3200例宫颈液基细胞学筛查分析

为探讨宫颈癌普查工作中宫颈液细胞学诊断与组织病理学诊断的符合情况,对宫颈液基细胞学检查结果异常者做阴道镜及宫颈多点活检行组织病理学检查。细胞学诊断采用TBS(2001)分级报告系统,阳性诊断包括意义不明的不典型鳞状细胞(ASC-US)以上病变,细胞学结果与阳性病例组织学诊断结果进行对照分析。结果为10例HSIL组织病理诊断对照中有9例≥CINⅡ,占90%;25例LSIL组织病理学诊断中有13例CINⅠ,占52%;18例ASC-H组织病理诊断中有15例≥CINⅡ,占83.3%;123例ASC-US组织病理诊断中有47例CINⅠ,6例≥CINⅡ。宫颈细胞学检查是筛查宫颈癌及癌前病变的一种有效方法,对已婚妇女宫颈液细胞学普查中进行宫颈癌的筛查是非常必要的。     

彩色多普勒超声与磁共振成像在原发性肝外胆管癌患者诊断中的价值差异

目的：探讨彩色多普勒超声与磁共振成像（MRI）在原发性肝外胆管癌患者诊断中的应用价值。方法回顾性分析120例原发性肝外胆管癌患者彩色多普勒超声和MRI资料,比较两种检查方法诊断的阳性率、误诊率、漏诊率及梗阻部位准确率。结果两种检查方法对肝外胆管癌诊断的阳性率、误诊率及梗阻部位准确率差异无统计学意义（P＞0.05）;但彩色多普勒超声检查漏诊率明显高于MRI（P＜0.05）。结论彩色多普勒超声可作为肝外胆管癌首选影像学筛查方法,但对于临床高度怀疑肝外胆管癌、而彩色多普勒超声未检出者应加行 MRI,以提高诊断的准确性。     

雷替曲塞联合伊立替康治疗晚期结肠癌患者的疗效及安全性

目的 探讨雷替曲塞联合伊立替康治疗晚期结肠癌患者的疗效及安全性.方法 选取2018年1月至2019年12月沈阳市肛肠医院收治的50例晚期结肠癌患者作为研究对象,按治疗方案不同分为对照组与观察组,各25例.对照组采用伊立替康、5-氟尿嘧啶和亚叶酸钙治疗,观察组给予伊立替康联合雷替曲塞治疗,比较两组治疗效果及安全性.结果 ...     

非小细胞肺癌靶向治疗药物的疗效及经济性研究综述

目的综述非小细胞肺癌靶向治疗药物的临床疗效及药物经济学评价结果。方法基于非小细胞肺癌的流行病学特征和治疗发展趋势,选取临床应用较多的靶向治疗药物,并检索国内外相关文献,对其治疗非小细胞肺癌的临床疗效和经济性进行综合分析。结果吉非替尼和厄洛替尼是目前针对非小细胞肺癌最受关注的靶向治疗药物。针对不同类型的患者,两者表现出不同的临床疗效,而较少的药物经济学研究显示了其经济性。结论吉非替尼和厄洛替尼的临床疗效和经济性在总体上优于其它治疗方案,但还需更深入的研究。     

短肽型肠内营养剂对结直肠癌围手术期患者的影响

目的探讨短肽型肠内营养剂对结直肠癌围手术期患者的影响。方法选取2017年6月至2019年8月滨州医学院附属医院收治的结直肠癌手术患者104例作为研究对象,随机分为试验组和对照组,各52例。试验组采用短肽型肠内营养剂进行营养支持,对照组患者采用传统清洁灌肠,比较患者手术前1 d及术后1 d、3 d、7 d IgC、IgA、IgM、CD3^+、CD4^+、CD8^+水平和术中肠道清洁情况。结果术后7 d,CD3^+、CD4^+逐渐升高,试验组的升高情况明显优于对照组,差异有统计学意义(P<0.05)。试验组患者术中肠道清洁情况与对照组比较,差异无统计学意义(P>0.05)。结论对结直肠癌患者围手术期采用短肽型肠内营养剂进行治疗,有利于患者术后免疫功能恢复。     

Value of clinical trial narrative data to estimate the costs of adverse event management: a feasibility study

Abstract

Aims: The objective of this feasibility study was to determine the extent to which data from randomized controlled trials (RCTs) may serve as a useful source for collecting health care resource use (HCRU) for the purposes of estimating costs of managing adverse events (AEs), specifically, grade 3–4 nausea and thrombocytopenia, which may be experienced during chemotherapy treatment.

