同步放化疗治疗直肠癌期间患者报告的急性胃肠道症状

2011-06-07 Chen RC, Mamon HJ, Chen YH, Gelman RS, Suh WW, Talcott JA, Clark JW, Hong TS. MedSci原创

背景:虽然目前已知基于5-氟尿嘧啶的直肠癌标准放化疗方案会导致明显的急性胃肠道(GI)毒性,但是关于患者报告的结局(PROs)的研究仍然十分有限。作者通过本研究评估了将PRO评价整合于常规临床实践的可行性,并描述了治疗期间症状发展的轨迹。 方法:77名在2006-2008年间接受治疗的连续患者被纳入研究。患者每周在医师处复诊后立即完成一份有7个项目的肠道问题量表。 结果:问卷完成率为95%。个

背景:虽然目前已知基于5-氟尿嘧啶的直肠癌标准放化疗方案会导致明显的急性胃肠道(GI)毒性,但是关于患者报告的结局(PROs)的研究仍然十分有限。作者通过本研究评估了将PRO评价整合于常规临床实践的可行性,并描述了治疗期间症状发展的轨迹。

方法:77名在2006-2008年间接受治疗的连续患者被纳入研究。患者每周在医师处复诊后立即完成一份有7个项目的肠道问题量表。

结果:问卷完成率为95%。个体的GI症状发展轨迹各异。第5周时,约40%的患者出现了有临床意义的疼痛、急便或里急后重,第1周时并无上述表现;30%患者发生腹泻、腹绞痛以及粘液便。然而,症状总体程度为中度。75%第1周出现直肠出血的患者经过3周治疗后情况得到改善。在由医师评估的每一腹泻等级内,患者的发生情况差异很大。例如,根据放疗肿瘤组急性发病率量表,在50名发生2级腹泻的患者中,报告仅偶尔出现症状的患者数量与报告经常或频繁出现症状的患者数量相似。

结论:
PRO提供了其他方法无法得到的关于放化疗治疗直肠癌期间患者症状的信息,并且将PRO整合于常规临床实践是可行的。医师在开始治疗前可将本研究的结果对患者进行建议,并为比较使用新疗法的试验提供基准。

BACKGROUND: Although it is known that standard 5-fluorouracil-based chemoradiation therapy for rectal cancer causes significant acute gastrointestinal (GI) toxicity, research on patient-reported outcomes (PROs) is limited. The authors undertook the current study to assess the feasibility of incorporating PRO measurement into routine clinical practice and to describe the trajectory of symptom development during treatment.

METHODS: Seventy-seven consecutive patients who were treated between 2006 and 2008 were eligible. Patients completed the 7-item Bowel Problems Scale immediately before weekly physician visits.

RESULTS: The questionnaire completion rate was 95%. Individual GI symptoms had different trajectories of development. By Week 5, approximately 40% of all patients developed clinically meaningful pain, bowel urgency, or tenesmus that was not present during Week 1; 30% developed diarrhea, abdominal cramping, and passing mucus. However, overall symptom burden was moderate. Seventy-five percent of patients who presented with rectal bleeding at Week 1 improved by Week 3 of treatment. Within each physician-assessed grade of diarrhea, patient experience varied widely. For example, of the 50 patients who developed grade 2 diarrhea on the Radiation Therapy Oncology Group Acute Morbidity Scale, the numbers of patients reporting only occasional symptoms versus those reporting frequent or very frequent symptoms were similar.

CONCLUSIONS: PROs provided information on patient symptoms during chemoradiation treatment for rectal cancer that was not captured otherwise, and it was feasible to incorporate PROs into routine clinical practice. The current results may be used by physicians to counsel their patients before treatment initiation and to provide a benchmark against which trials that use new therapies may be compared.

专家评价:

肿瘤患者治疗期间会发生什么状况?目前直肠癌放化疗会导致患者出现症状已得到公认。在该研究中,77名接受基于5-氟尿嘧啶的放化疗方案治疗的连续患者(大部分以该方案作为新辅助疗法)每周完成一份有7个项目的肠道问题量表,共进行5周。肠道问题量表是之前制定用于评估接受盆腔放疗的前列腺癌患者的。作者发现,患者的依从性为95%,研究5周内6种症状(包括严重症状)的严重性累积发生率增大。与医师评定的毒性评估进行比较发现,患者报告的结局大量处于毒性评估范围之内。该信息性论文强调了治疗期间的生活质量问题以及是否应该通过患者报告或医师评定的毒性评价该问题。

在3期临床试验中,生活质量的评估是在较长的时间间隔内以较长的量表进行评估的,然后比较组间造成生活质量降低的问题。患者依从性高达95%表明较短的症状量表可用于测量患者报告的结局。毒性等级评定相同的患者出现症状的情况不同与最近Basch等的发现是互补的{1}:患者报告的结局与毒性等级评定互补。本人发现随时间变化的得到的累及毒性等级评定是一种表现从患者角度得到的经验的有效方法。

本研究验证了一种患者报告结局的方法,该方法可不断得到已知会导致毒性的治疗中进行性加重的症状。这就对临床医师和临床试验设计者提出了问题。对于临床医师而言,问题在于当患者接受治疗时,如何以及何时随访患者、如何进行干预。对于临床试验人员而言,该法强调了毒性与患者自评的数据收集之间存在的差异,并提出了如下问题:应在哪种场所搜集何种患者自评的信息。将来的研究应在其他场所通过较大的患者队列的不同病变部位对该法进行研究。

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    2011-06-09 yzh399
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