Tsavaris Nikolas, Kosmas Christos, Gouveris Panagiotis, Gennatas Kostadinos, Polyzos Aris, Mouratidou Despina, Tsipras Heracles, Margaris Helias, Papastratis George, Tzima Evanthia, Papadoniou Nikitas, Karatzas Gavrilos, Papalambros Efstathios
Hellenic Group of Oncology, Athens, Greece.
Invest New Drugs. 2004 Apr;22(2):193-8. doi: 10.1023/B:DRUG.0000011797.09549.53.
To evaluate the efficacy and safety of weekly administration of gemcitabine treatment in chemotherapy-naïve patients with advanced biliary tract and gallbladder cancer.
Gemcitabine at a dose of 800 mg/m2 was administered weekly as a 30-min infusion to patients with previously operated, histologically confirmed, metastatic, or unresectable locally advanced cholangiocarcinoma. Treatment was continued until unacceptable toxicity or disease progression.
A total of 30 patients (median age 66 years; range 54-72 years) were included in the study. A median of 14 (range, 4-33) weekly doses was administered. Out of 30 patients evaluable for response, nine partial responses were observed (30.0%), while a further 11 patients demonstrated stable disease (36.7%). The median time to disease progression was 7 months (range, 5-34). Overall response rate was superior in patients with cancer of the gallbladder (ORR = 35.7%) compared with those patients with biliary duct cancer (ORR = 27.3%). This correlated to a significantly longer time to progression of 6.4 months (95% confidence interval (CI), 5.6-7.1 months) versus 3.6 months (95% CI, 2.9-4.3 months; p = 0.03) and a significantly better overall survival of 17.1 months (95% CI, 15.8-18.5 months) versus 11.4 months (95% CI, 10.2-12.6 months, p = 0.021). Toxicities were generally mild with only one case of grade 3 neutropenia. There were no cases of febrile neutropenia and no treatment-related deaths.
Weekly administration of gemcitabine provides a safe, well-tolerated, and effective treatment for chemotherapy naïve patients with advanced cholangiocarcinoma, particularly with a gallbladder origin.
评估吉西他滨每周给药方案对初治晚期胆管癌和胆囊癌患者的疗效及安全性。
对既往接受过手术、经组织学确诊为转移性或不可切除的局部晚期胆管癌患者，以800mg/m²的剂量每周静脉输注30分钟给予吉西他滨治疗。治疗持续至出现不可接受的毒性或疾病进展。
共有30例患者（中位年龄66岁；范围54 - 72岁）纳入本研究。中位给予14次（范围4 - 33次）每周剂量的治疗。在30例可评估疗效的患者中，观察到9例部分缓解（30.0%），另有11例患者病情稳定（36.7%）。疾病进展的中位时间为7个月（范围5 - 34个月）。胆囊癌患者的总缓解率（ORR = 35.7%）高于胆管癌患者（ORR = 27.3%）。这与显著更长的进展时间相关，分别为6.4个月（95%置信区间(CI)，5.6 - 7.1个月）和3.6个月（95% CI，2.9 - 4.3个月；p = 0.03），以及更好的总生存期，分别为17.1个月（95% CI，15.8 - 18.5个月）和11.4个月（95% CI，10.2 - 12.6个月，p = 0.021）。毒性反应一般较轻，仅1例3级中性粒细胞减少。无发热性中性粒细胞减少病例，也无治疗相关死亡病例。
对于初治的晚期胆管癌患者，尤其是胆囊源性患者，吉西他滨每周给药方案是一种安全、耐受性良好且有效的治疗方法。
