Icahn School of Medicine at Mount Sinai, Queens Cancer Center of NYC Health + Hospitals/Queens, Jamaica, NY, USA.
Dana Farber Cancer Institute - ECOG-ACRIN Biostatistics Center, Boston, MA, USA.
Ann Surg Oncol. 2023 Feb;30(2):1099-1109. doi: 10.1245/s10434-022-12705-8. Epub 2022 Oct 28.
Studies suggest that adjuvant chemotherapy should be initiated at the earliest possible time. The Eastern Cooperative Oncology Group (ECOG) and Intergroup evaluated the effect of perioperative fluorouracil (5-FU) on overall survival (OS) for colon cancer.
This phase III trial randomized patients to receive continuous infusional 5-FU for 7 days starting within 24 h after curative resection (arm A) or no perioperative 5-FU (arm B). Patients with Dukes' B3 and C disease received adjuvant chemotherapy per standard of care. The primary endpoint of the trial was overall survival in patients with Dukes' B3 and C disease. The secondary objective was to determine whether a week of perioperative infusion would affect survival in patients with Dukes' B2 colon cancer with no additional chemotherapy.
From August 1993 to May 2000, 859 patients were enrolled and 855 randomized (arm A: 427; arm B: 428). The trial was terminated early due to slow accrual. The median follow-up is 15.4 years (0.03-20.3 years). Among patients with Dukes' B3 and C disease, there was no statistically significant difference in OS [median 10.3 years (95% CI 8.4, 13.2) for perioperative chemotherapy and 9.3 years (95% CI 5.7, 12.3) for no perioperative therapy, one-sided log-rank p = 0.178, HR = 0.88 (95% CI 0.66, 1.16)] or disease-free survival (DFS). For patients with Dukes' B2 disease, there was also no significant difference in OS (median 16.1 versus 12.9 years) or DFS. There was no difference between treatment arms in operative complications. One week of continuous infusion of 5-FU was tolerable; 18% of arm A patients experienced grade 3 or greater toxicity.
研究表明辅助化疗应尽早开始。东部肿瘤协作组（ECOG）和联合组评估了围手术期氟尿嘧啶（5-FU）对结肠癌总生存（OS）的影响。
这项 III 期试验将患者随机分配接受连续输注 5-FU，在根治性切除后 24 小时内开始输注 7 天（A 组）或不接受围手术期 5-FU（B 组）。Dukes'B3 和 C 期疾病的患者接受标准辅助化疗。试验的主要终点是 Dukes'B3 和 C 期疾病患者的总生存。次要目标是确定一周的围手术期输注是否会影响 Dukes'B2 结肠癌患者的生存，这些患者没有接受额外的化疗。
1993 年 8 月至 2000 年 5 月，共纳入 859 例患者，855 例随机分组（A 组：427 例；B 组：428 例）。由于入组缓慢，试验提前终止。中位随访时间为 15.4 年（0.03-20.3 年）。在 Dukes'B3 和 C 期疾病患者中，围手术期化疗组和无围手术期治疗组的 OS 无统计学差异[中位 OS 分别为 10.3 年（95%CI8.4,13.2）和 9.3 年（95%CI5.7,12.3），单侧对数秩检验 p = 0.178，HR = 0.88（95%CI0.66,1.16）]或无病生存（DFS）。对于 Dukes'B2 期疾病患者，OS（中位 OS 分别为 16.1 年和 12.9 年）或 DFS 也无显著差异。两组间手术并发症无差异。5-FU 连续输注 1 周是可耐受的，A 组 18%的患者发生 3 级或更高级别的毒性。
