Constenla Manuel, Garcia-Arroyo Ramon, Lorenzo Isabel, Carrete Nancy, Campos Begoña, Palacios Patricia
Medical Oncology Service, Complexo Hospitalario de Pontevedra, C/Loureiro Crespo, 2, 36001 Pontevedra, Spain.
Gastric Cancer. 2002;5(3):142-7. doi: 10.1007/s101200200025.
Previous studies have shown that the taxane, docetaxel, is effective in treating gastric cancer. The aim of this study was to assess the efficacy and safety of docetaxel in combination with 5-fluorouracil (5-FU) and leucovorin (LV).
Thirty patients with histologically proven locally advanced and/or metastatic gastric cancer with WHO performance status 0-2 were enrolled and received either 75 or 100 mg/m(2) docetaxel as a 1-h intravenous infusion on day 1 every 28 days. All patients also received 5-FU (1800 mg/m(2)) plus LV (500 mg/m(2)), by continuous intravenous infusion over 24 h on days 1, 8, and 15 every 28 days. Chemotherapy was given for at least two cycles.
Of the 25 evaluable patients, 3 showed a complete response, 4 showed a partial response, and 11 patients had stable disease. The overall response rate was 28.0% (95% confidence interval [CI], 10.4, 45.6). The median time to progression was 5.9 months (95% CI, 5.4, 6.5), and the median overall survival was 7.7 months (95% CI, 7.2, 8.3) for the intent-to-treat population. The most frequent grade III and IV hematological toxicities were neutropenia and anemia. Febrile neutropenia was observed in 10% of patients and 2.4% of cycles. The prophylactic use of granulocyte colony-stimulating factor (G-CSF) in 3 patients reduced the incidence and severity of neutropenia. Other hematological toxicities were rare.
Docetaxel in combination with weekly 5-FU and LV is effective in treating patients with advanced/metastatic gastric cancer. This new docetaxel-containing combination shows promise as a third-generation treatment option for gastric cancer.
既往研究表明，紫杉烷类药物多西他赛对胃癌有效。本研究旨在评估多西他赛联合5-氟尿嘧啶（5-FU）和亚叶酸钙（LV）的疗效和安全性。
30例经组织学证实为局部晚期和/或转移性胃癌且世界卫生组织体能状态为0-2级的患者入组，每28天在第1天接受75或100mg/m²多西他赛静脉滴注1小时。所有患者还在每28天的第1、8和15天接受24小时持续静脉输注5-FU（1800mg/m²）加LV（500mg/m²）。化疗至少进行两个周期。
25例可评估患者中，3例完全缓解，4例部分缓解，11例病情稳定。总缓解率为28.0%（95%置信区间[CI]，10.4，45.6）。意向性治疗人群的中位疾病进展时间为5.9个月（95%CI，5.4，6.5），中位总生存期为7.7个月（95%CI，7.2，8.3）。最常见的Ⅲ级和Ⅳ级血液学毒性是中性粒细胞减少和贫血。10%的患者和2.4%的周期出现发热性中性粒细胞减少。3例患者预防性使用粒细胞集落刺激因子（G-CSF）降低了中性粒细胞减少的发生率和严重程度。其他血液学毒性罕见。
多西他赛联合每周一次的5-FU和LV对晚期/转移性胃癌患者有效。这种含多西他赛的新联合方案有望成为胃癌的第三代治疗选择。
