Gemcitabine and oxaliplatin in patients with unresectable biliary cancer including gall bladder cancer: a Korean Cancer Study Group phase II trial
Gemcitabine and oxaliplatin in patients with unresectable biliary cancer including gall bladder cancer: a Korean Cancer Study Group phase II trial
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DOI：
10.1007/s00280-009-1069-7
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发表时间：
2010-03-01
影响因子：
3
通讯作者：
Lee, Sang Jae
中科院分区：
文献类型：
--
作者：
Jang, Joung-Soon;Lim, Ho Yeong;Lee, Sang Jae
化疗是一种姑息性治疗，在胆道癌（BTC）患者中反应率低，中位生存期不到6个月。本研究的目的是评价吉西他滨联合奥沙利铂（GEMOX）治疗包括胆囊癌在内的BTCs的疗效和安全性，我们在全国范围内开展了一项多中心II期临床研究，评价GEMOX作为一线治疗晚期BTCs的疗效和安全性。既往未经治疗的局部晚期或转移性BTCs合格患者接受吉西他滨1，000 mg/m（2）奥沙利铂100 mg/m2（第1天），每3周1次，共53例，其中胆管癌60%，胆囊癌40%;治疗人群的客观缓解率为18.9%（10/53例患者，包括1例完全缓解）[14.9%; 95%置信区间（CI），7.4-25.7%]。27/53例（50.9%）患者病情稳定，疾病控制率为69.8%。中位无进展生存期为4.8个月（3.1-6.5，95% CI），中位总生存期为8.3个月（5.8-10.8，95% CI）。3/4级毒性包括中性粒细胞减少症（33.9%的患者）和血小板减少症（7.6%）AEMOX方案显示出适度的抗肿瘤活性，并且在患有晚期BTC的患者中耐受良好。
Chemotherapy represents a palliative treatment, with poor response rates and a median survival of less than 6 months in patients with biliary tract cancers (BTCs). The aim of this study was to evaluate the efficacy and safety of the combination chemotherapy with gemcitabine and oxaliplatin (GEMOX) in patients with BTCs including gall bladder cancer.We carried out a nationwide multicenter phase II study evaluated the efficacy and safety of GEMOX as first-line therapy in patients with advanced BTCs. Eligible patients with previously untreated locally advanced or metastatic BTCs received gemcitabine 1,000 mg/m(2) (day 1 and 8) and oxaliplatin 100 mg/m(2) (day 1), every 3 weeks.Fifty-three patients were evaluated, 60% had cholangiocarcinoma and the remaining 40% gall bladder cancer; the objective response rate was 18.9% (10/53 patients including 1 Complete response) [14.9%; 95% confidence interval (CI), 7.4-25.7%] in the treated population. Stable disease were observed in 27/53 (50.9%) patients, disease control rate was achieved in 69.8% of all patients. Median progression-free survival was 4.8 months (3.1-6.5, 95% CI) and median overall survival was 8.3 months (5.8-10.8, 95% CI). Grade 3/4 toxicities included neutropenia (33.9% of patients) and thrombocytopenia (7.6%).The GEMOX regimen demonstrated a modest antitumor activity and is well tolerated in patients with advanced BTCs.