A Multicenter phase II study of docetaxel in combination with gefitinib in gemcitabine-pretreated patients with advanced/metastatic pancreatic cancer

A Multicenter phase II study of docetaxel in combination with gefitinib in gemcitabine-pretreated patients with advanced/metastatic pancreatic cancer
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DOI:
10.1159/000106064
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发表时间:
2006-01-01
期刊:
影响因子:
3.5
通讯作者:
Georgoulias, Vassilis
Georgoulias, Vassilis
中科院分区:
医学3区
文献类型:
--
作者:
Ignatiadis, Michail;Polyzos, Aris;Georgoulias, Vassilis

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目的:评价多西他赛联合吉非替尼二线治疗晚期胰腺癌的疗效和耐受性。患者和方法:26例接受吉西他滨化疗的患者入组本研究。多西他赛75 mg/m2,i. v.)的每3周给药最多6个周期,吉非替尼(250 mg/天,p.o.)是连续给予的。结果:5例(19.2%)患者病情稳定。中位疾病控制持续时间为4.8个月(范围1-13.2),中位疾病进展时间为2.1个月(范围1-7.3),中位生存时间为2.9个月(范围1-13.9)。9例(34.6%)患者记录了3/ 4级中性粒细胞减少,但仅1例(3.8%)患者发生了2级发热性中性粒细胞减少。1例(3.8%)患者发生3级疲乏,2例(7.7%)患者发生3级腹泻。在13例(50%)患者中观察到1/ 2级皮疹。未发生给药相关死亡。结论:多西他赛/吉非替尼联合治疗虽然安全,但对吉西他滨化疗失败的晚期胰腺癌无挽救治疗作用。
Purpose: To evaluate the efficacy and tolerance of the docetaxel/ gefitinib combination as second-line treatment in patients with advanced pancreatic cancer. Patients and Methods: Twenty-six patients pretreated with gemcitabine-based chemotherapy were enrolled in the study. Docetaxel (75 mg/ m(2), i. v.) was administered every 3 weeks for a maximum of 6 cycles and gefitinib (250 mg/ day, p. o.) was given continuously. Results: Five (19.2%) patients achieved stable disease. The median duration of disease control was 4.8 months (range 1-13.2), the median time to disease progression 2.1 months (range 1-7.3) and the median survival time 2.9 months (range 1-13.9). Grade 3/ 4 neutropenia was recorded in 9 (34.6%) patients, although only 1 (3.8%) developed grade 2 febrile neutropenia. One (3.8%) patient experienced grade 3 fatigue and 2 (7.7%) grade 3 diarrhea. Grade 1/ 2 rash was observed in 13 (50%) patients. There were no treatment-related deaths. Conclusion: The docetaxel/ gefitinib combination, although safe, has no activity as salvage treatment for advanced pancreatic cancer after failure of gemcitabine-based chemotherapy.