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多模式治疗原发性不可切除直肠癌后的健康相关生活质量(HRQoL)。一项 III 期研究的长期结果。

Health-related quality of life (HRQoL) after multimodal treatment for primarily non-resectable rectal cancer. Long-term results from a phase III study.

机构信息

Dept. of Oncology, Oslo University Hospital, Oslo, Norway.

出版信息

Eur J Cancer. 2012 Apr;48(6):813-9. doi: 10.1016/j.ejca.2011.06.035. Epub 2011 Jul 23.

Abstract

BACKGROUND

A randomised study in non-resectable rectal cancer showed that preoperative chemoradiotherapy (CRT) resulted in better local control and disease-specific survival, but not overall survival than radiotherapy alone. The present paper presents long-term (>4 years) health-related quality of life (HRQoL) and a comparison between the results and reference values from the Norwegian general population.

MATERIAL AND METHODS

A total of 207 patients with primarily non-resectable rectal cancer were randomised to preoperative CRT (2Gyx25+5FU/leucovorin) or RT (2Gyx25) before surgery. HRQoL was assessed using EORTC QLQ-C30, completed at baseline and sent to all patients alive in Norway and Sweden (n=105) after a minimum of 4 years post treatment. A difference of ≥5 points on the 0-100 scales was considered clinically significant.

RESULTS

Seventy-six (72%) patients answered at follow-up. No statistically significant differences between the CRT and RT groups appeared at follow-up, although clinically significant differences in social functioning, dyspnoea and diarrhoea were found. Over time, a clinically significant reduction in physical functioning was found in both groups. Moreover, reduced social functioning and less diarrhoea in the CRT group and better role functioning and more diarrhoea in the RT group were found. Comparisons between the study group and age and gender matched reference values indicate impaired social functioning and more diarrhoea among the patients.

CONCLUSION

There were no statistically significant differences in HRQoL between the randomisation groups. In general, despite having impaired social functioning and more diarrhoea, patients reported HRQoL comparable with the reference population several years after treatment.

摘要

背景

一项针对不可切除直肠癌的随机研究表明,术前放化疗(CRT)比单纯放疗在局部控制和疾病特异性生存方面更有效,但在总生存方面没有改善。本文报告了长期(>4 年)的健康相关生活质量(HRQoL)结果,并与来自挪威一般人群的参考值进行了比较。

材料与方法

共纳入 207 例初诊不可切除直肠癌患者,随机分为术前 CRT(2Gy×25+5FU/亚叶酸)或 RT(2Gy×25)组,在治疗后至少 4 年,向所有在挪威和瑞典存活的患者(n=105)发送 EORTC QLQ-C30 进行 HRQoL 评估。0-100 量表上的差异≥5 分被认为具有临床意义。

结果

76 例(72%)患者在随访时应答。CRT 和 RT 组之间在随访时无统计学差异,但在社会功能、呼吸困难和腹泻方面存在临床显著差异。随着时间的推移,两组的身体功能均出现临床显著下降。此外,CRT 组的社会功能和腹泻减少,RT 组的角色功能和腹泻增加。与研究组和年龄及性别匹配的参考值比较表明,患者的社会功能受损,腹泻更多。

结论

两组之间的 HRQoL 无统计学差异。总体而言,尽管社会功能受损和腹泻更多,患者在治疗后数年报告的 HRQoL 与参考人群相当。

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