Nielsen O S, Dombernowsky P, Mouridsen H, Crowther D, Verweij J, Buesa J, Steward W, Daugaard S, van Glabbeke M, Kirkpatrick A, Tursz T
Centre for Bone and Soft Tissue Sarcomas, Aarhus University Hospital, Denmark.
Br J Cancer. 1998 Dec;78(12):1634-9. doi: 10.1038/bjc.1998.735.
The activity and toxicity of single-agent standard-dose doxorubicin were compared with that of two schedules of high-dose epirubicin. A total of 334 chemonaive patients with histologically confirmed advanced soft-tissue sarcomas received (A) doxorubicin 75 mg m(-2) on day 1 (112 patients), (B) epirubicin 150 mg m(-2) on day 1 (111 patients) or (C) epirubicin 50 mg m(-2) day(-1) on days 1, 2 and 3 (111 patients); all given as bolus injection at 3-week intervals. A median of four treatment cycles was given. Median age was 52 years (19-70 years) and performance score 1 (0-2). Of 314 evaluable patients, 45 (14%) had an objective tumour response (eight complete response, 35 partial response). There were no differences among the three groups. Median time to progression for groups A, B and C was 16, 14 and 12 weeks, and median survival 45, 47 and 45 weeks respectively. Neither progression-free (P = 0.93) nor overall survival (P = 0.89) differed among the three groups. After the first cycle of therapy, two patients died of infection and one owing to cardiovascular disease, all on epirubicin. Both dose schedules of epirubicin were more myelotoxic than doxorubicin. Cardiotoxicity (> or = grade 3) occurred in 1%, 0% and 2% respectively. Regardless of the schedule, high-dose epirubicin is not a preferred alternative to standard-dose doxorubicin in the treatment of patients with advanced soft-tissue sarcomas.
将单剂量标准剂量阿霉素的活性和毒性与两种高剂量表阿霉素方案进行了比较。共有334例经组织学确诊的晚期软组织肉瘤初治患者接受了以下治疗：(A)第1天给予阿霉素75mg/m²（112例患者），(B)第1天给予表阿霉素150mg/m²（111例患者），或(C)第1、2和3天给予表阿霉素50mg/m²（111例患者）；均以推注方式给药，每3周一次。中位给予四个治疗周期。中位年龄为52岁（19 - 70岁），体能状态评分为1（0 - 2）。在314例可评估患者中，45例（14%）有客观肿瘤反应（8例完全缓解，35例部分缓解）。三组之间无差异。A、B和C组的中位进展时间分别为16、14和12周，中位生存期分别为45、47和45周。三组之间无进展生存期（P = 0.93）和总生存期（P = 0.89）的差异。在第一个治疗周期后，两名患者死于感染，一名死于心血管疾病，均接受表阿霉素治疗。表阿霉素的两种剂量方案均比阿霉素的骨髓毒性更大。心脏毒性（≥3级）分别发生在1%、0%和2%的患者中。无论方案如何，在晚期软组织肉瘤患者的治疗中，高剂量表阿霉素都不是标准剂量阿霉素的首选替代药物。
