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1.
目的 探讨多西他赛联合替吉奥对比多西他赛单药二线冶疗晚期非小细胞肺癌的临床疗效.方法 收集经一线治疗后进展的晚期非小细胞肺癌患者100例,参照抽签法将患者随机分为试验组和对照组,每组各50例.试验组患者行多西他赛(60 mg/m2,静滴1 h,第1天)联合替吉奥(40 mg/m2,早晚饭后各服1次,连服14 d,每3周重复)治疗;对照组患者行多西他赛单药治疗(75 mg/m2,静滴1 h,第1天,每3周重复),所有患者随访至疾病进展或死亡.对比两组患者的临床疗效、生存情况及不良反应发生情况.结果 试验组患者的疾病控制率(72.00%)高于对照组患者(56.00%)(P﹤0.05);两组患者的客观缓解率比较,差异无统计学意义(P﹥0.05);试验组患者的中位无进展生存期为4.6个月(95%CI:3.994~5.206)长于对照组患者的3.1个月(95%CI:2.494~3.706)(P﹤0.05);试验组患者的中位生存期为9.2个月(95%CI:8.871~10.529)长于对照组患者的7.9个月(95%CI:5.575~10.225)(P﹤0.05);两组患者各种不良反应发生率及总不良反应发生率比较,差异均无统计学意义(P﹥0.05).结论 多西他赛联合替吉奥二线治疗晚期非小细胞肺癌的临床疗效优于多西他赛单药治疗.  相似文献   

2.
Docetaxel has been the only single active agent against chemotherapy-pretreated non-small-cell lung cancer (NSCLC). The purpose of this phase II study was to evaluate the efficacy and safety of docetaxel combined with gemcitabine, another effective drug, in patients with NSCLC previously treated with platinum-based chemotherapy. Thirty-three patients were enrolled. Prior chemotherapy was cisplatin combined with etoposide in 24 patients and vinorelbine in 9 patients. Tumors were sensitive (n=15), resistant (n=9), and refractory (n=9) to front-line chemotherapy. Treatment was docetaxel 85 mg/m2 on d 1, and gemcitabine 1200 mg/m2 on d 1 and 8, with cycles repeated every three weeks. Ten patients (30.3%, 95% CI: 15.6–48.7) achieved a partial response and 15 (45.5%) stable disease. Responses were similar frequencies in platinum-sensitive and platinum-resistant/refractory tumors. With a median follow-up period of 5.7 mo (range 1.6–20.0), the median and 6-mo event-free survival were 5.5 mo, 40.6%, respectively. Median and 6-mo over-all survival were 7.3 mo and 52.7%. Patients with progressive disease to chemotherapy (p=0.0008), higher LDH (p=0.005), and NSE levels (p=0.03) survived shorter than other patients. In patients refractory to prior chemotherapy, survival was poor as borderline significantly (p=0.06). The major hematological toxicity was neutropenia. Grade III–IV neutropenia was noted in 14 (42%) patients, with three episodes of febrile neutropenia in 111 cycles. Docetaxel combined with gemcitabine is an active and safe second-line therapy for patients with NSCLC.  相似文献   

3.

Background:

Combination of S-1, an oral fluorouracil derivative, plus docetaxel against non-small cell lung cancer (NSCLC) showed promising efficacy but clinically problematic emesis. A phase I/II study utilising a new schedule for this combination was conducted.

Methods:

A biweekly regimen of docetaxel on day 1 with oral S-1 on days 1–7 was administered to previously treated NSCLC patients. Doses of docetaxel/S-1 were escalated to 30/80, 35/80, and 40/80 mg m−2, respectively, and its efficacy was investigated at the recommended dose below maximum tolerated dose (MTD).

Results:

In phase I study employing 13 patients, dose-limiting toxicities were febrile neutropenia and treatment delay, with the respective MTDs for docetaxel 40 mg m−2/S-1 80 mg m−2. In the phase II study, 34 patients were treated with docetaxel 35 mg m−2/S-1 80 mg m−2 for a median cycle of 6. The response and disease control rates were 34.3% (95% confidence interval (CI), 18.6–50.0%) and 62.9% (95% CI, 46.8–72.9%), respectively. Median progression-free survival was 150.5 days. Haematologic grade 4 toxicities were observed in neutropenia (11.8%) and thrombocytopenia (2.9%). Regarding non-haematologic toxicities, including emesis, there were no grade 3/4 side effects.

