不同剂量吉西他滨联合卡铂一线治疗晚期非小细胞肺癌的临床疗效

[目的]比较不同剂量吉西他滨联合卡铂一线治疗晚期非小细胞肺癌的疗效和不良反应。[方法]回顾性分析行一线GC方案化疗的晚期非小细胞肺癌患者,共83例,均接受吉西他滨1250mg/m2（38例）或1000mg/m2（45例）联合卡铂（AUC=5）化疗。Kaplan-Meier法进行生存分析和比较。[结果]吉西他滨高剂量组（1250mg/m2）中位无进展生存期为5.2个月,低剂量组（1000mg/m2）中位无进展生存期为4.8个月（P=0.67）,中位总生存期分别为14.5个月和15.8个月,差异亦无统计学意义（P=0.65）。两组有效率分别为31.6%和35.6%（P=0.70）,疾病控制率分别为78.9%和73.3%（P=0.55）。吉西他滨高剂量组血小板降低比例高于低剂量组。[结论]与1250mg/m2化疗组相比,吉西他滨1000mg/m2联合卡铂一线治疗晚期非小细胞肺癌患者疗效及生存期相当,但不良反应降低。     

影响晚期肺鳞癌一线化疗疗效的临床因素分析

目的:分析影响铂二联方案一线治疗晚期肺鳞癌的临床因素,为一线治疗提供临床依据。方法:回顾性分析2008年6月至2012年12月109例经病理及影像学检查确诊、一线应用铂二联方案化疗的IV期肺鳞癌患者的临床因素,包括:性别、年龄、是否吸烟、是否存在远处转移、一线化疗方案、一线方案的疗效及周期数、是否接受局部放疗及二线治疗;分析这些临床因素对一线方案近期及远期疗效的影响。近期疗效用客观有效率代表,远期疗效用中位生存期代表。结果:109例患者中,部分缓解者35例,疾病稳定者34例,疾病进展者40例,客观有效率 32.1%,疾病控制率 63.3%。中位生存期为12.00个月（95%CI:11.05~12.95个月）,一线治疗中位至疾病进展时间为5.0个月（95%CI:4.26~5.74个月）。单因素分析表明患者性别、年龄、是否吸烟、是否存在远处转移、一线方案对一线化疗疗效的影响不具有统计学意义。Kaplan-Meier分析及COX回归分析均表明:性别、年龄、是否吸烟、治疗前是否存在远处转移以及一线方案对患者生存期的影响不具有统计学意义;而一线化疗疗效、一线化疗周期数、是否接受局部放疗及二线治疗则对患者生存期的影响具有统计学意义。结论:一线化疗的疗效及周期数、是否接受二线治疗及局部放疗是影响晚期肺鳞癌患者预后的独立因素。     

吉西他滨联合长春瑞滨与联合紫杉醇姑息治疗铂类耐药的Ⅳ期鼻咽癌患者的随机对照试验

目的:观察吉西他滨联合长春瑞滨与联合紫杉醇方案作为姑息治疗方案治疗铂类耐药的Ⅳ期鼻咽癌患者的有效性及安全性。方法:收集2012年7月至2014年7月含铂一线治疗失败的晚期鼻咽癌患者共105例的临床资料,随机分为吉西他滨联合长春瑞滨组（GV组）与吉西他滨联合紫杉醇组（GT组）,比较两方案在总有效率（ORR）、疾病控制率（DCR）、无进展生存期（PFS）、总生存期（OS）及不良反应发生率等方面的差异。采用Log-rank检验比较PFS及OS。结果:两组间的ORR无统计学差异（P=0.491）,DCR存在统计学差异（GT组较优,P=0.034）。两组间的PFS、OS的差别均无统计学意义（P=0.387,P=0.673）。不良反应方面,GV组Ⅰ度感觉异常较多,而GT组Ⅲ度白细胞降低、Ⅰ度疲乏无力、过敏反应、肌肉关节疼痛、脱发及Ⅱ度脱发较多,差别均有统计学意义。结论:GV、GT两种方案治疗铂类耐药的晚期鼻咽癌患者在总有效率、无进展生存期及总生存期上近似,GT方案可提高患者疾病控制率（DCR）,不良反应较GV方案多,多为轻中度,患者可耐受。     

