Toremifene, a selective estrogen receptor modulator, significantly improved biochemical recurrence in bone metastatic prostate cancer: a randomized controlled phase II a trial.
Toremifene, a selective estrogen receptor modulator, significantly improved biochemical recurrence in bone metastatic prostate cancer: a randomized controlled phase II a trial.
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DOI：
10.1186/s12885-015-1871-z
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发表时间：
2015-11-02
期刊：
影响因子：
3.8
通讯作者：
Homma Y
中科院分区：
文献类型：
--
作者：
Fujimura T;Takahashi S;Kume H;Urano T;Takayama K;Yamada Y;Suzuki M;Fukuhara H;Nakagawa T;Inoue S;Homma Y
前列腺癌 (PC) 雄激素剥夺疗法 (ADT) 的持久性有限。额外的选择性雌激素受体调节剂 (SERM) 可能会延长 ADT 的持久性，因为雄激素和雌激素信号传导会驱动 PC 进展。初治骨转移性 PC 的男性以 1:1:1 的方式随机分配接受 ADT、托瑞米芬 60 mg 加 ADT (TOPADT) 或雷洛昔芬 60 mg 加 ADT (RAPADT)。主要终点是生化复发（BCR）率，次要终点是视觉模拟评分（VAS）和癌症治疗功能评估（FACT）评分的变化。总共 15 名男性，每人 5 人，被分配到三个治疗组之一。基础血清前列腺特异性抗原 (PSA) 水平为 198 ng/mL（中位数，范围；30–8428）。根据疾病程度，骨转移分为1级（n = 11）、2级（n = 3）和3级（n = 1）。在 1370 天（范围：431-1983）的中位随访期间，ADT、TOPADT 和 RAPADT 组中分别有 3 名、0 名和 2 名男性发生 BCR。 ADT、TOPADT 和 RAPADT 组的 5 年 BCR 无发生率分别为 30%、100% 和 53%（p = 0.04，ADT 与 TOPADT，p = 0.48，ADT 与 RAPADT 和 p = 0.12，TOPADT 与 RAPADT）。所有组的 VAS 评分均有所改善，并在整个研究过程中保持稳定。该分析仅限于单个中心的初步结果。托瑞米芬联合常规 ADT 显着提高了初治骨转移性 PC 的 BCR 率。需要进一步的临床试验来证实这种联合疗法的有前景的临床疗效。该协议于 2011 年 9 月 25 日在大学医院医疗信息网络 (UMIN ID;0,000,064,000) 注册。本文的在线版本 (doi:10.1186/s12885-015-1871-z) 包含补充材料，可供授权用户使用。
Durability of androgen-deprivation therapy (ADT) for prostate cancer (PC) is limited. Additional selective estrogen receptor modulators (SERMs) may prolong the durability of ADT, because androgen and estrogen signaling drive PC progression. Men with treatment-naïve bone metastatic PC were randomly assigned in 1:1:1 fashion to receive ADT, toremifene 60 mg plus ADT (TOPADT), or raloxifene 60 mg plus ADT (RAPADT). The primary endpoint was the biochemical recurrence (BCR) rate, and secondary endpoints were changes of scores of the visual analogue scale (VAS) and the functional assessment of cancer therapy (FACT). A total of 15 men, 5 each, were allocated to one of the three treatment arms. The basal serum prostate-specific antigen (PSA) level was 198 ng/mL (median, range; 30–8428). Bone metastases were graded as 1 (n = 11), 2 (n = 3), and 3 (n = 1) by the extent of disease. During the median follow-up period of 1370 days (range; 431–1983), BCR occurred in 3, 0 and 2 men in ADT, TOPADT and RAPADT group, respectively. The 5-year BCR-free rate was 30, 100 and 53 %, in ADT, TOPADT and RAPADT group, respectively (p = 0.04, ADT v.s. TOPADT, p = 0.48, ADT v.s. RAPADT and p = 0.12, TOPADT v.s. RAPADT). Scores of VAS improved in all groups and remained stable throughout the study. This analysis is limited as a preliminary result in a single center. Toremifene with conventional ADT significantly improved the BCR rate in treatment-naïve bone metastatic PC. Further clinical trials are warranted to confirm the promising clinical efficacy of this combination therapy. The protocol was registered at the University Hospital Medical Information Network (UMIN ID;0,000,064,000) in Sep 25, 2011. The online version of this article (doi:10.1186/s12885-015-1871-z) contains supplementary material, which is available to authorized users.