吉非替尼对比培美曲塞二线治疗晚期非小细胞肺癌的临床研究

目的：观察吉非替尼与培美曲塞二线治疗晚期非小细胞肺癌（non-small cell lung cancer,NSCLC）情况,比较二者对晚期NSCLC患者的治疗效果、安全性的影响。方法将一线化疗治疗失败后的105例晚期NSCLC患者,随机分为吉非替尼组和培美曲塞组,分别接受吉非替尼与培美曲塞二线治疗,比较两组患者的治疗效果和安全性。结果近期疗效比较结果显示,吉非替尼组和培美曲塞组客观有效率（ORR）分别为24.0%和29.1%（P=0.987）,疾病控制率（DCR）分别为64.0%和70.9%（P=0.776）;吉非替尼组和培美曲塞组中位无进展生存时间（PFS）分别为5.2个月和4.1个月（P=0.026）,中位总生存期（OS）分别为7.9个月和6.7个月（P=0.031）,吉非替尼组PFS和OS均优于培美曲塞组。吉非替尼组的不良反应主要为非血液学毒性,培美曲塞组的主要不良反应为血液学毒性。结论吉非替尼及培美曲塞均可用于晚期NSCLC患者的二线治疗,疗效相当,但二者的不良反应各异,可根据患者的个体差异择优选用。     

吉非替尼治疗化疗失败晚期非小细胞肺癌的临床观察

目的：探讨吉非替尼（gefitinib）治疗化疗失败的晚期非小细胞肺癌（non-small cell lung cancer, NSCLC）患者的疗效和毒性反应。方法：收集2005年6月至2009年8月期间我科收治的64例晚期 NSCLC患者,接受吉非替尼治疗,250 mg每天顿服,直至病情进展或因不良反应而终止治疗,观察患者的临床疗效和不良反应。结果：64例晚期NSCLC患者中,无1例CR,PR 22例,SD 23例,PD 19例,全组有效率（CR+PR）为34.38％,疾病稳定率为35.94％,疾病控制率（CR+PR+SD）为70.31％。中位生存期为5.9个月,截止随访时间35.94％（23/64）的患者仍存活。吉非替尼的疗效与性别及吸烟史相关（P＜005）,女性疗效优于男性（P<0.05）,无吸烟史优于有吸烟史。最常见的药物不良反应主要表现为Ⅰ、Ⅱ度皮疹（32.81％、26.57％）、腹泻（12.5％）。结论：对于化疗失败的晚期 NSCLC,吉非替尼能较好地缓解女性、腺癌、未吸烟患者的疾病相关症状,是一种安全、有效并具有较好耐受性的药物。     

吉非替尼与多西紫杉醇二线治疗晚期非小细胞肺癌

[目的]分析比较吉非替尼与多西紫杉醇单药,在一线治疗失败的晚期非小细胞肺癌（NSCLC）患者中的有效性和安全性。[方法]回顾性分析北京协和医院2002年4月1日～2006年6月1日期间标准一线化疗失败的78例晚期NSCLC患者的临床资料,患者接受吉非替尼口服或多西紫杉醇单药治疗,其中吉非替尼组44例．多西紫杉醇组34例。采用Kaplan—Meier方法和Log—Rank分析比较两组患者无疾病进展生存时间（PFS）和中位生存时间（MS）。[结果]吉非替尼组客观有效率明显高于多西紫杉醇组,分别为29．5％和2．9％;疾病控制率相近,分别为72．7％和70．6％。吉非替尼组和多西紫杉醇组患者的MS分别为17．5个月（95％CI：9.3—25．7）和26．8个月（95％CI：15．1～38．51（Х^2=3．35,P=0．0672）;中位PFS分别为9．8个月（95％CI：6．2～13．4）和4．4个月（95％CI：2．5～6．3）（Х^2=11．33,P=0．0008）。吉非替尼组和多西紫杉醇组1年生存率分别为56％和74％。多西紫杉醇组3／4级血液学毒性反应高达58．8％,吉非替尼组未观察到3／4级血液学毒性。[结论]吉非替尼作为晚期NSCLC患者的二线治疗药物,客观有效率及PFS明显高于多西紫杉醇组,且有更高的安全性。     

