国产多西他赛联合顺铂治疗晚期非小细胞肺癌疗效观察

目的观察国产多西他赛联合顺铂（DDP）治疗晚期非小细胞肺癌的近期疗效、临床受益和毒副反应。方法70例晚期NSCLC患者给予DP方案化疗：国产多西他赛75mg/m^2，静滴，d1；顺铂75mg/m^2，静滴，d1；21d为1周期。每例患者治疗2周期以上。结果全组完全缓解2例，部分缓解29例，稳定36例，进展3例，总有效率44．3％。中位生存期10．1个月，1年生存率38．6％（27／70）。临床受益疗效：行为状态阳性率51．4％，体重阳性率47．1％。毒副反应主要为骨髓抑制，脱发和消化系统反应。其中白细胞减少占75．7％，G-CSF治疗后较快恢复。结论国产多西他赛联合顺铂无论一线还是二线治疗晚期NSCLC近期疗效和临床受益良好，毒副反应可耐受。     

A randomized trial of different docetaxel schedules in non-small cell lung cancer patients who failed previous platinum-based chemotherapy

STUDY OBJECTIVE: Docetaxel has shown activity in the second-line treatment of non-small cell lung cancer (NSCLC). Phase II studies have suggested that weekly therapy with docetaxel probably has a better toxicity profile than the conventional schedule of once every 3 weeks. Our aim was to evaluate and compare the efficacy of different docetaxel schedules in NSCLC patients who did not respond to previous platinum-based chemotherapy. SETTING: National teaching hospital in Taiwan. METHODS: Treatment consisted of the following: (1) docetaxel, 35 mg/m(2) IV infusion (D(35)) on days 1, 8, and 15 every 4 weeks; (2) docetaxel, 40 mg/m(2) IV (D(40)) on days 1 and 8 every 3 weeks; and (3) docetaxel, 75 mg/m(2) IV (D(75)) on day 1 every 3 weeks. Patients were randomized at a ratio of 2:2:1, with the D(75) arm as the control arm. From 2002 to 2004, 161 patients were enrolled into the study. RESULTS: The number of patients enrolled in each arm of the study was as follows: D(35) group, 64 patients; D(40) group, 64 patients; D(75) group, 33 patients. The mean ages of patients were as follows: D(35) group, 65 years of age; D(40) group, 63 years of age; D(75) group, 64 years of age. The median number of cycles of chemotherapy received in each group was as follows: D(35) group, 4; D(40) group, 3; D(75) group, 4. The objective response rates were as follows: D(35) group, 17.2%; D(40) group, 10.9%; D(75) group, 6.1% (p = 0.615). The major toxicity was myelosuppression. Grades 3/4 leukopenia and neutropenia were significantly higher in the D(75) arm of the study (p < 0.001). Drug-induced pneumonitis occurred more frequently in patients on a weekly schedule than in those on a schedule of every 3-weeks (p = 0.05). The median survival times were as follows: D(35) group, 8.4 months; D(40) group, 7.2 months; and D(75) group, 9.5 months (p = 0.855). The 1-year survival rates were 32.8%, 31.9%, and 28.7%, respectively. Lung cancer symptom scores showed no obvious differences among the different treatment arms, except for some minor items. CONCLUSIONS: Weekly docetaxel chemotherapy produces less myelosuppression, and better compliance and response rates than the conventional chemotherapy administered every 3 weeks. These effects were more evident in the D(35) group weekly schedule than in the D(40) weekly schedule. However, physicians should pay more attention to the possibility of a higher frequency of docetaxel-induced pneumonitis in patients receiving treatment on the weekly schedule of treatment.     

Combination chemotherapy with carboplatin and docetaxel for elderly patients with non-small-cell lung cancer

