von Delius Stefan, Lersch Christian, Schulte-Frohlinde Ewert, Mayr Martina, Schmid Roland M, Eckel Florian
Department of Internal Medicine II, Technical University of Munich, Klinikum rechts der Isar, Ismaninger Str, 22, 81675 München, Germany.
BMC Cancer. 2005 Jun 12;5:61. doi: 10.1186/1471-2407-5-61.
Patients with advanced gallbladder and biliary tract carcinoma face a dismal prognosis, as no effective palliative chemotherapy exists. The antitumor effect of gemcitabine is schedule-dependent rather than dose-dependent. We evaluated the activity of a prolonged infusion of gemcitabine in advanced gallbladder and biliary tract carcinomas.
Nineteen consecutive eligible patients were enrolled. All patients were required to have histologically confirmed diagnosis and measurable disease. Gemcitabine was infused over 24 hours at a dose of 100 mg/m2 on days 1, 8, and 15. Treatment was repeated every 28 days until progression of disease or limiting toxicity. Tumor response was evaluated every second course by computed tomography (CT) scans.
Eighteen patients were evaluable for response. A total of 89 cycles of therapy were administered. One partial response was observed (6%; 95% confidence interval (CI): 0-27%) and ten additional patients had stable disease for at least two months (disease control rate 61%; 95% CI: 36-83%). The therapy was well tolerated, with moderate myelosuppression as the main toxicity. The median time to tumor progression and median overall survival was 3.6 months (95% CI 2.6-4.6 months) and 7.5 months (95% CI 6.5-8.5 months), respectively.
Weekly 24-hour gemcitabine at a dose of 100 mg/m2 is well tolerated. There was a relatively high rate of disease control for a median duration of 5.3 months (range 2.8-18.8 months). However, the objective response rate of this regimen in gallbladder and biliary tract carcinomas was limited.
晚期胆囊癌和胆管癌患者预后不佳，因为目前尚无有效的姑息化疗方案。吉西他滨的抗肿瘤作用取决于给药方案而非剂量。我们评估了吉西他滨持续输注对晚期胆囊癌和胆管癌的疗效。
连续纳入19例符合条件的患者。所有患者均需经组织学确诊且有可测量病灶。吉西他滨于第1、8和15天以100mg/m²的剂量持续输注24小时。每28天重复治疗，直至疾病进展或出现剂量限制性毒性。每两个疗程通过计算机断层扫描（CT）评估肿瘤反应。
18例患者可评估疗效。共进行了89个疗程的治疗。观察到1例部分缓解（6%；95%置信区间（CI）：0-27%），另有10例患者疾病稳定至少两个月（疾病控制率61%；95%CI：36-83%）。该治疗耐受性良好，主要毒性为中度骨髓抑制。肿瘤进展的中位时间和总生存的中位时间分别为3.6个月（95%CI 2.6-4.6个月）和7.5个月（95%CI 6.5-8.5个月）。
每周一次24小时输注100mg/m²的吉西他滨耐受性良好。疾病控制率相对较高，中位持续时间为5.3个月（范围2.8-18.8个月）。然而，该方案在胆囊癌和胆管癌中的客观缓解率有限。
