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原发肿瘤切除术对接受化疗的结直肠癌伴同步转移患者生存的影响:来自多中心、随机试验 Fédération Francophone de Cancérologie Digestive 9601 的结果。

Impact of primary tumour resection on survival of patients with colorectal cancer and synchronous metastases treated by chemotherapy: results from the multicenter, randomised trial Fédération Francophone de Cancérologie Digestive 9601.

机构信息

Institut Gustave Roussy, Gastro-intestinal Unit, Department of Oncologic Medicine, Université Paris Sud, Villejuif, France.

出版信息

Eur J Cancer. 2013 Jan;49(1):90-7. doi: 10.1016/j.ejca.2012.07.006. Epub 2012 Aug 25.

Abstract

OBJECTIVE

To assess the impact of primary tumour resection on overall survival (OS) of patients diagnosed with stage IV colorectal cancer (CRC).

DESIGN

Among the 294 patients with non-resectable colorectal metastases enrolled in the Fédération Francophone de Cancérologie Digestive (FFCD) 9601 phase III trial, which compared different first-line single-agent chemotherapy regimens, 216 patients (73%) presented with synchronous metastases at study entry and constituted the present study population. Potential baseline prognostic variables including prior primary tumour resection were assessed by univariate and multivariate Cox analyses. Progression-free survival (PFS) and OS curves were compared with the logrank test.

RESULTS

Among the 216 patients with stage IV CRC (median follow-up, 33 months), 156 patients (72%) had undergone resection of their primary tumour prior to study entry. The resection and non-resection groups did not differ for baseline characteristics except for primary tumour location (rectum, 14% versus 35%; p=0.0006). In multivariate analysis, resection of the primary was the strongest independent prognostic factor for PFS (hazard ratio (HR), 0.5; 95% confidence interval [CI], 0.4-0.8; p=0.0002) and OS (HR, 0.4; CI, 0.3-0.6; p<0.0001). Both median PFS (5.1 [4.6-5.6] versus 2.9 [2.2-4.1] months; p=0.001) and OS (16.3 [13.7-19.2] versus 9.6 [7.4-12.5]; p<0.0001) were significantly higher in the resection group. These differences in patient survival were maintained after exclusion of patients with rectal primary (n=43).

CONCLUSION

Resection of the primary tumour may be associated with longer PFS and OS in patients with stage IV CRC starting first-line, single-agent chemotherapy.

摘要

目的

评估原发肿瘤切除术对诊断为 IV 期结直肠癌(CRC)患者总生存期(OS)的影响。

设计

在比较不同一线单药化疗方案的 294 例不可切除结直肠转移患者中,FFCD 9601 三期试验中,216 例(73%)患者在研究入组时为同步转移,构成本研究人群。通过单变量和多变量 Cox 分析评估潜在的基线预后变量,包括先前的原发肿瘤切除术。采用对数秩检验比较无进展生存期(PFS)和 OS 曲线。

结果

在 216 例 IV 期 CRC 患者(中位随访时间 33 个月)中,156 例(72%)患者在研究入组前已行原发肿瘤切除术。除原发肿瘤位置(直肠,14%比 35%;p=0.0006)外,两组患者的基线特征无差异。多变量分析显示,原发肿瘤切除术是 PFS(风险比(HR),0.5;95%置信区间[CI],0.4-0.8;p=0.0002)和 OS(HR,0.4;CI,0.3-0.6;p<0.0001)的最强独立预后因素。切除组的中位 PFS(5.1 [4.6-5.6]比 2.9 [2.2-4.1]个月;p=0.001)和 OS(16.3 [13.7-19.2]比 9.6 [7.4-12.5];p<0.0001)均显著延长。在排除 43 例直肠原发肿瘤患者后,这些生存差异仍然存在。

结论

在开始一线单药化疗的 IV 期 CRC 患者中,原发肿瘤切除术可能与更长的 PFS 和 OS 相关。

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