XELOX vs FOLFOX-4 as first-line therapy for metastatic colorectal cancer: NO16966 updated results.
XELOX vs FOLFOX-4 as first-line therapy for metastatic colorectal cancer: NO16966 updated results.
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DOI：
10.1038/bjc.2011.201
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发表时间：
2011-06-28
影响因子：
8.8
通讯作者：
Saltz, L.
中科院分区：
文献类型：
--
作者：
Cassidy, J.;Clarke, S.;Diaz-Rubio, E.;Scheithauer, W.;Figer, A.;Wong, R.;Koski, S.;Rittweger, K.;Gilberg, F.;Saltz, L.
我们报告了来自研究NO16966的更新的总生存期（OS）数据，该研究比较了卡培他滨联合奥沙利铂（XALIX）与5-氟尿嘧啶/亚叶酸联合奥沙利铂（FOLFOX 4）作为转移性结直肠癌的一线治疗。NO16966是一项XALIX与FOLFOX 4的随机化、两组、非劣效性、III期比较，随后修订为2 × 2析因设计，并进一步随机分配至贝伐珠单抗或安慰剂组。对OS进行了计划的随访探索性分析。意向治疗（ITT）人群包括2034例患者（双臂部分，n=634; 2 × 2析因部分，n=1400）。对于整个NO16966研究人群，汇总XALFOX/XALFOX-安慰剂/XALFOX-贝伐珠单抗组的中位OS为19.8个月，汇总FOLFOX 4/FOLFOX 4-安慰剂/FOLFOX 4-贝伐珠单抗组为19.5个月（风险比0.95（97.5% CI 0.85-1.06））。在汇总XALFOX/XALFOX-安慰剂组中，汇总FOLFOX 4/FOLFOX 4-安慰剂组的中位OS为19. 0个月vs 18. 9个月（风险比0. 95（97. 5% CI 0. 83 - 1. 09））。FOLFOX 4与3/4级中性粒细胞减少症/粒细胞减少症和发热性中性粒细胞减少症的相关性高于XCRIX，XCRIX与3级腹泻和3级手足综合征的相关性高于FOLFOX 4。研究NO16966的更新生存期数据显示，XTREX与FOLFOX 4相似，证实了无进展生存期的主要分析。XALCOX可以被认为是转移性结直肠癌患者的常规一线治疗选择。
We report updated overall survival (OS) data from study NO16966, which compared capecitabine plus oxaliplatin (XELOX) vs 5-fluorouracil/folinic acid plus oxaliplatin (FOLFOX4) as first-line therapy in metastatic colorectal cancer. NO16966 was a randomised, two-arm, non-inferiority, phase III comparison of XELOX vs FOLFOX4, which was subsequently amended to a 2 × 2 factorial design with further randomisation to bevacizumab or placebo. A planned follow-up exploratory analysis of OS was performed. The intent-to-treat (ITT) population comprised 2034 patients (two-arm portion, n=634; 2 × 2 factorial portion, n=1400). For the whole NO16966 study population, median OS was 19.8 months in the pooled XELOX/XELOX-placebo/XELOX-bevacizumab arms vs 19.5 months in the pooled FOLFOX4/FOLFOX4-placebo/FOLFOX4-bevacizumab arms (hazard ratio 0.95 (97.5% CI 0.85–1.06)). In the pooled XELOX/XELOX-placebo arms, median OS was 19.0 vs 18.9 months in the pooled FOLFOX4/FOLFOX4-placebo arms (hazard ratio 0.95 (97.5% CI 0.83–1.09)). FOLFOX4 was associated with more grade 3/4 neutropenia/granulocytopenia and febrile neutropenia than XELOX, and XELOX with more grade 3 diarrhoea and grade 3 hand-foot syndrome than FOLFOX4. Updated survival data from study NO16966 show that XELOX is similar to FOLFOX4, confirming the primary analysis of progression-free survival. XELOX can be considered as a routine first-line treatment option for patients with metastatic colorectal cancer.
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