单药健择治疗高龄非小细胞肺癌临床观察

目的:评价单药健择化疗对高龄非小细胞肺癌患者的疗效和耐受性.方法:20例70岁以上高龄非小细胞肺癌患者选用单药健择1.0g/m2,静滴30分钟,第1天、第8天给药,21天为一周期,共65周期.结果;有效率25%,毒副反应轻微,以骨髓抑制为主,不加重合并症.结论:健择单药化疗对高龄非小细胞肺癌患者有效,耐受性好.     

健择单药与联合顺铂方案治疗70岁以上晚期非小细胞肺癌

[目的]评价健择单药与健择联合顺铂治疗70岁及以上老年人晚期非小细胞肺癌的临床疗效和毒副反应。[方法]选用46例70岁及以上老年晚期非小细胞肺癌（NSCLC）患者，单药组19例，采用健择1．0g／m^2，静脉点滴，第1，8天；联合方案组27例，采用健择1.0g/m^2，静脉点滴，第1，8天，加顺铂（DDP）75mg／m^2静脉点滴第1～3天。[结果]单药组有效率26．3％（5／19），联合方案组有效率40．7％（11／27），两组间无显著差异（Х^2=2．21，P〉0．05），联合方案组毒副反应发生率较单药组高。[结论]单药健择不仅疗效较好，毒副反应轻，而且有效提高老年患者生存质量及用药安全性。     

单药健择与联合方案治疗老年晚期非小细胞肺癌的临床观察

目的　评价单药健择与健择联合顺铂治疗老年晚期非小细胞肺癌的临床疗效与不良反应。方法　选用 48例老年晚期非小细胞肺癌 (NSCLC)患者 ,单药组 2 7例 ,采用健择 1.0 /m2 静脉点滴 ,第 1,8,15天 ;联合方案组 2 1例 ,采用健择 1.0 /m2 静脉点滴 ,第 1,8天加顺铂 (DDP) 75mg/m2 静脉点滴第 1～ 3天。结果　单药组有效率 2 9.6% ( 8/2 7) ,联合治疗组 47.6% ( 10 /2 1) ,有显著差异 (P <0 .0 1) ,联合治疗组不良反应率较单药组高。结论　单药健择不仅疗效较好 ,不良反应轻 ,而且有效提高老年患者生存质量及用药安全性。     

单药健择治疗高龄非小细胞肺癌临床观察

目的：评价单药健择化疗对高龄非小细胞肺癌患者的疗效和耐受性。方法：20例70岁以上高龄非小细胞肺癌患者选用单药健择1．0g／m^2，静滴30分钟，第1天、第8天给药，21天为一周期，共65周期。结果；有效率25％，毒副反应轻微，以骨髓抑制为主，不加重合并症。结论：健择单药化疗对高龄非小细胞肺癌患者有效，耐受性好。     

健择联合艾恒治疗56例老年晚期非小细胞肺癌

[目的]应用健择(GEM)加艾恒(OXA)治疗老年晚期非小细胞肺癌(NSCLC),观察其近期临床疗效及毒副反应。[方法]健择(GEM)1000mg/m2,静滴30min,d1,8;艾恒(OXA)130mg/m2,静脉滴注,d1,21d为1个周期。2个周期以上评价疗效。[结果]56例老年晚期NSCLC患者共行化疗156个周期。全组总有效率35.7%,主要毒副反应为骨髓抑制及轻度肢端感觉异常,消化道反应及肝肾功能损害均较轻。[结论]健择联合艾恒治疗晚期NSCLC有效率高,毒副反应轻,临床应用安全,适合于老年患者。     

健择联合奥沙利铂治疗老年中晚期非小细胞肺癌的临床研究

目的 观察健择联合奥沙利铂治疗老年中晚期非小细胞肺癌的临床疗效及毒副反应.方法 50例老年中晚期非小细胞肺癌采用健择、奥沙利铂联合方案化疗:健择1 000 mg/m2静脉滴注,d1,8,奥沙利铂 100 mg/m2静脉滴注,d121 d为1周期.采用 WHO 疗效及毒副反应评价标准,完成治疗2个周期以上的患者进行临床疗效及毒副反应评估.结果 可评价疗效50例,有效(RR)率42%(21/50),其中完全缓解(CR)5例,部分缓解(PR)16例.稳定(SD)23例.进展(PD)6例.缓解期为1.5-12个月,中位缓解期为7个月.生存期为4-19个月,中位生存期为10个月,1年生存率48%(24/50).50例共化疗121个周期,主要毒副反应为骨髓抑制9例(18%)、贫血6例(12%)、血小板减少7例(14%);非血液毒性反应较轻,主要表现为胃肠道反应7例(14%).结论 健择联合奥沙利铂方案治疗老年中晚期非小细胞肺癌的疗效较好,毒副反应较轻,患者的耐受性好.     

