TY - JOUR
T1 - Activity of exemestane in metastatic breast cancer after failure of nonsteroidal aromatase inhibitors
T2 - A phase II trial
AU - Lønning, Per Eystein
AU - Bajetta, Emilio
AU - Murray, Robin
AU - Tubiana-Hulin, Michèle
AU - Eisenberg, Peter D.
AU - Mickiewicz, Elizabeth
AU - Celio, Luigi
AU - Pitt, Paula
AU - Mita, Monica
AU - Aaronson, Neil K.
AU - Fowst, Camilla
AU - Arkhipov, Alexei
AU - Salle, Enrico Di
AU - Polli, Anna
AU - Massimini, Giorgio
PY - 2000/6
Y1 - 2000/6
N2 - Purpose: To evaluate the antitumor activity and toxicity of a new steroidal aromatase inactivator, exemestane, in postmenopausal women with metastatic breast cancer who had progressive disease (PD) after treatment with a nonsteroidal aromatase inhibitor. Patients and Methods: In this phase II trial, eligible patients were treated with exemestane 25 mg daily (n = 241) followed, at the time PD was determined, by exemestane 100 mg daily (n = 58). Results: On the basis of the intent-to-treat analysis by independent review, exemestane 25 mg produced objective responses in 6.6% of patients (95% confidence interval [CI], 3.8% to 10.6%) and overall success (complete response + partial response + no change for 24 weeks or longer) in 24.3% (95% CI, 19.0% to 30.2%). The median durations of objective response and overall success were 58.4 weeks (95% CI, 49.7 to 71.1 weeks) and 37.0 weeks (95% CI, 35.0 to 39.4 weeks), respectively. Increasing the dose of exemestane to 100 mg upon the development of PD produced one partial response (1.7%; 95% CI, 0.0% to 9.2%). Both dosages were well tolerated and were discontinued because of adverse events in only 1.7% of patients. Conclusion: Exemestane 25 mg once daily seems to be an attractive alternative to chemotherapy for the treatment of patients with metastatic breast cancer after multiple hormonal therapies have failed. (C) 2000 by American Society of Clinical Oncology.
AB - Purpose: To evaluate the antitumor activity and toxicity of a new steroidal aromatase inactivator, exemestane, in postmenopausal women with metastatic breast cancer who had progressive disease (PD) after treatment with a nonsteroidal aromatase inhibitor. Patients and Methods: In this phase II trial, eligible patients were treated with exemestane 25 mg daily (n = 241) followed, at the time PD was determined, by exemestane 100 mg daily (n = 58). Results: On the basis of the intent-to-treat analysis by independent review, exemestane 25 mg produced objective responses in 6.6% of patients (95% confidence interval [CI], 3.8% to 10.6%) and overall success (complete response + partial response + no change for 24 weeks or longer) in 24.3% (95% CI, 19.0% to 30.2%). The median durations of objective response and overall success were 58.4 weeks (95% CI, 49.7 to 71.1 weeks) and 37.0 weeks (95% CI, 35.0 to 39.4 weeks), respectively. Increasing the dose of exemestane to 100 mg upon the development of PD produced one partial response (1.7%; 95% CI, 0.0% to 9.2%). Both dosages were well tolerated and were discontinued because of adverse events in only 1.7% of patients. Conclusion: Exemestane 25 mg once daily seems to be an attractive alternative to chemotherapy for the treatment of patients with metastatic breast cancer after multiple hormonal therapies have failed. (C) 2000 by American Society of Clinical Oncology.
UR - http://www.scopus.com/inward/record.url?scp=17144472154&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=17144472154&partnerID=8YFLogxK
M3 - Article
C2 - 10829043
AN - SCOPUS:17144472154
VL - 18
SP - 2234
EP - 2244
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
SN - 0732-183X
IS - 11
ER -