Gemcitabine versus cisplatin, epirubicin, fluorouracil, and gemcitabine in advanced pancreatic cancer: a randomised controlled multicentre phase III trial
Gemcitabine versus cisplatin, epirubicin, fluorouracil, and gemcitabine in advanced pancreatic cancer: a randomised controlled multicentre phase III trial
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DOI：
10.1016/s1470-2045(05)70175-3
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发表时间：
2005-06-01
期刊：
影响因子：
51.1
通讯作者：
Di Carlo, V
中科院分区：
文献类型：
--
作者：
Reni, M;Cordio, S;Di Carlo, V
背景：晚期胰腺癌患者的疗效差，无进展生存期和标准治疗的总生存期都很低。方法52例患者随机分为两组，顺铂40 mg/m(2)，表阿霉素40 mg/m(2)，静滴第1天600 mg/m(2)，吉西他滨第1、8天1小时以上；氟尿嘧啶200 mg/m(2)，持续滴注1~28天(PEFG方案)。其中47例给予吉西他滨1000 mg/m(2)静脉滴注30min以上，每周1次，连续8周中的7周，此后4周中的3周。主要终点是4个月的无进展生存期。次要终点是总体存活率、客观反应、安全性和生活质量。根据治疗意向进行分析。结果发现，51名接受PEFG治疗的患者和46名接受吉西他滨治疗的患者病情进展。PEFG组有49名患者和吉西他滨组有46名患者死于进展性疾病。接受PEFG治疗的患者比单用吉西他滨的患者在4个月后无进展性疾病的患者更多(60%[95%可信区间46-72]比28%[17-42]；风险比[HR]0.46[0.26-0.79])。PEFG组1年总生存率为38.5%(25.3-51.7)，吉西他滨组为21.3%(9.6-33.0；HR为0.68[0.42-1.09])。接受PEFG治疗的患者比接受吉西他滨治疗的患者有更多的疾病反应(38.5%[25.3-51.7]比8.5%[0.5-16.5]；优势比6.6[2.11-20.60]，p=0.0008)。PEFG组出现3-4度中性粒细胞减少和血小板减少的患者多于吉西他滨组(P<；0-0001)，说明PEFG方案可考虑用于晚期胰腺癌的治疗。
Background Patients with advanced pancreatic adenocarcinoma have a poor response, progression-free survival, and overall survival with standard treatment. We aimed to assess whether a four-drug regimen could improve 4-month progression-free survival compared with gemcitabine alone.Methods In a randomised multicentre phase III trial, 52 patients were randomly assigned to 40 mg/m(2) cisplatin and 40 mg/m(2) epirubicin both given on day 1,600 mg/m(2) gemcitabine given intravenously over 1 h on days 1 and 8, and 200 mg/m(2) fluorouracil a day given by continuous infusion on days 1-28 of a 4-week cycle (PEFG regimen), and 47 were assigned to 1000 mg/m(2) gemcitabine given intravenously over 30 min once a week for 7 of 8 consecutive weeks in cycle 1 and for 3 of 4 weeks thereafter. The primary endpoint was 4-month progression-free survival. Secondary endpoints were overall survival, objective response, safety, and quality of life. Analyses were by intention to treat.Findings 51 patients assigned PEFG and 46 assigned gemcitabine alone had disease progression. 49 patients in the PEFG group and 46 in the gemcitabine group died from progressive disease. More patients allocated PEFG than gemcitabine alone were alive without progressive disease at 4 months (60% [95% CI 46-72] vs 28% [17-42]; hazard ratio [HR] 0.46 [0.26-0.79]). 1-year overall survival in the PEFG group was 38.5% (25.3-51.7) and in the gemcitabine group was 21.3% (9.6-33.0; HR 0.68 [0.42-1.09]). More patients assigned PEFG showed disease response than did those assigned gemcitabine (38.5% [25.3-51.7] vs 8.5% [0.5-16.5]; odds ratio 6.60 [2.11-20.60], p=0.0008). More patients in the PEFG group had grade 3-4 neutropenia and thrombocytopenia than in the gemcitabine group (p < 0 - 0001).Interpretation The PEFG regimen could be considered for treatment of advanced pancreatic adenocarcinoma.