Postoperative Hepatic Arterial Infusion With Oxaliplatin After Surgery of Four or More Colorectal Liver Metastases: A Randomized Phase II Trial.

Methods

Patients with an Eastern Cooperative Oncology Group performance status 0-1, who underwent resection or ablation of ≥4 CRLM after preoperative IV chemotherapy were enrolled.

招募了东部肿瘤协作组（ECOG）表现状态为0-1的患者，这些患者在术前接受了静脉化疗后进行了≥4个CRLM的切除或消融。

Patients were randomly assigned (1:1) to receive adjuvant oxaliplatin via HAI (HAI group, n = 50) or IV infusion (IV group, n = 49), both combined with IV LV5FU2 for at least 3 months.

患者被随机分配（1:1），分别接受经肝动脉灌注（HAI组，n=50）或静脉输注（IV组，n=49）辅助奥沙利铂治疗，两种方式均与静脉注射LV5FU2联合使用至少3个月。

The primary end point was hepatic recurrence-free survival (h-RFS).

主要终点是无肝复发生存（h-RFS）。

Secondary end points included RFS, overall survival(OS), safety, and feasibility.

次要终点包括无复发生存期（RFS）、总生存（OS）、安全性和可行性。

Results

After a median follow-up of 59 months (IQR, 45-71), the median h-RFS was 25 (95% CI, 16 to 37) months in the HAI group versus 12 (95% CI, 8 to 19) months in the IV group (hazard ratio[HR], 0.63 [95% CI, 0.40 to 0.99]; P = .047).

经过中位随访59个月（四分位数间距，45-71），HAI组的中位无复发生存期为25个月（95%置信区间，16至37个月），而IV组为12个月（95%置信区间，8至19个月）（风险比[HR]，0.63 [95%置信区间，0.40至0.99]；P = .047）。

Median RFS was 14 months (95% CI, 10 to 20) in the HAI group versus 9 months (95% CI, 7 to 11) in the IV group (HR, 0.63 [95% CI, 0.41 to 0.97]; P = .03).

HAI组的中位无复发生存期为14个月（95%置信区间，10至20个月），而IV组为9个月（95%置信区间，7至11个月）（风险比，0.63 [95%置信区间，0.41至0.97]；P = .03）。

Median OS was 74 months (95% CI, 51 to not defined) in the HAI group versus 57 months (95% CI, 37 to 69) in the IV group (HR, 0.61 [95% CI, 0.33 to 1.12]; P = .11).

HAI组的中位总生存期为74个月（95%置信区间，51至未定义），而IV组为57个月（95%置信区间，37至69个月）（风险比，0.61 [95%置信区间，0.33至1.12]；P = .11）。

Five-year OS was 62% in the HAI arm compared with 47% in the IV arm.

HAI组的5年总生存率为62%，而IV组为47%。

Grade 3 to 4 adverse events occurred in 58% of HAI patients and 32% of IV patients (P = .02).

HAI患者中3至4级不良事件的发生率为58%，而IV患者为32%（P = .02）。

No treatment-related deaths were reported.

未报告与治疗相关的死亡事件。

Four or more cycles of adjuvant chemotherapy were delivered in 81% of patients in the HAI group and 78% in the IV group (P = .75).

在HAI组中，81%的患者接受了四个或更多周期的辅助化疗，在IV组中这一比例为78%（P = .75）。

Conclusions

Adjuvant oxaliplatin HAI plus LV5FU2 improves h-RFS after curative-intent surgery of CRLM in high-risk patients, with an acceptable safety profile.

辅助性奥沙利铂肝动脉灌注联合LV5FU2在高危患者根治性切除CRLM术后改善了肝复发自由生存（h-RFS），具有可接受的安全性剖面。

These results support further evaluation in a phase III trial.

这些结果支持在III期试验中进一步评估。