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1.
A phase I study combining a fixed dose of gemcitabine with differing doses of CPT-11 every two weeks for previously treated non-small cell lung cancer (NSCLC) patients. PATIENTS AND METHODS: A total of 21 patients with previously treated non-small cell lung cancer were treated every two weeks with CPT-11 followed by gemcitabine. The gemcitabine dose was fixed at 1000 mg/m2. The starting dose of CPT-11 (50 mg/m2) was then escalated different patients in 25 mg/m2 increments until 150 mg/m2 (level 5), the recommended dose as a single agent in Japan. RESULTS: Dose-limiting toxicity was only observed at level 5, in three of nine patients receiving the highest dose of CPT-11. One patient had grade 3 diarrhea, and two could not continue chemotherapy with grade 1 diarrhea or grade 1 neutropenia on day 15. Hematologic toxicity with this combination regimen, however, was generally mild. No grade 4 neutropenia, and only one case of grade 3 leukopenia was noted at level 5. Compliance with the combination regimen was good and there was no cumulative toxicity with the subsequent courses. Twenty-five courses of therapy were given at level 5 and the percentage of actual delivered doses/planned doses was 82%. CONCLUSIONS: The combination chemotherapy has only very mild toxicity and dose which can be recommended with this regimen are 1000 mg/m2 for gemcitabine and 150 mg/m2 for CPT-11 every two weeks.  相似文献   

2.
长春瑞滨加奥沙利铂治疗晚期非小细胞肺癌的临床研究   总被引:1,自引:0,他引:1  
目的观察长春瑞滨(Vinorelbine,商品名:盖诺)加奥沙利铂(Oxaliplatin,商品名:艾恒)联合化疗治疗晚期非小细胞肺癌(NSCLC)的临床效果和毒副反应.方法 26例晚期非小细胞肺癌患者采用盖诺25 mg/m2静脉推注,第1、8天;艾恒130 mg/m2,静脉滴注4 h,第1天,21~28 d重复.结果全组部分缓解(PR)9例,稳定(SD)12例,进展(PD)5例,总有效率(RR)为34.6%.主要毒副反应为骨髓抑制(Ⅲ~Ⅳ度白细胞减少发生率为42.3%)、神经毒性(80.8%)及恶心呕吐(42.3%)等.结论长春瑞滨加奥沙利铂联合化疗方案治疗晚期非小细胞肺癌的疗效较高,耐受性好,值得临床进一步研究.  相似文献   

3.
PURPOSE: To assess the efficacy and toxicity of 6-hydroxymethylacylfulvene (HMAF; MGI-114, irofulven) as therapy for relapsed or refractory non-small cell lung cancer. METHODS: A two-stage phase II design was employed separately for refractory and relapsed patients to differentiate between ineffective treatment (response rate < or =10%) and active treatment (response rate > or =30%). Eligible patients received HMAF 11 mg/m2 per day intravenously over 5 min on days 1-5, with cycles repeated every 28 days. RESULTS: Thirty-six patients (15 relapsed; 21 refractory) were treated, and no responses were seen. TOXICITY: Grade 3 neutropenia and grade 3 thrombocytopenia each occurred in 11% of the patients. Grade 3 nausea occurred in 47%; grade 3-4 vomiting in 42%. Twenty-two percent developed grade 3 fatigue. Eleven percent developed grade 3 hallucinations. CONCLUSIONS: HMAF, administered at this dose and schedule, is not active as salvage therapy for relapsed or refractory non-small cell lung cancer.  相似文献   