Conclusion:

Combination of 1-week administration of S-1 with biweekly docetaxel is safe and active for NSCLC.  相似文献   

4.
OBJECTIVE: To evaluate the efficacy and safety of the single-agent gemcitabine in advanced non-small cell lung cancer (NSCLC) as second-line chemotherapy. METHODS: Between February 2002 and November 2004, a total of 27 patients, who had previously been treated with paclitaxel and platinum as first line chemotherapy, were enrolled in the study. Patients were treated with gemcitabine (1000 mg/m(2)) on days 1, 8 and 15 in a 28 day cycle. The response was assessed every two cycles. Toxicities were evaluated according to common toxicity criteria (CTC). RESULTS: The median age was 62 (range, 46-79) years old. Among the 27 patients, 26 were male. Twenty-three patients had an ECOG performance status of 0 or 1 and four patients had a status of 2. Pathologically, 24 patients had squamous cell carcinoma and 3 had adenocarcinoma. Partial responses were observed in 15 patients. All patients were evaluated for response and toxicity. The overall response rate was 18.5% (95% confidence interval, 5-33%) and the median response duration was 17 (range, 7.4 to 49+) weeks. The median time to progression was 10 (range, 7 to 34+) weeks. The median overall survival for all patients was 38 (range, 10 to 122+) weeks. During a total of 87 cycles, granulocytopenia greater than CTC grade 2 occurred in 7%, thrombocytopenia in 1% and anemia in 24% of case. Non-hematologic toxicities were minor and easily controlled. CONCLUSION: This study confirms the activity and safety of the single-agent gemcitabine as a second-line therapy in pretreated patients with advanced NSCLC.  相似文献   

5.
OBJECTIVE: Gemcitabine and docetaxel are non-platinum agents with activity in non-small cell lung cancer (NSCLC). This study was conducted to determine and evaluate the recommended regimen of gemcitabine-docetaxel and evaluated its efficacy and safety in chemonaive Japanese NSCLC patients. METHODS: In phase I, patients with stage IIIB/IV NSCLC were randomized and received either gemcitabine on days 1 and 8 plus docetaxel on day 1 or gemcitabine on days 1 and 8 plus docetaxel on day 8. The recommended regimen was the dose level preceding the maximum tolerated dose; once determined, patients were enrolled in phase II. Efficacy and toxicity were evaluated in all patients. RESULTS: Twenty-five patients were enrolled in phase I and six patients were given the recommended regimen; gemcitabine 1000 mg/m(2) on days 1 and 8 plus docetaxel 50 mg/m(2) on day 8. An additional 34 patients were enrolled into phase II and administered with the recommended regimen. The response rate was 32.2% [95% confidence interval (CI) 20.6-45.6%] overall and 30.0% (95% CI 16.6-46.5%) in patients with the recommended regimen (40 patients). Although grade 3 interstitial pneumonia was observed in two patients (5.0%) who received the recommended regimen, both recovered shortly after steroid treatment. No unexpected events were observed throughout this study. CONCLUSIONS: Gemcitabine 1000 mg/m(2) on days 1 and 8 plus docetaxel 50 mg/m(2) on day 8 has comparable efficacy and more tolerable toxicities than previously reported platinum-based regimens. These results should be verified by a phase III study.  相似文献   

6.
多西他赛二线治疗23例晚期非小细胞肺癌   总被引:4,自引:0,他引:4  
目的:评价单药多西他赛[泰索帝)作为二线化疗耐晚期非小细胞肺癌(NSCLC)的疗效和不良反应,方法:23例经病理和(或)细胞学诊断的晚期非小细胞肺癌.曾用含铂类方案化疗,治疗后复发或进展.接受泰素帝75mg/m^2静滴1小时.第1天.每3周重复。结果:可评价疗效23例中.无完全缓解(CR),部分缓解(PR)17%(4/23),稳定(SD)57%(13/23),进展(PD)26%(6/23),有效率17%(4/23);中位生存期9个月,一年生存率39%(9,23)。不良反应主要是血液学毒性,但患者可以耐受。结论:泰素帝草药用于二线化疗治疗晚期非小细胞肺癌疗效肯定.耐受性较好。  相似文献   

