伊立替康联合顺铂与吉西他滨联合顺铂一线治疗晚期非小细胞肺癌的随机对照研究

目的　探讨伊立替康（ＣＰＴ １１）联合顺铂（ＤＤＰ）方案（ＩＰ方案）与吉西他滨（ＧＥＭ）联合ＤＤＰ方案（ＧＰ方案）一线治疗非小细胞肺癌（ＮＳＣＬＣ）的近期疗效和毒副反应。方法　采用前瞻性、开放性、随机对照的临床研究设计,纳入经组织学或细胞学确诊的初治晚期ＮＳＣＬＣ患者８８例,按２∶１比例随机分入ＩＰ方案组和ＧＰ方案组,ＩＰ方案组６０例,ＧＰ方案组２８例。ＩＰ方案组：ＣＰＴ-11 １００ｍｇ／ｍ２,ｄ１、ｄ８;ＤＤＰ２５ｍｇ／ｍ２,ｄ１ ～ｄ３;２１天为１周期。ＧＰ方案组：ＧＥＭ １０００ｍｇ／ｍ２,ｄ１、ｄ８;ＤＤＰ２５ｍｇ／ｍ２,ｄ１～ｄ３;２１天为１周期。２个周期评价疗效和不良反应。结果　ＩＰ方案组获ＰＲ２７例,ＳＤ１６例,ＰＤ１２例,死亡１例,有效率按意向性治疗分析（ＩＴＴ）为４５.０％,按符合方案分析（ＰＰ）为４８.２％,中位生存时间为１１.２个月,１年生存率为４６.４％;ＧＰ方案组获ＰＲ１０例,ＳＤ９例,ＰＤ７例,有效率按ＩＴＴ为３５.７１％,按ＰＰ为３８.５％,中位生存时间为１１.８个月,１年生存率为４６.２％。两组主要不良反应为血液学毒性、消化道反应、疲乏和脱发,ＩＰ方案组腹泻、疲乏、脱发的发生率高于ＧＰ方案组,血小板减少发生率低于ＧＰ方案组（Ｐ＜０.０５）。结论　ＩＰ方案和ＧＰ方案治疗晚期ＮＳＣＬＣ的疗效确切且无显著差异,毒副反应均可耐受。     

NP与GP方案治疗晚期非小细胞肺癌68例疗效分析

为了评价NP和GP方案治疗晚期非小细胞肺癌的疗效和不良反应。将1999年12月2日～2004年5月2日收治的68例非小细胞肺癌(nonsmallcelllungcancer,NSCLC)患者随机分为两组,分别应用NP和GP方案治疗。NP方案:长春瑞滨(NVB)25mg/m2,d1、d8;顺铂(DDP)50mg,d3～d5。GP方案:健择(Gemcitabine)1000mg/m2,d1、d8;DDP50mg,d3～d5,两种方案均21d为1个周期,至少治疗2个周期。结果为NP组35例,无CR,PR17例(48.6%),SD13例(37.1%),PD5例(14.3%),总有效率为48.6%(17/35),临床受益率85.7%(30/35)。GP组33例,CR1例(3.0%),PR14例(42.4%),SD13例(39.4%),PD5例(15.2%),总有效率为45.5%(15/33),临床受益率84.8%(28/33)。NP组和GP组中位进展时间分别为3.2和3.3个月,初治优于复治(NP组60%vs33%,GP组52.6%vs35.7%)。剂量限制性毒性主要为骨髓抑制,NP组和GP组白细胞及血小板下降的发生率分别为80%、22.9%和51.5%、51.5%。NP组静脉炎及胃肠道反应较GP组重(31.4%vs6.1%和57.1%vs45.5%)。初步研究结果提示,NP和GP方案治疗晚期NSCLC均安全有效,疗效相当,不良反应均可耐受。     

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.     

