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CytRx公司宣布FDA同意蒽环类抗生素阿多柔比星(aldoxorubicin)治疗软组织肉瘤的新药申请。Ⅱb期临床试验入选31个医疗点123名晚期软组织肉瘤患者,按2∶1随机分到350 mg/m2试验组83名,多柔比星(doxorubicin)75 mg/m2组40名,每3周1次,共6个疗程。Ⅲ期临床试验入选79个医疗点433名转移晚期不可手术软组织肉瘤患者,按1∶1随机分到试验组或另一种有效化疗药组,包括多柔比星、环磷酰胺、达卡巴嗪、
CytRx Announces FDA Approval of New Drug Application for Treatment of Soft Tissue Sarcoma with Anthracycline, aldoxorubicin. Phase IIb clinical trial selected 123 medical units of 123 patients with advanced soft tissue sarcoma, were randomly divided into two groups according to 2: 1 in the test group of 350 mg / m2 83, doxorubicin 75 mg / m2 group 40, every 3 weeks 1 times, a total of 6 courses. Phase III clinical trials included 79 medical sites in 433 patients with advanced unresectable soft tissue sarcoma who were randomized to either a test group or another effective chemotherapeutic group at 1: 1, including doxorubicin, cyclophosphamide, dacarbazine ,