7.
艾素联合奈达铂治疗中晚期非小细胞肺癌的临床研究   总被引:4,自引:2,他引:4  
目的:观察艾素(Docetaxel TAX)联合奈达铂(Nedapltin NDP)治疗中晚期非小细胞肺癌(NSCLC)的疗效及不良反应。方法:入组36例中晚期非小细胞肺癌患者。TAX 60mg/m2,静滴1小时,第一天;NDP 80-100mg/m2,第2天。每3周为1个周期。结果:入组36例均可评价疗效,CR 1例,PR15例,SD13例,PD7例,RR为44.44%(16/36)。结论:艾素联合奈达铂治疗中晚期非小细胞肺癌的疗效较好,副作用可耐受,可作为治疗中晚期非小细胞肺癌一线或二线化疗方案。  相似文献   

8.
目的:对比观察多西他赛联合卡铂每周方案与三周方案治疗晚期非小细胞肺癌的临床疗效及不良反应.方法:84例晚期非小细胞肺癌患者分为两组,每周方案组(A组 42例):多西他赛25mg/m2 静脉滴注第1、8、15天,卡铂AUC=5静脉滴注第1天,每21天重复.三周方案组(B组 42例):多西他赛75mg/m2 静脉滴注第1天,卡铂AUC=5静脉滴注第1天,每21天重复.治疗2个周期评价疗效,每周期评价毒性.结果:所有患者均可评价疗效及不良反应.A组与B组的有效率分别为45.2%和42.9%,两组比较差异无统计学意义(P>0.05);中位TTP分别为5.4个月和5.3个月,两组比较差异无统计学意义(P>0.05);中位生存期分别为10.3个月和10.5个月,两组比较差异无统计学意义(P>0.05);Ⅲ/Ⅳ度中性粒细胞减少分别为16.7%和33.3%,两组比较差异有统计学意义(P<0.05);Ⅲ/Ⅳ度恶心呕吐分别为9.5%和16.7%,两组比较差异有统计学意义(P<0.05).结论:多西他赛联合卡铂每周方案与三周方案相比,疗效近似,每周方案骨髓抑制及恶心呕吐明显下降,耐受性较好.  相似文献   

9.
背景与目的:晚期非小细胞肺癌(non-small cell lung cancer,NSCLC)二线治疗效果不佳,可选择的方案有限。尽管单药多西他赛已经被证实能使患者获益,但其缓解期和生存期均较短,因此探索两药联合治疗方案对化疗失败的NSCLC患者有重要临床意义。本文旨在评价卡培他滨联合多西他赛治疗化疗失败的NSCLC患者的疗效并观察不良反应。方法:48例化疗失败的患者随机分为两组,卡培他滨联合多西他赛组(联合组)23例:卡培他滨625 mg/m2,每日2次,第5~18天,多西他赛30 mg/m2,第1、8天。单药多西他赛组(单药组)25例:多西他赛35 mg/m2,第1、8天。主要研究终点为至肿瘤进展时间(time to progression,TTP),次要研究终点为总生存期(overall survival,OS)、有效率(response rate,RR)和疾病控制率(disease controlrate,DCR)。结果:两组中位TTP、中位生存期(MST)和1年总生存率分别为7个月、12个月、47.6%和3个月、12个月、39.6%。联合组中位TTP明显长于单药组,差异有统计学意义(χ2=4.763,P=0.029)。联合组和单药组的RR和DCR分别为:13.0%(3/23)、78.3%(18/23)和12.0%(3/25)、76%(19/25),差异无统计学意义(P>0.05)。两组不良反应均较轻,主要是粒细胞减少、乏力、恶心。联合组未出现严重手足综合征。结论:与单药组相比,联合组患者TTP显著延长,获得了较好的DCR,且不良反应较轻,其对长期生存的作用值得在Ⅲ期试验中研究。  相似文献   

10.

