Trump D L, Elson P, Madajewicz S, Dickman S H, Hahn R G, Harris J E, Vogl S E
University of Wisconsin Clinical Cancer Center, Madison.
J Urol. 1990 Nov;144(5):1119-22. doi: 10.1016/s0022-5347(17)39672-6.
A total of 83 patients with metastatic transitional cell carcinoma who had previously received no systemic therapy entered a randomized phase II evaluation of carboplatin and cis-dichloro-transdihydroxy-bis-isopropylamine platinum IV (CHIP), administered respectively at 400 and 270 mg./m.2 every 28 days. Among evaluable patients with measurable disease response rates were 3 of 22 (14%, 95% confidence interval 5 to 35%) for carboplatin and 4 of 25 (16%, 95% confidence interval 5 to 36%) for CHIP. Among 17 patients with evaluable but not measurable metastases (10 carboplatin and 7 CHIP recipients) there were no responses. Median survival for 64 evaluable patients was 4.8 months (5.0 months for carboplatin and 4.3 months for CHIP recipients). Independent factors prognostic for survival (p less than 0.01) were performance status (0 or 1 versus 2 or 3), liver metastases, prior radiation therapy and recent weight loss (p = 0.02). Multivariate analysis confirmed that a performance status of 2 or 3 and liver metastases were predictive of shorter survival. A total of 31% of the patients treated with carboplatin and 34% of those who received CHIP experienced severe or life-threatening myelosuppression. While the response rates with carboplatin and CHIP are modest, we believe that the characteristics of these agents indicate that they should be evaluated further.
共有83例先前未接受过全身治疗的转移性移行细胞癌患者进入了一项关于卡铂和顺-二氯-反-二羟基-双-异丙胺铂IV（CHIP）的随机II期评估，分别以400和270mg/m²的剂量每28天给药一次。在可评估的有可测量疾病的患者中，卡铂组22例中有3例有反应（14%，95%置信区间5%至35%），CHIP组25例中有4例有反应（16%，95%置信区间5%至36%）。在17例有可评估但不可测量转移灶的患者中（10例接受卡铂治疗，7例接受CHIP治疗），无反应。64例可评估患者的中位生存期为4.8个月（卡铂组为5.0个月，CHIP组为4.3个月）。对生存有预后意义的独立因素（p<0.01）为体能状态（0或1与2或3）、肝转移、既往放疗和近期体重减轻（p = 0.02）。多变量分析证实，体能状态为2或3以及肝转移可预测生存期较短。接受卡铂治疗的患者中有31%、接受CHIP治疗的患者中有34%出现了严重或危及生命的骨髓抑制。虽然卡铂和CHIP的反应率一般，但我们认为这些药物的特性表明它们应进一步评估。