吉西他滨联合顺铂方案与多西他赛联合奈达铂方案对晚期肺鳞癌的疗效比较

目的 比较吉西他滨+顺铂方案及多西他赛+奈达铂方案治疗晚期肺鳞癌患者的疗效及安全性.方法 选取晚期肺鳞癌患者60例作为研究对象,分别采用吉西他滨+顺铂方案(GP)及多西他赛+奈达铂方案(TN)化疗,比较其治疗效果、生存期、不良反应.结果 GP组患者PR患者4例,SD患者8例,PD患者18例,总有效率为40.00％,TN组总有效率30％,差异有统计学意义(P ＜0.05);GP组6个月生存28例,占93.33％,1年生存率为76.67％,2年生存率为50.00％,均明显高于TN组,差异有统计学意义(P＜0.05);GP组WBC减少占40.00％,PLT减少占30.00％,均高于TN组,末梢神经毒性、脱发发生率均低于TN组,差异有统计学意义(P＜0.05);在恶心呕吐、贫血、肝毒性、肾毒性等方面两组比较差异无统计学意义(P＞0.05).结论 对晚期肺鳞癌患者采用吉西他滨联合顺铂方案、多西他赛联合奈达铂方案化疗,均能取得较高的治疗效果,吉西他滨联合顺铂方案化疗能更好的延长晚期肺鳞癌患者生存期方面均有一定的优势,不良反应可耐受,安全性较好.     

洛铂联合吉西他滨治疗晚期肺鳞癌疗效分析

目的 明确洛铂联合吉西他滨方案在晚期肺鳞癌中的疗效和安全性.方法 入组66例晚期肺鳞癌患者分为2组,试验组30例患者接受洛铂联合吉西他滨化疗,对照组36例患者接受顺铂联合吉西他滨化疗,并比较观察2组的近期疗效和毒副反应.结果 试验组有效率为36.7%,对照组为36.1%,差异无统计学意义(P＞0.05);试验组Ⅲ、Ⅳ度血小板减少多于对照组,而Ⅲ、Ⅳ度恶心呕吐、乏力少于对照组,差异均有统计学意义(P均＞0.05).结论 洛铂联合吉西他滨一线治疗晚期肺鳞癌近期疗效与顺铂联合吉西他滨方案相似,毒副反应方面存在差异,值得临床进一步研究.     

多西他赛或吉西他滨联合替吉奥二线治疗晚期食管鳞癌的临床疗效和安全性分析

目的 比较多西他赛或吉西他滨联合替吉奥二线治疗晚期食管鳞癌的临床疗效和安全性.方法 选取一线紫杉醇联合铂类化疗方案治疗失败或缓解后再进展的晚期食管鳞癌患者61例,根据二线化疗方案不同将患者分为多西他赛组和吉西他滨组,多西他赛组(n=31)给予多西他赛联合替吉奥治疗,吉西他滨组(n=30)给予吉西他滨联合替吉奥治疗.两组患者均每2个周期评价疗效,并对两组患者的疗效、不良反应发生情况、无进展生存情况进行比较.结果 多西他赛组和吉西他滨组患者的有效率(RR)分别为25.806%、16.667%,疾病控制率(DCR)分别为61.290%、56.667%,中位无进展生存期(PFS)分别为4.5个月、4.0个月,差异均无统计学意义(P>0.05).两组患者的主要不良反应均为血液学不良反应和消化道不良反应,经过对症治疗均可缓解,多西他赛组的中性粒细胞减少、血小板减少、乏力及皮疹的发生率低于吉西他滨组(P<0.05).结论 多西他赛或吉西他滨联合替吉奥药物作为二线化疗方案治疗晚期食管鳞癌疗效相当,但多西他赛相较吉西他滨可有效降低化疗不良反应发生率.     

