Hirshaut Y, Pinsky C M, Wanebo H J, Braun D W
Eur J Cancer Clin Oncol. 1984 May;20(5):583-91. doi: 10.1016/0277-5379(84)90002-6.
The toxicity of intravenously administered Corynebacterium parvum was observed in 14 patients with stage II melanoma and in 14 patients with advanced ovarian carcinoma. Those with melanoma were rendered disease-free by surgery prior to treatment. The ovarian cancer patients had failed chemotherapy with alkylating agents and were receiving C. parvum prior to chemotherapy as part of an immunochemotherapy trial. Both clinical and laboratory parameters were observed. The mean daily C. parvum dose for melanoma patients was 2.03 mg/m2 and for ovarian carcinoma patients 2.02 mg/m2. The most important clinical toxic effects noted were fever, chills, blood pressure changes, headache, nausea, vomiting and diaphoresis. Laboratory toxicity was mild, with small decreases in hemoglobin levels, white blood cell counts and uric acid and albumin concentrations occurring in some patients. Serum bilirubin and SGOT levels tended to rise. In addition to determining the frequency of clinical toxic effects by treatment course, consideration was also given to frequency per treatment day, correlation of the occurrence of different toxicities in the same patient, time of onset of each toxicity and, for vital signs, to intensity of change and duration. In this analysis no major differences in toxicity were observed when C. parvum was given to the two patient groups.
观察了14例II期黑色素瘤患者和14例晚期卵巢癌患者静脉注射短小棒状杆菌的毒性。黑色素瘤患者在治疗前通过手术使疾病处于无瘤状态。卵巢癌患者接受烷化剂化疗失败,在化疗前接受短小棒状杆菌治疗,作为免疫化疗试验的一部分。观察了临床和实验室参数。黑色素瘤患者短小棒状杆菌的平均每日剂量为2.03mg/m²,卵巢癌患者为2.02mg/m²。观察到的最重要的临床毒性作用为发热、寒战、血压变化、头痛、恶心、呕吐和出汗。实验室毒性较轻,一些患者的血红蛋白水平、白细胞计数、尿酸和白蛋白浓度略有下降。血清胆红素和谷草转氨酶水平有升高趋势。除了按疗程确定临床毒性作用的频率外,还考虑了每日治疗频率、同一患者不同毒性发生的相关性、每种毒性的发作时间,对于生命体征,还考虑了变化强度和持续时间。在该分析中,对两组患者给予短小棒状杆菌时,未观察到毒性有重大差异。