吉西他滨联合顺铂一线或二线治疗晚期三阴性乳腺癌的临床观察

目的　观察吉西他滨联合顺铂一线或二线方案治疗晚期三阴性乳腺癌的近期疗效和毒副反应。方法　５４例晚期三阴性乳腺癌患者接受吉西他滨联合顺铂治疗,其中一线治疗４５例,二线９例,具体方案：吉西他滨１０００ｍｇ／ｍ^２ｄ_１、ｄ_８,顺铂２５ｍｇ／ｍ^２ｄ_１～ｄ_３,２１天为１周期。每２周期评价疗效,每周期进行安全性评估。结果　５４例患者中位治疗周期数为６周期（２～８周期）,获ＣＲ８例（１４.８％）,ＰＲ２４例（４４.４％）,ＳＤ１８例（３３.３％）,ＰＤ４例（７.４％）,总有效率（ＣＲ＋ＰＲ）为５９.２％。主要毒副反应为骨髓毒性和消化道反应,３～４级毒性分别为中性粒细胞减少４０.７％,血小板减少３５.２％,乏力１８.５％,食欲下降１４.８％,贫血１１.１％,恶心呕吐９.２％,外周神经毒性１.９％。结论　吉西他滨联合顺铂治疗晚期三阴性乳腺癌近期疗效好,毒副反应可以耐受,可推荐作为晚期三阴性乳腺癌的治疗选择。     

ＧＤＰ方案治疗难治性弥漫大Ｂ细胞淋巴瘤的临床研究

目的　观察由吉西他滨（ＧＥＭ）联合顺铂（ＤＤＰ）、地塞米松（ＤＸＭ）组成的ＧＤＰ方案治疗难治性弥漫大Ｂ细胞淋巴瘤（ＤＬＢＣＬ）的疗效和毒副反应。方法　２００６年３月至２００８年９月收治的２５例难治性ＤＬＢＣＬ患者,给予吉西他滨１０００ｍｇ／ｍ^２,第１、８天,静脉滴注;顺铂２５ｍｇ／ｍ^２,第１～３天,静脉滴注;地塞米松４０ｍｇ／ｄ,第１～４天,口服。２１天为１周期。２个周期后评价疗效,并随访疾病进展情况。结果　２５例患者中,１８例获缓解（７２％）,其中完全缓解８例（３２％）,部分缓解１０例（４０％）。２５例患者中位肿瘤进展时间（ＴＴＰ）为７.５个月（９５％ＣＩ：７.１７～７.８２个月）。主要不良反应为骨髓抑制和轻中度的消化道反应。骨髓抑制主要表现为３～４级白细胞减少７例,３级血小板减少５例。结论　吉西他滨联合顺铂、地塞米松的ＧＤＰ方案治疗难治性ＤＬＢＣＬ的近期疗效较好,安全性较高。     

国产吉西他滨联合奈达铂治疗晚期非小细胞肺癌的临床观察

目的：观察国产吉西他滨（ＧＥＭ）联合奈达铂（ＮＤＰ）组成的ＧＮ方案治疗晚期非小细胞肺癌（ＮＳＣＬＣ）的疗效和安全性。方法：５２例ＮＳＣＬＣ患者采用ＧＮ方案：ＧＥＭ１ ０００ｍｇ／ｍ^２,第１、８天静脉滴注,ＮＤＰ８０ｍｇ／ｍ^２,第２天静脉滴注,２１天为１周期。结果：全组５２例中,完全缓解３例（５.７７％）,部分缓解１７例（３２.６９％）,稳定２３例（４４.２３％）,进展９例（１７.３１％）,有效率为３８.４６％,疾病控制率８２.６９％。主要毒副反应为骨髓抑制,经对症处理后可以缓解,无治疗相关死亡。结论：国产吉西他滨联合奈达铂治疗晚期ＮＳＣＬＣ疗效较好,毒副反应轻。     

