Combination therapy consisting of gemcitabine, carboplatin, and docetaxel as an active treatment for advanced urothelial carcinoma
Combination therapy consisting of gemcitabine, carboplatin, and docetaxel as an active treatment for advanced urothelial carcinoma
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DOI：
10.1007/s10147-011-0224-4
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发表时间：
2011-03
影响因子：
3.3
通讯作者：
H. Tsuruta;T. Inoue;S. Narita;Y. Horikawa;M. Saito*;T. Obara;K. Numakura;S. Maita;S. Satoh
中科院分区：
文献类型：
--
作者：
H. Tsuruta;T. Inoue;S. Narita;Y. Horikawa;M. Saito*;T. Obara;K. Numakura;S. Maita;S. Satoh
作为一项II期试验，评估吉西他滨、卡铂和多西紫杉醇（GCD）联合化疗对晚期尿路上皮癌（UC）患者的疗效和毒性。材料和方法转移性或局部晚期不可切除UC患者符合本试验的条件。所有入选的患者都被认为“不适合”顺铂化疗，或有甲氨蝶呤、长春碱、阿霉素、顺铂（MVAC）难治性UC。化疗方案包括吉西他滨1000 mg/m2（第1天和第8天）和卡铂（靶区在曲线5下）和多西他赛70 mg/m2（第1天）；每21天重复一次。结果纳入35例患者，中位年龄为68岁。共给予89个周期（中位数为2个周期）。主要毒性为3/4级中性粒细胞减少症28例（80.0%），3/4级血小板减少症18例（51.5%）。客观缓解率（ORR）为11 / 21(52.4%)，其中1例完全缓解（4.8%）。中位总生存期（OS）为13.1个月（1年生存率为60%），中位无进展生存期（PFS）为5.0个月。在16例既往接受MVAC治疗的患者中，ORR、中位PFS、中位OS和1年生存率分别为56.3%、5.0个月、12.6个月和54%。结论sgcd化疗作为晚期UC患者的一线或二线治疗具有良好的活性和耐受性。有效率、持续时间和生存率在有和没有MVAC治疗史的患者之间没有差异。
BackgroundTo evaluate the efficacy and toxicity of a combination chemotherapy consisting of gemcitabine, carboplatin, and docetaxel (GCD) in patients with advanced urothelial carcinoma (UC) as a phase II trial.Materials and methodsPatients with metastatic or locally advanced unresectable UC were eligible for this trial. All enrolled patients were considered to be “unfit” for cisplatin-based chemotherapy, or to have methotrexate, vinblastine, doxorubicin, cisplatin (MVAC)-refractory UC. The chemotherapy regimen consisted of gemcitabine 1000 mg/m2on days 1 and 8, and carboplatin (with a target area under the curve of 5) and docetaxel 70 mg/m2on day 1; this was repeated every 21 days.ResultsThirty-five patients were enrolled, with a median age of 68 years. A total of 89 cycles were administered (median, 2 cycles). Major toxicities were Grade 3/4 neutropenia in 28 (80.0%) patients and Grade 3/4 thrombocytopenia in 18 (51.5%). An objective response rate (ORR) was 11 of 21 patients (52.4%), including a complete response in 1 (4.8%). The median overall survival (OS) was 13.1 months (1-year survival rate, 60%) and the median progression-free survival (PFS) was 5.0 months. Among 16 patients who had previously received MVAC, the ORR, the median PFS, the median OS and 1-year survival rate was 56.3%, 5.0 months, 12.6 months and 54%, respectively.ConclusionsGCD chemotherapy is active and well tolerated as a first- or second-line therapy for patients with advanced UC. Response rate, duration and survival did not differ between those with and without a history of MVAC treatment.