Trial Watch
Trial Watch
复制标题
DOI：
10.1586/14760584.4.6.791
复制
发表时间：
2005-12
影响因子：
6.2
通讯作者：
中科院分区：
文献类型：
--
作者：
一项治疗性胰腺癌疫苗的II期临床试验结果显示，与历史生存率相比，1年和2年生存率有所提高。该试验检查了约翰霍普金斯金梅尔癌症中心（MD，美国）的60名患者的结果，这些患者除了接受化疗和手术外还接受了疫苗。该中心的专业人员报告1年生存率为88%，2年生存率为76%。据报道，历史1年和2年生存率分别为60%和40%。由Kimmel癌症中心的Elizabeth Jafee开发的霍普金斯疫苗被设计用于增强对手术和放化疗后持续存在的胰腺癌细胞的免疫反应，并且来自经过遗传修饰以分泌免疫刺激蛋白粒细胞巨噬细胞集落刺激因子（GM-CSF）的辐射癌细胞。第一剂疫苗在手术切除癌症后8-10周接种，随后进行6个月的放疗和5-氟尿嘧啶化疗，每隔1个月再接种4剂疫苗。这项试验是在早期的一项小型II期试验之后进行的，该试验涉及14名胰腺癌患者，其中3名患者在接受疫苗接种后7年多仍无癌症。研究人员继续监测参与最近试验的60名患者，并计划进行一项包括500-600名患者的更大规模的试验。美国癌症协会副首席医疗官Len Lichtenfeld说：“与历史数据相比，这些患者使用这种疫苗的情况更好，这令人兴奋。”“但是，虽然我们取得了令人兴奋的成果，但还有很多工作要做。”Lichtenfield指出，胰腺癌患者目前的前景并不好，部分原因是该疾病的发现较晚。美国胰腺癌的年发病率为32，000，死亡人数大致相同。Sidney Kimmel中心研究的结果由首席研究员丹尼尔拉赫鲁在美国癌症研究协会、国家癌症研究所和欧洲癌症研究和治疗组织（AACR-NCI-EORTC）（PA，美国）第17届国际会议上发表。
Promising results from a Phase II trial of a therapeutic pancreatic cancer vaccine show improved 1and 2-year survival compared with historic survival rates. The trial examined the outcome of 60 patients at the John Hopkins Kimmel Cancer Center (MD, USA) who received the vaccine in addition to both chemotherapy and surgery. Professionals at the center reported survival rates of 88% at 1 year and 76% at 2 years. Historic 1and 2-year survival rates are reported to be 60% and 40%, respectively. The Hopkins vaccine, developed by Elizabeth Jafee of the Kimmel Cancer Center, was engineered to boost the immune response to pancreatic cancer cells that persist after surgery and chemoradiation, and is derived from irradiated cancer cells genetically modified to secrete the immune-stimulatory protein granulocyte–macrophage colony-stimulating factor (GM-CSF). The first vaccine dose is administered 8–10 weeks after surgical resection of the cancer, followed by a 6-month course of radiation and 5-fluoracil-based chemotherapy, with four more doses of the vaccine given at 1-month intervals. This trial follows an earlier small Phase II trial involving 14 pancreatic cancer patients in which three remain cancerfree more than 7 years after receiving the vaccine. Researchers continue to monitor the 60 patients involved in the more recent trial, and a larger trial including 500–600 patients is planned. “When compared to the historical data, these patients are doing better with this vaccine, and that is exciting,” said Len Lichtenfeld, deputy chief medical officer of the American Cancer Society. “But while we have exciting results, there is a lot of work yet to be done.” Lichtenfield noted that current prospects for pancreatic patients are not good, partly due to the late detection of the disease. The annual incidence of pancreatic cancer in the USA is 32,000, and the number of deaths is approximately the same. The results of the Sidney Kimmel center study were presented by lead investigator, Daniel Laheru, at the at the 17th International Conference of the American Association of Cancer Research, National Cancer Institute and European Organisation for Research and Treatment of Cancer (AACR-NCI-EORTC) (PA, USA).