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异环磷酰胺治疗复发性或播散性肺癌:两种剂量方案的II期研究

Ifosfamide in the treatment of recurrent or disseminated lung cancer: a phase II study of two dose schedules.

作者信息

Costanzi J J, Gagliano R, Loukas D, Panettiere F J, Hokanson J A

出版信息

Cancer. 1978 May;41(5):1715-9. doi: 10.1002/1097-0142(197805)41:5<1715::aid-cncr2820410510>3.0.co;2-x.

Abstract

Ifosfamide was administered to 21 patients with recurrent or disseminated lung cancer at a dose of 4.0 gm/M2 iv every 3 weeks. The response rate was 33% with an additional 14% showing no response or stable disease. At a dose of 1.2 gm/M2 daily for 5 days every 4 weeks, 57% of 14 patients responded with 35% showing no response or stable disease. The majority of the patients (28) had epidermoid carcinoma. Two (7%) had complete response with 9 (32%) showing partial responses. Other responses included 1/2 oat cell carcinomas and 3/6 large cell undifferentiated carcinomas. Toxicity was equal in both regimens for nausea, vomiting, increased serum LDH and neutropenia but the 5 day program had significantly less hemorrhagic cystitis. Survival was greatly influenced by response. There was no statistical difference in overall length of response between responders and the non responding/stable disease patients. But these two groups had a very significant survival advantage when compared to those patients with increasing disease. Similarly, there was a significant improvement in response duration for the low dosage regimen. Therefore, the low dose 5 day regimen is recommended because of its response rate, it has less hemorrhagic cystitis and it has better patient acceptance in that it can be given as an outpatient and does not require a Foley catheter.

摘要

对21例复发性或播散性肺癌患者每3周静脉注射异环磷酰胺,剂量为4.0克/平方米。缓解率为33%,另有14%无反应或病情稳定。每4周每天静脉注射异环磷酰胺1.2克/平方米,连用5天,14例患者中57%有反应,35%无反应或病情稳定。大多数患者(28例)为表皮样癌。2例(7%)完全缓解,9例(32%)部分缓解。其他反应包括1/2例燕麦细胞癌和3/6例大细胞未分化癌。两种方案在恶心、呕吐、血清乳酸脱氢酶升高和中性粒细胞减少方面的毒性相同,但5天方案的出血性膀胱炎明显较少。缓解情况对生存有很大影响。缓解者与无反应/病情稳定患者的总体缓解时长无统计学差异。但与病情进展的患者相比,这两组患者的生存优势非常显著。同样,低剂量方案的缓解持续时间有显著改善。因此,推荐低剂量5天方案,因其缓解率高、出血性膀胱炎较少且患者接受度较好,因为该方案可门诊给药且无需留置导尿管。

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