吉西他滨联合铂类治疗64例晚期非小细胞肺癌临床疗效研究

目的:比较吉西他滨(gemcitabine)联合顺铂(cisplatin)、卡铂(carboplatin)和奥沙利铂(oxaliplatin)三种化疗方案对晚期非小细胞肺癌(NSCLC)的疗效和毒性反应。方法:经病理和细胞学证实的64例晚期NSCLC患者随机分为吉西他滨 顺铂(gemcitabine cisplatin,Gcis)、吉西他滨 卡铂(gemcitabine carbopl-atin,Gcarb)和吉西他滨 奥沙利铂(gemcitabine oxaliplatin,GLOHP)三组。三组均选用吉西他滨1000mg/m2静脉滴注第1、8天。GCis组:顺铂70mg/m2静脉滴注,第1天;GCarb组:卡铂AUC4～6(初治6,复治4～5),静脉滴注,第1天;GLOHP组:奥沙利铂LOHP130mg/m2静脉滴注,第1天。三组均21天为一周期,连续使用2～3周期评价疗效和毒副反应。结果:Gcis、Gcarb、GLOHP三种方案治疗晚期非小细胞肺癌的有效率分别为52.38%(11/21)、50.00%(10/20)和60.87%(14/23)(P>0.05)。三种方案毒副反应主要为可耐受的骨髓抑制、消化道反应、脱发和外周神经毒性等。结论:吉西他滨联合三种不同铂类的化疗方案均为治疗晚期非小细胞肺癌较为安全有效的化疗方案。     

吉西他滨联合顺铂治疗晚期非小细胞肺癌30例临床分析

目的观察吉西他滨联合顺铂治疗晚期非小细胞肺癌的疗效及毒副反应。方法采用吉西他滨1000mg／m^2，静脉滴注，第1，8天；顺铂20mg／m^2，静脉滴注，第2～5天；3～4周为1周期，2周期后评价疗效及毒副反应。结果30例中完全缓解1例(3.3％)，部分缓解9例(30％)，总有效率33．3％，毒副反应主要为血小板减少.     

吉西他滨联合顺铂与吉西他滨联合去甲长春碱治疗非小细胞肺癌的随机对照研究

背景与目的含铂类方案目前是晚期非小细胞肺癌（NSCLC）的标准治疗，但其严重的不良反应促使人们寻找新的替代方案。本研究拟比较吉西他滨联合顺铂（GP）方案与吉西他滨联合去甲长春碱（GN）方案治疗晚期NSCLC的疗效、生存率及毒副反应。方法对103例经病理或细胞学证实的晚期NSLC的初治患者给予联合化疗，随机分为GP组或GN组。GP方案组52例，GN方案组51例，两组病例具有可比性。吉西他滨l000mg／m^2，静脉滴注第1、8天，顺铂80mg／m^2，静脉滴注第1天，去甲长春碱25mg／m^2静脉推注第1、8天。21天为一个周期。每例患者治疗不超过6个周期。结果GP组患者总有效率为34．6％，1年生存率为68．8％，中位生存期14．4个月；GN组患者总有效率为27．5％，1年生存率为73．1％，中位生存期19．5个月。两组间有效率、1年生存率比较差异无显著性。最常见的毒副反应为恶心及呕吐，GP组和GN组的Ⅲ＋Ⅳ度反应发生率分别为51．9％和2．0％，差别有统计学意义（P=0．0005）。其余毒副反应轻微，可耐受。结论吉西他滨联合顺铂与吉西他滨联合去甲长春碱相比，疗效相似，但吉西他滨联合去甲长春碱方案的毒副反应（恶心／呕吐）小于吉西他滨联合顺铂方案。     

吉西他滨联合铂类化疗药物治疗晚期非小细胞肺癌临床观察

目的评价吉西他滨联合铂类化疗药物治疗晚期非小细胞肺癌（NSCLC）的临床疗效与毒副反应。方法51例晚期NSCLC患者接受吉西他滨与铂类联合化疗：吉西他滨1000mg／m^2,第1天和第8天;顺铂25mg／m^2,第1-3天或卡铂AUC=5第1天;21天为1个周期。结果完全缓解3例,部分缓解20例,有效率45．1％。中位疾病进展时间5．2个月,中位生存期10．1个月,1年生存率39．2％。主要毒副反应为血液学毒性,恶心呕吐等。结论吉西他滨联合铂类化疗药物是治疗晚期NSCLC安全、有效的联合化疗方案,值得临床进一步研究。     

