紫杉醇脂质体联合顺铂与吉西他滨联合顺铂一线治疗晚期肺鳞癌患者的疗效比较

目的探讨注射用紫杉醇脂质体联合顺铂(LP方案)与吉西他滨联合顺铂(GP方案)一线治疗晚期肺鳞癌患者的临床疗效和不良反应。方法选取2010年7月至2016年7月间山东省肿瘤医院收治的200例晚期肺鳞癌患者,根据治疗方法不同分为LP组和GP组,每组100例。LP组患者采用注射用紫杉醇脂质体联合顺铂治疗,GP组患者采用吉西他滨联合顺铂一线化疗治疗,比较两组患者的临床疗效和不良反应。结果 LP组患者有效率(RR)为39. 0%,疾病控制率(DCR)为88. 0%,GP组患者RR为43. 0%,DCR为87. 0%; LP组患者中位无进展生存时间(OS)为5. 6个月,中位总生存时间(PFS)为14. 1个月; GP组患者PFS为6. 1个月,OS为13. 5个月。两组比较,差异均无统计学意义(均P> 0. 05)。GP组患者的白细胞减少、血小板减少和胃肠道反应较LP组更明显,差异均有统计学意义(均P <0. 05)。结论 LP和GP两种方案治疗晚期肺鳞状细胞癌患者的临床疗效相似,LP方案不良反应较轻。     

伊立替康或足叶乙甙联合顺铂方案一线治疗小细胞肺癌的临床随机对照研究

  目的  本研究为比较伊立替康联合顺铂(irinotecan plus cisplatin, IP)方案与足叶乙甙联合顺铂(etoposide plus cisplatin, EP)方案一线治疗小细胞肺癌(SCLC)的近期疗效、远期生存及不良反应。  方法  首都医科大学附属北京胸科医院肿瘤内科从2008年3月至2010年3月收治的60例SCLC患者, 随机分为两组, 分别接受IP和EP方案的治疗。主要研究终点为无进展生存期(progression-freesurvival, PFS), 次要研究终点为总生存(overall survival, OS), 客观反应率(response rate, RR)和不良反应。  结果  60例患者中, 59例可评价疗效, 其中IP组RR 65.4%(19/29), 中位PFS为9.6个月, 中位OS为17.3个月; EP组RR 73.3%(22/30), 中位PFS为9.7个月, 中位OS为17.4个月, 两组比较均无统计学差异(P=0.864;P=0.982;P=0.997)。两组主要不良反应均为骨髓抑制和胃肠道反应, 但Ⅲ+Ⅳ度不良反应均无统计学差异(P > 0.05), IP组腹泻发生率高于EP组(26.6%vs.0), 两组比较差异具有统计学意义(P=0.003)。  结论  IP方案一线治疗SCLC近期疗效及远期生存均与EP方案相当, 且不良反应可耐受。      

紫杉醇脂质体单药与紫杉醇脂质体联合奥沙利铂一线治疗老年晚期非小细胞肺癌的随机对照研究

背景与目的目前推荐第三代药物单药治疗老年晚期非小细胞肺癌(non-small cell lung cancer,NSCLC),本研究旨在比较紫杉醇脂质体与紫杉醇脂质体联合奥沙利铂一线治疗老年晚期NSCLC的临床疗效及毒副作用。方法 2008年7月-2010年8月未经过治疗的经病理学或细胞学确诊的老年晚期NSCLC患者69例随机分成紫杉醇脂质体单药组(35例)和紫杉醇脂质体联合奥沙利铂组(34例),单药组给予紫杉醇脂质体135 mg/m~2 d1;联合组给予紫杉醇脂质体135mg/m~2 d1+奥沙利铂125mg/m~2 d1,每21天重复,至少治疗2个周期,评价疗效和不良反应。结果单药组与联合组相比,治疗有效率(22.9%vs 35.3%,P=0.297)、疾病控制率(60.0%vs 70.6%,P=0.450)和1年生存率(28.6%vs 41.2%,P=0.724)差异均无统计学意义,联合组的无疾病进展生存期(progression free survival,PFS)较单药组延长1.5个月(5.0个月vs 3.5个月,P=0.024)。在毒副作用方面,两组白细胞减少(P=0.808)、血小板减少(P>0.999)、贫血(P=0.477)、恶心和呕吐的发生率(P=0.777)相当;两组发生神经毒性的患者分别为33例和3例(97.1%vs 8.6%,P<0.001),但均为Ⅰ度-Ⅱ度。结论紫杉醇脂质体联合奥沙利铂用于一线治疗老年晚期NSCLC疗效略优于紫杉醇脂质体单药,能延长患者的PFS,临床应用安全性好。     

