André Thierry, Boni Corrado, Mounedji-Boudiaf Lamia, Navarro Matilde, Tabernero Josep, Hickish Tamas, Topham Clare, Zaninelli Marta, Clingan Philip, Bridgewater John, Tabah-Fisch Isabelle, de Gramont Aimery
Hôpital Tenon, Paris.
N Engl J Med. 2004 Jun 3;350(23):2343-51. doi: 10.1056/NEJMoa032709.
The standard adjuvant treatment of colon cancer is fluorouracil plus leucovorin (FL). Oxaliplatin improves the efficacy of this combination in patients with metastatic colorectal cancer. We evaluated the efficacy of treatment with FL plus oxaliplatin in the postoperative adjuvant setting.
We randomly assigned 2246 patients who had undergone curative resection for stage II or III colon cancer to receive FL alone or with oxaliplatin for six months. The primary end point was disease-free survival.
A total of 1123 patients were randomly assigned to each group. After a median follow-up of 37.9 months, 237 patients in the group given FL plus oxaliplatin had had a cancer-related event, as compared with 293 patients in the FL group (21.1 percent vs. 26.1 percent; hazard ratio for recurrence, 0.77; P=0.002). The rate of disease-free survival at three years was 78.2 percent (95 percent confidence interval, 75.6 to 80.7) in the group given FL plus oxaliplatin and 72.9 percent (95 percent confidence interval, 70.2 to 75.7) in the FL group (P=0.002 by the stratified log-rank test). In the group given FL plus oxaliplatin, the incidence of febrile neutropenia was 1.8 percent, the incidence of gastrointestinal adverse effects was low, and the incidence of grade 3 sensory neuropathy was 12.4 percent during treatment, decreasing to 1.1 percent at one year of follow-up. Six patients in each group died during treatment (death rate, 0.5 percent).
Adding oxaliplatin to a regimen of fluorouracil and leucovorin improves the adjuvant treatment of colon cancer.
结肠癌的标准辅助治疗是氟尿嘧啶加亚叶酸钙（FL）。奥沙利铂可提高该联合方案对转移性结直肠癌患者的疗效。我们评估了FL加奥沙利铂在术后辅助治疗中的疗效。
我们将2246例已接受II期或III期结肠癌根治性切除的患者随机分组，分别单独接受FL或联合奥沙利铂治疗6个月。主要终点为无病生存期。
每组各随机分配1123例患者。中位随访37.9个月后，接受FL加奥沙利铂治疗的组中有237例患者发生了癌症相关事件，而接受FL治疗的组中有293例患者发生了此类事件（21.1%对26.1%；复发风险比为0.77；P = 0.002）。接受FL加奥沙利铂治疗的组三年无病生存率为78.2%（95%置信区间为75.6至80.7），接受FL治疗的组为72.9%（95%置信区间为70.2至75.7）（分层对数秩检验P = 0.002）。在接受FL加奥沙利铂治疗的组中，发热性中性粒细胞减少症的发生率为1.8%，胃肠道不良反应发生率较低，治疗期间3级感觉神经病变的发生率为12.4%，随访一年时降至1.1%。每组有6例患者在治疗期间死亡（死亡率为0.5%）。
在氟尿嘧啶和亚叶酸钙方案中添加奥沙利铂可改善结肠癌的辅助治疗。
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