] United States
• PMID: 9556785 (Publication Type: Journal Article, Review)

Chemical References

• Antineoplastic Agents, Hormonal
• Estrogen Antagonists
• Receptors, Estrogen
• Tamoxifen
• Toremifene

Topics

• Antineoplastic Agents, Hormonal (administration & dosage, therapeutic use)
• Breast Neoplasms (drug therapy, pathology)
• Clinical Trials, Phase I as Topic
• Clinical Trials, Phase II as Topic
• Disease Progression
• Disease-Free Survival
• Drug Administration Schedule
• Estrogen Antagonists (administration & dosage, therapeutic use)
• Female
• Humans
• Neoplasms, Hormone-Dependent (drug therapy, pathology)
• Randomized Controlled Trials as Topic
• Receptors, Estrogen (drug effects)
• Survival Analysis
• Tamoxifen (therapeutic use)
• Toremifene (administration & dosage, therapeutic use)
• Treatment Outcome