吉非替尼治疗放化疗失败晚期肺腺癌患者54例

[目的]观察吉非替尼(gefitinib)单药治疗放疗或化疗失败的晚期肺腺癌患者的疗效及安全性。[方法]54例Ⅲb或Ⅳ期的肺腺癌患者,口服吉非替尼单药250mg/d,直至疾病进展或出现不可耐受的毒副反应。[结果]中位生存时间9个月,无进展中位生存时间7个月,1年、2年生存率分别为57.2%和23.5%。主要毒副反应为皮疹、腹泻和恶心呕吐。[结论]吉非替尼治疗放疗或化疗失败的晚期肺腺癌,有较好的有效性和安全性。     

吉非替尼治疗化疗失败的晚期非小细胞肺癌疗效观察

目的观察吉非替尼治疗化疗失败的晚期非小细胞肺癌(NSCLC)的疗效及毒副反应。方法对32例化疗失败的晚期NSCLC患者给予吉非替尼250 mg,口服,每天1次,至病情进展或出现不可耐受的毒副反应。结果 32例患者中,CR 0例(0.00%),PR 8例(25.00%),SD 13例(40.62%),PD 11例(34.38%),有效率为25.00%,疾病控制率为65.62%,中位疾病进展时间为5.2个月,中位生存时间为9.3个月,1 a生存率为34.38%。结论吉非替尼治疗晚期NSCLC有较好的疗效,毒副反应可耐受。     

三维适形放疗联合EGFR-TKI治疗老年局部晚期肺腺癌临床观察

目的评价表皮生长因子受体(EGFR)突变的老年局部晚期肺腺癌行三维适形放疗(3DCRT)联合表皮生长因子受体酪氨酸激酶抑制剂(EGFR-TKI)治疗的近期疗效和安全性。方法 26例EGFR突变的老年局部晚期肺腺癌患者接受3DCRT联合EGFR-TKI(吉非替尼或厄洛替尼)治疗。结果全组26例EGFR突变的老年局部晚期肺腺癌患者的有效率88.5%,疾病控制率96.2%,中位生存期32.9个月,中位无进展生存期18.7个月,1、2 a生存率分别为95.0%、72.0%。主要毒副反应为放射性肺炎、放射性食管炎、皮疹和骨髓抑制,所有毒副反应经相应处理后均未影响治疗的顺利进行。结论 3DCRT联合EGFR-TKI治疗EGFR突变的老年局部晚期肺腺癌疗效好,且毒副反应均可耐受。     

培美曲塞治疗全身化疗和吉非替尼治疗失败的肺腺癌32例临床观察

背景与目的 吉非替尼二线或三线治疗晚期非小细胞肺癌的维持时间尚不理想.本研究旨在观察培 美曲塞对全身化疗和吉非替尼治疗失败后肺腺癌患者的疗效和毒副反应.方法 32例经过全身化疗和吉非替尼治 疗后肿瘤进展的晚期肺腺癌患者,培美曲塞500 mg/m2静脉滴注,第1天,每21天为1周期,并口服地塞米松、叶酸 和肌肉注射维生素B12以减轻毒副反应.根据实体瘤疗效评价标准对客观缓解率进行评价,毒副反应按美国国立癌 症研究所制定的通用药物毒性评价标准(第3版)进行评价.结果 32例患者中,部分缓解4例(12.5%),疾病稳 定11例(34.4%),疾病进展17例(53.1%),中位无进展生存期为2.7个月,中位生存期为11.0个月,1年生存率为 37.5%,最常见的毒副反应为骨髓抑制,多为I、II级.非血液学毒性反应较轻,病人耐受性良好.结论 对于晚期肺 腺癌患者,在化疗和吉非替尼治疗失败后,给予培美曲塞解救治疗有临床获益.     

