Single-agent capecitabine as maintenance therapy after induction of XELOX (or FOLFOX) in first-line treatment of metastatic colorectal cancer: randomized clinical trial of efficacy and safety
Single-agent capecitabine as maintenance therapy after induction of XELOX (or FOLFOX) in first-line treatment of metastatic colorectal cancer: randomized clinical trial of efficacy and safety
复制标题
XELOX（或 FOLFOX）诱导后单药卡培他滨作为转移性结直肠癌一线治疗的维持治疗：疗效和安全性的随机临床试验
DOI：
10.1093/annonc/mdw101
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发表时间：
2016-06-01
影响因子：
50.5
通讯作者：
Xu, R. H.
中科院分区：
文献类型：
--
作者：
Luo, H. Y.;Li, Y. H.;Xu, R. H.
背景：对于mCRC患者维持治疗的最佳策略存在争议。本研究旨在评价卡培他滨维持治疗与诱导化疗后观察治疗转移性结直肠癌患者的疗效和安全性，在这项随机、开放标签、多中心、III期试验中，接受18-24周XALFOX或FOLFOX诱导化疗并达到疾病控制的患者被随机集中分配（1：1）接受卡培他滨维持治疗或仅观察直至疾病进展。主要终点是随机化后的无进展生存期（PFS）;次要终点包括总生存期（OS）、诱导治疗后的PFS（PFS 2）和安全性。本试验注册于ClinicalTrials.gov，注册号为NCT 02027363。2010年7月30日至2013年9月15日，274例患者从中国11个研究中心入组研究，随机分配至维持组（n = 136）或观察组（n = 138）。两组的临床病理特征平衡。自随机化的中位随访时间为29.0个月[四分位距（IQR）21-36个月]。卡培他滨维持组主要终点PFS较观察组显著延长{6.43 [95%可信区间（CI）5.26-7.71] vs 3.43（2.83-4.16）个月，HR 0.54（0.42-0.70），P < 0.001}。卡培他滨维持组的中位OS长于观察组，但无统计学意义[25.63（22.46-27.80）vs 23.30（19.68-26.92）个月; HR 0.85（0.64-1.11），P = 0.2247]。在两组中观察到相似的安全性特征。卡培他滨维持治疗组与观察组相比，最常见的3级或4级毒性反应为中性粒细胞减少、手足综合征和粘膜炎。在毒性可接受的mCRC患者中，在XCRIX或FOLFOX诱导治疗后，卡培他滨单药维持治疗可视为适当的选择。NCT 02027363。
Background: The optimal strategy of maintenance therapy for patients with mCRC is controversial. This study was to evaluate the efficacy and safety of maintenance therapy with capecitabine versus observation following inductive chemotherapy in patients with metastatic colorectal cancer.In this randomized, open-label, multicenter, phase III trial, patients who received 18-24 weeks of induction chemotherapy with XELOX or FOLFOX and achieved disease control were randomly assigned centrally (1:1) to receive maintenance therapy of capecitabine or only observation until disease progression. The primary end point was progression-free survival (PFS) from randomization; the secondary end points included overall survival (OS), PFS from induction treatment (PFS2) and safety. Analyses were done by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT02027363.Between 30 July 2010 and 15 September 2013, 274 patients were enrolled in the study from 11 sites in China and randomly assigned to maintenance group (n = 136) or observation group (n = 138). Clinicopathological characteristics were balanced in two groups. The median follow-up time from randomization was 29.0 months [interquartile range (IQR) 21-36 months]. The primary end point of PFS was statistically significantly longer in capecitabine maintenance group than in observation group {6.43 [95% confidence interval (CI) 5.26-7.71] versus 3.43 (2.83-4.16) months, HR 0.54 (0.42-0.70), P < 0.001}. The median OS of capecitabine maintenance group was longer than that of observation group, but not statistically significant [25.63 (22.46-27.80) versus 23.30 (19.68-26.92) months; HR 0.85 (0.64-1.11), P = 0.2247]. Similar safety profiles were observed in both arms. The most common grade 3 or 4 toxicities in capecitabine maintenance group versus observation group were neutropenia, hand-foot syndrome, and mucositis.Maintenance therapy with a single agent of capecitabine can be considered an appropriate option following the induction of XELOX or FOLFOX in mCRC patients with acceptable toxicities.NCT02027363.