最佳支持治疗与吉非替尼治疗80岁以上老年非小细胞肺癌比较分析

[目的]比较最佳支持治疗(BSC)与吉非替尼一线治疗年龄大于80岁的非小细胞肺癌(NSCLC)患者的疗效。[方法]回顾性研究40例经病理学或细胞学确诊的老年NSCLC患者,24例一线应用吉非替尼(250mg,1次/d,口服)治疗,另外16例接受最佳支持治疗。吉非替尼组的患者直到病情进展或出现严重不良反应,进而评估吉非替尼疗效与毒副作用。[结果]吉非替尼组与BSC组生存期比较,无论肿瘤分期早晚,吉非替尼组生存期均较BSC组延长(P=0.0353,0.0466),吉非替尼组生存率与客观有效率均显著高于BSC组(P=0.0367,0.0294)。吉非替尼组CR 0例,PR 8例(33.3%),SD 8例(33.3%),PD 8例(33.3%)。有效率(RR)33.3%,疾病控制率(DCR)66.7%。女性RR优于男性(P=0.0069)。腺癌患者DCR优于非腺癌患者(P=0.0277),ECOG评分≤2的患者DCR优于评分>2的患者(P=0.0351)。吉非替尼主要毒副反应为皮疹、腹泻、皮肤干燥,均为轻度。[结论]对于老年NSCLC患者,吉非替尼一线治疗疗效肯定,毒副作用相对较小,患者耐受性好。生存期、客观有效率及生存率均优于最佳支持治疗。     

吉非替尼记名供药计划治疗晚期复发非小细胞肺癌的疗效和预后因素分析

目的 研究吉非替尼治疗中国晚期非小细胞肺癌(NSCLC)患者的安全性和疗效.方法 2002年9月至2005年3月共入选晚期复发NSCLC患者120例,其中可评价疗效者103例.给予吉非替尼口服每次250 mg,每天1次,用药1个月后首次进行影像学疗效评价,此后每2～3个月复查影像学,直至出现病情进展或出现不能耐受的不良反应.停止吉非替尼治疗后,每6个月随访1次,直至患者死亡或随访结束.结果 103例患者的客观有效率为18.4%(19/103),疾病控制率为51.5%(53/103),中位疾病进展时间(TTP)为3个月(0.2～40个月),中位生存时间(MST)为9.8个月(0.5～51个月),1、2和3年生存率分别为44.7%、26.4%和13.2%.全组共有41例患者的TTP≥6个月,其MST为25.5个月.Cox多因素分析显示,腺癌、治疗后出现皮疹、体力状态(PS)评分<2分的患者具有更长的,TTP,而PS评分<2分、获得疾病控制的患者具有更长的生存期.本组患者的不良反应主要为皮疹、皮肤干燥、腹泻和转氨酶升高,多为Ⅰ～Ⅱ度.结论 吉非替尼对于部分晚期复发的NSCLC患者有效,部分疾病控制者具有较长的生存期,而不良反应可耐受.     

吉非替尼或多西他赛治疗一线化疗失败的非小细胞肺癌的临床分析

目的 探讨既往一线化疗失败的晚期非小细胞肺癌(NSCLC)患者接受吉非替尼或多西他赛治疗的疗效和安全性.方法 222例NSCLC患者随机分为吉非替尼组和多西他赛组,两组患者在性别、年龄、病理类型、分期等方面大致平衡.采用Kaplan-Meier法进行生存分析和比较,采用生活质量量表法评价患者治疗后生存质量的改善情况.结果 吉非替尼组和多西他赛组的中位生存时间分别为11.0个月和14.0个月(P=0.783),中位无疾病进展生存时间(PFS)分别为3.4个月和3.8个月,6个月的PFS率分别为35.1%和18.5%,客观有效率分别为21.9%和9.1%(P=0.016).吉非替尼组中,有3例(2.8%)患者因不良反应调整药物剂量;而多西他赛组中,有36例(33.3%)患者因不良反应调整药物剂量.多西他赛组中,3～4级不良反应的发生率为61.1%;吉非替尼组中,3～4级不良反应的发生率为13.1%.吉非替尼组患者在生活质量和耐受性方面也明显优于多西他赛组.结论 在既往治疗失败的晚期NSCLC患者中,吉非替尼与多西他赛的总体疗效相似,但吉非替尼的耐受性更好,患者的生活质量有所改善,是替代多西他赛治疗的重要药物之一.     

