Riechelmann Rachel P, Townsley Carol A, Chin Sheray N, Pond Gregory R, Knox Jennifer J
Department of Medical Oncology, Albert Einstein Hospital, Sao Paulo, Brazil.
Cancer. 2007 Sep 15;110(6):1307-12. doi: 10.1002/cncr.22902.
A phase 2 trial of gemcitabine and capecitabine (GemCap) in patients with advanced biliary cancer led to an objective response in approximately 30% of patients and a median survival of 14 months. In the current study, the authors report further efficacy data of a larger cohort of such patients treated with the GemCap regimen.
Patients aged >18 years and who had a diagnosis of locally advanced biliary cancer received first-line treatment with capecitabine at a dose of 650 mg/m(2) twice daily for 14 days and gemcitabine at a dose of 1,000 mg/m(2) on Day 1 and Day 8, every 3 weeks until disease progression. Tumor response was assessed by Response Evaluation Criteria In Solid Tumors (RECIST) criteria.
Between July 2001 and January 2005, 75 patients were enrolled in the study. At a median follow-up of 9.5 months, the overall response rate was 29% (95% confidence interval [95% CI], 19.4-41%), with a median duration of 9.7 months (range, 3-36 months). Three patients achieved complete responses, with a median duration of 17 months (range, 9-27 months). The median progression-free survival and overall survivals were 6.2 months (95% CI, 4.4-8.3 months) and 12.7 months (95% CI, 9.5-31 months), respectively.
The GemCap regimen is active in patients with biliary cancer. Randomized trials are warranted to define the impact of such a regimen on patient survival and quality of life.
一项针对晚期胆管癌患者的吉西他滨与卡培他滨（GemCap）2期试验使约30%的患者出现客观缓解，中位生存期为14个月。在本研究中，作者报告了接受GemCap方案治疗的更多此类患者的进一步疗效数据。
年龄>18岁且诊断为局部晚期胆管癌的患者接受一线治疗，卡培他滨剂量为650mg/m²，每日两次，共14天，吉西他滨剂量为1000mg/m²，于第1天和第8天给药，每3周重复一次，直至疾病进展。采用实体瘤疗效评价标准（RECIST）评估肿瘤反应。
2001年7月至2005年1月期间，75例患者入组本研究。中位随访9.5个月时，总缓解率为29%（95%置信区间[95%CI]，19.4 - 41%），中位缓解持续时间为9.7个月（范围3 - 36个月）。3例患者达到完全缓解，中位缓解持续时间为17个月（范围9 - 27个月）。中位无进展生存期和总生存期分别为6.2个月（95%CI，4.4 - 8.3个月）和12.7个月（95%CI，9.5 - 31个月）。
GemCap方案对胆管癌患者有活性。有必要进行随机试验以确定该方案对患者生存及生活质量的影响。