Irinotecan monotherapy offers advantage over combination therapy with irinotecan plus cisplatin in second-line setting for treatment of advanced gastric cancer following failure of fluoropyrimidine-based regimens

The optimal regimen of chemotherapy for gastric cancer in a second-line setting remains to be clarified. The aim of this retrospective study was to evaluate the efficacy and safety of second-line irinotecan treatment. A total of 134 patients with gastric cancer who had received prior chemotherapy with fluoropyrimidine-based regimens were treated with irinotecan (150 mg/m(2) on days 1 and 15) alone every 4 weeks (Arm I) or irinotecan (70 mg/m(2) on days 1 and 15) plus cisplatin (80 mg/m(2) on day 1) every 4 weeks (Arm IP) between April, 2004 and March, 2009. Patient characteristics, response rate, progression-free survival, overall survival and safety were investigated. Of 134 patients with recurrent or unresectable gastric cancer, 92 were treated in Arm I and 42 patients in Arm IP. Overall response rate in Arm I was 8.1%, compared with 20.0% in Arm IP (P=0.65). Median progression-free survival (Arm I vs. IP; 2.6 vs. 2.7 months, P=0.73) and median overall survival (Arm I vs. IP; 9.8 vs. 8.0 months, P=0.67) did not differ between the two treatment groups. Neutropenia, leukopenia and anorexia were the most common grade 3/4 adverse events, occurring significantly more frequently in Arm IP than in Arm I (P<0.05). Irinotecan may be a key agent, and serial irinotecan monotherapy is more beneficial as compared to irinotecan plus cisplatin in the treatment of advanced gastric cancer in second-line settings. Irinotecan monotherapy is beneficial compared to irinotecan plus cisplatin in second-line settings for the treatment of advanced gastric cancer refractory to fluoropyrimidine-based regimens.     

依立替康/顺铂与吉西他滨/顺铂方案一线治疗晚期非小细胞肺癌随机对照临床研究

背景与目的:晚期非小细胞肺癌仍以全身化疗为主,吉西他滨为第三代化疗药物,其与铂类联合治疗晚期非小细胞肺癌已广泛应用,依立替康加铂类一线治疗晚期非小细胞肺癌疗效问题国内尚未见随机研究报道。本研究采用前瞻性开放性随机对照研究方法,评价依立替康(irinotecan,CPT-11)联合顺铂(IP方案)与吉西他滨(gemcitabine,GEM)联合顺铂(GP方案)一线治疗晚期非小细胞肺癌的近期疗效和毒副反应。方法:63例患者随机采用IP或GP方案化疗。IP组:CPT-11 100 mg/m2,第1、8天;DDP 25 mg/m2,第1~3天。GP组:GEM1 000mg/m2,第1、8天;DDP 25 mg/m2,第1~3天。化疗至少2周期后评价疗效及不良反应。结果:IP组31例,PR 11例,SD 12例,PD 5例,在全样本疗效分析(ITT分析)时有效率35.5%,在有效样本疗效分析(PP分析)时有效率39.3%。GP组32例,PR 11例,SD 14例,PD 6例,在ITT分析时有效率34.4%,在PP分析时有效率35.5%;PFS时间IP组为4个月,GP组为4.2个月;两组比较差异均无显著性(P>0.05)。不良反应有所不同,IP组腹泻发生率为48.4%,与GP组差异有显著性(P<0.001)。GP组WBC减少发生率略低于IP组,但血小板下降发生率高于IP组,与IP组相比,差异有显著性(P<0.05).结论:依立替康或吉西他滨联合DDP一线治疗晚期NSCLC具有较好的耐受性和临床疗效,两者近期疗效比较差异无显著性,IP组不良反应以WBC下降和腹泻为主,GP组不良反应以WBC下降和血小板下降为主,但都可以耐受。     

TC方案与NP方案治疗非小细胞肺癌的随机对照研究

 目的 比较TC方案与NP方案治疗初治中晚期非小细胞肺癌（NSCLC）的近期疗效和毒副反应。方法 85例Ⅲa～Ⅳ期NSCLC患者随机分为：（1）TC组43例：紫杉醇135～175 mg／m2静脉滴注3 h，第1天；顺铂30 mg／m2静脉滴注，第2 ~ 4天，或卡铂按AUC=6静脉滴注，第2天；（2）NP组42例，长春瑞滨25 mg／m2静脉滴注，第1、5天，顺铂30 mg／m2静脉滴注，第1 ~ 3天。两方案均是每21 d为1周期，每例至少化疗2个周期。结果 TC组的总有效率和中位缓解期分别为41.9 %和4.3个月，而NP组为38.1 %和4.1个月，两组间的差异无统计学意义（均P＞0.05）。TC组和NP组的白细胞减少率各为85.9 %和95.9 %（P＞0.05）；TC组的肢端感觉异常和肌肉关节酸痛发生率均高于NP组（均P＜0.05），而NP组的恶心呕吐发生率高于TC组（P＜0.05）。结论 TC方案和NP方案治疗中晚期初治NSCLC的近期疗效相近，两个方案的主要毒副反应均为骨髓抑制和恶心呕吐，患者耐受性都较好。     

