PP-8-3 Double-blind trial in postmenopausal (PMP) women with advanced breast cancer (ABC) showing a dose-effect and superiority of 2.5 mg letrozole over megestrol acetate (MA)

Smith, I. E.; Dombemowsky, P.; Falkson, Geoffrey; Leonard, R. C. F.; Panasci, Lawrence C.; Bellmunt, Joaquim; Wr, Bezwoda; Gardin, G.; Gudgeon, Anne; Chaudri, H. A.; Hornberger, Ulrike

doi:10.1016/0959-8049(96)84236-5

Cited by 10 publications

(7 citation statements)

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“…Efficacy of AG was 11.11% and curative effect of ITT was 10.17%, which were less than that of letrozole. There was no significant difference in curative effects between two groups for small samplesize [2] . The rate of NC was 20.31% and 20.34% in two groups respectively.…”

Section: Discussionmentioning

confidence: 99%

Comparison of Letrozole and Aminoglutethimide in Treatment of 113 Cases of Postmenopausal Women with Advanced Breast Cancer

Liu¹,

Guan²,

Shen

et al. 2004

Chinese-German J Clin Oncol

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Objective: To compare the efficacy and tolerability of letrozole with aminoglutethimide (AG) in postmenopausal women with advanced breast cancer. Methods: The multicenter, randomized controlled clinical trial was conducted in 113 patients. They randomly received letrozole 2.5 mg once daily (letrozole group) or AG 250 mg 4 times daily (AG group) with hydrocortisone. Results: The OR in letrozole group was 23.73% (2 cases of CR and 12 cases of PR, ITT OR was 21.88%), which was higher than in AG group (the OR 11.11%, 1 case of CR and 5 cases of PR, ITT 10.17%), but there was no statistically significant difference (P >0.05). Adverse events (AE) and the treatment related AE (RAE) in letrozole group (n=59) was 18.54 % and 13.56 % respectively, significantly lower than those (42.11% and 33.33% respectively) in AG group (n=57, P =0.002). Conclusion: The OR of letrozole in the treatment of postmenopausal advanced breast cancer positive or unknown for hormonal receptor is 23.73%, showing no significant difference to that of AG. The AE of letrozole are significantly less than AG.

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Section: Discussionmentioning

confidence: 99%

Comparison of Letrozole and Aminoglutethimide in Treatment of 113 Cases of Postmenopausal Women with Advanced Breast Cancer

Liu¹,

Guan²,

Shen

et al. 2004

Chinese-German J Clin Oncol

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“…A series of triazole derivatives, anastrozole (Arimidex),19 20 letrozole (Femara),21 22 and vorozole (Rivizor)23 24 have all been shown to have excellent selectivity for aromatase in preclinical models, and this has been confirmed in clinical studies. Their intrinsic potency is considerably greater than that of aminoglutethimide.…”

Section: Aromatase Inhibitorsmentioning

confidence: 94%

Recent advances in endocrine therapy of breast cancer

Howell

Dowsett

1997

BMJ

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Regression of advanced breast cancer as a result of endocrine therapy was first described over 100 years ago.1 Interest in this form of treatment increased when treatment with the antioestrogen tamoxifen after surgery for breast cancer was shown to improve patients' survival. Treatment also reduced the incidence of new cancers in the contralateral breast, which has led to a number of trials of tamoxifen as a preventive measure in women at high risk. 4 New, potentially more active endocrine agents are now being introduced into clinical practice. In this review we outline the mechanism of action of these treatments and summarise recent results of clinical trials assessing their efficacy in comparison with older drugs; we also speculate about future trends in endocrine therapy and summarise clinical trials in progress. MethodsThis article is based, in part, on our own collaborative experimental work and close association with pharmaceutical companies developing new endocrine agents. Additional reviews and original articles were obtained from searches of oncological journals. Recent data were obtained from presentations at the May meeting of the American Society for Clinical Oncology. Mechanism of action of newer endocrine therapiesBreast cancer cells that are endocrine dependent need oestrogen to proliferate.5 Most endocrine therapies either block the binding of oestrogen to its receptor in the nucleus of responsive cells or reduce serum and tumour concentrations of oestradiol. In postmenopausal women androgens (mainly from the adrenal glands) are converted into oestrogens by the enzyme aromatase, which is present in a range of tissues and is found in 60-70% of breast carcinomas. The trend for endocrine therapies over the past 100 years has been towards simpler and more widely applicable treatments. Originally pharmacological doses of oestrogens were used to block the proliferative effect of oestrogen, but now this is achieved with tamoxifen.2 Oestrogen concentrations were reduced by surgery (oophorectomy, adrenalectomy, and hypophysectomy), but now analogues of luteinising hormone releasing hormone, which effectively ablate ovarian steroidogenesis, may be used in premenopausal women; aromatase inhibitors are used in postmenopausal women.

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“…The trial is published in abstract form only. Thromboembolic events and weight gain were more common in patients on megestrol acetate than letrozole,10 and letrozole was also better tolerated than aminoglutethimide particularly in terms of rash and drowsiness 11…”

Section: Clinical Studiesmentioning

confidence: 95%

“…Weight gain is less common with either drug than with megestrol acetate. Letrozole, but not anastrozole, seems less likely than megestrol acetate to cause thromboembolic events 7 , 10. Both drugs tend to be well tolerated and their unwanted effects are generally mild.…”

Section: Unwanted Effectsmentioning

confidence: 96%

“…In a randomised, controlled, double-blind trial, published as an abstract, 551 postmenopausal women with advanced breast cancer who had failed on anti-oestrogen therapy were given either once-daily oral doses of letrozole (0.5mg or 2.5mg) or oral megestrol 160mg daily 10. In terms of time to treatment failure and tumour response rates, 2.5mg of letrozole was more effective than megestrol acetate while survival and time to disease progression was similar for both treatments.…”

Section: Clinical Studiesmentioning

confidence: 99%

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New aromatase inhibitors for breast cancer

1997

DTB

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wAnastrozole (Arimidex -Zeneca) and wletrozole (Femara -Novartis) are the first selective, oral, non-steroidal aromatase inhibitors. They are licensed for the treatment of advanced breast cancer in postmenopausal women where tamoxifen or other anti-oestrogen therapy has failed. The manufacturers of both drugs claim that their products are more effective, less toxic and better tolerated than the progestogen megestrol acetate, the standard therapy in this clinical situation. We assess these claims.

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PP-8-3 Double-blind trial in postmenopausal (PMP) women with advanced breast cancer (ABC) showing a dose-effect and superiority of 2.5 mg letrozole over megestrol acetate (MA)

Cited by 10 publications

References 0 publications

Comparison of Letrozole and Aminoglutethimide in Treatment of 113 Cases of Postmenopausal Women with Advanced Breast Cancer

Comparison of Letrozole and Aminoglutethimide in Treatment of 113 Cases of Postmenopausal Women with Advanced Breast Cancer

Recent advances in endocrine therapy of breast cancer

New aromatase inhibitors for breast cancer

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