Materials and Methods: The feasibility study was conducted in four steps: (1) HCRU data were extracted from patient narratives in four phase 3 RCTs in non–small cell lung cancer; (2) missing HCRU data were imputed; (3) unit costs were applied to the resulting HCRU data set and costs of managing AEs were estimated; and (4) the overall utility of using RCT data as a source for estimating costs of AEs was evaluated.

Results: 33 nausea and 68 thrombocytopenia AEs met eligibility criteria and were evaluated in this study. Medication usage was recorded as a treatment in 76% of nausea AEs, although only 14% of the instances of medication usage included the minimum data elements required for costing. Platelet transfusions were provided in 24% of thrombocytopenia AEs; however, in only one instance were the minimum data elements recorded. Of nausea and thrombocytopenia AEs, 18% and 72%, respectively, required no missing data assumptions or imputation.

Limitations: Only two AEs were considered, and they may not be representative of all AEs in terms of suitability for use in estimating HCRU and costs of managing AEs. Not all grade 3–4 AEs met the criteria for requiring a patient narrative. HCRU data in the narratives were incomplete.

Conclusions: The usefulness of RCTs for estimating the costs of AEs may be improved by using a standardized form to collect HCRU data for key AEs, including an appropriate level of detail required to estimate costs of managing the AEs.     

Economic analysis of BRAF gene mutation testing in real world practice using claims data: costs of single gene versus panel tests in patients with lung cancer

Aims: To assess the time to BRAF testing, compare the characteristics of tested vs not-tested patients, and describe the costs for sequential vs next-generation sequencing (NGS) BRAF testing.

Methods: Patients diagnosed with lung cancer after December 1, 2013 were identified from two US claims databases; their characteristics were assessed during the 12 months before diagnosis (index date). Testing modalities were analyzed from the index date to end of continuous health plan enrollment or data availability (December 2015), based on combinations of Current Procedural Terminology (CPT) procedure codes. Time to BRAF testing was assessed using Kaplan-Meier analysis. Costs were analyzed from a payer’s perspective.

Results: A total of 28,011 patients newly-diagnosed with lung cancer were identified. Of them, 1,260 (4.5%) were tested for BRAF: 3.2% and 4.2% were tested at 6 and 12 months, respectively, after the index date. Compared to non-tested patients, tested patients were younger (58.3 vs 65.3 years; p?<?.001), had a lower Charlson Comorbidity Index (2.8 vs 2.9; p?=?.005), and a higher proportion had metastases (70.9% vs 43.4%; p?<?.001). In 76.0% of cases, BRAF was tested along with KRAS. BRAF was tested using NGS in 6.6% of cases. The average reimbursed amounts for the 10 most common CPT code combinations were $207–$2,074. Using the average costs of individual mutation tests, the total cost of sequential testing comprising KRAS, EGFR, ALK, ROS1, and BRAF tests was $3,763 ($464, $696, $1,070, $1,127, and $406, respectively), that of NGS was $2,860.

Limitations: Claims data did not include BRAF test results.

Conclusions: Among patients newly-diagnosed with lung cancer, 4.5% were tested for BRAF. Tested patients were younger and had a lower comorbidity burden, but more advanced disease. While reimbursed amounts varied greatly based on combinations of testing procedures, NGS testing was associated with cost savings compared to sequential testing of individual mutations.     

Economic evaluation for the US of nab-paclitaxel plus gemcitabine versus FOLFIRINOX versus gemcitabine in the treatment of metastatic pancreas cancer

Background: Nab-paclitaxel plus gemcitabine (NAB-P?+?GEM) and FOLFIRINOX have shown superior efficacy over gemcitabine (GEM) in the treatment of metastatic pancreatic ductal adenocarcinoma (mPDA). Although the incremental clinical benefits are modest, both treatments represent significant advances in the treatment of a high-mortality cancer. In this independent economic evaluation for the US, the aim was to estimate the comparative cost-utility and cost-effectiveness of these three regimens from the payer perspective.

Methods: In the absence of a direct treatment comparison in a single clinical trial, the Bucher indirect comparison method was used to estimate the comparative efficacy of each regimen. A Markov model evaluated life years (LY) and quality-adjusted life years (QALY) gained with NAB-P?+?GEM and FOLFIRINOX over GEM, expressed as incremental cost-effectiveness (ICER) and cost-utility ratios (ICUR). All costs and outcomes were discounted at 3%/year. The impact of parameter uncertainty on the model was assessed by probabilistic sensitivity analyses.