健择联合顺铂每周用药治疗晚期非小细胞肺癌的临床观察

目的:评价健择联合顺铂每周用药治疗晚期非小细胞肺癌的疗效和毒性反应.方法:37例晚期非小细胞肺癌患者应用联合方案化疗,健择1000mg/m2,静滴半小时,第1、8天;DDP 50mg/m2,静滴,第1、8天.结果:37例中,CR 1例,PR 15例,CR+PR 16例,总有效率为43.2%.主要不良反应为白细胞及血小板减少,绝大部分病人均能耐受.结论:健择联合顺铂每周用药方案对晚期非小细胞肺癌有较好疗效,不良反应可以耐受.     

健择为主联合方案治疗晚期非小细胞肺癌临床研究

目的观察健择为主联合化疗方案治疗晚期非小细胞肺癌的临床疗效及毒副反应.方法42例晚期非小细胞肺癌,26例采用健择1 000 mg/m2,d1、d8;DDP 30 mg/m2,d1～d3.16例采用健择1 000 mg/m2,d1、d8;紫杉醇60 mg/m2,d1、d8.两方案均3个周重复,3个周期以上评价疗效.结果42例中CR 1例,PR 20例,SD 14例,PD 7例,有效(CR+PR)率50%(21/42),初治有效率54.2%(13/24),复治有效率44.4%(8/18).健择+DDP组(其中24例为初治),CR 1 例,PR 12例,有效率50%(13/26).健择+紫杉醇组有效率50%(8/16).毒副反应主要为骨髓抑制和消化道反应,126个周期中Ⅲ～Ⅳ度粒细胞下降19例次(15.0%),Ⅲ～Ⅳ度血小板下降32例次(25.4%),Ⅲ～Ⅳ度消化道反应45例次(35.7%);Ⅱ～Ⅲ度肝功能损害50例次(39.6%).结论健择为主联合化疗方案治疗晚期非小细胞肺癌有较好疗效,毒副反应可耐受,特别是健择+紫杉醇治疗复治非小细胞肺癌有较高疗效,值得临床进一步研究观察.     

吉西他滨联合顺铂治疗47例老年晚期非小细胞肺癌

[目的]观察吉西他滨（商品名健择）联合顺铂治疗老年晚期非小细胞肺癌（NSCLC）的近期疗效、毒副反应。[方法]健择（GEM）1000mg/m2静滴30min,d1,8;顺铂30mg/m2,静滴d1～3;21d为一个周期。完成2个周期以上评价疗效。[结果]47例老年晚期NSCLC患者共行化疗189个周期,全组总有效率38.3%。（全组42例均可评价,有效率为38.3%）。主要毒副反应为胃肠反应（Ⅲ～Ⅳ度为23.4%）和血液学毒性（Ⅲ～Ⅳ度白细胞下降率为27.7%,Ⅲ～Ⅳ度血小板下降率为14.9%）。[结论]健择联合顺铂治疗老年人非小细胞肺癌,有效率高,毒副反应轻,可以耐受。     

长春瑞滨联合顺铂、亚叶酸钙/5-氟脲嘧啶治疗晚期食管癌

目的:观察长春瑞滨(NVB)联合亚叶酸钙(CF)、5-氟脲嘧啶(5-Fu)和顺铂(DDP)方案治疗晚期食管癌的近期疗效和毒性反应.方法:NVB 25mg/m2静脉注入,第1、8天给药;CF 200 mg静滴,第2天～6天给药;5-Fu 500mg/m2静滴6小时,第2天～6天给药;DDP 35mg/m2静滴,第2天～4天给药.28天为一个周期,完成2周期化疗后评价疗效.结果:23例晚期食管癌患者中,完全缓解2例(8.7%),部分缓解10例(43.5%),总有效率为52.2%.毒副反应主要是骨髓抑制、胃肠道反应、静脉炎.结论:NVB联合DDP、CF及5-Fu方案治疗晚期食管癌疗效较好,毒副反应可以耐受,是一个较好的联合化疗方案.     