The efficacy and toxicity of treatment with carboplatin (AUC= 5)+ docetaxel (70mg/m2) were analyzed retrospectively in 27 elderly patients with advanced non-small-cell lung cancer (NSCLC) aged 70 years or more. The median age of the patients was 74 years (range, 70-83 years). The performance status (ECOG), clinical stage, and tumor histology in the patients were as follows: PS: PS 0, 12 patients; PS 1, 11 patients; PS 2, 4 patients; disease stage: stage IIIA, 5 patients; stage IIIB, 11 patients; stage IV, 11 patients; tumor histology: adenocarcinoma, 18 patients; squamous cell carcinoma, 9 patients. The median number of treatment cycles administered was 4. The median survival time was 11.1 months and the 1-year survival rate was 40.7%. The response rate was 33.3%. The major toxicities were leukopenia and neutropenia; grade 3/4 neutropenia occurred in 22 patients (81.5%). Nonhematologic toxicities were generally mild, including grade 3 anorexia in 13 patients (48.1%) and grade 3 febrile neutropenia in 9 patients (33.3%). No treatment-related deaths were observed. Thus, it was concluded that the combination of carboplatin + docetaxel is a feasible, well-tolerated, and effective regimen for fit elderly patients with NSCLC. Prospective studies comparing carboplatin + docetaxel with third-generation single-agent chemotherapy or non-platinum-based combination chemotherapy are needed to confirm the efficacy and safety of this drug combination.     

胸腔镜与传统肺叶切除对肺癌患者生存质量影响的研究

目的比较电视辅助胸腔镜手术(video-assisted thoracoscopic surgery,VATS)和传统切口开胸肺切除治疗临床早期肺癌术后的生活质量。方法肺癌130例进行研究。随机分为胸腔镜组(n=45)和传统手术组(n=85)手术,利用肺癌患者生存质量量表FACT-L中文版(V4.0)通过自评方式作出评分。对比研究两组患者的生理状况、社会家庭影响、功能状况、情感状况及附加关注情况。结果 VATS组与传统手术组对肺癌患者术后生理状况、情感状况、功能状况、附加关注情况等方面的影响明显较小(P<0.05);对社会家庭状况影响两者相似。结论与传统肺切除手术组对比,胸腔镜术后的肺癌生存质量明显占优。     

多西紫杉醇周疗联合小剂量顺铂治疗晚期非小细胞肺癌76例疗效观察

目的观察多西紫杉醇周疗联合小剂量顺铂治疗晚期非小细胞肺癌的疗效及毒副反应。方法对2005年7月至2007年10月哈尔滨医科大学附属第二医院经病理证实的76例非小细胞肺癌患者进行多西紫杉醇周疗 小剂量顺铂联合化疗。结果76例患者中部分缓解32例,稳定25例,进展19例,总有效率为42.1%。初治组有效率为46.3%,复治组有效率为37.1%。最常见的毒副反应为骨髓抑制,毒副反应均可耐受。结论多西紫杉醇周疗联合小剂量顺铂治疗非小细胞肺癌有较好的疗效,毒性反应小可以耐受,具有较好应用价值。     

异长春花碱加顺铂治疗晚期非小细胞肺癌48例临床观察

目的 观察国产异长春花碱(盖诺)加顺铂治疗晚期非小细胞肺癌的疗效及毒副反应。方法 共治疗48例患者，男性35例，女性13例。病理类型以腺癌为主(23例)，Ⅲb期30例，Ⅳ期18例。34例初治，14例复治。异长春花碱25mg／m^2静点，第1、8天，顺铂30mg／m^2静点，第1～3天，3周为1周期，化疗2～3周期后评价疗效。结果 完全缓解(CR)1例，部分缓解(PR)17例，无变化(NC)21例，进展(PD)9例，有效率(CR PR)37．50％(18／48)。毒副反应主要为自细胞减少、恶心呕吐及静脉炎。结论 国产异长春花碱加顺铂治疗晚期非小细胞肺癌，疗效较高且毒副反应可以耐受。     

多西他赛联合奈达铂治疗一线化疗失败的非小细胞肺癌的临床研究

目的观察多西他赛联合奈达铂二线治疗晚期非小细胞肺癌（NSCLC）的临床疗效及毒副反应,并进行安全评估。方法 65例一线治疗失败的晚期NSCLC患者采用多西他赛＋奈达铂化疗4周期后,用世界卫生组织（WHO）的疗效及抗肿瘤药物急性及亚急性毒性反应分度评价疗效和毒性。结果 65例患者均完成4周期以上化疗,完全缓解（CR）5例,部分缓解（PR）16例,总有效率32.0%,临床症状明显改善,常见的毒性反应有骨髓抑制、胃肠道症状和脱发。结论多西他赛联合奈达铂治疗一线化疗失败的NSCLC疗效确切,可以提高生活质量,毒副反应较轻,耐受性好,值得临床进一步推广研究。     