吉非替尼或多西他赛治疗一线化疗失败的非小细胞肺癌的临床分析

目的 探讨既往一线化疗失败的晚期非小细胞肺癌(NSCLC)患者接受吉非替尼或多西他赛治疗的疗效和安全性.方法 222例NSCLC患者随机分为吉非替尼组和多西他赛组,两组患者在性别、年龄、病理类型、分期等方面大致平衡.采用Kaplan-Meier法进行生存分析和比较,采用生活质量量表法评价患者治疗后生存质量的改善情况.结果 吉非替尼组和多西他赛组的中位生存时间分别为11.0个月和14.0个月(P=0.783),中位无疾病进展生存时间(PFS)分别为3.4个月和3.8个月,6个月的PFS率分别为35.1%和18.5%,客观有效率分别为21.9%和9.1%(P=0.016).吉非替尼组中,有3例(2.8%)患者因不良反应调整药物剂量;而多西他赛组中,有36例(33.3%)患者因不良反应调整药物剂量.多西他赛组中,3～4级不良反应的发生率为61.1%;吉非替尼组中,3～4级不良反应的发生率为13.1%.吉非替尼组患者在生活质量和耐受性方面也明显优于多西他赛组.结论 在既往治疗失败的晚期NSCLC患者中,吉非替尼与多西他赛的总体疗效相似,但吉非替尼的耐受性更好,患者的生活质量有所改善,是替代多西他赛治疗的重要药物之一.     

埃克替尼治疗215例复治晚期非小细胞肺癌

摘 要：［目的］ 观察盐酸埃克替尼治疗复治晚期非小细胞肺癌（NSCLC）患者的疗效及安全性。［方法］ 对215例复治晚期NSCLC患者应用埃克替尼125mg/次,一日3次,直到疾病进展或者出现不可耐受的不良反应。［结果］ 全组患者达到完全缓解（CR） 2例（0.9%）,部分缓解（PR） 75例（34.9%）,疾病稳定（SD） 67例（31.2%）,疾病进展（PD） 71例（33.0%）。客观缓解率（RR）35.8%,疾病控制率（DCR）67.0%。女性、腺癌、ECOG PS 评分≤1、非吸烟及 EGFR基因突变阳性患者 RR 显著性高于男性、非腺癌、ECOG PS 评分≥2、吸烟及EGFR基因突变未知及野生型患者（P<0.05）。女性、ECOG PS 评分≤1及非吸烟患者 DCR 显著性高于男性、ECOG PS 评分≥2及吸烟患者（P<0.05）。中位无进展时间（mPFS）为 6.8 个月（95%CI：5.9～7.7 个月）,中位生存时间（mOS）为 15.5 个月（95%CI：14.0~16.9 个月）。女性、非吸烟、腺癌、ECOG PS 评分≤1及EGFR基因突变阳性患者mPFS明显优于男性、吸烟、非腺癌、ECOG PS 评分≥2及EGFR基因突变未知及野生型患者（P<0.05）。主要不良反应多为Ⅰ～Ⅱ度的皮疹（39.5%）和腹泻（27.4%）,大部分患者均可耐受。［结论］ 埃克替尼用于复治NSCLC患者尤其是EGFR基因突变阳性腺癌患者具有较好的疗效,不良反应多可耐受。     

吉非替尼一线治疗老年晚期肺腺癌临床观察

目的观察选择吉非替尼一线治疗老年晚期肺腺癌临床疗效及不良反应。方法 23例初治晚期肺腺癌、不吸烟、不适于全身化疗的老年患者接受吉非替尼治疗至疾病进展或不良反应不可耐受,观察近期疗效、体力状态改善情况及不良反应。结果 23例患者均可进行疗效评估,部分缓解率39.1%,疾病稳定率47.8%;治疗后65.2%的患者体力状态有所改善。主要不良反应为Ⅰ/Ⅱ度皮疹、乏力、腹泻。结论吉非替尼一线治疗老年晚期肺腺癌疗效确切,耐受性良好。     