紫杉醇联合顺铂一线治疗晚期食管癌疗效及预后分析

目的:探讨紫杉醇联合顺铂一线治疗晚期食管癌的疗效及安全性.方法:回顾性分析2008年1月至2013年6月我院收治的以紫杉醇联合顺铂作为一线化疗方案的晚期食管癌患者的临床及病理资料,根据上述纳入患者的性别、年龄、肿瘤位置、肿瘤分化程度、肿瘤进展情况等一般资料,按1∶1的比例选取同期以多西他赛联合顺铂作为一线化疗方案的晚期食管癌患者进行配对.比较病例组(紫杉醇联合顺铂)和对照组(多西他赛联合顺铂)一线化疗不良反应发生情况及生存情况的差异.结果:病例组因食管癌及其相关疾病死亡26例,存活14例,一线化疗后进展27例.PFS 3~30.5个月,中位PFS 10.7个月.OS 2~31个月,中位OS 13个月.对照组因食管癌及其相关疾病死亡25例,存活15例,一线化疗后进展30例.PFS 2.9~47个月,中位PFS 12个月.OS 1~49个月,中位OS 10个月.两组患者PFS及OS的差异,具有统计学意义(P<0.05).单因素和多因素分析显示,除临床分期和初治时远处转移器官数目外,一线化疗方案中紫杉醇联合顺铂与否也是影响两组患者PFS和OS的独立预后因素.结论:与多西他赛联合顺铂相比,紫杉醇联合顺铂一线治疗晚期食管癌的疗效显著,对于进展期食管癌患者来说是一个可供选择的一线治疗方案.     

铂类为基础的三种化疗方案治疗晚期非小细胞肺癌的临床研究

目的:观察紫杉醇(paclitaxel,Taxel)、长春瑞滨(vinorelbine,NVB)、吉西他滨(gemcitabine,GEM)分别联合顺铂(cisplatin,DDP)方案对晚期非小细胞肺癌(non-small cell lung cancel,NSCLC)的疗效及毒副反应.方法:93例晚期非小细胞肺癌患者随机分为TP组(紫杉醇 顺铂)32例、NP组(长春瑞滨 顺铂)31例、GP组(吉西他滨 顺铂)30例.给药方法:紫杉醇135mg/m2,第1天;长春瑞滨25mg/m2,吉西他滨1000mg/m2,均在第1、8天使用;顺铂80mg/m2,分2天使用.统计各组有效率(CR PR)、中位生存期(medi-an duration of survival)、1年生存率(1 year survival rate).结果:TP组有效率(CR PR)为43.8%,中位生存期为8.6月,1年生存率为32.1%;NP组有效率为38.7%,中位生存期为8.4月,1年生存率为26.5%;GP组有效率为36.7%,中位生存期为9.4月,1年生存率为38.1%,三组问疗效无显著差异(P>0.05).主要不良反应为骨髓抑制、消化道反应,均可耐受.TP组骨髓抑制发生率相对较高,NP组静脉炎发生率高于TP、GP组,有显著性差异(P＜0.05).结论:三种联合化疗方案对晚期NSCLC疗效确切,三种方案间无显著差异,均可作为一线化疗方案在临床应用.     

