FDA批准阿替利珠单抗联合化疗用于III期dMMR结肠癌辅助治疗：无病生存风险降低50%，适用2岁以上患者
美国食品药品监督管理局（FDA）10月8日批准阿替利珠单抗（atezolizumab，商品名Tecentriq，基因泰克生产）联合氟嘧啶类与奥沙利铂化疗，用于III期错配修复缺陷（dMMR）结肠癌成人及2岁以上儿童患者的术后辅助治疗；其皮下注射剂型阿替利珠单抗/透明质酸酶（Tecentriq Hybreza）联合相同化疗，则获批用于12岁以上、体重不低于40公斤的患者。
批准基于ATOMIC/ML39057临床试验：711名成人与1名儿童患者在完整切除肿瘤后按1比1随机分组，分别接受阿替利珠单抗联合mFOLFOX6方案12个周期、其后再以阿替利珠单抗单药治疗6个月，或单用mFOLFOX6方案12个周期。主要终点无病生存期显示，联合治疗组风险比为0.50（95%置信区间0.35至0.73，p=0.0001），即复发或死亡风险降低一半；两组的中位无病生存期均尚未达到。
dMMR结肠癌对免疫治疗较为敏感，是近年来结直肠癌辅助治疗的重要突破口。FDA同时提示该药的免疫介导不良反应、输注反应、造血干细胞移植并发症与胚胎-胎儿毒性等警告。具体用药须由肿瘤专科医生根据患者分型检测结果评估。
FDA Approves Atezolizumab Plus Chemotherapy for Stage III dMMR Colon Cancer, Halving Disease-Free Survival Risk
The US Food and Drug Administration on October 8 approved atezolizumab (Tecentriq, Genentech) in combination with a fluoropyrimidine and oxaliplatin for the adjuvant treatment of adult and pediatric patients aged 2 and older with Stage III mismatch repair-deficient (dMMR) colon cancer. The subcutaneous formulation, atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza), was approved with the same chemotherapy for patients 12 and older weighing at least 40 kg.
The approval rests on the ATOMIC/ML39057 trial, in which 711 adults and one pediatric patient who had undergone complete resection were randomized 1:1 to atezolizumab plus 12 cycles of mFOLFOX6 followed by six months of atezolizumab monotherapy, or 12 cycles of mFOLFOX6 alone. The major efficacy outcome, disease-free survival, showed a hazard ratio of 0.50 (95% CI 0.35–0.73; p=0.0001) — a halving of the risk of recurrence or death — with median disease-free survival not reached in either arm.
The FDA labeling carries warnings for immune-mediated adverse reactions, infusion-related reactions, complications of stem-cell transplantation and embryo-fetal toxicity. Mismatch repair-deficient tumors are among the colon cancers most responsive to immunotherapy, making this an important addition to adjuvant options; treatment decisions rest with the patient's oncology team based on biomarker testing.
来源：GSM·美国（原文链接）
图片来源：癌组织中的T细胞显微图像。Image: NIH Image Gallery, public domain