国产吉西他滨加顺铂治疗晚期非小细胞肺癌的临床研究

 目的 评价国产吉西他滨（泽菲）加顺铂治疗晚期非小细胞肺癌（NSCLC）的疗效和毒副反应。方法 泽菲1 000 mg／m2，第1，8天静脉滴注，顺铂25 mg／m2，第1 ~ 3天静脉滴注，3周重复。结果 全组25例，共完成76个周期，平均3个周期（2 ~ 6个周期），完全缓解1例，部分缓解9例，客观有效率44 %（11／25），主要毒副反应为骨髓抑制、消化道反应、静脉炎。结论 国产吉西他滨加顺铂的两联化疗在晚期非小细胞肺癌中有较好疗效，毒性可以耐受。     

吉西他滨联合顺铂或卡铂方案治疗晚期非小细胞肺癌的临床对比观察

目的 本研究旨在观察初治的晚期非小细胞肺癌患者接受吉西他滨加顺铂(GCis)和吉西他滨加卡铂(GCarb)是否具有相同的治疗效果,卡铂能否完全替代顺铂,从而成为晚期非小细胞肺癌患者化疗的标准含铂二药联合方案.方法 吉西他滨1 000 mg/m2,静脉滴注,d1,8;顺铂75 mg/m2,d1或25 mg/m2,d1-3;卡铂AUG=5;每21 d为1周期,分别化疗3～6周期.结果 入组76例均可评价疗效,GCis组:33例中,CR 1例,PR 13例,MR 3例,SD 7例,PD 9例,有效率42.42%(14/33);疾病控制率72.73%(24/33);中位TTP 5个月;中位生存期14个月;1年生存率66.67%(22/33);2年生存率12.12%(4/33).GCarb组:43例中,PR 13例,MR 11例,SD 7例,PD 12例,有效率30.23%(13/43);疾病控制率72.09%(31/43);中位TTP 4个月;中位生存期11个月;1年生存率48.84%(21/43);2年生存率2.33%(1/43).其中中位生存时间(MST)二组差异有统计学意义(χ2=2.45,P=0.017).主要毒副反应为轻中度骨髓抑制和恶心呕吐.结论 两组方案对晚期NSCLC患者有相似的疗效和较好的毒副反应耐受性,总体GCis组略优于GCarb组,卡铂仍不能替代顺铂成为晚期NSCLC标准的一线化疗方案.     

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。     

吉西他滨联合顺铂治疗非小细胞肺癌

目的：研究吉西他滨联合顺铂治疗非小细胞肺癌的疗效及毒性反应。方法：经病理组织学或细胞学证实的28例非小细胞肺癌患者给予吉西他滨1000mg/m^2静滴，第1，8，15天，顺铂80mg/m^2静滴，第1天，4周为1周期；或吉西他滨1200mg/m^2，第1，8天，顺铂80mg/m^2静滴，第8天，3周为1周期。结果：可评价疗效28例，总效率53．6％（均为部分缓解）。四周方案与三周方案有效率分别为58．3％和50．0％，两者差异无显著性。毒副反应主要为白细胞及血小板降低，但均可耐受。结论：吉西他滨联合顺铂治疗非小细胞肺癌具有较好的疗效，毒性可以耐受，不同用药方法疗效及毒副反应的差异值得进一步研究。     

吉西他滨联合顺铂治疗晚期非小细胞肺癌30例临床分析

目的观察吉西他滨联合顺铂治疗晚期非小细胞肺癌的疗效及毒副反应。方法采用吉西他滨1000mg/m2,静脉滴注,第1,8天;顺铂20mg/m2,静脉滴注,第2～5天;3～4周为1周期,2周期后评价疗效及毒副反应。结果30例中完全缓解1例(3.3%),部分缓解9例(30%),总有效率33.3%,毒副反应主要为血小板减少。     