吉非替尼与多西紫杉醇二线治疗非小细胞肺癌的疗效比较

目的 探讨吉非替尼与多西紫杉醇单药二线治疗晚期非小细胞肺癌的疗效和不良反应。方法 将既往一线化疗失败的62例晚期非小细胞肺癌患者随机分为吉非替尼组和多西紫杉醇组进行治疗观察。结果吉非替尼组疾病控制率为56.3％,1年生存率为37.5％;多西紫杉醇组疾病控制率为43.3％,1年生存率为33.3％。两组疾病控制率比较差异无...     

同步放化疗治疗Ⅲ期非小细胞肺癌的临床观察

目的观察和比较同步放化疗与单纯放疗治疗Ⅲ期非小细胞肺癌(NSCLC)的临床疗效和毒副反应。方法将我院已确诊的40例Ⅲ期NSCLC患者,随机分入对照组和观察组各20例。对照组患者给予三维适形常规分割放疗,观察组患者在放疗基础上予以顺铂联合多西他赛化疗1周期。治疗后比较两组患者1年、3年生存率,有效率及毒副反应发生率。结果同步放化疗组和常规化疗组有效率分别为75.0%和35%,患者1年、3年总生存率分别为50.0%、40.0%和40.0%、12.5%,差异具有统计学意义。两组Ш度以上急性毒副反应发生率分别为31.0%和29.6%,差别无统计学意义。结论对Ш期NSCLC患者选择同步放化疗方案与单纯放疗方案相比,可提高患者临床疗效和生存率且毒副反应可耐受。     

以铂类为基础的两药联合方案治疗老年晚期非小细胞肺癌临床研究

目的 评价老年晚期非小细胞肺癌(NSCLC)患者接受以铂类为基础的两药联合化疗的疗效和安全性. 方法 对我院41例年龄≥70岁的老年晚期NSCLC患者应用以铂类为基础的两药联合方案化疗的情况进行了回顾性分析. 结果 41例患者中采用长春瑞滨方案的18例(43.9%),吉西他滨方案的9例(22.0%)、紫杉醇和多西紫杉醇方案各7例(17.1%).全组总有效率为19.5%,中位疾病进展时间和中位生存期分别为5.8个月和14.2个月,1年生存率为65.8%.化疗的主要不良反应为骨髓抑制,主要以白细胞和血小板减低为主,给予对症处理后可以恢复.患者无化疗相关死亡发生,有3例患者因出现Ⅲ～Ⅳ度骨髓抑制仪化疗1个周期. 结论 以铂类为基础的联合化疗方案治疗一般状况较好的老年晚期NSCLC疗效确切且耐受性较好.     

Second Line Therapy with Weekly Low-dose Docetaxel for Pretreated Non-Small-Cell Lung Carcinoma Patients: A Multicenter Italian Phase II Study

Docetaxel is one of the most active drugs in second-line therapy for non-small-cell-lung-carcinoma (NSCLC). The aim of this multicenter study was to evaluate the safety and efficacy of weekly low-dose docetaxel. Forty-two patients with advanced NSCLC pretreated with cisplatinum-based chemotherapy were enrolled. Docetaxel was administered at a dose of 25 mg/m² weekly for 12 consecutive weeks. A total of 386 doses were given with a median number of 10 doses per patient (range: 3–12). Treatment showed low incidence of hematologic toxicity and modest non-hematologic toxicity. An episode of grade 4 thrombocytopenia was reported but no episodes of grade 3 or 4 neutropenia. Most frequent non-hematologic toxicities were asthenia and alopecia. Response rate was 10.5% and median survival time (MST) was 12.8 weeks. Weekly treatment with 25 mg/m² docetaxel for 12 consecutive weeks appears to be a feasible and active regimen with mild toxicity in heavily pretreated NSCLC patients.     

