Atezolizumab plus FOLFOX for Stage III Mismatch Repair-Deficient Colon Cancer.

Whether the addition of atezolizumab (an anti-programmed death ligand 1 agent) to a modified FOLFOX6 regimen (fluorouracil, oxaliplatin, and leucovorin; called mFOLFOX6) would improve outcomes in patients with stage III colon cancer with mismatch repair-deficient (dMMR) status is unclear.

尚不清楚将阿替利珠单抗（一种抗程序性死亡配体1药物）添加到改良的FOLFOX6方案（氟尿嘧啶、奥沙利铂和亚叶酸钙；称为mFOLFOX6）中，是否能改善具有错配修复缺陷（dMMR）状态的III期结肠癌患者的预后。

Methods

In a phase 3 trial, we randomly assigned, in a 1:1 ratio, patients with resected stage III dMMR tumors to receive either adjuvant atezolizumab plus mFOLFOX6 for 6 months, with atezolizumab continued as monotherapy (for a total of 12 months of therapy), or mFOLFOX6 alone for 6 months.

在一项III期试验中，我们以1:1的比例随机分配了接受切除的III期dMMR肿瘤患者，让他们接受6个月的辅助性atezolizumab加mFOLFOX6治疗，随后继续单独使用atezolizumab治疗（总共12个月的治疗），或者单独接受6个月的mFOLFOX6治疗。

The primary end point was disease-free survival. Secondary end points were overall survivaland the adverse-event profile.

主要终点是无病生存期。次要终点是总生存期和不良事件特征。

Results

A total of 355 patients were assigned to receive atezolizumab plus mFOLFOX6 and 357 to receive mFOLFOX6 alone.

共有355名患者被分配接受阿替利珠单抗联合mFOLFOX6治疗，另外357名患者仅接受mFOLFOX6治疗。

The median age of the patients was 64 years, 55.1% were women, and 53.9% had tumors that were T4, N2, or both (indicating high risk).

患者的中位年龄为64岁，55.1%为女性，53.9%的患者肿瘤为T4、N2或两者兼有（表明高风险）。

At a median follow-up of 40.9 months, the 3-year disease-free survival was 86.3% (95% confidence interval[CI], 81.8 to 89.8) in the atezolizumab-mFOLFOX6 group, as compared with 76.2% (95% CI, 70.9 to 80.6) in the mFOLFOX6 group (hazard ratiofor disease recurrence or death, 0.50; 95% CI, 0.35 to 0.73; P<0.001).

在中位随访40.9个月时，atezolizumab-mFOLFOX6组的3年无病生存率为86.3%（95%置信区间[CI]，81.8至89.8），而mFOLFOX6组为76.2%（95% CI，70.9至80.6）（疾病复发或死亡的风险比为0.50；95% CI，0.35至0.73；P<0.001）。

Adverse events of grade 3 or 4 occurred in 84.1% of the patients who received atezolizumab plus mFOLFOX6 and in 71.9% of those who received mFOLFOX6 alone.

在接受atezolizumab加mFOLFOX6治疗的患者中，有84.1%的患者出现了3级或4级不良事件，而在仅接受mFOLFOX6治疗的患者中，这一比例为71.9%。

Conclusions

The addition of atezolizumab to mFOLFOX6 significantly improved disease-free survival among patients with stage III dMMR colon cancer.

在III期dMMR结肠癌患者中，阿替利珠单抗联合mFOLFOX6显著提高了无病生存率。

(Funded by the National Cancer Institute of the National Institutes of Health and Genentech; ATOMIC ClinicalTrials.gov number, NCT02912559.).

（该研究由美国国立卫生研究院国家癌症研究所和基因泰克资助；ATOMIC临床试验注册号为NCT02912559。）