背景:手术后病理指导辅助治疗是结肠癌的标准治疗方法。来自FOxTROT临床试验的数据显示,在T3/T4患者中,6周新辅助化疗(NACT)的潜在益处。本研究评估了一个全国可切除结肠癌患者队列中新辅助治疗的实际结果。
方法:169,120例临床I期患者,II,纳入了国家癌症数据库注册表中的III期结肠癌。患者被归类为接受新辅助治疗后手术(NACT),手术,然后辅助化疗(AC),或者单独手术。评估与治疗顺序和结果相关的因素。
结果:在确定的患者中,1.4%获得NACT,包括第一阶段的0.5%,第二阶段的1.8%,和第三阶段的3.0%。对于第一阶段,AC后5年总生存率(OS)为74.7%,NACT后62.2%,SA后76.4%。对于第二阶段,AC后的5-yOS为73.2%,NACT后66.8%,SA后为64.3%。对于第三阶段,AC后的5-yOS为67.3%,NACT后67.7%,SA后为42.4%。Cox比例风险模型表明,在临床阶段I(风险比[HR]=1.59,95%置信区间[CI]1.39-1.85,P<0.01)和II(HR=1.37,95%CI1.23-1.52,P<0.01),NACT的预后较差。在第三阶段,NACT和AC的OS差异无统计学意义(HR=1.1,95%CI0.99~1.22,P=0.05)。
结论:在一个真实的全国可切除结肠癌患者队列中,NACT与AC相比没有操作系统优势。未来的研究应该检查哪些患者子集可能受益于新辅助方法。
BACKGROUND: Surgery followed by pathology-guided adjuvant therapy is standard treatment for colon cancer. Data from the FOxTROT clinical trial showed potential benefit of a 6-wk neoadjuvant chemotherapy (NACT) in T3/T4 patients. The present study evaluated real-world outcomes of neoadjuvant therapy in a national cohort of patients with resectable colon cancer.
METHODS: 169,120 patients with clinical stage I, II, or III colon cancer from the National Cancer Database registry were included. Patients were categorized as having received neoadjuvant therapy followed by surgery (NACT), surgery then adjuvant chemotherapy (AC), or surgery alone. Factors associated with treatment sequencing and outcomes were assessed.
RESULTS: Of identified patients, 1.4% received NACT including 0.5% of stage I, 1.8% of stage II, and 3.0% of stage III. For stage I, 5-y overall survival (OS) was 74.7% after AC, 62.2% after NACT, and 76.4% after SA. For stage II, 5-y OS was 73.2% after AC, 66.8% after NACT, and 64.3% after SA. For stage III, 5-y OS was 67.3% after AC, 67.7% after NACT, and 42.4% after SA. Cox proportional-hazards model suggested NACT had worse outcomes versus AC in clinical stages I (hazard ratio [HR] = 1.59, 95% confidence interval [CI] 1.39-1.85, P < 0.01) and II (HR = 1.37, 95% CI 1.23-1.52, P < 0.01). In stage III, there was no difference in OS between NACT and AC (HR = 1.1, 95% CI 0.99-1.22, P = 0.05).
CONCLUSIONS: In a real-world national cohort of patients with resectable colon cancer, NACT had no OS benefit over AC. Future studies should examine which subset of patients might benefit from neoadjuvant approaches.