4.
目的:分析伽马刀联合复方红豆杉胶囊治疗高龄晚期非小细胞肺癌的疗效。方法:2008年1月至2011年11月期间,我院收治的高龄晚期非小细胞肺癌15例采用伽马刀治疗+复方红豆杉胶囊0.6g口服3次/日,21天为1疗程,此后每月按疗程连续口服。伽马刀治疗以50%~80%等剂量曲线为处方剂量线,平均剂量(45.1667±4.7346)Gy/(6~14)f,3.5~8Gy/f,5f/w,1f/d。治疗结束后,每1~3月复查血常规、血生化、肿瘤标志物及影像学检查。随访3~60个月至2013年9月结束。结果:局部有效率(CR+PR)95.83%,中位生存期18个月(6~60个月),1、2、3、4、5年生存率分别为66.7%、33.3%、33.3%、6.7%、6.7%。消化道反应:I度1例、II度3例;血液学毒性:白细胞降低I度2例、II度1例,血小板降低I度1例、II度1例;放射性肺炎III级9例。结论:伽马刀联合复方红豆杉胶囊治疗高龄晚期非小细胞肺癌有效,可延长患者生存期,不良反应可接受。  相似文献   

5.
目的评价紫杉醇脂质体联合顺铂治疗晚期非小细胞肺癌的临床疗效和不良反应。方法紫杉醇脂质体(135mg/m2,静脉滴注3h,第1天)联合顺铂(25mg/m2,静脉滴注,第1~3天)治疗,每21天为1个周期,每化疗2个周期按RECIST标准评价疗效。结果全组43例患者共接受138个周期化疗,CR0例,PR16例,SD20例,PD7例,总有效率为37.2%,不良反应主要为骨髓抑制、胃肠道反应、周围神经毒性。骨髓抑制以白细胞减少为主,Ⅲ~Ⅳ级发生率为32.6%,胃肠道反应及周围神经毒性症状均较轻,全组无过敏反应发生,无治疗相关性死亡。结论紫杉醇脂质体联合顺铂治疗晚期非小细胞肺癌的疗效确切,不良反应轻,值得临床推广。  相似文献   

6.
目的 探讨调强放疗结合培美曲赛和顺铂同期化疗局部晚期非小细胞肺癌的疗效及副反应.方法 42例Ⅲ期非小细胞肺癌患者(ⅢA期25例,ⅢB期17例)接受DT66 Cy调强放疗,疗中给予培美曲塞500 mg/m2静脉滴注第1天,顺铂75 mg/m2静脉滴注第1天,21 d为1个周期,共4个周期.放化疗在同大开始进行,先化疗后放疗.2例放疗总量54 Gy,2例56 Gy;3例完成了2周化疗,1例完成了 3周化疗.结果 34例患者完成了治疗计划.全组总有效率为79%,1年总生存率为65%.≥3级骨髓抑制2例,3级放射性食管炎3例,≥2级放射性肺炎4例,3级黏膜炎1例.结论 培美曲赛和顺铂同期放化疗局部晚期非小细胞肺癌患者具有较好的近期疗效,副反应可耐受.
Abstract:
Objective To observe the therapeutic effect and toxicity of chemoradiation of locally advanced non-small cell lung cancer by intensity modulated irradiation combined with pemetrexed and cisplatin. Methods Fourty-two patients presented with Ⅲ - stage non-small cell lung cancer(Ⅲ、 25 patients, ⅢB 17 patients)received concurrent chemoradiotherapy. Intensity modulated irradiation technique was used to the total dose of 66 Gy and concurrent chemotherapy consisted of pemetrexed 500 mg/m2 on Day 1 and cisplatin 75 mg/m2 on Day 1 by intravenous infusion once every 3 weeks at the initiation of radiation.Patients received 4 cycles of chemotherapy. Results Thirty-four patients finished the whole of therapeutic schedule. And 2 patients received radiation with total dose of 54 Gy, 2 patients 56 Gy;3 patients received 2 cycles of chemotherapy, 1 patients 3 cycles of chemotherapy. Total effective rate was 79%. There were 2 patients with ≥3 grade marrow depression, 3 patients with 3 grade radiation esophagitis, 4 patients with ≥2 radiation pneumonitis, and 1 patient with 3 grade mucositis. The 1-year survival rate was 65%.Conclusion Recent effect was favourable and toxicity was tolerable for chemoradiation of locally advanced non-small cell lung cancer by intensity modulated irradiation combined with pemetrexed and cisplatin.  相似文献   

