TREATMENT OF RELAPSED T CELL LYMPHOMAS WITH RECOMBINANT LEUKOCYTE A INTERFERON

以前的试验已经证明了显著的抗肿瘤活性。 干扰素α在皮肤T细胞淋巴瘤患者中的应用 最初试验中使用的剂量是最大耐受量 每平方米肌肉注射5000万单位的剂量 每周三次。那次试验的应答率是 大约50%，所有反应都是部分反应。 所有患者都需要减少剂量，因为进行性的 干扰素相关的毒副作用。在这个协议中，我们 试图以50%的剂量周期性地给予干扰素 每天肌肉内每平方百万单位，共四个 连续几天(最初剂量为1000万单位/平方米 在第一天)每隔三周。希望病人们能 从干扰素相关的副作用中恢复过来，并且 实际传递给患者的干扰素的数量可能会增加 以这种方式实施治疗。如果这是可能的， 可能会达到更高的应答率。24名患者接受了 已输入，其中22个是可评估的回应。有一个 持续7个月以上的完全缓解，6个部分缓解 持续时间中位数为7.5个月，6个轻微反应和9个 患者无反应。在治疗的前12周， 预计干扰素总剂量的94.5%是 给药反映了患者对此的合理耐受性 不同的干扰素给药方案。相比之下， 不到50%的患者预计给药 5000万单位肌肉注射，每周三次 在旧的协议上。类似的总体应答率 最初的研究表明，没有剂量-反应关系 这种疾病的干扰素α至少超过剂量范围 检查过了。

Previous trials have demonstrated significant antitumor activity of interferon alfa in patients with cutaneous T-cell lymphomas. The dose used in the original trial was the maximally tolerated dose of 50 million units per meter squared given intramuscularly three times per week. The response rate in that trial was approximately 50 percent, and all responses were partial responses. All patients required dose reductions because of progressive interferon-related toxic side effects. In this protocol, we attempted to administer interferon cyclically at a dose of 50 million units per meter squared intramuscularly daily for four consecutive days (following an initial dose of 10 million units/m2 on day 1) every third week. The hope was that patients would recover from interferon-related side effects and that the amount of interferon actually delivered to patients might be increased by administering the therapy in this manner. If this was possible, higher response rates might be attained. Twenty-four patients were entered of whom 22 are evaluable for response. There was one complete remission lasting 7+ months, six partial remissions lasting a median of 7.5 months, six minor responses, and nine patients without response. In the first twelve weeks of therapy, 94.5 percent of the projected total dose of interferon had been administered reflecting reasonable patient tolerance to this different schedule of interferon administration. This compares to a less than 50 percent projected delivery of drug in patients treated with 50 million units intramuscularly three times per week on the older protocol. The similar overall response rate to the original study suggests that there is no dose-response relationship of this disease with interferon alfa at least over the dose range examined.