铂类为基础的3种化疗方案治疗晚期非小细胞肺癌

目的 :观察 3种常用的抗癌药 (长春瑞滨、吉西他滨和紫杉醇 )联合铂类方案治疗晚期非小细胞肺癌的疗效及毒副反应。方法 :经组织学证实的 70例晚期非小细胞肺癌患者 ,分为 3组化疗。PC组 :紫杉醇 135mg/m2 ,静滴 3小时 ,第 1天 ,卡铂按药时曲线下面积 (AUC)等于 5计算 ,静滴 ,第 2天 ,每 3周为一周期 ;NP组 :长春瑞宾2 5mg/ (m2·d)静注 ,第 1、8天 ,顺铂 75mg/m2 静滴 ,第 1天 ,每 3周为 1周期 ;GP组 :吉西他滨 10 0 0mg/ (m2 ·d)静滴 30分钟第 1、8、15天 ,顺铂 75mg/m2 静滴第 1天 ,每 4周为一周期。连续应用 2周期后评价疗效及不良反应。结果 :PC组 (n =2 4 )总有效率 (10 / 2 4 ) 4 1.7% ;NP组 (n =2 5 )总有效率 (10 / 2 5 ) 4 0 % ;GP组 (n =2 1)总有效率 (9/ 2 1) 4 2 .9% ,各组间比较总有效率差异无统计学意义 (P >0 .0 5 ) ;毒副反应方面 ,3组白细胞下降及贫血相近 ,NP组血小板降低较其他两组轻 ,PC组胃肠道反应及肾功能损害较其他两组轻 ,但外周神经毒性较其他两组多。结论 :作为晚期非小细胞肺癌一线治疗 ,PC、NP、GP 3种方案疗效相似 ,但 3种方案毒性存在差异 ,应根据患者个体情况进行选择。     

长春瑞宾联合顺铂或顺铂/丝裂霉素一线治疗不可手术非小细胞肺癌

目的比较长春瑞宾联合顺铂和丝裂霉素(MNP)和长春瑞宾联合顺铂(NP)一线治疗晚期非小细胞肺癌(NSCLC)的疗效与安全性.方法65例经细胞学或病理确诊的NSCLC患者分别接受MNP或NP方案化疗.长春瑞宾25 mg/m2静注,d18 c;顺铂为75 mg/m2,静脉滴注d1;MNP方案中丝裂霉素用法为6 mg/m2,静注第1天.两方案均每3周重复,两周期后评价疗效,并随访毒副反应.结果两组中位化疗周期数均为3.NP组PR为11例,总体有效率为33%;PD 5例(15%);MNP组PR为12例(38%),PD为5例(16%),与NP组相比,差异无显著性(P＞0.05).常见副反应有白细胞减少、贫血、便秘、恶心、呕吐等.MNP组Ⅲ与Ⅳ度白细胞减少症发生率高达41%;有3例因中性粒细胞减少并发感染而发热,其中1例死亡.NP与MNP组中位生存期分别为12与11个月,差异无统计学意义.结论长春瑞宾联合顺铂和丝裂霉素一线治疗晚期NSCLC在疗效上不优于长春瑞宾联合顺铂,毒副反应增加;不应作为晚期NSCLC的常规一线方案.     

Randomised phase II study of docetaxel/cisplatin vs docetaxel/irinotecan in advanced non-small-cell lung cancer: a West Japan Thoracic Oncology Group Study (WJTOG9803)

Docetaxel plus cisplatin and docetaxel plus irinotecan are active and well-tolerated chemotherapy regimens for advanced non-small-cell lung cancer (NSCLC). A randomised phase II study compared their efficacy and toxicity in 108 patients with stage IIIb/IV NSCLC, who were randomised to receive docetaxel 60 mg m(-2) and cisplatin 80 mg m(-2) on day 1 (DC; n=51), or docetaxel 60 mg m(-2) on day 8 and irinotecan 60 mg m(-2) on day 1 and 8 (DI; n=57) every 3 weeks. Response rates were 37% for DC and 32% for DI patients. Median survival times and 1- and 2-year survival rates were 50 weeks (95% confidence interval: 34-78 weeks), 47 and 25% for DC, and 46 weeks (95% confidence interval: 37-54 weeks), 40 and 18% for DI, respectively. The progression-free survival time was 20 weeks (95% confidence interval: 14-25 weeks) with DC and 18 (95% confidence interval: 12-22 weeks) with DI. Significantly more DI than DC patients had grade 4 leucopenia and neutropenia (P<0.01); more DC patients had grade >/=2 thrombocytopenia (P<0.01). Nausea and vomiting was more pronounced with DC (P<0.01); diarrhoea was more common with DI (P=0.01). Three treatment-related deaths occurred in DC patients. In conclusion, although the DI and DC regimens had different toxicity profiles, there was no significant difference in survival.     

