Tjoa B A, Erickson S J, Bowes V A, Ragde H, Kenny G M, Cobb O E, Ireton R C, Troychak M J, Boynton A L, Murphy G P
Pacific Northwest Cancer Foundation, Cancer Research Division, Northwest Hospital, Seattle, Washington 98125, USA.
Prostate. 1997 Sep 1;32(4):272-8. doi: 10.1002/(sici)1097-0045(19970901)32:4<272::aid-pros7>3.0.co;2-l.
We recently conducted a phase I clinical trial administering autologous dendritic cells pulsed with prostate-specific membrane antigen (PSMA) peptides to advanced prostate cancer patients. Participants were divided into 5 groups receiving 4 or 5 infusions of peptides alone (PSM-P1 or -P2; groups 1 and 2, respectively), autologous DC (group 3), or DC pulsed with PSM-P1 or -P2 (groups 4 and 5, respectively). Seven partial responders were observed. Follow-up evaluation of these responders is presented in this report.
Clinical monitoring for hematological studies and prostate markers was conducted up to 370 days from the start of the phase I study. Data collected include: lymphocyte, hematocrit, alkaline phosphatase, prostate-specific antigen (PSA), free PSA, and PSMA levels.
Groups 4 and 5 (patients infused with DC pulsed with PSM-P1 or -P2) represented 5/7 responders. The length of response was between 100 days (1 patient) to 200 days or above (6 patients). Four patients still remained responsive at the end of the period of observation.
The responses observed in this phase I clinical trial are significant and of long duration. Most of the responders were in treatment groups infused with DC pulsed with PSM-P1 or -P2, suggesting the requirement of both components for effective immunotherapy.
我们最近开展了一项I期临床试验，向晚期前列腺癌患者输注用前列腺特异性膜抗原（PSMA）肽脉冲处理的自体树突状细胞。参与者被分为5组，分别接受4次或5次单独肽输注（PSM-P1或- P2；分别为第1组和第2组）、自体树突状细胞（第3组），或用PSM-P1或- P2脉冲处理的树突状细胞（分别为第4组和第5组）。观察到7例部分缓解者。本报告展示了对这些缓解者的随访评估。
从I期研究开始起，对血液学研究和前列腺标志物进行长达370天的临床监测。收集的数据包括：淋巴细胞、血细胞比容、碱性磷酸酶、前列腺特异性抗原（PSA）、游离PSA和PSMA水平。
第4组和第5组（输注用PSM-P1或- P2脉冲处理的树突状细胞的患者）占7例缓解者中的5例。缓解时长在100天（1例患者）至200天及以上（6例患者）之间。在观察期结束时，有4例患者仍保持缓解状态。
在这项I期临床试验中观察到的缓解具有显著意义且持续时间长。大多数缓解者来自输注用PSM-P1或- P2脉冲处理的树突状细胞的治疗组，这表明有效免疫疗法需要这两种成分。
