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. 254-S Urological Cancer Study Group.
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. 254-S Urological Cancer Study Group.
复制标题
顺式二氨（乙醇酸）铂 254-S 在晚期生殖细胞睾丸癌、前列腺癌和尿路移行细胞癌患者中的 II 期研究。
DOI：
--
复制
发表时间：
1992
影响因子：
3
通讯作者：
Y. Aso
中科院分区：
文献类型：
--
作者：
H. Akaza;M. Togashi;Y. Nishio;T. Miki;T. Kotake;Y. Matsumura;O. Yoshida;Y. Aso
开展了一项多中心合作研究，评价第二代抗癌铂络合物顺式二氨（乙醇酸）铂（254-S）治疗泌尿生殖系癌症的临床疗效和安全性。 254-S 静脉注射100 mg/m2，间隔 4 周。结果，35 名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，客观缓解率为 28.6% [95% 置信区间 (CI)，分别为 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。虽然大约没有进行水合作用。 40%的患者中，肾毒性反应的发生率较低，大多数都是轻微的，例外的是一名患者在第一次治疗后表现出严重的肾功能不全。恶心和呕吐发生在大约。 70%的患者，但大多数胃肠道毒性无需止吐治疗即可得到控制。此外，很少观察到肝功能损害。我们的结论是，254-S 是一种有前途的顺铂类似物，用于治疗泌尿生殖系统癌症，值得在单药和联合治疗方案中与其他铂衍生物进行大规模、随机比较研究中进一步研究。
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% CI, 4.0%-45.6%), and 80.0% (95% CI, 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.