Ariyan S, Kirkwood J M, Mitchell M S, Nordlund J J, Lerner A B, Papac R J
Surgery. 1982 Sep;92(3):459-63.
A prospective, controlled study of surgical adjuvant immunotherapy with intralymphatic methanol-extractable residue (MER) of bacillus Calmette-Guerin (BCG) is preliminarily reported in 25 consecutive patients with high-risk malignant melanoma of the extremities. Patients were allocated on a random basis to receive preoperative intralymphatic immunotherapy with MER-BCG, surgical excision with regional lymphadenectomy and intraoperative infiltration of MER-BCG, and postoperative monthly intradermal vaccinations with BCG; or surgery and lymphadenectomy alone. Twenty patients followed for more than 1 year are the basis of this report. Fifteen patients accepted randomization, whereas four patients entered the immunotherapy group and one entered the control group at their own insistence. Immunotherapy improved the disease-free survival of patients in this trial. There was one recurrence with death in the 13 patients treated with preoperative intralymphatic MER-BCG; whereas four of seven patients in the control group had recurrence (P = 0.015), at all four of these patients died during the same interval.
初步报告了一项针对25例连续性高危肢体恶性黑色素瘤患者的前瞻性对照研究，该研究采用卡介苗（BCG）的淋巴管内甲醇可提取物（MER）进行手术辅助免疫治疗。患者被随机分配接受术前MER-BCG淋巴管内免疫治疗、手术切除加区域淋巴结清扫以及术中MER-BCG浸润，以及术后每月皮内接种BCG；或仅接受手术和淋巴结清扫。本报告基于20例随访超过1年的患者。15例患者接受了随机分组，而4例患者自行坚持进入免疫治疗组，1例进入对照组。免疫治疗改善了该试验中患者的无病生存期。接受术前淋巴管内MER-BCG治疗的13例患者中有1例复发死亡；而对照组的7例患者中有4例复发（P = 0.015），这4例患者均在同一时间段内死亡。
