Bakker W, Nijhuis-Heddes J M, van der Velde E A
Cancer Immunol Immunother. 1986;22(2):155-9. doi: 10.1007/BF00199131.
Of a total study group of 99 patients 56 received intrapleural BCG in three different dosages (5 patients 16 X 10(6), 25 patients 32 X 10(6), and 26 patients 64 X 10(6) culturable particles) following resection treatment for lung cancer. This study group was compared with an historical control population, very closely matched with regard to age, sex, stage of disease, histology and type of operation. Although the clinical condition of the patients selected for BCG treatment was above average, no survival benefit ensued from the intrapleural BCG. On the contrary, disease-free survival in BCG receivers with stage I and II squamous cell carcinoma was shortened significantly at 2 years follow-up due to the earlier appearance of local recurrences, with the same tendency still present after 5 years. This observation suggests an enhancement of tumour growth by the intrapleural BCG treatment. This alarming phenomenon could be a warning to clinicians when planning clinical immunotherapy trials to be aware of the potentially deleterious effects of such treatment.
在总共99名患者的研究组中，56名患者在肺癌切除治疗后接受了三种不同剂量的胸膜内卡介苗注射（5名患者为16×10⁶个、25名患者为32×10⁶个、26名患者为64×10⁶个可培养颗粒）。该研究组与一个历史对照人群进行了比较，在年龄、性别、疾病分期、组织学和手术类型方面非常匹配。尽管接受卡介苗治疗的患者临床状况高于平均水平，但胸膜内卡介苗并未带来生存益处。相反，在2年随访时，I期和II期鳞状细胞癌的卡介苗接受者的无病生存期因局部复发出现较早而显著缩短，5年后仍有相同趋势。这一观察结果表明胸膜内卡介苗治疗会促进肿瘤生长。这种令人担忧的现象可能是一个警示，提醒临床医生在规划临床免疫治疗试验时要意识到这种治疗可能产生的有害影响。