吉西他滨联合顺铂与联合多西紫杉醇治疗非小细胞肺癌的随机对照研究

目的含铂类方案目前是治疗晚期非小细胞肺癌（NSCLC）的标准方案,但其严重的毒副反应促使人们寻找新的替代方案,本研究探讨用吉西他滨联合多西紫杉醇与吉西他滨联合顺铂方案治疗晚期NSCLC的疗效、生存率及毒副反应。方法对62例经病理或细胞学证实的晚期NSCLC的初治患者给予联合化疗,随机分为GT（吉西他滨联合多西紫杉醇）组与GP（吉西他滨联合顺铂）组,两组病例具有可比性,GT组31例,吉西他滨1000mg／m^2,静脉滴注,d1,8,多西紫杉醇（艾素）75mg／m^2加入生理盐水200mL中静脉滴注1h,d1;GP组31例,吉西他滨1000mg／m^2,静脉滴注,d1,8,顺铂25mg/m^2,静脉滴注,d1-3,21d为1个周期,每例治疗不超过6个周期。结果GT组患者总有效率为35．4％,1年生存率为76．2％,中位生存期18．6个月,中位TTP4．9个月,中位PFS3．0个月;GP组患者总有效率为32．2％,1年生存率为67．8％,中位生存期为14．6个月,中位4．4个月,中位PFS3．0个月。两组间有效率、1年生存率、中位生存期差异无统计学意义。最常见的毒副反应为恶心呕吐,GT和GP组的Ⅲ＋Ⅳ度反应发生率分别为3．2％和54．8％,差异有统计学意义（P〈0．05）,其余毒副反应轻微,可耐受。结论吉西他滨联合多西紫杉醇与吉西他滨联合顺铂相比疗效相似,但毒副反应轻,安全可行,耐受性好,中位生存期、1年生存率及生活质量以吉西他滨联合多西紫杉醇的非铂方案较好,值得临床推荐应用。     

白蛋白结合型紫杉醇联合吉西他滨一线治疗晚期胰腺癌的疗效观察

目的 探讨白蛋白结合型紫杉醇联合吉西他滨一线治疗晚期胰腺癌的疗效和安全性。方法 本院2012年3月至2015年1月收治的27例经病理确诊为晚期转移性胰腺癌患者,接受白蛋白结合型紫杉醇联合吉西他滨一线治疗,具体方案：白蛋白结合型紫杉醇125 mg／m²静滴,d₁、d₈;吉西他滨1000 mg／m²静滴,d₁、d₈,每21天为1个周期。2个周期后按照RECIST 1.1版标准评价客观疗效,采用国立癌症研究所毒性判定标准（NCI CTC）3.0评价化疗毒性反应,同时随访其生存情况并比较不同临床病理特征的中位无进展生存期（PFS）和总生存期（OS）。结果 所有患者均可评价疗效,无CR病例,PR 2例,SD 19例,有效率（RR）和疾病控制率（DCR）分别为 7.4％和77.8％。全组患者的中位PFS和OS分别为5.0个月（95%CI：4.0～6.7个月）和8.0个月（95%CI：7.5～13.8个月）。亚组分析显示化疗周期数与患者的PFS和OS有关。主要不良反应为恶心呕吐（48.1％）、疲劳（55.5％）、发热（7.4％）、皮疹（3.7％）及周围神经异常（11.1％）;严重不良反应主要为骨髓抑制,其中3～4级血液学毒性包括白细胞减少、血小板减少和血红蛋白减少。结论白蛋白结合型紫杉醇联合吉西他滨治疗国人晚期胰腺癌疗效确切,不良反应可以耐受。     

