Flanigan R C, Salmon S E, Blumenstein B A, Bearman S I, Roy V, McGrath P C, Caton J R, Munshi N, Crawford E D
Loyola University Stritch School of Medicine, Maywood, Ill., USA.
N Engl J Med. 2001 Dec 6;345(23):1655-9. doi: 10.1056/NEJMoa003013.
The value of nephrectomy in metastatic renal-cell cancer has long been debated. Several nonrandomized studies suggest a higher rate of response to systemic therapy and longer survival in patients who have undergone nephrectomy.
We randomly assigned patients with metastatic renal-cell cancer who were acceptable candidates for nephrectomy to undergo radical nephrectomy followed by therapy with interferon alfa-2b or to receive interferon alfa-2b therapy alone. The primary end point was survival, and the secondary end point was a response of the tumor to treatment.
The median survival of 120 eligible patients assigned to surgery followed by interferon was 11.1 months, and among the 121 eligible patients assigned to interferon alone it was 8.1 months (P=0.05). The difference in median survival between the two groups was independent of performance status, metastatic site, and the presence or absence of a measurable metastatic lesion.
Nephrectomy followed by interferon therapy results in longer survival among patients with metastatic renal-cell cancer than does interferon therapy alone.
肾切除术在转移性肾细胞癌中的价值长期以来一直存在争议。几项非随机研究表明，接受肾切除术的患者对全身治疗的反应率更高，生存期更长。
我们将适合接受肾切除术的转移性肾细胞癌患者随机分为两组，一组先接受根治性肾切除术，然后接受α-2b干扰素治疗，另一组仅接受α-2b干扰素治疗。主要终点是生存期，次要终点是肿瘤对治疗的反应。
120例被分配接受手术加干扰素治疗的符合条件患者的中位生存期为11.1个月，而121例仅被分配接受干扰素治疗的符合条件患者的中位生存期为8.1个月（P = 0.05）。两组中位生存期的差异与患者的体能状态、转移部位以及是否存在可测量的转移病灶无关。
与单纯干扰素治疗相比，肾切除术后加用干扰素治疗可使转移性肾细胞癌患者生存期延长。
