Beretta K R, Hoeffken K, Kvinnsland S, Trunet P, Chaudri H A, Bhatnagar A S, Goldhirsch A, Cavalli F
Servizio Oncologica Ticinese, Ospedale San Giovanni, Bellinzona, Switzerland.
Ann Oncol. 1990 Nov;1(6):421-6. doi: 10.1093/oxfordjournals.annonc.a057795.
Forty-six postmenopausal women with either locally advanced or metastatic breast cancer were treated with the aromatase inhibitor CGS 16949A in three different daily doses (0.3 mg, 0.6 mg and 0.9 mg total daily dose). 41 patients (89%) were pretreated by endocrine treatment for metastatic disease; 30 of these 41 were also pretreated with chemotherapy. Of the remaining 5 patients (11%) 3 were previously treated with chemotherapy alone and 2 were not pretreated. Evaluable sites of disease were: skin and soft tissue (including local recurrence) in 34, bone in 31, lung in 14 and viscera in 13 instances, respectively. 1 PR (3%) and 9 stable diseases (24%) were observed in the 37 patients assessable for response. All but two of these results were observed in the 0.9 mg group. Time to progression was 14 months for the patient showing a PR, and the median time to progression for those with stable disease was 6 months (range 6 to 23 months). Plasma estradiol and estrone levels were measured in patients receiving the daily dose of 0.6 mg (n = 4) and 0.9 mg (n = 15). The estrone levels decreased from a mean of 23.1 pg/mL (SD 17.1) to 10.5 pg/mL (SD 6.6) in the 0.6 mg-group and from 21.2 pg/mL (SD 18.9) to 9.1 pg/mL (SD 5.5) in the 0.9 mg-group within 4 days of drug administration (p less than 0.0001 from baseline in both groups, with no significant difference between doses).(ABSTRACT TRUNCATED AT 250 WORDS)
46名患有局部晚期或转移性乳腺癌的绝经后女性接受了芳香化酶抑制剂CGS 16949A治疗，每日剂量分三种（每日总剂量0.3毫克、0.6毫克和0.9毫克）。41名患者（89%）曾接受过转移性疾病的内分泌治疗；这41名患者中有30名还接受过化疗。其余5名患者（11%）中，3名曾单独接受过化疗，2名未接受过预处理。可评估的疾病部位分别为：皮肤和软组织（包括局部复发）34例、骨骼31例、肺部14例和内脏13例。在可评估疗效的37名患者中，观察到1例部分缓解（PR，3%）和9例病情稳定（24%）。除2例外，所有这些结果均在0.9毫克组中观察到。出现PR的患者疾病进展时间为14个月，病情稳定患者的中位疾病进展时间为6个月（范围6至23个月）。对接受每日剂量0.6毫克（n = 4）和0.9毫克（n = 15）的患者测量了血浆雌二醇和雌酮水平。在给药4天内，0.6毫克组的雌酮水平从平均23.1皮克/毫升（标准差17.1）降至10.5皮克/毫升（标准差6.6），0.9毫克组从21.2皮克/毫升（标准差18.9）降至9.1皮克/毫升（标准差5.5）（两组与基线相比p均小于0.0001，不同剂量之间无显著差异）。（摘要截选至250字）