吉非替尼治疗晚期非小细胞肺癌临床观察

目的 评价吉非替尼二线和三线方案治疗晚期非小细胞肺癌(NSCLC)的疗效和毒副反应.方法 选择符合入组条件的38例晚期NSCLC,均给予吉非替尼250 mg/d,口服,1个月为1个治疗周期,每个周期结束后进行疗效评价.有效者继续治疗,直至出现疾病进展或发生不可耐受的药物毒副反应.结果 38例均可评价疗效,总有效率(RR)为31.6%(12/38),临床受益率(CBR)为86.8%(33/38),中位疾病进展时间为5.8个月,1年生存率为42.1%(16/38),腺癌患者的有效率明显高于鳞癌患者(P<0.05).15例(39.5%)至少出现一种药物相关性毒副反应,但多数较轻,且可逆.主要毒副反应为皮疹.结论 吉非替尼二线和三线方案治疗晚期NSCLC有较好疗效,且毒副反应可耐受.     

吉非替尼治疗晚期肺腺癌的疗效和毒副作用

目的评价吉非替尼(Gefitinib)治疗晚期肺腺癌的疗效及毒副反应。方法对55例化疗失败或不宜化疗的Ⅳ期肺腺癌患者给予吉非替尼口服250mg/d,至病情进展或出现不可耐受的不良反应。结果55例患者中无CR患者,PR 21例(38.2%),SD水相逢15例(27.3%),疾病控制率(DCR=CR+PR + SD)65.5%,PD19例(34.5%)。中位肿瘤进展时间(TTP)为7.2月,1年生存率为43.6%。与药物相关的不良反应依次为痤疮样皮疹28 例(50.9%),皮肤干燥19例(34.5%),腹泻14例（25.5%), 恶心7例(12.7%),肝功能异常(ALT,AST 升高)1例(1.8%)。结论吉非替尼治疗晚期肺腺癌有效,毒副反应轻微,患者依从性和耐受性好     

吉非替尼治疗复治晚期非小细胞肺腺癌12例

[目的]观察吉非替尼治疗复治晚期非小细胞肺腺癌的疗效及其不良反应。[方法]12例Ⅳ期非小细胞肺腺癌患者口服吉非替尼,每日口服一片(250mg)。观察近期疗效。[结果]12例患者中CR1例,PR7例,SD3例,PD1例,中位疾病进展时间4.5个月,中位生存时间14.7个月。毒副反应:12例患者中2例出现皮疹,1例出现腹泻。均能耐受,未发生因毒性停药的现象。[结论]吉非替尼对部分Ⅳ期非小细胞肺腺癌患者有效,且不良反应轻微。     

吉非替尼治疗化疗耐药的中晚期非小细胞肺癌42例

目的观察吉非替尼治疗化疗耐药的中、晚期非小细胞肺癌的疗效和不良反应。方法对经病理确诊的中、晚期非小细胞肺癌,经多程化疗后无效或不能耐受放化疗的患者给予吉非替尼250mg,口服,每日1次,至病情进展为止,观察吉非替尼的疗效和不良反应以及患者的生存期和疾病进展时间。结果42例患者,CR1例,PR13例,SD16例,PD12例,总缓解率33．33％,疾病控制率71．43％,中位疾病进展时间6．0个月,中位生存期9．2个月,吉非替尼的主要不良反应有皮疹、皮肤瘙痒、腹泻。结论吉非替尼单药治疗化疗耐药的中、晚期非小细胞肺癌安全、有效,毒副反应可耐受,可作为多程治疗后疗效欠佳或不能耐受放化疗患者的选择。     

吉非替尼治疗31例男性晚期非小细胞肺癌临床观察

目的：观察吉非替尼（Iressa）对男性晚期非小细胞肺癌（NSCLC）患者疗效及毒副反应。方法：31例经病理组织学或细胞学确诊的男性晚期NSCLC口服Iressa250mg/d,直至病灶进展或出现不可耐受的副反应,每月CT扫描,评价疗效,同时记录不良反应。结果：31例入选患者中,30例可评价疗效,无完全缓解（CR）,部分缓解（PR）6例,均为肺腺癌,稳定（SD）12例,其中鳞癌1例,12例病情进展（PD）,有效率（RR）为20%（6/30）,疾病控制率（CR＋PR＋SD）为60%（18/30）,中位肿瘤进展时间5个月,1年生存率40%。最常见的毒副反应为皮疹和腹泻。结论：对于无法耐受化疗或化疗失败的亚洲男性晚期NSCLC患者,尤其是肺腺癌患者,持续口服吉非替尼同样是较理想的方案。     

