Phase III trial in metastatic gastroesophageal adenocarcinoma with fluorouracil, leucovorin plus either oxaliplatin or cisplatin:: A study of the arbeitsgemeinschaft internistische onkologie
Phase III trial in metastatic gastroesophageal adenocarcinoma with fluorouracil, leucovorin plus either oxaliplatin or cisplatin:: A study of the arbeitsgemeinschaft internistische onkologie
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DOI：
10.1200/jco.2007.13.9378
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发表时间：
2008-03-20
影响因子：
45.3
通讯作者：
Jaeger, Elke
中科院分区：
文献类型：
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作者：
Al-Batran, Salah-Eddin;Hartmann, Joerg Thomas;Jaeger, Elke
目的本研究旨在将氟尿嘧啶、亚叶酸和奥沙利铂与氟尿嘧啶、亚叶酸和顺铂治疗晚期胃癌患者进行比较。 患者和方法先前未经治疗的晚期胃或食管胃交界部腺癌患者被随机分配接受 24 小时输注氟尿嘧啶 2,600 mg/m(2) 或亚叶酸 200 mg/m(2)，奥沙利铂 85 mg/m(2) (FLO) 每 2 周一次，或氟尿嘧啶 2,000 mg/m(2) 通过 24 小时输注，亚叶酸每周 200 mg/m(2)，顺铂 50 mg/m(2) 每 2 周 (FLP)。主要终点是无进展生存期 (PFS)。结果 220 名患者（中位年龄，64 岁；转移性，94%）被随机分配。 FLO 显着减少（任何级别）贫血（54% vs 72%）、恶心（53% vs 70%）、呕吐（31% vs 52%）、脱发（22% vs 39%）、疲劳（19% vs 34%）、肾毒性（11% vs 34%）、血栓栓塞事件（0.9% vs 7.8%）以及与治疗相关的严重不良事件（9% vs 19%）。 FLP 与周围神经病变的发生率显着降低相关（22% vs 63%）。 FLO 与 FLP 相比，有改善中位 PFS 的趋势（分别为 5.8 个月和 3.9 个月；P = 0.077），而中位总生存期没有显着差异（分别为 10.7 个月和 8.8 个月）。然而，在 65 岁以上的患者 (n = 94) 中，与 FLO 治疗相比，FLO 治疗的缓解率 (41.3% vs 16.7%；P = .012)、治疗失败时间 (5.4 vs 2.3 个月；P < .001) 和 PFS (6.0 vs 3.1 个月；P = .029) 以及 OS 改善 (13.9 vs 7.2 个月) 均显着优于 FLO分别为FLP。 结论与FLP 相比，FLO 降低了毒性。在老年患者中，FLO 似乎也与疗效提高有关。
PurposeThis study was designed to compare fluorouracil, leucovorin, and oxaliplatin with fluorouracil, leucovorin, and cisplatin in patients with advanced gastric cancer.Patients and MethodsPatients with previously untreated advanced adenocarcinoma of the stomach or esophagogastric junction were randomly assigned to receive either fluorouracil 2,600 mg/m(2) via 24-hour infusion, leucovorin 200 mg/m(2), and oxaliplatin 85 mg/m(2) (FLO) every 2 weeks or fluorouracil 2,000 mg/m(2) via 24-hour infusion, leucovorin 200 mg/m(2) weekly, and cisplatin 50 mg/m(2) every 2 weeks (FLP). The primary end point was progression-free survival (PFS).ResultsTwo hundred twenty patients (median age, 64 years; metastatic, 94%) were randomly assigned. FLO was associated with significantly less (any grade) anemia (54% v 72%), nausea (53% v 70%), vomiting (31% v 52%), alopecia (22% v 39%), fatigue (19% v 34%), renal toxicity (11% v 34%), thromboembolic events (0.9% v 7.8%), and serious adverse events related to the treatment (9% v 19%). FLP was associated with significantly less peripheral neuropathy (22% v 63%). There was a trend toward improved median PFS with FLO versus FLP (5.8 v 3.9 months, respectively; P = .077) and no significant difference in median overall survival (10.7 v 8.8 months, respectively). However, in patients older than 65 years (n = 94), treatment with FLO resulted in significantly superior response rates (41.3% v 16.7%; P = .012), time to treatment failure (5.4 v 2.3 months; P < .001), and PFS (6.0 v 3.1 month; P = .029) and an improved OS (13.9 v 7.2 months) as compared with FLP, respectively.ConclusionFLO reduced toxicity as compared with FLP. In older adult patients, FLO also seemed to be associated with improved efficacy.