重组人白细胞介素-2和干扰素-2b在晚期恶性肿瘤中的门诊应用

Jens Atzpodien, Hartmut Kirchner
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引用次数: 25

摘要

我们研究了54例晚期癌症患者皮下联合给药重组人白细胞介素-2和干扰素α -2b的安全性、耐受性和临床效果,这些患者没有有效的标准治疗方法。疗程包括2天白介素-2脉冲(1440 - 1800万单位(MU) m2/天),随后3.6至4.8 MU/m2/天,每周5天,连续6周,干扰素α -2b 3至6 MU/m2,每周2- 3次,连续6周。总体而言,患者分别接受了超过90%的预期剂量的白细胞介素-2和干扰素α -2b。在54例可评估的患者中(32例肾细胞癌,12例黑色素瘤,8例结直肠癌,1例b细胞淋巴瘤,1例霍奇金病),4例肾细胞癌患者出现完全缓解,6例肾细胞癌患者和1例黑色素瘤患者肿瘤大小缩小50%以上(部分缓解)。21例(13例为肾癌)病情稳定。完全缓解的中位反应持续时间为19个月(范围16-22个月)。临床反应与平均外周血嗜酸性粒细胞计数大于1000 /μL (P <0.05 vs无反应者)。在80%以上接受治疗的患者中,全身性毒性包括发热、寒战、恶心、厌食和低血压(WHO分级为I级和II级)。无治疗相关死亡发生。这种皮下注射重组白介素-2和干扰素α -2b的组合显著减少了通常用高剂量静脉注射重组白介素-2观察到的副作用,需要住院治疗。它已被证明可以诱导进行性转移性肾细胞癌和恶性黑色素瘤门诊患者的客观肿瘤消退。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
The out-patient use of recombinant human interleukin-2 and interferon alfa-2b in advanced malignancies

We studied the safety, tolerance, and clinical effects of the combined administration of subcutaneous recombinant human interleukin-2 and interferon alfa-2b in 54 patients with advanced cancer, for whom no effective standard therapy was available. Treatment courses consisted of a 2-day interleukin-2 pulse (14.4–18 million units (MU) m2/day), followed by 3.6 up to 4.8 MU/m2/day, 5 days per week, over 6 consecutive weeks and interferon alfa-2b at 3 up to 6 MU/m2, administered two-three times weekly for 6 weeks. Overall, patients received more than 90% of the projected dose of interleukin-2 and interferon alfa-2b, respectively. Of 54 evaluable patients (32 renal cell cancer, 12 melanoma, eight colorectal cancer, one B-cell lymphoma, one Hodgkin's disease), four complete responses occurred in patients with renal cell carcinoma, and a greater than 50% reduction in tumour size (partial response) in six renal cell carcinoma patients and one melanoma patient. Moreover, 21 patients (13 renal carcinoma) had stable disease. The median duration of response was 19 months (range 16–22 months) in complete responders. Clinical responses were associated with a mean peripheral blood eosinophil count of more than 1,000/μL (P < 0.05 versus non-responders). Systemic toxicities included fever, chills, nausea, anorexia, and hypotension limited to WHO grades I and II in more than 80% of patients treated. No treatment-related deaths occurred. This combination of subcutaneously administered recombinant interleukin-2 and interferon alfa-2b has significantly diminished the side effects normally observed with high-dose intravenous recombinant interleukin-2, which requires admission to hospital. It has been shown to induce objective tumour regression in out-patients with progressive metastatic renal cell carcinoma and malignant melanoma.

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