Doxorubicin vs epirubicin, report of a second-line randomized phase II/III study in advanced breast cancer. EORTC Breast Cancer Cooperative Group.
Doxorubicin vs epirubicin, report of a second-line randomized phase II/III study in advanced breast cancer. EORTC Breast Cancer Cooperative Group.
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阿霉素与半圆霉素，一项二线随机II/III研究的报告。 EORTC乳腺癌合作组。
DOI：
10.1038/bjc.1998.375
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发表时间：
1998-06
影响因子：
8.8
通讯作者：
van Oosterom, A T
中科院分区：
文献类型：
--
作者：
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
EORTC乳腺癌协作组进行了一项随机试验，比较阿霉素与表阿霉素作为转移性乳腺癌患者的二线化疗。259例至少有一个转移性疾病部位的患者入组本试验，其中232例患者合格。治疗包括多柔比星75 mg m（-2）或表阿霉素90 mg m（-2）静脉注射，每3周一次。多柔比星和表柔比星的总有效率分别为36%和28%（P = 0.173）。多柔比星组的中位进展时间为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）。阿霉素组的中位生存期为47周，表阿霉素组为44周（P = 0.196）。多柔比星治疗组再治疗日的白细胞计数（P = 0.011）和血小板最低值（P = 0.031）显著较低。多柔比星组的粘膜炎（P < 0.001）、腹泻（P = 0.005）和出血（P = 0.048）也明显加重。在本研究中使用的剂量水平下，两个治疗组之间的缓解率和生存期无统计学差异。多柔比星治疗往往导致反应持续时间和进展时间略长，但多柔比星的毒性比表柔比星更大。
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.