吉西他滨和顺铂联合用药治疗晚期胰腺癌患者利弊的Meta分析

目的:通过Meta分析，探讨吉西他滨和顺铂联合与吉西他滨单药治疗晚期胰腺癌的优缺点。方法:计算机检索中国知网、维普、万方数据库及中国生物医学数据库、PubMed、Sciencedirect、Embase、Cochrane Database、OVID Medline、Springer Link、EBSCO数据库，筛选观察组为吉西他滨与顺铂联合用药，对照组为吉西他滨单药治疗晚期胰腺癌的试验。检索期限为建库至2018年3月31日，同时手工查阅检索相似文献及参考文献。以上资料均由两位研究者独立进行文献筛选和资料提取，采用Review Manager 5.3软件进行Meta分析，计算结果以HR或OR值及95%置信区间（95%CI）表示。结果:共纳入文献12篇，包括观察组850例和对照组753例。Meta分析结果显示:疗效方面，总生存期、1年生存率及半年生存率方面吉西他滨和顺铂联合用药与吉西他滨单独用药无明显区别［HR总生存期=0.97，95%CI为（0.83，1.12）,P=0.65＞0.05；OR1年生存率=1.02，95%CI为（0.76，1.38），P=0.89＞0.05；OR半年生存率=1.12，95%CI为（0.77，1.64），P=0.56＞0.05］；而客观缓解率（ORR）则具有边缘性统计意义［OR客观缓解率=1.54，95%CI为（1.00，2.37），P=0.05］；毒副反应方面，吉西他滨和顺铂联合用药的毒副作用明显高于吉西他滨单独用药［OR3/4度中性粒细胞减少=1.70，95%CI为（1.27，2.27），P=0.000 4＜0.05；OR3/4度血小板减少=1.96，95%CI为（1.55，2.49），P＜0.000 01；OR胃肠道毒副作用=2.98，95%CI为（1.95，4.55），P＜0.000 01］。结论:吉西他滨联合顺铂治疗晚期胰腺癌虽然在ORR中能使患者受益，但不能使患者获得比单用吉西他滨更好的临床疗效及远期预后，反而使中性粒细胞减少、血小板减少及胃肠道反应等毒副反应加剧。因此，临床上不应提倡吉西他滨联合顺铂用药作为一线临床用药，应选用更加合理有效的化疗用药方案。     

吉西他滨单药或联合白蛋白结合型紫杉醇治疗东亚人群晚期胰腺癌临床疗效的荟萃分析

目的 系统评价吉西他滨单药和吉西他滨联合白蛋白结合型紫杉醇一线治疗东亚人群晚期转移性胰腺癌的疗效，以期为中国转移性胰腺癌临床一线治疗的合理用药提供依据。方法 按照预设的纳入和排除标准，在万方、Cochran Library、MEDLINE、PubMed和CNKI等数据库中系统性检索2010年1月至2018年6月发表的文献。主要观察终点为客观缓解率（ORR）， 次要终点为无进展生存期（PFS） 和总生存期（OS）。提取纳入文献的相关资料，采用Rav Man 3.5.0版软件进行Meta分析。结果 共纳入38项研究，合计1945例患者。吉西他滨单药治疗晚期胰腺癌的ORR为0.15（95％CI：0.11～0.18）、中位PFS为3.39（95％CI：2.74～4.05）个月、中位OS为7.39（95％CI：6.54～8.23）个月；吉西他滨联合白蛋白结合型紫杉醇治疗晚期胰腺癌的ORR为0.40（95％CI：0.29～0.52）、中位PFS为5.68（95％CI：4.30～7.06）个月、中位OS为9.80（95％CI：7.89～11.71）个月。结论 吉西他滨联合白蛋白结合型紫杉醇与吉西他滨单药比较， 具有明显的优效性，适合东亚人群，特别是中国晚期胰腺癌患者。     

吉西他滨/多西他赛联合铂类一线治疗转移性鼻咽癌的临床对照研究

目的:观察吉西他滨联合铂类与多西他赛联合铂类方案在转移性鼻咽癌一线治疗中的疗效及耐受性。方法:2011年1 月至 2015年12月广西医科大学第四附属医院诊疗的转移性鼻咽癌120例。随机分两组接受一线化疗:吉西他滨联合铂类组60例,多西他赛联合铂类组60例。观察疾病缓解率（RR）、疾病控制率(DCR)及不良反应;采用 Kaplan-Meier法、Log-rank检验分析中位无进展生存（mPFS）、中位总生存（mOS）。结果:113例可评价病例,吉西他滨联合组56例,多西他赛联合组57例。吉西他滨联合组RR显著高于多西他赛联合组,差异有统计学意义(71.4% vs 52.6%,P=0.04)。中位随访15.8个月,与多西他赛联合组比较,吉西他滨联合组mPFS、mOS显著延长,差异有统计学意义（mPFS:9.7个月 vs 7.8个月,P=0.014; mOS:20.6个月 vs 16.8个月,P=0.005)。两组主要不良反应为均为骨髓抑制、胃肠道反应,但差异无统计学意义（P＞0.05）。多西他赛联合组1级末梢神经损害发生率显著高于吉西他滨联合组,差异有统计学意义(12.3% vs 1.8%,P=0.030),但两组均无2～4级末梢神经损害发生。结论:与多西他赛联合铂类方案比较,吉西他滨联合铂类一线治疗转移性鼻咽癌患者有更高的RR,可显著延长患者的PFS及OS时间,耐受性良好,末梢神经毒性更轻,可作为转移性鼻咽癌一线治疗的良好选择。     

