Taguchi Satoru, Buti Sebastiano, Fukuhara Hiroshi, Otsuka Masafumi, Bersanelli Melissa, Morikawa Teppei, Miyazaki Hideyo, Nakagawa Tohru, Fujimura Tetsuya, Kume Haruki, Igawa Yasuhiko, Homma Yukio
Department of Urology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.
Medical Oncology Unit, University Hospital of Parma, Parma, Italy.
PLoS One. 2017 Feb 27;12(2):e0172341. doi: 10.1371/journal.pone.0172341. eCollection 2017.
The benefit of adjuvant immunotherapy after nephrectomy in renal cell carcinoma (RCC) is controversial. The present study aimed to examine the possible benefit of adjuvant immunotherapy in various clinical settings.
We retrospectively reviewed 436 patients with pT1-3N0-2M0 RCC who underwent radical or partial nephrectomy with curative intent at our institution between 1981 and 2009. Of them, 98 (22.5%) patients received adjuvant interferon-α (IFN-α) after surgery (adjuvant IFN-α group), while 338 (77.5%) did not (control group). The primary endpoint was cancer-specific survival (CSS). Univariate and multivariate analyses were conducted using log-rank tests and Cox proportional hazards models, respectively.
Fifty-two (11.9%) patients died from RCC with a median follow-up period of 96 months. Preliminary univariate analyses comparing CSS among treatment groups in each TNM setting revealed that CSS in the control group was equal or superior to that in the adjuvant IFN-α group in earlier stages, while the opposite trend was observed in more advanced stages. We evaluated the TNM cutoffs and demonstrated maximized benefit of adjuvant IFN-α in patients with pT2b-3cN0 (P = 0.0240). In multivariate analysis, ≥pT3 and pN1-2 were independent predictors for poor CSS in all patients. In the subgroups with ≥pT2 disease (n = 123), pN1-2 and no adjuvant treatment were significant poor prognostic factors.
Adjuvant immunotherapy after nephrectomy may be beneficial in pT2b-3cN0 RCC. Careful consideration is, however, required for interpretation of this observational study because of its selection bias and adverse effects of IFN-α.
肾细胞癌(RCC)肾切除术后辅助免疫治疗的益处存在争议。本研究旨在探讨辅助免疫治疗在不同临床情况下的潜在益处。
我们回顾性分析了1981年至2009年间在我院接受根治性或部分肾切除术且有治愈意图的436例pT1-3N0-2M0期RCC患者。其中,98例(22.5%)患者术后接受了辅助干扰素-α(IFN-α)治疗(辅助IFN-α组),而338例(77.5%)患者未接受(对照组)。主要终点是癌症特异性生存率(CSS)。分别使用对数秩检验和Cox比例风险模型进行单因素和多因素分析。
52例(11.9%)患者死于RCC,中位随访期为96个月。在每个TNM分期中对治疗组间CSS进行初步单因素分析显示,在早期阶段,对照组的CSS等于或优于辅助IFN-α组,而在更晚期阶段则观察到相反的趋势。我们评估了TNM分界点,结果表明辅助IFN-α对pT2b-3cN0患者的益处最大(P = 0.0240)。多因素分析中,≥pT3和pN1-2是所有患者CSS不良的独立预测因素。在≥pT2期疾病亚组(n = 123)中,pN1-2和未接受辅助治疗是显著的不良预后因素。
肾切除术后辅助免疫治疗可能对pT2b-3cN0期RCC有益。然而,由于本观察性研究存在选择偏倚和IFN-α的不良反应,因此在解释研究结果时需要谨慎考虑。