Vergote I, Robertson J F R, Kleeberg U, Burton G, Osborne C K, Mauriac L
Department of Gynecologic Oncology, University Hospitals, Leuven, Belgium.
Breast Cancer Res Treat. 2003 May;79(2):207-11. doi: 10.1023/a:1023983032625.
This retrospective evaluation of data from two randomized, multicenter trials examined whether tumor responses to further endocrine therapy were seen in postmenopausal women with advanced breast cancer who had progressed on both initial endocrine therapy, usually tamoxifen, and on the estrogen receptor (ER) antagonist fulvestrant ('Faslodex').
A combined total of 423 patients received fulvestrant 250 mg as a monthly intramuscular injection. After progression on fulvestrant, some patients received another endocrine therapy. Responses to subsequent endocrine therapy were assessed using a questionnaire sent to the trial investigators. Best responses were classified as a complete or partial response (CR or PR), stable disease (SD) lasting > or = 24 weeks, or disease progression.
Follow-up data were available for 54 patients who derived clinical benefit (CB, defined as CR, PR or SD) from fulvestrant and who received subsequent endocrine therapy, resulting in a PR in 4 patients, SD in 21 patients, and disease progression in 29 patients. Data were available for 51 patients who derived no CB from fulvestrant and who received further endocrine therapy, resulting in a PR in 1 patient, SD in 17 patients, and disease progression in 33 patients. Aromatase inhibitors were used as subsequent endocrine therapy in > 80% of patients.
After progression on fulvestrant, patients may retain sensitivity to other endocrine agents. Fulvestrant provides an additional option to existing endocrine therapies for the treatment of advanced or metastatic breast cancer in postmenopausal women, and may provide the opportunity to extend the sequence of endocrine regimens before cytotoxic chemotherapy is required.
这项对两项随机、多中心试验数据的回顾性评估,研究了在初始内分泌治疗(通常为他莫昔芬)以及雌激素受体(ER)拮抗剂氟维司群(“芙仕得”)治疗中均出现疾病进展的绝经后晚期乳腺癌女性患者,是否对进一步的内分泌治疗有肿瘤反应。
总共423例患者接受每月一次250mg氟维司群肌肉注射。在氟维司群治疗进展后,部分患者接受了另一种内分泌治疗。通过向试验研究者发送问卷来评估对后续内分泌治疗的反应。最佳反应分为完全缓解或部分缓解(CR或PR)、持续≥24周的疾病稳定(SD)或疾病进展。
54例从氟维司群中获得临床获益(CB,定义为CR、PR或SD)并接受后续内分泌治疗的患者有随访数据,其中4例患者达到PR,21例患者为SD,29例患者疾病进展。51例未从氟维司群中获得CB并接受进一步内分泌治疗的患者有数据,其中1例患者达到PR,17例患者为SD,33例患者疾病进展。超过80%的患者将芳香化酶抑制剂用作后续内分泌治疗。
在氟维司群治疗进展后,患者可能对其他内分泌药物仍保持敏感性。氟维司群为绝经后女性晚期或转移性乳腺癌的现有内分泌治疗提供了额外选择,并且可能提供在需要细胞毒性化疗之前延长内分泌治疗方案序列的机会。