多西紫杉醇联合卡铂治疗晚期非小细胞肺癌的疗效观察

目的观察多西紫杉醇联合卡铂治疗晚期非小细胞肺癌近期疗效及毒副反应。方法47例晚期非小细胞肺癌住院患者给予多西紫杉醇联合卡铂治疗,多西紫杉醇75mg/m2,静滴,d1,卡铂根据AUC5计算用量,静滴,d1,21d为1周期,每个患者均完成2个周期以上,评价疗效和不良反应,并随访生存期。结果47例患者治疗后CR0例、PR24例、NC17例、PD6例,有效率为51.1%。KS评分增加者70.2%(33/47)、稳定21.3%(10/47)、下降8.5%(4/47)。中位生存期9个月(95%CI8～10个月),1年生存率27.1%。最常见的毒副反应为骨髓抑制,全组68.1%(32/47)出现白细胞下降,其中Ⅲ度～Ⅳ度白细胞减少发生率为25.5%,恶心、呕吐29.8%(14/47),脱发87.2%(41/47)。其余毒副反应轻微,均可耐受。结论多西紫杉醇联合卡铂治疗晚期非小细胞肺癌有较好的疗效,毒副反应比较轻微。     

A multicenter phase II study of the efficacy and safety of docetaxel plus cisplatin in Asian chemonaïve patients with metastatic or locally advanced non-small cell lung cancer

AIMS: To evaluate the efficacy and safety of docetaxel-cisplatin in patients with metastatic or locally advanced non-small cell lung cancer (NSCLC). METHODS: Chemotherapy-na?ve patients with histologically confirmed TNM stage III or IV NSCLC were recruited from 12 Asian trial centers. Patients received docetaxel (75 mg/m2) and cisplatin (75 mg/m2) every 3 weeks for 6 cycles. RESULTS: 130 of 146 patients were evaluable for efficacy (60% stage IV). Three complete and 58 partial responses were observed (overall response rate: 46.9%; 95% CI: 38.3-55.5%). Median time to progression was 6.9 months and median survival was 14.0 months; 1-year survival was 59.5%. Grade 3/4 neutropenia, thrombocytopenia and anemia occurred in 69.2%, 6.2% and 18.5% of patients, respectively. Grade 3/4 vomiting was observed in 13.7% and grade 3/4 neurosensory effects were observed in 2.7% of patients. There was one case of treatment-related death due to sepsis. CONCLUSION: Docetaxel-cisplatin is an effective and well-tolerated treatment in Asian patients with NSCLC.     

Improving Survival and Reducing Toxicity with Chemotherapy in Advanced Non-Small Cell Lung Cancer

The role of chemotherapy in the treatment of advanced non-small cell lung cancer (NSCLC) has been debated over three decades, but it is only relatively recently that chemotherapy has become a standard of care for this disease. In addition to prolonging survival, chemotherapy can palliate distressing symptoms. Concerns that the adverse effects of chemotherapy are likely to outweigh its benefits have largely not been confirmed by quality-of-life data reported among patients with good performance status. Platinum-based chemotherapy regimens in which cisplatin or carboplatin are partnered by a third-generation cytotoxic drug such as gemcitabine, paclitaxel or vinorelbine, have similar activity and efficacy, but differ in adverse effect profiles. Response rates of 30-40% should be expected with median and 1-year survival of 8-10 months and 30-40%, respectively. In the second-line setting chemotherapy with docetaxel has been shown to be significantly superior to best supportive care alone. In a recent trial that compared docetaxel to the novel antifolate, pemetrexed the response rates and survival rates did not differ, but the toxicity profile favored pemetrexed. Overall, these data demonstrate that progress has been made in the use of chemotherapy to improve survival in patients with NSCLC without increasing the incidence of further toxicity. In the past, the potential to survive 1 year was extremely small, whereas now many more patients reach this milestone as well as the 2-year point. However, a plateau has probably been reached with existing cytotoxic drugs and there is a general belief that the next significant advance in the treatment of NSCLC will come from the addition of drugs that target specific molecular pathways in sequence with standard chemotherapy regimens.     

