Ravaud A, Audhuy B, Gomez F, Escudier B, Lesimple T, Chevreau C, Douillard J Y, Caty A, Geoffrois L, Ferrero J M, Linassier C, Drevon M, Négrier S
Department of Medicine, Institut Bergonié, Bordeaux, France.
J Clin Oncol. 1998 Aug;16(8):2728-32. doi: 10.1200/JCO.1998.16.8.2728.
A phase II trial was designed to determine the efficacy and the tolerance of interleukin-2 (IL-2), interferon alfa-2a (IFNalpha), and fluorouracil (5-FU) in patients with metastatic renal cell carcinoma.
One hundred eleven patients were included. Patients received subcutaneous IL-2 9 x 10(6) IU daily for 6 days and IFNalpha 6 x 10(6) IU on days 1, 3, and 5 every other week for 8 weeks. 5-FU was administered through a continuous infusion at 600 mg/m2 for 5 consecutive days for 1 week every 4 weeks.
The response rate was 1.8% (95% confidence interval [CI], 0% to 4.3%) with only two partial responses (PRs). Toxicity was moderate with 3.6% grade 4 events and two deaths related to treatment.
This regimen of IL-2, IFNalpha, and 5-FU in patients with metastatic renal cell carcinoma was ineffective. The results raise the question of the dose and schedule of subcutaneous cytokines that must be used in metastatic renal carcinoma.
设计一项II期试验，以确定白细胞介素-2（IL-2）、干扰素α-2a（IFNα）和氟尿嘧啶（5-FU）对转移性肾细胞癌患者的疗效和耐受性。
纳入111例患者。患者每日皮下注射IL-2 9×10⁶IU，共6天，每隔一周的第1、3和5天皮下注射IFNα 6×10⁶IU，共8周。5-FU以600mg/m²的剂量持续输注，连续5天，每4周进行1周。
缓解率为1.8%（95%置信区间[CI]，0%至4.3%），仅出现2例部分缓解（PR）。毒性为中度，4级事件发生率为3.6%，有2例死亡与治疗相关。
IL-2、IFNα和5-FU联合方案对转移性肾细胞癌患者无效。结果引发了关于转移性肾癌皮下细胞因子使用剂量和给药方案的问题。