Randomized phase II study of gemcitabine plus cisplatin versus etoposide plus cisplatin for the treatment of locally advanced or metastatic non-small cell lung cancer: Korean Cancer Study Group experience

BACKGROUND: Several randomized trials have demonstrated superior response rates and survivals for new agent platinum doublets than for older platinum doublets in advanced non-small cell lung cancer (NSCLC), however, few trials have been performed in Asian populations. Thus, we conducted a randomized study to compare gemcitabine-cisplatin (GP) with etoposide-cisplatin (EP) in Korean patients with advanced NSCLC. METHODS: Patients with histologically confirmed, locally advanced or metastatic NSCLC were randomized to receive either gemcitabine 1250 mg/m2 on days 1 and 8 plus cisplatin 75 mg/m2 on day 1, or etoposide 100 mg/m2 on days 1-3 plus cisplatin 75 mg/m2 on day 1. Treatment was repeated every 21 days in both groups. The primary endpoint was response rate. RESULTS: Between May 2000 and December 2001, 83 patients at 9 Korean centers were enrolled in this study. The GP arm showed a significantly higher response rate (52.6% versus 19.4%; P = 0.002), a longer time to progression (4.3 months in both arms; P = 0.018) and a marginally significant prolongation of overall survival (18.3 months versus 10.9 months; P = 0.059) than the EP arm. Grades 3 and 4 thrombocytopenia (18% versus 0%) was more common in the GP arm whereas grades 3 and 4 neutropenia was more common in EP arm (48.7% versus 71.8%). Other toxicities were comparable in both arms. CONCLUSION: GP provided a significantly higher response rate and a longer time to progression than EP and should be considered a standard treatment in advanced NSCLC in Korean population.     

NP和GP方案治疗晚期非小细胞肺癌疗效分析

目的:评价NP和GP两组化疗方案治疗晚期非小细胞肺癌(nonsmallcelllungcancer,NSCLC)的疗效和不良反应。方法:将有明确的病理学和(或)细胞学诊断的63例晚期NSCLC患者分为两组,NP组33例,国产长春瑞滨(盖诺,NVB)25mg/m2,静脉推注,d1、d8;顺铂(DDP)80～90mg/m2,静脉滴入,d1;GP组30例,吉西他滨(健择,GEM)1.25g/m2,静脉滴入,d1、d8;DDP80～90mg/m2,静脉滴入,d1。两组同时配合水化利尿,每21d为1个周期,化疗3个周期后评价疗效,化疗期间记录不良反应。结果:NP与GP方案的有效率分别为36.3%和40.0%,中位生存时间分别为12.2和12.0个月,1年生存率分别为47.2%和43.5%,2年生存率分别为21.1%和17.8%。不良反应主要为血液学毒性和恶心、呕吐。结论:NP和GP两组化疗方案在治疗晚期NSCLC的近期疗效、中位生存期、1年和2年生存率方面相近,化疗不良反应可耐受。     

A randomized phase III trial of oral S-1 plus cisplatin versus docetaxel plus cisplatin in Japanese patients with advanced non-small-cell lung cancer: TCOG0701 CATS trial