紫杉醇联合顺铂治疗晚期非小细胞肺癌的临床观察

目的观察紫杉醇(PTX)加顺铂(CDDP)联合化疗治疗晚期非小细胞肺癌的近期疗效及毒副反应。方法PTX135~175mg/m2静脉滴注,第1天;CDDP75mg/m2,分三次用完。每21天为1个周期,连用2或3周期。结果可评价疗效者37例,其中PR16例,总有效率为43.2%。毒副反应主要是骨髓抑制和恶心呕吐。结论PTX DDP治疗晚期非小细胞肺癌可获得较高疗效,毒副反应轻,是一个较好的联合化疗方案。     

小剂量多西他赛治疗老年晚期非小细胞肺癌的疗效研究

目的 观察小剂量多西他赛单药治疗老年晚期非小细胞肺癌（NSCLC）的疗效和不良反应.方法 46例老年NSCLC（Ⅲ～Ⅳ期）患者均经病理学或细胞学检查确诊.应用江苏恒瑞生产多西他赛（艾素）35mg/m2,1次/周,连用6周,休息两周为1周期,两周期后评价疗效.结果 46例患者均可评价疗效,CR 1例,PR 11例,有效率26.0%,中位生存期8.3个月,中位疾病进展时间（TTP）7.2个月,1年生存率45.5%.主要不良反应为白细胞减少和过敏反应,均可耐受.结论 小剂量多西他赛单药治疗老年晚期NSCLC疗效确切,可改善老年患者生存质量,延长生存期,不良反应轻.     

化疗同时补充氨基酸对老年非小细胞肺癌患者生活质量的影响

目的 探讨老年非小细胞肺癌(non-small cell lung cancer,NSCLC)患者化疗同时补充氧基酸对其生活质量(quality of life,QOL)的影响.方法 74例老年NSCLC患者随机分为试验组与对照组,统一采用长春瑞滨+顺铂方案NP化疗3个周期,试验组化疗同时补充9复合氨基酸(9-AA)500 mud,对照组单纯化疗.跟踪调查3个月,采用欧洲癌症研究与治疗组织(EORTC)生活质量核心问卷(QLQ-C30)和肺癌特异性模块QLQ-LC13调查随访患者化疗期间的QOL状态,并按WHO标准评价疗效.结果 化疗后,试验组患者躯体功能、情绪功能、社会功能较对照组好转(P＜0.05).试验组有效率分别为87.8%,83.8%和77.0%对照组分别为77.0%、45.9%和45.9%);试验组失眠、食欲丧失和疲倦症状较对照组减轻(P＜0.05),试验组各症状加重率分别为8.1%、5.4%和47.3%,对照组为17.6%、17.6%和59.5%.化疗前,两组患者以咳嗽、咯血、疼痛、呼吸困难为主要症状,化疗后均得到改善;试验组出现口舌疼痛症状比对照组患者少,分别占8.3%和18.4%(P＜0.05).按WHO标准进行疗效评价显示,两组化疗疗效差异无统计学意义.结论 化疗同时补充氨基酸可改善老年NSCLC化疗患者的QOL;500 ml/d的氮基酸补充,安全性好.     

局部晚期非小细胞肺癌化疗与放化联合治疗观察

目的比较放化联合治疗与单纯化疗对局部晚期非小细胞肺癌（NSCLC）的临床疗效及安全性。方法回顾性分析68例不能手术的NSCLC患者,纯化疗组30例（A组）,放化联合组38例（B组）,两组均予长春瑞滨联合顺铂方案化疗两周期,疾病无进展者,A组继给予多西他赛联合顺铂方案化疗两周期,B组给予常规放疗60Gy后再予多西他赛联合顺铂方案化疗两周期,对比两组疗效及安全性。结果A组治疗有效率、中位生存期及1、3年生存率、分别为33.3%、8.9月、36.7%和0。B组分别为68.4%、12.6月、68.4%和5.3%,B组较A组明显提高,差异有显著性（P〈0.05）。主要毒副反应为骨髓抑制及肝功能异常。A组白细胞减少、血小板减少及肝功能异常发生率分别为63.3%,16.7%和66.7%,B组分别为78.9%、18.4%和68.4%,两组相比差异均无显著性（P〉0.05）。结论对局部晚期NSCLC放化联合治疗优于单纯化疗,毒副反应能耐受。     

Toxicity and efficacy of chemotherapy for non-small cell lung cancer with cavitary lesions

