Randomized phase III trial of high-dose interleukin-2 versus subcutaneous interleukin-2 and interferon in patients with metastatic renal cell carcinoma
Randomized phase III trial of high-dose interleukin-2 versus subcutaneous interleukin-2 and interferon in patients with metastatic renal cell carcinoma
复制标题
DOI：
10.1200/jco.2005.03.206
复制
发表时间：
2005-01-01
影响因子：
45.3
通讯作者：
Atkins, MB
中科院分区：
文献类型：
--
作者：
McDermott, DF;Regan, MM;Atkins, MB
细胞因子工作组进行了一项随机III期试验，以确定转移性肾癌患者门诊白细胞介素-2 （IL-2）和干扰素-2b （IFN）相对于高剂量（HD） IL-2的价值。患者和方法根据骨和肝转移、原发肿瘤原位和东部肿瘤合作组表现状态0或1对患者进行分层，然后随机分配在第1天每8小时皮下注射3次IL-2 （5 MIU/m(2)）。然后每天5天/周，连续4周)和IFN （5 MIU/m，每周皮下注射3次，连续4周）每6周或HD IL-2 （600,000 U/kg/剂量，每8小时静脉注射，第1至5天和第15至19天[最多28个闭合]）每12周。结果1997年4月至2000年7月共入组192例患者。这些方案的毒性与预期一致。HD IL-2治疗的有效率为23.2%（95例患者中22例），而IL-2/IFN治疗的有效率为9.9%（91例患者中9例）（P = 0.018）。10名接受IL-2治疗的HD患者在3年时无进展，而3名接受IL-2和IFN治疗的患者（P = 0.082）。中位缓解持续时间分别为14个月和7个月（P = 0.14），中位生存期分别为17.5个月和13个月（P = 0.24）。对于骨或肝转移（P = 0.001）或原发肿瘤（P = 0.040）的患者，HD IL-2的生存率更高。结论：这项随机III期试验提供了额外的证据，证明HD IL-2应该仍然是转移性肾细胞癌患者的首选治疗方法。
Purpose The Cytokine Working Group conducted a randomized phase III trial to determine the value of outpatient interleukin-2 (IL-2) and interferon alfa-2b (IFN) relative to high-dose (HD) IL-2 in patients with metastatic renal cell carcinoma.Patients and Methods Patients were stratified for bone and liver metastases, primary tumor in place, and Eastern Cooperative Oncology Group performance status 0 or 1 and then randomly assigned to receive either IL-2 (5 MIU/m(2) subcutaneously every 8 hours for three doses on day 1, then daily 5 days/wk for 4 weeks) and IFN (5 MIU/m(2) subcutaneously three times per week for 4 weeks) every 6 weeks or HD IL-2 (600,000 U/kg/dose intravenously every 8 hours on days I through 5 and 15 to 19 [maximum 28 closes]) every 12 weeks.Results One hundred ninety-two patients were enrolled between April 1997 and July 2000. Toxicities were as anticipated for these regimens. The response rate was 23.2% (22 of 95 patients) for HD IL-2 versus 9.9% (nine of 91 patients) for IL-2/IFN (P = .018). Ten patients receiving HD IL-2 were progression-free at 3 years versus three patients receiving IL-2 and IFN (P = .082). The median response durations were 14 and 7 months (P = .14), and median survivals were 17.5 and 13 months (P = .24). For patients with bone or liver metastases (P = .001) or a primary tumor in place (P = .040), survival was superior with HD IL-2.Conclusion This randomized phase III trial provides additional evidence that HD IL-2 should remain the preferred therapy for selected patients with metastatic renal cell carcinoma.