Unit of Medical Oncology 2, University Hospital of Pisa, Pisa, Italy.
Department of Translational Research and New Technologies in Medicine and Surgery, University of Pisa, Pisa, Italy.
J Clin Oncol. 2024 Aug 1;42(22):2637-2644. doi: 10.1200/JCO.23.02728. Epub 2024 Jun 12.
JCO We report 4-year results of the phase II randomized AtezoTRIBE study. Eligible patients with metastatic colorectal cancer (mCRC) received first-line fluorouracil, leucovorin, oxaliplatin, and irinotecan (FOLFOXIRI)/bevacizumab (control group, n = 73) or FOLFOXIRI/bevacizumab plus atezolizumab (experimental group, n = 145). We present overall survival (OS) and updated outcomes according to tumor immune-related biomarkers, both in the intention-to-treat (ITT) population and the cohort of patients with proficient mismatch repair (pMMR) tumors. Median follow-up was 45.2 months (IQR, 42.6-49.2). In the ITT population, median OS was 33.0 and 27.2 months for experimental and control groups, respectively (hazard ratio [HR], 0.78 [80% CI, 0.61 to 0.98]; = .084). An interaction effect between Immunoscore Immune-Checkpoint (IC) and treatment arm was observed (, .089), with higher benefit from atezolizumab in the Immunoscore IC-high group. In the pMMR cohort (N = 202), median OS was 30.8 and 29.2 months for experimental and control groups, respectively (HR, 0.80 [80% CI, 0.63 to 1.02]; = .117). Interactions between treatment group and tumor mutational burden (TMB) and Immunoscore IC were reported (, .043 and .092, respectively), with patients bearing TMB-high and Immunoscore IC-high tumors deriving higher benefit from the addition of atezolizumab. First-line FOLFOXIRI/bevacizumab plus atezolizumab improves OS in patients with mCRC. In the pMMR group, patients with Immunoscore IC-high and/or TMB-high tumors are identified as a subgroup of interest to further develop this treatment.
我们报告了 II 期随机 AtezoTRIBE 研究的 4 年结果。符合条件的转移性结直肠癌（mCRC）患者接受一线氟尿嘧啶、亚叶酸、奥沙利铂和伊立替康（FOLFOXIRI）/贝伐珠单抗（对照组，n = 73）或 FOLFOXIRI/贝伐珠单抗加阿替利珠单抗（实验组，n = 145）治疗。我们根据肿瘤免疫相关生物标志物，在意向治疗（ITT）人群和 proficient mismatch repair（pMMR）肿瘤患者队列中，介绍了总生存期（OS）和更新的结果。中位随访时间为 45.2 个月（IQR，42.6-49.2）。在 ITT 人群中，实验组和对照组的中位 OS 分别为 33.0 和 27.2 个月（风险比 [HR]，0.78 [80%CI，0.61-0.98]；=.084）。观察到免疫评分免疫检查点（IC）与治疗臂之间存在交互作用（=.089），阿替利珠单抗在免疫评分 IC 高组中获益更高。在 pMMR 队列（N = 202）中，实验组和对照组的中位 OS 分别为 30.8 和 29.2 个月（HR，0.80 [80%CI，0.63-1.02]；=.117）。报告了治疗组与肿瘤突变负荷（TMB）和免疫评分 IC 之间的交互作用（=.043 和.092），TMB 高和免疫评分 IC 高的患者从添加阿替利珠单抗中获益更高。一线 FOLFOXIRI/贝伐珠单抗加阿替利珠单抗可改善 mCRC 患者的 OS。在 pMMR 组中，免疫评分 IC 高和/或 TMB 高的患者被确定为进一步开发这种治疗方法的一个感兴趣的亚组。
World J Gastroenterol. 2025-6-28
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