Lancet. 1999 Jan 2;353(9146):14-7.
Metastatic renal carcinoma has a 2-year survival of around 20% and is largely resistant to chemotherapy. The use of interferons in the treatment of metastatic renal carcinoma remains controversial. Although non-randomised studies suggest that biological therapy with interferons produces a small number of tumour responses, most clinicians judge such treatment to be ineffective. We have investigated the effect of treatment with interferon-alpha on survival in patients with metastatic renal carcinoma.
In a multicentre, randomised trial, patients with metastatic renal carcinoma were randomly assigned subcutaneous interferon-alpha (three doses--5 MU, 5 MU, 10 MU--for the first week, then 10 MU three times per week for a further 11 weeks; n=174) or oral medroxyprogesterone acetate (MPA; 300 mg once daily for 12 weeks; n=176). The primary endpoint was overall survival. Analysis was by intention to treat. The trial used a triangular sequential design for early termination as soon as results were conclusive. The trial was stopped in November, 1997, when data were available for 335 patients (167 interferon-alpha, 168 MPA).
A total of 111 patients have died in the interferon-alpha group, and 125 patients have died in the MPA group. There was a 28% reduction in the risk of death in the interferon-alpha group (hazard ratio 0.72 [95% CI 0.55-0.94], p=0.017). Interferon-alpha gave an improvement in 1-year survival of 12% (MPA 31% survival, interferon-alpha 43%), and an improvement in median survival of 2.5 months (MPA 6 months, interferon-alpha 8.5 months).
The benefit of treatment with interferon-alpha should be weighed against the drug's toxic effects. Combination regimens of biological therapy and chemotherapy should now be compared with interferon-alpha monotherapy in randomised controlled trials.
转移性肾癌患者的2年生存率约为20%，且对化疗大多耐药。干扰素用于治疗转移性肾癌仍存在争议。尽管非随机研究表明，用干扰素进行生物治疗能产生少量肿瘤反应，但大多数临床医生认为这种治疗无效。我们研究了α干扰素治疗对转移性肾癌患者生存的影响。
在一项多中心随机试验中，转移性肾癌患者被随机分配接受皮下注射α干扰素（首周3剂，分别为5 MU、5 MU、10 MU，之后11周每周3次，每次10 MU；n = 174）或口服醋酸甲羟孕酮（MPA；每日1次，每次300 mg，共12周；n = 176）。主要终点为总生存期。分析采用意向性治疗。该试验采用三角序贯设计以便在结果确凿时尽早终止。1997年11月，当有335例患者（167例接受α干扰素，168例接受MPA）的数据可用时，试验停止。
α干扰素组共有111例患者死亡，MPA组有125例患者死亡。α干扰素组死亡风险降低了28%（风险比0.72 [95%可信区间0.55 - 0.94]，p = 0.017）。α干扰素使1年生存率提高了12%（MPA组生存率为31%，α干扰素组为43%），中位生存期延长了2.5个月（MPA组为6个月，α干扰素组为8.5个月）。
应权衡α干扰素治疗的益处与其毒性作用。现在应在随机对照试验中将生物治疗与化疗的联合方案与α干扰素单药治疗进行比较。
