[Treatment of advanced metastatic breast cancer with exemestane, a multicenter randomized controlled study of 195 cases].

OBJECTIVE

To observe the efficacy of exemestane for postmenopausal advanced metastatic breast cancer, and to assess its side effects.

METHODS

A randomized, double-blind, and parallel controlled study was conducted among 195 patients with postmenopausal advanced metastatic breast cancer from December 2001 to June 2002. Except for the 4 cases who were lost to follow-up, the remaining 191 patients were divided into two groups: study group (n = 96, treated with exemestane capsule 25 mg and one model tablet of letrozole orally q.d. for 8 weeks), and control group (n = 95, treated with letrozole 2.5 mg and one model capsule of exemestane orally q.d. for 8 weeks). Physical examination, roentgenography and CT were conducted to observe the outcome of the tumor and the level of estrogen was tested 2 weeks before and 4 and 8 weeks after the beginning of treatment.

RESULTS

The effective rate was 44.8% in the study group and 45.3% in the control group (P = 0.971). The level of estradiol was 5.17 +/- 6.68 x 10(4) pg/L and 4.19 +/- 3.06 x 10(4) pg/L in the study group and control group respectively; and was 3.08 +/- 2.80 x 10(4) pg/L and 2.76 +/- 1.98 x 10(4) pg/L in the study group and control group respectively 8 weeks after the beginning of treatment, both decreased by 43.7% in comparison with those before treatment (both P < 0.001), however, there was no significant difference between the study group and control group (P = 0.141). The side effects of exemestane included thirst, giddiness, and nausea.

CONCLUSION

An effective hormonal medicine, exemestane has good therapeutic efficacy in postmenopausal advanced metastatic breast cancer with only mild side effects.