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一项关于[90Y]钇-卡普睾酮治疗前列腺癌根治术后复发男性患者的II期研究。

A phase II study of [90Y] yttrium-capromab pendetide in the treatment of men with prostate cancer recurrence following radical prostatectomy.

作者信息

Kahn D, Austin J C, Maguire R T, Miller S J, Gerstbrein J, Williams R D

机构信息

Nuclear Medicine Section, Iowa City Veterans Affairs Medical Center, IA 52246, USA.

出版信息

Cancer Biother Radiopharm. 1999 Apr;14(2):99-111. doi: 10.1089/cbr.1999.14.99.

DOI:10.1089/cbr.1999.14.99
PMID:10850293
Abstract

There is currently no curative therapy for men who have disseminated prostate cancer following failed radical prostatectomy. The purpose of this trial was to investigate systemic radioimmunotherapy in these men. Eight patients with occult metastatic prostate cancer following radical prostatectomy as evidenced solely by a rising serum PSA and evidence of soft tissue lesions outside the prostatic fossa detected by an [111I]indiumcapromab pendetide scan received an infusion of 10 mg of capromab pendetide labeled with 9 mCi/m2 of [90Y]yttrium. Serum PSA was used to measure response rate. There were no complete or partial responses by PSA criteria. Significant unexpected bone marrow toxicity developed in the first 6 of 8 patients treated. The last two patients received co-infusion of edetate calcium disodium in an effort to decrease marrow suppression. In these two patients less marrow toxicity was seen. Repeat 111In-capromab pendetide scans were uninterpretable due to grossly altered whole-body biodistribution of the radioimmunoconjugate. Retrospective analysis of serial PSA values after closure of the study showed a decrease in the log slope PSA for seven of eight patients following radioimmunotherapy, with a statistically significant change in the mean log slope (p = 0.01). The clinical significance of this small but measurable change is uncertain. We conclude that radioimmunotherapy for occult metastatic prostate cancer using 90Y-capromab-pendetide at the dose described does not lower serum PSA, is associated with significant hematologic toxicity, and leads to complexation of the immunoconjugate following subsequent capromab pendetide infusion.

摘要

对于根治性前列腺切除术后出现播散性前列腺癌的男性患者,目前尚无治愈性疗法。本试验的目的是研究这些男性患者的全身放射免疫疗法。8例根治性前列腺切除术后隐匿性转移性前列腺癌患者,仅血清PSA升高及[111I]铟喷曲肽扫描检测到前列腺窝外软组织病变作为证据,接受了10mg标记有9mCi/m2[90Y]钇的喷曲肽静脉输注。用血清PSA来衡量缓解率。按照PSA标准,未出现完全或部分缓解。在接受治疗的8例患者中的前6例出现了严重的意外骨髓毒性。最后2例患者接受了依地酸钙钠联合输注,以减轻骨髓抑制。在这2例患者中,骨髓毒性较轻。由于放射免疫缀合物的全身生物分布发生了显著改变,重复的[111In]铟喷曲肽扫描无法解读。研究结束后对系列PSA值进行回顾性分析显示,8例患者中有7例在放射免疫治疗后PSA的对数斜率下降,平均对数斜率有统计学意义的变化(p = 0.01)。这种微小但可测量的变化的临床意义尚不确定。我们得出结论,使用所述剂量的[90Y]钇喷曲肽对隐匿性转移性前列腺癌进行放射免疫治疗不会降低血清PSA,会导致显著的血液学毒性,并在随后输注喷曲肽后导致免疫缀合物的络合。

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