晚期非小细胞肺癌二线治疗不同方案的疗效及成本效益分析

目的 评价多西他赛、培美曲塞、厄洛替尼和吉非替尼4种方案二线治疗晚期非小细胞肺癌（NSCLC）的疗效,并进行成本效益分析。方法 160例晚期NSCLC患者按二线治疗方案分为4组,每组40例。4种方案分别为：多西他赛75mg／m2 iv.,d1;培美曲塞500mg／m2 iv.,d1;厄洛替尼150mg,每日1次;吉非替尼250mg,每日1次。前两组以21天为1周期,共化疗2～6个周期;后两组口服至病情进展或出现无法耐受的不良反应停药。对所有患者进行近期疗效和无进展生存期（PFS）评价,以获得1个单位（1个月）PFS的花费计算4种方案的成本效益比。结果 多西他赛组、培美曲塞组、厄洛替尼组、吉非替尼组有效率分别为7.5％、10.0％、20.0％和22.5％（P=0.165）;疾病控制率分别为32.5％、50.0％、65.0％和52.5％（P=0.035）;中位PFS分别为2.7个月、2.8个月、3.5个月和3.5个月（P=0.677）。4种方案的3～4级不良反应以多西他赛多见。每获得1个单位PFS,4种方案的花费分别为5635.6、10 279.6、20 814.0和17 587.8元;以多西他赛组为参照,培美曲塞组、厄洛替尼组和吉非替尼组的成本-效益比分别为46 434.7、119 729.4和103 171.0元／月。敏感度分析与成本效益分析的结论一致。结论 多西他赛、培美曲塞、厄洛替尼和吉非替尼4种二线治疗方案治疗晚期NSCLC的疗效未见差异,多西他赛方案的成本-效益比最优;厄洛替尼或吉非替尼治疗的花费高,但不良反应较轻。     

吉非替尼单药治疗晚期非小细胞肺癌

目的观察吉非替尼单药治疗晚期非小细胞肺癌（NSCLC）的疗效和不良反应。方法对50例晚期NSCLC患者给予吉非替尼250mg／d口服治疗,观察疗效和不良反应,采用欧洲癌症研究和治疗组织生活质量调查核心问卷QLQ-C30和简明乏力量表（BFI）对患者的生活质量及临床症状的改善进行评价,观察疾病进展时间（TTP）和中位生存时间（MST）。结果50例晚期NSCLC患者中,无完全缓解者,部分缓解（PR）8例（16．0％）,临床获益率为60．0％,临床获益率与性别、病理类型及吸烟史有关。到随访截止日期,50例患者中,20例（40．0％）存活,其MST为13个月;30例死亡患者TTP为5个月,MST为6个月。PR患者MST为9个月。综合生活质量改善率为58．0％,乏力症状缓解率为52．6％,出现症状缓解的中位时间为15d。不良反应主要为Ⅰ、Ⅱ度皮疹和腹泻,对症处理后可缓解。3例既往因放疗而引起放射性肺炎的患者中,2例放射性肺炎加重。结论吉非替尼有明显抗肿瘤作用,能明显提高晚期NSCLC患者的生活质量,改善临床症状,不良反应可以耐受。     

吉非替尼治疗化疗失败的晚期非小细胞肺癌临床观察

目的：评价吉非替尼治疗化疗失败的晚期非小细胞肺癌（NSCLC）的疗效及不良反应。方法：对68例化疗失败的经病理或细胞学证实的晚期NSCLC患者给予吉非替尼250mg,qd,口服,至病情进展或出现不可耐受的不良反应。结果：68例患者中,CR 1例,PR 20例,SD 23例,PD 24例。有效率30.88%（21/68）,疾病控制率为64.71%（44/68）;全组中位疾病进展时间（TTP）为5.2个月,中位生存时间为9.3个月,1年生存率为52.94%（36/68）。与药物相关的不良反应主要为Ⅰ、Ⅱ度皮疹和腹泻,皮疹发生率为26.47%（18/68）,腹泻发生率为19.12%（13/68）,多在用药后1周内出现,症状轻不需特殊处理。1例出现Ⅰ度转氨酶升高。结论：吉非替尼治疗化疗失败的晚期非小细胞肺癌安全有效,不良反应轻微,患者耐受性和依从性良好。     

吉非替尼治疗晚期非小细胞肺癌的临床观察

目的：研究吉非替尼对晚期非小细胞肺癌（NSCLC）的疗效。方法：收集13例晚期NSCLC患者,口服吉非替尼250mg/d,直到病情进展或因不良反应不能耐受为止,观察其疗效及不良反应。结果：21例中部分缓解（PR）10例,稳定（SD）7例,进展（PD）4例,缓解率47.6%,疾病控制率80.9%。结论：吉非替尼治疗晚期NSCLC患者有一定疗效,不良反应轻。     

