Randomized comparison of tamoxifen and two separate doses of toremifene in postmenopausal patients with metastatic breast cancer

Daniel F. Hayes, J. A. Van Zyl, Anne Hacking, Louis Goedhals, W. R. Bezwoda, James A. Mailliard, Stephen E. Jones, Charles Vogel, Robert F. Berris, Irving Shemano, John Schoenfelder

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Abstract

Purpose: To perform a randomized three-arm comparison of tamoxifen (TAM; 20 mg/d) and two separate doses of toremifene (TOR; 60 mg/d [TOR60] and 200 mg/d [TOR200]) in postmenopausal patients with hormone receptor-positive or - unknown metastatic breast cancer. Materials and Methods: Six hundred forty- eight patients with hormone receptor-positive or -unknown metastatic breast cancer were randomly assigned to receive TAM (n = 215), TOR60 (n = 221), or TOR200 (n = 212). Results: The combined response rates (by intent to treat) were as follows: TAM, 44%; TOR60, 50%; and TOR200, 48%. Complete and partial response rates were as follows: TAM, 19%; TOR60, 21%, and TOR200, 23% (not statistically different). Median times to progression and overall survival were not significantly different. Adverse events (lethal, serious but nonlethal, and important but non-life-threatening) were similar in all three arms, except that patients in the TOR200 arm had a statistically significantly increased rate of nausea (37% v 26% and 26% for TOR200, TAM, and TOR60, respectively; P = .027). Quality-of-life assessments were not different among the three arms. Conclusion: The activity, toxicity, and side effects of TOR in postmenopausal women with hormone receptor-positive or - unknown metastatic breast cancer are similar if not equivalent to those of TAM. We detected no clear evidence of a dose-response effect for TOR. TOR60 is an effective and safe agent for the treatment of postmenopausal women with hormone receptor-positive metastatic breast cancer and can be considered an alternative to TAM as first-line treatment for such patients.

Original languageEnglish
Pages (from-to)2556-2566
Number of pages11
JournalJournal of Clinical Oncology
Volume13
Issue number10
StatePublished - Oct 1 1995
Externally publishedYes

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Toremifene
Tamoxifen
Hormones
Breast Neoplasms
Nausea
Quality of Life
Survival
Therapeutics

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

Hayes, D. F., Van Zyl, J. A., Hacking, A., Goedhals, L., Bezwoda, W. R., Mailliard, J. A., ... Schoenfelder, J. (1995). Randomized comparison of tamoxifen and two separate doses of toremifene in postmenopausal patients with metastatic breast cancer. Journal of Clinical Oncology, 13(10), 2556-2566.

Randomized comparison of tamoxifen and two separate doses of toremifene in postmenopausal patients with metastatic breast cancer. / Hayes, Daniel F.; Van Zyl, J. A.; Hacking, Anne; Goedhals, Louis; Bezwoda, W. R.; Mailliard, James A.; Jones, Stephen E.; Vogel, Charles; Berris, Robert F.; Shemano, Irving; Schoenfelder, John.

In: Journal of Clinical Oncology, Vol. 13, No. 10, 01.10.1995, p. 2556-2566.

Research output: Contribution to journalArticle

Hayes, DF, Van Zyl, JA, Hacking, A, Goedhals, L, Bezwoda, WR, Mailliard, JA, Jones, SE, Vogel, C, Berris, RF, Shemano, I & Schoenfelder, J 1995, 'Randomized comparison of tamoxifen and two separate doses of toremifene in postmenopausal patients with metastatic breast cancer', Journal of Clinical Oncology, vol. 13, no. 10, pp. 2556-2566.
Hayes DF, Van Zyl JA, Hacking A, Goedhals L, Bezwoda WR, Mailliard JA et al. Randomized comparison of tamoxifen and two separate doses of toremifene in postmenopausal patients with metastatic breast cancer. Journal of Clinical Oncology. 1995 Oct 1;13(10):2556-2566.
Hayes, Daniel F. ; Van Zyl, J. A. ; Hacking, Anne ; Goedhals, Louis ; Bezwoda, W. R. ; Mailliard, James A. ; Jones, Stephen E. ; Vogel, Charles ; Berris, Robert F. ; Shemano, Irving ; Schoenfelder, John. / Randomized comparison of tamoxifen and two separate doses of toremifene in postmenopausal patients with metastatic breast cancer. In: Journal of Clinical Oncology. 1995 ; Vol. 13, No. 10. pp. 2556-2566.
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abstract = "Purpose: To perform a randomized three-arm comparison of tamoxifen (TAM; 20 mg/d) and two separate doses of toremifene (TOR; 60 mg/d [TOR60] and 200 mg/d [TOR200]) in postmenopausal patients with hormone receptor-positive or - unknown metastatic breast cancer. Materials and Methods: Six hundred forty- eight patients with hormone receptor-positive or -unknown metastatic breast cancer were randomly assigned to receive TAM (n = 215), TOR60 (n = 221), or TOR200 (n = 212). Results: The combined response rates (by intent to treat) were as follows: TAM, 44{\%}; TOR60, 50{\%}; and TOR200, 48{\%}. Complete and partial response rates were as follows: TAM, 19{\%}; TOR60, 21{\%}, and TOR200, 23{\%} (not statistically different). Median times to progression and overall survival were not significantly different. Adverse events (lethal, serious but nonlethal, and important but non-life-threatening) were similar in all three arms, except that patients in the TOR200 arm had a statistically significantly increased rate of nausea (37{\%} v 26{\%} and 26{\%} for TOR200, TAM, and TOR60, respectively; P = .027). Quality-of-life assessments were not different among the three arms. Conclusion: The activity, toxicity, and side effects of TOR in postmenopausal women with hormone receptor-positive or - unknown metastatic breast cancer are similar if not equivalent to those of TAM. We detected no clear evidence of a dose-response effect for TOR. TOR60 is an effective and safe agent for the treatment of postmenopausal women with hormone receptor-positive metastatic breast cancer and can be considered an alternative to TAM as first-line treatment for such patients.",
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AU - Shemano, Irving

AU - Schoenfelder, John

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N2 - Purpose: To perform a randomized three-arm comparison of tamoxifen (TAM; 20 mg/d) and two separate doses of toremifene (TOR; 60 mg/d [TOR60] and 200 mg/d [TOR200]) in postmenopausal patients with hormone receptor-positive or - unknown metastatic breast cancer. Materials and Methods: Six hundred forty- eight patients with hormone receptor-positive or -unknown metastatic breast cancer were randomly assigned to receive TAM (n = 215), TOR60 (n = 221), or TOR200 (n = 212). Results: The combined response rates (by intent to treat) were as follows: TAM, 44%; TOR60, 50%; and TOR200, 48%. Complete and partial response rates were as follows: TAM, 19%; TOR60, 21%, and TOR200, 23% (not statistically different). Median times to progression and overall survival were not significantly different. Adverse events (lethal, serious but nonlethal, and important but non-life-threatening) were similar in all three arms, except that patients in the TOR200 arm had a statistically significantly increased rate of nausea (37% v 26% and 26% for TOR200, TAM, and TOR60, respectively; P = .027). Quality-of-life assessments were not different among the three arms. Conclusion: The activity, toxicity, and side effects of TOR in postmenopausal women with hormone receptor-positive or - unknown metastatic breast cancer are similar if not equivalent to those of TAM. We detected no clear evidence of a dose-response effect for TOR. TOR60 is an effective and safe agent for the treatment of postmenopausal women with hormone receptor-positive metastatic breast cancer and can be considered an alternative to TAM as first-line treatment for such patients.

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