Long-course preoperative chemoradiation versus 5 x 5 Gy and consolidation chemotherapy for clinical T4 and fixed clinical T3 rectal cancer: long-term results of the randomized Polish II study
Long-course preoperative chemoradiation versus 5 x 5 Gy and consolidation chemotherapy for clinical T4 and fixed clinical T3 rectal cancer: long-term results of the randomized Polish II study
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DOI：
10.1093/annonc/mdz186
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发表时间：
2019-08-01
影响因子：
50.5
通讯作者：
Bujko, K.
中科院分区：
文献类型：
--
作者：
Cisel, B.;Pietrzak, L.;Bujko, K.
背景资料：本试验评估了在临床（c）T4或固定cT 3的直肠癌中，术前短程放疗和巩固化疗（CCT）是否上级放化疗。以前，我们报道的早期结果显示根治性手术率（主要终点）没有差异。在短期/CCT组中，我们观察到术前治疗的急性毒性较低，总生存期（OS）较好。我们更新了结果，以确定OS的益处是否持续，并评估晚期并发症。患者和方法：cT 4或固定cT 3直肠癌患者随机接受术前5 x 5戈伊和3个周期的FOLFOX 4或放化疗结果：患者（N = 515）符合分析条件，其中短程/CCT组261例，放化疗组254例。中位随访时间为7.0年。OS差异不显著[风险比（HR）0.90; 95%置信区间（CI）0.70-1.15; P = 0.38）。然而，再次观察到早期OS的差异有利于之前报告的短期/CCT，3年时为9%（95% CI 0.5%-17%）。这种差异后来消失; 8年时，两组的OS均为49%。短期/CCT组与放化疗组8年无病生存率无差异（HR 0.95; 95% CI 0.75-1.19; P = 0.65），分别为43%和41%。局部失败和远处转移累积发生率的相应值无差异，分别为HR = 1.08，95% CI 0.70-1.23，P = 0.60，35% vs 32%和HR = 1.10，95% CI 0.68-1.23，P = 0.54，36% vs 34%。晚期并发症的发生率相似（P = 0.66），3+级分别为11%和9%，在短期/CCT组与放化疗group.Conclusion：术前短期/CCT的优越性，没有表现出。
Background: This trial evaluated whether preoperative short-course radiotherapy and consolidation chemotherapy (CCT) were superior to chemoradiation in rectal cancers with clinical (c)T4 or fixed cT3. Previously, we reported early results showing no differences in the radical surgery rate (primary end point). In the short-course/CCT group, we observed lower acute toxicity of preoperative treatment and better overall survival (OS). We updated results to determine whether the benefit in OS was sustained and to evaluate late complications.Patients and methods: Patients with cT4 or fixed cT3 rectal cancer were randomized either to preoperative 5 x 5 Gy and three cycles of FOLFOX4 or to chemoradiation (50.4 Gy with bolus 5-Fu, leucovorin and oxaliplatin).Results: Patients (N = 515) were eligible for analysis, 261 in the short-course/CCT group and 254 in the chemoradiation group. The median follow-up was 7.0 years. The difference in OS was insignificant [hazard ratio (HR) 0.90; 95% confidence interval (CI) 0.70-1.15; P = 0.38). However, the difference in early OS favouring short-course/CCT previously reported was observed again, being 9% at 3 years (95% CI 0.5% to 17%). This difference disappeared later; at 8 years OS was 49% in both groups. There was no difference in disease-free survival (HR 0.95; 95% CI 0.75-1.19; P = 0.65) at 8 years 43% versus 41% in the short-course/CCT group versus the chemoradiation group, respectively. The corresponding values for cumulative incidences of local failure and distant metastases did not differ and were HR = 1.08, 95% CI 0.70-1.23, P = 0.60, 35% versus 32% and HR = 1.10, 95% CI 0.68-1.23, P = 0.54, 36% versus 34%, respectively. The rate of late complications was similar (P = 0.66), grade 3+ being 11% versus 9% in the short-course/CCT group versus the chemoradiation group, respectively.Conclusion: The superiority of preoperative short-course/CCT over chemoradiation was not demonstrated.