安罗替尼胶囊治疗晚期非小细胞肺癌的有效性

目的探究安罗替尼胶囊治疗晚期非小细胞肺癌的有效性。方法从我院2018年6月-2019年6月选取44例晚期非小细胞肺癌患者,将患者随机分成两组,每组22例,一组为对照组,使用安慰剂。另一组为观察组,使用安罗替尼胶囊。观察比较两组患者的无进展生存期(progression free survival,PFS)、总生存期(overall survival,OS),以及治疗安全性。结果观察组患者的无进展生存期(PFS)和总生存期(OS)高于对照组,差异具有统计学意义(P <0.05)。观察组患者的不良反应发生率为27.27%,对照组为22.73%,两组差异无统计学意义(P> 0.05)。结论安罗替尼胶囊有利于晚期非小细胞肺癌的治疗,能够有效延长患者的无进展生存期、总生存期,并且有一定的安全性。     

非小细胞肺癌治疗的经济学评价

该文系统评价了非小细胞肺癌(NSCLC)不同分期治疗上的成本效益,并将分析重点放在新近批准的药物制剂上。对于处于局限期的病人,辅助性化疗似乎更具成本效益,但公开发表的数据较少。对于局部晚期肺癌,综合治疗(化疗,手术和/或放疗)可能是具有成本效益的,但目前缺乏高质量的经济评价。在可以接受的增量成本效益下,三代化疗可成为治疗晚期非小细胞肺癌病人的一线治疗。在二线治疗中,新的制剂(多西紫杉醇,培养曲塞和埃罗替尼)具有令人满意的成本效益。该文提示:当病人身体状态不错时,大部分非小细胞肺癌的治疗是具备成本效益的;多数情况下,每一个生命年病人的增量成本效益比率低于50 000美元。     

观察盐酸安罗替尼治疗晚期非小细胞肺癌的临床效果

目的:观察对晚期非小细胞肺癌患者应用盐酸安罗替尼的治疗效果。方法:选取2019年2～2020年2月以非小细胞肺癌为主要诊断,同时已经发展为晚期的患者42例,采用随机对照法以及排除法分为对照组以及观察组,对照组患者采用支持治疗,观察组患者采用盐酸安罗替尼治疗,观察两组患者的临床指标。结果:对照组患者缓解有效率为4.76%,观察组患者为23.81%,两者相比不具有统计学意义(P0.05);病情控制程度方面,对照组患者为57.14%,观察组患者为85.71%,数据对比有意义(P0.05);在不良反应结果方面,两组数据相比也具有意义(P0.05)。结论:对晚期非小细胞肺癌患者应用盐酸安罗替尼具有积极的临床效果,不良反应可以得到控制。     

采用克唑替尼治疗EML4-ALK阳性的晚期非小细胞肺癌的研究

目的:探讨使用克唑替尼治疗EML4-ALK阳性的晚期非小细胞肺癌的临床疗效分析。方法:将我院肿瘤科2013年7月-2015 年7月期间收治的确诊为EML4-ALK阳性的晚期非小细胞肺癌患者30例,将患者分为治疗组和对照组各15例,其中对对照组的患者进行多西他赛单药化疗,而治疗组的患者使用口服克唑替尼治疗,以连续治疗21天为一个疗程,治疗三个疗程之后对比两组患者的临床资料,分析患者的临床治疗效果。结果:治疗组的患者当中有9例患者的肿瘤细胞得到了有效的控制,总的治疗有效率为60%,而对照组的患者当中的治疗有效率为40%,结果具有明显差异(P0.05)。同时,治疗组患者有1例患者出现了明显的呕吐副作用,而对照组当中有6例患者发生不良反应。讨论:使用克唑替尼用于治疗EML4-ALK阳性的晚期非小细胞肺癌患者不仅较传统的治疗药物有更好的效果,而且药物不良反应更低,因此可以考虑将克唑替尼作为治疗EML4-ALK阳性的晚期非小细胞肺癌的一线治疗方案。     

