Karakousis C P, Emrich L J
J Surg Oncol. 1987 Sep;36(1):64-7. doi: 10.1002/jso.2930360115.
Fifty-nine patients with regional or hematogenous recurrence of malignant melanoma following resection of all the gross tumor were randomized to observation or chemotherapy. The chemotherapy consisted of BCNU 80 mg/M2 I.V. every 4 weeks, actinomycin-D 0.01 mg/kg and vincristine 1.0 mg/M2 I.V. every 2 weeks, for a total of 6 months. The chemotherapy protocol was tolerated well without appreciable objective side effects. At a median follow-up period of 11.5 months, the disease-free survival time for the chemotherapy treated group is significantly longer than for the control group (P = 0.01). The estimated median disease-free survival time is 4 months in the surgical control group and 9 months in the chemotherapy group. At present, the proportion of patients remaining disease-free is 43% for the surgical control and 55% for the chemotherapy treated group. More patients and follow-up are needed, but this preliminary report suggests that nitrosourea-based protocols need to be evaluated further as adjuvant treatment of malignant melanoma.
59例在全部肉眼可见肿瘤切除后出现恶性黑色素瘤局部或血行复发的患者被随机分为观察组或化疗组。化疗方案为每4周静脉注射卡莫司汀80mg/M²,每2周静脉注射放线菌素-D 0.01mg/kg和长春新碱1.0mg/M²,共6个月。化疗方案耐受性良好,无明显的客观副作用。在中位随访期11.5个月时,化疗治疗组的无病生存时间显著长于对照组(P = 0.01)。手术对照组的估计中位无病生存时间为4个月,化疗组为9个月。目前,手术对照组无病患者的比例为43%,化疗治疗组为55%。需要更多的患者和随访,但这份初步报告表明,基于亚硝基脲的方案作为恶性黑色素瘤的辅助治疗需要进一步评估。