7.
PURPOSE: Squalamine is an antitumor agent that has been shown to have antiangiogenic activity in animal models. This Phase I/IIA study was designed to assess the safety, clinical response, and pharmacokinetics of squalamine when administered as a 5-day continuous infusion in conjunction with standard chemotherapy every 3 weeks in patients with stage IIIB (pleural effusion) or stage IV non-small cell lung cancer. EXPERIMENTAL DESIGN: Patients with chemotherapy-naive non-small cell lung cancer were treated with escalating doses of squalamine in combination with standard doses of paclitaxel and carboplatin. Paclitaxel and carboplatin were administered on day 1, followed by squalamine as a continuous infusion on days 1-5, every 21 days. RESULTS: A total of 45 patients were enrolled (18 patients in the Phase I dose escalation arm and 27 in the Phase IIA arm). The starting dose of squalamine was 100 mg/m(2)/day and escalated to 400 mg/m(2)/day; two of three patients at 400 mg/m(2)/day had dose-limiting toxicity that included grade 3/4 arthralgia, myalgia, and neutropenia. On the basis of safety and toxicity, 300 mg/m(2)/day was selected as the Phase II dose of squalamine in this combination regimen. An additional 27 patients (a total of 33) were enrolled according to the protocol treatment schema at 300 mg/m(2)/day. There was no pharmacokinetic evidence of drug interactions for the combination of squalamine, carboplatin, and paclitaxel. Forty-three patients were evaluable for response. Partial tumor responses were observed in 12 (28%) of these patients; an additional 8 evaluable patients (19%) were reported to have stable disease. For all of the patients treated, the median survival was 10.0 months; and 1-year survival was 40%. CONCLUSIONS: The combination of squalamine given continuously daily for 5 days, with paclitaxel and carboplatin given on day 1, is well tolerated. Patient survival data and the safety profile of this drug combination suggests that the use of squalamine given at its maximum tolerated dose with cytotoxic chemotherapy should be explored further as a potentially effective therapeutic strategy for patients with stage IIIB or IV non-small cell lung cancer.  相似文献   

8.
AIMS AND BACKGROUND: Based on the results of a preclinical study, a phase I trial was conducted to evaluate the feasibility of administering docetaxel followed by gemcitabine in non-small cell lung cancer patients. STUDY DESIGN: Sixteen patients with advanced non-small cell lung cancer (stages III B-IV) were treated on the 1st day with docetaxel and on the 8th day with gemcitabine. Treatment was repeated every three weeks for a maximum of six cycles. Five groups received docetaxel/gemcitabine (mg/ml): 50/800, 60/800, 60/900, 60/1,000, 70/1,000. All patients and 57 cycles were assessed for toxicity. RESULTS: The most important side effects were grade IV neutropenia in 4 patients (2 at the 60/1000 level and 2 at the 70/1000 level) and grade III leukopenia and neutropenia without fever in 4 and 6 patients, respectively. Maximum tolerated dose was not reached. CONCLUSIONS: The sequence docetaxel-gemcitabine appears well tolerated and easy to administer. For this reason, a phase II study is ongoing to fully assess its antitumor activity.  相似文献   

9.
目的:研究抗肿瘤新生血管生成抑制剂重组人血管内皮抑制素(恩度)联合治疗晚期非小细胞肺癌的临床疗效和毒性反应。方法:30例非小细胞肺癌均为ⅢB~Ⅳ期患者,初治或复治,采用化疗等联合恩度治疗,化疗采用常规方案,恩度15mg/次,每日1次,连续14天,每月重复使用。30例病理类型为:腺癌22例,鳞癌2例,其它类型6例;恩度联合一线化疗者5例,恩度联合二线化疗者15例,恩度联合三线及以上治疗者10例。结果:全组30例有效率(CR+PR)为26.6%,临床受益率(CBR)为79.9%;中位TTP3.6个月。使用恩度1个疗程有8例,中位生存期2.5个月;2~3个疗程14例,中位生存期3个月;4~5个疗程6例,中位生存期5.5个月;≥6个疗程2例,中位生存期9个月。毒副反应主要为食欲不振,疲乏,轻度的心脏毒副反应,包括心悸、胸闷、早搏等。其他为化疗相关的毒副反应如骨髓抑制和Ⅰ~Ⅱ度的胃肠道及外周神经毒性。结论:恩度联合化疗安全有效,耐受性好,毒副反应以Ⅰ~Ⅱ度为主,初治与复治均有效果,有效患者长期使用获益更大。  相似文献   