厄洛替尼治疗90例晚期非小细胞肺癌临床观察

目的:观察并讨论厄洛替尼治疗晚期非小细胞肺癌的临床疗效对照分析。方法:选取2012年12月~2015年12月来我院治疗的90例晚期非小细胞肺癌患者实施回顾性分析,随机分成两组。两组患者均接受临床常规治疗,给予参照组患者多西他赛治疗,给予实验组患者厄洛替尼治疗。观察两组患者在经过各自治疗后的临床总疗效、疾病控制率及不良反应。结果:经比较得知,采取厄洛替尼治疗的实验组患者在临床疗效及疾病控制率方面明显优于参照组,两组患者存在显著差异(P0.05),具有统计学意义。结论:对晚期非小细胞肺癌患者施以厄洛替尼靶向治疗具有较高的临床价值,有助于延长患者生存期,安全性高,值得加大临床的推广及应用。     

医保谈判对多纳非尼治疗肝细胞癌药品经济性的影响

目的 立足于我国卫生服务体系角度，评价医保谈判前后，多纳非尼对比索拉非尼一线治疗晚期肝细胞癌（hepatocellular carcinoma, HCC）的药品经济性。方法 基于一项在中国晚期肝细胞癌患者开展的临床试验（ZGDH3研究）及已发表的文献数据，构建分区生存模型模拟患者长期生存获益和治疗成本，支付意愿（willingness to pay, WTP）阈值设定为1～3倍我国2021年人均国内生产总值（gross domestic product, GDP），并进行单因素敏感性分析和概率敏感性分析以检验模型稳健性。结果 基础分析显示，医保谈判前后，多纳非尼组对比索拉非尼组的增量成本-效果比（incremental cost-effectiveness ratio, ICER）分别为280 745.92元/质量调整生命年（quality-adjusted life year, QALY）与181 477.87元/QALY（低于3倍人均GDP,242 928元）；单因素敏感性分析显示，多纳非尼成本、疾病进展（progressed disease, PD）状态效用值是影响ICER的主要...     

分子靶向药物吉非替尼治疗晚期非小细胞肺癌的疗效观察

目的观察分子靶向药物吉非替尼治疗晚期非小细胞肺癌的临床效果。方法选取我院2015年6月至2017年6月收治的40例晚期非小细胞肺癌患者,随机分为研究组和对照组各20例。对照组采用传统常规化疗方案治疗,研究组应用分子靶向药物吉非替尼治疗。对比分析两组患者的疾病控制率和不良反应发生率。结果研究组的疾病控制率为95%,明显高于对照组的70%,差异有统计学意义(P<0.05)。研究组的不良反应发生率为10%,明显低于对照组的40%,差异有统计学意义(P<0.05)。结论分子靶向药物吉非替尼治疗晚期非小细胞肺癌的效果较好,能够有效控制病情发展,不良反应发生率较低,安全性较高,值得临床推广。     

信迪利单抗对比卡瑞利珠单抗一线治疗晚期非鳞状非小细胞肺癌的经济学评价

目的：对信迪利单抗联合化疗相比于卡瑞利珠单抗联合化疗治疗晚期非鳞状非小细胞肺癌的经济性展开评价。方法：采用Orient 11及Camel试验数据，基于分数多项式模型构建非恒定风险比例的网状Meta分析；采用分区生存模型进行决策分析；考虑到参数的不确定性，进行单因素敏感性分析与概率敏感性分析，并绘制龙卷风图、成本效果散点图及成本效果可接受曲线。结果：卡瑞利珠单抗组和信迪利单抗组总成本分别为113 656元和147 240元，总效用值分别为1.01和1.60QALY,ICER为56 922，显著低于研究阈值，信迪利单抗组具有明显的成本效果优势。结论：信迪利联合化疗治疗晚期非鳞状非小细胞肺癌相比于卡瑞利珠单抗联合化疗具有经济学优势。     