吉西他滨单药与联合顺铂化疗治疗中老年晚期非小细胞肺癌的疗效观察

目的:评价吉西他滨联合顺铂治疗非小细胞肺癌(NSCLC)与单独使用吉西他滨的疗效与安全性.方法:140例晚期NSCLC(Ⅲb/Ⅳ期)患者随机均分为吉西他滨联合顺铂组(n=70)和单独使用吉西他滨组(n=70).联合给药组患者静脉注射吉西他滨(1 250 mg/m2,第1、8天)和顺铂(75 mg/m2,第1天);单独给药组患者静脉注射吉西他滨(1 250 mg/m2,第1、8天).每21天为一个疗程,共持续4个疗程.结果:吉西他滨与顺铂联合给药组疗效优于吉西他滨单独给药组(P＜0.05).而在血细胞减少、血红蛋白减少以及恶心呕吐等不良反应上,吉西他滨单独给药组低于联合给药组,但组间比较差异无统计学意义(P＞0.05).治疗后2年的随访结果也显示经吉西他滨与顺铂联合治疗的患者1年有效率及中位生存期均优于吉西他滨单独治疗组(P＜0.05).结论:吉西他滨联合顺铂治疗中老年晚期非小细胞肺癌疗效确切,未明显增加不良反应,患者耐受性好,值得临床推广.     

吉西他滨联合卡培他滨或替吉奥治疗蒽环类和紫杉类耐药的晚期乳腺癌的临床观察

目的:比较吉西他滨联合卡培他滨或替吉奥治疗蒽环类和紫杉类耐药的晚期乳腺癌的疗效及不良反应。方法:蒽环类和紫杉类耐药的晚期乳腺癌患者90例,随机分为吉西他滨联合卡培他滨组（GX组）和吉西他滨联合替吉奥组（GS组）各45例。GX组患者的具体方案为:吉西他滨1 000 mg/m2静脉滴注,d1、8,卡培他滨1 000 mg/m2口服,每日两次,d1~14;GS组患者的具体方案为:吉西他滨1 000 mg/m2静脉滴注,d1、8,替吉奥60 mg（体表面积≥1.5 m2）,50 mg（1.25 m2<体表面积<1.5 m2）,40 mg（体表面积≤1.25 m2）,每日两次口服,d1~14。所有患者21天为1个治疗周期,治疗2个周期后评价近期疗效,每周期评价不良反应。结果:90例患者均可评价疗效。其中GX组45例患者中CR 4例,PR 18例,SD 17例,PD 6例,有效率(RR)和疾病控制率（DCR）分别为48.9%和86.7%;GS组45例患者中CR 4例,PR 19例,SD 15例,PD 7例,有效率(RR)和疾病控制率（DCR）分别为51.1%和84.4%。两组患者的RR和DCR相比差异无统计学意义（P>0.05）。GX组患者的中位疾病进展时间为8.1个月,与GS组患者（7.7个月）比较,差异无统计学意义（P>0.05）;GX组患者的中位生存时间为31.5个月,与GS组患者（29.8个月）比较,差异无统计学意义（P>0.05）;GX组患者的1年生存率为82.2%,与GS组患者（77.7%）比较,差异无统计学意义（P>0.05）;GX组患者的2年生存率为68.9%,与GS组患者（64.4%）比较,差异无统计学意义（P>0.05）。两组的主要不良反应为骨髓抑制和消化道反应,以Ⅰ-Ⅱ度为主,均可耐受。GX组患者手足综合征的发生率高于GS组,差异有统计学意义（P<0.05）。结论:吉西他滨联合卡培他滨或替吉奥治疗蒽环类和紫杉类耐药的晚期乳腺癌患者的近远期疗效相当,不良反应较轻且均可耐受,吉西他滨联合替吉奥方案的手足综合征发生率较低,两种方案均值得临床进一步研究。     

Combination therapy with gefitinib, an epidermal growth factor receptor tyrosine kinase inhibitor, gemcitabine and cisplatin in patients with advanced solid tumors.