吉西他滨联合顺铂治疗耐药三阴性晚期乳腺癌的临床观察

目的　观察吉西他滨联合顺铂方案治疗ＥＲ、ＰＲ、ＨＥＲ-２均阴性对蒽环类耐药的晚期转移性乳腺癌的疗效和安全性。方法　３４例对蒽环或紫杉类耐药晚期转移性乳腺癌患者,经免疫组化证实ＥＲ、ＰＲ、ＨＥＲ-２均阴性,给予吉西他滨联合顺铂方案治疗,具体用药为：吉西他滨１０００ｍｇ／ｍ^２静脉滴注,第１,８天;顺铂２５ｍｇ／ｍ^２静脉滴注,第１～３天。２１天为１周期,至少２个周期,２周期后评价疗效和毒副反应。结果　３４例患者均可评价疗效,获完全缓解（ＣＲ）２例（５.９％）,部分缓解（ＰＲ）１２例（３５.３％）,稳定（ＳＤ）１４例（４１.２％）,进展（ＰＤ）６例（１７.６％）,总有效率（ＣＲ＋ＰＲ）为４１.２％;中位疾病进展时间为５.２个月。主要不良反应包括骨髓抑制和胃肠道反应,无化疗相关死亡。结论　吉西他滨联合顺铂方案对蒽环类或紫杉类耐药的转移性三阴性乳腺癌有较好的近期疗效,不良反应可耐受,是有效的解救方案之一。     

紫杉醇脂质体联合顺铂、氟尿嘧啶一线治疗晚期胃癌的临床观察

目的：评价紫杉醇脂质体联合顺铂、氟尿嘧啶（ＰＣＦ方案）一线治疗晚期胃癌的临床疗效和毒副反应。方法：ＰＣＦ方案一线治疗４２例晚期胃癌的具体用法：紫杉醇脂质体１７５ｍｇ／ｍ^２,第１天静滴９０ｍｉｎ;顺铂７５ｍｇ／ｍ^２,第１天静滴;亚叶酸钙４００ｍｇ／ｍ^２,第１天滴注２ｈ;氟尿嘧啶２６ｇ／ｍ^２,亚叶酸钙滴注结束后立即持续泵入４６ｈ。２１天为１周期,每２周期按ＲＥ ＳＩＳＴ标准评价疗效,所有患者至少接受２周期化疗。结果：４２例患者共接受１９２个周期的化疗,所有患者均可评价疗效。完全缓解３例（７.１％）,部分缓解２０例（４７.６％）,稳定１２例（２８.６％）,进展７例,总有效率为５４.８％,中位进展时间（ＴＴＰ）６.５个月,中位生存时间（ＭＳＴ）１３.９个月。常见的不良反应为血液学毒性,胃肠反应、肌肉酸痛、外周神经毒性较轻,以Ⅰ、Ⅱ级为主。１０例（２３.８％）发生Ⅲ ～Ⅳ级粒细胞减少,伴发热１例（２.４％）;Ⅲ级恶心呕吐反应４例（９.５％）,Ⅲ级肌肉酸痛３例（７.１％）,Ⅲ级外周神经毒性２例（４.７％）,无化疗相关性死亡病例。结论：紫杉醇脂质体联合顺铂、氟尿嘧啶（ＰＣＦ方案）一线治疗晚期胃癌疗效确切,不良反应轻,值得临床推广应用。     

同步放化疗治疗老年局部晚期非小细胞肺癌的临床研究

目的：探讨长春瑞滨、吉西他滨分别联合三维适形放疗治疗老年局部晚期非小细胞肺癌（ＮＳＣＬＣ）的疗效和毒性反应。方法：８１例患者分为两组,长春瑞滨组：三维适形放疗同步化疗,长春瑞滨２５ｍｇ／ｍ^２,静滴,第１、８天。吉西他滨组：三维适形放疗同步化疗,吉西他滨１０００ｍｇ／ｍ^２,静滴第１、８天。均２１天为１周期。两组均治疗２～４周期。结果：长春瑞滨组ＣＲ率１７.５％,ＰＲ率５０.０％,总有效率（ＣＲ＋ＰＲ）为６７.５％;吉西他滨组ＣＲ率１９.５％,ＰＲ率４６.３％,总有效率（ＣＲ＋ＰＲ）为６５.８％,两组差异无显著性（Ｐ＞０.０５）。长春瑞滨组和吉西他滨组的１、２年生存率分别为６９３％、３６.４％和６８.７％和１８.６％,中位生存时间分别为１７个月和１６.２个月,差异无显著性（Ｐ＞０.０５）。长春瑞滨３～４级血液毒性高于吉西他滨组（Ｐ＜０.０５）。结论：长春瑞滨或吉西他滨联合三维适形放疗同步治疗老年局部晚期ＮＳＣＬＣ安全、有效。     

