Giuliani F, Gebbia V, Maiello E, Borsellino N, Bajardi E, Colucci G
Division of Medical Oncology, National Institute of Oncology, Bari, Italy.
Ann Oncol. 2006 Jun;17 Suppl 7:vii73-7. doi: 10.1093/annonc/mdl956.
The aim of the study was to test the clinical efficacy and toxicity profile of gemcitabine (GEM) in combination with cisplatin (CDDP) in a series of patients affected by unresectable and/or metastatic biliary tree carcinoma (BTC) previously untreated with chemotherapy.
Overall 38 consecutive patients who satisfied eligibility criteria (10 with gall-bladder carcinoma and 28 with bile duct carcinoma) were included in this phase II study. Median age was 61 years with median PS 1. Treatment included GEM 1000 mg/m(2)/week as 30 min i.v. on days 1 and 8, and CDDP 75-80 mg/m(2) on day 1 with adequate hydration protocol and forced diuresis. Treatment was repeated every 3 weeks for three cycles before first re-evaluation of disease status.
According to an intent-to-treat analysis a complete response (CR) was achieved in 1 patient (3%) with duration of 8 months. A partial response (PR) was recorded in 11 cases (29%; 95% CI 6% to 48%) with a median duration of 6.4 months (range 5-11 months) for an overall response rate (ORR) of 32%. Stable disease (SD) was seen in eight cases (21%), while the remaining 18 patients showed progressive disease (PD). Tumor growth control rate was 53%. Objective responses were recorded at loco-regional disease, liver and nodal metastases. Lung and peritoneal metastases did not respond. Time-to-progression was 4 months (range 2-11 months) and median overall survival was 8+ months (range 2-15 months). Side-effects were mild with few cases of grade 4 hematological toxicity. Transient and reversible liver toxicity was recorded in nearly one-quarter of patients. Infection without severe grade 4 neutropenia was observed in three cases. In no case was chemotherapy withdrawn for toxicity.
The GEM/CDDP regimen is active against advanced and/or metastatic BTC with a favourable toxicity profile. This regimen represents a reasonable therapeutic choice for palliation of advanced BTC. Inferences concerning overall survival are difficult to draw due to the phase II nature of the study.
本研究旨在测试吉西他滨（GEM）联合顺铂（CDDP）对一系列既往未接受过化疗的不可切除和/或转移性胆管癌（BTC）患者的临床疗效和毒性特征。
本II期研究共纳入38例符合入选标准的连续患者（10例胆囊癌患者和28例胆管癌患者）。中位年龄为61岁，中位体能状态为1。治疗方案包括第1天和第8天静脉滴注30分钟给予GEM 1000mg/m²/周，第1天给予CDDP 75 - 80mg/m²，并采用适当的水化方案和强制利尿。在首次重新评估疾病状态前，每3周重复治疗3个周期。
根据意向性分析，1例患者（3%）达到完全缓解（CR），持续时间为8个月。11例患者（29%；95%CI 6%至48%）记录为部分缓解（PR），中位持续时间为6.4个月（范围5 - 11个月），总缓解率（ORR）为32%。8例患者（21%）疾病稳定（SD），其余18例患者疾病进展（PD）。肿瘤生长控制率为53%。在局部区域疾病、肝脏和淋巴结转移处记录到客观缓解。肺和腹膜转移无反应。疾病进展时间为4个月（范围2 - 1个月），中位总生存期为8 +个月（范围2至15个月）。副作用较轻，4级血液学毒性病例较少。近四分之一的患者记录有短暂且可逆的肝毒性。3例患者观察到无严重4级中性粒细胞减少的感染。无一例因毒性而停止化疗。
GEM/CDDP方案对晚期和/或转移性BTC有效，毒性特征良好。该方案是晚期BTC姑息治疗的合理选择。由于本研究的II期性质，难以得出关于总生存期的推断。