含铂两药方案治疗老年晚期非小细胞肺癌的临床分析

目的 评价老年晚期非小细胞肺癌（NSCLC）患者接受以铂类为基础的两药联合化疗的疗效及安全性。方法 回顾性分析2003年1月至2009年12月北京胸科医院肿瘤内科收治的晚期NSCLC患者115例,年龄≥65岁,均接受以铂类为基础的两药联合一线化疗。具体化疗方案为：顺铂50～60mg／m2或卡铂曲线下面积（AUC）4～5静滴,第1天;紫杉醇135～150mg／m2静滴3～4h,第1天;或长春瑞滨25mg／m2静滴6～10min,第1、8天;或吉西他滨1000mg／m2静滴30min,第1、8天。上述方案3～4周为1个周期。观察并随访治疗疗效及主要不良反应。结果 115例患者中,应用铂类联合紫杉醇方案化疗44例（38.3％）,联合吉西他滨方案31例（27.0％）,联合长春瑞滨方案40例（34.7％）。全组患者的有效率（RR）为26.1％,疾病控制率（DCR）为76.5％,中位无进展生存时间（PFS）为5.5个月,中位总生存时间（OS）为14.0个月,1、2年生存率分别为50％和15％。化疗相关不良反应主要为骨髓抑制,包括白细胞及血小板减少,对症处理后可恢复。按照不同年龄、方案、铂类药物及ECOG评分进行亚组分析,其中不同ECOG评分及铂类药物的中位PFS及OS差异有统计学意义（P＜0.05）。结论 以铂类为基础联合第3代细胞毒性药物的两药方案一线治疗一般状态较好的老年晚期NSCLC的疗效较好,毒副反应可以耐受。     

Outcome of advanced nonsmall cell lung cancer patients receiving gemcitabine and weekly paclitaxel as first-line treatment

BACKGROUND: Gemcitabine and paclitaxel are both indicated for advanced nonsmall cell lung cancer (NSCLC) patients. Combinations of gemcitabine and paclitaxel with various doses and schedules were shown to be effective treatment for these patients. Nevertheless, the survival outcome of these patients is not clear. PATIENTS AND METHODS: Patients with advanced NSCLC in a phase II study of weekly paclitaxel and gemcitabine as first-line treatment were followed until their death. Second- and further-lines of treatment were recorded. RESULTS: Thirty-seven patients receiving a total of 188 cycles of gemcitabine and paclitaxel treatment were accrued. Toxicities were mild. Twenty-three patients had partial response to treatment (overall response rate, 62%; 95% confidence interval (CI), 46-78%). Median time to treatment failure was 6.0 months. Twenty-seven (73%) patients received second-line anticancer drug treatment. Twenty-three (62%) patients were able to receive platinum doublet as second-line chemotherapy. Median survival after second-line treatment was 10.9 months. Median, 1- and 2-year survivals of 37 patients were 16.8 months, 59% and 27%, respectively. There was a statistically significant difference in median survival between patients who could or could not receive second-line treatment (21.9 vs. 3.1 months, p<0.00001). CONCLUSIONS: Weekly paclitaxel with gemcitabine is effective and well tolerated as first-line treatment for advanced NSCLC patients. The favorable survival may be due to platinum doublet second-line chemotherapy.     

