Pritchard K I, Cowan D H, Baker M A, Osoba D, Phillips R A, Clark D A
Med Pediatr Oncol. 1976;2(2):173-81. doi: 10.1002/mpo.2950020207.
This study assess the effects of oral BCG, as a single agent, on tumor progression and on cell-mediated immune function in patients with metastatic malignant melanoma. Thirty patients were studied including 22 with measurable metastatic lesions and 8 with no detectable disease, following treatment of metastases by surgery, radiotherapy, or 5-(3, 3-dimethyl-1 -triazeno)-imidazole-4-carboxamide (DTIC; DIC). Oral BCG was given in doses of 120--240 mg, 1--3 times per week for periods ranging from 9 to 80 weeks and to total doses of from 1.2 to 20.1 gm. Patients were assessed by direct measurements of tumor mass, PPD skin test and in vitro blastogenic responses to PPD PHA. Of the 22 patient with measureable disease, 19 showed tumor progression and none showed regression of any lesion. Of the 8 without apparent disease, 5 remained stable and 3 had tumor recurrence. Of the total group of 30 patients, 8 showed some increased sensitivity to skin testing with PPD. Of 19 tested, 3 showed an increased PPD response in vitro, while 3 showed a decreased response. Six of 20 tested showed an increased PHA response in vitro. Oral BCG alone was not effective as an antitumor agent in patients with metastatic malignant melanoma.
本研究评估了口服卡介苗作为单一药物对转移性恶性黑色素瘤患者肿瘤进展及细胞介导免疫功能的影响。研究了30例患者，其中22例有可测量的转移性病灶，8例在通过手术、放疗或5 -（3,3 - 二甲基 - 1 - 三氮烯）-咪唑 - 4 - 甲酰胺（DTIC；DIC）治疗转移灶后无可检测到的疾病。口服卡介苗的剂量为120 - 240毫克，每周1 - 3次，疗程为9至80周，总剂量为1.2至20.1克。通过直接测量肿瘤大小、PPD皮肤试验以及对PPD、PHA的体外成淋巴细胞反应来评估患者。在22例有可测量疾病的患者中，19例显示肿瘤进展，无一例显示任何病灶消退。在8例无明显疾病的患者中，5例病情稳定，3例出现肿瘤复发。在30例患者的总体中，8例对PPD皮肤试验显示出某种程度的敏感性增加。在19例接受检测的患者中，3例体外PPD反应增加，而3例反应降低。在20例接受检测的患者中，6例体外PHA反应增加。单独口服卡介苗对转移性恶性黑色素瘤患者作为抗肿瘤药物无效。