吉非替尼治疗晚期非小细胞肺癌31例临床观察

目的观察吉非替尼治疗晚期非小细胞肺癌（NSCLC）的疗效及不良反应。方法对经病理确诊的晚期非小细胞肺癌,不能耐受化疗或化疗失败的晚期NSCLC患者31例,给予吉非替尼250mg,口服,每日1次,服药时间至少1月以上,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31例患者中经治疗后完全缓解2例,部分缓解8例,稳定8例,进展13例。有效率32.3%,疾病控制率58.1%,中位肿瘤进展时间为3.8月,1年生存14例（45.2%）,8例患者出现皮疹,4例有恶心、腹泻症状,2例患者出现一过性血尿素氮升高,3例出现转氨酶上升,1例出现轻微肺纤维化改变。结论吉非替尼治疗晚期NSCLC有一定疗效,不良反应较轻,可作为经多程化学治疗后疗效欠佳或不能耐受放疗、化疗患者的选择。     

厄罗替尼治疗晚期非小细胞肺癌19例临床疗效

目的评价厄罗替尼治疗ⅢB～Ⅳ期非小细胞肺癌（NSCLC）的疗效和患者不良反应。方法19例患者均为经病理证实的、至少接受过一种方案全身化疗的晚期NSCLC患者。厄罗替尼150mg／次,1次／d,口服,直至病情进展或出现不能耐受的不良反应。采用实体瘤疗效评价标准（RECIST）评价疗效,美国国立癌症研究所毒性评价标准（CTCAE）评价不良反应。结果19例患者客观缓解率（ORR）为21．1％（4／19）。疾病控制率（完全缓解＋部分缓解＋稳定）为84．2％（16／19）,疾病无进展生存时间（PFS）3～36个月,中位PFS7．5个月;生存时间9～39个月,中位生存时间15．9个月。不良反应主要是皮疹16例（84．2％）,腹泻11例（57．9％）,多为Ⅰ～Ⅱ度;Ⅲ度丙氨酸氨基转移酶升高1例;未出现Ⅳ度药物相关不良反应。结论厄罗替尼对既往化疗失败的局部晚期或转移性NSCLC患者有较好的疗效和安全性。     

厄洛替尼对化疗失败的晚期非小细胞肺癌的疗效及安全性研究

目的：观察厄洛替尼对化疗失败的晚期非小细胞肺癌的疗效及安全性。方法：82例既往化疗失败的Ⅲ一Ⅳ期非小细胞肺癌（NSCLC）患者,均EFGR监测阳性,给予单用厄洛替尼150mg／d,服药至病情进展或出现不能耐受的不良反应,观察厄洛替尼的疗效和不良反应,对其生存期进行分析。结果：82例患者均可评价疗效,中位治疗时间为5个月（1—14个月）;客观有效率为36．5％;疾病控制率为56．1％。性别、吸烟史、Ps评分及病理类型,临床分期对疗效无统计学关联。中位肿瘤进展时间（214±26）d;中位生存期（375±21）d,1年生存率30．3％,其中肺腺癌疗效较好占30％。最常见的不良反应为皮疹（21．9％）。结论：厄洛替尼对化疗失败的中晚期非小细胞肺癌疗效确切,且不良反应轻,耐受性好。     

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.     

Phase II prospective study of the efficacy of gefitinib for the treatment of stage III/IV non-small cell lung cancer with EGFR mutations, irrespective of previous chemotherapy

PURPOSE: Mutations in the epidermal growth factor receptor (EGFR) gene are associated with increased sensitivity of non-small cell lung cancer (NSCLC) to gefitinib, an EGFR tyrosine kinase inhibitor. The objective of this study was to prospectively evaluate the efficacy of gefitinib in patients with stage III/IV NSCLC whose tumors carried EGFR mutations, irrespective of previous chemotherapy. EXPERIMENTAL DESIGN: Genomic DNA was extracted from tumor specimens and EGFR mutations in exons 19 and 21 analyzed by direct sequencing. Patients with stage III/IV NSCLC whose tumors had the EGFR mutations received gefitinib (250 mg/day orally). Response, toxicity and survival data were assessed. RESULT: From November 2004-May 2006, 21 patients with EGFR mutations received gefitinib (median age: 59 years; 17 females; 19 non-smokers; all had adenocarcinomas). Two patients discontinued gefitinib and withdrew from the study 3 weeks after gefitinib initiation (interstitial pneumonitis, 1 patient; facial acne, 1 patient). Of 19 patients, 3 achieved complete response, 13 exhibited partial response and 3 had stable disease. Response and disease control rates were 76% (95% confidence interval [CI] 53-92) and 90% (95% CI 70-99), respectively. The most common adverse event was skin toxicity (67%); however, no grade 4 skin toxicities were seen. Ten patients relapsed and three died at a median follow-up period of 12.6 months (range 5.6-23.8 months); median progression-free survival was 12.9 months. CONCLUSION: Analysis of tumor EGFR mutations in patients with NSCLC could be used to identify patients suitable for treatment with gefitinib to obtain optimum response and disease control rates.     

