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BACKGROUND

Colorectal cancer (CRC) patients have a better prognosis if metastases are resectable. Initially, unresectable liver-only metastases can be converted to resectable with chemotherapy plus a targeted therapy. We assessed which of chemotherapy doublet (2-CTx) or triplet (3-CTx), combined with targeted therapy by RAS status, would be better in this setting.

METHODS

PRODIGE 14 was an open-label, multicenter, randomised Phase 2 trial. CRC patients with initially defined unresectable liver-only metastases received either, 2-CTx (FOLFOX or FOLFIRI) or 3-CTx (FOLFIRINOX), plus bevacizumab/cetuximab by RAS status. The primary endpoint was to increase the R0/R1 liver-resection rate from 50 to 70% with the 3-CTx.

RESULTS

Patients (n = 256) were mainly men with an ECOG PS of 0, and a median age of 60 years. In total, 109 patients (42.6%) had RAS-mutated tumours. After a median follow-up of 45.6 months, the R0/R1 liver-resection rate was 56.9% (95% CI: 48-66) with the 3-CTx versus 48.4% (95% CI: 39-57) with the 2-CTx (P = 0.17). Median overall survival was 43.4 months with 3-CTx versus 40 months with 2-CTx.

CONCLUSION

We failed to increase from 50 to 70% the R0/R1 liver-resection rate with the use of 3-CTx combined with bevacizumab or cetuximab by RAS status in CRC patients with initially unresectable liver metastases.

背景

如果转移灶可切除，结直肠癌（CRC）患者的预后较好。最初，不可切除的肝转移灶可通过化疗加靶向治疗转化为可切除。我们评估了联合 RAS 状态的化疗双联（2-CTx）或三联（3-CTx）哪种方案在这种情况下更好。

方法

PRODIGE 14 是一项开放标签、多中心、随机 2 期试验。最初定义为不可切除的肝转移灶的 CRC 患者接受 2-CTx（FOLFOX 或 FOLFIRI）或 3-CTx（FOLFIRINOX），联合贝伐珠单抗/西妥昔单抗，根据 RAS 状态。主要终点是将 3-CTx 的肝切除 R0/R1 率从 50%提高到 70%。

结果

患者（n=256）主要为男性，ECOG PS 为 0，中位年龄为 60 岁。共有 109 例（42.6%）患者存在 RAS 突变肿瘤。中位随访 45.6 个月后，3-CTx 的 R0/R1 肝切除率为 56.9%（95%CI：48-66），2-CTx 为 48.4%（95%CI：39-57）（P=0.17）。3-CTx 的中位总生存期为 43.4 个月，2-CTx 为 40 个月。

结论

我们未能将联合 RAS 状态的贝伐珠单抗或西妥昔单抗的 3-CTx 用于初始不可切除肝转移的 CRC 患者，将 R0/R1 肝切除率从 50%提高到 70%。

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