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.     

Treatment of advanced breast cancer with gemcitabine and vinorelbine plus human granulocyte colony‐stimulating factor

Purpose. A phase II trial was performed to investigate the efficacy and tolerance of gemcitabine, vinorelbine, and recombinant human granulocyte colonystimulating factor (GCSF) in advanced breast cancer. Patients and methods. Between April 96 and August 97, 60 patients entered this trial. Fortyfive patients were previously untreated and 15 patients had failed previous palliative chemotherapy with (n = 10) or without anthracyclines (n = 5). Therapy consisted of gemcitabine 1000mg/m² on days 1 + 15 + 21 and vinorelbine 40mg/m² on days 1 + 21, both diluted in 250ml saline and infused over 30min. GCSF was administered at 5g/kg/day subcutaneously from days 2–6 and 22–26. Courses were repeated every 5 weeks. Treatment was continued in case of response or stable disease until a total of six courses. Results. The overall response rate was 55.5% for patients who had not received prior palliative chemotherapy (95% confidence interval, 40%–70.3%), including 5 CR (11.1%) and 20 PR (44.4%) 12 patients (27%) had stable disease (SD), and 8 (18%) progressed. Secondline treatment with this regimen resulted in 6/15 (40%) objective remissions, 5 had SD, and 4 PD. The median time to progression was 9.5 months (range, 1.5–28) in previously untreated patients, and 7.0 months (range, 2–23) in those who had failed prior chemotherapy. After a median followup time of 15 months, 44 patients (73%) are still alive with metastatic disease. Myelosuppression was commonly observed, though WHO 3 and 4 neutropenia occured in only 9 (l5%) and 2 patients (3%), and was never complicated by septicaemia; grade 3 anemia was noted in 2 patients. Severe (WHO grade 3) nonhematologic toxicity was rarely observed, and included nausea/emesis in 3 and constipation in 2 patients. Conclusions. Our data suggest that gemcitabine and vinorelbine plus GCSF is an effective and tolerable first as well as secondline combination regimen for treatment of advanced breast cancer.     

Vinorelbine, cisplatin and continuous infusion of 5-fluorouracil (ViFuP) in metastatic breast cancer patients: A phase II study

Purpose:Chemotherapy regimens for patients with advanced breastcancer or large primary tumours (including locally advanced disease) usuallycontain anthracyclines, taxanes or both. We investigated a multi-agent regimenfor patients for whom anthracyclines and/or taxanes may not be suitable. Weassessed efficacy in terms of response rate and time to progression of acombination with continuous infusion 5-fluorouracil (5-FU), vinorelbine andcisplatin (ViFuP regimen), as a first or subsequent line treatment formetastatic breast cancer patients. Patients and methods:One hundred consecutive patients withadvanced breast cancer were treated with 5-FU 200 mg/m²administered continuously through a permanent central venous line; vinorelbinewas given on days 1 and 3 at a dose of 20 mg and cisplatin was administeredat 60 mg/m² on day one. Therapy was given every three weeks. Themedian age was 50 years (range 23–72). Fifty-two patients had receivedprior chemotherapy for metastatic breast cancer, and sixty-one percent hadpreviously received anthracyclines, thirty-five percent taxanes andtwenty-nine percent 5-FU as a bolus injection. All patients were assessablefor toxicity, four patients were not assessable for response. Results:There were four complete responses (4%).Forty-nine patients had a partial response (overall response rate, 55%;95% confidence interval (CI): 45%–65%). After amedian follow-up of 10.2 months, median duration of response is 5.2 months(range 1.5–20.7+ months), time to progression (TTP) is 6.8 months (range0.3–24.7 months). Acute toxicity, including myelosuppression, was mild:only 18% of patients had grade 4 granulocytopenia and one patientexperienced grade 4 diarrhea. Only 15% of patients had anynon-hematological grade 3 toxicity including nausea (4%), stomatitis(4%), diarrhea (2%), fatigue (1%), fever (1%),photosensitivity (1%), hand–foot syndrome (1%). Grade 2alopecia was observed only in six patients (6%). Eleven patientsdeveloped a right diaphragmatic supra elevation, while deep vein thrombosis,central venous catheter associated, occurred in eight patients. Conclusions:We identified a combination chemotherapy withnoteworthy efficacy and well tolerated subjectively as either a first- orsecond-line treatment for metastatic breast cancer patients. The regimenwarrants further development focusing on the comparison with either continuousadministration of oral fluoropyrimidine derivatives.     

