TREATMENT WITH I131 METAIODOBENZYLGUANIDINE IN METASTATIC CARCINOID

这是I-131间苯基胍治疗的I期研究。 (MIBG)在转移性类癌患者中。的主要目标是 本研究旨在确定人体对I-131MIBG的最大耐受量。 未经治疗的转移性类癌患者。有一份文件记录在 文献表明，转移性类癌患者摄取MIBG， 至少可以在与疾病相关的主观上得到改善 使用I-131MIBG治疗的症状学。可容忍的最大值 剂量还没有确定，这是目前的目标 学习。我们希望更高的剂量会改善反应，两者 主观上和客观上。17名患者参加了 学习。I-131MIBG 500mCI的5号队列达到剂量限制 中性粒细胞减少(ANC&lt；1500)和血小板减少(&lt；50,000)的毒性 持续2周或更长时间。这些都不需要住院或 输液，未见严重不良反应。他们的数量 随访(16周)结束后恢复正常。所有患者 每次CT扫描均有主观反应，病情稳定。只有3个 患者按协议接受第二次治疗。三个人有进步性 疾病，1例三尖瓣置换术，病情稳定， 14人无法负担进一步治疗的费用 放射性物质或不希望在此进行第二次处理 时间到了。接受第二次治疗的3名患者仅显示 第一剂有主观反应，但确实有客观反应 用第二剂。在这组患者中没有发现骨髓毒性。 病人。

This was a Phase I study for treatment with I-131 Metaiodobenzylguanidine (MIBG) in patients with metastatic carcinoid. The primary objective of the study was to determine the maximum tolerated dose of I-131 MIBG in patients with untreated metastatic carcinoid. There was documentation in the literature that patients with metastatic carcinoid, that uptake MIBG, can obtain at least subjective improvement in their disease related symptomatology with treatment using I-131 MIBG. The maximum tolerated dose had not yet been determined and that was the goal of the current study. We hoped that higher doses would improve response, both subjectively and objectively. Seventeen patients were enrolled in the study. Cohort #5 at 500 mCi of I-131 MIBG reached dose limiting toxicities with neutropenia (ANC<1500) and thrombocytopenia (<50,000) with a duration of 2 weeks or longer. These did not require hospitalization or transfusions, and no serious adverse reactions were seen. Their counts returned to normal by completion of follow-up (16 weeks). All patients showed subjective response and stable disease per CT scan. Only 3 patients received a second treatment on protocol. Three had progressive disease, 1 required surgery for tricuspid valve replacement and is stable, 14 were unable to afford further treatment due to the cost of the radioactive material or did not wish to pursue a second treatment at this time. The 3 patients that received a second treatment showed only subjective response with the first dose but did show an objective response with the second dose. No bone marrow toxicity was seen in this group of patients.