Mani S, Todd M, Poo W J
Yale University School of Medicine and the Yale Comprehensive Cancer Center, New Haven, Connecticut, USA.
Am J Clin Oncol. 1996 Apr;19(2):187-9. doi: 10.1097/00000421-199604000-00020.
We report on the clinical course of 15 patients with metastatic renal cell carcinoma (RCC) who were treated with recombinant beta-interferon as part of a phase I-II study. There were no objective responders among the 15 patients treated with recombinant beta-interferon at an i.v. dose escalating from 90 X 10(6) U given three times a week until there was documented disease progression or complete response (CR). Overall median survival was 24 months. One patient refused further treatment after 7 weeks. The major side effects of treatment included cardiovascular events (20%), mental status change requiring cessation of drug (6.7%), and grade 3 headaches/myalgias (26.7%). There were no life-threatening side effects observed; however, cardiac events led to the termination of treatment in three patients. Other minor toxicities included fatigue (46.7%), proteinuria (60%), diarrhea (6.7%), nausea and vomiting (13.3%), persistent fever (6.7%) and transient visual disturbance (6.7%). Thus, at our institution, in a cohort of 15 patients with metastatic RCC, recombinant beta-interferon when given i.V. at a dose < or equal to 720 X 10(6) U three times per week, yielded no clinical antitumor activity. A review of the literature on the use of beta-interferon for metastatic RCC suggests that there may be some efficacy, but our experience with escalating i.v. doses < or equal to 720 X 10(6) U given three times a week does not support it. Moreover, at these doses, one may find serious cardiovascular events although further studies need to be done in order to clearly define dose-related side effects as well as optimal efficacy-to-toxicity ratio.
我们报告了15例转移性肾细胞癌（RCC）患者的临床病程，这些患者接受了重组β干扰素治疗，作为I-II期研究的一部分。在15例接受重组β干扰素静脉注射治疗的患者中，从每周三次给予90×10⁶U开始剂量递增，直至记录到疾病进展或完全缓解（CR），没有客观缓解者。总体中位生存期为24个月。1例患者在7周后拒绝进一步治疗。治疗的主要副作用包括心血管事件（20%）、需要停药的精神状态改变（6.7%）和3级头痛/肌痛（26.7%）。未观察到危及生命的副作用；然而，心脏事件导致3例患者终止治疗。其他轻微毒性包括疲劳（46.7%）、蛋白尿（60%）、腹泻（6.7%）、恶心和呕吐（13.3%）、持续发热（6.7%）和短暂视力障碍（6.7%）。因此，在我们机构，在一组15例转移性RCC患者中，每周三次静脉注射剂量≤720×10⁶U的重组β干扰素未产生临床抗肿瘤活性。对使用β干扰素治疗转移性RCC的文献综述表明可能存在一定疗效，但我们每周三次递增静脉注射剂量≤720×10⁶U的经验并不支持这一点。此外，在这些剂量下，可能会出现严重的心血管事件，尽管需要进一步研究以明确定量相关的副作用以及最佳的疗效与毒性比。