Background:

Docetaxel is widely used as a chemotherapeutic agent for gastric cancer treatment. A combined regimen with sunitinib demonstrated a synergistic antitumour effect in a preclinical model. The aim of this study was to evaluate the efficacy and safety of this combination in patients with unresectable or metastatic advanced gastric cancer following failure of treatment with a fluoropyrimidine and platinum combination.

Methods:

This open-label, phase II, randomised trial enrolled patients with unresectable or metastatic gastric cancer. Patients were assigned to either a docetaxel monotherapy arm (D only arm: 60 mg m−2, every 3 weeks) or a combination arm (DS arm: docetaxel+sunitinib 37.5 mg every day). The primary end point of the study was time to progression and the secondary end points were overall response rate, disease control rate, overall survival, and toxicity profile. A pharmacokinetic study was also performed.

Results:

A total of 107 patients were entered into the study. The TTP was not significantly prolonged in the DS arm when compared with the D only arm (DS vs D only arm: 3.9 months (95% confidence interval (CI) 2.9–4.9) vs 2.6 months (95% CI 1.8–3.5) (P=0.206). The hazard ratio for TTP was 0.77 (95% CI 0.52–1.16). However, the objective response rate was significantly higher in the DS arm (41.1% vs 14.3%, P=0.002). Patients in the DS arm experienced stomatitis, diarrhoea, and hand–foot syndrome more frequently.

Conclusion:

The addition of sunitinib to docetaxel did not significantly prolong TTP, although it significantly increased response.  相似文献   

11.
Capecitabine and docetaxel have considerable single-agent activity in gastric cancer with distinct mechanisms of action and no overlap of key toxicities. A synergistic interaction between these two drugs is mediated by taxane-induced upregulation of thymidine phosphorylase. We investigated the activity and the feasibility of capecitabine and docetaxel combination chemotherapy in patients with previously untreated advanced gastric cancer (AGC). From September 2001 to March 2003, 42 patients with AGC received 21-day cycles of oral capecitabine (1250 mg x m(-2) twice daily on days 1-14) and docetaxel (75 mg x m(-2) i.v. on day 1). The patients received a total of 164 cycles of chemotherapy. The median age was 53.5 years (range 33-73 years). The overall response rate in the 38 efficacy-evaluable patients was 60% (95% confidence interval, 45-74%). The median progression-free survival was 5.2 months (range, 1.0-15.5+ months) and the median overall survival was 10.5 months (range, 2.9-23.7+ months). The most common grade 3/4 adverse events were hand-foot syndrome (HFS: G3 50%), neutropenia (15%) and leucopenia (12%). Further studies of this combination are clearly warranted, albeit with lower doses of both agents (1000 mg x m(-2) twice daily and 60 mg x m(-2)) to reduce the rate of HFS and onycholysis.  相似文献   

12.
Objective:The aim of our study was to evaluate the clinical efficacy and side effects of docetaxel as single chemotherapy for elderly patients with advanced non-small-cell lung cancer (NSCLC). Methods: Forty-two elderly patients with advanced NSCLC who were chemotherapy-naive were enrolled in this study. Docetaxel at the doses of 70 mg/m2 was administrated intravenously every 21 days as a cycle, each patient received 2-4 cycles. All patients were followed up until disease progressed or patients died. Result...  相似文献   

13.
目的:观察多西紫杉醇每周给药联合奥沙利铂一线治疗晚期非小细胞肺癌(NSCLC)的临床疗效及不良反应.方法:选择有病理理诊断的肺癌病人35例,给予多西紫杉醇35mg/(m2·d), d1,8;奥沙利铂130mg/(m·2d),d1;21d为1个周期.每位患者至少接受2个周期化疗.结果:35例患者中CR 2例,PR 16例,SD 11例,PD 6例,总有效率(RR)为51.4%(18/35),临床获益率为82.8%(29/35),TTP 4.4个月,MST 11个月,1年生存率42.8%(15/35).常见不良反应为脱发、乏力和感觉神经异常,但症状轻,Ⅲ-Ⅳ度粒细胞减少11.4%(4/35),全组无治疗相关性死亡.结论:多西他赛每周给药联合奥沙利铂一线治疗晚期非小细胞肺癌疗效确切,不良反应较轻,耐受性好,是一种安全有效、值得临床推广应用的方法.  相似文献   

