Blumenstein B, Crawford E D, Saiers J H, Stephens R L, Rivkin S E, Coltman C A
Southwest Oncology Group Statistical Center, Seattle, Washington.
J Urol. 1993 Aug;150(2 Pt 1):411-3. doi: 10.1016/s0022-5347(17)35496-4.
In a Southwest Oncology Group phase II clinical trial, 68 patients with hormone refractory carcinoma of the prostate were treated with a combination of doxorubicin, mitomycin C and 5-fluorouracil. Of the patients 11 were classified as good risk and 57 as poor risk. There were 1 complete and 10 partial remissions for a response rate of 16.2% (exact 95% confidence interval 8.4 to 27.1%). Median survival was 9 months (maximum 14) for good risk patients and 10 months (maximum 42) for poor risk patients. Toxicity was significant with leukopenia identified as dose limiting. Because of the low rate of response and significant toxicity, this regimen cannot be recommended as standard therapy for metastatic hormone refractory prostate cancer.
在西南肿瘤协作组的一项II期临床试验中,68例激素难治性前列腺癌患者接受了阿霉素、丝裂霉素C和5-氟尿嘧啶的联合治疗。这些患者中,11例被归类为低风险,57例为高风险。有1例完全缓解和10例部分缓解,缓解率为16.2%(精确95%置信区间为8.4%至27.1%)。低风险患者的中位生存期为9个月(最长14个月),高风险患者为10个月(最长42个月)。毒性反应显著,白细胞减少被确定为剂量限制性毒性。由于缓解率低且毒性显著,该方案不能作为转移性激素难治性前列腺癌的标准治疗方案推荐。