Jaeckle K A, Mittelman A, Hill F H
Department of Neurology, University of Utah Health Sciences Center, Salt Lake City 84132.
J Clin Oncol. 1990 Aug;8(8):1408-18. doi: 10.1200/JCO.1990.8.8.1408.
Nineteen assessable patients with recurrent malignant astrocytomas who had failed standard therapy (surgery, radiation, and/or chemotherapy) were treated on a phase I-II trial with a biologic extract of Serratia marcescens (ImuVert; Cell Technology, Boulder, CO) a new biologic response modifier (BRM). Two complete responses (CRs) were seen, of 63 and 77+ weeks duration. One minor response (MR) occurred, of 6 weeks duration. There were four additional stable (S) patients, with durations of 58+, 39, 12, and 7 weeks. Median time to progression and median survival in the CR plus MR patients were 63 and 129+ weeks, respectively. Overall, median time to progression and median survival were 12 and 19 weeks, respectively. Three patients are alive greater than or equal to 2.5 years from study entry. Common toxicities included transient (less than 72 hours) tenderness, induration, and erythema at the injection sites. Systemic toxicities were less frequent and included fever, chills, nausea/vomiting, headache, arthralgia, and hypotension. The response rate (CR plus MR) to this new BRM is modest (16%). However, the observation of CRs in patients with advanced recurrent malignant astrocytomas, with acceptable overall toxicity, warrants further study of this agent.
19例复发性恶性星形细胞瘤患者，标准治疗（手术、放疗和/或化疗）失败后，参加了一项I-II期试验，接受粘质沙雷氏菌生物提取物（ImuVert；细胞技术公司，科罗拉多州博尔德市）治疗，这是一种新型生物反应调节剂（BRM）。观察到2例完全缓解（CR），持续时间分别为63周和77周以上。出现1例轻微缓解（MR），持续时间为6周。另有4例病情稳定（S）的患者，持续时间分别为58周以上、39周、12周和7周。CR加MR患者的中位进展时间和中位生存期分别为63周和129周以上。总体而言，中位进展时间和中位生存期分别为12周和19周。3例患者自研究入组起存活时间大于或等于2.5年。常见毒性包括注射部位短暂（小于72小时）压痛、硬结和红斑。全身毒性较少见，包括发热、寒战、恶心/呕吐、头痛、关节痛和低血压。这种新型BRM的缓解率（CR加MR）为16%，较为一般。然而，在晚期复发性恶性星形细胞瘤患者中观察到CR，且总体毒性可接受，因此有必要对该药物进行进一步研究。
