Department of Oncology, First Affiliated Hospital of Nanchang University, China.
Anticancer Drugs. 2012 Jun;23(5):561-6. doi: 10.1097/CAD.0b013e328350dd0d.
This study aimed at assessing the efficacy and safety of biweekly oxaliplatin in combination with continuous infusional 5-fluorouracil and leucovorin (modified FOLFOX regimen) in patients with advanced small bowel adenocarcinoma (SBA). Thirty-three eligible patients with previously untreated SBA received 85 mg/m(2) of oxaliplatin intravenously over a 2-h period on day 1, together with 400 mg/m(2) of leucovorin over 2 h, followed by a 46-h infusion of 5-FU 2600 mg/m(2) every 2 weeks. All patients were evaluable for efficacy and toxicity. A median of nine cycles (range 3-18) was administered. The objective response rate was 48.5% [95% confidence interval (95% CI): 31-67%], with one complete response, 15 partial responses, 12 stable diseases, and five progressions. The median time to progression was 7.8 months (95% CI: 6.0-9.6) and the median overall survival was 15.2 months (95% CI: 11.0-19.4). Toxicity was fairly mild. Grade 3 toxicities included neutropenia (12.1%), thrombocytopenia (3.0%), nausea (6.1%), vomiting (3.0%), diarrhea (3.0%), peripheral neuropathy (9.1%), and fatigue (3.0%), and grade 4 toxicities occurred in none of the patients. The modified FOLFOX regimen is highly active and well tolerated as first-line chemotherapy for advanced SBA patients.
本研究旨在评估奥沙利铂每两周联合持续输注 5-氟尿嘧啶和亚叶酸（改良 FOLFOX 方案）治疗晚期小肠腺癌（SBA）患者的疗效和安全性。33 例未经治疗的晚期 SBA 患者接受奥沙利铂 85mg/m2 静脉输注 2 小时，第 1 天；亚叶酸 400mg/m2 静脉输注 2 小时，随后每 2 周给予氟尿嘧啶 5-FU 2600mg/m2 持续输注 46 小时。所有患者均进行疗效和毒性评估。中位治疗周期为 9 个（范围 3-18）。客观缓解率为 48.5%[95%置信区间（95%CI）：31-67%]，其中完全缓解 1 例，部分缓解 15 例，稳定 12 例，进展 5 例。中位无进展生存期为 7.8 个月（95%CI：6.0-9.6），中位总生存期为 15.2 个月（95%CI：11.0-19.4）。毒性相当轻微。3 级毒性包括中性粒细胞减少症（12.1%）、血小板减少症（3.0%）、恶心（6.1%）、呕吐（3.0%）、腹泻（3.0%）、周围神经病变（9.1%）和乏力（3.0%），无 4 级毒性。改良 FOLFOX 方案作为晚期 SBA 患者的一线化疗方案，具有高度活性且耐受性良好。
