Popov I, Radosevic-Jelic L, Jezdic S, Milovic M, Borojevic N, Stojanovic S, Stankovic V, Josifovski T, Kezic I
Department for Medical Oncology, Institute for Oncology and Radiology of Serbia, Belgrade, Serbia.
J BUON. 2008 Oct-Dec;13(4):505-11.
To compare a bi-weekly infusion of leucovorin (LV) 5-fluorouracil (5-FU) for 2 days, plus oxaliplatin (LV5- FU2-oxaliplatin) and LV5-FU2-cisplatin (CDDP) regimens with respect to toxicity, objective response rates, time to progression (TTP) and overall survival (OS) in patients with advanced gastric cancer.
Patients received LV5-FU2- oxaliplatin (oxaliplatin 85 mg/m(2), day 1; folinic acid 200 mg/m(2), days 1-2; 5-FU 400 mg/m(2), i.v. bolus, days 1-2; 5-FU 600 mg/m(2), 22-hour continuous infusion, days 1-2) or LV5- FU2-CDDP (CDDP 50 mg/m(2), day 1; plus LV5-FU2). A total of 72 patients were enrolled into this study (36 vs. 36).
A total of 305 cycles were administered in the LV5-FU2-oxaliplatin arm (median 8) and 272 cycles in the LV5-FU2-CDDP arm (median 8). Grades 3-4 toxicity were as follows (LV5-FU2-oxaliplatin %/LV5-FU2-CDDP %; p<0.05): neutropenia 5/49, thrombocytopenia 2/6, anemia 6/16 nausea/vomiting 2/15, and mucositis 0/3. Response rate of LV5-FU2-oxaliplatin was 41% (partial response/PR 41%, stable disease/SD 31%, progressive disease/PD 28%; 95% confidence internal/95% CI 27-58) and of LV5-FU2-CDDP was 25% (PR 25%, SD 36%, PD 39%; 95% CI 14-41; p =0.013). The median TTP of the patients in the LV5-FU2-oxaliplatin arm was 8 months and 6 months for those in the LV5- FU2-CDDP arm (p=0.073). The median survival time of the patients in the LV5-FU2-oxaliplatin arm was 10 months and 7 months for those in the LV5-FU2-CDDP arm (p=0.003).
Our study showed that oxaliplatin may be substituted for cisplatin with LV5-FU2 with favorable safety and efficacy profile. The encouraging results from our study support the effectiveness of oxaliplatin-fluoropyrimidine- containing chemotherapy in gastric cancer and could provide a new core on which to add other agents in future investigations.
比较每两周输注亚叶酸（LV）和5-氟尿嘧啶（5-FU）2天，联合奥沙利铂（LV5-FU2-奥沙利铂）与LV5-FU2-顺铂（CDDP）方案在晚期胃癌患者中的毒性、客观缓解率、疾病进展时间（TTP）和总生存期（OS）。
患者接受LV5-FU2-奥沙利铂（奥沙利铂85mg/m²，第1天；亚叶酸200mg/m²，第1 - 2天；5-FU 400mg/m²，静脉推注，第1 - 2天；5-FU 600mg/m²，22小时持续输注，第1 - 2天）或LV5-FU2-CDDP（顺铂50mg/m²，第1天；加LV5-FU2）。本研究共纳入72例患者（36例对比36例）。
LV5-FU2-奥沙利铂组共进行了305个周期（中位数8个），LV5-FU2-CDDP组进行了272个周期（中位数8个）。3 - 4级毒性如下（LV5-FU2-奥沙利铂%/LV5-FU2-CDDP%；p<0.05）：中性粒细胞减少5/49，血小板减少2/6，贫血6/16，恶心/呕吐2/15，黏膜炎0/3。LV5-FU2-奥沙利铂的缓解率为41%（部分缓解/PR 41%，疾病稳定/SD 31%，疾病进展/PD 28%；95%置信区间/95%CI 27 - 58），LV5-FU2-CDDP的缓解率为25%（PR 25%，SD 36%，PD 39%；95%CI 14 - 41；p =0.013）。LV5-FU2-奥沙利铂组患者的中位TTP为8个月，LV5-FU2-CDDP组为6个月（p=0.073）。LV5-FU2-奥沙利铂组患者的中位生存时间为10个月，LV5-FU2-CDDP组为7个月（p=0.003）。
我们的研究表明，奥沙利铂可替代顺铂与LV5-FU2联合使用，具有良好的安全性和疗效。我们研究中令人鼓舞的结果支持含奥沙利铂-氟嘧啶化疗在胃癌中的有效性，并可为未来研究中添加其他药物提供新的核心依据。
