Lümmen G, Goepel M, Möllhoff S, Hinke A, Otto T, Rübben H
Department of Urology, University of Essen Medical School, Germany.
J Urol. 1996 Feb;155(2):455-8.
In a randomized phase II study we evaluated response, survival and side effects of low dose recombinant interferon-gamma in 30 patients (group 1) versus recombinant interleukin-2 and interferon-alpha 2b in 30 (group 2) with metastatic renal cell carcinoma.
Group 1 received 200 micrograms interferon-gamma subcutaneously once a week. Group 2 received 4 x 4.8 x 10(6) IU/m.2 interleukin-2 subcutaneously on days 1 and 22, 2 x 4.8 x 10(6) IU/m.2 on days 2 and 23, and 2 x 2.4 x 10(6) IU/m.2 combined with interferon-alpha 2b subcutaneously at 3 x 10(6) IU/m.2 on days 3, 5, 24 and 26, and 6 x 10(6) IU/m.2 3 times weekly for 6 weeks.
Toxicity grades 2 and 3 (World Health Organization) were observed in group 2 only. After followup of 13 months there was no remission in group 1 compared to 7 remissions in group 2, with 23 cases of progressive disease detected.
Combination therapy showed an objective response rate of 23% (p = 0.01). Although survival was not a primary aim of the study, there was a tendency toward no significant difference in survival when evaluating these relatively small groups (p = 0.49).
在一项随机II期研究中，我们评估了30例转移性肾细胞癌患者（第1组）接受低剂量重组干扰素-γ与30例（第2组）接受重组白细胞介素-2和干扰素-α 2b治疗后的反应、生存率和副作用。
第1组患者每周皮下注射200微克干扰素-γ。第2组患者在第1天和第22天皮下注射4×4.8×10⁶ IU/m²白细胞介素-2，第2天和第23天皮下注射2×4.8×10⁶ IU/m²，第3天、第5天、第24天和第26天皮下注射2×2.4×10⁶ IU/m²并联合3×10⁶ IU/m²干扰素-α 2b，之后6周内每周3次皮下注射6×10⁶ IU/m²。
仅在第2组观察到2级和3级（世界卫生组织标准）毒性反应。随访13个月后，第1组无缓解病例，而第2组有7例缓解，检测到23例疾病进展。
联合治疗的客观缓解率为23%（p = 0.01）。尽管生存并非本研究的主要目的，但在评估这些相对较小的组时，生存率有无显著差异的趋势（p = 0.49）。
