Jacquillat C, Banzet P, Maral J
Recent Results Cancer Res. 1982;80:254-8. doi: 10.1007/978-3-642-81685-7_40.
We report here two randomized prospective clinical trials of adjuvant treatment in the management of primary malignant melanoma of Clark's level III, IV or V. All patients had curative resection of the primary tumor. In the first trial, 117 patients were randomized between control (surgery alone) systemic chemotherapy and intraarterial chemotherapy. Intraarterial chemotherapy consisted of DTIC 80 mg/m2 + 8 days prior to surgery. Systemic chemotherapy consisted of courses of vinblastine (6 mg/m2), thiotepa (6 mg/m2), rufocromycine (60 microgram/m2), methotrexate (15 mg/m2) on day 1, and procarbazine (30 mg/m12 X 7 days. Courses were repeated every 2 weeks X 6, then every 4 weeks X 15. Twenty-two of 55 patients relapsed in the control group versus 22 of 67 in the chemotherapy group (NS). For male patients, the difference in disease-free survival was significant (P less than 0.005, log rank test), though not in women. In the second trial, 352 patients were entered from July, 1976. Men were randomized between chemotherapy and chemoimmunotherapy. Women were randomized between surgery alone and chemoimmunotherapy. Chemotherapy was identical, except for the addition of DTIC (300 mg/m2) for each course. Immunotherapy consisted of BCG every 4 weeks and C. parvum every week. Immunotherapy seemed to be of no additional benefit.
我们在此报告两项关于辅助治疗原发性克拉克三级、四级或五级恶性黑色素瘤的随机前瞻性临床试验。所有患者均接受了原发性肿瘤的根治性切除术。在第一项试验中，117名患者被随机分为对照组（单纯手术）、全身化疗组和动脉内化疗组。动脉内化疗在手术前8天给予达卡巴嗪80mg/m²。全身化疗方案为第1天给予长春碱（6mg/m²）、噻替派（6mg/m²）、链黑霉素（60μg/m²）、甲氨蝶呤（15mg/m²），丙卡巴肼（30mg/m²，连用7天）。每2周重复一个疗程，共6个疗程，然后每4周重复一个疗程，共15个疗程。对照组55名患者中有22名复发，化疗组67名患者中有22名复发（无显著性差异）。对于男性患者，无病生存率存在显著差异（P<0.005，对数秩检验），而女性患者则无差异。在第二项试验中，从1976年7月开始纳入352名患者。男性患者被随机分为化疗组和化学免疫治疗组。女性患者被随机分为单纯手术组和化学免疫治疗组。化疗方案相同，但每个疗程增加了达卡巴嗪（300mg/m²）。免疫治疗包括每4周接种卡介苗和每周接种短小棒状杆菌。免疫治疗似乎没有额外的益处。
