© 2004 European Society for Medical Oncology
Original Article |
Toremifene and tamoxifen are equally effective for early-stage breast cancer: first results of International Breast Cancer Study Group Trials 12-93 and 14-93
1 See Appendix for the names and affiliations of the participants and authors of the International Breast Cancer Study Group Trials 12-93 and 14-93
* Correspondence to: Dr O. Pagani, Instituto Oncologico Svizzera Italiana IOSI, Ospedale Beata Vergine, 6850 Mendrisio, Switzerland. Tel: +41-91-811-3467; Fax: +41-91-811-3038;opagani{at}siak.ch
Background: Toremifene is a chlorinated derivative of tamoxifen, developed to improve its risk–benefit profile. The International Breast Cancer Study Group (IBCSG) conducted two complementary randomized trials for peri- and postmenopausal patients with node-positive breast cancer to compare toremifene versus tamoxifen as the endocrine agent and simultaneously investigate a chemotherapy-oriented question. This is the first report of the endocrine comparison after a median follow-up of 5.5 years.
Patients and methods: 1035 patients were available for analysis: 75% had estrogen receptor (ER)-positive primary tumors, the median number of involved axillary lymph nodes was three and 81% received prior adjuvant chemotherapy.
Results: Toremifene and tamoxifen yielded similar disease-free (DFS) and overall survival (OS): 5-year DFS rates of 72% and 69%, respectively [risk ratio (RR)=0.95; 95% confidence interval (CI)=0.76–1.18]; 5-year OS rates of 85% and 81%, respectively (RR = 1.03; 95% CI = 0.78–1.36). Similar outcomes were observed in the ER-positive cohort. Toxicities were similar in the two treatment groups with very few women (<1%) experiencing severe thromboembolic or cerebrovascular complications. Quality of life results were also similar. Nine patients developed early stage endometrial cancer (toremifene, six; tamoxifen, three).
Conclusions: Toremifene is a valid and safe alternative to tamoxifen in postmenopausal women with endocrine-responsive breast cancer.
Key words: adjuvant therapy, early-stage breast cancer, tamoxifen, toremifene
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