Clinical benefit with docetaxel plus fluorouracil and cisplatin compared with cisplatin and fluorouracil in a phase III trial of advanced gastric or gastroesophageal cancer adenocarcinoma: The V-325 study group
Clinical benefit with docetaxel plus fluorouracil and cisplatin compared with cisplatin and fluorouracil in a phase III trial of advanced gastric or gastroesophageal cancer adenocarcinoma: The V-325 study group
复制标题
DOI：
10.1200/jco.2006.10.4968
复制
发表时间：
2007-08-01
影响因子：
45.3
通讯作者：
Van Cutsem, Eric
中科院分区：
文献类型：
--
作者：
Ajani, Jaffer A.;Moiseyenko, Vladimir M.;Van Cutsem, Eric
目的对于晚期胃癌或胃食管癌（AGGEC）患者，提供改善的姑息治疗是非常可取的。然而，在AGGEC患者的临床效益的前瞻性评价从来没有被报道在III期setting.Patients和MethodsIn多国试验（V325），445例患者被随机分配和治疗多西他赛加顺铂和氟尿嘧啶（DCF）或顺铂和氟尿嘧啶（CF）。本试验将临床获益作为次要终点进行前瞻性评价。临床获益分析的主要指标是至一种或多种Karnofsky体力状态（KPS）明确恶化的时间。次要临床获益终点包括至5%明确体重减轻的时间、至食欲明确恶化一级的时间、无痛生存期（定义为至首次出现疼痛的时间）和至首次摄入癌痛相关阿片类药物的时间。临床效益评估记录在每个诊所visit.ResultsClinical效益评估进行了超过75%的患者在整个V325。与CF相比，DCF显著延长了至KPS明确恶化的时间（中位数，6.1 vs 4.8个月;风险比，1.38; 95% CI，1.08 - 1.76;对数秩P = 0.009）。虽然到最终体重减轻的时间和到最终食欲恶化的时间有利于DCF，但结果没有统计学意义。无痛生存期和时间第一次癌症疼痛相关的阿片类药物intake compared.ConclusionTo我们所知，V325是第一个III期试验报告AGGEC患者的临床获益。评估了方案特异性化疗以外的临床获益。与CF相比，在CF中添加D不仅显著改善了临床获益，而且改善了生活质量、至进展时间和总生存期。
PurposeFor patients with advanced gastric or gastroesophageal cancer (AGGEC) providing clinical benefit with improved palliation is highly desirable. However, a prospective evaluation of clinical benefit in AGGEC patients has never before been reported in a phase III setting.Patients and MethodsIn a multinational trial (V325), 445 patients were randomly assigned and treated with either docetaxel plus cisplatin and fluorouracil (DCF) or cisplatin and fluorouracil (CF). Clinical benefit was prospectively evaluated in this trial as a secondary end point. The primary measure for clinical benefit analysis was time to definitive worsening by one or more categories of Karnofsky performance status (KPS). Secondary clinical benefit end points included time to 5% definitive weight loss, time to definitive worsening of appetite by one grade, pain-free survival (defined as time to first appearance of pain), and time to first cancer pain-related opioid intake. Clinical benefit assessments were recorded at each clinic visit.ResultsClinical benefit assessments were performed in more than 75% of patients throughout V325. DCF significantly prolonged time to definitive worsening of KPS compared with CF (median, 6.1 v 4.8 months; hazard ratio, 1.38; 95% Cl, 1.08 to 1.76; log-rank P = .009). Although time to definitive weight loss and time to definitive worsening of appetite favored DCF, the results were not statistically significant. Pain-free survival and time to first cancer pain-related opioid intake were comparable.ConclusionTo our knowledge, V325 is the first phase III trial to report clinical benefit in AGGEC patients. Clinical benefit was assessed beyond protocol-specific chemotherapy. The addition of D to CF not only significantly improved clinical benefit but also improved quality of life, time to progression, and overall survival compared with CF.