吉非替尼(Iressa)在晚期肺腺癌的靶向治疗疗效观察

背景与目的 吉非替尼是选择性表皮生长因子受体酪氨酸激酶抑制剂,用于治疗非小细胞肺癌,特别是腺癌.本研究的目的是探讨吉非替尼在晚期肺腺癌中的疗效、副反应及影响因素.方法 收集26例晚期肺腺癌,应用吉非替尼250 mg口服,每日1次,直至出现任何疾病进展的客观证据或发生不可耐受的不良事件.定期复查,并进行生存分析.结果 26例患者中CR 1例(3.8%),PR 11例(42.3%),SD 9例(34.6%),PD 5例(19.2%).客观缓解率为46.2%,疾病控制率为80.8%.其中位无进展生存期为8.2个月,中位总体生存期为10.4个月,1年生存率为31.6%.年龄(＜70岁)、产生皮疹及CEA降低与较好的预后有密切关系,吉非替尼治疗级别及化疗次数等因素与预后无明显关系.用药前平均PS(ECOG)为3.0,用药后平均为1.8.平均症状缓解时间为5.2天.结论 吉非替尼是一种疗效好、副作用少、可以明显提高肺腺癌患者生活质量的靶向治疗药物,对没有化疗条件的腺癌患者,可以作为一线治疗首选用药.     

吉非替尼治疗91例晚期非小细胞肺癌疗效分析

目的 总结表皮生长因子受体酪氨酸激酶抑制剂吉非替尼治疗91例晚期非小细胞肺癌患者的疗效、中位肿瘤进展时间（TTP）、中位生存期和毒副反应,分析与疗效、生存期可能相关的因素。方法 91例化疗失败的晚期非小细胞肺癌患者,中位化疗周期数为6（1～17）周期,68例（74．7％）患者至少经过二线方案化疗,疾病仍进展;Ⅳ期76例（83．5％）,其中42例（46．2％）至少有2个转移部位。口服吉非替尼剂量为250mg／d。运用SPSS11．5统计软件进行统计分析。结果 全组客观有效率为20．9％（19／91）,疾病控制率为63．7％（58／91）,症状改善率为72．7％（40／55）,ECOG评分稳定及改善为71．4％（65／91）。腺癌、至少接受二线方案化疗及出现皮肤毒性者与疾病控制率呈明显正相关（P值分别为0．04、0．02及0．00）。中位TTP 5．0个月（95％CI为3．26～6．74）,中位随访7．5（1～18．5）个月,1年生存率为56．4％。目前仍存活56例（61．5％）,其中29例（51．8％）仍处于疾病控制中,20例生存期已超过1年（12～18．5个月）。对生存有益的单因素为不吸烟、疾病控制、出现皮肤毒性及吉非替尼治疗过程中控制转移灶。经Cox回归分析发现,不吸烟、疾病控制是独立预后因素（P值分别为0．01和0．00）。毒副反应主要为Ⅰ、Ⅱ度皮肤毒性。结论 靶向治疗药物吉非替尼对传统治疗失败的晚期难治性非小细胞肺癌患者有明显疗效,有改善症状及延长生存期作用,且耐受性好。     

