ADRIAMYCIN VERSUS EPIRUBICIN IN ADVANCED SOFT-TISSUE SARCOMAS - A RANDOMIZED PHASE-II PHASE-III STUDY OF THE EORTC SOFT-TISSUE AND BONE SARCOMA GROUP
ADRIAMYCIN VERSUS EPIRUBICIN IN ADVANCED SOFT-TISSUE SARCOMAS - A RANDOMIZED PHASE-II PHASE-III STUDY OF THE EORTC SOFT-TISSUE AND BONE SARCOMA GROUP
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DOI：
10.1016/0277-5379(87)90089-7
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发表时间：
1987-10-01
期刊：
影响因子：
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通讯作者：
SYLVESTER, R
中科院分区：
文献类型：
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作者：
MOURIDSEN, HT;BASTHOLT, L;SYLVESTER, R
这项随机II/III期研究的目的是观察等摩尔剂量的阿霉素(ADM)和4-表阿霉素(EPI)治疗局部晚期和/或转移性软组织肉瘤的疗效和毒性。ADM和EPI的剂量为75 mg/m2，静脉滴注。团注，每3周一次。来自18个机构的210名患者进入了这项研究。28名患者不合格，15名患者不可评估，剩下167名可评估患者。两个治疗组在性别、表现状况、年龄、既往放射治疗、疾病范围和部位方面都达到了良好的平衡。两组在中位有效时间(45周对77周，P=0.08)、进展时间(15周对12周，P=0.945)和中位生存期(41周对48周，P=0.363)方面无显著差异。以白细胞减少为表现的骨髓毒性在阿霉素治疗的患者中明显更明显(P=0.002)。ADM组脱发、恶心呕吐等其他不良反应也更为严重(P分别为0.02和0.06)。总而言之，在晚期软组织肉瘤中，使用等摩尔剂量的ADM和EPI产生的有效率没有显著差异，仅略有利于ADM。然而，这是以更高的毒性为代价的。
The objective of this randomized phase II/phase III study was to investigate the efficacy and toxicity of equimolar doses of adriamycin (ADM) and 4-epiadriamycin (EPI) in patients with locally advanced and/or metastatic soft tissue sarcoma. Doses of ADM and EPI were 75 mg/m2 given as an i.v. bolus injection every 3 weeks. Two hundred and ten patients were entered into the study by 18 institutions. Twenty-eight patients were ineligible and 15 were non-evaluable, leaving 167 evaluable patients. The two treatment groups were well balanced for sex, performance status, age, prior radiotherapy, extent and site of disease. Rates of response were similar, 25% in the ADM group compared to 18% in the EPI group (P = 0.33), and there were no significant differences between the ADM and EPI groups with respect to median duration of response (45 weeks vs. 77 weeks, P = 0.08), time to progression (15 weeks vs. 12 weeks, P = 0.945), and median survival (41 weeks vs. 48 weeks, P = 0.363). Myelotoxicity as shown by leucopenia was significantly more pronounced in the ADM treated patients (P = 0.002). Other toxicities such as alopecia and nausea/vomiting were also more severe in the ADM group (P = 0.02 and 0.06, respectively). In conclusion, the use of equimolar doses of ADM and EPI in advanced soft tissue sarcoma produced response rates which did not differ significantly and were only slightly in favour of ADM. However, this was achieved at the expense of higher toxicity.