BACKGROUND: The aim of this study was to investigate the tolerability, pharmacokinetic interaction and antitumor activity of gefitinib ("Iressa", ZD1839), an orally active, selective epidermal growth factor receptor tyrosine kinase inhibitor, combined with gemcitabine and cisplatin in chemotherapy-na?ve patients with advanced solid tumors. PATIENTS AND METHODS: This was an open-label feasibility trial evaluating two doses of gefitinib (250 and 500 mg/day) in combination with gemcitabine and cisplatin. Gefitinib was administered daily from day 2 onwards. Gemcitabine 1250 mg/m(2) was given on days 1 and 8 and cisplatin 80 mg/m(2) on day 1 for up to six 3-week cycles. Patients could then continue to receive gefitinib monotherapy. RESULTS: Eighteen patients were entered, nine at each gefitinib dose level. Two patients developed dose-limiting toxicity: one grade 3 convulsion (250 mg/day dose group) and one grade 3 rash (500 mg/day dose group). The most frequently occurring adverse events in the combination phase were vomiting (17 patients), asthenia (16), nausea (14), diarrhea (14) and skin rash (13). The most common grade 3/4 adverse events were vomiting (seven patients), asthenia (six), thrombocytopenia (six), diarrhea (five) and anorexia (five). Pharmacokinetic analyses showed no apparent pharmacokinetic interaction between gefitinib and cisplatin or gemcitabine, with the exception of a possible small increase in the geometric mean exposure to gemcitabine seen on day 8 of therapy when given alone with the higher dose of gefitinib. Of 17 evaluable patients, nine had confirmed partial responses, seven had stable disease and one had progressive disease. CONCLUSIONS: Combination therapy of gefitinib with cisplatin and gemcitabine had a manageable and predictable safety profile, no major effect on exposure to any of the three drugs and antitumor activity.     

康莱特联合吉西他滨治疗进展期胰腺癌的疗效观察

目的：观察康莱特联合吉西他滨治疗进展期胰腺癌的临床疗效、临床获益反应和不良反应.方法：40例未接受过全身化疗的进展期胰腺癌患者,至少接受2个周期的康莱特联合吉西他滨化疗方案.康莱特200ml静滴,每天1次,吉西他滨1000mg/m2,第1天和第8天,每21天为一个周期.结果：40例患者中3例临床缓解,13例部分缓解,11例稳定.总的疾病控制率为67.5％.疼痛缓解率为88.6％.骨髓抑制发生率为37.5％.无化疗相关死亡.结论：康莱特联合吉西他滨治疗进展期胰腺癌可提高疾病控制率,改善患者生活质量,减轻疼痛,减少不良反应的发生.     

A dose-escalation study of irinotecan (CPT-11) in combination with gemcitabine in patients with advanced non-small cell lung cancer previously treated with a cisplatin-based front line chemotherapy

PURPOSE: CPT-11 and gemcitabine are both active agents against non-small cell lung cancer (NSCLC). We conducted a phase I study to determine the maximum-tolerated dose (MTD) and the dose-limiting toxicities (DLTs) of their combination in patients with previously treated advanced NSCLC. PATIENTS AND METHODS: Twenty-seven patients with histologically confirmed NSCLC, who had failed cisplatin-based front-line chemotherapy, were enrolled. The patients' median age was 56 years, 24 were male and 22 had a performance status (WHO) 0-1. Gemcitabine was administered on days 1 and 8, as a 30-minute i.v. infusion, at escalated doses ranging from 900 to 1200 mg/m2. CPT-11 was given over a 60-minute i.v. infusion on day 8 at escalated doses ranging from 200 to 350 mg/m2, following gemcitabine administration. The treatment was repeated every three weeks. RESULTS: The MTD was exceeded at dose-level 7 with CPT-11 350 mg/m2 and gemcitabine 1200 mg/m2, where all three enrolled patients presented DLTs (one patient grade 4 thrombocytopenia, one grade 3 diarrhea and one grade 3 asthenia). The recommended doses for future phase II studies are CPT-11 300 mg/m2 on day 8 and gemcitabine 1200 mg/m2 on days 1 and 8. A total of 107 treatment cycles were administered. Grade 3/4 neutropenia was observed in 13 (13%) cycles, febrile neutropenia in 3 (3%) and grade 3/4 thrombocytopenia in 2 (2%). Grade 2/3 diarrhea was seen in 6 (6%) cycles, grade 2/3 nausea and vomiting in 13 (13%) and grade 2/3 asthenia in 8 (8%). Other toxicities were mild. Among 23 patients evaluable for response, PR was achieved in one (4.5%), SD in 12 (52.5%) and PD in 10 (43%). CONCLUSION: The results of this phase I study clearly demonstrate that gemcitabine and CPT-11 can be efficiently combined in a low-toxicity regimen with doses equal or near monotherapy levels. Further studies are needed to evaluate the efficacy of this combination in both chemotherapy-naive and pre-treated patients with advanced NSCLC.     

