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 cond...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.展开更多
Objective： To compare the response and adverse reactions of aminoglutethimide with that of femara, an oral aromatase inhibitor, in postmenopausal women with advanced breast cancer. Methods： Fifty patients were rando...Objective： To compare the response and adverse reactions of aminoglutethimide with that of femara, an oral aromatase inhibitor, in postmenopausal women with advanced breast cancer. Methods： Fifty patients were randomly assigned to femara 2.5 mg once daily （n=26） or aminoglutethimide （n=24） 125 mg twice daily in the first week, 250 mg twice daily in the second week, 250 mg three times daily in the third week and 250 mg four times daily in the fourth week, 30 days for one cycle for both groups. Results： Overall objective response rate （complete＋partial） of 26.9% for femara was 12.5% higher than that of aminoglutethimide, but there was no significant difference （P=0.294）. The percentages of stable disease were 53.8% and 50.0% respectively in both treatment groups and that of progressive disease of two groups were 19.2% and 37.5%. There was no significant difference between two arms in the receptor status, disease-free intervals, sites of disease and stages of treatment. Femara-related adverse events were fatigue （15.4%）, anorexia （11.5%）, dizziness （7.7%）, nausea （3.8%） and somnolence （3.8%）. However, incidence of nausea （25.0%） and vomiting （16.7%） in aminoglutethimide group was obviously higher and severer than that in femara group （P=0.045 and P=0.046）. Compared to femara group, frequency in dizziness （25.0%）, fatigue （20.8%）, anorexia （16.7%）, somnolence （12.5%） and cutaneous pruritus （12.5%） was higher in aminoglutethimide group. Allergic rash occurred in aminoglutethimide group. Conclusion： Femara was more effective and well tolerated than aminoglutethimide with respect to side effects in the treatment of postmenopausal women with advanced breast cancer.展开更多
文摘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.
文摘Objective： To compare the response and adverse reactions of aminoglutethimide with that of femara, an oral aromatase inhibitor, in postmenopausal women with advanced breast cancer. Methods： Fifty patients were randomly assigned to femara 2.5 mg once daily （n=26） or aminoglutethimide （n=24） 125 mg twice daily in the first week, 250 mg twice daily in the second week, 250 mg three times daily in the third week and 250 mg four times daily in the fourth week, 30 days for one cycle for both groups. Results： Overall objective response rate （complete＋partial） of 26.9% for femara was 12.5% higher than that of aminoglutethimide, but there was no significant difference （P=0.294）. The percentages of stable disease were 53.8% and 50.0% respectively in both treatment groups and that of progressive disease of two groups were 19.2% and 37.5%. There was no significant difference between two arms in the receptor status, disease-free intervals, sites of disease and stages of treatment. Femara-related adverse events were fatigue （15.4%）, anorexia （11.5%）, dizziness （7.7%）, nausea （3.8%） and somnolence （3.8%）. However, incidence of nausea （25.0%） and vomiting （16.7%） in aminoglutethimide group was obviously higher and severer than that in femara group （P=0.045 and P=0.046）. Compared to femara group, frequency in dizziness （25.0%）, fatigue （20.8%）, anorexia （16.7%）, somnolence （12.5%） and cutaneous pruritus （12.5%） was higher in aminoglutethimide group. Allergic rash occurred in aminoglutethimide group. Conclusion： Femara was more effective and well tolerated than aminoglutethimide with respect to side effects in the treatment of postmenopausal women with advanced breast cancer.
