RANDOMIZED TRIAL OF DOXORUBICIN ALONE OR COMBINED WITH VINCRISTINE AND MITOMYCIN-C IN WOMEN WITH METASTATIC BREAST-CANCER
RANDOMIZED TRIAL OF DOXORUBICIN ALONE OR COMBINED WITH VINCRISTINE AND MITOMYCIN-C IN WOMEN WITH METASTATIC BREAST-CANCER
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DOI：
10.1097/00000421-198912000-00003
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发表时间：
1989-12-01
影响因子：
2.6
通讯作者：
FOLEY, JF
中科院分区：
文献类型：
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作者：
INGLE, JN;MAILLIARD, JA;FOLEY, JF
进行了一项随机临床试验，以确定在先前化疗失败的转移性乳腺癌患者中，多柔比星、长春新碱和丝裂霉素C （DVM）联合治疗是否优于单用多柔比星。185名女性随机接受每月疗程的D治疗（60 mg/m2, 500 mg/m2后观察）；或D (50mg /m2，最大累积剂量500mg /m2), V （1mg /m2）和M （10mg /m2，每隔一个周期给药）。单独D治疗失败的患者可给予V（每周1mg，连续5周，然后每5周1.2 mg/m2） + M（每5周12mg /m2）。95例患者中有24例（25%）单独使用D， 90例患者中有39例（43%）单独使用DVM（双侧p = 0.01）。DVM的疾病进展时间分布明显优于DVM（双侧p = 0.02），但优势幅度较小，D和DVM的中位时间分别为2.7个月和4.2个月。两种治疗方案的生存率无显著差异。白细胞减少的程度对于DVM来说更大，无论是白细胞中位数最低点（1300 /.mu）。1 /亩比1 /亩。L)和最低点< 1000 /.mu的患者百分比。L（33%对16%）。总共有45例患者在D后接受了VM，只有7例（16%）获得了客观反应。我们的结论是，尽管有更高的反应率和更长的进展时间，但临床获益的程度不足以推荐DVM联合而不是D单独作为转移性乳腺癌妇女的二线治疗。VM作为第三疗法的疗效水平很低，而且其程度表明V对M的作用很小，但对M有毒性。
A randomized clinical trial was performed to determine if combination therapy with doxorubicin, vincristine, and mitomycin C (DVM) was superior to doxorubicin alone in women with metastatic breast cancer for whom prior chemotherapy had failed. A total of 185 women were randomized to monthly courses of D (60 mg/m2, observation after 500 mg/m2); or D (50 mg/m2, maximum cumulative dose 500 mg/m2), V (1 mg/m2), and M (10 mg/m2, given every other cycle). Patients failing after D alone could receive V (1 mg weekly for 5 weeks, then 1.2 mg/m2 every 5 weeks) plus M (12 mg/m2 every 5 weeks). Objective responses were seen in 24 of 95 patients (25%) on D alone and 39 of 90 patients (43%) on DVM (two-sided p = 0.01). The time to disease progression distribution was significantly better for DVM (two-sided p = 0.02), but the magnitude of the advantage was small with the medians being 2.7 months for D and 4.2 months for DVM. There was no significant difference in survival between the two regimens. The degree of leukopenia was greater for DVM both in terms of median white blood cell nadir (1,300/.mu.L versus 1,700/.mu.L) and percentage of patients with a nadir < 1,000/.mu.L (33% versus 16%). A total of 45 patients received VM following D alone, and only seven (16%) achieved an objective response. We conclude that, despite a significantly higher response rate and longer time to progression, the degree of clinical benefit is not sufficient to recommend the combination of DVM over D alone as second-line therapy for women with metastatic breast cancer. The level of efficacy seen with VM as tertiary therapy is low and is of such a magnitude to suggest that V adds little but toxocity to M.