ADJUVANT COMBINATION CHEMOTHERAPY (AMF) FOLLOWING RADICAL RESECTION OF CARCINOMA OF THE PANCREAS AND PAPILLA OF VATER - RESULTS OF A CONTROLLED, PROSPECTIVE, RANDOMIZED MULTICENTER STUDY
ADJUVANT COMBINATION CHEMOTHERAPY (AMF) FOLLOWING RADICAL RESECTION OF CARCINOMA OF THE PANCREAS AND PAPILLA OF VATER - RESULTS OF A CONTROLLED, PROSPECTIVE, RANDOMIZED MULTICENTER STUDY
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DOI：
10.1016/s0959-8049(05)80349-1
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发表时间：
1993-01-01
影响因子：
8.4
通讯作者：
KAMBESTAD, B
中科院分区：
文献类型：
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作者：
BAKKEVOLD, KE;ARNESJO, B;KAMBESTAD, B
1984年至1987年，61例胰腺癌（n=47）和乏特氏乳头癌（n=14）根治性切除患者随机接受术后辅助联合化疗（AMF）; 5-氟尿嘧啶500 mg/m2，阿霉素40 mg/m2，丝裂霉素C 6 mg/m2（n=30），每3周一次，共6个周期，对照组31例（未行辅助化疗）。治疗组的中位生存期为23个月，对照组为11个月（P=0.02，中位数检验），这取决于治疗组在最初2年的生存获益（P=0.04广义Wilcoxon）。2年后的长期预后相同，生存率相同（P=0.10，把握度=0.83）。治疗组1、2、3、5年生存率分别为70%、43%、27%、4%，对照组分别为45%、32%、30%、8%。1例患者死于败血症，可能归因于化疗。2例患者出现肾毒性和血管毒性。这些结果表明，辅助化疗确实推迟了根治性手术后前2年的复发率，但未观察到治愈率增加。
Between 1984 and 1987, 61 radically resected patients with carcinoma of the pancreas (n=47) or the papilla of Vater (n=14) were randomised either into postoperative adjuvant combination chemotherapy (AMF); 5-fluorouracil 500 mg/m2, doxorubicin 40 mg/m2, mitomycin C 6 mg/m2 (n=30) once every 3 weeks for six cycles, or into a control group (no adjuvant chemotherapy) (n=31). The median survival in the treatment group was 23 months compared with 11 months (P=0.02, median test) in the control group, dependant on a survival benefit in the treatment group during the initial 2 years (P=0.04 generalised Wilcoxon). The long-term prognosis was the same with an identical survival after 2 years (P=0.10, power=0.83). The observed 1, 2, 3 and 5-year survivals in the treatment group were 70, 43, 27 and 4% compared with 45, 32, 30 and 8 in the control group. 1 patient succumbed to sepsis probably attributable to chemotherapy. Cardiotoxicity and nephrotoxicity were recorded in 2 patients. These results suggest that adjuvant chemotherapy does postpone the incidence of recurrence in the first 2 years following radical surgery but increased cure rate was not observed.