罗替高汀与普拉克索治疗帕金森病的成本效果分析

目的:分析罗替高汀与普拉克索(常释剂/缓释剂)治疗帕金森病的成本效果。方法:基于卫生服务体系的角度,根据临床指南中的标准临床路径及H&Y分级,采用动态Markov模型,模拟患者终生的直接医疗成本和质量调整生命年。结果:在治疗帕金森病中,与普拉克索常释剂相比,罗替高汀提高0.0629个质量调整生命年,费用提高70361.06元,增量成本效果比为1118617.81元/QALY;与普拉克索缓释剂相比,罗替高汀提高0.1712个质量调整生命年,费用提高52325.57元,增量成本效果比为305640.01元/QALY。结论:与普拉克索(常释剂与缓释剂)相比,罗替高汀可以提高帕金森病患者质量调整生命年,同时也增加医疗成本;以世界卫生组织3倍人均GDP作为判断阈值,对比普拉克索,罗替高汀不具有成本效果。     

放疗联合吉非替尼治疗EGFR突变型晚期非小细胞肺癌的疗效

目的探讨放疗联合吉非替尼在EGFR基因阳性晚期非小细胞肺癌治疗中的有效性及安全性。方法选取我院2012年3月至2014年3月收治并经病理证实的EGFR突变阳性非小细胞肺癌患者62例,其中34例实施放疗与吉非替尼联合治疗的患者作为观察组,28例吉非替尼维持治疗患者作为对照组。定期随访后对两组治疗患者进行疗效和安全性评价。结果观察组疾病控制率为91.18%,明显高于对照组的67.86%,差异具有统计学意义(P<0.05)。观察组中位生存时间为11.5月,与对照组(10月)相比差异不显著(P>0.05),两组患者1年生存率相比差异不显著(P>0.05)。结论使用放疗联合吉非替尼的综合疗法并发症发生率低,能显著改善晚期肺癌近期疗效,但对总生存时间的影响仍需进一步研究。     

Cost-Effectiveness of Cemiplimab Versus Standard of Care in the United States for First-Line Treatment of Advanced Non-small Cell Lung Cancer With Programmed Death-Ligand 1 Expression ≥50%

ObjectivesThis study aimed to evaluate the cost-effectiveness, from a US commercial payer perspective, of cemiplimab versus other first-line treatments for advanced non-small cell lung cancer with programmed death-ligand 1 expression ≥50%.MethodsA 30-year “partitioned survival” model was constructed. Overall survival and progression-free survival were estimated by applying time-varying hazard ratios from a network meta-analysis of randomized clinical trials. Overall survival and progression-free survival were estimated from EMPOWER-Lung 1 (cemiplimab monotherapy vs chemotherapy) and KEYNOTE-024 and KEYNOTE-042 (pembrolizumab monotherapy vs chemotherapy). Drug acquisition costs were based on published 2020 US list prices. A 3% discount rate was applied to life-years, quality-adjusted life-years (QALYs), and costs. A deterministic analysis was performed on the base case; 1-way sensitivity and probabilistic sensitivity analyses assessed model and parameter uncertainties.ResultsCemiplimab was associated with increased time in the “preprogression” (13.08 vs 7.90 and 6.08 months) and “postprogression” (47.30 vs 29.49 and 14.78 months) health states versus pembrolizumab and chemotherapy, respectively. Compared with pembrolizumab and chemotherapy, cemiplimab generated 1.00 (95% CI ?0.266 to 2.440) and 1.78 (95% CI 0.607-3.20) incremental QALYs, respectively, with incremental cost-effectiveness ratios of $68 254 and $89 219 per QALY for cemiplimab versus pembrolizumab and cemiplimab versus chemotherapy, respectively. The probability of cemiplimab being cost-effective at a willingness-to-pay threshold of $100 000 to $150 000 per QALY was 62% to 76% versus pembrolizumab and 56% to 84% versus chemotherapy.ConclusionsFindings suggest that cemiplimab, versus pembrolizumab or versus chemotherapy, is a cost-effective first-line treatment option for advanced non-small cell lung cancer with programmed death-ligand 1 expression ≥50%.     

