Radical nephrectomy plus interferon-alfa-based immunotherapy compared with interferon alfa alone in metastatic renal-cell carcinoma: a randomised trial
Radical nephrectomy plus interferon-alfa-based immunotherapy compared with interferon alfa alone in metastatic renal-cell carcinoma: a randomised trial
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DOI：
10.1016/s0140-6736(01)06103-7
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发表时间：
2001-09-22
期刊：
影响因子：
168.9
通讯作者：
Sylvester, R
中科院分区：
文献类型：
--
作者：
Mickisch, GHJ;Garin, A;Sylvester, R
背景手术是局部肾细胞癌的主要治疗方法，但对于转移性疾病，采用根治性肾切除术是非常有争议的。我们的目的是确定在基于干扰素的免疫治疗之前进行根治性肾切除术是否比单独使用干扰素改善了进展时间和总生存期（主要终点）。方法选取1995年6月~ 1998年7月收治的85例患者，其中2例（每组1例）不符合要求。83名参与者中的42名被随机分配到联合治疗组（研究组）和43名单独免疫治疗组（对照组）。所有患者均有组织学证实的转移性肾细胞癌，入院时为进展性肾细胞癌。在研究患者中，手术在随机化的4周内完成，免疫治疗(5 × 10（6) IU/m(2)皮下注射，每周3次）在2-4周后开始。在对照组中，免疫治疗在随机化后1个工作日内开始。随访是每月一次。所有的分析都是为了治疗。结果：75例患者中有40例（53%）接受了至少16周的干扰素治疗，这也是治疗的中位持续时间。研究患者的进展时间（5个月vs 3个月，风险比0.60,95% CI 0.36-0.97）和中位生存时间显著优于对照组（17个月vs 7个月，0.54,0.31-0.94）。5例患者对联合治疗完全有效，1例仅对α干扰素有效。32%的患者需要调整剂量，最常见的原因是非血液学副作用。解释：对于表现良好的转移性肾癌患者，在干扰素免疫治疗前进行根治性肾切除术可能会大大延迟进展时间，并提高患者的生存率。
Background Surgery is the main treatment for localised renal cell carcinoma, but use of radical nephrectomy for metastatic disease is highly controversial. We aimed to establish whether radical nephrectomy done before interferon-alfa-based immunotherapy improved time to progression and overall survival (primary endpoints) compared with interferon alfa alone.Methods We included 85 patients from June, 1995, to July, 1998: two (one per group) were ineligible. 42 of the 83 participants were randomly assigned combined treatment (study group) and 43 immunotherapy alone (controls). All patients had metastatic renal-cell carcinoma that had been histologically confirmed and was progressive at entry. In study patients, surgery was done within 4 weeks of randomisation, and immunotherapy (5x10(6) IU/m(2) subcutaneously three times per week) started 2-4 weeks later. In controls, immunotherapy was started within 1 working day of randomisation. Follow-up visits were monthly. All analyses were by intention to treat.Findings 40 (53%) of 75 patients received at least 16 weeks of interferon-alfa treatment, which was also the median duration of treatment. Time to progression (5 vs 3 months, hazard ratio 0.60, 95% CI 0.36-0.97) and median duration of survival were significantly better in study patients than in controls (17 vs 7 months, 0.54, 0.31-0.94). Five patients responded completely to combined treatment, and one to interferon alfa alone. Dose modification was necessary in 32% of patients, most commonly because of non-haematological side-effects.Interpretation Radical nephrectomy before interferon-based immunotherapy might substantially delay time to progression and improve survival of patients with metastatic renal cell carcinoma who present with good performance status.