吉非替尼治疗125例晚期非小细胞肺癌患者的临床观察

目的 探讨吉非替尼治疗晚期非小细胞肺癌(NSCLC)的疗效及安全性.方法 125例经化疗失败的或不能耐受化疗及不愿接受化疗的Ⅲb～Ⅳ期NSCLC患者,口服吉非替尼250 mg/d,直到病变进展或出现不可耐受的不良反应.结果 125例患者的总有效率为35.2%(44/125),疾病控制率为77.6%(97/125),中位无疾病进展生存时间(PFS)为5.8个月,中位生存时间(MST)为11.2个月,1年生存率为40.5%%.女性、腺癌、不吸烟患者的有效率明显高于男性、非腺癌、吸烟患者(P<0.05),ECOG评分和既往有无化疗对吉非替尼疗效无显著影响(P>0.05).体力状态ECOG评分0～1和吉非替尼治疗有效患者的中位PFS明显优于ECOG评分≥2和吉非替尼治疗无效的患者(P<0.01).腺癌、不吸烟、吉非替尼治疗有效患者的MST明显优于非腺癌、吸烟和吉非替尼治疗无效的患者(P<0.05).最常见的不良反应为皮疹(51.2%)和腹泻(34.4%),多为轻度.结论 吉非替尼治疗晚期NSCLC安全、有效.不良反应轻,患者可耐受.     

Gefitinib in the treatment of advanced, refractory non-small-cell lung cancer: results in 124 patients

To evaluate the feasibility, toxicity, and efficacy of oral gefitinib (ZD1839, Iressa) in patients with refractory non-small-cell lung cancer (NSCLC) treated in a community-based setting. One hundred twenty-four patients with advanced, refractory NSCLC received treatment with gefitinib 250 mg orally each day. Ninety-six percent of patients had received >or= 1 previous chemotherapy regimens and 79% had received previous platinum and taxane therapy. Patients were evaluated for response after 6-12 weeks of daily gefitinib therapy; patients with objective response or stable disease continued gefitinib until disease progression occurred. Gefitinib was well-tolerated in these patients with advanced, refractory NSCLC. There were no grade 4 toxicities, and grade 3 skin toxicity and diarrhea were observed in only 4% and 2% of patients, respectively. Nine of 120 evaluable patients (8%) had partial responses to treatment; however, 54 patients (45%) had no evidence of progression at first reevaluation, and a total of 35 patients (29%) reported improvement in lung cancer-related symptoms while receiving gefitinib. Median survival for the entire group was 6.5 months, with a 1-year survival rate of 35%. Gefitinib is active and very well-tolerated in patients with advanced, refractory NSCLC. Although the major response rate was low, nearly 50% of patients derived substantial palliative benefit from gefitinib therapy. The median survival of 6.5 months achieved in this large group of relatively unselected patients is unprecedented in the third-line treatment setting, and compares favorably to other available second-line treatment including docetaxel. A therapeutic trial of gefitinib should be considered in all patients with refractory NSCLC.     

培美曲塞单药治疗复治晚期肺腺癌27例疗效分析

目的 探讨培美曲塞单药治疗复治晚期肺腺癌的疗效及毒副反应.方法 27例复治晚期肺腺癌,给予培美曲塞500 mg/m2,静脉滴注,d1,每3周重复;并口服地塞米松、叶酸和肌内注射维生素B12以减轻毒副反应.每2个周期后进行疗效评价.结果 27例患者均可评价疗效,疗效评价为CR 0例,PR 3例,SD 10例,PD 14例...     

Gefitinib is of more benefit in chemotherapy-naive patients with good performance status and adenocarcinoma histology: retrospective analysis of 575 Korean patients