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.     

Efficacy and tolerability of gefitinib in pretreated elderly patients with advanced non-small-cell lung cancer (NSCLC)

The activity and toxicity profile of gefitinib in non-small cell lung cancer (NSCLC) patients aged 70 years or older has been only partially evaluated. The aim of this study was to evaluate the response rate and safety of gefitinib in elderly NSCLC patients. Elderly NSCLC patients pretreated with chemotherapy and with at least one measurable lesion received gefitinib at the daily dose of 250 mg until disease progression, unacceptable toxicity or refusal. From August 2001 to May 2003, 40 consecutive elderly patients have been enrolled onto the study in three Italian institutions. We observed one complete (2.5%) and one partial response (2.5%), 18 disease stabilisations (NC: 45%) lasting at least 2 months, including six patients (15%) who had disease stabilisation of 6 months or longer, for an overall disease control rate of 50% (95% CI: 34.5-65.5%). The median duration of response was 4.4 months (range 1.7-9.2). The side effects were generally mild and consisted of diarrhoea and skin toxicity. Grade 1-2 diarrhoea occurred in 23.6%, and one patient experienced grade 4 diarrhoea, requiring hospitalisation. Grade 1-2 skin toxicity, including rash, pruritus, dry skin, and acne, occurred in 20 patients (52.6%). Gefitinib is safe and well tolerated in elderly pretreated NSCLC patients. The disease-control rate achieved suggests that this drug could represent a valid option in the management of this unfavourable subgroup of patients.     

加速康复外科理念在行腹腔镜膀胱根治性切除术患者围术期中应用的临床观察#br#

目的探讨加速康复外科（ERAS）理念在腹腔镜膀胱根治性切除中应用的有效性和安全性。 方法收集2015年6月至2017年6月潍坊市人民医院收治的58例膀胱癌患者,分为传统组（n=28）和ERAS组（n=30）。比较两组患者的手术时间、手术出血量、术后排气时间、术后重度疼痛的发生数、麻醉苏醒时间、盆腔引流时间、术后住院天数以及术后并发症的发生情况。 结果ERAS组和传统组手术时间分别为（1722±379）min和（1873±218）min;术中出血量分别为（1597±465）ml 和（1771±469）ml,差异均无统计学意义（P＞005）。ERAS组和传统组麻醉苏醒时间分别为（254±54）min和（417±98）min;术后排气时间分别为（16±07）d和（22±07）d;盆腔引流时间分别为（25±11）d和（50±16）d;术后住院天数分比为（76±14）d和（110±18）d;术后疼痛VAS评分＞7分发生率分别为100％（3／30）和429％（12／28）;两组差异均有统计学意义（P＜005）。ERAS组1例刀口液化,1例发生肾结石;传统组2例肠梗阻,1例发生坠积性肺炎,1例发生肾结石。两组患者中均无尿瘘患者。 结论加速康复外科理念在腹腔镜下膀胱根治性切除术患者中的临床应用是安全、有效的,可加速患者的术后康复,值得临床推广应用。     

吉非替尼一线治疗34例晚期非小细胞肺癌的疗效分析

背景与目的：分子靶向药物吉非替尼单药治疗晚期非小细胞肺癌具有较好的疗效和安全性。本文观察吉非替尼一线治疗晚期非小细胞肺癌的疗效和不良反应。方法：34例病理确诊的不愿或不能接受传统细胞毒性药物化疗的非小细胞肺癌患者,口服吉非替尼250rng,每目1次,持续用药直至肿瘤进展或出现不可耐受的小良反应。结果：吉非替尼的有效率为29．4％,疾病控制率为61．8％,症状改善率为47．1％,中位无进展生存期为3．0个月,中位生存期为10．2个月,1年生存率为35．3％。其中不吸烟患者客观缓解率高于吸烟患者（P=0．023）。出现皮疹患者疾病控制率高于无皮疹患者（P=0．005）,LogistiC回归提示皮疹是疾病控制的独立因素（P=0．003）。最常见的不良反应是皮疹和腹泻。结论：对于不愿或不能接受传统细胞毒性药物化疗的非小细胞肺癌患者,吉非替尼为这些患者提供了另一个选择。     

The EGFR mutation and its correlation with response of gefitinib in previously treated Chinese patients with advanced non-small-cell lung cancer.

