DOXORUBICIN VERSUS CYVADIC VERSUS DOXORUBICIN PLUS IFOSFAMIDE IN FIRST-LINE TREATMENT OF ADVANCED SOFT-TISSUE SARCOMAS - A RANDOMIZED STUDY OF THE EUROPEAN-ORGANIZATION-FOR-RESEARCH-AND-TREATMENT-OF-CANCER SOFT-TISSUE AND BONE SARCOMA GROUP
DOXORUBICIN VERSUS CYVADIC VERSUS DOXORUBICIN PLUS IFOSFAMIDE IN FIRST-LINE TREATMENT OF ADVANCED SOFT-TISSUE SARCOMAS - A RANDOMIZED STUDY OF THE EUROPEAN-ORGANIZATION-FOR-RESEARCH-AND-TREATMENT-OF-CANCER SOFT-TISSUE AND BONE SARCOMA GROUP
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DOI：
10.1200/jco.1995.13.7.1537
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发表时间：
1995-07-01
影响因子：
45.3
通讯作者：
VANOOSTEROM, A
中科院分区：
文献类型：
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作者：
SANTORO, A;TURSZ, T;VANOOSTEROM, A
目的：本试验的目的是比较单药阿霉素和两种多药方案治疗成人晚期软组织肉瘤患者的活性和毒性。患者和方法：这是一项由欧洲癌症研究和治疗组织(EORTC)软组织和骨肉瘤组织内的35个癌症中心进行的前瞻性随机III期试验。663例符合条件的患者随机分为阿霉素75 mg/m(2组)(A组)、环磷酰胺、长春新碱、阿霉素、达卡巴津(B组)(B组)和异环磷酰胺5g/m(2组)加阿霉素50 mg/m(2组)(C组)。结果：A组总有效率为24%(95%可信区间，20.7%~27.3%)，C组为26%。在缓解率(A组，23.3%；B组，28.4%；C组，28.1%)、缓解期(中位数，A组46周、B组48周、C组44周)或总生存期(中位数A组52周、B组51周、C组55周)方面，三个研究组之间的差异没有统计学意义。异环磷酰胺和阿霉素联合用药的骨髓抑制程度明显高于其他两种方案。结论：在成人晚期软组织肉瘤中，单药阿霉素仍是标准化疗药物，应与更强化或新药治疗进行比较。联合化疗不能在没有对照临床试验的情况下推荐，不能排除某些肉瘤患者亚群，对这些患者来说，显着的肿瘤体积缩小可能是化疗方案的重要终点。(C)1995年，由美国临床肿瘤学会主办。
Purpose: The aim of this trial was to compare the activity and toxicity of single-agent doxorubicin with that of two multidrug regimens in the treatment of patients with adult advanced soft tissue sarcomas.Patients and Methods: This was a prospective randomized phase III trial performed by 35 cancer centers within the Soft Tissue and Bone Sarcoma Group of the European Organization for Research and Treatment of Cancer (EORTC). Six hundred sixty-three eligible patients were randomly allocated to receive either doxorubicin 75 mg/m(2) (arm A), cyclophosphamide, vincristine, doxorubicin, and dacarbazine (CYVADIC) (arm B), or ifosfamide 5 g/m(2) plus doxorubicin 50 mg/m(2) (arm C).Results: The overall response rate was 24% (95% confidence interval, 20.7% to 27.3%) among eligible patients and 26% among assessable patients. No statistically significant difference was detected among the three study arms in terms of response rate (arm A, 23.3%; arm B, 28.4%; and arm C, 28.1%), remission duration (median, 46 weeks on arm A, 48 weeks on arm B, and 44 weeks on arm C), or overall survival (median, 52 weeks on arm A, 51 weeks on arm B, and 55 weeks on arm C). The degree of myelosuppression was significantly greater for the combination of ifosfamide and doxorubicin than for the other two regimens. Cardiotoxicity was also more frequent in this arm, but other toxicities were similar.Conclusion: In advanced soft tissue sarcomas of adults, single agent doxorubicin is still the standard chemotherapy against which more intensive or new drug treatments should be compared. Combination chemotherapy cannot be recommended outside a controlled clinical trial with the exclusion of some subsets of sarcoma patients for whom significant tumor volume reduction may be an important end point of a chemotherapy regimen. (C) 1995 by American Society of Clinical Oncology.