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直肠癌新辅助放化疗后患者报告结局的多中心前瞻性观察研究。

Patient-reported outcomes after neoadjuvant chemoradiotherapy for rectal cancer: a multicenter prospective observational study.

机构信息

Dipartimento di Scienze Oncologiche e Chirurgiche, Sezione di Clinica Chirurgica II, Università di Padova, Italy.

出版信息

Ann Surg. 2011 Jan;253(1):71-7. doi: 10.1097/SLA.0b013e3181fcb856.

Abstract

OBJECTIVE

To prospectively describe patient-reported outcomes (PROs) after preoperative chemoradiotherapy (pCRT) for rectal cancer.

BACKGROUND

Little evidence is available on PROs after pCRT for rectal cancer.

PATIENTS AND METHODS

Patients with rectal cancer, candidates to receive pCRT, were enrolled in a multicenter prospective observational trial. Health-related quality of life was assessed using the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 and its colorectal cancer module (QLQ-CR38), and fecal incontinence and bowel function were evaluated using the fecal incontinence score questionnaire and a set of ad hoc questions. Questionnaires were filled out before CRT (t₀), 2 to 3 weeks after completion of CRT (t₁), and at 6 (t₂) and 12 months (t₃) after surgery. Primary analysis of selected scales included: global quality of life, physical functioning, social functioning, fatigue, body image, future prospective, and gender-related sexual problems.

RESULTS

Of 149 eligible patients, questionnaires were completed in 100%, 95%, 88% and 77% of cases at t0, t₁, t₂, and t₃, respectively. At t₃, 78% of patients reported stool fractionation and 72% sensation of incomplete defecation. Only 14% of patients had optimal continence. Physical/social functioning, fatigue, and body image showed a decrease just after pCRT and returned to baseline levels at 1 year after treatment. Global quality of life was stable over time. Male sexual problems were greatly impaired throughout the study period (P < 0.001) with major clinically meaningful changes between baseline and 1 year after treatment.

CONCLUSIONS

These findings add to the body of evidence available regarding pCRT and help clinicians to make more informed treatment decisions.

摘要

目的

前瞻性描述直肠癌术前放化疗(pCRT)后的患者报告结局(PROs)。

背景

关于直肠癌 pCRT 后的 PROs,证据有限。

患者和方法

患有直肠癌、适合接受 pCRT 的患者入组了一项多中心前瞻性观察性试验。使用欧洲癌症研究与治疗组织(EORTC)生活质量核心问卷(QLQ-C30)及其结直肠癌模块(QLQ-CR38)评估健康相关生活质量,并使用粪便失禁评分问卷和一组专门问题评估粪便失禁和肠道功能。问卷在 CRT 前(t₀)、CRT 完成后 2-3 周(t₁)以及手术后 6 个月(t₂)和 12 个月(t₃)填写。对选定量表的主要分析包括:整体生活质量、身体功能、社会功能、疲劳、身体形象、未来前景和与性别相关的性问题。

结果

在 149 名符合条件的患者中,100%、95%、88%和 77%的患者分别在 t0、t₁、t₂和 t₃完成了问卷。在 t₃时,78%的患者报告大便分段,72%的患者报告有不完全排便感。只有 14%的患者有最佳的控便能力。身体/社会功能、疲劳和身体形象在 pCRT 后立即下降,并在治疗 1 年后恢复到基线水平。整体生活质量在整个研究期间保持稳定。男性性问题在整个研究期间受到严重影响(P < 0.001),治疗前后 1 年之间存在重大临床意义的变化。

结论

这些发现增加了有关 pCRT 的证据,帮助临床医生做出更明智的治疗决策。

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