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重组α干扰素治疗低度非霍奇金淋巴瘤:31例患者的合作II期试验结果

Recombinant alpha interferon in the treatment of low-grade non-Hodgkin's lymphoma: results of a cooperative phase II trial in 31 patients.

作者信息

Mantovani L, Guglielmi C, Martelli M, Chierichini A, Deriu L, Sertoli M R, Ardizzoni A, Mandelli F

出版信息

Haematologica. 1989 Nov-Dec;74(6):571-5.

PMID:2628239
Abstract

Thirty-one patients with advanced stage of favorable histology non-Hodgkin's lymphomas were entered into a multicenter phase II trial with recombinant alpha A interferon as single agent. Interferon was administered intramuscular in doses of 6 x 10(6)/IU/m2 three times per week for 12 weeks. Dose escalation was applied, in the absence of toxicities greater than WHO grade II, in patients not responding after 4 weeks. In responding patients treatment was continued at the same dose with a weekly maintenance schedule for 12 additional weeks. Objective responses (4 complete, 10 partial) were obtained in 14 of the 27 evaluable patients (52%). Median time to progression was 15 months for partial responders, while none of the complete responders has relapsed up to the present time. Toxicity was generally moderate and manageable. Treatment was discontinued in three patients because of side effects, and one patient refused therapy after 3 weeks. Our study shows that recombinant alpha A interferon has antitumor activity in patients with favorable histology non-Hodgkin's lymphoma.

摘要

31例组织学类型良好的晚期非霍奇金淋巴瘤患者进入一项以重组αA干扰素作为单一药物的多中心II期试验。干扰素通过肌肉注射给药,剂量为6×10(6)/IU/m²,每周3次,共12周。对于4周后无反应且毒性不超过WHO II级的患者,进行剂量递增。对于有反应的患者,以相同剂量继续治疗,并采用每周维持方案,再持续12周。在27例可评估患者中的14例(52%)获得了客观缓解(4例完全缓解,10例部分缓解)。部分缓解者的中位进展时间为15个月,而截至目前,完全缓解者均未复发。毒性一般为中度且可控制。3例患者因副作用停止治疗,1例患者在3周后拒绝治疗。我们的研究表明,重组αA干扰素对组织学类型良好的非霍奇金淋巴瘤患者具有抗肿瘤活性。

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