BackgroundPlatinum-based two-drug combination chemotherapy has been standard of care for patients with advanced nonsmall-cell lung cancer (NSCLC). The primary aim was to compare overall survival (OS) of patients with advanced NSCLC between the two chemotherapy regimens. Secondary end points included progression-free survival (PFS), response, safety, and quality of life (QoL).Patients and methodsPatients with previously untreated stage IIIB or IV NSCLC, an Eastern Cooperative Oncology Group performance status of 0–1 and adequate organ function were randomized to receive either oral S-1 80 mg/m²/day on days 1–21 plus cisplatin 60 mg/m² on day 8 every 4–5 weeks, or docetaxel 60 mg/m² on day 1 plus cisplatin 80 mg/m² on day 1 every 3–4 weeks, both up to six cycles.ResultsA total of 608 patients from 66 sites in Japan were randomized to S-1 plus cisplatin (n = 303) or docetaxel plus cisplatin (n = 305). OS for oral S-1 plus cisplatin was noninferior to docetaxel plus cisplatin [median survival, 16.1 versus 17.1 months, respectively; hazard ratio = 1.013; 96.4% confidence interval (CI) 0.837–1.227]. Significantly higher febrile neutropenia (7.4% versus 1.0%), grade 3/4 neutropenia (73.4% versus 22.9%), grade 3/4 infection (14.5% versus 5.3%), and grade 1/2 alopecia (59.3% versus 12.3%) were observed in the docetaxel plus cisplatin than in the S-1 plus cisplatin. There were no differences found in PFS or response between the two arms. QoL data investigated by EORTC QLQ-C30 and LC-13 favored the S-1 plus cisplatin.ConclusionOral S-1 plus cisplatin is not inferior to docetaxel plus cisplatin and is better tolerated in Japanese patients with advanced NSCLC.Clinical trial numberUMIN000000608.     

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.     

Phase II study of irinotecan plus cisplatin with concurrent radiotherapy for the patients with limited-disease small-cell lung cancer

BACKGROUND: A recently conducted randomized, phase III study that compared irinotecan plus cisplatin (IP) with etoposide plus cisplatin for the patients with extensive disease SCLC revealed a superior median survival rate and a superior 2-year survival rate for the IP combination therapy. Yet there have been few such reports on the patients suffering with limited disease SCLC (LD-SCLC). We conducted a phase II trial to evaluate the efficacy and toxicity of administering IP with concurrent radiotherapy for the patients with LD-SCLC. PATIENTS AND METHODS: Twenty chemotherapy-na?ve patients with LD-SCLC were enrolled in our study. The patients were treated with 40 mg/m(2) irinotecan on days 1, 8 and 15 and with 60 mg/m(2) cisplatin on day 1 every 4 weeks until a maximum of six cycles was delivered. Once-daily radiotherapy included the administration of 50.4 Gy in 28 fractions. After completion of the radiation therapy, the dose of irinotecan was increased to 60 mg/m(2). RESULTS: The response rate was 85% (CR: 6; partial response, PR: 11). The median survival was 20.0 months (95% CI: 15.6-24.4 months) with 1-year and 2-year overall survival rates of 85 and 35%, respectively. The median progression free survival (PFS) was 12 months (95% CI: 6.2-18.1 months) with a 1-year PFS of 36%. The major hematologic toxicities of this regimen were neutropenia (60%), leukopenia (55%), anemia (20%) and thrombocytopenia (10%). The non-hematologic toxicities were nausea/vomiting (55%), diarrhea (35%) and dysphagia (15%). CONCLUSIONS: Our data show that IP with concurrent radiotherapy is an effective and tolerable regimen for the treatment of LD-SCLC and these findings warrant further investigation.     

NP与TP及GP方案治疗晚期非小细胞肺癌的近期疗效观察

目的比较长春瑞滨(vinorelbine,NVB)加顺铂(cisplatin,DDP)、紫杉醇(pacli-axe,PTX)联合DDP与吉西他滨(gemcit-abine,dFdC)加DDP分别组成的3种联合方案(NP、TP和GP)治疗晚期非小细胞肺癌(non-smallcelllungcarcinoma,NSCLC)的近期疗效和不良反应。方法NP组102例,TP组133例,GP组100例。NP组NVB25mg/m2,d1、d8;DDP70mg/m2分天给药。TP组PTX135mg/m2,d1;DDP总量90mg/m2,d2~d6。GP组dFdC1000mg/m2,30min,d1、d8;DDP总量90mg/m2,d2~d6。对临床疗效和不良反应进行对比观察。结果NP组有效率(RR)为42.16%,TP组为45.11%,GP组为47.00%。3组RR比较差异无统计学意义,P>0.05。不良反应均以骨髓抑制、脱发及恶心呕吐为主,均可耐受。GP组血小板降低较其他2组严重,P<0.05。结论NVB、dFdC或PTX联合DDP治疗晚期NSCLC具有较好的耐受性和临床疗效,不良反应可以耐受。应根据患者特点,尽可能选择个体化治疗。     

