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2015年ASCO GI研讨会于1月15日-17日在美国旧金山举行。在1月17日(周六)的口头报告专场,上海中山医院许剑民教授等将带来术前肝动脉和区域动脉灌注化疗(PHRAC)对II/III期结直肠癌预后影响的精彩报告(摘要号#511)。下面提前和大家分享这项研究:
研究背景
旨在评价一项多中心试验中,增加术前肝动脉和区域动脉灌注化疗(PHRAC)对II期和III结直肠癌预后的影响。
研究方法
将临床II期或III期结直肠癌(CRC)患者随机分为PHRAC加辅助治疗(PHRAC组)或单独辅助治疗组(对照组)。主要终点指标是无病生存率(DFS)。次要终点指标是出现异时性肝转移,总生存期(OS)和安全性。
研究结果
来自中国5家医疗中心的688例患者随机分到各组。PHRAC组和对照组的五年DFS分别为75%和61%(HR 0.60;95%CI,0.45-0.80; P <0.001)。PHRAC组和对照组的五年肝脏转移率分别为8%和18%(HR0.39;95%CI,0.24-0.64; P <0.001)。PHRAC组和对照组的五年OS分别为81%和72%(HR0.59;95%CI,0.42-0.84; P = 0.003)。两组间的发病率和死亡率没有显著差异。符合条件患者的结果几乎没有什么变化。亚组分析显示III期患者的DFS,肝转移率和OS存在显著差异,但II期患者则未见差异。
结论
增加PHRAC可减少异时性肝转移率,提高III期CRC患者的DFS和OS,但不影响患者的安全性。
英文摘要
Effect of preoperative hepatic and regional arterial chemotherapy on metachronous liver metastasis after curative colorectal cancer resection: A prospective, multicenter, randomized controlled trial.(Abstract No:511)
Background: To evaluate the addition of preoperative hepatic and regional arterial chemotherapy (PHRAC) on prognosis for stage II and III colorectal cancer in a multicenter setting.
Methods: Patients with clinical stage II or stage III colorectal cancer (CRC) were randomly assigned to receive PHRAC plus adjuvant therapy (PHRAC arm) or adjuvant therapy alone (control arm). The primary end point was disease free survival (DFS). Second end points were incidence of metachronous liver metastasis, overall survival (OS) and safety.
Results: A total of 688 patients from 5 centers of China were randomly assigned to each arm. Five-year DFS were 75% for PHRAC arm and 61% for control arm (HR 0.60; 95% CI, 0.45 to 0.80; p<0.001). Five-year liver-metastasis rate was 8% and 18% in PHRAC arm and control arm, respectively (HR 0.39; 95% CI, 0.24 to 0.64; p<0.001). Five-year OS was 81% in PHRAC arm and 72% in control arm (HR 0.59; 95% CI, 0.42 to 0.84; p=0.003). There were no significant differences in morbidity or mortality between two arms. The results of eligible patients were barely changed. Subgroup analysis shows differences of DFS, liver-metastasis rate and OS were significant in stage III patients, but not in stage II patients.
Conclusions: Additional PHRAC could reduce the incidence of metachronous liver metastasis and improve DFS and OS in patients with stage III CRC, without compromising patient safety.
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