吉西他滨联合奥沙利铂或顺铂治疗老年人晚期非小细胞肺癌的随机对照临床研究

背景与目的化疗可延长患者生存期，改善生活质量，是治疗晚期非小细胞肺癌的主要方法。对于70岁及以上的老年晚期非小细胞肺癌患者，治疗的毒副反应和治疗耐受性尤其重要。本研究的目的是观察比较吉西他滨联合奥沙利铂和吉西他滨联合顺铂治疗70岁及以上老年人晚期非小细胞肺癌的疗效和毒副反应。方法42例患者按随机表法分为GO组20例（吉西他滨1000mg／m^2，第1、8天；奥沙利铂65mg／m^2，第1、8天）和GP组22例（吉西他滨1000mg／m^2，第1、8天；顺铂30mg／m^2，第1～3天），28天为一周期，均治疗2周期以上。结果GO组CR1例，PR10例，SD7例，PD2例，有效率为55．0％；中位生存期为11．2月，1年生存率为45％。GP组PR9例，SD10例，PD3例，有效率为40．9％；中位生存期为11．8月，1年生存率为50％。两组有效率、中位生存期和1年生存率比较均无显著性差异（P均〉0．05）。毒副反应以白细胞降低和胃肠道反应为主，GP组Ⅲ＋Ⅳ度白细胞下降发生率和恶心呕吐发生率均显著高于GO组（17．4％VS4．8％，20．7％VS3．6％，P均〈0．05），GP组Ⅰ＋Ⅱ度脱发和肾功能异常发生率均显著高于GO组（43．5％ vs 10．7％，14．1％ vs 2．4％，P均〈0．05）。结论对于70岁及以上老年人晚期非小细胞肺癌，吉西他滨加奥沙利铂方案有较好的近期疗效，毒副反应轻，治疗耐受性好，临床应用更安全。     

吉西他滨联合顺铂或卡铂方案一线治疗晚期非小细胞肺癌的疗效和毒性比较

Objective:To compare the efficacy and toxicity between gemdtabine plus cisplatin and plus carboplatin in firstline treatment of advanced non-small call lung cancer (NSCLC).Methods:Gemcitabine 1000 mg/m2 iv,d1,8;cisplatin 75 mg/m2 iv,d1,or 25 mg/m2 iv,d1-3;carboplatin AUC = 5 iv,d1;repeated every 21 days.Results:All 76 cases were available for objective response.Gemcitabine cisplatin (GCis) group:among 33 cases,CR 1 case,PR 13 cases,MR 3 cases,SD 7 cases,PD 9 cases,response rate,disease control rate,time to progress (TTP),median survival time (MST) and 1-,2-year survival rates were 42.42% (14/33),72.73% (24/33),5 months,14 months and 66.67% (22/33),12.12% (4/33),respectively;Gemcitabine carboplatin (GCarb) group:among 43 cases,PR 13 cases,MR 11 cases,SD 7 cases,PD 12 cases,the results while comparing with those of GCis group were 30.23% (13/43),72.09% (31/43),4 months,11 months and 48.84% (21/43),2.33% (1/43),respectively.Among them,only MST between the two groups had significant statistic difference (x2 = 2.45,P = 0.017).Mild to modest myelo-suppression as well as nausea and vomiting were observed.Conclusion:Both GCis and GCarb regimens had active and well-tolerated toxicity for advanced NSCLC.Cisplatin-based chemotherapy yields a substantial effective advantage over carboplatin-based regimens.Therefore,carboplatin and cisplatin are not equal-active and that cisplatin-based doublet regimens should remain the standard first-line therapy for patients with advanced NSCLC with good performance status.     

国产吉西他滨联合顺铂治疗63例晚期非小细胞肺癌的临床观察

目的：评价吉西他滨联合顺铂治疗晚期非小细胞肺癌的疗效和毒性。方法：60例患者采用吉西他滨1000mg／m^2，iv，d1-8顺铂75mg／m^2，iv，d。125mg／m^2，iv，d1-3，化疗。每3周期评价疗效。结果：初治病例RR44．6％，复治病例RR30．8％。主要不良反应为骨髓抑制。结论：吉西他滨联合顺铂冶疗晚期非小细胞肺癌具有较高有效率，毒性可以耐受。     

