Randomized Phase II/III Trial Comparing Hepatectomy, Followed by mFOLFOX6 With Hepatectomy Alone for Liver Metastasis From Colorectal Cancer: Long-Term Results of JCOG0603.

Here, we report OS after long-term follow-up.

在这里，我们报告了长期随访后的总生存（OS）数据。

Eligible patients with colorectal adenocarcinoma and an unlimited number of liver metastases were randomized to adjuvant mFOLFOX6 or hepatectomy alone.

符合条件的结直肠腺癌患者，无论肝转移数目多少，均被随机分配接受辅助mFOLFOX6治疗或仅接受肝切除术。

DFS was the primary endpoint, and OS was a secondary endpoint.

无病生存期（DFS）是主要终点，总生存（OS）是次要终点。

Between March 2007 and January 2019, 151 and 149 patients were randomized to adjuvant chemotherapy and hepatectomy alone, respectively.

在2007年3月至2019年1月期间，共有151名和149名患者分别被随机分配到辅助化疗组和单纯肝切除组。

At a median follow-up of 7.7 years for disease-free surviving patients, 54 (35.8%) and 51 (34.2%) patients had died in the respective arms, (hazard ratio[HR], 1.07 [95% CI, 0.73 to 1.57]).

在无病生存患者的中位随访7.7年时，分别有54名（35.8%）和51名（34.2%）患者在各自的治疗组中死亡，（风险比[HR]，1.07 [95% 置信区间，0.73至1.57]）。

Five-year OS was 73.4% (95% CI, 65.5 to 79.7) and 80.1% (95% CI, 72.6 to 85.7) and 7-year OS was 69.4% (95% CI, 61.2 to 76.2) and 72.4% (95% CI, 64.2 to 79.1), respectively.

五年总生存率分别为73.4%（95%置信区间，65.5至79.7）和80.1%（95%置信区间，72.6至85.7），而七年总生存率分别为69.4%（95%置信区间，61.2至76.2）和72.4%（95%置信区间，64.2至79.1）。

One patient in the adjuvant chemotherapy arm possibly died of protocol treatment-related toxicity, and one in the hepatectomy-alone arm died of post-protocol treatment complications.

辅助化疗组有一名患者可能因方案相关治疗毒性死亡，而单纯肝切除组有一名患者死于方案后治疗并发症。

Five-year DFS was respectively 49.7% (95% CI, 41.5 to 57.3) and 40.5% (95% CI, 32.5 to 48.3) in the adjuvant chemotherapy and hepatectomy-alone arms (HR, 0.72 [95% CI, 0.54 to 0.97]).

辅助化疗组和单纯肝切除组的5年无病生存率分别为49.7%（95%置信区间，41.5至57.3）和40.5%（95%置信区间，32.5至48.3）（HR，0.72 [95%置信区间，0.54至0.97]）。

Long-term OS did not differ with adjuvant mFOLFOX6 compared with hepatectomy alone in resectable CRLM.

在可切除的结直肠癌肝转移患者中，与单纯肝切除相比，辅助mFOLFOX6化疗并未改善长期总生存。

Adjuvant mFOLFOX6 may delay recurrence but did not improve long-term survival.

辅助性 mFOLFOX6 可能会延迟复发，但并未改善长期生存。