Phase I/II study of combination chemotherapy with gemcitabine and UFT for advanced pancreatic cancer in a multi-center trial

The aim of this phase I/II study was to evaluate the tolerability and efficacy of combination chemotherapy with gemcitabine (GEM) and UFT for advanced pancreatic cancer. In phase I study UFT was given orally every day for 14 days and GEM was infused on day 1 and 8 at three dose levels (800, 900, 1,000 mg/m(2)/week) every 21 days. GEM 1,000 mg/m(2) and UFT 400 mg/m(2) did not reach the maximum tolerated dose. We decided that the recommended dose (RD) was GEM 1,000 mg/m(2)and UFT 400 mg/m(2). In phase II study 27 patients were enrolled and received GEM and UFT at RD. The tumor response rate was 17.6%, and the median survival was 221 days, which was very similar to that of GEM monotherapy. Due to adverse events, especially liver dysfunction, protocol therapy was discontinued in 12 patients. This study could not revealed the superiority of the GEM monotherapy.     

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。     

吉西他滨联合顺铂治疗晚期乳腺癌的临床观察

目的观察吉西他滨联合顺铂治疗晚期乳腺癌的疗效及不良反应。方法47例晚期乳腺癌患者采用吉西他滨1000mg/m^2,静脉滴注30min,d1,d8;顺铂25～40mg/m^2,d2～4。21d一周期,治疗2周期后评价疗效及不良反应。结果47例均可评价疗效,共完成周期数为206个。完全缓解（CR）4例,部分缓解（PR）17例,稳定（SD）15例,进展（PD）11例,总有效率（CR＋PR）44.7%,疾病控制率（CR＋PR＋SD）76.6%,中位疾病进展时间8.7个月,中位生存期为12.3个月（2.0～52.5个月）。主要不良反应为骨髓抑制、胃肠道反应。结论吉西他滨联合顺铂治疗晚期乳腺癌疗效较好,毒副反应轻,耐受性好,是晚期乳腺癌的有效治疗方案。     

沙利度胺联合GEMOX方案治疗中晚期肝癌的临床观察

目的观察沙利度胺联合吉西他滨及奥沙利铂（GEMOX方案）治疗原发性肝癌的有效性和安全性。方法对15例中晚期肝癌患者行沙利度胺（400 mg/天）,吉西他滨（1 000 mg/m2,第1,8天）及奥沙利铂（130 mg/m2,第1天）方案联合化疗2,1天为1个周期。以RECIST标准评价疗效,以NCI标准评价不良反应。结果 15例患者均可评价客观疗效及不良反应。其总有效率（RR）为40.0%（6/15）,疾病控制率（DCR）为73.3%（11/15）。中位疾病进展时间（TTP）5.5个月。治疗后KPS评分明显改善。结论沙利度胺联合吉西他滨及奥沙利铂治疗原发性肝癌安全有效,耐受性良好。     

国产吉西他滨联合顺铂治疗28例晚期非小细胞肺癌

目的:评价国产吉西他滨(gemcitabine,GEM)联合顺铂方案治疗晚期非小细胞肺癌的疗效和不良反应。方法:对经病理组织学或细胞学证实的28例晚期非小细胞肺癌患者采用GP方案化疗:GEM1000mg/m2ivdrip第1、8日,DDP30mg/m2ivdrip第1~3日,21日为1周期。结果:CR0例,PR12例,SD14例,PD2例,总有效率为42.8%,初治、复治各14例,均有6例PR,有效率均为42.8%,不良反应以消化道反应及白细胞、血小板下降为主,均可耐受。结论:国产吉西他滨联合顺铂对晚期非小细胞肺癌有较好疗效,毒副反应可以耐受,可作为一线或二线化疗方案。