10.
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。  相似文献   

11.
BACKGROUND: The combination of paclitaxel (225 mg/m(2), 3 h infusion) and carboplatin [area under the curve (AUC) 6 mg/ml x min] is used widely for non-small cell lung cancer in the USA and is one of the standard regimens in the Southwest Oncology Group. In Japan, however, the upper limit of the approved dose for single-use paclitaxel is 210 mg/m(2) and the optimum dose of this agent in combination with carboplatin has not yet been established. This study was designated to determine whether the paclitaxel dose of 225 mg/m(2 ) plus carboplatin (AUC = 6) is tolerable for Japanese patients with untreated advanced non-small cell lung cancer. METHODS: Ten patients were enrolled between October 1999 and June 2000 and all of these patients were evaluable for toxicity. Chemotherapy consisted of carboplatin (AUC = 6 mg/ml x min) and 225 mg/m(2 )of paclitaxel on day 1 every 3 weeks. RESULTS: Neutropenia was the major toxicity and grade 4 neutropenia was observed in seven of the 10 patients (70%), but febrile neutropenia was not observed. Grade 4 anemia as a dose-limiting toxicity was observed in two patients. This was due to gastric ulcer bleeding in both patients. Only one patient experienced grade 3 peripheral neuropathy. No grade 3 or more myalgia or arthralgia was reported. Overall, 44 courses of chemotherapy were administered in 10 patients. Partial responses were observed in six of the 10 patients (60%). Median survival time was 7.7 months. CONCLUSION: Paclitaxel at 225 mg/m(2) in a 3 h infusion and carboplatin AUC = 6 appears to be tolerable in Japanese patients with untreated advanced non-small cell lung cancer.  相似文献   

12.
目的评估吉西他滨联合顺铂治疗晚期非小细胞肺癌的近期疗效和安全性。方法对33例晚期非小细胞肺癌患者采用吉西他滨1000 mg/m2,静滴,第1、8天;顺铂35 mg/m2,静滴,第1、2天。3周为1个周期,2个周期后进行一次疗效评价。结果33例患者中完全缓解(CR)0例,部分缓解(PR)14例,稳定(SD)14例,进展(PD)5例,总有效率(CR PR)为42.4%。初治优于复治(54.2%对11.1%,P=0.030)。中位疾病进展时间(TTP)5.2个月。本方案的主要毒副作用是Ⅲ/Ⅳ度血小板减少和胃肠道反应。结论吉西他滨联合顺铂3周方案治疗晚期非小细胞肺癌患者具有良好的疗效和较低的毒副作用。  相似文献   

13.
目的研究培美曲塞(PEM)联合顺铂对比吉西他滨(GEM)联合顺铂的一线治疗晚期非小细胞肺癌的有效性和安全性。方法 2006年10月至2008年10月,50例晚期非小细胞肺癌按随机数字表随机分为PEM组和GEM组各25例,PEM组给予PEM500mg/m2,d1;DDP75mg/m2,d1、2、3。GEM组给予GEM1000mg/m2,d1、8,DDP75mg/m2,d1、2、3,均为21d一周期,至少完成2周期化疗后评价两组的有效率、不良反应、疾病进展时间(TTP)和总生存时间(OS)。结果两组患者均可评价疗效,PEM组总有效率为44.0%,GEM组为40.0%,两组间差异无显著性(P〉0.100),TTP及OS方面有统计学意义,但毒副反应方面,血液学、消化道生化学毒性,PEM组明显低于GEM组。结论培美曲塞联合顺铂一线治疗晚期非小细胞肺癌有稳定的治疗效果,更低的毒性,更好的耐受性,对非小细胞肺癌中非鳞癌的疗效是否更佳有待进一步研究观察。  相似文献   

