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卡波金与烟酰胺用于局部晚期膀胱癌:一项III期随机试验的早期结果

Carbogen and nicotinamide in locally advanced bladder cancer: early results of a phase-III randomized trial.

作者信息

Hoskin Peter J, Rojas Ana M, Saunders Michele I, Bentzen S M, Motohashi K J

机构信息

CR-UK Tumour Biology and Radiation Research Group, Northwood, Middlesex, UK.

出版信息

Radiother Oncol. 2009 Apr;91(1):120-5. doi: 10.1016/j.radonc.2008.10.001. Epub 2008 Nov 5.

DOI:10.1016/j.radonc.2008.10.001
PMID:18992952
Abstract

PURPOSE

Phase II studies in laryngeal and bladder carcinoma of accelerated radiotherapy with carbogen and nicotinamide (RT+CON) suggested a therapeutic advantage. Therefore, a randomized phase-III trial of RT+CON in locally advanced bladder carcinoma compared to radiotherapy (RT) alone was undertaken.

METHODS

One hundred and sixty-five patients with muscle-invasive transitional cell bladder carcinoma were randomized to RT alone and 168 to RT+CON. This paper reports on compliance and toxicity to nicotinamide (NAM) and carbogen and on early radiation-induced adverse bowel and urinary events.

RESULTS

Of those receiving RT+CON, 65-69% accepted all doses of NAM. Sixty-four percent of patients presented Grade 1 NAM toxicity (nausea or vomiting), which was severe in 13%. Compliance to carbogen was 85% and none (32 fractions) and 2% (20 fractions) of patients presented severe toxicity. The highest prevalence of severe radiation acute morbidity was seen for urinary frequency (RT: 18% and RT+CON: 15%) and for diarrhea (RT: 3% and RT+CON: 5%).

CONCLUSIONS

There is no indication of an increase in radiation-induced morbidity by combining the tumour radiosensitizers carbogen and nicotinamide with radiotherapy. Late morbidity and treatment outcome will ultimately determine if there is a therapeutic benefit.

摘要

目的

Ⅱ期研究表明,在喉癌和膀胱癌中采用加用卡波金和烟酰胺的加速放疗(RT+CON)具有治疗优势。因此,开展了一项局部晚期膀胱癌的Ⅲ期随机试验,比较RT+CON与单纯放疗(RT)的疗效。

方法

165例肌层浸润性移行细胞膀胱癌患者被随机分为单纯放疗组和RT+CON组,每组分别为165例和168例。本文报告了患者对烟酰胺(NAM)和卡波金的依从性及毒性,以及早期放疗引起的肠道和泌尿系统不良事件。

结果

在接受RT+CON治疗的患者中,65% - 69%接受了所有剂量的NAM。64%的患者出现1级NAM毒性(恶心或呕吐),其中13%较为严重。卡波金的依从率为85%,无一例(32次分割)和2%(20次分割)的患者出现严重毒性。严重放疗急性并发症的最高发生率出现在尿频(RT组:18%,RT+CON组:15%)和腹泻(RT组:3%,RT+CON组:5%)方面。

结论

没有迹象表明将肿瘤放射增敏剂卡波金和烟酰胺与放疗联合使用会增加放疗引起的发病率。晚期发病率和治疗结果将最终决定是否具有治疗益处。

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