Merimsky O, Chaitchik S
Department of Oncology, Ichilov Hospital, Tel Aviv Sourasky Medical Center, Israel.
Mol Biother. 1992 Sep;4(3):130-4.
Our 3-year clinical experience using recombinant interferon (rIFN) alpha-C in patients with metastatic renal cell carcinoma (RCC) is summarized. This type of IFN is a new subspecies of the IFN-alpha protein family. Its specific activity is 1-2 x 10(9) U/mg protein, the highest among IFN-alpha species presently available. Pharmacokinetic study indicated good bioavailability of the preparation from the intramuscular injection. A phase II study was performed to assess the response rate related to rIFN-alpha C at a low dosage. A dose of 3 x 10(6) U daily was administered, followed by 3 x 10(6) U/m2 every other day to avoid severe toxicity. Among 33 treated patients, a partial remission rate of 9.7% and stable disease rate of 25.8% were achieved. Side effects were usually mild and the treatment was well tolerated by the patients. However, mental deterioration and behavioral changes were observed in five patients with RCC treated by rIFN-alpha C and were related to neurotoxicity of IFN. The role of vinblastine in addition to IFN in the treatment of RCC was assessed in nine patients who had failed on IFN alone. No response was observed. It appeared that vinblastine had little if any effect in being added to IFN as second-line therapy. We conclude that rIFN-alpha C has moderate activity in the treatment of RCC. Familiarity with the possible toxicity of this agent will lead to more careful management of patients.
总结了我们使用重组干扰素（rIFN）α-C治疗转移性肾细胞癌（RCC）患者的3年临床经验。这种类型的干扰素是干扰素α蛋白家族的一个新亚种。其比活性为1-2×10⁹U/mg蛋白，是目前可用的干扰素α种类中最高的。药代动力学研究表明，该制剂经肌肉注射后具有良好的生物利用度。进行了一项II期研究，以评估低剂量rIFN-αC的缓解率。每天给予3×10⁶U的剂量，随后每隔一天给予3×10⁶U/m²，以避免严重毒性。在33例接受治疗的患者中，部分缓解率为9.7%，疾病稳定率为25.8%。副作用通常较轻，患者对治疗耐受性良好。然而，在5例接受rIFN-αC治疗的RCC患者中观察到精神恶化和行为改变，这与干扰素的神经毒性有关。在9例仅接受干扰素治疗失败的患者中评估了长春碱联合干扰素治疗RCC的作用。未观察到反应。似乎长春碱作为二线治疗添加到干扰素中几乎没有效果。我们得出结论，rIFN-αC在治疗RCC方面具有中等活性。熟悉该药物可能的毒性将有助于更谨慎地管理患者。
