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α2干扰素联合阿霉素治疗实体瘤的I期研究。

Phase I study of alpha 2-interferon plus doxorubicin in patients with solid tumors.

作者信息

Sarosy G A, Brown T D, Von Hoff D D, Spiegel R J, Golando J P, Beougher K L, Kuhn J G, Kisner D L

出版信息

Cancer Res. 1986 Oct;46(10):5368-71.

PMID:3756887
Abstract

Cytotoxic chemotherapy and interferon have shown synergistic antitumor activity in vitro. The purpose of this study was to determine the maximally tolerated dose of doxorubicin given every 3 weeks, in patients receiving recombinant alpha 2-interferon [10 X 10(6) IU/m2 s.c. three times per week (Monday, Wednesday, and Friday)] during the first 2 weeks of each cycle of doxorubicin. Fourteen patients received a total of 41 cycles. Hematological toxicity was dose limiting with granulocytopenia (total granulocyte count, less than 1000) occurring in 50% of patients treated with doxorubicin at 40 mg/m2 and in 25% of patients treated with doxorubicin at 30 mg/m2. Nonhematological toxicities included a flu-like syndrome, alopecia, nausea, vomiting, diarrhea, and transient mild increases in liver function tests. A partial response was seen in one patient with metastatic squamous cell carcinoma of the skin and in another patient with metastatic adenocarcinoma of the pancreas. Concomitant administration of recombinant alpha 2-interferon given on this schedule limits the amount of doxorubicin that can be administered. However, the responses noted in this study are encouraging enough to warrant additional studies of doxorubicin plus recombinant alpha 2-interferon.

摘要

细胞毒性化疗药物与干扰素在体外已显示出协同抗肿瘤活性。本研究的目的是确定在多柔比星每3周给药一次的情况下,最大耐受剂量,研究对象为在多柔比星每个疗程的前2周接受重组α2干扰素[10×10(6)IU/m2皮下注射,每周3次(周一、周三和周五)]的患者。14例患者共接受了41个疗程。血液学毒性是剂量限制性的,多柔比星40mg/m2治疗的患者中50%出现粒细胞减少(总粒细胞计数少于1000),多柔比星30mg/m2治疗的患者中25%出现粒细胞减少。非血液学毒性包括流感样综合征、脱发、恶心、呕吐、腹泻以及肝功能检查结果短暂轻度升高。1例皮肤转移性鳞状细胞癌患者和另1例胰腺转移性腺癌患者出现部分缓解。按此方案同时给予重组α2干扰素会限制多柔比星的给药量。然而,本研究中观察到的反应足以令人鼓舞,值得对多柔比星加重组α2干扰素进行更多研究。

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