Comparison of intermittent and continuous palliative chemotherapy for advanced colorectal cancer: a multicentre randomised trial
Comparison of intermittent and continuous palliative chemotherapy for advanced colorectal cancer: a multicentre randomised trial
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DOI：
10.1016/s0140-6736(03)12461-0
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发表时间：
2003-02-08
期刊：
影响因子：
168.9
通讯作者：
Stephens, RJ
中科院分区：
文献类型：
--
作者：
Maughan, TS;James, RD;Stephens, RJ
英国临床医生关于晚期结直肠癌患者化疗持续时间的政策并不一致。我们的目的是比较连续和间歇化疗在这类患者中的有效性。方法在接受de Gramont和Lokich描述的方案或雷替曲塞化疗12周后有反应或病情稳定的患者随机接受间歇化疗，（中断化疗，在进展时重新开始使用同一种药物），或持续化疗直至进展。（178例间歇性，176例连续性）从42家英国中心入组。在随机分组时，41%的参与者有部分或完全反应; 59%稳定。只有66例（37%）分配到间歇治疗的患者按计划重新开始治疗，中位时间为130天。重新开始后的中位治疗时间为84天。连续治疗组的患者继续接受治疗的中位时间为92天。两组接受二线治疗的患者比例相似。间歇化疗组的毒副反应和严重不良反应明显少于连续化疗组。没有明确的证据表明总生存率的差异（风险比0.87有利于间歇性，95%CI 0.69-1.09，p=0.23）。解释我们的研究结果没有提供明确的证据表明无限期持续治疗直至疾病进展是有益的。他们表明，对于化疗敏感的晚期结直肠癌患者，在12周后停止化疗并在进展时重新开始相同的治疗是安全的。
Background Policies of UK clinicians regarding the duration of chemotherapy for patients with advanced colorectal cancer are not consistent. We aimed to compare effectiveness of continuous and intermittent chemotherapy in such patients.Methods Patients who responded or had stable disease after receiving 12 weeks of the regimens described by de Gramont and Lokich, or raltitrexed chemotherapy, were randomised to either intermittent (a break in chemotherapy, re-starting on the same drug on progression), or continuous chemotherapy until progression.Findings 354 patients (178 intermittent, 176 continuous) were enrolled from 42 UK centres. At randomisation, 41% of participants had part or complete response; 59% were stable. Only 66 (37%) patients allocated to intermittent treatment restarted as planned, after a median of 130 days. Median time on treatment after restarting was 84 days. Patients in the continuous group remained on treatment for a median of a further 92 days. Similar proportions of patients in both groups received second-line therapy. Patients on intermittent chemotherapy had significantly fewer toxic effects and serious adverse events than those in the continuous group. There was no clear evidence of a difference in overall survival (hazard ratio 0.87 favouring intermittent, 95% CI 0.69-1.09, p=0.23).Interpretation Our findings provided no clear evidence of a benefit in continuing therapy indefinitely until disease progression. They showed that it is safe to stop chemotherapy after 12 weeks and re-start the same treatment on progression in patients with chemosensitive advanced colorectal cancer.