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SCALOP研究中与健康相关的生活质量,一项比较局部晚期胰腺癌放化疗方案的随机2期试验

Health-Related Quality of Life in SCALOP, a Randomized Phase 2 Trial Comparing Chemoradiation Therapy Regimens in Locally Advanced Pancreatic Cancer.

作者信息

Hurt Christopher N, Mukherjee Somnath, Bridgewater John, Falk Stephen, Crosby Tom, McDonald Alec, Joseph George, Staffurth John, Abrams Ross A, Blazeby Jane M, Bridges Sarah, Dutton Peter, Griffiths Gareth, Maughan Tim, Johnson Colin

机构信息

Wales Cancer Trials Unit, College of Biomedical and Life Sciences, Cardiff University, Cardiff, Wales, United Kingdom.

Cancer Research UK/MRC Oxford Institute for Radiation Oncology, Oxford University, NIHR Biomedical Research, Oxford, United Kingdom.

出版信息

Int J Radiat Oncol Biol Phys. 2015 Nov 15;93(4):810-8. doi: 10.1016/j.ijrobp.2015.08.026. Epub 2015 Aug 24.

DOI:10.1016/j.ijrobp.2015.08.026
PMID:26530749
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4627359/
Abstract

PURPOSE

Chemoradiation therapy (CRT) for patients with locally advanced pancreatic cancer (LAPC) provides survival benefits but may result in considerable toxicity. Health-related quality of life (HRQL) measurements during CRT have not been widely reported. This paper reports HRQL data from the Selective Chemoradiation in Advanced Localised Pancreatic Cancer (SCALOP) trial, including validation of the QLQ-PAN26 tool in CRT.

METHODS AND MATERIALS

Patients with locally advanced, inoperable, nonmetastatic carcinoma of the pancreas were eligible. Following 12 weeks of induction gemcitabine plus capecitabine (GEMCAP) chemotherapy, patients with stable and responding disease were randomized to a further cycle of GEMCAP followed by capecitabine- or gemcitabine-based CRT. HRQL was assessed with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) and the EORTC Pancreatic Cancer module (PAN26).

RESULTS

A total of 114 patients from 28 UK centers were registered and 74 patients randomized. There was improvement in the majority of HRQL scales during induction chemotherapy. Patients with significant deterioration in fatigue, appetite loss, and gastrointestinal symptoms during CRT recovered within 3 weeks following CRT. Differences in changes in HRQL scores between trial arms rarely reached statistical significance; however, where they did, they favored capecitabine therapy. PAN26 scales had good internal consistency and were able to distinguish between subgroups of patients experiencing toxicity.

CONCLUSIONS

Although there is deterioration in HRQL following CRT, this resolves within 3 weeks. HRQL data support the use of capecitabine- over gemcitabine-based chemoradiation. The QLQ-PAN26 is a reliable and valid tool for use in patients receiving CRT.

摘要

目的

对于局部晚期胰腺癌(LAPC)患者,放化疗(CRT)可带来生存获益,但可能导致相当大的毒性。CRT期间与健康相关的生活质量(HRQL)测量尚未得到广泛报道。本文报告了晚期局部胰腺癌选择性放化疗(SCALOP)试验中的HRQL数据,包括QLQ - PAN26工具在CRT中的验证。

方法和材料

符合条件的患者为局部晚期、无法手术、非转移性胰腺癌患者。在接受12周的吉西他滨加卡培他滨(GEMCAP)诱导化疗后,疾病稳定和有反应的患者被随机分配接受进一步的GEMCAP周期治疗,随后接受基于卡培他滨或吉西他滨的CRT。使用欧洲癌症研究与治疗组织生活质量问卷(EORTC QLQ - C30)和EORTC胰腺癌模块(PAN26)评估HRQL。

结果

来自英国28个中心的114例患者登记入组,74例患者被随机分组。诱导化疗期间,大多数HRQL量表有所改善。CRT期间疲劳、食欲减退和胃肠道症状显著恶化的患者在CRT后3周内恢复。试验组之间HRQL评分变化的差异很少达到统计学显著性;然而,当达到时,更有利于卡培他滨治疗。PAN26量表具有良好的内部一致性,能够区分经历毒性的患者亚组。

结论

尽管CRT后HRQL有所下降,但在3周内即可恢复。HRQL数据支持使用基于卡培他滨而非吉西他滨的放化疗。QLQ - PAN26是用于接受CRT患者的可靠且有效的工具。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6997/4627359/1b83456d4dc5/gr4.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6997/4627359/1708c87d1c73/gr1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6997/4627359/f2af273e8a19/gr2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6997/4627359/c5bcef554274/gr3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6997/4627359/1b83456d4dc5/gr4.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6997/4627359/1708c87d1c73/gr1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6997/4627359/f2af273e8a19/gr2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6997/4627359/c5bcef554274/gr3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6997/4627359/1b83456d4dc5/gr4.jpg

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