培美曲塞或吉西他滨联合顺铂一线治疗晚期非小细胞肺癌的临床随机对照研究

目的:比较培美曲塞联合顺铂(PEM)方案与吉西他滨联合顺铂(GEM)方案一线治疗晚期非小细胞肺癌(NSCLC)的疗效及耐受性.方法:30例经组织学确诊的ⅢB期或Ⅳ期初治NSCLC患者随机分成PEM组和GEM组,每组各15例.结果:PEM组RR为40.0％,PFS为5.60个月,OS为18.07个月;GEM组RR为20.0％,PFS为6.50个月,OS为18.10个月,两组比较差异均无统计学意义,P值分别为0.182、0.431和0.516.肺腺癌中PEM组RR、PFS及OS均好于GEM组,但差异无统计学意义,P＞0.05.两组主要毒副反应均为骨髓抑制和胃肠道反应,PEM组患者Ⅲ/Ⅳ度血液学毒性发生率均低于GEM组患者,差异无统计学意义,P＞0.05.结论:培美曲塞联合顺铂一线治疗晚期非小细胞肺癌,特别是肺腺癌,疗效确切,耐受性良好.     

紫杉醇联合卡铂三周方案同步胸部放疗治疗不宜手术的局部晚期非小细胞肺癌疗效和安全性研究:一项来自单中心的回顾性研究

背景与目的 对于局部晚期非小细胞肺癌(non-small cell lung cancer,NSCLC)同步放化疗是推荐的标准治疗.理想的化疗方案并未确立.本研究拟回顾性分析紫杉醇/卡铂(paclitaxel/carboplatin,PC)三周方案同步胸部放疗治疗局部晚期NSCLC的疗效和安全性,并与标准的依托泊苷/顺铂(cisplatin/etoposide,PE)方案进行比较.方法 回顾性分析北京协和医院2012年1月-2014年6月收治的局部晚期NSCLC患者共43例,其中15例接受PC三周方案同步胸部放疗,28例接受PE方案同步胸部放疗.比较两组患者的临床特征、疗效和不良反应.结果 全组患者:客观缓解率(objective response rate,ORR)为41.9％,疾病控制率(disease control rate,DCR)为90.7％,中位无疾病进展生存时间(progression-free survival,PFS)为10,6个月(95％CI:7.4-13.8),中位总生存期(overall survival,OS)为19.2个月(95％Ch15.3-23.1).PC组和PE组在疗效上无统计学差异(ORR:33.3％vs 46.4％,DCR:86.7％vs 92.9％,P=0.638;PFS:6.6个月vs 12.2个月,P=0.389;OS:16.1个月vs 22.1个月,P=0.555).不良反应可处理,两组均未发生治疗相关死亡.结论 PC三周方案同步胸部放疗治疗局部晚期NSCLC与标准PE方案疗效相似,不良反应可接受,在临床中可采用.     

紫杉醇脂质体联合卡铂治疗培美曲塞联合顺铂化疗失败的晚期肺腺癌的临床观察

目的:探讨紫杉醇脂质体联合卡铂治疗培美曲塞联合顺铂化疗失败的晚期肺腺癌的临床疗效及安全性.方法:收集2012年1月至2015年4月22例对培美曲塞联合顺铂方案化疗失败的晚期肺腺癌患者,给予紫杉醇脂质体联合卡铂治疗,具体用药:紫杉醇脂质体175 mg/m2,静脉滴注,第1天;卡铂AUC 5,静脉滴注,第1天,21天为1个周期.至少化疗2个周期后评价疗效及不良反应.结果:全组22例患者均可评价疗效和不良反应.获完全缓解(complete response,CR)0例,部分缓解(partial response,PR)10例,稳定(stable disease,SD)8例,进展(progression disease,PD)4例,有效率(response rate,RR)为45.5%,疾病控制率(disease control rate,DCR)81.8%,中位无进展生存时间(progression free survival,PFS)5.6个月,中位总生存时间(overall survival,OS)9.5个月,1年生存率36.4%.主要不良反应为骨髓抑制,经对症处理后均缓解.结论:紫杉醇脂质体联合卡铂治疗培美曲塞和顺铂化疗失败的晚期肺腺癌疗效较好,不良反应可耐受.     