厄洛替尼治疗晚期非小细胞肺癌92例临床观察

背景与目的 厄洛替尼是一种选择性表皮生长因子受体酪氨酸激酶抑制剂,已被证实为治疗晚期非小细胞肺癌患者的有效药物,本研究旨在探讨厄洛替尼治疗晚期非小细胞肺癌的疗效及安全性.方法 对92例Ⅲb-Ⅳ期经化疗失败的或不能耐受化疗及不愿接受化疗的晚期非小细胞肺癌用厄洛替尼每次150 mg/d.直到病变进展或出现不可耐受的毒副作用.结果 本组可评价疗效92例,完全缓解2例(2.2%),部分缓解22例(23.9%),稳定48例(52.2%);进展20例(21.7%),有效率(RR)为26.1%(24/92),疾病控制率(DCR)为78.3%(72/92).有皮疹患者RR和DCR优于无皮疹患者(P<0.05).ECOG评分0-1分的患者RR优于ECOG评分≥2分(P=0.023),女性患者DCR显著优于男性患者(P=0.014).非吸烟患者DCR优于吸烟患者(P=0.042).但病理类型和既往有无化疗对疗效无明显影响,最常见的毒副反应为皮疹(84.8%)和腹泻(31.5%),多为轻、中度.结论 厄洛替尼治疗晚期非小细胞肺癌疗效明确,不良反应较轻,耐受性较好.     

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.     

吉非替尼治疗晚期NSCLC 70例临床观察

目的:评价吉非替尼对晚期非小细胞肺癌(NSCLC)的疗效和安全性.方法:70例晚期NSCLC应用吉非替尼250mg/d,直至肿瘤进展或出现不可耐受的不良反应.结果:ORB12.9%,DCB57.2%,PFS4月(1-21月),TTD 7月(1-31月),1年生存率40%,2年生存率17.1%.疗效与性别、吸烟状态、病理类型相关(P＜0.05).治疗后生活质量(QOL)和症状改善超过50%,改善时间在用药1月内.常见的不良事件为皮疹和腹泻,1例因ILD死亡.结论:吉非替尼对晚期NSCLC疗效较好,可明显改善症状、提高QOL,毒副反应轻.     

培美曲塞单药或联合吉非替尼治疗EGFR-TKI耐药后晚期非小细胞肺癌临床观察

背景与目的:生长因子受体-酪氨酸激酶抑制剂(epidermal growth factor receptor-tyrosine kinase inhibitor,EGFR-TKI)治疗晚期非小细胞肺癌(non-small cell lung cancer,NSCLC)获得性耐药后尚无标准的治疗方案,亟待探寻有效的后续治疗方法.为临床应用提供指导,该研究旨在比较后续治疗采用培美曲塞单药或联合吉非替尼治疗EGFR-TKI获得性耐药的晚期NSCLC的临床疗效及安全性.方法:入组既往接受过EGFR-TKI治疗后进展的晚期NSCLC患者62例.其中32接受培美曲塞联合吉非替尼治疗,设为联合组;30例单用培美曲塞治疗,设为化疗组.评价临床疗效及不良反应.结果:联合组客观有效率(objective response rate,ORR)为46.9%,高于化疗组的20%,差异有统计学意义(χ2=4.933,P<0.05);两组疾病控制率(disease control rate,DCR)差异无统计学意义(P>0.05);联合组的中位无病生存期(progression-free survival,PFS)为8.0个月,化疗组中位PFS为6.3个月,差异有统计学意义(χ2=8.063,P<0.05),两组总生存期(overall survival,OS)差异无统计学意义(P>0.05).联合组中性粒细胞减少、皮疹的发生率高于化疗组,差异有统计学意义(P<0.05),Ⅲ~Ⅳ不良反应两组差异无统计学意义(P>0.05).结论:晚期NSCLC患者EGFR-TKI获得性耐药后,采用培美曲塞联合吉非替尼较单用培美曲塞显示出更优势临床有效率和中位PFS,不良反应可耐受,值得临床推广运用.     

Efficacy of gefitinib for non-adenocarcinoma non-small-cell lung cancer patients harboring epidermal growth factor receptor mutations: a pooled analysis of published reports

The efficacy of gefitinib for patients with non-adenocarcinoma non-small-cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) mutations is unclear, because only a small percentage of patients enrolled in the clinical trials to evaluate the efficacy of gefitinib for tumors harboring EGFR mutation were non-adenocarcinoma NSCLC. A pooled analysis was conducted to clarify the efficacy of gefitinib for non-adenocarcinoma NSCLC patients harboring EGFR mutations. A systematic search of the PUBMED databases was conducted to identify all clinical reports that contained advanced non-adenocarcinoma NSCLC patients harboring EGFR mutations and treated with gefitinib. The selected patients were advanced non-adenocarcinoma NSCLC patients harboring EGFR mutations who were treated with gefitinib and described in reports containing the data of the histology, status of EGFR mutations and response to gefitinib. This study selected 33 patients from 15 reports. Twenty-seven and three of the 33 patients were squamous cell carcinoma and adenosquamous cell carcinoma, respectively. One patient each had large-cell carcinoma, pleomorphic carcinoma and spindle cell carcinoma. Twenty-one patients (64%) had sensitive EGFR mutations. The response rate (RR), disease control rate (DCR) and median progression-free survival (mPFS) was 27%, 67-70% and 3.0 months, respectively. These factors were statistically significantly inferior in the non-adenocarcinoma NSCLC patients harboring EGFR mutations to adenocarcinoma patients harboring EGFR mutations selected from the same published reports (RR: 27%vs 66%, P = 0.000028; DCR: 67-70%vs 92-93%, P = 0.000014; mPFS: 3.0 vs 9.4 months, P = 0.0001, respectively). Gefitinib is less effective in non-adenocarcinoma NSCLC harboring EGFR mutations than adenocarcinoma harboring EGFR mutations.     