We analyzed data from 575 patients with advanced or metastatic non-small cell lung cancer treated with gefitinib in National Cancer Center, Goyang, Korea between 2002 and 2005. The overall response rate was 25.7% (95% CI, 22.1-29.6). At a median follow-up of 26 months, the median survival time from the date of gefitinib administration was 10.6 months with 1 year-survival rate of 47.7%. The median survival time calculated from the first diagnosis of advanced/metastatic disease or recurrent disease was 21.6 months. In a multivariate logistic regression model, adenocarcinoma histology, smoking history, performance status, and history of prior chemotherapy were statistically significant predictors for tumor response to gefitinib. The response rate of the most favorable subgroup, chemotherapy-naive never-smokers with adenocarcinoma, was 52.2% (95% CI, 42.6-61.7). In a multivariate Cox proportional hazard model, performance status, adenocarcinoma histology, and history of prior chemotherapy were the independent predictors of survival (p<0.001, p<0.001, and p=0.002, respectively). This retrospective analysis suggests that gefitinib was of great benefit for chemotherapy-naive patients who had good performance status and adenocarcinoma histology. These findings are required to be validated in further prospective clinical studies, which should include translational research characterizing the molecular predictors.     

Gefitinib as front-line treatment in Chinese patients with advanced non-small-cell lung cancer

PURPOSE: This phase II single arm, open label study was designed to evaluate the efficacy and toxicity of oral gefitinib (250mg) daily in previously untreated patients with advanced non-small-cell lung cancer (NSCLC). METHODS: Eligible patients had stage IIIB or IV NSCLC with adequate organ functions, and were chemona?ve. All eligible patients were treated with oral administration of 250mg of gefitinib until intolerable toxicity, disease progression or death occurred. Responses were assessed after every 8 weeks of therapy. RESULTS: For a total of 53 patients, the objective response rate (ORR) was 32.1% and overall disease control rate (DCR) was 52.8%. Median overall and progression-free survivals (PFS) were 9.4 (95% CI, 8.8-13.3) and 3.2 months (95% CI, 1.1-5.2) months, and 1-year survival rate was 41.5%. Patients with adenocarcinoma (n=35) had a higher response rate. Adenocarcinoma, female gender (n=24), and response to gefitinib were predictive factors for better survival. The most commonly seen adverse events (AEs) were skin toxicity (54.7%), diarrhea (43.4%) and nail change (16.9%). Most AEs were mild to moderate and considered manageable. Drug-related interstitial pneumonia was clinically diagnosed in four cases (7.5%). CONCLUSIONS: Oral gefitinib, as compared to conventional chemotherapy, has comparable effect but less toxicity as a first-line treatment in Chinese patients who have advanced NSCLC, especially in those with adenocarcinoma histology. A further phase III prospective study comparing gefitinib to standard chemotherapy to define the efficacy of gefitinib is appropriate in advanced NSCLC patients.     

Sequential administration of docetaxel followed by maintenance gefitinib, as salvage treatment in patients with advanced NSCLC: a multicenter phase II trial

PURPOSE: 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). PATIENTS AND TREATMENT: 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. RESULTS: 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. CONCLUSIONS: The sequential administration of docetaxel and gefitinib was well tolerated and moderately active against advanced pre-treated NSCLC.     

吉非替尼一线治疗局部晚期或转移性非小细胞肺癌的临床观察

目的：评价吉非替尼一线治疗局部晚期或转移性非小细胞肺癌（ＮＳＣＬＣ）的疗效和安全性。方法：４５例局部晚期或转移性ＮＳＣＬＣ一线应用吉非替尼２５０ｍｇ／ｄ,直至出现肿瘤进展或不可耐受的毒副反应。结果：４５例可评价病例中,无完全缓解（ＣＲ）,部分缓解（ＰＲ）１５例,病情稳定（ＳＤ）１７例,疾病进展（ＰＤ）１３例。全组有效率为３３.３％,疾病控制率为７１.１％。疾病相关症状缓解率为７２.５％,中位缓解时间为８天。中位生存期１５.３个月,中位无进展生存期为６.０个月。主要的毒副作用为皮疹２４例（５３.３％）,腹泻１５例（３３.３％）,皮肤干燥脱屑１２例（２６.７％）,皮肤瘙痒１０例（２２.２％）,恶性呕吐８例（１７.８％）,转氨酶升高３例（６.７％）及口腔溃疡２例（４.４％）。结论：吉非替尼一线治疗局部晚期或转移性ＮＳＣＬＣ有较好的疗效和安全性。