Bontenbal M, Andersson M, Wildiers J, Cocconi G, Jassem J, Paridaens R, Rotmensz N, Sylvester R, Mouridsen H T, Klijn J G, van Oosterom A T
Department of Medical Oncology, Rotterdam Cancer Institute (Dr Daniel den Hoed Kliniek), The Netherlands.
Br J Cancer. 1998 Jun;77(12):2257-63. doi: 10.1038/bjc.1998.375.
The EORTC Breast Cancer Cooperative Group carried out a randomized trial to compare doxorubicin with epirubicin as second-line chemotherapy in patients with metastatic breast cancer. Two hundred and fifty-nine patients with at least one site of metastatic disease entered this trial, of whom 232 patients were eligible. Treatment consisted of doxorubicin 75 mg m(-2) or epirubicin 90 mg m(-2) i.v. every 3 weeks. The overall response rates for doxorubicin and epirubicin were 36% and 28% respectively (P = 0.173). The median time to progression was 23 weeks for doxorubicin and 19 weeks for epirubicin (P = 0.063) and the median duration of response was 40 weeks for doxorubicin and 32 weeks for epirubicin (P = 0.059). The median survival was 47 weeks for doxorubicin and 44 weeks for epirubicin (P = 0.196). Leucocyte count on retreatment day (P = 0.011) and platelet nadir (P = 0.031) were significantly lower in the doxorubicin-treated group. Also mucositis (P < 0.001), diarrhoea (P = 0.005) and haemorrhage (P = 0.048) were significantly worse in the doxorubicin arm. Nine patients on doxorubicin and two patients on epirubicin experienced congestive heart failure (CHF). At the dose levels used in this study, no statistical differences in response rate and survival were found between the two treatment arms. Treatment with doxorubicin tended to result in a slightly longer duration of response and time to progression but doxorubicin was more toxic than epirubicin.
欧洲癌症研究与治疗组织乳腺癌协作组开展了一项随机试验，比较多柔比星与表柔比星作为转移性乳腺癌患者二线化疗药物的疗效。259例至少有一处转移病灶的患者进入该试验，其中232例符合条件。治疗方案为多柔比星75 mg/m²或表柔比星90 mg/m²静脉注射，每3周一次。多柔比星和表柔比星的总体缓解率分别为36%和28%（P = 0.173）。多柔比星组的中位疾病进展时间为23周，表柔比星组为19周（P = 0.063）；多柔比星组的中位缓解持续时间为40周，表柔比星组为32周（P = 0.059）。多柔比星组的中位生存期为47周，表柔比星组为44周（P = 0.196）。多柔比星治疗组再次治疗日的白细胞计数（P = 0.011）和血小板最低点（P = 0.031）显著更低。此外，多柔比星组的黏膜炎（P < 0.001）、腹泻（P = 0.005）和出血（P = 0.048）也明显更严重。9例接受多柔比星治疗的患者和2例接受表柔比星治疗的患者发生了充血性心力衰竭（CHF）。在本研究使用的剂量水平下，两个治疗组在缓解率和生存率方面未发现统计学差异。多柔比星治疗往往导致缓解持续时间和疾病进展时间略长，但多柔比星的毒性比表柔比星更大。