联合奥沙利铂或顺铂二线治疗晚期非小细胞肺癌的临床研究

背景与目的：晚期非小细胞肺癌(non-small cell lung cancer,NSCLC)二线化疗可选择单药多西他赛或培美曲塞,联合铂类能否提高疗效及延长生存尚不明确。本研究比较单药多西他赛或培美曲塞与联合奥沙利铂或顺铂方案二线治疗晚期NSCLC近期疗效、生存期和安全性。方法：经一线联合顺铂或卡铂治疗失败的121例晚期NSCLC患者按3∶2∶1比例随机分组,对照组(n=56)：多西他赛75 mg/m2(所有肺癌)或培美曲塞500 mg/m2(非鳞癌),第1天;顺铂组(n=45)：顺铂25 mg/m2,第1~3天联合多西他赛或培美曲塞;奥沙利铂组(n=20)：奥沙利铂130 mg/m2,第1天联合多西他赛或培美曲塞。3周为1个周期,治疗每个周期评价不良反应,每2个周期评价疗效,回访生存期。结果：3组的治疗疾病反应率、无进展生存期(progression free survival,PFS)、总生存期(overall survival,OS)及不良反应差异均无统计学意义(P＞0.05)。≥60岁老年患者较＜60岁患者PFS更长(HR=0.56,95%CI：0.35~0.90,P=0.015);PS评分0~1分患者PFS和OS更长(HR=1.52,95%CI：1.01~2.30,P=0.048;HR=1.90,95%CI：1.17~3.09,P=0.009)。治疗反应率与PFS和OS相关(HR=2.93,95%CI：2.01~4.26,P=0.000;HR=2.03,95%CI：1.37~3.01,P=0.000)。化疗后发生贫血患者PFS和OS呈缩短趋势(HR=1.59,95%CI：0.97~2.61,P=0.066;HR=1.60,95%CI：0.94~2.75,P=0.085),血小板减少患者OS更短(HR=2.97,95%CI：1.01~8.78,P=0.049)。有神经毒性患者PFS呈缩短趋势(HR=3.36,95%CI：0.92~12.25,P=0.066)。二线治疗失败后接受后续治疗者OS有获益(HR=0.36,95%CI：0.22~0.61,P=0.000)。结论：二线联合奥沙利铂或顺铂治疗NSCLC患者疗效和生存期无提高。疾病反应、PS评分与PFS及OS相关,治疗后发生贫血、血小板减少、神经毒性患者预后可能更差。二线治疗失败后接受后续治疗能延长生存期。     

奥沙利铂联合紫杉醇脂质体治疗晚期胃癌的疗效分析

目的 探讨奥沙利铂联合紫杉醇脂质体或替吉奥治疗晚期胃癌的临床疗效及不良反应.方法 选取46例晚期胃癌患者作为研究对象.按照随机数字表法将46例晚期胃癌患者随机分为A组和B组,每组23例.其中,A组患者接受奥沙利铂联合紫杉醇脂质体方案化疗,B组患者接受奥沙利铂联合替吉奥方案化疗.比较两组患者的客观缓解率(ORR)、疾病控制率(DCR)、无进展生存期(PFS)、总生存期(OS)和不良反应发生情况.结果 A组患者的ORR为47.8%,DCR为78.3%;B组患者的ORR为43.5%,DCR为69.6%;两组患者的ORR和DCR比较,差异均无统计学意义(P=0.767、0.502).A组和B组患者的中位OS分别为9.4个月和9.5个月,两组比较,差异无统计学意义(P=0.911).A组患者的中位PFS为6.9个月(95%CI:6.2~7.8个月),长于B组患者的5.4个月(95%CI:4.0~5.9个月),差异有统计学意义(P=0.048).两组患者的中性粒细胞减少、血小板减少、贫血、疲劳乏力、腹泻、关节肌肉疼痛、恶心呕吐以及神经毒性的发生率比较,差异均无统计学意义(P﹥0.05).结论 奥沙利铂联合紫杉醇脂质体方案和奥沙利铂联合替吉奥方案治疗晚期胃癌的临床疗效接近,但在晚期胃癌患者的无进展生存期方面,奥沙利铂联合紫杉醇脂质体方案可能优于奥沙利铂联合替吉奥方案.     

