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Efficacy and safety of amrubicin hydrochloride for treatment of relapsed small cell lung cancer

机译:盐酸氨柔比星治疗复发性小细胞肺癌的疗效和安全性

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摘要

Long-term survival is quite uncommon in refractory small cell lung cancer (SCLC) patients, with less than 25% of patients with limited-stage disease and 1%-2% of patients with extensive-stage disease remaining alive at five years. Recent clinical studies have demonstrated the promising efficacy of amrubicin for patients with relapsed SCLC. This review presents the results of clinical studies showing the efficacy and safety of amrubicin for the treatment of relapsed SCLC. Amrubicin is a synthetic anthracycline agent with a similar structure to doxorubicin, in which the hydroxyl group at position 9 in amrubicin is replaced by an amino group to enhance efficacy. It is converted to an active metabolite, amrubicinol, which is 5-54 times more active than amrubicin. Amrubicin and amrubicinol are inhibitors of DNA topoisomerase II, exerting their cytotoxic effects by stabilizing a topoisomerase II-mediated cleavable complex. The toxicity of amrubicin is similar to that of doxorubicin, although amrubicin shows almost no cardiotoxicity. In the relevant trials, amrubicin was administered intravenously at a dose of 35-40 mg/m2 on days 1-3 every three weeks. The response rate was 34%-52% and median survival times were 8.1-12.0 months. Common hematologic toxicities included neutropenia, leucopenia, anemia, thrombocytopenia, and febrile neutropenia. Nonhematologic adverse events included Grade 3-4 anorexia, asthenia, hyponatremia, and nausea. The results of the studies which demonstrated the efficacy of monotherapy for relapsed SCLC involved mainly Japanese patients. Therefore, it is necessary to conduct more clinical studies in non-Japanese patients to confirm the efficacy of amrubicin.
机译:难治性小细胞肺癌(SCLC)患者的长期存活率非常罕见,其中只有不到25%的有限期患者和1%-2%的广泛期患者在5年后仍然存活。最近的临床研究表明,氨柔比星对SCLC复发患者具有令人鼓舞的疗效。这篇综述提供了临床研究的结果,表明氨柔比星治疗复发性SCLC的有效性和安全性。 Amrubicin是一种合成的蒽环类药物,具有与阿霉素相似的结构,其中Amrubicin中9位的羟基被氨基取代以增强药效。它被转化为活性代谢产物氨柔比星醇,其活性比氨柔比星强5-54倍。 Amrubicin和amrubicinol是DNA拓扑异构酶II的抑制剂,通过稳定拓扑异构酶II介导的可裂解复合物发挥其细胞毒性作用。氨柔比星的毒性类似于阿霉素,尽管氨柔比星几乎没有心脏毒性。在相关试验中,每三周1-3天以35-40 mg / m2的剂量静脉注射氨柔比星。缓解率为34%-52%,中位生存时间为8.1-12.0个月。常见的血液学毒性包括中性粒细胞减少,白细胞减少,贫血,血小板减少和高热性中性粒细胞减少。非血液学不良事件包括3-4级厌食,乏力,低钠血症和恶心。研究结果表明,单一疗法对复发性小细胞肺癌的疗效主要涉及日本患者。因此,有必要在非日本患者中进行更多的临床研究,以确认氨柔比星的疗效。

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