吡柔比星联合顺铂二线治疗进展期软组织肉瘤的临床观察

目的　观察吡柔比星联合顺铂二线治疗进展期软组织肉瘤的临床疗效和不良反应。方法　阿霉素和异环磷酰胺一线化疗失败的进展期软组织肉瘤患者９例,吡柔比星５０ｍｇ／ｍ^２第１天静滴,顺铂２５ｍｇ／ｍ^２第１～３天静滴。２１天为１周期,完成２～６个周期,中位周期数为４。结果　全组患者ＣＲ０例,ＰＲ２例（２２.2％）,ＳＤ５例（５５.6%）,ＰＤ２例（２２.２％）,有效率（ＲＲ）为２２.２％（２／９）,疾病控制率（ＤＣＲ）７７.８％（７／９）。中位无进展生存时间（ＰＦＳ）为３个月（２～２１个月）,中位总生存时间（ＯＳ）为７个月（３～２７个月）。主要不良反应为粒细胞减少、胃肠道反应和脱发,其他不良反应少见。结论　进展期软组织肉瘤患者阿霉素和异环磷酰胺一线化疗失败后改用吡柔比星联合顺铂二线治疗,能够有效控制疾病进展,不良反应可以耐受,值得进一步深入研究。     

周剂量多西紫杉醇联合卡培他滨二线治疗晚期食管癌的临床观察

目的　观察周剂量多西紫杉醇联合卡培他滨二线治疗晚期食管癌的疗效和安全性。方法　２８例经顺铂加氟尿嘧啶方案一线化疗失败的晚期食管癌患者,应用多西紫杉醇２５ｍｇ／ｍ^２,静脉滴注１ｈ,ｄ_１、ｄ_８、ｄ_１５,卡培他滨（希罗达）１５００ｍｇ／ｍ^２,分每日２次口服,ｄ_１～ｄ_１４,２８天为１周期。结果　２８例患者中２６例可评价疗效,获ＣＲ１例,ＰＲ１０例,ＳＤ８例,ＰＤ７例,总有效率（ＣＲ＋ＰＲ）为３９.３％。所有患者中位疾病进展时间（ＴＴＰ）为４.２个月（９５％ＣＩ：１.６～６.０个月）,中位生存时间（ＯＳ）为７.８个月（９５％ＣＩ：６.３～９.３个月）。主要毒副反应为骨髓抑制,出现３～４级中性粒细胞减少１２例（４２.９％）,３级贫血５例（１７.９％）,３级血小板减少３例（１０.７％）,无治疗相关性死亡。结论　周剂量多西紫杉醇联合卡培他滨二线治疗晚期食管癌有一定疗效,患者耐受性较好,值得临床进一步研究。     

