Renal function changes and NHS resource use in breast cancer patients with metastatic bone disease treated with IV zoledronic acid or oral ibandronic acid: a four-centre non-interventional study

Abstract

Aims: To describe renal function monitoring practice in patients with metastatic bone disease (MBD) treated with IV zoledronic acid (ZA) and oral ibandronic acid (IA), the management pathways and NHS hospital resources used.

Methods: Medical records of 189 patients; IA (91), ZA (98) with primary breast cancer and MBD were reviewed, and data collected on renal monitoring and hospital visits during bisphosphonate therapy. Time and motion review of resources to administer the bisphosphonates was also conducted.

Results: Only 30% of patients given ZA and no patient given IA had baseline creatinine clearance (CrCl) recorded. Calculated baseline CrCl suggested impaired renal function in 33% ZA and 29% IA patients. Dose reductions were not made correctly in 29 ZA and 2 IA patients whose monitoring suggested it. ZA patients made more clinic and day care attendances than IA-treated patients, at twice the cost. Staff activity and patient time per visit was higher with ZA than IA.

Conclusion: Although limited by retrospective design, these results demonstrate that in many patients, CrCl is not calculated before or during treatment with bisphosphonates. Renal function deteriorated in many patients during therapy. In view of these effects, practice should be reviewed to ensure appropriate dosing.     

吸入用布地奈德混悬液雾化联合盐酸丙卡特罗治疗喘息性支气管炎患儿的疗效

目的探讨吸入用布地奈德混悬液雾化联合盐酸丙卡特罗治疗喘息性支气管炎患儿的临床效果。方法选取2018年7月至2020年12月辽宁省健康产业集团阜新矿总医院收治的喘息性支气管炎患儿96例作为研究对象,依据治疗方案不同分为观察组与对照组,各48例。对照组接受吸入用布地奈德混悬液雾化治疗,观察组在对照组基础上加用盐酸丙卡特罗治疗,比较两组疗效、症状(三凹征、肺部哮鸣音、喘息、咳嗽)消退时间及治疗前、治疗7d、14d肺功能[潮气呼气中期流速(ME)/潮气吸气中期流速(MI)、潮气呼气峰流速(PTEF)]、血清炎症介质[肿瘤坏死因子-α(TNF-α)、白细胞介素-6(IL-6)]、氧化应激指标[总抗氧化能力(T-AOC)、超氧化物歧化酶(SOD)、丙二醛(MDA)]水平。结果观察组治疗有效率为95.83%高于对照组81.25%(P<0.05);观察组三凹征消退时间、肺部哮鸣音消退时间、喘息消退时间、咳嗽消退时间短于对照组(P<0.05);治疗7 d、14 d观察组ME/MI、PTEF低于对照组(P<0.05);治疗7 d、14 d观察组血清TNF-α、IL-6水平低于对照组(P&...     

毛细支气管炎患儿潮气呼吸肺功能评价的临床研究

目的评价潮气呼吸肺功能检测评价毛细支气管炎病情的疗效。方法选择2012年1月至2013年1月于我院接受治疗的毛细支气管炎患儿75例,纳入观察组,对照组则选同期日常保健健康儿45例。比较毛细支气管炎患儿急性期和恢复期的潮气呼吸肺功能,并观察各因素与肺功能间的关系。结果观察组急性期患儿呼吸频率增快,达峰时间、达峰容积均明显低于对照组,各项指标的组间差异均有统计学意义(P<0.01)。恢复期达峰时间、达峰容积均优于本组急性期,差异有统计学意义(P<0.01)。潮气呼吸功能参数变化比较,观察组急性期患儿潮气量减低,达峰时间比、达峰容积比和吸呼时间比均明显低于对照组,组间各项指标的差异均有统计学意义(P均<0.01)。恢复期吸呼时间比好于本组急性期,差异有统计学意义(P<0.01)。结论婴幼儿潮气呼吸肺功能是评价毛细支气管炎病情的客观指标及进行早期干预治疗的依据之一。     

Inhaled nitric oxide in term/late preterm neonates with hypoxic respiratory failure: estimating the financial impact of earlier use

Abstract

Objective:

We reported recently that early use of inhaled nitric oxide therapy (iNO) for term and late preterm infants with hypoxic respiratory failure (HRF) at an oxygenation index (OI) of ≥15 and <20 is associated with earlier discharge from the hospital, relative to babies treated at OI ≥25. The objective of the present analysis is to determine whether earlier use of iNO in this cohort leads to lower cost of medical care.     

Treatment patterns and cost-effectiveness of first line treatment of advanced non-squamous non-small cell lung cancer in Medicare patients

Aim: To assess the cost-effectiveness of first-line pemetrexed/platinum and other commonly administered regimens in a representative US elderly population with advanced non-squamous non-small cell lung cancer (NSCLC).

Materials and methods: This study utilized the Surveillance Epidemiology and End Results (SEER) cancer registry linked to Medicare claims records. The study population included all SEER-Medicare patients diagnosed in 2008–2009 with advanced non-squamous NSCLC (stages IIIB–IV) as their only primary cancer and who started chemotherapy within 90 days of diagnosis. The study evaluated the four most commonly observed first-line regimens: paclitaxel/carboplatin, platinum monotherapy, pemetrexed/platinum, and paclitaxel/carboplatin/bevacizumab. Overall survival and total healthcare cost comparisons as well as incremental cost-effectiveness ratios (ICERs) were calculated for pemetrexed/platinum vs each of the other three. Unstratified analyses and analyses stratified by initial disease stage were conducted.