14.
Aim:   Two 21-day gemcitabine–carboplatin schedules were evaluated in patients with advanced non-small cell lung cancer in order to assess the effect of timing of the carboplatin dose on toxicity and efficacy.
Methods:   Patients were randomized to gemcitabine (1000 mg/m2 on days 1 and 8 of a 21-day cycle) and carboplatin (AUC 5, on day 1) (Carbo d1 arm) or the same gemcitabine schedule with carboplatin given on day 8 (Carbo d8 arm). Twenty patients with Stage IIIB or IV non-small-cell lung cancer were enrolled in each arm.
Results:   The achieved dose intensities of both gemcitabine and carboplatin were significantly higher in the Carbo d1 arm. The total rates of grade 3 or 4 hematological and non-hematological toxicities (any toxicity, any cycle) were 80% and 65%, respectively, with no significant differences between the two arms. Nine patients in the Carbo d1 arm, but only one patient in the Carbo d8 arm, required a platelet transfusion. There were 10 partial responses (four Carbo d1 arm, six Carbo d8 arm), giving an overall response rate of 25% (95% CI 13–41%).
Conclusion:   Administration of carboplatin on day 8 of this regimen confers no clear advantage compared with day 1 carboplatin, with similar toxicity but lower dose intensity. A formula for the prediction of thrombocytopenia is proposed.  相似文献   

15.
BACKGROUND: A combination of cisplatin and vinorelbine chemotherapy is effective in cases of advanced non-small cell lung cancer, but the optimum administration schedule for both drugs has not yet been defined. The aim of this study was to determine the maximum dose of vinorelbine that can be tolerated while receiving a fixed dose of cisplatin every 3 weeks and to observe the response in Japanese patients with advanced non-small cell lung cancer who had not previously received chemotherapy. METHODS: Cisplatin was given at a dose of 80 mg/m2 on day 1. Vinorelbine was administered on days 1 and 8 at a starting dose of 25 mg/m2 that was then increased by 5 mg/m2 increments. This treatment was repeated every 3 weeks. RESULTS: Twenty-one patients received a total of 54 chemotherapy cycles consisting of three different vinorelbine dosages. Toxicity and efficacy were evaluated in all of the patients. The main dose-limiting toxicity was neutropenia. Grades 3-4 leukopenia and neutropenia were observed in 57% and 86% of all cycles, respectively. These conditions were reversible and did not result in death from toxicity. The most severe non-hematological toxicity symptom was a grade 3 infection and reaction at the site of injection. The maximum tolerated dose of vinorelbine was 35 mg/m2. The objective response was noted in one of six patients at dose level 1, in four of 12 patients at dose level 2 and in two of three patients at dose level 3. CONCLUSION: The recommended doses were 80 mg/m2 for cisplatin and 30 mg/m2 for vinorelbine. The combination of cisplatin and vinorelbine repeated every 3 weeks is well tolerated and has shown promising anti-tumor activity against non-small cell lung cancer.  相似文献   

16.
Encouraging response rates have been reported in Stage III non-small cell lung cancer when 5-fluorouracil (5-FU), etoposide (VP-16), and cisplatin (FED) have been combined with radiation therapy (RT) or RT and surgery. The current study evaluated the effectiveness of FED chemotherapy in 32 patients with metastatic non-small cell lung cancer. Treatment consisted of 5-FU (800 mg/m2/d) on days 1 to 4 by continuous infusion, intravenous (IV) VP-16 (60 mg/m2) over 1 hour on days 1 to 4, and IV cisplatin (60 mg/m2) over 1 hour on day 1. Treatment cycles were repeated every 28 days as toxicity permitted. Partial responses occurred in 7 of 32 patients (22%; 95% confidence limit [CL] 0.09, 0.40), including 6 of 19 patients (32%) with performance status of 0 or 1, and 1 of 13 patients (8%) with performance status of 2 or 3. The median response duration was 5.0 months. Although toxicity was modest and consisted of primarily hematologic and gastrointestinal side effects, this combination does not appear to provide an advantage over other cisplatin combinations in Stage IV non-small cell lung cancer.  相似文献   