同步放化疗治疗局部晚期非小细胞肺癌的Ⅲ期临床研究

目的：探讨周剂量长春瑞滨、顺铂同步放射治疗局部晚期非小细胞肺癌的近期疗效和毒性反应。方法：８７例局部晚期非小细胞肺癌患者,ＫＰＳ评分≥７０,中位年龄５７岁（３５～７０岁）,随机分为同步组（２８例）、序贯组（３０例）和放疗组（２９例）。放射治疗采用６～８ＭＶ加速器,常规分割,总剂量６０～６４Ｇｙ;化疗采用长春瑞滨与顺铂联合;同步组化疗为长春瑞滨１２.５ｍｇ／ｍ^２,顺铂２０～４０ｍｇ／ｍ²,每周一给药１次,共６～７次;序贯组化疗为长春瑞滨２０ｍｇ／ｍ^２,ｄ_１、ｄ_８,顺铂８０～１００ｍｇ／ｍ²,ｄ_１或分为ｄ_１～ｄ_３。每３周为１周期,共３～４周期。３组用药前均给予预处理。治疗后按ＷＨＯ标准评价疗效和毒性。结果：８７例中有１例死亡,８６例完成治疗并可评价疗效和毒性。３组有效率分别为７５.００％、５８.６２％和４４.８２％（Ｐ＜０.０５）。平均生存时间分别为１５.７个月、１３.５个月及８.６个月。１年生存率分别为７１.４３％、６０.８８％和３５.９８％（Ｐ＝０.０１３７）。ⅢＡ期患者１年生存率分别为７５.００％、５７.１４％和４４.４４％（Ｐ＝０.３３９４）。ⅢＢ期患者１年生存率分别为７０.００％、６３.６４％和３５.００％（Ｐ＝０.０３３６）。３组毒副反应主要为骨髓抑制,未见明显肺及食道毒性。治疗后ＫＰＳ评分及体重同步组和序贯组均得到改善。结论：同步放化疗治疗局部晚期非小细胞肺癌疗效明显优于序贯放化疗及单纯放疗,患者的生存质量提高而未明显增加肺、食道的毒性。     

吉西他滨联合长春瑞滨治疗晚期三阴性乳腺癌的临床观察

目的：观察吉西他滨联合长春瑞滨（ＧＮ方案）治疗ＥＲ、ＰＲ、ＨＥＲ ２均阴性（三阴性）晚期转移性乳腺癌的疗效与安全性。方法：２００４年１月～２００８年１月共３７例经免疫组化证实ＥＲ、ＰＲ、ＨＥＲ ２均阴性的晚期转移性乳腺癌复治患者参与研究。患者接受吉西他滨联合长春瑞滨方案治疗：吉西他滨１ ０００ｍｇ／ｍ２,静脉滴注３０ｍｉｎ,ｄ_１、ｄ_８;长春瑞滨２５ｍｇ／ｍ^２静脉滴注１５ｍｉｎ,ｄ_１、ｄ_８。２１天重复。结果：全组３７例共完成１３６个周期的治疗,中位数４个周期,范围２～６个周期,均可评价疗效。完全缓解１例（２.７％）,部分缓解８例（２１.６％）,病情稳定２０例（５１.４％）,病情进展９例（２１.６％）,客观有效率为２４.３％;中位疾病进展时间（ｍＴＴＰ）６个月（９５％ ＣＩ：４～８个月）,中位生存期（ＯＳ）２４个月（９５％ ＣＩ：１１～３７个月）,１年生存率为（６６.２４±８.４３）％,３年生存率为（２８.７７±１１.９６）％。毒副反应主要为Ⅰ ～Ⅱ度骨髓抑制、末梢神经毒性、胃肠道反应、流感样症状、轻度肝功能损伤等。结论：吉西他滨联合长春瑞滨治疗晚期三阴性乳腺癌患者,初步观察有一定的疗效,其毒副作用患者可以耐受。     

健择联合顺铂治疗晚期非小细胞肺癌疗效观察

目的 :探讨健择 (gemcitabine ,gemzar,GEM)联合顺铂治疗晚期非小细胞肺癌 (NSCLC)的疗效。方法 :36例初治晚期NSCLC患者应用健择 1g m2 ,静脉滴入 ,d1、d8,顺铂 10 0mg m2 ,静脉滴入 ,d1,每 2 1d为 1个周期 ,2～ 3个周期后评价疗效和毒副作用。结果 :完全缓解 (CR) 1例 ,部分缓解 (PR) 14例 ,总缓解率 4 1 7% ,中位生存期 39周 ,1年生存率 4 4 4 %。主要不良反应为骨髓抑制和恶心、呕吐。结论 :健择联合顺铂是治疗晚期NSCLC疗效较好方案 ,毒性可耐受。     