Cost-Effectiveness and Value of Information of Erlotinib,Afatinib, and Cisplatin-Pemetrexed for First-Line Treatment of Advanced EGFR Mutation-Positive Non-Small-Cell Lung Cancer in the United States

ObjectivesTo determine the cost-effectiveness of tyrosine kinase inhibitors erlotinib or afatinib, or chemotherapy cisplatin-pemetrexed, for first-line treatment of advanced epithelial growth factor receptor mutation-positive non–small-cell lung cancer in the United States. We also assessed the expected benefit of further research to reduce uncertainty regarding which treatment is optimal.MethodsWe developed a Markov model to compare the cost-effectiveness of erlotinib, afatinib, and cisplatin-pemetrexed. Model transition and adverse-effect probabilities were from two published phase III trials: EURTAC (Erlotinib versus standard chemotherapy as first-line treatment for European patients with advanced EGFR mutation-positive non-small-cell lung cancer) and LUX-Lung (Afatinib versus cisplatin-based chemotherapy for EGFR mutation-positive lung adenocarcinoma) 3. EURTAC survival estimates were corrected for patients entering the trial with more severe disease, compared with LUX-Lung 3. Health utilities and costs were from national estimates or the published literature. Inputs were modeled as distributions for probabilistic sensitivity analysis and expected value of perfect information (EVPI) analysis to estimate the expected benefit of reducing uncertainty regarding the decision of optimal treatment.ResultsIn the base case, both tyrosine kinase inhibitors were more cost-effective than cisplatin-pemetrexed. Erlotinib had an incremental cost-effectiveness ratio of $61,809/quality-adjusted life-year (QALY) compared with afatinib. The acceptability curve showed that erlotinib was the optimal treatment at a willingness-to-pay threshold of $100,000/QALY (10-year population EVPI = $85.9 million). At a willingness-to-pay threshold of $50,000/QALY to $70,000/QALY (EVPI = $211.5 million–$261.8 million), however, there was considerable uncertainty whether erlotinib or afatinib was the optimal treatment.ConclusionsOur analysis suggests that erlotinib is the preferred first-line treatment for advanced epithelial growth factor receptor mutation-positive non–small-cell lung cancer. Further research comparing erlotinib and afatinib is potentially justified, although accurate data are needed on the required cost and sample size of the trial.     

Cost-Effectiveness of First-Line Pembrolizumab Monotherapy Versus Chemotherapy in High Programmed Death-Ligand 1 Advanced Non–Small Cell Lung Cancer in the Irish Healthcare Setting

ObjectivesThis study aimed to assess the cost-effectiveness of pembrolizumab monotherapy in the first-line treatment of advanced non–small cell lung cancer (NSCLC) in adults whose tumors expressed programmed death-ligand 1 (PD-L1) with a tumor proportion score (TPS) ≥ 50% in the Irish healthcare setting.MethodsEffectiveness inputs were derived from the 5-year analysis of KEYNOTE-024 phase III clinical trial. The intervention was pembrolizumab monotherapy; the comparator was a weighted average of the 5 chemotherapy regimens from the trial. The population included those with previously untreated advanced PD-L1 TPS ≥ 50% NSCLC. A de novo partitioned survival model was developed. Survival modeling was done using Bayesian model averaging on fitted parametric functions. Costs included drug acquisition, treatment initiation, administration and monitoring, adverse events, subsequent treatments, and terminal care. Costs and health state utilities were sourced from the literature and Irish sources. The model had a 20-year time horizon. The perspective taken was the Health Service Executive. A 4% discount rate was applied. Outcomes were expressed as an incremental cost-effectiveness ratio (ICER), measured in terms of incremental costs per quality-adjusted life-year (QALY). Probabilistic sensitivity analysis and 1-way sensitivity analyses were conducted.ResultsThe model estimated a base case ICER of €54 237 per QALY. The probabilistic sensitivity analysis estimated an average ICER of €54 568 per QALY and a 11% probability of cost-effectiveness at the Irish cost-effectiveness threshold of €45 000 per QALY.ConclusionAt the current list price, first-line pembrolizumab monotherapy is not considered cost-effective for the treatment of advanced PD-L1 TPS ≥ 50% NSCLC in the Irish healthcare setting.     