14.
  目的   观察多西他赛联合阿帕替尼二线治疗晚期非鳞癌非小细胞肺癌的疗效及安全性。   方法   选取2015年2月至2016年8月平顶山市第一人民医院收治的符合标准的晚期非小细胞肺癌患者39例,随机进入研究组和对照组。研究组接受多西他赛60 mg/m2,d1,甲磺酸阿帕替尼500 mg/d,d1~21,21 d为1个周期。对照组接受多西他赛单药化疗,直到疾病进展(progressive disease,PD)或不良反应不可耐受。分析两组患者的疾病控制率(disease control rate,DCR)、不良事件发生率、无进展生存时间(progression-freesurvival,PFS)。   结果   中位随访时间4.6个月,研究组和对照组的DCR率分别为63.2%和30.0%,两组比较具有统计学意义(P=0.039);研究组最常见的3~4级不良事件为血液学毒性(47.3%),与对照组(15%)比较差异具有统计学意义(P=0.032)。研究组和对照组的中位PFS分别为5.6个月(95%CI:4.8~6.3)和3.0个月(95%CI:1.8~4.1),两者比较差异有统计学意(χ2=4.17,P=0.04)。   结论   多西他赛联合阿帕替尼二线治疗晚期非鳞癌非小细胞肺癌不良反应可控,可显著提高DCR及PFS。   相似文献   

15.
Objective: To investigate the clinical efficacy and toxicity of weekly dose docetaxel monotherapy schedule in elderly with advanced non-small cell lung cancer (NSCLC). Methods: 28 patients aged over 65 with advanced NSCLC were recived with docetaxel (Aisu) 35 mg/m2 on days 1, 8 and 15 every 28 days. A clinical evaluation on effectiveness, quality of life and toxicities was performed. Results: 28 patients were given 86 cycles' chemotherapy altogether. The overall response rate was 35.7% (10/28). The clinical beneficial rate was 64.3% (18/28). Mean KPS was increased from 75.5 at baseline to 87.7 after chemotherapy (P < 0.01); lung cancer symptom scale (LCSS) scores of cough, hemoptysis, chest pain and dyspnea were increased from 64, 65, 62 and 65 to 90, 92, 87 and 88, respectively (P < 0.01). The median time to progression (TTP) was 5.3 months; median survival time (MST) was 8.5 months. The main toxicities were fatigue, leukopenia and decrease of hemoglobin with well tolerance. Conclusion: Weekly dose docetaxel monotherapy schedule is a feasible, well-tolerated, and active scheme in the treatment of the elderly patients with advanced NSCLC.  相似文献   

16.
目的:观察脾多肽对多西他赛联合顺铂治疗中晚期非小细胞肺癌(NSCLC)的疗效和不良反应.方法:将60例NSCLC患者随机分为两组:脾多肽组(30例):脾多肽联合多西他赛+顺铂;对照组(30例):单用多西他赛+顺铂.脾多肽组于开始联合化疗方案时即给予脾多肽6 ml/d,静脉滴注,连续应用2周.分别于化疗前后对患者血常规(包括外周血白细胞,血小板,血红蛋白),肝肾功能,消化道反应,免疫功能,生存评分,疗效进行评价.结果:脾多肽组及对照组的总有效率分别是46.7%和43.3%.治疗后,脾多肽组的白细胞、红细胞、血红蛋白、血小板较治疗前的下降程度均比对照组低;治疗后,脾多肽组免疫指标:NK细胞、T细胞、CD4阳性细胞百分率及CD4/CD8比值均较治疗前和对照组明显增加.结论:脾多肽联合多西他赛+顺铂治疗晚期非小细胞肺癌可以增加疗效,减轻骨髓毒性,提高机体免疫力,提高患者生存质量和化疗耐受性值得临床推广.  相似文献   

