(1) Background: The standard first-line therapy for advanced adrenocortical carcinoma (ACC) is represented by EDP-M (etoposide, doxorubicin, cisplatin + mitotane). Progestins have shown cytotoxic activity both in vitro and in vivo on ACC; better EDP-M tolerability and efficacy have been hypnotized due to the association with progestins. (2) Methods: The feasibility and tolerability of EDP-M combined with oral megestrol acetate (EDP-MM) were tested in 24 patients (pts) affected by metastatic ACC with a low performance status (PS); the case group was compared with a 48 pts control group according to the propensity score. The secondary objectives were clinical benefit rate (CBR), progression-free survival (PFS), and overall survival (OS). (3) Results: Thirteen pts (54.2%) in the EDP-MM population experienced progestin-related toxicities; in particular, five pts experienced vaginal bleeding (20.8%); four pts experienced weight gain (16.7%); and thromboembolic events, worsening of hypertension, skin rashes, and hyperglycemia were registered in one patient each (4.2%). This led to the discontinuation of megestrol acetate in four pts (16.7%). EDP-M-related toxicities were similar in both groups. No differences in PFS and OS curves were observed; the CBR was 75.0% and 60.4%, respectively. (4) Conclusions: The association of EDP-M + megestrol acetate in ACC pts with a low PS is feasible and well tolerated; its efficacy appeared to be non-inferior to EDP-M administered to pts with a good PS.
(1)背景:晚期肾上腺皮质癌(ACC)的标准一线治疗方案为EDP-M(依托泊苷、多柔比星、顺铂联合米托坦)。孕激素在体外及体内实验中均显示出对ACC的细胞毒性作用;联合孕激素治疗被认为可能提升EDP-M方案的耐受性与疗效。(2)方法:本研究对24例体能状态(PS)较差的转移性ACC患者进行了EDP-M联合口服醋酸甲地孕酮(EDP-MM)方案的可行性及耐受性评估;通过倾向评分匹配法,将病例组与48例对照组进行比较。次要研究目标包括临床获益率(CBR)、无进展生存期(PFS)和总生存期(OS)。(3)结果:EDP-MM组中13例患者(54.2%)出现孕激素相关毒性反应,具体表现为:5例(20.8%)发生阴道出血,4例(16.7%)出现体重增加,另有血栓栓塞事件、高血压恶化、皮疹及高血糖各1例(4.2%)。其中4例患者(16.7%)因此停用醋酸甲地孕酮。两组EDP-M相关毒性反应发生率相似。PFS与OS曲线未见显著差异;临床获益率分别为75.0%和60.4%。(4)结论:对于PS较差的ACC患者,EDP-M联合醋酸甲地孕酮方案具有可行性且耐受性良好;其疗效不劣于对PS良好患者单独使用EDP-M方案。