Interferon-alfa as a comparative treatment for clinical trials of new therapies against advanced renal cell carcinoma
Interferon-alfa as a comparative treatment for clinical trials of new therapies against advanced renal cell carcinoma
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DOI：
10.1200/jco.20.1.289
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发表时间：
2002-01-01
影响因子：
45.3
通讯作者：
Mazumdar, M
中科院分区：
文献类型：
--
作者：
Motzer, RJ;Bacik, J;Mazumdar, M
目的：确定接受干扰素-α 作为初始全身治疗的转移性肾细胞癌 (RCC) 患者的结果数据和预后标准。这些数据可用于设计和解释针对这种难治性恶性肿瘤的新药和治疗方案的临床试验。 患者和方法：本次回顾性分析的对象是六项前瞻性临床试验中使用干扰素-a 作为一线全身治疗的 463 名晚期肾细胞癌患者。通过分层 Cox 比例风险模型，根据五种治疗前临床特征确定了预测生存的三个风险类别。结果：中位总生存时间为 13 个月。中位进展时间为 4.7 个月。五个变量被用作短生存的危险因素：低卡诺夫斯基体能状态、高乳酸脱氢酶、低血清血红蛋白、高校正血清钙以及从最初诊断肾细胞癌到开始干扰素-a治疗的时间不到一年。每个患者被分配到三个风险组之一：风险因素为零的组（有利风险）、风险因素为一或两个的组（中风险）以及风险因素为三个或以上的组（低风险）。被视为有利风险的患者的中位死亡时间为 30 个月。中等风险组的中位生存时间为 14 个月。相比之下，低风险组的中位生存时间为5个月。结论：干扰素-a治疗的无进展生存期和总生存期可以与11期和III期临床研究中的新疗法进行比较。该预后模型适用于使用干扰素-a 作为比较治疗组的 III 期试验的风险分层。 20011 年美国临床肿瘤学会。
Purpose: To define outcome data and prognostic criteria for patients with metastatic renal cell carcinoma (RCC) treated with interferon-alfa as initial systemic therapy. The data can be applied to design and interpretation of clinical trials of new agents and treatment programs against this refractory malignancy.Patients and Methods: Four hundred sixty-three patients with advanced RCC administered interferon-a as first-line systemic therapy on six prospective clinical trials were the subjects of this retrospective analysis. Three risk categories for predicting survival were identified on the basis of five pretreatment clinical features by a stratified Cox proportional hazards model.Results: The median overall survival time was 13 months. The median time to progression was 4.7 months. Five variables were used as risk factors for short survival: low Karnofsky performance status, high lactate dehydrogenase, low serum hemoglobin, high corrected serum calcium, and time from initial RCC diagnosis to start of interferon-a therapy of less than one year. Each patient was assigned to one of three risk groups: those with zero risk factors (favorable risk), those with one or two (intermediate risk), and those with three or more (poor risk). The median time to death of patients deemed favorable risk was 30 months. Median survival time in the intermediate-risk group was 14 months. In contrast, the poor-risk group had a median survival time of 5 months.Conclusion: Progression-free and overall survival with interferon-a treatment can be compared with new therapies in phase 11 and III clinical investigations. The prognostic model is suitable for risk stratification of phase III trials using interferon-a as the comparative treatment arm. 20011 by American Society of Clinical Oncology.