Ingle James N, Suman Vera J, Mailliard James A, Kugler John W, Krook James E, Michalak John C, Pisansky Thomas M, Wold Lester E, Donohue John H, Goetz Matthew P, Perez Edith A
Mayo Clinic and Mayo Foundation, Rochester, MN, USA..
Breast Cancer Res Treat. 2006 Jul;98(2):217-22. doi: 10.1007/s10549-005-9152-1. Epub 2006 Mar 15.
This clinical trial evaluated the addition of fluoxymesterone (Flu) to tamoxifen (Tam) in women with resected early stage breast cancer and attempted to corroborate the findings of superiority for the combination over Tam alone seen in a previous randomized trial in metastatic disease.
Postmenopausal women with early stage breast cancer that was known to be estrogen receptor (ER) positive were randomized to treatment with Tam (20 mg per day orally for 5 years) alone or combined with Flu (10 mg orally twice per day for 1 year). The primary endpoint was relapse-free survival (RFS) defined as local-regional or distant recurrence including ductal carcinoma in situ of the ipsilateral, but not contralateral breast, and death from any cause.
There were 541 eligible patients entered between 1991 and 1995 and the treatment arms were balanced with respect to patient characteristics. The median follow up of patients still alive was 11.4 years. No significant difference was found between Tam plus Flu and Tam alone in terms of RFS or overall survival. The adjusted hazard ratio (Tam+Flu/Tam) for relapse or death without relapse was estimated to be 0.84 (95% CI: 0.64-1.10) and that for death was 0.89 (95% CI: 0.67-1.18). As expected there was more virilization in women who received Flu.
This clinical trial did not demonstrate superiority of Tam plus Flu over Tam alone as adjuvant therapy for postmenopausal women with resected early breast cancer known to be ER positive.
本临床试验评估了在接受手术切除的早期乳腺癌女性中，氟甲睾酮（Flu）联合他莫昔芬（Tam）的疗效，并试图证实该联合方案相较于之前在转移性疾病的随机试验中观察到的他莫昔芬单药治疗的优势结果。
已知雌激素受体（ER）阳性的绝经后早期乳腺癌女性被随机分为两组，一组接受他莫昔芬单药治疗（每日口服20毫克，共5年），另一组接受他莫昔芬联合氟甲睾酮治疗（每日口服10毫克，分两次服用，共1年）。主要终点为无复发生存期（RFS），定义为局部区域或远处复发，包括同侧但不包括对侧乳腺的导管原位癌，以及任何原因导致的死亡。
1991年至1995年间共有541例符合条件的患者入组，各治疗组在患者特征方面均衡。仍存活患者的中位随访时间为11.4年。在无复发生存期或总生存期方面，他莫昔芬联合氟甲睾酮组与他莫昔芬单药组之间未发现显著差异。复发或未复发死亡的调整风险比（他莫昔芬联合氟甲睾酮组/他莫昔芬单药组）估计为0.84（95%置信区间：0.64 - 1.10），死亡风险比为0.89（95%置信区间：0.67 - 1.18）。正如预期的那样，接受氟甲睾酮治疗的女性出现男性化的情况更多。
对于已知雌激素受体阳性且接受手术切除的绝经后早期乳腺癌女性患者，本临床试验未证明他莫昔芬联合氟甲睾酮作为辅助治疗优于他莫昔芬单药治疗。
