Scheele J, Stangl R, Altendorf-Hofmann A, Gall F P
Chirurgische Klinik mit Poliklinik, Universität Erlangen-Nürnberg.
Zentralbl Chir. 1991;116(21):1215-35.
From 1970 to 1987, a total of 112 patients underwent regional chemotherapy as primary treatment of colorectal liver metastases. 68 patients received 250-750 mg 5-FU 2-3 times per week via external devices, 40 patients with port catheters had 5-day courses of Mitomycin C (8 mg/m2/day 1) and 5-FU (600 mg/m2/day 1-5) at 4 week intervals, and four patients were treated with FUDR (0.2 mg/m2/day 1-14/28) using an Infusaid pump. Median and maximum survival were 13.2 and 58 months, respectively. The overall response rate in patients suitable to imaging criteria who underwent treatment for more than three months and was 83% (CR 14%, PR 40%, SD 29%). The influence of various factors on Kaplan/Meier survival was checked the Logrank test. Response to treatment was of superior importance (p = 0.0000016), but hepatomegaly, Karnofski index, the percentage of liver volume replaced by tumour, and various liver related biochemical tests were also highly significant prognostic determinants (p greater than 0.01). There was no difference between external and fully implantable devices. A subgroup of 68 patients without extrahepatic disease, treatment of more than three months was retrospectively compared to 121 untreated patients with a similar stage of disease. There was no obvious effect of regional chemotherapy on survival (p = 0.16). Although the untreated patients consist a historical control group only, this result indicates that regional chemotherapy must continuously be restricted to well prospective clinical trials.
1970年至1987年期间，共有112例患者接受了区域化疗作为结直肠癌肝转移的主要治疗方法。68例患者通过外部装置每周接受2-3次250-750毫克氟尿嘧啶治疗，40例使用端口导管的患者每4周接受5天疗程的丝裂霉素C（第1天8毫克/平方米）和氟尿嘧啶（第1-5天600毫克/平方米）治疗，4例患者使用Infusaid泵接受氟尿苷（0.2毫克/平方米/天，共1-14/28天）治疗。中位生存期和最长生存期分别为13.2个月和58个月。接受治疗超过三个月且符合影像学标准的患者总体缓解率为83%（完全缓解14%，部分缓解40%，病情稳定29%）。采用对数秩检验检查了各种因素对Kaplan/Meier生存曲线的影响。治疗反应最为重要（p = 0.0000016），但肝肿大、卡氏指数、肿瘤取代肝脏体积的百分比以及各种肝脏相关生化检查也是高度显著的预后决定因素（p大于0.01）。外部装置和完全植入式装置之间没有差异。对68例无肝外疾病且治疗超过三个月的患者亚组与121例疾病分期相似的未治疗患者进行了回顾性比较。区域化疗对生存没有明显影响（p = 0.16）。尽管未治疗患者仅构成一个历史对照组，但该结果表明区域化疗必须持续局限于严格的前瞻性临床试验。
