Division of Medical Oncology E.O. Ospedali Galliera, Genoa, Italy.
Epidemiology and Biostatistics Unit, European Institute of Oncology, Milan, Italy.
Gynecol Oncol. 2017 Sep;146(3):504-513. doi: 10.1016/j.ygyno.2017.06.036. Epub 2017 Jul 10.
Steroid hormones promote epithelial ovarian cancer (EOC) growth and their receptor expression is associated with disease outcome. Hormone therapy is frequently used in pretreated EOC, but the magnitude of activity overall and by specific agents or tumor characteristics is unknown.
Clinical Benefit Rates (CBR) and deaths from clinical trials of endocrine agents were meta-analyzed. Summary estimates of CBR (SCBR) and Odd Ratio for death (SOR) were calculated according with type of drug, ER and PgR status, platinum resistance, line of therapy, tumor grade and tamoxifen dose.
Fifty-three trials in 2490 patients were analyzed. Overall, SCBR was 41% (95%CI, 0.34-0.48) for any endocrine treatment, 43% (95%CI, 0.30-0.56) for tamoxifen, 39% (95%CI, 0.29-0.50) for aromatase inhibitors and 37% (95%CI, 0.26-0.48) for progestins. The SCBR for ER+ and/or PgR+ tumors was 46% (95%CI, 0.34-0.57) versus 37% (95%CI, 0.27-0.48) in tumors with unknown receptors and 55% in platinum sensitive (95%CI, 0.28-0.80) versus 40% (95%CI, 0.29-0.51) in platinum resistant tumors The SOR for death calculated from 6 out of 9 randomized clinical trials (RCTs) showed a reduced mortality with endocrine therapy (SOR=0.69, 95%CI, 0.50-0.97), with a possible tendency for a greater effect in first line and low grade tumors. The overall quality of the RCTs was low.
The activity of endocrine therapy in advanced EOC is worth considering and seems to support large properly designed randomized trials in the first treatment of hormone sensitive EOC.
甾体激素促进卵巢上皮癌（EOC）的生长，其受体表达与疾病结局相关。激素治疗常用于预处理后的 EOC，但总的治疗效果以及特定药物或肿瘤特征的治疗效果尚不清楚。
对内分泌治疗药物的临床试验的临床受益率（CBR）和死亡进行了荟萃分析。根据药物类型、ER 和 PgR 状态、铂耐药性、治疗线数、肿瘤分级和他莫昔芬剂量，计算了 CBR 的汇总估计值（SCBR）和死亡的优势比（SOR）。
分析了 2490 名患者的 53 项试验。总体而言，任何内分泌治疗的 SCBR 为 41%（95%CI，0.34-0.48），他莫昔芬为 43%（95%CI，0.30-0.56），芳香化酶抑制剂为 39%（95%CI，0.29-0.50），孕激素为 37%（95%CI，0.26-0.48）。ER+和/或 PgR+肿瘤的 SCBR 为 46%（95%CI，0.34-0.57），而受体未知的肿瘤为 37%（95%CI，0.27-0.48），铂敏感肿瘤为 55%（95%CI，0.28-0.80），而铂耐药肿瘤为 40%（95%CI，0.29-0.51）。从 9 项随机临床试验（RCT）中的 6 项计算得出的死亡 SOR 显示，内分泌治疗降低了死亡率（SOR=0.69，95%CI，0.50-0.97），一线和低级别肿瘤的效果可能更大。RCT 的总体质量较低。
内分泌治疗在晚期 EOC 中的活性值得考虑，并且似乎支持在激素敏感的 EOC 的一线治疗中进行大型、恰当设计的随机试验。