Single agent gefitinib as first line therapy in patients with advanced non-small cell lung cancer: Washington University experience

Gefitinib has modest activity with an overall response rate of 11-18% in patients with metastatic non-small cell lung cancer (NSCLC) who have had progressive disease following platinum containing chemotherapy. However, the efficacy of gefitinib in previously untreated metastatic NSCLC is not known. We retrospectively analyzed the efficacy of gefitinib as a first line therapy in 26 patients with advanced NSCLC enrolled in the expanded access program. Patients received gefitinib 250 mg a day orally if they had a poor performance status (PS) or if they refused cytotoxic chemotherapy. Treatment was continued as long as there was no evidence of disease progression or unacceptable treatment related toxicities. The characteristics of 25 evaluable patients enrolled between the period of May 2001 and August 2002 include: 15 women, 10 men; median age 73 years (range 56-86), 81% had an ECOG performance status of two. Only one patient had a partial response and 32% had stable disease as their best response for a disease control rate of 36%; 32% of patients had disease control lasting 5 months or longer. The median overall survival and progression-free survival (PFS) were 14.1 and 2.9 months, respectively. Toxicities were minimal and included rash and diarrhea. Gefitinib was well tolerated and had interesting activity in previously untreated patients with advanced NSCLC.     

Gefitinib as first-line, compassionate use therapy in patients with advanced non-small-cell lung cancer

PURPOSE: To evaluate the efficacy of single-agent gefitinib (Iressa, ZD1839), an oral, epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor, as first-line compassionate use therapy for advanced non-small-cell Lung cancer (NSCLC). PATIENTS AND METHODS: Twenty-five patients who were unfit or refused chemotherapy received oral gefitinib 250mg daily as first-line therapy for the treatment of recurrent or metastatic NSCLC in a compassionate use program at a single institution. RESULTS: Four of 22 evaluable patients (18%), two with adenocarcinomas and two with bronchioloalveolar carcinomas, had an objective response and five patients (23%) had stable disease. Duration of response or stable disease was 3.5-22+ months. Median time to progression was 2.2 months, median survival was 12.6 months and 1-year survival 52%. The partial response plus stable disease rate by Eastern Cooperative Oncology Group (ECOG) performance status (PS) was 4/5 for PS 0 patients; 3/6 for PS 1-2 patients; and 2/14 for PS 3-4 patients. The two patients with PS > 2 who derived benefit from gefitinib had PS 3 due to co-morbidities. Two patients discontinued therapy due to severe toxicities: one patient had severe liver dysfunction and hemorrhagic cystitis, and another patient developed diarrhea with hypotension. A correlation between rash and antitumor activity was noted. Of seven patients who received chemotherapy subsequent to gefitinib, one had a partial response, three had stable disease, two progressed, and one was non-evaluable for response. CONCLUSION: We report encouraging response and survival results with gefitinib as first-line treatment in unselected patients with advanced NSCLC. Gefitinib monotherapy should undergo further evaluation as first-line therapy in advanced NSCLC.     