紫杉醇脂质体联合顺铂对比吉西他滨联合顺铂一线治疗伴有区域淋巴结转移的晚期非小细胞肺癌的临床研究

背景与目的：区域淋巴结转移与非小细胞肺癌(non-small cell lung cancer,NSCLC)患者预后显著相关,本研究旨在比较紫杉醇脂质体联合顺铂(liposomal paclitaxel plus cisplatin,LP)与吉西他滨联合顺铂(gemcitabine plus cisplatin,GP)一线治疗伴有区域淋巴结转移的NSCLC的近期疗效、远期生存及不良反应。方法：共随机入组55例患者(LP组和GP组分别为29例和26例),分别采用注射用紫杉醇脂质体(175 mg/m2)联合顺铂(75 mg/m2)和注射用吉西他滨(1 000 mg/m2)联合顺铂(75 mg/m²)进行治疗,21 d为1个周期。结果：对于肺癌原发灶,LP和GP组客观缓解率分别为37.9%和30.8%,疾病控制率分别为93.1%和80.8%,差异无统计学意义(P>0.05);对于区域转移的淋巴结,LP和GP组的客观缓解率分别为44.8%和15.4%,差异有统计学意义(P=0.022);LP组疾病控制率(93.1%)高于GP组(73.1%),差异无统计学意义(P=0.101)。LP和GP组的中位生存期分别为17.0个月和12.0个月,差异有统计学意义(P<0.05),两组患者1年生存率分别为86.2%(25/29)和57.7%(15/26),差异有统计学意义(P=0.039)。LP组血小板减少、胃肠道反应发生率明显低于GP组(P<0.05),而贫血、粒细胞减少、肝肾功能损伤、过敏反应等发生率两组差异无统计学意义(P>0.05)。结论：对于伴有区域淋巴结转移的NSCLC患者,LP方案可能更能使患者获益,不良反应更轻,耐受性好,值得进一步研究和临床推广应用。     

胃癌患者血清微小RNA 30水平及其临床意义#br# #br#

目的探讨胃癌患者的血清微小RNA 30（miR 30）水平并分析其与临床病理特征和预后的关系。 方法收集本院2014年3月至2017年5月108例胃癌患者的术前血清及同期100例健康体检者的血清样本,采用实时定量PCR（QPCR）检测以上样本的miR 30水平,比较胃癌患者与健康体检者的miR 30水平差异,以miR 30水平的均值为界值分为低表达组（＜均值）和高表达组（≥均值）,分析miR 30水平与临床病理参数（性别、年龄、淋巴结转移、肿瘤大小、TNM分期、浸润深度、Lauren分型和分化程度）的关系,根据随访数据比较不同血清miR 30水平的预后情况。 结果胃癌患者的血清miR 30水平为0624±0075,低于对照组的1028±0094,差异有统计学意义（P＜005）。ROC曲线分析结果显示miR 30诊断胃癌的曲线下面积为0802（95％CI：0742～0861,P＜0001）,诊断阈值取0798时,敏感度和特异度分别为759％和760％。胃癌患者的血清miR 30水平与性别、年龄、浸润深度和Lauren分型均无关（P＞005）,而与淋巴结转移、肿瘤大小、TNM分期和分化程度有关（P＜005）,其中淋巴结转移、肿瘤大小≥5 cm、TNM Ⅲ～Ⅳ期和低分化者的低表达率分别为632％（48／76）、726％（45／62）、923％（36／39）和681％（32／47）,均高于淋巴结无转移、肿瘤大小＜5 cm、TNM Ⅰ～Ⅱ期和中高分化者的375％（12／32）、326％（15／46）、348％（24／69）和459％（28／61）,差异有统计学意义（P＜005）。miR 30低表达组的中位总生存期为230个月,短于高表达组的360个月,差异有统计学意义（P＜005）。 结论miR 30在胃癌患者血清中低表达,参与胃癌的发生发展且低水平者的预后较差,具有作为胃癌筛查和预后预测标志物的潜能。     

