Di Leo A, Bajetta E, Buzzoni R, Bochicchio A M, Nolè F, Biganzoli L, D'Aprile M, Veltri E, Comella G, Aitini E
Division of Medical Oncology B, Istituto Nazionale per lo Studio e la Cura dei Tumori, Milan, Italy.
Am J Clin Oncol. 1995 Jun;18(3):239-44. doi: 10.1097/00000421-199506000-00011.
The evaluation of drug efficacy in patients with advanced prostatic cancer who have progressed to hormonal therapy is difficult, although palliation of the pain related to bone involvement still represents an important endpoint. In this study, epirubicin (EpiADM) plus medroxyprogesterone acetate (MPA) were given to advanced prostatic cancer patients with symptomatic bone involvement who had progressed to hormonal therapy. EpiADM was administered at a dose of 30 mg/m2 i.v. weekly and MPA at a daily dose of 1,000 mg p.o. for the first month and 500 mg thereafter. Fifty-four patients entered the trial, all of whom were evaluable. Amelioration of pain and a > or = 50% reduction in analgesic intake were observed in 52% of cases, with a mean duration of 4 months. Of the 28 responsive patients, 26 had already received two lines of hormonal therapy or were resistant to first-line therapy. Of the 23 patients with measurable lesions, 6 obtained a > or = 50% tumor shrinkage at these sites. The treatment was well tolerated, and no cardiac toxicity was observed up to a total cumulative EpiADM dose of 660 mg/m2. In conclusion, this regimen seems to have a palliative effect in patients with advanced prostatic cancer who have progressed to hormonal therapy, and it is feasible in an outpatient setting.
对于已进展至激素治疗阶段的晚期前列腺癌患者，评估药物疗效存在困难，尽管缓解与骨转移相关的疼痛仍是一个重要的终点指标。在本研究中，对已进展至激素治疗阶段且有骨转移症状的晚期前列腺癌患者给予表柔比星（EpiADM）加醋酸甲羟孕酮（MPA）治疗。表柔比星静脉注射剂量为30mg/m²，每周一次，醋酸甲羟孕酮口服，第一个月每日剂量为1000mg，之后为500mg。54例患者进入试验，均具有可评估性。52%的病例观察到疼痛改善且止痛药物摄入量减少≥50%，平均持续时间为4个月。在28例有反应的患者中，26例已经接受过二线激素治疗或对一线治疗耐药。在23例有可测量病灶的患者中，6例在这些部位的肿瘤缩小≥50%。该治疗耐受性良好，在表柔比星总累积剂量达660mg/m²之前未观察到心脏毒性。总之，该方案对于已进展至激素治疗阶段的晚期前列腺癌患者似乎具有姑息治疗作用，且在门诊环境中可行。
