FOLFOX对比paclitaxel/LV5Fu2治疗晚期胃癌的研究

目的 回顾性比较FOLFOX以及paclitaxel/LV5Fu2方案治疗晚期胃癌的有效率(RR)、毒副作用、肿瘤进展时间(TTP)及总生存期(OS),寻找晚期胃癌全身化疗的更佳方案.方法 选择1999年11月至2005年6月在我院就诊的132例Ⅳ期胃癌患者入组.分为A、B两组,两组性别、年龄、病理类型及临床分期资料差异无显著性.A组60例患者使用FOLFOX方案:奥沙利铂85～100 mg/m2,静脉滴注2 h;亚叶酸钙200 mg/m2,静脉滴注2 h,氟尿嘧啶400 mg/m2,静脉推注10 min;氟尿嘧啶2.6g/m2,静脉灌注48 h;每2周重复1次,每2次为1个疗程.B组72例患者使用紫杉醇75mg/m2,静脉滴注3 h,亚叶酸钙和氟尿嘧啶用量和用法同A组.结果 132例患者共化疗544周期,均可评价疗效和毒性反应.A组有效率(RR)35.0%,完全缓解率1.67%;B组有效率为41.7%,完全缓解率5.56%.两组有效率差别无统计学意义(35.0%:41.7%,P＞0.05).A组和B组TTP分别为6.13±1.26月(95%CI,3.65～8.61)和5.92±0.49月(95%CI,4.97～6.87).A组和B组OS分别为10.67±1.55月(95%CI,7.63～13.71)和10.8±3.07月(95%CI,4.78～16.82).两组TTP、OS比较无统计学意义(P＞0.05).血液学毒性绝大多数为Ⅰ、Ⅱ度.Ⅲ、Ⅳ度白细胞减少发生率分别为5例(8.33%)和8例(11.11%);Ⅲ、Ⅳ度血小板减少发生率分别为1例(1.67%)和2例(2.78%);两组血液学毒性差异无统计学意义.非血液学毒性多数为Ⅰ、Ⅱ度,主要有恶心、呕吐、口腔炎、腹泻、脱发.A组和B组患者的Ⅰ、Ⅱ度脱发分别为15例(25.00%)和42例(58.33%)两组有统计学差异(P＜0.05).A组和B组Ⅰ、Ⅱ度周围神经毒性分别为26例(43.33%)和4例(5.55%);Ⅰ、Ⅱ度周围神经毒性A组明显高于B组,两组差异有统计学意义(P＜0.01).结论 对于晚期胃癌患者使用PLF或FOLFOX方案均具有一定的疗效,毒副反应相似,可以耐受,值得临床推广使用.

FOLFOX versus PLF regimen in treatment of advanced gastric adenocarcinoma

OBJECTIVE: To compare the efficacy and tolerability of the regimen FOLFOX [1eucovorin (LV), 5-fluorouracil (5-Fu) and oxaliplatin] and the regimen PLF (Paclitaxel, leucovorin and 5-Fu) for treatment of advanced gastric adenocarcinoma. METHODS: We retrospectively studied the clinical data of 132 patients with stage IV gastric adenocarcinoma treated by FOLFOX (group A, n=60) or PLF (group B, n=72). The tumor response rate, toxicity, time to progress (TTP) and overall survival (OS) were compared between the two groups. RESULTS: A total of 544 cycles were administrated in these patients. The overall response rate was 35.0% with FOLFOX regimen and 41.7% with PLF regimen, showing no significant difference between them (P>0.05). The TTP was 6.13-/+1.26 (95%CI, 3.65-8.61) months in group A, and 5.92-/+0.49 (95%CI, 4.97-6.87) months in group B; the OS was 10.67-/+1.55 (95%CI, 7.63-13.71) months in group A, and 10.8-/+3.07 (95%CI, 4.78-16.82) months in group B. Neither TTP or OS showed significant differences between the two groups (P>0.05). Five patients in group A (8.33%) and 8 in group B (11.11%) had grade 3 and 4 leukopenia. The non-hematological toxicities were mostly mild, including nausea, vomiting, stomatitis, diarrhea and alopecia. The main adverse effects were grade 1 or 2 sensory neuritis in FOLFOX group, and alopecia in PLF group, without significant difference between the two groups (P<0.05). CONCLUSION: Both FOLFOX and PLF can serve as effective first-line treatment of stage IV gastric adenocarcinoma with good tolerance.