Results: NAB-P?+?GEM was associated with differentials of +0.180 LY and +0.127 QALY gained over GEM at an incremental total cost of $25,965; yielding an ICER of $144,096/LY and ICUR of $204,369/QALY gained. FOLFIRINOX was associated with differentials of +0.368 LY and +0.249 QALY gained over GEM at an incremental total cost of $93,045; yielding an ICER of $253,162/LY and ICUR of $372,813/QALY gained. In indirect comparison, the overall survival hazard ratio (OS HR) for NAB-P?+?GEM vs FOLFIRINOX was 0.79 (95%CI?=?0.59–1.05), indicating no superiority in OS of either regimen. FOLFIRINOX had an ICER of $358,067/LY and an ICUR of $547,480/QALY gained over NAB-P?+?GEM. Tornado diagrams identified variation in the OS HR, but no other parameters, to impact the NAB-P?+?GEM and FOLFIRINOX ICURs.

Conclusions: In the absence of a statistically significant difference in OS between NAB-P?+?GEM and FOLFIRINOX, this US analysis indicates that the greater economic benefit in terms of cost-savings and incremental cost-effectiveness and cost-utility ratios favors NAB-P?+?GEM over FOLFIRINOX.     

Cost drivers for breast,lung, and colorectal cancer care in a commercially insured population over a 6-month episode: an economic analysis from a health plan perspective

Aims: In the absence of clinical data, accurate identification of cost drivers is needed for economic comparison in an alternate payment model. From a health plan perspective using claims data in a commercial population, the objective was to identify and quantify the effects of cost drivers in economic models of breast, lung, and colorectal cancer costs over a 6-month episode following initial chemotherapy.

Research design and methods: This study analyzed claims data from 9,748 Cigna beneficiaries with diagnosis of breast, lung, and colorectal cancer following initial chemotherapy from January 1, 2014 to December 31, 2015. We used multivariable regression models to quantify the impact of key factors on cost during the initial 6-month cancer care episode.

Results: Metastasis, facility provider affiliation, episode risk group (ERG) risk score, and radiation were cost drivers for all three types of cancer (breast, lung, and colorectal). In addition, younger age (p?p?p?p?p?Conclusions: Value-based reimbursement models in oncology should appropriately account for key cost drivers. Although claims-based methodologies may be further augmented with clinical data, this study recommends adjusting for the factors identified in these models to predict costs in breast, lung, and colorectal cancers.     

The real-world cost-effectiveness of adjuvant trastuzumab in HER-2/neu-positive early breast cancer in Taiwan

Background: Trastuzumab was considered a cost-effective adjuvant treatment for HER 2-positive early breast cancer. Since 2010, the Taiwanese National Health Insurance (NHI) has started to reimburse for 1-year adjuvant treatment. This study aims to provide an updated cost-effectiveness analysis from the NHI perspective, which explores assumptions about long-term cardiac toxicity and treatment benefit of 1-year adjuvant treatment sequentially after chemotherapy.

Methods: A Markov model was used to evaluate the cost-effectiveness of 1-year adjuvant trastuzumab for HER-2/neu positive early breast cancer over a 20-year life-time horizon. A probability sensitivity analysis using Monte Carlo simulation was performed to characterize uncertainties in the expected outcomes, which are expressed as an incremental costs effectiveness ratio (ICER, cost/QALY). A willingness-to-pay threshold of 3-times the per capita gross domestic product was adopted according to the WHO definition. The Taiwan per capita gross domestic product in 2015 was US$22,355; thus, a threshold was considered as NT$2,011,950 (US$67 065, 1USD?=30 NTD in 2015).

Results: The model showed that adjuvant trastuzumab treatment in HER-2/neu positive early breast cancer yielded 1.631 quality-adjusted life-years (QALY) compared with no trastuzumab treatment. The ICER was US $51,863 per QALY gained in the base-case scenario. The Monte Carlo simulation by varying all variables simultaneously demonstrated that the probability of cost-effectiveness at the willingness-to-pay threshold of US$67,065 was 50% for 1-year adjuvant trastuzumab.

Conclusions: From this real-world study, 1-year adjuvant trastuzumab treatment is likely to be a cost-effective therapy for patients with HER-2 positive breast cancer at the willingness-to-pay threshold of 3-times GDP per capita in Taiwan.