17.
Park SH  Choi SJ  Kyung SY  An CH  Lee SP  Park JW  Jeong SH  Cho EK  Shin DB  Hoon Lee J 《Cancer》2007,109(4):732-740
BACKGROUND: There is increasing interest in the use of a weekly administration of docetaxel as a way of reducing its hematologic toxicity. The purpose of the current randomized study was to evaluate the toxicity and efficacy of docetaxel plus cisplatin combination on 2 schedules in patients with previously untreated, advanced nonsmall-cell lung cancer (NSCLC). METHODS: Consenting patients with advanced NSCLC were randomized to receive first-line chemotherapy with cisplatin 75 mg/m(2) on Day 1, plus 3-weekly (75 mg/m(2) on Day 1) or weekly (35 mg/m(2) on Days 1, 8, and 15 of a 4-week cycle) docetaxel, for up to 6 cycles. RESULTS: Of 86 patients accrued, 41 patients were treated with 3-weekly and 43 with weekly docetaxel plus cisplatin. The most frequent grade 3/4 toxicity in the 3-weekly arm was neutropenia (56% of patients). In those receiving the weekly regimen, the frequent grade 3/4 toxicities were fatigue (44%) and nausea/vomiting (35%). The overall response rate was 40% with the 3-weekly and 39% with the weekly arm (P = .74). The median progression-free survival was 4.3 months in the 3-weekly arm and 3.9 months in the weekly arm (P = .08) and the median survival was 10.3 and 10.0 months, respectively (P = .76). Quality of life data showed no relevant difference between the arms. CONCLUSIONS: The weekly schedule of docetaxel plus cisplatin combination as first-line chemotherapy for advanced NSCLC, while feasible, has no clear advantage over the standard 3-weekly regimen.  相似文献   

18.
目的:探讨多西他赛每周给药联合奈达铂治疗晚期高龄非小细胞肺癌(NSCLC)的疗效及不良反应.方法:对33例晚期高龄NSCLC患者用多西他赛30mg/m2,每周给药,连用3周休息1周;奈达铂80mg/m2,每周期的第1d给药,每28d为1个治疗周期.3周期评价疗效,以上化疗方案每4周重复,每例进行2-4周期化疗.结果:全组33例,有效率36.36%(12/33),其中CR 1例,PR 11例,SD 16例,PD 5例,Ⅲ-Ⅳ度的中性粒细胞减少发生率为15.15%(5/33),非血液学毒性主要为消化系统不良反应,其他不良反应轻微.结论:多西他赛每周给药联合奈达铂治疗晚期高龄NSCLC疗效较好,骨髓毒性较轻.  相似文献   

19.
目的:评价多西紫杉醇联合卡培他滨治疗进展期胃癌疗效。方法:试验组采用多西他赛联合希罗达方案姑息化疗,对照组采用DCF方案姑息化疗,比较两种方案治疗进展期胃癌的疗效。结果:试验组及对照组患者有效率分别为38.24%和29.41%,两组之间未见统计学差异。两组患者在手足综合征和Ⅲ-Ⅳ骨髓抑制方面有统计学差异。结论:多西他赛联合卡培他滨方案一线治疗进展期胃癌疗效肯定,毒副反应能耐受。  相似文献   

20.
李彬  温福刚  周立中  刘君 《现代肿瘤医学》2006,14(11):1393-1394
对32例有病理或细胞学诊断并有可测量病灶、多程化疗后复发的晚期非小细胞肺癌(NSCLC)患者给予多西他塞(Docetaxel)35mg/m2静脉滴注,第1,8天,异环磷酰胺(Ifosamide,IFO)1.2g/m2静脉滴注,第2~4天,21天为1周期,平均2~4周期。32例患者中无CR,PR8例,SD14例,PD10例,总有效率(CR PR)25.0%(8/32),临床受益率(CR PR SD)68.8%,中位生存期为8.5个月,1年生存率31.3%。主要毒性反应为白细胞下降,其发生率为90.6%,Ⅲ~Ⅳ度白细胞下降占9.4%。初步临床观察结果为多西他塞联合异环磷酰胺治疗晚期复发的非小细胞肺癌疗效好,毒性反应可以耐受。  相似文献   

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