NP和GP方案治疗晚期非小细胞肺癌的疗效比较

目的 诺维本加顺铂(NP)和健择加顺铂(GP)方案均是目前治疗晚期非小细胞肺癌的常用方案,本研究对两种方案进行了有效率、存活率和不良反应等方面的比较.方法 自1999～2004年,总共80例晚期非小细胞肺癌(Ⅲb期或Ⅳ期)参与研究,采用NP方案治疗40例、GP方案40例,比较其疗效及不良反应.结果 总有效率NP方案为27.5%,GP方案为22.5%(P＞0.05);平均存活时间NP方案为9.4个月,GP方案为8.6个月(P＞0.05);1年存活率NP方案为10.0%,GP方案为7.5%(P＞0.05).两种方案的主要不良反应均为骨髓抑制,白细胞下降至Ⅲ、Ⅳ度者NP方案为45%,GP方案为40%(P＞0.05);化疗后出现Ⅲ、Ⅳ度便秘者NP方案为25.0%,GP方案为7.5%(P＜0.05).结论 NP方案和GP方案治疗晚期非小细胞肺癌效果确实,且较一致,耐受性均较好,但使用NP方案要注意预防便秘.     

红参发酵产物联合长春瑞滨及顺铂化疗方案治疗晚期非小细胞肺癌患者的疗效

目的探讨红参发酵产物联合长春瑞滨及顺铂化疗方案治疗晚期非小细胞肺癌患者的疗效。方法将104例晚期非小细胞肺癌患者随机分为治疗组及对照组,每组52例。对照组患者给予单纯长春瑞滨^+顺铂化疗方案,治疗组患者在对照组基础上联合应用红参发酵产物。分别在治疗前后采用疲劳症状量表(FSI)、肺癌治疗功能评价量表(FACT-L)评价两组患者疲劳症状及生活质量,并比较治疗前后两组患者血清肿瘤标志物水平、免疫功能指标水平、药物不良反应及生存情况。结果治疗前,两组患者FSI各维度评分及总分,FACT-L各维度评分及总分,细胞角质蛋白19片段抗原21-1(CYFRA21-1)、神经元特异性烯醇化酶(NSE)、癌胚抗原(CEA)、自然杀伤(NK)细胞、CD3^+、CD4^+、CD8^+、CD4^+/CD8^+水平比较,差异均无统计学意义(P﹥0.05)。治疗后,对照组患者FSI各维度评分及总分均高于治疗前及治疗组;治疗组患者生理状态、情绪状态、对疾病关注度评分及总分均高于治疗前,且生理状态、社会家庭状态、情绪状态、功能状态、对疾病关注度评分及总分均高于对照组;两组患者CEA、CYFRA21-1及NSE水平均较治疗前下降,且治疗组患者均低于对照组患者;治疗组患者NK细胞、CD3^+、CD4^+及CD4^+/CD8^+水平均较治疗前上升,且均高于对照组患者,差异均有统计学意义(P﹤0.05)。治疗组患者血液学不良反应发生例数少于对照组,差异有统计学意义(P﹤0.05)。结论红参发酵产物联合长春瑞滨及顺铂化疗方案能够有效提高晚期非小细胞肺癌患者的免疫功能及生活质量,降低血清肿瘤标志物水平,并减轻血液学不良反应。     