17.
GP方案治疗晚期非小细胞肺癌疗效观察   总被引:5,自引:3,他引:2  
目的观察GP方案治疗晚期非小细胞肺癌的疗效与毒性反应。方法60例符合条件的患者接受下述联合方案化疗2周期,吉西他滨1250mg/m2iv d1、8,顺铂25 mg/m2iv d1~3,至少2周期进行评价。结果本组患者总有效率为46.67%;III期及IV期与复发转移者比较疗效均无显著性差别;鳞癌与腺癌比较疗效无显著性差异。毒性反应以骨髓抑制为主,III~IV度白细胞减少发生率61.82%,其中粒细胞减少性发热30.91%。其它不良反应耐受性良好。结论GP方案是治疗晚期非小细胞肺癌有效、耐受性良好的方案。  相似文献   

18.
To determine the activity and toxicity of gemcitabine in non-small cell lung cancer, three phase II studies of single agent gemcitabine have been conducted between 1990 and 1994. In an early phase II study, gemcitabine was administered of 800 mg/m2 on day 1, 8, 15 every four weeks (step I), and 1,000 mg/m2 (step II). Response was observed in 3 of 13 patients with previously untreated non-small cell lung cancer, although there was no responders in the previously treated patients. Late phase II studies were performed at 20 (group A) and 24 (group B) Japanese institutions to confirm the efficacy and safety of gemcitabine administered alone in patients with non-small cell lung cancer. Seventy-three patients (group A) and 67 patients (group B) were entered into these studies. All patients had no previous chemotherapy and had measurable disease. Gemcitabine was administered at a starting dose of 1,000 mg/m2/wk for 3 weeks followed by a week of rest. The dose was escalated to 1,250 mg/m2 if severe toxicity was not seen in the previous course. Nineteen of 73 patients (26%) had a partial response in group A. Of 67 patients, 14 (20.9%) showed a partial response in group B. Grade 3 or greater toxicities included anemia (20.5%) and leukopenia (9.6%) in group A, and in 13.4% and seven 10.4% in group B, respectively. And grade 3 thrombocytopenia was observed in 1.4%. Other toxicities including hepatic toxicity, fatigue, nausea/vomiting, and fever were mild and transient. Pulmonary toxicity was observed in five patients, two of whom died of ARDS. The median durations of response were 19.6 weeks in group A and 20 weeks in group B, and median survival times were 44 and 39 weeks, respectively. In conclusion, gemcitabine is an active agent against non-small cell lung cancer with very mild toxicities. These results suggest that gemcitabine has potential utility in advanced non-small cell lung cancer on an outpatient basis. Further trials in combination with other active agents are warranted.  相似文献   

19.
长春瑞滨联合顺铂治疗晚期非小细胞肺癌38例疗效观察   总被引:1,自引:0,他引:1  
目的观察NP方案治疗晚期非小细胞肺癌的疗效与毒性。方法应用长春瑞滨25mg/m^2静脉点滴,第1,8天,DDP80~100mg/m^2静脉点滴,第1,2天。结果38例无CR,PR16例,NC16例,PD6例,总有效率42.1%。结论长春瑞滨联合顺铂治疗晚期NSCLC有效率高,毒副反应能耐受。  相似文献   

20.
目的观察NP方案治疗晚期非小细胞肺癌的疗效与毒性。方法应用长春瑞滨25 mg/m2静脉点滴,第1,8天,DDP 80~100mg/m2静脉点滴,第1,2天。结果38例无CR,PR 16例,NC 16例,PD 6例,总有效率42.1%。结论长春瑞滨联合顺铂治疗晚期NSCLC有效率高,毒副反应能耐受。  相似文献   

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