Phase III trial of interferon alfa-2a with or without 13-cis-retinoic acid for patients with advanced renal cell carcinoma
Phase III trial of interferon alfa-2a with or without 13-cis-retinoic acid for patients with advanced renal cell carcinoma
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DOI：
10.1200/jco.2000.18.16.2972
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发表时间：
2000-08-01
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;Murphy, BA;Mazumdar, M
目的：进行一项随机 III 期试验，以确定对于晚期肾细胞癌 (RCC) 患者，13-顺式视黄酸 (13-CRA) 加干扰素 α-2a (IFN α 2a) 联合治疗是否优于单独使用 IFN α 2a。 患者和方法：284 名患者被随机分配接受 IFN α 2a 加 13-CRA 治疗或单独接受 IFN α 2a 治疗。每天皮下注射 IFN α 2a，起始剂量为 300 万单位 (MU)。剂量每 7 天从 3 MU 递增至 9 MU（增量为 3 MU），除非发生大于或等于 2 级毒性，在这种情况下停止剂量递增。随机接受联合治疗的患者口服 13-CRA 1 mg/kg/d 加 IFN α 2a。评估生活质量 (QOL)。 结果：接受 IFN α 2a 加 13-CRA 治疗的患者中有 12% 获得完全或部分缓解，而接受 IFN α 2a 治疗的患者中有 6% 获得完全或部分缓解 (P = .14)。联合治疗组的中位缓解持续时间（完全和部分联合）为 33 个月（范围为 9 至 50 个月），而第二组为 22 个月（范围为 5 至 38 个月）（P = .03）。接受 IFN α 2a 加 13-CRA 治疗的患者中有 19% 在 24 个月时无进展，而单独接受 IFN α 2a 治疗的患者只有 10% (P = .05)。所有患者的中位生存时间为 15 个月，两个治疗组之间的生存时间没有差异 (P = .26)。在治疗的前 8 周内，生活质量下降，随后 CT 部分恢复。较低的评分与联合治疗相关。 结论：对于晚期 RCC 患者，在 IFN α 2a 治疗中添加 13-CRA 后，缓解比例和生存率并未显着改善。 13-CRA 可能会延长 IFN α 2a 敏感肿瘤患者对 IFN α 2a 治疗的反应。治疗，尤其是联合治疗，与生活质量下降相关。 (C) 2000 年美国临床肿瘤学会。
Purpose: A randomized phase III trial was conducted to determine whether combination therapy with 13-cis-retinoic acid (13-CRA) plus interferon alfa-2a (IFN alpha 2a) is superior to IFN alpha 2a alone in patients with advanced renal cell carcinoma (RCC).Patients and Methods: Two hundred eighty-four patients were randomized to treatment with IFN alpha 2a plus 13-CRA or treatment with IFN alpha 2a alone. IFN alpha 2a was given daily subcutaneously, starting at ct dose of 3 million units (MU). The dose was escalated every 7 days from 3 to 9 MU (by increments of 3 MU), unless greater than or equal to grade 2 toxicity occurred, in which case dose escalation was stopped. patients randomized to combination therapy were given oral 13-CRA 1 mg/kg/d plus IFN alpha 2a. Quality of life (QOL) was assessed.Results: Complete or partial responses were achieved by 12% of patients treated with IFN alpha 2a plus 13-CRA and 6% of patients treated with IFN alpha 2a (P = .14). Median duration of response (complete and partial combined) in the group treated with the combination was 33 months (range, 9 to 50 months), versus 22 months (range, 5 to 38 months) for the second group (P = .03). Nineteen percent of patients treated with IFN alpha 2a plus 13-CRA were progression-free at 24 months, compared with 10% of patients treated with IFN alpha 2a alone (P = .05). Median survival time for all patients was 15 months, with no difference in survival between the two treatment arms (P = .26). QOL decreased during the first 8 weeks of treatment, and ct partial recovery followed. Lower scores were associated with the combination therapy.Conclusion: Response proportion and survival did not improve significantly with the addition of 13-CRA to IFN alpha 2a therapy in patients with advanced RCC. 13-CRA may lengthen response to IFN alpha 2a therapy in patients with IFN alpha 2a-sensitive tumors. Treatment, particularly the combination therapy, was associated with a decrease in QOL. (C) 2000 by American Society of Clinical Oncology.