含顺铂的三组联合化疗方案治疗晚期非小细胞肺癌的随机对照临床研究

背景与目的：长春瑞滨（vinorelbine,NVB）、紫杉醇（paclitaxel,TAX）和吉西他滨（gemcitabine,GEM）是目前治疗肺癌的一线药物,它们分别与顺铂（cisplatin,DDP）联合治疗晚期非小细胞肺癌（non-small cell lung cancer,NSCLC）疗效确切。但是关于三种联合化疗方案疗效及不良反应的比较,目前国内多为回顾性研究。本研究对这三组含DDP的联合化疗方案治疗晚期NSCLC的近期疗效及不良反应进行对比,为临床选择合适的化疗方案提供参考。方法：采用前瞻性开放性随机对照临床研究方法．对276例人组患者随机采用NP（NVB、DDP）、TP（TAX、DDP）或GP（GEM、DDP）方案化疗,化疗至少2周期后评价疗效及不良反应．进行组间比较。结果：NP组、TP组、GP组有效率分别是42.3％（41／97）、43．0％（40／93）和43.4％（36／83）;CR率分别为1．0％（1／97）,2．2％（1／93）和0（0／83）;中位生存期分别为8．5、8．8、9．2个月;无病生存期分别为4．1、3．8、3．9个月;1年生存率分别为31．9％、33．3％和31.3％;各组间差异均无显著性。主要不良反应是Ⅲ～Ⅳ度骨髓抑制、恶心呕吐、乏力和静脉炎。GP组的白细胞减少（42．2％）、中性粒细胞减少（36．2％）发生率最低,血小板减少发生率（53．0％）最高,与NP组（77．8％、67．7％、12．1％）、TP组（71．0％、57．0％、13．0％）比较差异均具有显著性（P〈0．01）;GP组、TP组的恶心呕吐发生率分别为16．8％、25．8％．均显著低于NP组（41．4％）（P=0．000,0．022）。GP组的乏力症状发生率（38．5％）、NP组的静脉炎发生率（58．6％）显著高于其他两组（P〈0．01）。结论：TP、NP和GP方案治疗晚期NSCLC近期疗效差异无显著性。NP方案不良反应较多,患者耐磴性相对较尊：TP、GP方案耐受性较好并各有优势。     

Randomized phase II trial of two different schedules of docetaxel plus cisplatin as first-line therapy in advanced nonsmall cell lung cancer

BACKGROUND: There is increasing interest in the use of a weekly administration of docetaxel as a way of reducing its hematologic toxicity. The purpose of the current randomized study was to evaluate the toxicity and efficacy of docetaxel plus cisplatin combination on 2 schedules in patients with previously untreated, advanced nonsmall-cell lung cancer (NSCLC). METHODS: Consenting patients with advanced NSCLC were randomized to receive first-line chemotherapy with cisplatin 75 mg/m(2) on Day 1, plus 3-weekly (75 mg/m(2) on Day 1) or weekly (35 mg/m(2) on Days 1, 8, and 15 of a 4-week cycle) docetaxel, for up to 6 cycles. RESULTS: Of 86 patients accrued, 41 patients were treated with 3-weekly and 43 with weekly docetaxel plus cisplatin. The most frequent grade 3/4 toxicity in the 3-weekly arm was neutropenia (56% of patients). In those receiving the weekly regimen, the frequent grade 3/4 toxicities were fatigue (44%) and nausea/vomiting (35%). The overall response rate was 40% with the 3-weekly and 39% with the weekly arm (P = .74). The median progression-free survival was 4.3 months in the 3-weekly arm and 3.9 months in the weekly arm (P = .08) and the median survival was 10.3 and 10.0 months, respectively (P = .76). Quality of life data showed no relevant difference between the arms. CONCLUSIONS: The weekly schedule of docetaxel plus cisplatin combination as first-line chemotherapy for advanced NSCLC, while feasible, has no clear advantage over the standard 3-weekly regimen.     

Comparison of survival and quality of life in advanced non-small-cell lung cancer patients treated with two dose levels of paclitaxel combined with cisplatin versus etoposide with cisplatin: results of an Eastern Cooperative Oncology Group trial.

