A phase II study of biweekly oxaliplatin plus infusional 5-fluorouracil and folinic acid (FOLFOX-4) as first-line treatment of advanced gastric cancer patients
A phase II study of biweekly oxaliplatin plus infusional 5-fluorouracil and folinic acid (FOLFOX-4) as first-line treatment of advanced gastric cancer patients
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DOI：
10.1038/sj.bjc.6602573
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发表时间：
2005-05-09
影响因子：
8.8
通讯作者：
Bianco, AR
中科院分区：
文献类型：
--
作者：
De Vita, F;Orditura, M;Bianco, AR
本研究的目的是评估奥沙利铂每两周一次联合5-氟尿嘧啶（5-FU）和亚叶酸（FA）每两周一次输注（FOLFOX-4方案）治疗晚期胃癌（AGC）患者的毒性和临床活性。共61例既往未接受过治疗的AGC患者，第1天接受奥沙利铂85 mg m（-2），FA 200 mg m（-2）2 h输注，随后推注5-FU 400 mg m（-2）和5-FU 600 mg m（-2）22 h输注，每2周一次，连续2天重复。对所有患者的毒性和治疗反应进行评估。观察到4例（7%）完全缓解和19例部分缓解（总缓解率为38%）。在22例（36%）患者中观察到疾病稳定，在其他6例（10%）患者中观察到疾病进展。中位疾病进展时间（TTP）和中位总生存期（OS）分别为7.1和11.2个月。国家癌症研究所常见毒性标准3级和4级血液学毒性分别为36、10和5%的患者发生中性粒细胞减少症、贫血和血小板减少症。3例（5%）患者记录了3级周围神经病变。FOLFOX-4是一种活性且耐受性良好的化疗。缓解率（RR）、TTP和OS与其他基于奥沙利铂的方案相当，表明该联合治疗在胃癌中的作用。
The aim of the study was to assess the toxicity and the clinical activity of biweekly oxaliplatin in combination with infusional 5-fluorouracil (5-FU) and folinic acid (FA) administered every 2 weeks (FOLFOX-4 regimen) in patients with advanced gastric cancer (AGC). A total of 61 previously untreated AGC patients were treated with oxaliplatin 85 mg m(-2) on day 1, FA 200 mg m(-2) as a 2 h infusion followed by bolus 5-FU 400 mg m(-2) and a 22 h infusion of 5-FU 600 mg m(-2), repeated for 2 consecutive days every 2 weeks. All patients were assessable for toxicity and response to treatment. Four (7%) complete responses and 19 partial responses were observed (overall response rate, 38%). Stable disease was observed in 22 (36%) patients, with progressive disease in the other six (10%) patients. Median time to progression (TTP) and median overall survival (OS) were 7.1 and 11.2 months, respectively. National Cancer Institute Common Toxicity Criteria grade 3 and 4 haematologic toxicities were neutropenia, anaemia and thrombocytopenia in 36, 10 and 5% of the patients, respectively. Grade 3 peripheral neuropathy was recorded in three (5%) patients. FOLFOX-4 is an active and well-tolerated chemotherapy. Response rate (RR), TTP and OS were comparable with those of other oxaliplatin-based regimens, suggesting a role for this combination in gastric cancer.