Pallis A G, Christofillakis Ch, Tselepatiotis E, Agelaki S, Vamvakas L, Souglakos J, Vardakis N, Kalykaki A, Kotsakis A, Argiraki A, Mavroudis D, Georgoulias V
Department of Medical Oncology, University General Hospital of Heraklion, P.O. Box 1352, 71110 Heraklion, Crete, Greece.
Lung Cancer. 2007 Jan;55(1):101-7. doi: 10.1016/j.lungcan.2006.08.019. Epub 2006 Oct 17.
To evaluate the activity and toxicity of the sequential administration of docetaxel followed by gefitinib in patients with advanced non-small cell lung cancer (NSCLC).
Forty-one patients pre-treated with at least one prior chemotherapy regimen (platinum- or taxane-based) for advanced/metastatic NSCLC received three cycles of docetaxel 30 mg/m2, administered as a 1-h IV infusion, on days 1, 8 and 15 of each 4-week cycle followed by gefitinib 250 mg daily po. Gefitinib treatment was continued until disease progression, development of unacceptable toxicity, or withdrawal of patients consent.
Two (4.9%) patients achieved a partial response and 10 (24.4%) stable disease, for a disease control rate of 29.3% (95% CI: 15.3%-43.2%) while on weekly docetaxel treatment. Additionally, progressive disease (PD) was observed in 29 (70.7%). No objective responses were observed during the gefitinib maintenance therapy; however, 17 (41.5%) patients presented stable disease maintained for more than 2 months. Median time to progression was 3.0 months (range: 1-38.3 months; 95% CI: 2.4-3.6); median overall survival 6.9 months (range: 1.2-40.2 months; 95% CI: 5.34-8.52) while the 1-year survival was 28.8%. Therapy was generally well tolerated with diarrhea and rash being the most frequent toxicities.
The sequential administration of docetaxel and gefitinib was well tolerated and moderately active against advanced pre-treated NSCLC.
评估多西他赛序贯吉非替尼治疗晚期非小细胞肺癌（NSCLC）患者的活性和毒性。
41例既往接受过至少一种针对晚期/转移性NSCLC的化疗方案（铂类或紫杉烷类）治疗的患者，在每4周周期的第1、8和15天接受3个周期的多西他赛30mg/m²静脉滴注1小时，随后每日口服吉非替尼250mg。吉非替尼治疗持续至疾病进展、出现不可接受的毒性或患者撤回同意。
在接受每周一次多西他赛治疗期间，2例（4.9%）患者达到部分缓解，10例（24.4%）疾病稳定，疾病控制率为29.3%（95%CI：15.3%-43.2%）。此外，29例（70.7%）出现疾病进展。在吉非替尼维持治疗期间未观察到客观缓解；然而，17例（41.5%）患者疾病稳定维持超过2个月。中位进展时间为3.0个月（范围：1-38.3个月；95%CI：2.4-3.6）；中位总生存期为6.9个月（范围：1.2-40.2个月；95%CI：5.34-8.52），1年生存率为28.8%。治疗耐受性一般良好，腹泻和皮疹是最常见的毒性反应。
多西他赛和吉非替尼序贯给药耐受性良好，对晚期经治NSCLC有一定活性。
