Black K L, Ciacci J D, Ammirati M, Selch M T, Becker D P
Division of Neurosurgery, Jonnson Cancer Center, University of California, Los Angeles.
J Clin Oncol. 1993 Sep;11(9):1746-50. doi: 10.1200/JCO.1993.11.9.1746.
A clinical trial was undertaken to determine the safety and efficacy of combining a biologic response modifier derived from the bacterium Serratia marcescens (ImuVert) and radiation therapy (RT) in patients with newly diagnosed anaplastic astrocytoma (AA) or glioblastoma multiforme (GBM).
Fifteen patients who had undergone either a gross total resection, a partial resection, or a biopsy were treated concurrently with ImuVert and RT. Safety and tolerance were examined by assessment of symptomatic reactions recorded at each ImuVert treatment. Efficacy of treatment was examined in terms of time to progression of tumor and survival.
All patients experienced local reactions at the injection sites that consisted of erythema and induration. The majority of patients experienced flu-like symptoms. Hypotension was responsible for the most significant morbidity (which required fluid resuscitation and extended observation) and dose deescalation. No patients were removed from the study because of toxicity. There were no on-study deaths related to ImuVert treatment. Median time to progression was 33.4 weeks, and median survival was 78 weeks.
These results compare favorably with those of recent studies in patients with malignant astrocytomas who received multimodality therapy.
开展一项临床试验，以确定将源自粘质沙雷氏菌的生物反应调节剂（ImuVert）与放射治疗（RT）联合应用于新诊断的间变性星形细胞瘤（AA）或多形性胶质母细胞瘤（GBM）患者的安全性和疗效。
15例接受了全切除、部分切除或活检的患者同时接受ImuVert和RT治疗。通过评估每次ImuVert治疗时记录的症状反应来检查安全性和耐受性。从肿瘤进展时间和生存期方面检查治疗效果。
所有患者在注射部位均出现由红斑和硬结组成的局部反应。大多数患者出现流感样症状。低血压导致了最严重的发病情况（需要液体复苏和延长观察时间）以及剂量下调。没有患者因毒性而退出研究。没有与ImuVert治疗相关的研究期间死亡病例。中位进展时间为33.4周，中位生存期为78周。
这些结果与近期接受多模式治疗的恶性星形细胞瘤患者的研究结果相比具有优势。
