卡培他滨联合伊立替康（XELIRI方案）与5-氟尿嘧啶/亚叶酸钙联合伊立替康（FOLFIRI方案）作为不可切除的仅肝转移的转移性结直肠癌患者的新辅助治疗：一项随机前瞻性II期试验。
Capecitabine plus Irinotecan (XELIRI regimen) compared to 5-FU/LV plus Irinotecan (FOLFIRI regimen) as neoadjuvant treatment for patients with unresectable liver-only metastases of metastatic colorectal cancer: a randomised prospective phase II trial.
作者信息
Skof Erik, Rebersek Martina, Hlebanja Zvezdana, Ocvirk Janja
机构信息
Institute of Oncology, Division of Medical Oncology, Zaloska 2, 1000 Ljubljana, Slovenia.
出版信息
BMC Cancer. 2009 Apr 22;9:120. doi: 10.1186/1471-2407-9-120.
BACKGROUND
Phase II studies have shown that the combination of capecitabine and irinotecan (the XELIRI regimen) is active in metastatic colorectal cancer (MCRC). There are, however, no data about the use of the XELIRI regimen in the neoadjuvant treatment.
METHODS
Patients with unresectable liver-only metastases of MCRC with < or = 75 years of age were randomised to either the XELIRI (irinotecan 250 mg/m(2) given on day one and capecitabine 1000 mg/m(2) twice daily from day 2-15, every 21 days) or the FOLFIRI arm (irinotecan 180 mg/m(2), 5-FU 400 mg/m(2), LV 200 mg/m(2), 5-FU 2400 mg/m(2) (46-h infusion)--all given on day one, every 14 days). Primary end points were objective response rate (ORR) and rate of radical (R0) surgical resection. Secondary end points were progression-free survival (PFS), overall survival (OS) and safety.
RESULTS
Altogether 87 patients were enrolled (41 pts in the XELIRI and 46 pts in the FOLFIRI arm). The median age was 63 years (63 years in the XELIRI and 62 years in the FOLFIRI arm) (p = 0.33). ORR was 49% in the XELIRI and 48% in the FOLFIRI arm (p = 0.76). The rate of radical R0 resection was 24% in both arms of patients. At the end of treatment, 37% of patients in the XELIRI and 26% of patients in the FOLFIRI arm were without evidence of the disease (CR+R0 resection) (p = 0.56). There were no statistical differences in grade 3 or 4 adverse events between both arms: diarrhoea 7% vs. 6%, neutropenia 5% vs. 13%, ischemic stroke 0 vs. 2%, acute coronary syndrome 2% vs. 4%, respectively. At the median follow up of 17 (range 1-39) months, the median PFS was 10.3 months in the XELIRI and 9.3 months in the FOLFIRI arm (p = 0.78), the median OS was 30.7 months in the XELIRI arm and 16.6 months in the FOLFIRI arm (p = 0.16).
CONCLUSION
The XELIRI regimen showed similar ORR as the FOLFIRI regimen in the neoadjuvant treatment of patients with MCRC. In addition, the XELIRI regimen showed similar PFS and OS with acceptable toxicity compared to the FOLFIRI regimen.
TRIAL REGISTRATION
Current Controlled Trials ISRCTN19912492.
背景
II期研究表明，卡培他滨与伊立替康联合使用（XELIRI方案）对转移性结直肠癌（MCRC）有效。然而，尚无关于XELIRI方案用于新辅助治疗的数据。
方法
年龄≤75岁、无法切除的单纯肝转移MCRC患者被随机分为XELIRI组（第1天给予伊立替康250mg/m²，第2 - 15天给予卡培他滨1000mg/m²，每日2次，每21天重复）或FOLFIRI组（第1天给予伊立替康180mg/m²、5 - FU 400mg/m²、亚叶酸200mg/m²，5 - FU 2400mg/m²（46小时输注），每14天重复）。主要终点为客观缓解率（ORR）和根治性（R0）手术切除率。次要终点为无进展生存期（PFS）、总生存期（OS）和安全性。
结果
共纳入87例患者（XELIRI组41例，FOLFIRI组46例）。中位年龄为63岁（XELIRI组63岁，FOLFIRI组62岁）（p = 0.33）。XELIRI组ORR为49%，FOLFIRI组为48%（p = 0.76）。两组患者的根治性R0切除率均为24%。治疗结束时，XELIRI组37%的患者和FOLFIRI组26%的患者无疾病证据（CR + R0切除）（p = 0.56）。两组3/4级不良事件无统计学差异：腹泻分别为7% vs. 6%，中性粒细胞减少分别为5% vs. 13%，缺血性卒中分别为0 vs. 2%，急性冠状动脉综合征分别为2% vs. 4%。中位随访17（范围1 - 39）个月时，XELIRI组中位PFS为10.3个月，FOLFIRI组为9.3个月（p = 0.78），XELIRI组中位OS为30.7个月，FOLFIRI组为16.6个月（p = 0.16）。
结论
在MCRC患者的新辅助治疗中，XELIRI方案与FOLFIRI方案的ORR相似。此外，与FOLFIRI方案相比，XELIRI方案的PFS和OS相似，且毒性可接受。
试验注册号
Current Controlled Trials ISRCTN19912492
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