PURPOSE: Treatment with cisplatin-based chemotherapy provides a modest survival advantage over supportive care alone in advanced non-small-cell lung cancer (NSCLC). To determine whether a new agent, paclitaxel, would further improve survival in NSCLC, the Eastern Cooperative Oncology Group conducted a randomized trial comparing paclitaxel plus cisplatin to a standard chemotherapy regimen consisting of cisplatin and etoposide. PATIENTS AND METHODS: The study was carried out by a multi-institutional cooperative group in chemotherapy-naive stage IIIB to IV NSCLC patients randomized to receive paclitaxel plus cisplatin or etoposide plus cisplatin. Paclitaxel was administered at two different dose levels (135 mg/m(2) and 250 mg/m(2)), and etoposide was given at a dose of 100 mg/m(2) daily on days 1 to 3. Each regimen was repeated every 21 days and each included cisplatin (75 mg/m(2)). RESULTS: The characteristics of the 599 patients were well-balanced across the three treatment groups. Superior survival was observed with the combined paclitaxel regimens (median survival time, 9.9 months; 1-year survival rate, 38.9%) compared with etoposide plus cisplatin (median survival time, 7.6 months; 1-year survival rate, 31.8%; P =. 048). Comparing survival for the two dose levels of paclitaxel revealed no significant difference. The median survival duration for the stage IIIB subgroup was 7.9 months for etoposide plus cisplatin patients versus 13.1 months for all paclitaxel patients (P =.152). For the stage IV subgroup, the median survival time for etoposide plus cisplatin was 7.6 months compared with 8.9 months for paclitaxel (P =.246). With the exceptions of increased granulocytopenia on the low-dose paclitaxel regimen and increased myalgias, neurotoxicity, and, possibly, increased treatment-related cardiac events with high-dose paclitaxel, toxicity was similar across all three arms. Quality of life (QOL) declined significantly over the 6 months. However, QOL scores were not significantly different among the regimens. CONCLUSION: As a result of these observations, paclitaxel (135 mg/m(2)) combined with cisplatin has replaced etoposide plus cisplatin as the reference regimen in our recently completed phase III trial.     

Doxorubicin and paclitaxel versus doxorubicin and cyclophosphamide as first-line chemotherapy in metastatic breast cancer: The European Organization for Research and Treatment of Cancer 10961 Multicenter Phase III Trial.

PURPOSE: To compare the efficacy and tolerability of the combination of doxorubicin and paclitaxel (AT) with a standard doxorubicin and cyclophosphamide (AC) regimen as first-line chemotherapy for metastatic breast cancer. PATIENTS AND METHODS: Eligible patients were anthracycline-naive and had bidimensionally measurable metastatic breast cancer. Two hundred seventy-five patients were randomly assigned to be treated with AT (doxorubicin 60 mg/m(2) as an intravenous bolus plus paclitaxel 175 mg/m(2) as a 3-hour infusion) or AC (doxorubicin 60 mg/m(2) plus cyclophosphamide 600 mg/m(2)) every 3 weeks for a maximum of six cycles. A paclitaxel (200 mg/m(2)) and cyclophosphamide (750 mg/m(2)) dose escalation was planned at cycle 2 if no grade >or= 3 neutropenia occurred in cycle 1. The primary efficacy end point was progression-free survival (PFS). Secondary end points were response rate (RR), safety, overall survival (OS), and quality of life. RESULTS: A median number of six cycles were delivered in the two treatment arms. The relative dose-intensity and delivered cumulative dose of doxorubicin were lower in the AT arm. Dose escalation was only possible in 17% and 20% of the AT and AC patients, respectively. Median PFS was 6 months in the two treatments arms. RR was 58% versus 54%, and median OS was 20.6 versus 20.5 months in the AT and AC arms, respectively. The AT regimen was characterized by a higher incidence of febrile neutropenia, 32% versus 9% in the AC arm. CONCLUSION: No differences in the efficacy study end points were observed between the two treatment arms. Treatment-related toxicity compromised doxorubicin-delivered dose-intensity in the paclitaxel-based regimen     

