A pilot study of the liposomal MUC1 vaccine BLP25 in prostate specific antigen failures after radical prostatectomy
A pilot study of the liposomal MUC1 vaccine BLP25 in prostate specific antigen failures after radical prostatectomy
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DOI：
10.1016/s0022-5347(06)00494-0
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发表时间：
2006-07-01
影响因子：
6.6
通讯作者：
Venner, P.
中科院分区：
文献类型：
--
作者：
North, S. A.;Graham, K.;Venner, P.
目的：根治性前列腺切除术后生化失败的男性除了雄激素剥夺治疗外，几乎没有其他治疗选择。针对这一群体的靶向治疗是合适的，因为在这一患者群体中开始激素治疗的最佳时机尚不清楚。一项单机构试点试验使用BLP25脂质体疫苗在根治性前列腺切除术后前列腺特异性抗原失败的激素初始患者中进行，以确定前列腺特异性抗原进展是否可以停止。材料与方法：纳入根治性前列腺切除术后生化功能衰竭的男性患者。主要终点是MUC1 BLP25脂质体疫苗的有效性和安全性。同时评估前列腺特异性抗原倍增时间的变化。患者接受单次静脉注射剂量的环磷酰胺，随后接种BLP25脂质体疫苗长达1年。在基线和治疗期间测量前列腺特异性抗原，并计算这些间隔的前列腺特异性抗原倍增时间。结果：共纳入16例患者，中位年龄为60岁。所有患者均接受环磷酰胺治疗，16例患者中有15例完成了初级治疗期。10例患者完成了维持期。初次治疗8周后，16例患者中有8例前列腺特异性抗原稳定或降低。在最后一次研究中的前列腺特异性抗原测量中，1例患者保持稳定的前列腺特异性抗原，但所有其他患者均有进展。然而，与研究前相比，16例患者中有6例前列腺特异性抗原倍增时间延长了50%以上。结论：BLP25脂质体疫苗有望延长前列腺切除术后生化失败的激素初始患者前列腺特异性抗原倍增时间，且发病率低。这可能会导致激素治疗的推迟。在这一人群中进行进一步的检测是有必要的。
Purpose: Men with biochemical failure after radical prostatectomy have few therapeutic options other than androgen deprivation therapy. Targeted therapies in this group are appropriate because the optimal timing of the initiation of hormonal therapy in this patient population is unknown. A single institution pilot trial was performed using BLP25 liposome vaccine in hormone naive patients with prostate specific antigen failure after radical prostatectomy to determine if prostate specific antigen progression could be halted.Materials and Methods: Men with biochemical failure after radical prostatectomy were enrolled. Primary end points were efficacy and safety of the MUC1 BLP25 liposomal vaccine. Changes in prostate specific antigen doubling time were also evaluated. Patients received a single intravenous dose of cyclophosphamide, followed by vaccinations with BLP25 liposome vaccine for up to I year. Prostate specific antigen was measured at baseline and during treatment, and prostate specific antigen doubling time was calculated for these intervals.Results: A total of 16 patients with a median age of 60 years were enrolled. All patients received cyclophosphamide and 15 of 16 completed the primary treatment period. Ten patients completed the maintenance period. After the 8-week primary treatment period 8 of 16 patients had stable or decreased prostate specific antigen. At the last on-study prostate specific antigen measurement 1 patient maintained stable prostate specific antigen but all others had progression. However, 6 of the 16 patients had greater than 50% prolongation of prostate specific antigen doubling time compared to pre-study prostate specific antigen doubling time.Conclusions: BLP25 liposome vaccine shows promise for prolonging prostate specific antigen doubling time in hormone naive men with biochemical failure after prostatectomy and little morbidity. This could potentially translate into the deferral of hormonal therapy. Further testing in this population of patients is warranted.