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Quality of life in the FOXFIRE, SIRFLOX and FOXFIRE-global randomised trials of selective internal radiotherapy for metastatic colorectal cancer.
International Journal of Cancer ( IF 5.7 ) Pub Date : 2019-12-16 , DOI: 10.1002/ijc.32828
Jane Wolstenholme 1 , Francesco Fusco 1, 2 , Alastair M Gray 1 , Joanna Moschandreas 3, 4 , Pradeep S Virdee 3 , Sharon Love 3 , Guy Van Hazel 5 , Peter Gibbs 6 , Harpreet S Wasan 7 , Ricky A Sharma 8
Affiliation  

Selective internal radiotherapy (SIRT) is a liver‐directed treatment involving the injection of yttrium‐90 microspheres into the blood supply of liver tumours. There are very few studies assessing health‐related quality of life (HRQOL) in patients treated with SIRT. Patients with liver metastases from colorectal cancer (CRC) were randomised in the FOXFIRE (FFr; ISRCTN83867919), SIRFLOX (SF; NCT00724503) and FOXFIRE‐Global (FFrG; NCT01721954) trials of first‐line oxaliplatin–fluorouracil (FOLFOX) chemotherapy combined with SIRT versus FOLFOX alone. HRQOL was assessed using the three‐level EQ‐5D, European Organisation for Research and Treatment of Cancer Quality of Life (EORTC QLQ‐C30) and EORTC Colorectal Liver Metastases cancer module (EORTC QLQ‐LMC21) at baseline, ≤3 months, 6 months, 12 months and annually thereafter from randomisation, and at disease progression. Analyses were conducted on an intention‐to‐treat basis. In total, 554 patients were randomised to SIRT + FOLFOX and 549 patients to FOLFOX alone. HRQOL was statistically significant lower in SIRT + FOLFOX patients ≤3 months after SIRT administration in all three instruments, particularly global health, physical and role functioning and symptoms of fatigue, nausea/vomiting and appetite loss. By accepted thresholds, these differences were deemed not clinically important. Differences between SIRT + FOLFOX and FOLFOX alone over the 2‐year follow up and at disease progression were also not clinically important. Although there is some decrease in HRQOL for up to 3 months following SIRT, the addition of SIRT to FOLFOX chemotherapy does not change HRQOL to a clinically important degree in metastatic CRC patients.

中文翻译:

FOXFIRE,SIRFLOX和FOXFIRE全球性选择性结直肠癌选择性放疗的随机试验的生活质量。

选择性内部放射疗法(SIRT)是一种以肝脏为导向的治疗方法,涉及将90钇微球注入肝肿瘤的血液供应中。很少有研究评估接受SIRT治疗的患者的健康相关生活质量(HRQOL)。患有大肠癌(CRC)的肝转移患者在FOXFIRE(FFr; ISRCTN83867919),SIRFLOX(SF; NCT00724503)和FOXFIRE-Global(FFrG; NCT01721954)一线奥沙利铂-氟尿嘧啶(FOLFOX)化疗联合试验中被随机分配SIRT仅FOLFOX。HRQOL使用三级EQ-5D,欧洲癌症生活质量研究和治疗组织(EORTC QLQ-C30)和EORTC大肠肝转移癌模块(EORTC QLQ-LMC21)进行了基线评估,≤3个月,6此后的每月,12个月和每年,从随机分组开始,直至疾病进展。分析是在意向性治疗的基础上进行的。总共554例患者被随机分配为SIRT + FOLFOX,549例患者被随机分配为FOLFOX。在所有三种手段中,SIRT + FOLFOX给药后≤3个月的SIRT + FOLFOX患者,在所有三种手段中,HRQOL均具有统计学显着性降低,尤其是总体健康,身体和角色功能以及疲劳,恶心/呕吐和食欲不振的症状。通过公认的阈值,这些差异被认为在临床上不重要。在2年的随访中以及疾病进展时,仅SIRT + FOLFOX和FOLFOX之间的差异在临床上也不重要。尽管SIRT后长达3个月的HRQOL有所降低,但是在FOLFOX化疗中加入SIRT并不会在转移性CRC患者中将HRQOL改变到临床上重要的程度。
更新日期:2019-12-16
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