国产吉西他滨或长春瑞滨联合顺铂治疗进展期非小细胞肺癌的临床观察

目的:观察国产吉西他滨联合顺铂(GP组)与长春瑞滨联合顺铂(NP组)治疗进展期非小细胞肺癌的疗效及毒副反应。方法:经病理组织学或细胞学证实的不能手术的80例非小细胞肺癌患者,随机分为两组各40例,以吉西他滨1200mg/m2静滴,第1,8天;长春瑞滨25mg/m2静滴,第1,8天,分别联合顺铂80mg/m2第1天或分2~3天静滴,21天为1周期,3周期以上评价疗效。结果:两组的有效率分别为47.5%(19/40)、45.0%(18/40),无显著性差异;中位疾病进展时间分别为4.9个月和4.1个月,组间有显著性差异(P<0.05);1年生存率GP组为42.5%(17/40),NP组为40.0%(16/40),组间无显著性差异。GP组III~IV度血小板减少高于NP组,而III~IV度白细胞减少及脱发、静脉炎明显低于NP组。结论:两种方案治疗晚期NSCLC均安全、有效,在有效率、中位生存期及1年生存率方面均较接近,毒副反应均可耐受,但中位疾病进展时间GP组稍有优势。     

吉西他滨联合顺铂一线治疗晚期三阴乳腺癌疗效分析

目的分析吉西他滨联合顺铂（GP方案）治疗复发转移性三阴乳腺癌的反应率及不良反应,进一步了解该方案治疗可获取的疾病进展时间（TTP）和总生存时间（OS）。方法回顾性分析住院治疗的35例晚期三阴乳腺癌。所有患者均一线接受GC方案（吉西他滨针1 000 mg/m2,d1、d8＋顺铂针25 mg/m2,d1-3,每21天重复）化疗。患者每2周期接受疗效评价。统计肿瘤反应率和不良反应,通过后续随访,统计TTP和OS。结果 35例晚期三阴乳腺癌,均有可评价病灶。21例继往接受了含紫杉类药物辅助化疗,14例患者继往接受了含蒽环类药辅助化疗。入组后患者共接受2～6周期GP方案化疗,中位数为3.8周期。完全缓解（CR）2例（5.7%）,部分缓解（PR）10例（28.6%）,疾病稳定（SD）6例（17.1%）,疾病进展（PD）7例（20.0%）,总反应率（ORR）为34.3%。中位TTP为7.0月,中位OS为13.0月。结论晚期三阴乳腺癌接受GP方案化疗有较高反应率,耐受性好,但TTP较短,生存时间有限,需要寻找更为有效的治疗靶点。     

A phase II study of gemcitabine and cisplatin in chemotherapy-naive, unresectable gall bladder cancer

The primary objective of this study was to determine the response rates of the gemcitabine and cisplatin combination in unresectable gall bladder cancer patients. The secondary objectives were to evaluate the toxicity, time to progressive disease, and overall survival. Chemona?ve patients with histologically proven, unresectable bidimensionally measurable gall bladder cancer were enrolled into this study. All patients were required to have a Zubrod's performance status 相似文献   

吉西他滨不同给药方式联合顺铂治疗晚期乳腺癌的临床疗效及安全性

目的:观察吉西他滨不同给药方式联合顺铂治疗蒽环类或紫杉醇类耐药乳腺癌的临床疗效及安全性。方法:选取2014年8月至2017年9月期间入住我院及安徽省立医院的晚期乳腺癌病人,既往接受含蒽环类或紫杉醇类药物的化疗方案,共60例,根据化疗方案的不同,分为对照组(30例)和观察组（30例）。对照组:吉西他滨 1 000 mg/m2 d1、8,顺铂25 mg/m2 d1～3;观察组:吉西他滨 1 000 mg/m2 d1、5,顺铂25 mg/m2 d1～3。结果:对照组客观有效率为33.33%,疾病控制率为73.33%,观察组客观有效率为40.00%,疾病控制率为80.00%,差异无统计学意义（P>0.05）。两组的主要不良反应均为白细胞减少、中性粒细胞减低、血小板减少、胃肠道反应及肝功能异常,Ⅲ-Ⅳ级不良反应发生率差异无统计学意义(P>0.05)。结论:应用吉西他滨联合顺铂治疗蒽环类或紫杉醇类耐药晚期乳腺癌患者时,缩短吉西他滨给药间期,可获得与对照组相当的疗效,同时不增加不良反应,缩短了住院时间,减少了住院费用,可在临床进一步研究应用。     

