Effects of high dose raloxifene in selected patients with advanced breast carcinoma

William Gradishar, Joan Glusman, Yili Lu, Charles Vogel, Fredric J. Cohen, George W. Sledge

Research output: Contribution to journalArticle

91 Citations (Scopus)

Abstract

BACKGROUND. An earlier trial of raloxifene, conducted in women with metastatic breast carcinoma who initially had responded to tamoxifen and subsequently developed disease progression, suggested no antitumor activity for raloxifene in tamoxifen-refractory disease. However, preclinical studies and preliminary clinical data in healthy women suggest that raloxifene antagonizes growth of estrogen-dependent neoplasia. METHODS. Raloxifene HCl 150 mg twice daily was given to 22 postmenopausal women with metastatic (American Joint Committee on Cancer Stage IV) or locoregionally recurrent, initially estrogen receptor positive breast carcinoma. Prior systemic treatment of metastatic disease was not allowed. Prior adjuvant chemotherapy or hormonal therapy was required to have been completed at least 1 year before study entry. Tumor response was evaluated every other month either radiographically or by physical examination. Evaluable disease was defined as bidimensionally measurable lesions. RESULTS. Twenty-one patients were eligible for efficacy analysis; 6 had been treated previously with tamoxifen. There were no complete tumor responses. Four patients (19%; 95% confidence interval [95% CI], 2.2%, 36%) had partial tumor responses lasting 6.3, 17.5, 23.9, and 28.1 months, respectively. Prolonged stable disease (i.e., tumor size stable for ≥ 6 months) was observed in 3 patients (14%; 95% CI, 0.0%, 29%) and lasted 7.9, 12.2, and 25.1 months, respectively. Combining partial responses and prolonged stable disease yielded an overall clinical benefit rate of 33% (95% CI, 13%, 53%). Adverse events generally were consistent with the disease state; there were no serious adverse events or laboratory changes believed to be therapy-related. CONCLUSIONS. Raloxifene HCl, 150 mg, administered twice daily was safe, well tolerated, and modestly effective in highly selected postmenopausal women with advanced breast carcinoma. Further study of high dose raloxifene as monotherapy for advanced breast carcinoma most likely is unwarranted. (C) 2000 American Cancer Society.

Original languageEnglish
Pages (from-to)2047-2053
Number of pages7
JournalCancer
Volume88
Issue number9
DOIs
StatePublished - May 1 2000

Fingerprint

Breast Neoplasms
Tamoxifen
Neoplasms
Confidence Intervals
Adjuvant Chemotherapy
Estrogen Receptors
Physical Examination
Disease Progression
Raloxifene Hydrochloride
Estrogens
Therapeutics
Growth

Keywords

  • Antiestrogen
  • Breast carcinoma
  • Endocrine treatment
  • Postmenopausal women
  • Raloxifene
  • Selective estrogen receptor modulator (SERM)

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

Effects of high dose raloxifene in selected patients with advanced breast carcinoma. / Gradishar, William; Glusman, Joan; Lu, Yili; Vogel, Charles; Cohen, Fredric J.; Sledge, George W.

In: Cancer, Vol. 88, No. 9, 01.05.2000, p. 2047-2053.

Research output: Contribution to journalArticle

Gradishar, William ; Glusman, Joan ; Lu, Yili ; Vogel, Charles ; Cohen, Fredric J. ; Sledge, George W. / Effects of high dose raloxifene in selected patients with advanced breast carcinoma. In: Cancer. 2000 ; Vol. 88, No. 9. pp. 2047-2053.
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abstract = "BACKGROUND. An earlier trial of raloxifene, conducted in women with metastatic breast carcinoma who initially had responded to tamoxifen and subsequently developed disease progression, suggested no antitumor activity for raloxifene in tamoxifen-refractory disease. However, preclinical studies and preliminary clinical data in healthy women suggest that raloxifene antagonizes growth of estrogen-dependent neoplasia. METHODS. Raloxifene HCl 150 mg twice daily was given to 22 postmenopausal women with metastatic (American Joint Committee on Cancer Stage IV) or locoregionally recurrent, initially estrogen receptor positive breast carcinoma. Prior systemic treatment of metastatic disease was not allowed. Prior adjuvant chemotherapy or hormonal therapy was required to have been completed at least 1 year before study entry. Tumor response was evaluated every other month either radiographically or by physical examination. Evaluable disease was defined as bidimensionally measurable lesions. RESULTS. Twenty-one patients were eligible for efficacy analysis; 6 had been treated previously with tamoxifen. There were no complete tumor responses. Four patients (19{\%}; 95{\%} confidence interval [95{\%} CI], 2.2{\%}, 36{\%}) had partial tumor responses lasting 6.3, 17.5, 23.9, and 28.1 months, respectively. Prolonged stable disease (i.e., tumor size stable for ≥ 6 months) was observed in 3 patients (14{\%}; 95{\%} CI, 0.0{\%}, 29{\%}) and lasted 7.9, 12.2, and 25.1 months, respectively. Combining partial responses and prolonged stable disease yielded an overall clinical benefit rate of 33{\%} (95{\%} CI, 13{\%}, 53{\%}). Adverse events generally were consistent with the disease state; there were no serious adverse events or laboratory changes believed to be therapy-related. CONCLUSIONS. Raloxifene HCl, 150 mg, administered twice daily was safe, well tolerated, and modestly effective in highly selected postmenopausal women with advanced breast carcinoma. Further study of high dose raloxifene as monotherapy for advanced breast carcinoma most likely is unwarranted. (C) 2000 American Cancer Society.",
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AU - Glusman, Joan