吉非替尼治疗52例晚期非小细胞肺癌优势人群的临床观察

目的探讨吉非替尼单药治疗临床选择的晚期非小细胞肺癌患者的疗效与不良反应。方法2007年1月～2008年10月共52例、腺癌、不吸烟的晚期非小细胞肺癌患者接受吉非替尼250mg/d口服治疗,观察患者的疗效、TTP、MST和毒副反应。结果本组52例患者均可评价疗效,其中完全缓解3例,部分缓解21例,无变化22例,进展6例。有效率为46.2%,疾病控制率为88.5%,中位TTP为454.67天,1年无进展生存率为52%,MST为597.9天,1年生存率为60%。最常见不良反应主要为皮疹和腹泻。有效率与患者性别、年龄、一般状况、分期及既往治疗无关;与皮疹相关,没有皮疹的病人疗效差（ORR=0.143,95%CI：0.035～0.590）。TTP与患者性别、一般状况、分期及既往治疗无关;只有患者年龄与TTP相关,50岁以下病人的TTP明显缩短疾病进展风险增加（HR=4.196,P=0.0005）;腹泻与TTP相关,没有出现腹泻的病人疾病进展风险大（HR=2.637,P=0.0303）。结论吉非替尼治疗河南本地腺癌、不吸烟的晚期NSCLC的疗效显著,总体生存明显获益,不良反应轻微。     

Efficacy of EGFR tyrosine kinase inhibitors for non-adenocarcinoma NSCLC patients with EGFR mutation

Purpose

The epidermal growth factor receptor tyrosine kinase inhibitors (EGFR TKIs) gefitinib and erlotinib have shown dramatic response rate (RR) and significant prolongation of progression-free survival (PFS) in non-small-cell lung cancer (NSCLC) patients with EGFR mutation. Since only a few patients with non-adenocarcinoma histology have been enrolled in clinical trials, the efficacy of EGFR TKIs in non-adenocarcinoma NSCLC patients with EGFR mutation has not yet been fully determined.

Methods

We retrospectively analyzed clinical outcomes, including RR, PFS, and OS, in patients who were treated with the EGFR TKIs gefitinib or erlotinib and compared the results with those of adenocarcinoma patients with EGFR mutation and non-adenocarcinoma patients with wild-type EGFR.

Results

Among 250 patients with non-adenocarcinoma of the lung who underwent EGFR mutation genotyping, 21 were found to have an EGFR mutation (8.4?%). Twelve of the 21 patients were treated with the EGFR TKIs gefitinib (n?=?6) or erlotinib (n?=?6). The most common mutation was exon 19 deletion (n?=?7). The RR and disease control rate for 12 patients receiving EGFR TKIs were 50 and 75?%, respectively. The median PFS was 3.67?months (95?% CI: 1.34?C5.99), which was significantly lower than that of 269 adenocarcinoma patients with EGFR mutation (13.53?months) but better than that of 32 non-adenocarcinoma patients with wild-type EGFR (1.83?months) who were treated with EGFR TKIs.

Conclusions

The results of this study show that the EGFR mutation rate in Korean patients with non-adenocarcinoma of the lung is relatively high and that the clinical outcomes of EGFR TKIs are modest.     

A phase II study of days 1 and 8 combination of docetaxel plus gemcitabine for the second-line treatment of patients with advanced non-small-cell lung cancer and good performance status

OBJECTIVE: We conducted a phase II trial to evaluate the efficacy and toxicity of a combination consisting of second-line docetaxel and gemcitabine in patients with advanced non-small-cell lung cancer (NSCLC) previously treated with platinum-based chemotherapy. PATIENTS AND METHODS: Eligibility criteria: histologically confirmed advanced NSCLC with progressive disease to platinum-based chemotherapy, ECOG performance status (PS) 0 or 1, and adequate kidney, liver and bone marrow function. Treatment consisted of docetaxel 36 mg/m(2) i.v. over 60 min followed by gemcitabine 1000 mg/m(2) i.v. over 30 min on days 1 and 8 of each 3-week cycle for a planned six cycles or unacceptable toxicity. RESULTS: Of the 52 patients enrolled, 50 were evaluable for response and toxicity. The mean age was 59 years (range 42-79), 46 male and 4 female. Histology subtypes were: adenocarcinoma 26 patients, bronchioloalveolar 1 patient, large cell carcinoma 5 patients, and squamous cell carcinoma 18 patients. Thirty-eight patients had ECOG PS 1 and 12 patients had PS 0. The median number of cycles administered was four (range 2-6). The overall response rate was 28%. The median follow-up was 9 months (range 5-34 months). The median survival time (MST) was 8.2 months (95% CI, 4-12%), and the 1-year survival was 25%. The median progression-free survival was 4.4 months (95% CI, 2-6%). In the Cox regression model, survival was only significantly affected by the PS. The median survival in patients with PS 0 was 17.8 months (95% CI, 18.8-21.8%) compared with a median survival for patients with PS 1 of 6.1 months (95% CI, 4.1-8.2%) (P=0.0057). Toxicity: three patients had grade 3 anemia, three patients had grade 3 thrombocytopenia, four patients had grade 3 neutropenia and only one patient developed grade 4 febrile neutropenia. Non-hematologic toxicity was also mild; the most frequent was asthenia, with grade 3 in eight patients (16%), and one patient with grade 4. CONCLUSION: This regimen of docetaxel in combination with gemcitabine in advanced second-line NSCLC is an active and safe regimen.     

