PHASE-II STUDY OF CIS-DIAMMINE(GLYCOLATO)PLATINUM, 254-S, IN PATIENTS WITH ADVANCED GERM-CELL TESTICULAR CANCER, PROSTATIC-CANCER, AND TRANSITIONAL-CELL CARCINOMA OF THE URINARY-TRACT
PHASE-II STUDY OF CIS-DIAMMINE(GLYCOLATO)PLATINUM, 254-S, IN PATIENTS WITH ADVANCED GERM-CELL TESTICULAR CANCER, PROSTATIC-CANCER, AND TRANSITIONAL-CELL CARCINOMA OF THE URINARY-TRACT
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DOI：
10.1007/bf00685546
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发表时间：
1992-12-01
影响因子：
3
通讯作者：
ASO, Y
中科院分区：
文献类型：
--
作者：
AKAZA, H;TOGASHI, M;ASO, Y
本研究为多中心合作研究，评价第二代抗癌铂配合物顺二氨（乙醇酸）铂（254-S）治疗泌尿生殖系肿瘤的临床疗效和安全性。254-S以100 mg/m2静脉给药，间隔4周。结果，35例膀胱或肾盂输尿管移行细胞癌（TCC）患者获得2例完全缓解（CR）和8例部分缓解（PR），16例前列腺癌患者获得3例PR，15例睾丸癌患者获得6例CR和6例PR。客观缓解率分别为28.6% [95%置信区间（CI），14.6%-46.3%]、18.8%（95% CI，4.0%-45.6%）和80.0%（95% CI，51.9%-95.7%）。骨髓抑制是剂量限制性毒性，尽管它是可逆的。虽然没有水化进行了约。在40%的患者中，肾毒性反应的发生率较低，大多数为轻度，只有1例患者在首次治疗后显示重度肾功能不全。恶心和呕吐发生在大约。70%的患者，但大多数胃肠道毒性在未进行止吐治疗的情况下得到控制。此外，很少观察到肝功能损害。我们的结论是，254-S是一个很有前途的顺铂类似物用于治疗泌尿生殖系统癌症，是值得进一步调查的大规模，随机比较研究与其他铂衍生物的单药和联合方案。
A multicenter cooperative study was conducted to evaluate the clinical efficacy and safety of cis-diammine(glycolato)platinum (254-S), a second-generation anticancer platinum complex, in the treatment of genitourinary cancers. 254-S was given i.v. at 100 mg/m2 at 4-week intervals. As a result, 2 complete responses (CRs) and 8 partial responses (PRs) were obtained in 35 patients with transitional-cell carcinoma (TCC) of the urinary bladder or pyeloureter, 3 PRs were obtained in 16 subjects with prostatic cancer, and 6 CRs and 6 PRs were obtained in 15 patients with testicular cancer, generating objective response rates of 28.6% [95% confidence interval (CI), 14.6%-46.3%], 18.8% (95% Cl, 4.0%-45.6%), and 80.0% (95% Cl, 51.9%-95.7%), respectively. Bone marrow suppression was the dose-limiting toxicity, although it was reversible. Although no hydration was performed in approx. 40% of the patients, the incidence of nephrotoxic effects was low and most of those encountered were mild, the exception being one patient who showed severe renal insufficiency after the first treatment. Nausea and vomiting occurred in approx. 70% of the patients, but most gastrointestinal toxicities were controlled without antiemetic treatment. In addition, liver-function impairment was rarely observed. We conclude that 254-S is a promising cisplatin analogue for the treatment of genitourinary cancers and is worthy of further investigation in large-scale, randomized comparative studies with other platinum derivatives in both single-agent and combination regimens.