A phase II study of [90Y] yttrium-capromab pendetide in the treatment of men with prostate cancer recurrence following radical prostatectomy
A phase II study of [90Y] yttrium-capromab pendetide in the treatment of men with prostate cancer recurrence following radical prostatectomy
复制标题
DOI：
10.1089/cbr.1999.14.99
复制
发表时间：
1999-04-01
影响因子：
3.4
通讯作者：
Williams, RD
中科院分区：
文献类型：
--
作者：
Kahn, D;Austin, JC;Williams, RD
目前还没有根治性前列腺癌根治术失败后男性播散性前列腺癌的治疗方法。这项试验的目的是研究这些人的全身放射免疫治疗。8名前列腺癌根治术后的隐匿性转移性前列腺癌患者，仅通过血清PSA升高和经[I-111]铟-己二胺肽扫描发现的前列腺窝外软组织病变的证据，接受了10毫克的[Y-90]Y标记的9 mCI/m(2)的己丙酮肽的注射。用血清PSA测定应答率，按PSA标准无完全或部分反应。在接受治疗的8名患者中，前6名患者发生了明显的意想不到的骨髓毒性，最后两名患者联合输注依地特钙二钠，以努力减少骨髓抑制。在这两个患者中，骨髓毒性较小。由于放射免疫结合物在全身的生物分布发生了很大的变化，所以重复的In-111-己丙肽扫描是无法解释的。对研究结束后连续PSA值的回顾分析显示，在接受放射免疫治疗的8名患者中，有7名患者的对数斜率PSA下降，平均对数斜率有统计学意义的变化(p=0.01)。这一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Y-90-己丙酚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，与显著的血液毒性有关，并导致随后注射己丙酚后免疫结合物的络合作用。
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 [I-111]indium-capromab pendetide scan received an infusion of 10 mg of capromab pendetide labeled with 9 mCi/m(2) of [Y-90]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 In-111-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 Y-90-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.