Department of Breast Surgery, Matsuyama Red Cross Hospital, Matsuyama, Japan.
Department of Breast and Endocrine Surgery, Kumamoto University Graduate School of Medical Sciences, Kumamoto, Japan.
Jpn J Clin Oncol. 2023 Mar 7;53(3):203-211. doi: 10.1093/jjco/hyac184.
Only old evidence exists to back up the use of medroxyprogesterone acetate. Therefore, this study aimed to explore the factors that influence the time to treatment failure of medroxyprogesterone acetate in real-world settings as late-line treatment.
This was a cohort study that used the database of the Safari study on oestrogen receptor-positive post-menopausal advanced breast cancer (UMIN000015168). We created Kaplan-Meier curves for time to treatment failure with medroxyprogesterone acetate. Further, univariate and multivariate analyses were performed using a Cox hazard model of the clinicopathological factors involved in the time to treatment failure of medroxyprogesterone acetate.
From the 1031 patients in the Safari study, 279 patients were selected as the population for the analysis of effectiveness of medroxyprogesterone acetate monotherapy. In the analysis of medroxyprogesterone acetate by treatment line, the median time to treatment failure was 3.0 months for third-line treatment and 4.1 months for fourth and subsequent treatment lines. In cases where medroxyprogesterone acetate was used as a third-line or later endocrine treatment, multivariate analysis showed that the length of the disease-free interval was correlated with the length of time to treatment failure of medroxyprogesterone acetate (P = 0.004). With medroxyprogesterone acetate monotherapy as the fourth-line or later treatment, 20% of the patients achieved a time to treatment failure of 12 months or longer.
In actual clinical practice, patients treated with medroxyprogesterone acetate alone as the fourth or subsequent treatment lines showed a time to treatment failure of 4 months, suggesting that there is merit in using medroxyprogesterone acetate even in late treatment lines, especially in patients with long disease-free interval and those who are difficult to treat using other antineoplastic agents.
只有陈旧的证据支持醋酸甲羟孕酮的应用。因此，本研究旨在探索在晚期治疗中，影响醋酸甲羟孕酮治疗失败时间的因素。
这是一项使用 Safari 研究数据库进行的队列研究，该研究涉及雌激素受体阳性绝经后晚期乳腺癌（UMIN000015168）。我们绘制了醋酸甲羟孕酮治疗失败时间的 Kaplan-Meier 曲线。此外，我们使用 Cox 风险模型对涉及醋酸甲羟孕酮治疗失败时间的临床病理因素进行了单变量和多变量分析。
在 Safari 研究的 1031 名患者中，选择了 279 名患者作为醋酸甲羟孕酮单药治疗有效性分析的人群。在按治疗线分析醋酸甲羟孕酮时，三线治疗的中位治疗失败时间为 3.0 个月，四线及后续治疗线为 4.1 个月。在将醋酸甲羟孕酮作为三线或更后的内分泌治疗时，多变量分析显示无病间期的长度与醋酸甲羟孕酮治疗失败的时间相关（P=0.004）。对于接受醋酸甲羟孕酮单药治疗作为四线或更后的治疗，有 20%的患者达到了 12 个月或更长时间的治疗失败时间。
在实际临床实践中，单独使用醋酸甲羟孕酮作为四线或更后的治疗线的患者，其治疗失败时间为 4 个月，这表明即使在晚期治疗线中使用醋酸甲羟孕酮也有其价值，尤其是在无病间期较长且难以用其他抗肿瘤药物治疗的患者中。
