Paschke Stephan, Hebart Holger, Goeb Roland, Staib Ludger, Fleck Ullrich, Henne-Bruns Doris, Sander Silvia, Link Karl-Heinrich, Kornmann Marko
Clinic of General and Visceral Surgery, University Hospital of Ulm, Ulm, Germany.
Center for Internal Medicine, Stauferklinikum, Schwäbisch Gmünd, Germany.
Visc Med. 2019 Apr;35(2):124-132. doi: 10.1159/000491648. Epub 2018 Oct 30.
There is still the need to optimize adjuvant treatment of colon cancer (CC). Standard adjuvant chemotherapy using 5-fluorouracil (FU) and folinic acid (FA) was compared with a combination including irinotecan (Folfiri). The aim of the present report was to analyze overall survival (OS) after long-term follow-up, to summarize final recurrence rates and toxicity data, and to identify possible clinical and pathological factors associated with prognosis.
Patients (CC stage IIb and III) were randomized to a 6-month treatment with FUFA or Folfiri. The trial was closed after 275 of 588 planned patients, 269 of which were included in the intention-to-treat analysis.
133 and 136 patients received FUFA and Folfiri, respectively. Adjuvant therapy was not completed for 16 FUFA (12.0%) and 44 Folfiri (32.4%) patients. Toxicities grade III and IV were observed in 17 (12.8%) patients treated with FUFA and in 50 (36.8%) patients treated with Folfiri. Recurrences occurred in 46 of 133 (34.6%) and in 47 of 136 (34.6%) patients who received FUFA and Folfiri, respectively. 5-year OS rates were 69.9% (95% confidence interval (CI): 61.2-77.1) for FUFA and 72.7% (95% CI: 63.9-79.8) for Folfiri. OS was associated with tumor grading (1 & 2 vs. 3), tumor sub-stage (II vs. IIIa vs. IIIb vs. IIIc), and tumor location (left vs. right colon).
Folfiri cannot be generally recommended for adjuvant chemotherapy of CC. Besides tumor grading and sub-staging, prognosis of CC may depend on tumor location. Left-sided tumors had a significantly better prognosis irrespective of treatment.
结肠癌（CC）辅助治疗仍需优化。将使用5-氟尿嘧啶（FU）和亚叶酸（FA）的标准辅助化疗与包含伊立替康的联合方案（Folfiri）进行比较。本报告的目的是分析长期随访后的总生存期（OS），总结最终复发率和毒性数据，并确定与预后相关的可能临床和病理因素。
患者（CC IIb期和III期）被随机分配接受FUFA或Folfiri治疗6个月。在计划入组的588例患者中有275例完成试验，其中269例纳入意向性分析。
分别有133例和136例患者接受FUFA和Folfiri治疗。16例（12.0%）接受FUFA治疗的患者和44例（32.4%）接受Folfiri治疗的患者未完成辅助治疗。接受FUFA治疗的17例（12.8%）患者和接受Folfiri治疗的50例（36.8%）患者观察到III级和IV级毒性反应。接受FUFA和Folfiri治疗的患者中分别有46例（34.6%）和47例（34.6%）出现复发。FUFA组的5年总生存率为69.9%（95%置信区间（CI）：61.2 - 77.1），Folfiri组为72.7%（95% CI：63.9 - 79.8）。总生存期与肿瘤分级（1和2级与3级）、肿瘤亚分期（II期与IIIa期与IIIb期与IIIc期）以及肿瘤位置（左半结肠与右半结肠）相关。
Folfiri一般不推荐用于CC的辅助化疗。除肿瘤分级和亚分期外，CC的预后可能取决于肿瘤位置。无论接受何种治疗，左侧肿瘤的预后明显更好。
