健择联合顺铂治疗初治进展期食管癌II期临床研究

Ⅱ stage Study or gemcitabine in combination with cisplatin in patients with previously untreated advanced esophagus carcinoma

目的:观察健择联合顺铂治疗初治进展期食管癌的临床疗效和不良反应。方法:14例初治进展期食管癌患者,采用健择1g/m2d1、8,顺铂40g/m2d8、9,3周为一周期,2周期后评价疗效。结果:14例初治食管癌患者有效率42.9%(6/14),稳定35.7%(5/14)、进展21.4%(3/14)。均能耐受化疗,主要不良反应为骨髓抑制。结论:与传统标准FLP方案相比,健择联合顺铂方案有一定作用,但无明显优势。

Objictive:To evaluate the clinical activity and toxicity of gemcitabine in combination with cisplatin in patients with previously untreated advanced esophagus carcinoma. Methods: patients with previously untreated advanced esophagus carcinoma were treated with gemcitabine 1000 mg /m2 on days1, 8 and cisplatin 40 mg/m(2)on day 8, 9. Cycles were repeated every 21 days. Results: 14 eligible patients were accrued from 52cycles. Six out of 14(42.9%) evaluable patients had a major objective response and stable rate 35.7%(5/14) and progressive rate 21.4%(3/14). Toxicity was mild and mangeable. The most frequent toxicities were leukopenia and thrombocytopenia. Conclusions: This gemcitabine - cisplatin regimen was feasible, but there was no significant superiority compared with traditional regime of FLP.