Phase 2 trial of docetaxel and gefitinib in the first-line treatment of patients with advanced nonsmall-cell lung cancer (NSCLC) who are 70 years of age or older

BACKGROUND: This is a phase 2 study of chemotherapy-naive patients, 70 years of age or older, with nonsmall-cell lung cancer (NSCLC) who were treated with docetaxel and gefitinib. The primary endpoint was response rate (RR). Secondary endpoints were overall survival (OS) and progression-free survival (PFS). METHODS: Eligible patients were treated with docetaxel 75 mg/m(2) every 3 weeks and gefitinib 250 mg orally, daily. Docetaxel and gefitinib were given for 2 cycles beyond maximal response. Gefitinib was continued until disease progression. Comorbidities and activities of daily living were assessed (IADL). RESULTS: Forty-four patients initiated therapy between March 2003 and May 2005. Seventeen patients (40%; 95% confidence interval [CI], 26%-57%) had a partial response and 48% had stable disease. The median PFS was 6.9 months (95% CI, 3.95-7.8 months). Median survival time was 9.6 months (95% CI, 4.6-16.3 months). On univariate analyses, sex, Eastern Cooperative Oncology Group Performance Status (ECOG PS), and Charlson comorbidities index (CCI) score were predictors of improved survival. On multivariate analyses female sex was a statistically significant predictor of survival. The median survivals were 22.8 months in women and 4.8 months in men. This regimen was well tolerated, with the most common adverse events being hyperglycemia, fatigue, and lymphopenia. CONCLUSIONS: Docetaxel combined with gefitinib is active and well tolerated in patients with advanced NSCLC who are 70 years of age and older. This paradigm of treatment merits further investigation as a first-line treatment strategy. Female sex-specific confirmatory clinical trials with this regimen may be warranted.     

Gefitinib for previously untreated patients with non-small cell lung cancer (NSCLC)--a retrospective study of 12 patients treated in one institution

Gefitinib has a modest activity in previously treated patients with advanced non-small cell lung cancer (NSCLC). However, the efficacy and safety of gefitinib monotherapy in untreated advanced NSCLC is not known. We retrospectively reviewed the records of 12 patients of NSCLC who were unfit or refused cytotoxic chemotherapy, and were treated with a single-agent gefitinib as first-line therapy in our hospital. The patients were 6 males and 6 females. The median age was 76.5 years (range 34-82). The histological types were adenocarcinoma in all patients. Clinical stage was IIB in one patient, IIIB in four, and IV in seven. Five were elderly patients and four were patients with ECOG PS (performance status) 3. Five had partial response (PR), and two had stable disease (SD). The response rate was 41%. The median time to progression (TTP) was 126 days. Grade 1 diarrhea was observed in three patients, grade 1 or 2 eruption paronychia was in eight, and grade 1 or 2 liver dysfunction was in two. No grade 3 or 4 toxicities occurred. Gefitinib monotherapy may provide an opportunity for untreated NSCLC, particularly unsuitable patients with standard chemotherapy. Prospective studies of gefitinib monotherapy as first-line treatment are warranted.     

Gefitinib as a first-line therapy in patients with advanced non-small cell lung cancer

BACKGROUND: The objective of this study was to evaluate the efficacy and toxicity of gefitinib as a first-line therapy in patients with advanced non-small cell lung cancer (NSCLC). METHODS: We analyzed 19 patients with advanced NSCLC retrospectively, who were treated with gefitinib as a first-line therapy. These patients were not considered for systemic chemotherapy secondary to co-morbid conditions, poor performance status (PS) or refusal of chemotherapy. RESULTS: Median age 68 years, male/female 10/9, stage III/IV 7/12, smoker/non-smoker 12/7, adenocarcinoma/non-adeno 13/6, PS 0/1/2/3/4 0/4/7/5/3. Four patients had a partial response and the overall response rate was 21.0%. The median survival time was 6.8 months and 1-year survival was 27%. Overall toxicities were mild. Grade (G) 3 diarrhea was observed in one patient and G1 interstitial pneumonia in one. CONCLUSIONS: These results demonstrate that gefitinib is active as a first-line therapy in patients with advanced NSCLC.