Department of Gastrointestinal Surgery, Kanagawa Cancer Center, 1-1-2 Nakao, Asahi-ku, Yokohama 241-0815, Japan.
Gastric Cancer. 2009;12(4):212-8. doi: 10.1007/s10120-009-0528-5. Epub 2010 Jan 5.
The aim of this study was to establish the efficacy and safety of doxifluridine and docetaxel for patients with advanced or recurrent gastric cancer.
The regimen consisted of oral administration of doxifluridine 533 mg/m(2) per day on days 1-14 and an intravenous infusion of docetaxel 50 mg/m(2) on day 8. The primary endpoint was the overall response rate. The secondary endpoints were overall survival, progression-free survival, and toxicities.
Between June 2004 and December 2006, a total of 40 eligible patients were enrolled in this study. Seven of them showed a partial response, with an overall response rate of 17.5%. The response rate was 18.8% in 32 patients with refractory tumors. The median progression-free survival time and the median overall survival time were 2.6 months and 12.7 months, respectively, in all 40 patients; and 2.6 months and 14.0 months, respectively, in the 32 patients with refractory tumors. Grade 3/4 hematological toxicity included neutropenia in 52.5%, leukocytopenia in 17.5%, and febrile neutropenia in 7.5%. Grade 3 or more nonhematological toxicities were infrequent.
The combination chemotherapy of doxifluridine and docetaxel was well tolerated and relatively effective when used as a second-line chemotherapy for advanced or recurrent gastric cancer.
本研究旨在评估多西氟尿苷联合多西紫杉醇治疗晚期或复发性胃癌的疗效和安全性。
该方案包括多西氟尿苷 533mg/m²/d，口服，第 1-14 天；多西紫杉醇 50mg/m²，静脉滴注，第 8 天。主要终点为总缓解率。次要终点包括总生存期、无进展生存期和毒性。
2004 年 6 月至 2006 年 12 月，共有 40 例符合条件的患者入组本研究。其中 7 例患者部分缓解，总缓解率为 17.5%。32 例耐药肿瘤患者的缓解率为 18.8%。40 例患者的中位无进展生存期和中位总生存期分别为 2.6 个月和 12.7 个月；32 例耐药肿瘤患者的中位无进展生存期和中位总生存期分别为 2.6 个月和 14.0 个月。3/4 级血液学毒性包括中性粒细胞减少症（52.5%）、白细胞减少症（17.5%）和发热性中性粒细胞减少症（7.5%）。3 级或以上非血液学毒性不常见。
多西氟尿苷联合多西紫杉醇作为晚期或复发性胃癌的二线化疗药物，耐受性良好，疗效相对较好。
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