Gemcitabine/carboplatin in advanced non-small cell lung cancer

Gemcitabine/cisplatin is among the most widely used regimens in Europe for first-line treatment of non-small cell lung cancer (NSCLC). Problems with cisplatin use in this setting include significant nonhematologic toxicity and difficulty of use in outpatients. Carboplatin constitutes a reasonable alternative to cisplatin in this combination, since it shows synergy with gemcitabine in vitro, is easier to use in ambulatory patients, and has a better nonhematologic toxicity profile. Studies of gemcitabine/cisplatin on a 28-day schedule (gemcitabine on days 1, 8, 15 and carboplatin on day 1) generally indicate excessive thrombocytopenia. Use of a 21-day schedule (e.g. gemcitabine on days 1 and 8, carboplatin on day 1) is associated with reduced toxicity and comparable efficacy. Results of one randomized phase II study suggest reduced toxicity and reduced objective response rate with gemcitabine/carboplatin versus gemcitabine/cisplatin. We are currently conducting a phase III comparison of gemcitabine 1200 mg/m(2) on days 1 and 8 plus carboplatin at an area under the curve of 5 mg/ml/min on day 1 versus gemcitabine at the same dose plus cisplatin 80 mg/m(2) on day 1 every 21 days in chemotherapy-nai;ve patients with stage IIIB/IV NSCLC; interim analysis indicates comparable response rates (47 and 48%). A better understanding of the relative toxicities of these regimens should be provided by the final results of this trial.     

The development of gemcitabine and carboplatin in the treatment of non-small-cell lung cancer

Gemcitabine plus carboplatin is a widely used regimen for the treatment of advanced non-small-cell lung cancer (NSCLC). This two drug combination is effective, with a favorable safety profile, and is well tolerated in the outpatient setting. Gemcitabine/carboplatin prolongs survival compared with gemcitabine alone, but with greater hematological toxicity. The combination regimen appears to be superior to or equally effective as other regimens including mitomycin, ifosfamide and cisplatin (MIC), cisplatin/vinblastine, gemcitabine/paclitaxel, paclitaxel/carboplatin and gemcitabine/cisplatin. Gemcitabine combined with carboplatin is associated with more hematological toxicity, but the incidence of non-hematological toxicity is often significantly lower. Gemcitabine/carboplatin also improves patient quality of life, supporting its use in treating patients with advanced NSCLC in the outpatient setting.     

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。     

Gemcitabine plus cisplatin vs. gemcitabine plus carboplatin in stage IIIb and IV non-small cell lung cancer: a phase III randomized trial

PURPOSE: This randomized, multicenter, phase III trial was conducted to compare the tolerability of gemcitabine plus cisplatin (GP) vs. gemcitabine plus carboplatin (GC) in chemonaive patients with stage IIIb and IV non-small cell lung carcinoma (NSCLC). Secondary objectives were to evaluate response, duration of response, time to progressive disease (TTPD), and survival. PATIENTS AND METHODS: Eligible patients were required to have stage IIIb or IV NSCLC, no previous chemotherapy, Karnofsky performance status of at least 70, bidimensionally measurable disease, and age 18-75 years. Randomized patients in both arms were given gemcitabine 1200 mg/m(2) on days 1 and 8, followed on day 1 by cisplatin 80 mg/m(2) (GP) or carboplatin AUC=5 (GC). Treatment cycles were repeated every 21 days for a maximum of six cycles, or until disease progression or unacceptable toxicity occurred. RESULTS: Enrolled patients in both arms, 87 in GP and 89 in GC, were well balanced for demographics and disease characteristics. Dose intensity was 93.8 and 92.7% for gemcitabine in GP/GC arms, respectively; 97.7% for cisplatin and 99.9% for carboplatin. Patients with at least one grade 3/4 toxicity excluding nausea, vomiting or alopecia, were 44% in GP arm and 54% in GC arm. The only significantly different toxicities were, nausea and vomiting in GP and thrombocytopenia in GC group. The overall response rates, median TTPD, response duration and survival were, 41/29%, 5.87/4.75 months, 7.48/5.15 months, and 8.75/7.97 months for GP and GC arms, respectively. CONCLUSION: GP and GC are effective and feasible regimens for advanced NSCLC, and are comparable in efficacy and toxicity. GC may offer acceptable option to patients with advanced NSCLC, especially those who are unable to receive cisplatin.     