BackgroundConcurrent chemoradiation in stage III non-small cell lung cancer (NSCLC) patients with cavitary lesions is reported to cause serious lung complications and is a predictor of poor survival. However, the efficacy and toxicity associated with chemotherapy for advanced NSCLC patients with cavitary lesions is not clear. We investigated the toxicities, particularly hemoptysis and cavity infection, and efficacy associated with chemotherapy for NSCLC patients with cavitary lesions.MethodsWe retrospectively reviewed consecutive patients who received first-line chemotherapy, including platinum-based chemotherapy, single-agent chemotherapy, or epidermal growth factor receptor-tyrosine kinase inhibitors, at our institution between January 2008 and December 2010.ResultsWe found tumor cavitation prior to treatment in 23 of 415 NSCLC patients (5.5%). The response rate of all the patients was 30%, and the median survival time (MST) was 8.9 months. The MST of the 15 patients treated with platinum-based chemotherapy was 11 months. Grade 1 bronchopulmonary hemorrhage occurred in 2 patients. Grade 3 cavitary infection occurred in 2 patients, resulting in the discontinuation of chemotherapy.ConclusionsThis study indicates that the toxicity of chemotherapy for NSCLC patients with cavitary lesions is tolerable; however, the development of cavitary infection should be carefully considered. In addition, this study suggests that the efficacy of chemotherapy for NSCLC patients with cavitary lesions is similar to the response rates reported in the literature; however, the survival of these patients may be worse than that for general NSCLC patients.     

Pemetrexed versus docetaxel in second line non-small-cell lung cancer: Results and subsets analyses of a multi-center, randomized, exploratory trial in Chinese patients

BackgroundPemetrexed and docetaxel are established therapies in second line non-small cell lung cancer (NSCLC). Comparative data, concerning the two agents in the designated settings, however, are lacking in Chinese patients who account for the largest lung cancer population in the world.Methods and patientsWe designed and performed a multi-center, randomized, exploratory clinical trial of pemetrexed compared with docetaxel in second line chemotherapy in Chinese NSCLC patients. Eligible patients with histological or cytological diagnosis of stage IIIB or IV NSCLC, who were not suitable for curative therapy and had failed from prior first line chemotherapy regimen for at least 4 weeks, were randomized to receive either pemetrexed 500 mg/m² intravenously day 1 with vitamin B12, folic acid, and dexamethasone, or docetaxel 75 mg/m² intravenously day 1 with dexamethasone. Both regimens were implemented once every 21 days for 2 cycles. This study was designed to be a non-inferiority trial that compared tumor response for overall response rate (ORR) between the two drugs as primary endpoint. The secondary endpoints included disease control rate (DCR), Karnofsky performance status (KPS) scores and toxicities.Results260 patients were enrolled and randomly assigned to receive chemotherapy of either pemetrexed (132 patients) or docetaxel (128 patients). 106 patients in pemetrexed arm and 102 patients in docetaxel arm were evaluable for efficacy. The efficacy of pemetrexed was equivalent to that of docetaxel in the second-line treatment for Chinese NSCLC (ORR: pemetrexed vs. docetaxel = 9.4% vs. 4.9, p = 0.285, DCR: pemetrexed vs. docetaxel = 67.2% vs. 69.6%, p = 0.685). And pemetrexed seemed to slightly promote patients' average KPS score when comparing with docetaxel, although the difference was without statistical significance (changes of average KPS scores: pemetrexed vs. docetaxel = 0.28 ± 5.93 vs. -1.67 ± 8.57, p = 0.149). Patients receiving pemetrexed experienced significantly lower incidences of grade 3/4 neutropenia (7.0% vs. 27.6%, p < 0.001) and leucocytopenia (4.7% vs. 22.8%, p < 0.001) than those who received docetaxel. Also, there were lower incidences of alopecia, stomatitis, and neural abnormality for patients receiving pemetrexed than those receiving docetaxel. Incidence of serum glutamic oxaloacetic transaminase elevation, however, was higher in pemetrexed arm than in docetaxel arm (32.3% vs. 14.9%, p = 0.013). In addition, age ≥ 60 patients benefit from pemetrexed with equivalent efficacies yet much lower toxicities compared to docetaxel (DCR: pemetrexed vs. docetaxel = 66.67% vs. 81.58%, p = 0.146; grade 3/4 hematologic toxicities: pemetrexed vs. docetaxel = 17.25% vs. 39.6%, p = 0.016).ConclusionTreatment with pemetrexed resulted in equivalent efficacy outcomes and better safety profiles compared with docetaxel in second-line therapy for advanced NSCLC in Chinese lung cancer population. And age ≥ 60 patients may benefit from second-line single pemetrexed.