Treatment Outcomes of Gemcitabine in Refractory or Recurrent pithelial Ovarian Cancer Patients

Background: To study the response rate (RR), progression-free survival (PFS) and toxicity profiles of recurrent pithelial ovarian cancer (EOC) patients treated with gemcitabine. Materials and Methods: Recurrent EOC patients who were treated with gemcitabine between January 2000 and December 2013 at the Department of Obstetrics and Gynecology, Faculty of Medicine Vajira Hospital were identified and medical records were reviewed. Clinico-pathological features including data of gemcitabine treatment, response and toxicity were collected. Results: We identified 43 EOC patients who had gemcitabine treatment. All except one patient who did not receive any adjuvant treatment, had received platinum-based chemotherapy. Among these 42 patients, 31.0% had refractory cancer to first-line chemotherapy while 69.0% had recurrence with 48.8% being platinumsensitive. The total cycles of gemcitabine used were 203 (median 4, range 2-9 cycles). Overall RR was 11.6%: 19% in platinum-sensitive vs 4.5% in platinum-resistant groups (p=0.158) and 42.9% in the patients having gemcitabine together with platinum vs 5.6% using gemcitabine alone (P=0.024). Median PFS was 3.6 months (95% confidence interval [CI], 2.73-4.49 months): 8.1 months (95% CI, 2.73-4.49 months) in combination regimen vs 3.2 months (95% CI, 2.01-4.42 months) in single regimen (p=0.077) and 8.1 months (95% CI, 4.73-11.48 months) with the gemcitabine combination vs 2.7 months (95% CI, 1.98-3.38 months) by single gemcitabine in platinum sensitive patients (P=0.007). Common toxicities were hematologic which were well tolerated and manageable. Conclusions: Gemcitabine has modest activity in pre-treated EOC. A combination regimen had higher activity than single agent in platinum sensitive patients with a significant improvement in RR and PFS.     

A phase II study of biweekly paclitaxel (P) and gemcitabine (G), followed by maintenance weekly paclitaxel in elderly patients with advanced non-small cell lung cancer (NSCLC)

BACKGROUND: This phase II study was conducted to evaluate the efficacy and safety of a novel combination of paclitaxel (P) and gemcitabine (G) in an every 2 weeks schedule followed by weekly paclitaxel (P) as first-line treatment in elderly patients with locally advanced or metastatic NSCLC. METHODS: Elderly patients (> or =65 years of age) with 1997 TNM stage IIIB (pleural effusion)/stage IV NSCLC, performance status (PS) of 0-2 and normal organ function were eligible. Therapy consisted of P at 150 mg/m(2) and G at 2000 mg/m(2) administered every 2 weeks for 3 cycles followed, in progression-free patients, by P at 80 mg/m(2) every week for 6 consecutive weeks every 8 weeks for 2 cycles. RESULTS: Fifty-three eligible patients were enrolled: M/F 51/2; stage IIIB/IV 8/45; PS 0, 40%, PS 1 51%, PS 2 9%; median age, 73 years (range 67-82). The overall response rate was 32% (95% confidence interval [CI]: 19-45). The median overall survival was 7 months (95% CI: 5-9); the median progression-free survival was 5 months (95% CI: 3-6); and the 1- and 2-year survivals were 28.3% and 10.1%, respectively. Both phases of the treatment protocol were well tolerated. CONCLUSIONS: Biweekly P/G followed by weekly P is well tolerated and active as first-line therapy for elderly NSCLC patients.     

Effect of platinum combined with irinotecan or paclitaxel against large cell neuroendocrine carcinoma of the lung

