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一项在随机多中心III期试验(FFCD 9102)中使用斯皮策生活质量指数的比较性纵向生活质量研究:局部晚期可切除胸段食管鳞癌患者中,放化疗后手术与单纯放化疗的对比。

A comparative longitudinal quality of life study using the Spitzer quality of life index in a randomized multicenter phase III trial (FFCD 9102): chemoradiation followed by surgery compared with chemoradiation alone in locally advanced squamous resectable thoracic esophageal cancer.

作者信息

Bonnetain F, Bouché O, Michel P, Mariette C, Conroy T, Pezet D, Roullet B, Seitz J-F, Paillot B, Arveux P, Milan C, Bedenne L

机构信息

Féderation Francophone de Cancérologie Digestive, Faculty of Medicine, 7 Boulevard Jeanne d'Arc, 21079 Dijon Cedex, France.

出版信息

Ann Oncol. 2006 May;17(5):827-34. doi: 10.1093/annonc/mdl033. Epub 2006 Mar 8.

Abstract

BACKGROUND

The aim of the study was to compare the longitudinal quality of life (QoL) between chemoradiation with or without surgery in patients with locally advanced squamous resectable esophageal cancer included in a randomized multicenter phase III trial (FFCD 9102).

MATERIALS AND METHODS

All patients with locally advanced resectable (T3-4 N0-1 M0) epidermoid or glandular esophageal cancer (n = 451) received induction chemoradiation. Responders (n = 259) were randomized between surgery (arm A) and continuation of chemoradiation (arm B). The Spitzer QoL Index was scored (0-10) at inclusion and at each follow-up, every 3 months during 2 years. QoL at baseline and longitudinal changes were respectively compared with univariate ANOVA and mixed-model analysis of variance for repeated measurements. The time interval between the follow-up was assessed and the same analyses were performed among survivors with 2 years of follow-up.

RESULTS

The squamous histology was predominant in both arms. The mean QoL score decreased between baseline and the first follow-up and between the first and the second follow-ups. QoL scores at the first follow-up were comparatively worse in arm A than in arm B (7.52 versus 8.45, P < 0.01), whereas the longitudinal QoL study showed no difference between treatments (adjusted P = 0.26). Furthermore, the longitudinal QoL was not different (adjusted P = 0.23) among survivors with 2 years of follow-up.

CONCLUSIONS

Among patients responding to induction chemoradiation, surgery and continuation of chemoradiation had the same impact on QoL in patients with locally advanced, resectable esophageal cancer although a significantly greater decrease in the Spitzer Index was observed in the postoperative period.

摘要

背景

本研究的目的是在一项随机多中心III期试验(FFCD 9102)纳入的局部晚期可切除鳞状食管癌患者中,比较放化疗联合或不联合手术治疗后的纵向生活质量(QoL)。

材料与方法

所有局部晚期可切除(T3-4 N0-1 M0)的表皮样或腺性食管癌患者(n = 451)均接受诱导放化疗。缓解者(n = 259)被随机分为手术组(A组)和继续放化疗组(B组)。在入组时以及随后2年中每3个月的每次随访时,使用斯皮策生活质量指数进行评分(0-10分)。分别采用单因素方差分析和重复测量的混合模型方差分析,比较基线时的生活质量和纵向变化。评估随访之间的时间间隔,并在随访2年的幸存者中进行相同的分析。

结果

两组中鳞状组织学类型均占主导。从基线到第一次随访以及从第一次到第二次随访期间,平均生活质量评分均下降。第一次随访时,A组的生活质量评分相对低于B组(7.52对8.45,P < 0.01),而纵向生活质量研究显示治疗组之间无差异(校正P = 0.26)。此外,随访2年的幸存者之间纵向生活质量也无差异(校正P = 0.23)。

结论

在诱导放化疗有效的患者中,手术和继续放化疗对局部晚期可切除食管癌患者的生活质量影响相同,尽管术后斯皮策指数有明显更大幅度的下降。

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