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一项关于高活性186Re-HEDP联合自体外周血干细胞移植治疗骨转移的进展期激素难治性前列腺癌的2期研究。

A phase 2 study of high-activity 186Re-HEDP with autologous peripheral blood stem cell transplant in progressive hormone-refractory prostate cancer metastatic to bone.

作者信息

O'Sullivan J M, Norman A R, McCready V R, Flux G, Buffa F M, Johnson B, Coffey J, Cook G, Treleaven J, Horwich A, Huddart R A, Parker C C, Dearnaley D P

机构信息

Department of Oncology, Queen's University Belfast/Belfast City Hospital, Lisburn Road, Belfast, BT9 7AB, UK.

出版信息

Eur J Nucl Med Mol Imaging. 2006 Sep;33(9):1055-61. doi: 10.1007/s00259-005-0010-5. Epub 2006 Mar 30.

DOI:10.1007/s00259-005-0010-5
PMID:16572306
Abstract

PURPOSE

We investigated the potential for improvement in disease control by use of autologous peripheral blood stem cell transplant (PBSCT) to permit administration of high activities of (186)Re-hydroxyethylidene diphosphonate (HEDP) in patients with progressive hormone-refractory prostate cancer (HRPC).

METHODS

Eligible patients had progressive HRPC metastatic to bone, good performance status and minimal soft tissue disease. Patients received 5,000 MBq of (186)Re-HEDP i.v., followed 14 days later by PBSCT. Response was assessed using PSA, survival, pain scores and quality of life.

RESULTS

Thirty-eight patients with a median age of 67 years (range 50-77) and a median PSA of 57 ng/ml (range 4-3,628) received a median activity of 4,978 MBq (186)Re-HEDP (range 4,770-5,100 MBq). The most serious toxicity was short-lived grade 3 thrombocytopenia in 8 (21%) patients. The median survival of the group is 21 months (95%CI 18-24 months) with Kaplan-Meier estimated 1- and 2-year survival rates of 83% and 40% respectively. Thirty-one patients (81%, 95% CI 66-90%) had stable or reduced PSA levels 3 months post therapy while 11 (29%, 95% CI 15-49%) had PSA reductions of >50% lasting >4 weeks. Quality of life measures were stable or improved in 27 (66%) at 3 months.

CONCLUSION

We have shown that it is feasible and safe to deliver high-activity radioisotope therapy with PBSCT to men with metastatic HRPC. Response rates and survival data are encouraging; however, further research is needed to define optimal role of this treatment approach.

摘要

目的

我们研究了通过自体外周血干细胞移植(PBSCT)来提高疾病控制的可能性,以便在进展性激素难治性前列腺癌(HRPC)患者中给予高活度的(186)铼-羟基亚乙基二膦酸盐(HEDP)。

方法

符合条件的患者为有骨转移的进展性HRPC,体能状态良好且软组织疾病最少。患者静脉注射5000MBq的(186)铼-HEDP,14天后进行PBSCT。使用前列腺特异性抗原(PSA)、生存率、疼痛评分和生活质量来评估反应。

结果

38例患者,中位年龄67岁(范围50 - 77岁),中位PSA为57ng/ml(范围4 - 3628),接受的(186)铼-HEDP中位活度为4978MBq(范围4770 - 5100MBq)。最严重的毒性是8例(21%)患者出现短暂的3级血小板减少。该组的中位生存期为21个月(95%置信区间18 - 24个月),根据Kaplan-Meier法估计的1年和2年生存率分别为83%和40%。31例患者(81%,95%置信区间66 - 90%)在治疗后3个月时PSA水平稳定或降低,而11例(29%,95%置信区间15 - 49%)的PSA降低>50%且持续>4周。3个月时,27例(66%)患者的生活质量指标稳定或改善。

结论

我们已表明,对转移性HRPC男性患者采用PBSCT进行高活度放射性同位素治疗是可行且安全的。缓解率和生存数据令人鼓舞;然而,需要进一步研究来确定这种治疗方法的最佳作用。

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