Zaniboni A, Barni S, Labianca R, Marini G, Pancera G, Giaccon G, Piazza E, Signaroldi A, Legnani W, Luporini G
Servizio di Oncologia, Spedali Civili, Brescia, Italy.
Cancer. 1995 Nov 15;76(10):1694-9. doi: 10.1002/1097-0142(19951115)76:10<1694::aid-cncr2820761004>3.0.co;2-k.
A Phase II confirmatory multicenter trial was performed to evaluate a combination of epirubicin, cisplatin, and continuous infusion 5-fluorouracil (ECF) in treating patients with advanced gastric cancer.
Fifty-three patients with locally advanced (n = 7) or metastatic (n = 46) gastric cancer received a dose of epirubicin (50 mg/m2) and cisplatin (60 mg/m2) intravenously every 21 days for eight cycles with 5-fluorouracil (200 mg/m2/day) by intravenous continuous infusion for 21 consecutive weeks, administered through a central line using an external pump.
Eight complete responses and 22 partial responses (response rate = 56%, 95% confidence interval +/- 13) were achieved. Twelve patients had stable disease. The median duration of response was 10 months (range, 3-21 months), and the median survival for all the patients was 9+ months (range, 2-28 months). Overall toxicity, which was primarily hematologic, was mild with only three patients requiring hospitalization for neutropenic fever. No death due to toxicity occurred.
This study found that the ECF regimen is substantially active in treating patients with advanced gastric cancer and has a favorable pattern of toxicity. This schedule clearly deserves randomized comparative trials for palliation of metastatic disease and for adjuvant purposes.
开展了一项II期验证性多中心试验，以评估表柔比星、顺铂和持续输注5-氟尿嘧啶（ECF）联合方案治疗晚期胃癌患者的疗效。
53例局部晚期（n = 7）或转移性（n = 46）胃癌患者接受表柔比星（50 mg/m2）和顺铂（60 mg/m2）静脉注射，每21天一次，共8个周期，同时5-氟尿嘧啶（200 mg/m2/天）通过中心静脉导管经外置泵持续静脉输注21周。
获得8例完全缓解和22例部分缓解（缓解率 = 56%，95%置信区间±13）。12例患者病情稳定。缓解的中位持续时间为10个月（范围3 - 21个月），所有患者的中位生存期为9 +个月（范围2 - 28个月）。总体毒性主要为血液学毒性，程度较轻，仅有3例患者因中性粒细胞减少性发热住院。未发生因毒性导致的死亡。
本研究发现ECF方案治疗晚期胃癌患者具有显著活性，且毒性特征良好。该方案显然值得进行随机对照试验，用于转移性疾病的姑息治疗和辅助治疗。