贝伐珠单抗联合长春瑞滨二线治疗复发转移性宫颈癌患者的近期疗效

目的:观察贝伐珠单抗联合长春瑞滨治疗复发转移性宫颈癌的近期疗效及不良反应。方法:回顾性分析2014年1月至2016年12月贵州省人民医院收治的34例复发转移性宫颈癌患者的临床资料,所有患者均使用贝伐珠单抗联合长春瑞滨,21天为1个周期,行4～6个周期治疗,评价疗效及评定不良反应级别。结果:34例宫颈癌患者中无完全缓解患者,部分缓解7例（20.6%）、疾病稳定20例（58.8%）、疾病进展7例(20.6%）,总有效率为 20.6%（7/34）,疾病控制率为79.4%（27/34）。34例患者常见不良反应程度均较轻,可以耐受。结论:贝伐珠单抗联合长春瑞滨方案治疗复发转移性宫颈癌患者近期疗效好,其不良反应患者可耐受,远期疗效有待进一步的研究。     

复方苦参注射液联合NP方案治疗老年非小细胞肺癌

目的评价复方苦参注射液联合NP方案治疗70岁以上老年非小细胞肺癌(NSCLC)的疗效及安全性。方法65例老年Ⅱ~Ⅲb期NSCLC患者随机分为2组,治疗组33例接受复方苦参注射液联合NP方案化疗治疗,对照组32例不加用复方苦参注射液,其余同治疗组。以4周为1个周期,重复2个周期。观察近期疗效、毒副反应、生存质量以及体质量和免疫功能变化等。结果治疗组近期总有效率27%,对照组25%,2组比较无显著性差异(P>0.05);治疗组一定程度减少了化疗骨髓抑制及白细胞降低的不良反应,改善生存质量,减少体质量的降低,增强机体免疫力,与对照组比较有显著性差异(P均<0.05)。结论复方苦参注射液联合NP方案化疗治疗老年NSCLC患者是安全有效的,苦参有一定的减毒增效作用。     

Epirubicin/vinorelbine as first line therapy in metastatic breast cancer

This study was aimed at investigating the toxicity and activity of the combination epirubicin and vinorelbine in chemotherapy-naive patients with metastatic breast cancer. Fifty-one patients with measurable or evaluable metastatic breast cancer entered the study. The regimen consisted of epirubicin 90 mg/m² as a slow i.v. infusion on day 1, followed by vinorelbine 25 mg/m² by 30-minute intravenous infusion on days 1 and 8; the courses were repeated every 21 days for a maximum of 8 cycles. All the patients were assessable for toxicity and 47 were evaluable for response according to the World Health Organization (WHO) criteria.Objective responses were observed in 33 out of 47 evaluable patients (70.2%; 95% C.I. 55.1%–82.6%) with 4 complete (8.5%) and 29 partial responses (61.7%); 11 patients had stable disease (23.4%) and 3 patients progressed while on treatment. The median time to progression was 10 months (range 1 – 21) and the median overall survival was 23 months (range 2 – 32+). Neutropenia was the most frequent toxicity: a grade 4 neutropenia (WHO) was reported in 70% of 252 courses with a median duration of 3 days (range 1–6). Seventeen episodes of febrile neutropenia were observed but only 1 patient required hospital admission. Other hematologic toxicities were negligible. One patient experienced a paralytic ileus requiring hospitalization; no peripheral neuropathy such as muscle weakness or paresthesia was observed. No treatment-related cardiotoxicity was reported. The encouraging response rate achieved with epirubicin/vinorelbine, the easily manageable toxicities of the combination, and its feasibility in an outpatient setting make this combination worthy of further comparative trials with standard regimens.     

盖诺与顺铂治疗晚期非小细胞肺癌的近期疗效观察

目的 :观察国产去甲长春花碱 (盖诺 )与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 36例病人 ,盖诺 2 5mg/m2 静滴第 1、8天 ,顺铂 90mg/m2 分 3天 (第 1～ 3天 )静滴。 3周为 1周期 ,化疗 2周期后评价疗效 ,化疗期间记录毒副反应。结果 :CR 0例 ,PR 16例 ,SD 16例 ,PD 4例 ,有效率 4 4 4 % ;毒副反应主要为白细胞减少、恶心呕吐及静脉炎。结论 :盖诺与顺铂治疗晚期非小细胞肺癌疗效确切 ,毒副反应易于耐受 ,可作为晚期非小细胞肺癌的首选方案。