吉西他滨调整方案治疗晚期非小细胞肺癌的Ⅱ期临床试验

背景与目的吉西他滨与铂类的联合化疗是晚期非小细胞肺癌(non-small cell lung cancer,NSCLC)最常用的治疗方案。通常3周方案中的吉西他滨需间隔1周给药。为提高依从性,本研究将吉西他滨第8天给药时间调整为第5天,并评价调整方案一线治疗晚期NSCLC的疗效及安全性。方法 2007年10月-2009年10月共入组83例晚期NSCLC患者,采用吉西他滨1,000mg/m2-1,250mg/m2第1天、第5天静脉滴注30min,联合顺铂75mg/m2,或联合卡铂(AUC=5)第1天静滴,每21天为1周期,每例至少完成2周期治疗后评价疗效,观察毒性反应及无进展生存期和总生存期。结果 83例患者的客观有效率为37.3%,中位无进展生存期和中位生存期分别为6.1个月和15.0个月,1年、2年生存率分别为57.8%与16.2%。调整方案的主要不良反应为血液学毒性与胃肠道反应,III度-IV度白细胞、血红蛋白、血小板减少发生率分别为26.5%、10.8%、7.2%,联合顺铂治疗组III度-IV度胃肠道反应发生率为27.5%。无治疗相关死亡。结论吉西他滨联合铂类5天调整方案一线治疗晚期NSCLC疗效肯定,毒副反应可耐受,值得进一步开展随机对照研究。     

Gefitinib in combination with gemcitabine and cisplatin in advanced non-small-cell lung cancer: a phase III trial--INTACT 1.

PURPOSE: The purpose of this study was to determine whether the addition of the epidermal growth factor receptor tyrosine kinase inhibitor gefitinib (Iressa, ZD1839; AstraZeneca, Wilmington, DE) to standard first-line gemcitabine and cisplatin provides clinical benefit over gemcitabine and cisplatin alone in patients with advanced or metastatic non-small-cell lung cancer (NSCLC). Gefitinib has demonstrated encouraging efficacy in advanced NSCLC in phase II trials in pretreated patients, and a phase I trial of gefitinib in combination with gemcitabine and cisplatin showed favorable tolerability. PATIENTS AND METHODS: This was a phase III randomized, double-blind, placebo-controlled, multicenter trial in chemotherapy-naive patients with unresectable stage III or IV NSCLC. All patients received up to six cycles of chemotherapy (cisplatin 80 mg/m(2) on day 1 and gemcitabine 1,250 mg/m(2) on days 1 and 8 of the 3-week cycle) plus either gefitinib 500 mg/d, gefitinib 250 mg/d, or placebo. Daily gefitinib or placebo was continued until disease progression. End points included overall survival (primary), time to progression, response rates, and safety evaluation. RESULTS: A total of 1,093 patients were enrolled. There was no difference in efficacy end points between the treatment groups: for the gefitinib 500 mg/d, gefitinib 250 mg/d, and placebo groups, respectively, median survival times were 9.9, 9.9, and 10.9 months (global ordered log-rank [GOLrank] P =.4560), median times to progression were 5.5, 5.8, and 6.0 months (GOLrank; P =.7633), and response rates were 49.7%, 50.3%, and 44.8%. No significant unexpected adverse events were seen. CONCLUSION: Gefitinib in combination with gemcitabine and cisplatin in chemotherapy-naive patients with advanced NSCLC did not have improved efficacy over gemcitabine and cisplatin alone. The reasons for this remain obscure and require further preclinical testing.     

Three-arm randomized study of two cisplatin-based regimens and paclitaxel plus gemcitabine in advanced non-small-cell lung cancer: a phase III trial of the European Organization for Research and Treatment of Cancer Lung Cancer Group--EORTC 08975.

