Selective Internal Radiation Therapy (SIRT) with yttrium-90 resin microspheres plus standard systemic chemotherapy regimen of FOLFOX versus FOLFOX alone as first-line treatment of non-resectable liver metastases from colorectal cancer: the SIRFLOX study
Selective Internal Radiation Therapy (SIRT) with yttrium-90 resin microspheres plus standard systemic chemotherapy regimen of FOLFOX versus FOLFOX alone as first-line treatment of non-resectable liver metastases from colorectal cancer: the SIRFLOX study
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DOI：
10.1186/1471-2407-14-897
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发表时间：
2014-12-01
期刊：
影响因子：
3.8
通讯作者：
Van Hazel, Guy A.
中科院分区：
文献类型：
--
作者：
Gibbs, Peter;Gebski, Val;Van Hazel, Guy A.
背景：在结直肠癌（CRC）中，不可切除的肝转移与预后不良有关。采用FOLFOX（联合输注5-氟尿嘧啶、亚叶酸和奥沙利铂）等方案的全身化疗是标准的一线治疗。SIRFLOX试验旨在评估基于FOLFOX的化疗与选择性内放疗联合治疗的疗效和安全性（SIRT或放射栓塞）使用钇-90树脂微球（SIR-Spheres（R）; Sirtex Medical Limited，North Sydney，Australia）。SIRFLOX是一种随机，一项mFOLFOX 6化疗+/- SIRT作为仅肝脏或以肝脏为主的转移性CRC（mCRC）患者一线治疗的多中心试验。该试验旨在招募成年未经化疗的患者，这些患者经证实有肝转移，伴或不伴有限的肝外疾病，预期寿命>= 3个月，WHO体能状态为0-1。患者将随机接受mFOLFOX 6或SIRT + mFOLFOX 6（SIRT后第1-3周期奥沙利铂剂量减少）。两组患者均可根据研究者的判断接受贝伐珠单抗治疗。方案化疗将继续进行，直到出现不可接受的毒性、肿瘤进展的证据、癌性病变的完全手术切除或消融，或患者要求结束治疗。SIRFLOX试验的主要终点是无进展生存期（PFS）。次要终点包括：肝脏中的PFS;肿瘤缓解率（肝脏和任何部位）;肿瘤进展部位;健康相关生活质量;毒性和安全性;肝脏切除率;总生存期。假设在mFOLFOX 6中加入SIRT后中位PFS从9.4个月增加到12.5个月，招募≥ 450例患者将足以获得80%的功效和95%的confidence.Discussion：SIRFLOX试验将确立SIRT +标准全身化疗在不可切除肝转移的mCRC一线管理中的潜在作用。
Background: In colorectal cancer (CRC), unresectable liver metastases are linked to poor prognosis. Systemic chemotherapy with regimens such as FOLFOX (combination of infusional 5-fluorouracil, leucovorin and oxaliplatin) is the standard first-line treatment. The SIRFLOX trial was designed to assess the efficacy and safety of combining FOLFOX-based chemotherapy with Selective Internal Radiation Therapy (SIRT or radioembolisation) using yttrium-90 resin microspheres (SIR-Spheres(R); Sirtex Medical Limited, North Sydney, Australia).Methods/Design: SIRFLOX is a randomised, multicentre trial of mFOLFOX6 chemotherapy +/- SIRT as first-line treatment of patients with liver-only or liver-predominant metastatic CRC (mCRC). The trial aims to recruit adult chemotherapy-naive patients with proven liver metastases with or without limited extra-hepatic disease, a life expectancy of >= 3 months and a WHO performance status of 0-1. Patients will be randomised to receive either mFOLFOX6 or SIRT + mFOLFOX6 (with a reduced dose of oxaliplatin in cycles 1-3 following SIRT). Patients in both arms can receive bevacizumab at investigator discretion. Protocol chemotherapy will continue until there is unacceptable toxicity, evidence of tumour progression, complete surgical resection or ablation of cancerous lesions, or the patient requests an end to treatment. The primary endpoint of the SIRFLOX trial is progression-free survival (PFS). Secondary endpoints include: PFS in the liver; tumour response rate (liver and any site); site of tumour progression; health-related quality of life; toxicity and safety; liver resection rate; and overall survival. Assuming an increase in the median PFS from 9.4 months to 12.5 months with the addition of SIRT to mFOLFOX6, recruiting >= 450 patients will be sufficient for 80% power and 95% confidence.Discussion: The SIRFLOX trial will establish the potential role of SIRT + standard systemic chemotherapy in the first-line management of mCRC with non-resectable liver metastases.