奥沙利铂联合亚叶酸钙每周低剂量给药、推注和持续输注氟尿嘧啶（改良 FOLFOX4 方案）作为晚期胃癌患者的挽救治疗。
Oxaliplatin with biweekly low dose leucovorin and bolus and continuous infusion of 5-fluorouracil (modified FOLFOX 4) as a salvage therapy for patients with advanced gastric cancer.
机构信息
Department of Internal Medicine, Dong-A University College of Medicine, Busan, Korea.
出版信息
Cancer Res Treat. 2005 Oct;37(5):279-83. doi: 10.4143/crt.2005.37.5.279. Epub 2005 Oct 31.
PURPOSE
To determine the activity and the toxicity associated with a low dose regimen of leucovorin (LV) plus 5-fluorouracil (5-FU) combined with oxaliplatin every two weeks (modified FOLFOX 4) as a salvage therapy for advanced gastric cancer patients.
MATERIALS AND METHODS
Between December 2003 and December 2004, 33 patients were enrolled in this study. The patients were treated with oxaliplatin 85 mg/m(2) as a 2-hour infusion on the first day plus LV 20 mg/m(2) over 10 minutes. Subsequently, the patients were given a 5-FU bolus 400 mg/m(2) followed by a 22-hour continuous infusion of 600 mg/m(2) on days 1 approximately 2. The treatment was repeated at 2 week intervals.
RESULTS
The median age of the patients was 50 years (range: 31 approximately 74), 82% (27/33) had the Eastern Cooperative Oncology Group performance status was 0 and 1. Of the 30 patients who could be evaluated for their tumor response, 8 achieved a partial response, with an overall response rate of 26.7% (95% confidence interval (CI): 20.5 approximately 32.7%). Fifteen patients (50%) showed stable disease and 7 patients (23.3%) progressed during the course of treatment. The median time from the start of chemotherapy to progression was 3.5 months (95% CI: 2.6 approximately 4.4 months) and the median overall survival time was 7.9 months (95% CI: 5.9 approximately 9.9 months). The major grade 3/4 hematological toxicity encountered included neutropenia (45.4%) and thrombocytopenia (3.0%). Neutropenic fever occurred during only 2 of the 178 cycles. The most common non-hematological toxicity encountered was grade 1/2 nausea/vomiting, which occurred in 18.2% of patients, diarrhea in 12.1% and neuropathy in 15.2%. There were no treatment related deaths.
CONCLUSION
The modified FOLFOX 4 regimen appears to be a safe and effective salvage therapy for advanced gastric cancer patients.
目的
确定低剂量亚叶酸（LV）联合奥沙利铂每两周（改良 FOLFOX4）联合氟尿嘧啶（5-FU）用于晚期胃癌患者挽救治疗的活性和毒性。
材料和方法
2003 年 12 月至 2004 年 12 月，共 33 例患者入组本研究。患者接受奥沙利铂 85mg/m2，2 小时输注，第 1 天；LV 20mg/m2，10 分钟输注。随后，患者给予氟尿嘧啶 400mg/m2 推注，随后在第 1 天至第 2 天给予 600mg/m2 持续输注 22 小时。每 2 周重复一次。
结果
患者中位年龄为 50 岁（范围：31-74），82%（27/33）ECOG 体能状态为 0 或 1。在可评价肿瘤反应的 30 例患者中，8 例达到部分缓解，总缓解率为 26.7%（95%CI：20.5-32.7%）。15 例（50%）患者病情稳定，7 例（23.3%）患者在治疗过程中进展。从化疗开始到进展的中位时间为 3.5 个月（95%CI：2.6-4.4 个月），中位总生存时间为 7.9 个月（95%CI：5.9-9.9 个月）。主要的 3/4 级血液学毒性包括中性粒细胞减少（45.4%）和血小板减少（3.0%）。178 个周期中仅发生 2 例中性粒细胞减少发热。最常见的非血液学毒性为 1/2 级恶心/呕吐，发生率为 18.2%，腹泻发生率为 12.1%，神经病变发生率为 15.2%。无治疗相关死亡。
结论
改良 FOLFOX4 方案似乎是晚期胃癌患者安全有效的挽救治疗方案。
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