PURPOSE: To compare the therapeutic efficacy of paclitaxel plus cisplatin (arm A) versus gemcitabine plus cisplatin (arm B) and arm A versus paclitaxel plus gemcitabine (arm C) in chemotherapy-naive patients with advanced non-small-cell lung cancer (NSCLC).Materials and METHODS: Patients were randomly assigned to receive either paclitaxel 175 mg/m2 (3-hour infusion, day 1) or gemcitabine 1,250 mg/m2 (days 1 and 8) both combined with cisplatin 80 mg/m2 (day 1) or paclitaxel 175 mg/m2 (3-hour infusion, day 1) combined with gemcitabine 1,250 mg/m2 (days 1 and 8). Primary end point was comparison of overall survival for B versus A and C versus A. Secondary end points included response rate and duration, progression-free survival, toxicities, quality of life [QoL], and cost of treatment. RESULTS: Four hundred eighty patients (arm A, 159; arm B, 160; arm C, 161 patients) were enrolled; all baseline characteristics were balanced. Median survival times were as follows: arm A, 8.1 months; arm B, 8.9 months; arm C, 6.7 months. Response rates were 31.8% for arm A, 36.6% for arm B, and 27.7% for arm C. Other than myelosuppression (B v A, P <.005), no statistically or clinically significant differences were observed for secondary end points. The average treatment costs were 25% higher in arm C as compared with arms A and B. CONCLUSION: Gemcitabine plus cisplatin and paclitaxel plus gemcitabine do not increase overall survival in patients with advanced NSCLC as compared with paclitaxel plus cisplatin. Treatment was well tolerated, and most QoL parameters were similar, but costs associated with the nonplatinum arm were highest.     

Phase I/II study of 3-week cycle cisplatin-gemcitabine in advanced non-small cell lung cancer

BACKGROUND: The combination of cisplatin and gemcitabine is one of the most active chemotherapy regimens against non-small cell lung cancer. However, the optimum schedule for this combination has not been determined. This study was performed to determine the maximum tolerated dose of gemcitabine combined with cisplatin in a 3-week cycle regimen and to observe safety and efficacy for Japanese patients with advanced non-small cell lung cancer. METHODS: 80 mg/m(2) of cisplatin on day 1 and escalated doses of gemcitabine on days 1 and 8 were administered every 3 weeks to patients with previously untreated, advanced non-small cell lung cancer. The initial dose of gemcitabine was 1000 mg/m(2) and was escalated in 250 mg/m(2) increments. RESULTS: Twenty-four patients were enrolled between March and December 2000. In total, 64 courses were given. The main toxicities were neutropenia, thrombocytopenia and hepatotoxicity. The maximum tolerated dose was determined to be 1500 mg/m(2) of gemcitabine combined with 80 mg/m(2 )of cisplatin. Nine of 24 patients (37.5%) achieved a partial response. CONCLUSION: This study demonstrates that the combination of cisplatin and gemcitabine repeated every three weeks is tolerable for Japanese patients with advanced non-small cell lung cancer. We determined 1250 mg/m(2) of gemcitabine combined with 80 mg/m(2 )of cisplatin to be the recommended dose.     

Triplet chemotherapy combination with gemcitabine,cisplatin and ifosfamide in patients with advanced non-small-cell lung cancer: phase II study

A phase II study was conducted to evaluate the safety and efficacy of the combination GIP (gemcitabine, ifosfamide, and cisplatin) for the treatment of patients with advanced non-small-cell lung cancer (NSCLC). Thirty patients with stage III B/IV NSCLC were treated with a combination of GIP. Patients received gemcitabine 1,000 mg/m2 administered intravenously on days 1 and 8, ifosfamide 3,500 mg/m2 on day 2, and cisplatin 80 mg/m2 on day 2, repeated every 21 days. Two of the 30 patients (7%) showed a complete response and 14 patients (46%) showed a partial response. The overall response rate was 53%. The estimated median survival for all patients was 60 weeks. All patients enrolled onto the study were eligible for toxicity assessment. Toxicities were treatable and included World Health Organization grade III or IV leukopenia (29%), thrombocytopenia (18%), anemia (7%) and nausea, and vomiting (6%). Febrile neutropenia occurred in 3 of 30 patients. There were no treatment-related deaths. The combination therapy of GIP is active, well tolerated, and easy to administer on an outpatient basis in advanced NSCLC.