Song Hong Suk, Do Young Rok, Chang Heung Moon, Ryu Min Hee, Lee Kyung Hee, Kim Yeul Hong, Hong Dae Sik, Cho Jae Yong, Lee Kyoung Eun, Kim Si Young
Division of Hematooncology, Department of Internal Medicine, Dongsan Medical Center, Keimyung University School of Medicine, Dongsan-Dong, Chung-Gu, Daegu 200-712, South Korea.
Cancer Chemother Pharmacol. 2008 Oct;62(5):763-8. doi: 10.1007/s00280-007-0661-y. Epub 2008 Jan 3.
This open-label, multicenter phase II study was conducted to investigate the efficacy and safety of capecitabine plus gemcitabine combination chemotherapy as first-line treatment in patients with locally advanced or metastatic pancreatic cancer.
We enrolled 63 patients who received capecitabine 830 mg/m(2) orally twice daily on days 1-21 plus gemcitabine 1000 mg/m(2) as a 30-min infusion on days 1, 8 and 15 every 4 weeks for up to six cycles.
A total of 14 patients had partial responses giving an overall response rate of 22% (95% confidence interval [CI] 13-34%) in the intent-to-treat population. The median time to progression and overall survival were 3.9 months (95% CI 3.5-5.7) and 7.5 months (95% CI 5.0-10.0), respectively, and 1-year survival rate was 27.1% in the intent-to-treat population. Capecitabine plus gemcitabine was well tolerated. Grade 3 hematological adverse events were neutropenia (21%) and thrombocytopenia (2%); the only grade 4 hematological events were anemia (2%) and neutropenia (6%). Non-hematological adverse events were mainly gastrointestinal events and hand-foot syndrome, which affected 16% of patients. Grade 3/4 non-hematological events were infrequent.
The combination of capecitabine plus gemcitabine appears to be active and well tolerated as first-line treatment in patients with advanced/metastatic pancreatic cancer.
本开放标签、多中心II期研究旨在调查卡培他滨联合吉西他滨作为局部晚期或转移性胰腺癌患者一线治疗的疗效和安全性。
我们纳入了63例患者，这些患者在第1 - 21天每天口服两次卡培他滨830 mg/m²，联合吉西他滨1000 mg/m²，每4周在第1、8和15天进行30分钟静脉输注，最多进行6个周期。
在意向性治疗人群中，共有14例患者出现部分缓解，总缓解率为22%（95%置信区间[CI] 13 - 34%）。中位疾病进展时间和总生存期分别为3.9个月（95% CI 3.5 - 5.7）和7.5个月（95% CI 5.0 - 10.0），意向性治疗人群的1年生存率为27.1%。卡培他滨联合吉西他滨耐受性良好。3级血液学不良事件为中性粒细胞减少（21%）和血小板减少（2%）；唯一的4级血液学事件为贫血（2%）和中性粒细胞减少（6%）。非血液学不良事件主要是胃肠道事件和手足综合征，影响了16%的患者。3/4级非血液学事件不常见。
卡培他滨联合吉西他滨作为晚期/转移性胰腺癌患者的一线治疗似乎具有活性且耐受性良好。
