Neifeld J P, Terz J J, Kaplan A M, Lawrence W
J Surg Oncol. 1985 Feb;28(2):137-45. doi: 10.1002/jso.2930280215.
Patients with primary squamous cell epitheliomas of the oral cavity, pharynx, and larynx were stratified according to stage and site and randomized to receive either intratumoral immunotherapy with Corynebacterium parvum followed 2 weeks later by surgery and postoperative C parvum for 2 years or surgery alone. There were 209 patients entered into the trial and 176 were fully evaluable. All prognostic variables were similar between the two groups. There was no difference in disease-free survival or absolute survival between the two groups of patients. In addition, there was no difference noted for any stage and/or site. The only difference in sequential immunologic testing was that chemokinesis was increased following intratumoral C parvum, but neither this nor any other immunologic test correlated with ultimate recurrence or survival. These data demonstrate that immunotherapy using preoperative, intralesional C parvum and postoperative, subcutaneous C parvum is ineffective when used as an adjuvant to surgery for primary cancers arising in the oral cavity, pharynx, and larynx.
患有口腔、咽和喉原发性鳞状细胞上皮瘤的患者根据分期和部位进行分层，并随机分组，一组接受微小棒状杆菌瘤内免疫治疗，2周后进行手术，术后使用微小棒状杆菌治疗2年；另一组仅接受手术治疗。共有209例患者进入试验，其中176例可进行全面评估。两组之间所有预后变量均相似。两组患者的无病生存率或绝对生存率无差异。此外，在任何分期和/或部位均未发现差异。序贯免疫检测的唯一差异是瘤内注射微小棒状杆菌后趋化性增加，但无论是趋化性还是任何其他免疫检测均与最终复发或生存无关。这些数据表明，术前瘤内注射微小棒状杆菌和术后皮下注射微小棒状杆菌的免疫治疗作为口腔、咽和喉原发性癌症手术的辅助治疗无效。
