Pizzocaro G, Piva L, Colavita M, Ferri S, Artusi R, Boracchi P, Parmiani G, Marubini E
Division of Urology, Department of Surgery, Istituto Nazionale per lo Studio e la Cura dei Tumori, Milan, Italy.
J Clin Oncol. 2001 Jan 15;19(2):425-31. doi: 10.1200/JCO.2001.19.2.425.
Because interferon gave promising results in the management of metastatic renal cell carcinoma in the 1980s, a multicentric randomized controlled trial was planned to compare adjuvant recombinant interferon alfa-2b (rIFNalpha2b) with observation after radical nephrectomy in patients with Robson stages II and III renal cell carcinoma. Overall and event-free survival were to be evaluated together with prognostic factors.
Overall and event-free survival curves for 247 patients (124 controls and 123 treated) were estimated by the Kaplan-Meier method and compared using the log-rank test. Cox's multiple regression models were adopted to perform a joint analysis of treatment and prognostic factors.
The 5-year overall and event-free survival probabilities were 0.665 and 0.671, respectively, for controls and 0.660 and 0.567, respectively, for the treated group; the differences were not statistically significant (2P = .861 for overall and 2P = .107 for event-free survival with the log-rank test). Regarding prognostic factors, only grade, pT, and pN demonstrated a significant prognostic role. First-order interactions of treatment with pT and pN category were investigated; a significant interaction was found between pN and treatment. A harmful effect of rIFNalpha2b in the 97 treated pN0 patients and a protective effect in the 13 treated pN2/pN3 patients were statistically significant.
Adjuvant rIFNalpha2b is not indicated after radical nephrectomy for renal cell carcinoma. The protective effect in the small group of pN2/pN3 patients requires further investigation.
由于干扰素在20世纪80年代转移性肾细胞癌的治疗中取得了有前景的结果，因此计划开展一项多中心随机对照试验，比较辅助性重组干扰素α-2b（rIFNα2b）与对Robson分期II期和III期肾细胞癌患者行根治性肾切除术后进行观察的效果。对总生存期和无事件生存期以及预后因素进行评估。
采用Kaplan-Meier法估计247例患者（124例对照组和123例治疗组）的总生存期和无事件生存期曲线，并使用对数秩检验进行比较。采用Cox多元回归模型对治疗和预后因素进行联合分析。
对照组的5年总生存期和无事件生存期概率分别为0.665和0.671，治疗组分别为0.660和0.567；差异无统计学意义（对数秩检验，总生存期P = 0.861，无事件生存期P = 0.107）。关于预后因素，只有分级、pT和pN显示出显著的预后作用。研究了治疗与pT和pN分类的一级相互作用；发现pN与治疗之间存在显著相互作用。rIFNα2b对97例接受治疗的pN0患者有有害作用，对13例接受治疗的pN2/pN3患者有保护作用，差异有统计学意义。
肾细胞癌根治性肾切除术后不建议使用辅助性rIFNα2b。对一小部分pN2/pN3患者的保护作用需要进一步研究。
