Taylor S G, Sisson G A, Bytell D E, Raynor W J
Arch Otolaryngol. 1983 Aug;109(8):544-9. doi: 10.1001/archotol.1983.00800220050013.
Fifty-two patients with locally advanced squamous cell cancer were entered into a randomized trial of BCG vaccine following definitive local therapy. Patients were stratified and randomized to receive BCG vaccine (25 patients) or no adjuvant immunotherapy (27 patients). The BCG vaccine therapy began two weeks following definitive therapy with 2 to 4 X 10(6) Tice strain BCG organisms given intradermally (ID) in alternating sides of the neck every two weeks six times, then every four weeks nine times. In addition, all patients received methotrexate prior to definitive therapy. Median duration of follow-up at the time of analysis was 41 months. Groups were balanced by sex, disease site and stage, histologic grade, and prior therapy. Thirteen (52%) of the BCG vaccine-treated group remain disease free v seven (26%) of the controls. Similarly, 17 (68%) of the BCG vaccine-treated group survived v 11 (41%) of the controls. We conclude regional ID BCG vaccine increases disease-free and actuarial survival in this study population and adjuvant immunotherapy should be further explored in ear, nose, and throat cancer.
52例局部晚期鳞状细胞癌患者在接受确定性局部治疗后进入卡介苗疫苗随机试验。患者被分层并随机分为接受卡介苗疫苗组（25例患者）或不接受辅助免疫治疗组（27例患者）。卡介苗疫苗治疗在确定性治疗两周后开始，每两周在颈部两侧交替皮内注射（ID）2至4×10⁶ 蒂策株卡介苗菌液，共6次，然后每四周注射9次。此外，所有患者在确定性治疗前均接受甲氨蝶呤治疗。分析时的中位随访时间为41个月。两组在性别、疾病部位和分期、组织学分级以及既往治疗方面均衡。卡介苗疫苗治疗组有13例（52%）无疾病生存，而对照组为7例（26%）。同样，卡介苗疫苗治疗组有17例（68%）存活，而对照组为11例（41%）。我们得出结论，在本研究人群中，区域性皮内注射卡介苗疫苗可提高无疾病生存率和精算生存率，辅助免疫治疗在耳鼻喉癌中应进一步探索。
