Division of Gastrointestinal Oncology, Shizuoka Cancer Center, Shizuoka, Japan.
Jpn J Clin Oncol. 2010 Jun;40(6):567-72. doi: 10.1093/jjco/hyq005. Epub 2010 Feb 26.
No standard salvage chemotherapy regimen has been established for patients with advanced pancreatic cancer after failure of gemcitabine-based treatment. Although a Phase II study of S-1 monotherapy was conducted in patients with gemcitabine-refractory advanced pancreatic cancer, the number of patients enrolled was small.
We retrospectively reviewed 84 consecutive patients who received S-1 monotherapy as a second-line treatment after gemcitabine failure at the Shizuoka Cancer Center between May 2004 and April 2008. The selection criteria in this study were age 20-75 years, ECOG performance status <or=2 and preserved organ functions. S-1 was administered orally twice a day at a dose of 40 mg/m(2) for 28 days, followed by 14-day rest.
Fifty-two patients were selected for the analysis. Out of the 47/52 patients with measurable lesions, only 2 patients (4%) showed a partial response and 15 patients (32%) showed stable disease. The median progression-free survival was 2.1 months and the median overall survival was 5.8 months, with a 1-year survival rate of 12%. The common grade 3/4 toxicities were diarrhea (8%), anorexia (6%), fatigue (6%), anemia (6%) and leucopenia (4%).
S-1 monotherapy is marginally effective and well tolerated in the second-line setting in patients with gemcitabine-refractory advanced pancreatic cancer.
吉西他滨治疗失败后的晚期胰腺癌患者，尚未确立标准的挽救化疗方案。虽然在吉西他滨耐药的晚期胰腺癌患者中进行了 S-1 单药治疗的 II 期研究，但入组患者数量较少。
我们回顾性分析了 2004 年 5 月至 2008 年 4 月在静冈癌症中心接受吉西他滨失败后作为二线治疗的 S-1 单药治疗的 84 例连续患者。本研究的入选标准为年龄 20-75 岁，ECOG 表现状态<或=2，且器官功能正常。S-1 口服，每天 2 次，每次 40mg/m²，连用 28 天，然后休息 14 天。
52 例患者入选进行分析。在可测量病变的 47/52 例患者中，仅 2 例（4%）出现部分缓解，15 例（32%）病情稳定。无进展生存期的中位数为 2.1 个月，总生存期的中位数为 5.8 个月，1 年生存率为 12%。常见的 3/4 级毒性有腹泻（8%）、厌食（6%）、乏力（6%）、贫血（6%）和白细胞减少（4%）。
S-1 单药治疗在吉西他滨耐药的晚期胰腺癌二线治疗中具有一定疗效，且耐受性良好。