BACKGROUND: The efficacy of chemotherapy in patients with large cell neuroendocrine carcinoma of the lung (LCNEC) remains unclear. METHODS: Of 42 consecutive patients with LCNEC, 22 with measurable disease receiving chemotherapy were enrolled as the subjects of this study. The clinical characteristics and objective responses to chemotherapy in these patients were analysed retrospectively. RESULTS: The distribution of the disease stage in the patients consisting of 21 males and one female (median age: 67 years; range: 47-78 years) was as follows: stage IIB (n = 1), stage IIIA (n = 1), stage IIIB (n = 5), stage IV (n = 8), and post-operative recurrence (n = 7). Chemotherapy consisted of cisplatin and irinotecan (n = 9), a platinum agent and paclitaxel (n = 6), paclitaxel alone (n = 1), cisplatin and vinorelbine (n = 1), cisplatin and docetaxel (n = 1), and a platinum and etoposide (n = 4). The objective response rate in the 22 patients was 59.1% (95% CI, 38.1-80.1). An objective response was obtained in five of the nine patients receiving irinotecan and five of the seven patients receiving paclitaxel. The progression-free survival, median overall survival and 1-year survival rates were 4.1 months (95% CI, 3.1-5.1), 10.3 months (95% CI, 5.8-14.8) and 43.0% (95% CI, 20.7-65.3), respectively. The median overall survival of the patients treated with irinotecan or paclitaxel was 10.3 months (95% CI, 0-21.8), and the 1-year survival rate of these patients was 47.6% (95% CI, 20.4-74.8). CONCLUSION: Our results suggest that irinotecan and paclitaxel may be active against LCNEC.     

Gemcitabine and vinorelbine as second-line therapy for non-small cell lung cancer after treatment with paclitaxel plus platinum

OBJECTIVE: To investigate the activity and feasibility of combination therapy of gemcitabine and vinorelbine for patients with advanced NSCLC after the failure of initial treatment with paclitaxel plus platinum. METHODS: From March 2000 to August 2002, 38 evaluable patients (median age 55 years) with NSCLC, who had failed to recover after treatment with paclitaxel plus platinum, received vinorelbine (30 mg/m(2) i.v.) followed by gemcitabine (1000 mg/m(2) i.v.), both being administered on days 1 and 8 and recycled every 3 weeks. RESULTS: Objective responses were as follows: partial response, 8/38 [21%; 95% confidence interval (CI) 8-23%]; and stable disease, 21/38 (55%). Median time to progression was 3.9 months and the median overall survival was 8.1 months. Grades III and IV neutropenia were seen in 17 and 11% of patients, respectively. CONCLUSION: This combination chemotherapy with gemcitabine and vinorelbine is active and highly tolerable as a second-line therapy for NSCLC.     

Chemotherapy with an every-2-week regimen of gemcitabine and paclitaxel in patients with transitional cell carcinoma who have received prior cisplatin-based therapy.

BACKGROUND: An every-2-week regimen of gemcitabine and paclitaxel was adapted for patients with advanced transitional cell carcinoma (TCC) who had received prior cisplatin-based chemotherapy. METHODS: Forty-one patients with advanced or metastatic TCC who had received prior cisplatin-based systemic chemotherapy were treated with an outpatient regimen of gemcitabine 2500-3000 mg/m(2) and paclitaxel 150 mg/m(2) every 2 weeks. RESULTS: Forty of 41 patients had measurable disease. Response was observed in 24 patients (60%; 95% confidence interval [CI], 45-75%). Eleven (28%) achieved complete response, and 13 (33%) obtained partial response. Twenty of 25 patients (80%; 95% CI, 64-96%) who had been previously treated in the neoadjuvant or adjuvant setting responded versus 4 of 15 (27%; 95% CI, 5-49%) in patients who received prior methotrexate, vinblastine, doxorubicin, cisplatin (M-VAC) for metastatic disease. The median duration of survival for patients given gemcitabine and paclitaxel after failing neoadjuvant or adjuvant M-VAC was 12 months (range, 2-43+), as compared with only 8 months (range, 2-28) for patients who had been treated after failure of prior therapy for metastatic disease. For all patients, the median duration of response was 6.4 months (range, 2-43.3+ months), and the median survival was 14.4 months (range, 2-43+). Thirteen patients (32%) developed World Health Organization Grade 3-4 neutropenia, with febrile neutropenia in 3 (7%) patients. Granulocyte colony-stimulating factor was given to 10 (24%) patients. There was no Grade 3-4 anemia or thrombocytopenia. CONCLUSIONS: The combination of gemcitabine and taxol in previously treated patients with recurrent TCC is highly effective and produces objective durable responses. This every-2-week schedule is a well tolerated outpatient regimen with minimal toxicity.