吉西他滨单药维持治疗晚期非小细胞肺癌的疗效及安全性评估

目的评价吉西他滨单药维持治疗晚期非小细胞肺癌的疗效及安全性。方法选择秦皇岛市第二医院2006-2010年确诊的ⅢB~Ⅳ期非小细胞肺癌患者,经4周期标准紫杉醇、顺铂化疗方案治疗病情未进展的患者86例,随机分为治疗组和对照组,治疗组43例给予吉西他滨单药维持及最佳支持治疗,对照组43例给予最佳支持治疗,观察比较两组患者的疗效、生活质量及药物毒副作用。结果观察组治疗疗效和生活质量方面的总有效率分别为88.4%、95.3%,均明显高于对照组的69.8%、79.1%,组间差异均有统计学意义（P〈0.05）;治疗组的毒副作用发生情况明显低于对照组,两组间差异有统计学意义（P〈0.05）。结论吉西他滨单药维持治疗晚期非小细胞肺癌临床疗效满意,安全性高,是最佳的治疗方案之一。     

The Potential Clinical and Economic Outcomes of Pharmacogenomic Approaches to EGFR-Tyrosine Kinase Inhibitor Therapy in Non–Small-Cell Lung Cancer

Objectives:  Pharmacogenomic applications in oncology offer significant promise, but the clinical and economic implications remain unclear. The objective of this study was to evaluate the potential cost-utility of implementing epidermal growth factor receptor (EGFR) testing before initiating second-line therapy for advanced refractory non–small-cell lung cancer (NSCLC).
Methods:  We developed a decision analytic model to evaluate the cost-utility of EGFR protein expression or gene copy number testing compared to standard care with erlotinib in refractory advanced NSCLC patients. Costs and utilities were obtained from publicly available sources. We performed sensitivity analyses to evaluate uncertainty in the results.
Results:  The quality-adjusted life expectancies for erlotinib, EGFR protein expression testing, and gene copy number testing were: 0.44, 0.48, and 0.50 quality-adjusted life years (QALYs); and the costs were: $57,238, $63,512, and $66,447, respectively. The most cost-effective testing option, EGFR gene copy number testing, produced an incremental cost-effectiveness ratio of $162,018/QALY compared to no testing (erlotinib). The results were most sensitive to the survival estimates, health state utilities, and cost of disease progression. In the probabilistic sensitivity analyses, erlotinib without testing was the optimal treatment strategy until the $150,000/QALY willingness-to-pay threshold, after which gene copy testing was optimal. The discounted expected value of perfect information at a $100,000/QALY threshold in the USA over 5 years was $31.4 million.
Conclusions:  The study results suggest that EGFR pharmacogenomic testing has the potential to improve quality-adjusted life expectancy in the treatment of refractory NSCLC by a clinically meaningful margin at a value commensurate with the approved therapies in this setting. Additional research in this area is warranted.     

New therapies for non-small cell lung cancer

Lung cancer is one of the most frequent causes of death from cancer. Non-small cell lung cancer represents approximately 80% of the total pulmonary malignancies. Unfortunately, most non-small cell lung cancer patients present advanced disease at diagnosis and a very poor prognosis. Despite advances in our understanding of the molecular and genetic basis of non-small cell lung cancer, and improvement in therapy with surgery, conventional chemotherapy, and radiation, 5-year survival for patients with this diagnosis remains poor and the disease remains a clinical challenge. However, strategies of molecular based therapies are in development and it is hoped that these new approaches will continue to improve survival for patients with advanced lung cancer. Any categorization of these drugs is hard, with overlap in several features. The main investigated agents are epidermal growth factor receptor (EGFR) family inhibitors, angiogenesis inhibitors and antivascular drugs, signal transduction inhibitors, apoptosis inducers, eicosanoid pathway inhibitors and immunotherapeutic drugs. To date, few of these new drugs can offer trust of a substantial influence on the natural history of non-small cell lung cancer, and disappointing results are more commonly reported than encouraging ones. Nevertheless, tailored treatment for non-small cell lung cancer patients may represent a further chance of tumor control and symptom palliation. This review presents an overview of molecular targeted therapy in non-small cell lung cancer.     