Randomized,multicenter, phase II study of gemcitabine plus cisplatin versus gemcitabine plus carboplatin in patients with advanced non-small cell lung cancer

BACKGROUND: We conducted a phase II randomized study to assess the efficacy, with response as the primary endpoint, and the toxicity of gemcitabine/cisplatin (GP) and gemcitabine/carboplatin (GC) in patients with advanced non-small cell lung cancer (NSCLC). METHODS: Patients were randomized to GP (gemcitabine 1200 mg/m(2), days 1 and 8 plus cisplatin 80 mg/m(2) day 2) or GC (gemcitabine 1200 mg/m(2), days 1 and 8 plus carboplatin AUC=5 day 2). Cycles were repeated every 3 weeks. RESULTS: Sixty-two patients were randomized to GP and 58 to GC. A total of 533 cycles were delivered (264 GP, 269 GC), with a median of four cycles/patient. The objective response rate was 41.9% (95% C.I., 29.6-54.2%) for GP and 31.0% (95% C.I., 18.2-42.8%) for GC (P=0.29). No significant differences between arms were observed in median survival (10.4 months GP, 10.8 months GC) and median time to progression (5.4 months GP, 5.1 months GC). Both regimens were very well tolerated with no statistical differences between arms in grade 3/4 toxicities. When all toxicity grades were combined, emesis, neuropathy and renal toxicity occurred more frequently on the GP arm (P<0.005). CONCLUSIONS: GC arm did not provide a significant difference in response rate compared with GP arm, with better overall tolerability. Carboplatin could be a valid alternative to cisplatin in the palliative setting.     

低剂量持续静脉滴注吉西他滨一线治疗晚期非小细胞肺癌的临床研究

背景与目的:目前已将吉西他滨联合顺铂作为晚期非小细胞肺癌的一线化疗方案,吉西他滨的常规使用剂量和方法是1000mg/m2半小时静脉滴注,第1、8天,每3周为一个疗程。本研究旨在评价低剂量吉西他滨持续6h静脉滴注联合顺铂一线治疗晚期非小细胞肺癌的有效性和安全性。方法:48例经病理和/或细胞学检查确诊、未经化疗的晚期非小细胞肺癌患者,采用吉西他滨250mg/m2持续静脉滴注6h,第1、8天,顺铂75mg/m2,每3周为一疗程,连续使用2疗程以上。结果:48例患者中46例可评价疗效,所有患者可评价不良反应。完全缓解率2.2%,部分缓解率30.3%,总有效率为32.5%,中位治疗至进展时间为5.1个月,中位生存时间为10.2个月,1年生存率36.6%。白细胞减少发生率为60.4%,血小板减少发生率为39.5%,Ⅲ～Ⅳ度的白细胞和血小板减少发生率分别为20.8%和12.5%。结论:低剂量吉西他滨持续6h静脉滴注联合顺铂一线治疗晚期非小细胞肺癌疗效确切、不良反应轻。     

Randomized phase III study of cisplatin plus irinotecan versus carboplatin plus paclitaxel, cisplatin plus gemcitabine, and cisplatin plus vinorelbine for advanced non-small-cell lung cancer: Four-Arm Cooperative Study in Japan.

BACKGROUND: To compare the efficacy and toxicity of three platinum-based combination regimens against cisplatin plus irinotecan (IP) in patients with untreated advanced non-small-cell lung cancer (NSCLC) by a non-inferiority design. PATIENTS AND METHODS: A total of 602 patients were randomly assigned to one of four regimens: cisplatin 80 mg/m(2) on day 1 plus irinotecan 60 mg/m(2) on days 1, 8, 15 every 4 weeks (IP) carboplatin AUC 6.0 min x mg/mL (area under the concentration-time curve) on day 1 plus paclitaxel 200 mg/m(2) on day 1 every 3 weeks (TC); cisplatin 80 mg/m(2) on day 1 plus gemcitabine 1000 mg/m(2) on days 1, 8 every 3 weeks (GP); and cisplatin 80 mg/m(2) on day 1 plus vinorelbine 25 mg/m(2) on days 1, 8 every 3 weeks (NP). RESULTS: The response rate, median survival time, and 1-year survival rate were 31.0%, 13.9 months, 59.2%, respectively, in IP; 32.4%, 12.3 months, 51.0% in TC; 30.1%, 14.0 months, 59.6% in GP; and 33.1%, 11.4 months, 48.3% in NP. No statistically significant differences were found in response rate or overall survival, but the non-inferiority of none of the experimental regimens could be confirmed. All the four regimens were well tolerated. CONCLUSION: The four regimens have similar efficacy and different toxicity profiles, and they can be used to treat advanced NSCLC patients.