Hofmockel G, Langer W, Theiss M, Gruss A, Frohmüller H G
Department of Urology, University of Würzburg Medical School, Germany.
J Urol. 1996 Jul;156(1):18-21.
Promising results of recent clinical trials with a triple drug bio-chemotherapy regimen encouraged its use in patients with renal cell carcinoma.
In a phase II study of patients with metastatic renal cell carcinoma the efficacy and toxicity of a treatment regimen were evaluated using interleukin-2 and interferon-alpha 2 subcutaneously in combination with intravenous 5-fluorouracil. The treatment protocol consisted of an 8-week cycle given on an outpatient basis, with 6 to 9 MU/m2. interferon-alpha given 1 to 3 times a week during the 8 weeks, and sequentially combined with 5 to 20 MU/m2. interleukin-2, 3 times a week for 4 weeks and 750 mg./m.2 5-fluorouracil once a week for 4 weeks.
Among 25 consecutive men and 9 women treated 3 (9%) had a complete and 10 (29%) had a partial remission (overall objective response rate 38%). Median response duration (complete plus partial) was 12.5 months (range 3 to 20+). Stable disease lasting 3 to 24+ months was noted in 12 patients (35%). There were only minor side effects, for a maximum toxicity grade of I in 3 patients, II in 25 and III in 6 according to the World Health Organization classification. There were no dose limiting toxicities and no treatment related deaths.
Triple drug immunochemotherapy resulted in a significant clinical effect comparable to an aggressive intravenous interleukin-2 treatment regimen but without significant toxicity.
近期一项三联药物生物化疗方案的临床试验取得了令人鼓舞的结果，促使其应用于肾细胞癌患者。
在一项转移性肾细胞癌患者的II期研究中，评估了皮下注射白细胞介素-2和α-2干扰素联合静脉注射5-氟尿嘧啶的治疗方案的疗效和毒性。治疗方案包括一个为期8周的门诊周期，8周内每周1至3次给予6至9MU/m²的α-2干扰素，随后依次联合每周3次给予5至20MU/m²的白细胞介素-2，共4周，以及每周1次给予750mg/m²的5-氟尿嘧啶，共4周。
在连续治疗的25名男性和9名女性患者中，3例（9%）完全缓解，10例（29%）部分缓解（总体客观缓解率38%）。中位缓解持续时间（完全缓解加部分缓解）为12.5个月（范围3至20+个月）。12例患者（35%）出现持续3至24+个月的疾病稳定。根据世界卫生组织分类，仅有轻微副作用，3例患者最大毒性等级为I级，25例为II级，6例为III级。没有剂量限制性毒性，也没有与治疗相关的死亡。
三联药物免疫化疗产生了显著的临床效果，与积极的静脉注射白细胞介素-2治疗方案相当，但无明显毒性。