A randomized phase II study of docetaxel or vinorelbine in combination with cisplatin against inoperable, chemo-naïve non-small-cell lung cancer in Taiwan

Cisplatin plus a third-generation anti-cancer drug, such as vinorelbine, gemcitabine, or the taxanes, are the standard regimen used in the first-line treatment of advanced non-small-cell lung cancer (NSCLC), and there is no significant difference in efficacy among the different regimens. Our aim was to evaluate the efficacy of docetaxel plus cisplatin (DC) versus vinorelbine plus cisplatin (VC) in chemo-na?ve NSCLC patients. From December 2003 to May 2005, 94 patients were enrolled. The treatment dose was D 60 mg/m2 and C 60 mg/m2 intravenous infusion (IV) on day 1, or V 25 mg/m2 IV on days 1 and 8, and C 60 mg/m2 IV on day 1, every 3 weeks. In all, 209 cycles of DC and 230 cycles of VC were given to the patients in the DC (median five cycles) and VC (median five cycles) arms, respectively. There were 19 partial responses and one complete response (overall 43.5%) in the DC arm, and no complete responses, but 22 partial responses (overall 45.8%), in the VC arm. Myelosuppression was the major toxicity occurring in both arms, with grades 3 or 4 neutropenia occurring in 72.9% and 71.7% of patients, respectively. Except for alopecia (p=0.005) and diarrhea (p<0.001), which were more common in the DC arm, no significant differences in toxicity profiles were found between the two treatment arms. The median time to disease progression was 4.7 months in the DC arm and 6.3 months in the VC arm (p=0.7355). Median survival time was 13 months in the DC arm and 13.8 months in the VC arm (p=0.9656). The 1-year survival rate was 55.5% and 51.7%, respectively. After treatment, the Lung Cancer Symptom Scales showed no significant difference between the two treatment arms. We concluded that both DC and VC are appropriate regimens for use in the first-line treatment of Chinese NSCLC patients. Asthenia, one of the major side effects of docetaxel, was not a major problem in the present study. Although both regimens produced a high incidence of severe neutropenia, the majority of patients recovered rapidly without sequelae; and VC treatment is still a standard chemotherapy for Chinese NSCLC patients in Taiwan.     

Cisplatin and gemcitabine first-line chemotherapy followed by maintenance gemcitabine or best supportive care in advanced non-small cell lung cancer: a phase III trial

PURPOSE: The primary objective of this randomized phase III study was to show significant difference in median time to progression (TTP) in patients with advanced NSCLC treated with single-agent gemcitabine maintenance therapy versus best supportive care following gemcitabine plus cisplatin initial first-line therapy. PATIENTS AND METHODS: Chemonaive patients with stage IIIB/IV NSCLC received gemcitabine 1,250 mg/m(2) (days 1 and 8) plus cisplatin 80 mg/m(2) (day 1) every 21 days. Patients achieving objective response or disease stabilization following initial gemcitabine plus cisplatin therapy were randomized (2:1 fashion) to receive maintenance gemcitabine (1,250 mg/m(2) on days 1 and 8 every 21 days) plus best supportive care (GEM arm), or best supportive care only (BSC arm). RESULTS: Between November 1999 and November 2002, we enrolled 352 patients (median age: 57 years; stage IV disease: 74%; Karnofsky performance status (KPS) >80: 41%). Following initial therapy, 206 patients were randomized and treated with gemcitabine (138) or best supportive care (68). TTP throughout the study period was 6.6 and 5 months for GEM and BSC arms, respectively, while values for the maintenance period were 3.6 and 2.0 months (for p < 0.001 for both). Median overall survival (OS) throughout study was 13.0 months for GEM and 11.0 months for BSC arms (p = 0.195). The toxicity profile was mild, with neutropenia being most common grade 3/4 toxicities. CONCLUSION: Maintenance therapy with gemcitabine, following initial therapy with gemcitabine plus cisplatin, was feasible, and produced significantly longer TTP compared to best supportive care alone. Further studies are warranted to establish the place of maintenance chemotherapy in patients with advanced NSCLC.