培美曲塞联合顺铂与长春瑞滨联合顺铂一线治疗晚期NSCLC的对比研究

目的 比较培美曲塞或长春瑞滨联合顺铂一线治疗晚期非小细胞肺癌（NSCLC）的疗效及毒副反应。方法 回顾性分析我院2008年1月至2010年12月收治的68例晚期NSCLC患者,分别接受培美曲塞联合顺铂（PC方案组,32例）或长春瑞滨联合顺铂（NP方案组,36例）一线治疗。PC方案组：培美曲塞500mg／m2,d1;顺铂 25mg／m²,d₁～d₃。NP方案组：长春瑞滨 25mg／m²,d₁、d₈,顺铂25mg／m²,d₁～d₃。每3周为1周期,每2个周期评价疗效。结果 所有患者均可评价近期疗效。两组均无完全缓解病例,PC方案组与NP方案组的有效率（RR）分别为40.6%（13/32）和36.1%（13/36）,疾病控制率（DCR）分别为71.9%（23/32）和61.1%（22/36）,两组RR和DCR的差异均无统计学意义（P＞0.05）。两组中位疾病进展时间（TTP）分别为6.2和5.2个月,组间差异无统计意义（P＞0.05）。NP方案组3～4级白细胞减少、中性粒细胞减少的发生率高于PC方案组（P＜0.05）。 结论 培美曲塞联合顺铂与长春瑞滨联合顺铂一线治疗晚期NSCLC的疗效相当,但培美曲塞的毒副反应较少。     

三种化疗方案治疗晚期非小细胞肺癌的疗效分析

目的:评价MVP(MMC VDS PDD)、NP(Vinorelbine PDD)、TP(Paclitaxel PDD)三种化疗方案治疗晚期非小细胞肺癌的疗效.方法:114例晚期非小细胞肺癌患者分为3组,MVP组36例,MMC(丝裂霉素)8mg/m2,静脉推注,d1;Vindesine(长春地辛)3mg/m2,静脉点滴,d1,8;PDD(顺铂)80mg/m2,静脉点滴,d3.NP组4l例,Vinorelbine(长春瑞宾)25mg/m2,静脉点滴,d1,8,PDD 80mg/m2,静脉点滴,d3.TP组37例,Paclitaxel(紫杉醇)175mg/m2,静脉点滴,d1,PDD 80mg/m2,静脉点滴,d3.每4周为1周期,至少2周期.结果:MVP、NP及TP的有效率分别为33.2%、34.1%、40.5%;中位生存期分别为8.2个月、7.1个月、9.1个月;1年生存率分别为30.5%、34.1%、37.8%.主要不良反应MVP组为骨髓抑制及恶心、呕吐;NP组为骨髓抑制、恶心、呕吐及静脉炎;TP组为骨髓抑制、恶心、呕吐、肌肉关节疼痛及脱发.结论:MVP、NP及TP化疗方案在治疗晚期非小细胞肺癌的有效率、中位生存期及1年生存率相似,毒性可耐受.     

Randomized phase 2 study of irinotecan plus cisplatin versus gemcitabine plus vinorelbine as first-line chemotherapy with second-line crossover in patients with advanced nonsmall cell lung cancer

BACKGROUND: The current study was performed to compare the nonplatinum-based combination of gemcitabine and vinorelbine (GV) with the combination of irinotecan and cisplatin (IP) as first-line chemotherapy with second-line crossover in patients with advanced nonsmall cell lung cancer (NSCLC). METHODS: Patients were randomly assigned to received either irinotecan at a dose of 65 mg/m(2) plus cisplatin at a dose of 30 mg/m(2) (Arm A) or gemcitabine at a dose of 900 mg/m(2) plus vinorelbine at a dose of 25 mg/m(2) (Arm B), each of which was administered on Days 1 and 8 every 3 weeks as the first-line therapy followed by crossover at the time of disease progression. RESULTS: A total of 146 patients were enrolled (75 patients in Arm A and 71 patients in Arm B); 138 patients were evaluable for tumor response and toxicity. During first-line therapy, IP was found to result in more grade 2+ nausea and vomiting (toxicity was graded according to the National Cancer Institute Common Toxicity Criteria [version 2.0]) (41% vs 12%; P = .0001) and alopecia (36% vs 10%; P = .0003). Pneumonitis was noted only with GV therapy (7% vs 0%; P = .058). During second-line therapy, IP was found to result in more grade 3 diarrhea (17% vs 2%; P = .039) and GV featured more cases of grade 3+ neutropenia (78% vs 40%; P = .0003). IP tended to generate more tumor responses (38% vs 26% as first-line therapy, and 30% vs 13% as second-line therapy) compared with GV. IP also demonstrated a favorable trend in median progression-free survival (4.6 months vs 3.8 months as first-line therapy and 4.5 months vs 2.6 months as second-line therapy) and overall survival (15.9 months vs 13.1 months; P = .3), but this difference was not statistically significant. The majority of patients who were refractory to IP also failed to respond to GV in the second-line setting. CONCLUSIONS: The platinum-based IP regimen appeared to be superior to the GV combination in terms of response rate. However, given the similar survival and better tolerability of the nonplatinum GV regimen, either treatment sequence would appear to be acceptable for the treatment of patients with advanced NSCLC.     