BACKGROUND: The aim of the study was to evaluate the efficacy of gefitinib and the epidermal growth factor receptor (EGFR) mutation to gefitinib response in a series of Chinese patients with pretreated advanced non-small-cell lung cancer (NSCLC). METHODS: A total of 98 patients who had failed at least one platinum-based regimen received gefitinib 250 mg once daily. The mutation analysis of the EGFR kinase domain was performed for 30 patients using paraffin-embedded tumor tissue. RESULTS: The response rate was 31.6% and the disease control rate was 67.3%. Objective response was correlated with adenocarcinoma, female gender and non-smokers. Median progress free survival (PFS) was 7.0 months, median overall survival (OS) was 12.0 months and 1-year survival was 53.1%. The median PFS and OS were improved among patients with adenocarcinoma, gefitinib responders and non-smokers. Active gene mutation was detected in 12 patients. Mutation rates were higher among gefitinib responders, non-smokers, patients with adenocarcinoma and female patients. OS was longer for patients with gene mutation than for patients without mutation. CONCLUSION: Gefitinib demonstrated significant antitumor activity with a favorable toxicity profile for pretreated Chinese patients with advanced NSCLC. The active mutation of the EGFR kinase domain was strongly associated with response to gefitinib and prolonged overall survival.     

Continued gefitinib treatment after disease stabilisation prolongs survival of Japanese patients with non-small-cell lung cancer: Okayama Lung Cancer Study Group experience.

BACKGROUND: This study aimed to investigate the survival outcome of patients with non-small-cell lung cancer (NSCLC) who had obtained disease stabilisation with gefitinib treatment and to clarify the effect of continued treatment with gefitinib on prognosis. PATIENTS AND METHODS: We reviewed the clinical records of 365 Japanese patients with NSCLC who received gefitinib (250 mg/day). RESULTS: Of 324 (89%) patients assessable for response, 147 (45%) obtained disease stabilisation and 71 (22%) patients achieved an objective response. Overall survival in patients obtaining disease stabilisation was significantly longer than in patients with progressive disease (median survival time 12.1 versus 4.4 months; P <0.0001). In patients obtaining disease stabilisation, those who continued gefitinib treatment until disease progression tended to have longer overall and progression-free survival compared with those discontinuing gefitinib treatment (1-year survival rate 52.1% versus 36.6%, P = 0.08; 1-year progression-free survival rate 31.8% versus 5.2%, P = 0.001). Multivariate analysis showed discontinuing gefitinib was an independent risk factor for progression-free survival (hazard ratio 1.66; 95% confidence interval 1.07-2.56; P = 0.022) but not for overall survival. CONCLUSIONS: Our findings indicate the importance of achieving disease stabilisation with gefitinib treatment and continued gefitinib treatment in Japanese patients with disease stabilisation, although further studies are required to confirm these findings.     

Multicenter phase II trial of gefitinib first-line therapy followed by chemotherapy in advanced non-small-cell lung cancer (NSCLC): SAKK protocol 19/03.

BACKGROUND: Gefitinib is active in patients with pretreated non-small-cell lung cancer (NSCLC). We evaluated the activity and toxicity of gefitinib first-line treatment in advanced NSCLC followed by chemotherapy at disease progression. PATIENTS AND METHODS: In all, 63 patients with chemotherapy-naive stage IIIB/IV NSCLC received gefitinib 250 mg/day. At disease progression, gefitinib was replaced by cisplatin 80 mg/m(2) on day 1 and gemcitabine 1250 mg/m(2) on days 1, 8 for up to six 3-week cycles. Primary end point was the disease stabilization rate (DSR) after 12 weeks of gefitinib. RESULTS: After 12 weeks of gefitinib, the DSR was 24% and the response rate (RR) was 8%. Median time to progression (TtP) was 2.5 months and median overall survival (OS) 11.5 months. Never smokers (n = 9) had a DSR of 56% and a median OS of 20.2 months; patients with epidermal growth factor receptor (EGFR) mutation (n = 4) had a DSR of 75% and the median OS was not reached after the follow-up of 21.6 months. In all, 41 patients received chemotherapy with an overall RR of 34%, DSR of 71% and median TtP of 6.7 months. CONCLUSIONS: First-line gefitinib monotherapy led to a DSR of 24% at 12 weeks in an unselected patients population. Never smokers and patients with EGFR mutations tend to have a better outcome; hence, further trials in selected patients are warranted.     

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.