The Economic Potential of Smoking Cessation Interventions at the Point of Diagnosis of Non–Small Cell Lung Cancer

ObjectivesStopping smoking has proven benefits in nearly all illnesses but the impact and health economic benefits of stopping smoking after a diagnosis of lung cancer are less well defined. We assessed the cost-effectiveness of smoking cessation (SC) services for patients with newly diagnosed lung cancer against current usual care, where patients are unlikely to receive SC service referral.MethodsA health economic model was constructed in Excel. The modelled population comprised of patients with a new diagnosis of non–small cell lung cancer (NSCLC). Data from the LungCast data set (Clinical Trials Identifier NCT01192256) were used to estimate model inputs. A structured search of published literature identified inputs not represented in LungCast, including healthcare resource use and costs. Costs were estimated from a 2020/2021 UK National Health Service and Personal Social Services perspective. The model estimated the incremental quality-adjusted life-year (QALY) gained in patients with newly diagnosed NSCLC receiving targeted SC intervention than those receiving no intervention. Extensive one-way sensitivity analyses explored input and data set uncertainty.ResultsIn the 5-year base case, the model estimated an incremental cost of £14 904 per QALY gained through SC intervention. Sensitivity analysis estimated an outcome range of between £9935 and £32 246 per QALY gained. The model was most sensitive to the estimates of relative quit rates and expected healthcare resource use.ConclusionThis exploratory analysis indicates that SC intervention for smokers with patients with newly diagnosed NSCLC should be a cost-effective use of UK National Health Service resources. Additional research with focused costing is needed to confirm this positioning.     

吉非替尼治疗晚期非小细胞肺癌15例临床观察

目的观察吉非替尼治疗晚期非小细胞肺癌临床疗效及毒副反应。方法研究2008年6月至2010年6月晚期非小细胞肺癌患者口服吉非替尼治疗,250mg/d,观察其近期疗效及毒副反应。结果 15例患者中CR13.3%（2/15）、PR33.3%（5/15）、SD33.3%（5/15）、PD 20.0%（3/15）、临床获益率（CR＋PR＋SD）80.0%。毒副反应为唑疮样皮疹80.0%（12/15）、急性间质性肺病20.0%（3/15）、转氨酶升高13.3%（2/15）、腹泻13.3%（2/15）。结论吉非替尼治疗晚期非小细胞肺癌疗效较好,毒副反应轻微,临床获益率高,能明显改善患者的生活质量。     

Cost–Utility Analysis of Topical Intranasal Steroids for Otitis Media with Effusion Based on Evidence from the GNOME Trial

ObjectivesTo estimate the cost-effectiveness of topical intranasal steroids for the treatment of otitis media with effusion (OME) in primary care from the perspective of the UK National Health Service.MethodsAn economic evaluation was conducted based on evidence from the double-blind, randomized, placebo-controlled GPRF [General Practice Research Framework] Nasal Steroids for Otitis Media with Effusion (GNOME) trial. Participants comprised 217 children aged 4–11 years who had at least one episode of otitis media or related ear problem in the previous 12 months and had tympanometrically confirmed bilateral OME. Children were randomly allocated to receive either mometasone furoate 50 µg or placebo spray once daily into each nostril for 3 months. The main outcome measure was the incremental cost per quality-adjusted life-year (QALY) gained for topical steroids compared with placebo. The nonparametric bootstrap method was used to present cost-effectiveness acceptability curves at alternative willingness to pay thresholds.ResultsChildren receiving topical steroids accrued nonsignificantly higher costs (incremental cost/child: £11, 95% confidence interval [CI]: ?£199 to £222) and nonsignificantly fewer QALYs (incremental QALY gain/child: ?0.0166, 95% CI: ?0.0652 to 0.0320) than those receiving placebo. Topical steroids had a 24.19% probability of being cost-effective at a £20,000 per QALY gained threshold, a 23.82% probability of being more effective and a 46.25% probability of being less costly. Sensitivity and subgroup analyses showed incremental costs and benefits to be highly sensitive to the methods used and the patient group considered, although differences between groups did not reach statistical significance in any analysis.ConclusionsTopical steroids are unlikely to be a cost-effective treatment for OME in general practice.