Randomized, multinational, phase III study of docetaxel plus platinum combinations versus vinorelbine plus cisplatin for advanced non-small-cell lung cancer: the TAX 326 study group.

PURPOSE: To investigate whether docetaxel plus platinum regimens improve survival and affect quality of life (QoL) in advanced non-small-cell lung cancer (NSCLC) compared with vinorelbine plus cisplatin as first-line chemotherapy. PATIENTS AND METHODS: Patients (n = 1,218) with stage IIIB to IV NSCLC were randomly assigned to receive docetaxel 75 mg/m2 and cisplatin 75 mg/m2 every 3 weeks (DC); docetaxel 75 mg/m2 and carboplatin area under the curve of 6 mg/mL * min every 3 weeks (DCb); or vinorelbine 25 mg/m2/wk and cisplatin 100 mg/m2 every 4 weeks (VC). RESULTS: Patients treated with DC had a median survival of 11.3 v 10.1 months for VC-treated patients (P =.044; hazard ratio, 1.183 [97.2% confidence interval, 0.989 to 1.416]). The 2-year survival rate was 21% for DC-treated patients and 14% for VC-treated patients. Overall response rate was 31.6% for DC-treated patients v 24.5% for VC-treated patients (P =.029). Median survival (9.4 v 9.9 months [for VC]; P =.657; hazard ratio, 1.048 [97.2 confidence interval, 0.877 to 1.253]) and response (23.9%) with DCb were similar to those results for VC. Neutropenia, thrombocytopenia, infection, and febrile neutropenia were similar with all three regimens. Grade 3 to 4 anemia, nausea, and vomiting were more common (P <.01) with VC than with DC or DCb. Patients treated with either docetaxel regimen had consistently improved QoL compared with VC-treated patients, who experienced deterioration in QoL. CONCLUSION: DC resulted in a more favorable overall response and survival rate than VC. Both DC and DCb were better tolerated and provided patients with consistently improved QoL compared with VC. These findings demonstrate that a docetaxel plus platinum combination is an effective treatment option with a favorable therapeutic index for first-line treatment of advanced or metastatic NSCLC.     

奥沙利铂加长春瑞滨与顺铂加长春瑞滨治疗晚期非小细胞肺癌的随机对照研究

目的探索奥沙利铂＋长春瑞滨（NL方案）与顺铂＋长春瑞滨（NP方案）治疗晚期非小细胞肺癌（NSCLC）的疗效、不良反应及患者的生活质量。方法可评价疗效的NSCLC患者以2：1比例随机分入治疗组与对照组。治疗组70例,化疗方案为长春瑞滨25mg／m^2静脉冲入,第1。8天;奥沙利铂130mg／m^2静脉滴注,第2天;21d为1个周期。对照组32例,化疗方案为顺铂80mg／m^2静脉滴注,分2—3d给予;长春瑞滨用法同治疗组。结果治疗组与对照组的有效率分别为35．7％和43．8％（P=0．4）,中位肿瘤进展时间分别为4．7个月和5．5个月（P=0．6）,1年生存率分别为38．5％和58．6％（P=0．07）。治疗组Ⅰ-Ⅱ度感觉异常发生率为68．4％,显著高于对照组的36．4％（P：0．0017）;而治疗组I一Ⅱ度粒细胞减少率为49．4％,显著低于对照组的70．6％（P：0．037）。两组患者各项生活质量评分差异无统计学意义。结论奥沙利铂＋长春瑞滨治疗晚期NSCLC疗效确切,患者耐受性良好,为晚期NSCLC的治疗提供了一种新的选择。