AU - Lu, Yili

AU - Vogel, Charles

AU - Cohen, Fredric J.

AU - Sledge, George W.

PY - 2000/5/1

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N2 - BACKGROUND. An earlier trial of raloxifene, conducted in women with metastatic breast carcinoma who initially had responded to tamoxifen and subsequently developed disease progression, suggested no antitumor activity for raloxifene in tamoxifen-refractory disease. However, preclinical studies and preliminary clinical data in healthy women suggest that raloxifene antagonizes growth of estrogen-dependent neoplasia. METHODS. Raloxifene HCl 150 mg twice daily was given to 22 postmenopausal women with metastatic (American Joint Committee on Cancer Stage IV) or locoregionally recurrent, initially estrogen receptor positive breast carcinoma. Prior systemic treatment of metastatic disease was not allowed. Prior adjuvant chemotherapy or hormonal therapy was required to have been completed at least 1 year before study entry. Tumor response was evaluated every other month either radiographically or by physical examination. Evaluable disease was defined as bidimensionally measurable lesions. RESULTS. Twenty-one patients were eligible for efficacy analysis; 6 had been treated previously with tamoxifen. There were no complete tumor responses. Four patients (19%; 95% confidence interval [95% CI], 2.2%, 36%) had partial tumor responses lasting 6.3, 17.5, 23.9, and 28.1 months, respectively. Prolonged stable disease (i.e., tumor size stable for ≥ 6 months) was observed in 3 patients (14%; 95% CI, 0.0%, 29%) and lasted 7.9, 12.2, and 25.1 months, respectively. Combining partial responses and prolonged stable disease yielded an overall clinical benefit rate of 33% (95% CI, 13%, 53%). Adverse events generally were consistent with the disease state; there were no serious adverse events or laboratory changes believed to be therapy-related. CONCLUSIONS. Raloxifene HCl, 150 mg, administered twice daily was safe, well tolerated, and modestly effective in highly selected postmenopausal women with advanced breast carcinoma. Further study of high dose raloxifene as monotherapy for advanced breast carcinoma most likely is unwarranted. (C) 2000 American Cancer Society.

AB - BACKGROUND. An earlier trial of raloxifene, conducted in women with metastatic breast carcinoma who initially had responded to tamoxifen and subsequently developed disease progression, suggested no antitumor activity for raloxifene in tamoxifen-refractory disease. However, preclinical studies and preliminary clinical data in healthy women suggest that raloxifene antagonizes growth of estrogen-dependent neoplasia. METHODS. Raloxifene HCl 150 mg twice daily was given to 22 postmenopausal women with metastatic (American Joint Committee on Cancer Stage IV) or locoregionally recurrent, initially estrogen receptor positive breast carcinoma. Prior systemic treatment of metastatic disease was not allowed. Prior adjuvant chemotherapy or hormonal therapy was required to have been completed at least 1 year before study entry. Tumor response was evaluated every other month either radiographically or by physical examination. Evaluable disease was defined as bidimensionally measurable lesions. RESULTS. Twenty-one patients were eligible for efficacy analysis; 6 had been treated previously with tamoxifen. There were no complete tumor responses. Four patients (19%; 95% confidence interval [95% CI], 2.2%, 36%) had partial tumor responses lasting 6.3, 17.5, 23.9, and 28.1 months, respectively. Prolonged stable disease (i.e., tumor size stable for ≥ 6 months) was observed in 3 patients (14%; 95% CI, 0.0%, 29%) and lasted 7.9, 12.2, and 25.1 months, respectively. Combining partial responses and prolonged stable disease yielded an overall clinical benefit rate of 33% (95% CI, 13%, 53%). Adverse events generally were consistent with the disease state; there were no serious adverse events or laboratory changes believed to be therapy-related. CONCLUSIONS. Raloxifene HCl, 150 mg, administered twice daily was safe, well tolerated, and modestly effective in highly selected postmenopausal women with advanced breast carcinoma. Further study of high dose raloxifene as monotherapy for advanced breast carcinoma most likely is unwarranted. (C) 2000 American Cancer Society.

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