Quesada J R, Rios A, Swanson D, Trown P, Gutterman J U
J Clin Oncol. 1985 Nov;3(11):1522-8. doi: 10.1200/JCO.1985.3.11.1522.
Fifty-six patients with metastatic renal cell carcinoma (RCC) were treated with recombinant DNA-derived interferon alpha (rIFN alpha A). The first 30 patients were randomized between doses of 2 X 10(6) U/m2 and 20 X 10(6) U/m2 intramuscularly daily. No complete (CR) or partial (PR) remissions were achieved in 15 patients receiving the low dose. In contrast, 27% of those receiving the high dose achieved CR or PR. Subsequently, 26 additional patients were given the high dose and achieved a 31% response rate. Remissions lasted from 1 to more than 12 months (median, 3 months). Responses occurred predominantly in lung parenchyma or mediastinal node metastases. Toxicity of the high dose required dose reduction in 50% of the patients. Neutralizing antibodies to rIFN alpha A developed in seven of 12 responsive (58%) and nine of 29 (31%) nonresponsive patients (P = greater than .5). The median duration of remission among the antibody-positive and antibody-negative patients were 2 and 10 months, respectively (P = .009). The clinical significance of the antibodies to rIFN alpha A remains unclear, but the coincidence between the detection of antibodies and the early relapse of the disease in some responsive patients suggests that these antibodies may abrogate the biologic activity of rIFN alpha A. This effect, however, was not associated with adverse clinical sequelae.
56例转移性肾细胞癌（RCC）患者接受了重组DNA衍生的α干扰素（rIFNαA）治疗。前30例患者被随机分为两组，分别接受每日2×10⁶U/m²和20×10⁶U/m²的肌肉注射剂量。接受低剂量治疗的15例患者未达到完全缓解（CR）或部分缓解（PR）。相比之下，接受高剂量治疗的患者中有27%达到了CR或PR。随后，又有26例患者接受了高剂量治疗，缓解率为31%。缓解持续时间为1至12个月以上（中位数为3个月）。缓解主要发生在肺实质或纵隔淋巴结转移灶。高剂量治疗的毒性导致50%的患者需要减少剂量。12例有反应的患者中有7例（58%）和29例无反应的患者中有9例（31%）产生了针对rIFNαA的中和抗体（P＞0.5）。抗体阳性和抗体阴性患者的缓解持续时间中位数分别为2个月和10个月（P = 0.009）。针对rIFNαA的抗体的临床意义尚不清楚，但在一些有反应的患者中，抗体检测与疾病早期复发之间的巧合表明，这些抗体可能会消除rIFNαA的生物活性。然而，这种效应与不良临床后果无关。
