Gallardo J O, Rubio B, Fodor M, Orlandi L, Yáñez M, Gamargo C, Ahumada M
Sección Oncología, Hospital Clínico José Joaquín Aguirre Universidad de Chile, Santiago.
Ann Oncol. 2001 Oct;12(10):1403-6. doi: 10.1023/a:1012543223020.
Due to the high mortality rates from gallbladder carcinoma in Chile, we conducted a phase II trial to test the efficacy and safety of gemcitabine in patients with locally advanced or metastatic gallbladder carcinoma.
From January 1998 to February 2000, 26 patients with metastatic or unresectable gallbladder carcinoma and no prior chemotherapy received gemcitabine 1,000 mg/m2 over 30 minutes weekly for three weeks followed by a week of rest.
Patients received a median of 4.2 cycles (range 1-10). Out of the 25 patients whose response could be evaluated, 9 went into partial remission, an overall response rate of 36% (95% confidence interval (95% CI): 17.1% to 57.9%). In six (25.0%) patients, the cancer remained stable, and in 10 (40%) it progressed. Median survival time was 30 weeks (range 7-80+. Hematological toxicities were mild, with no cases of febrile neutropenia or hemorrhage. However, four and one patient(s) had grades 1-2 and 3-4 neutropenia, respectively, and two patients had grade 2 thrombocytopenia. Nine patients experienced grade 1-2 nausea/vomiting, but were able to continue treatment. There were no toxic deaths.
In this phase II trial, gemcitabine is an active chemotherapy in metastatic or inoperable gallbladder carcinoma, with a manageable toxicity profile.
由于智利胆囊癌的高死亡率，我们开展了一项II期试验，以测试吉西他滨对局部晚期或转移性胆囊癌患者的疗效和安全性。
1998年1月至2000年2月，26例转移性或不可切除的胆囊癌患者且未接受过化疗，接受吉西他滨1000mg/m²，静脉滴注30分钟，每周1次，共3周，随后休息1周。
患者接受的中位周期数为4.2个周期（范围1 - 10）。在25例可评估反应的患者中，9例达到部分缓解，总缓解率为36%（95%置信区间（95%CI）：17.1%至57.9%）。6例（25.0%）患者病情稳定，10例（40%）病情进展。中位生存时间为30周（范围7 - 80 +）。血液学毒性较轻，无发热性中性粒细胞减少或出血病例。然而，分别有4例和1例患者出现1 - 2级和3 - 4级中性粒细胞减少，2例患者出现2级血小板减少。9例患者出现1 - 2级恶心/呕吐，但能够继续治疗。无毒性死亡病例。
在这项II期试验中，吉西他滨对转移性或无法手术切除的胆囊癌是一种有效的化疗药物，且毒性易于控制。