Results: The final study population consisted of 2,461 patients. Greater administrative censorship of pemetrexed recipients at the end of the study period disproportionately reduced the observed mean survival for pemetrexed/platinum recipients. The disease stage-stratified ICER analysis found that the pemetrexed/platinum incurred total Medicare costs of $536,424 and $283,560 per observed additional year of life relative to platinum monotherapy and paclitaxel/carboplatin, respectively. The pemetrexed/platinum vs triplet comparator analysis indicated that pemetrexed/platinum was associated with considerably lower total Medicare costs, with no appreciable survival difference.

Limitations: Limitations included differential censorship of the study regimen recipients and differential administration of radiotherapy.

Conclusions: Pemetrexed/platinum yielded either improved survival at increased cost or similar survival at reduced cost relative to comparator regimens in the treatment of advanced non-squamous NSCLC. Limitations in the study methodology suggest that the observed pemetrexed survival benefit was likely conservative.     

Quality-adjusted survival with combination nab-paclitaxel + gemcitabine vs gemcitabine alone in metastatic pancreatic cancer: a Q-TWiST analysis

Objectives:

To use the Quality-Adjusted Time Without Symptoms or Toxicities (Q-TWiST) methodology to compare the quality-of-life and survival benefits associated with the combination of albumin-bound (nab)-paclitaxel and gemcitabine vs gemcitabine alone in the first-line treatment of metastatic pancreatic adenocarcinoma.

Methods:

Total survival time through 45 months was partitioned into time before disease progression without toxicity grade ≥3 (TWiST), time with adverse event grade ≥3 (TOX), and time of disease progression (REL). Mean Q-TWiST was calculated by multiplying time spent in each health state by its respective utility (i.e., TWiST?=?1.00; TOX/REL?=?0.50, 0–1 in sensitivity analyses). Non-parametric bootstrap 95% confidence intervals (CI) were derived to assess the significance of between-treatment differences in TOX, TWiST, REL, and Q-TWiST. A relative gain in Q-TWiST (vs mean overall survival of gemcitabine) of ≥10% and ≥15% was defined as clinically important and clearly clinically important, respectively.

Results:

Patients on nab-paclitaxel?+?gemcitabine spent a significantly longer time in every state and experienced significantly greater overall Q-TWiST (+1.7 months [95% CI?=?0.8, 2.7]) than those receiving gemcitabine alone (8.2 months [95% CI?=?7.5, 8.9] vs 6.5 months [95% CI?=?5.8, 7.0]), assuming base-case utilities of TOX/REL?=?0.50. This Q-TWiST gain ranged from 1.0 month (95% CI?=?0.1, 1.9), when REL/TOX utilities were both 0, to 2.5 months (95% CI?=?1.3, 3.7), when REL/TOX utilities were both 1. Relative gains in Q-TWiST were 21% in favor of nab-paclitaxel?+?gemcitabine in the base case, and ranged from 12–30% in sensitivity analyses.

Conclusions:

There are limitations to Q-TWiST analyses, e.g., imprecision when defining duration/severity of TOX and lack of prospective collection of utilities. This analysis addressed these issues via sensitivity analyses and conservative assumptions to show that nab-paclitaxel?+?gemcitabine results in statistically significant and clinically important gains in quality-adjusted survival, when compared to gemcitabine alone, in treatment-naive metastatic pancreatic adenocarcinoma patients.     

Economic outcomes of sequences which include monoclonal antibodies against vascular endothelial growth factor and/or epidermal growth factor receptor for the treatment of unresectable metastatic colorectal cancer

Background:

Patients with unresectable, metastatic colorectal cancer with wild type Kirsten ras mutational status are eligible for sequential treatments which include monoclonal antibodies as first line (1L), second line (2L), or third line (3L) regimens.

Objective:

To compare the economic outcomes of different sequences which include monoclonal antibodies for the treatment of unresectable metastatic colorectal cancer.

Methods:

Individual drug regimens for 1L, 2L, and 3L treatments were compiled according to the clinical studies in the Summary of Product Characteristics for monoclonal antibodies. They were combined into plausible treatment sequences. Health outcomes were approximated using additive median PFS benefit, and economic outcomes were calculated with a treatment sequencing costing tool. Limitations of the analysis include the clinical trial data sources, cost assumptions, and the additive PFS approach.

Results:

Seventeen sequences were evaluated. Results of the analysis show that sequences including 1L anti-EGFRs generally have relatively low-to-medium health outcomes at the highest comparative sequence costs compared to sequences including 2L anti-EGFRs, which have lower health outcomes at the lowest cost. Sequences including 3L anti-EGFRs (sequential bevazicumab-based 1L and 2L) have the highest health outcomes, with potential cost savings of €5972–€11,676 if replacing 2L anti-EGFRs or an additional cost of €5909–€12,708 if replacing 1L anti-EGFR regimens.

Conclusion:

Clinical sequences consisting of 1L and 2L line bevacizumab followed by 3L anti-EGFR potentially yield the greatest health outcomes associated with a reasonable trade-off in additional cost when replacing 1L anti-EGFRs and are potentially cost-saving if replacing 2L anti-EGFRs, per patient per lifetime. To maximize health outcomes, optimal sequences include anti-EGFRs as 3L regimen, with an approximately equivalent trade-off in costs between the most costly (anti-EGFR 2L) and least costly (anti-EGFR 1L) sequences.     

Healthcare utilization and costs associated with COPD among SEER-Medicare beneficiaries with NSCLC

Aim: To estimate the healthcare utilization and costs in elderly lung cancer patients with and without pre-existing chronic obstructive pulmonary disease (COPD).

Methods: Using Surveillance, Epidemiology and End Results (SEER)-Medicare data, this study identified patients with lung cancer between 2006–2010, at least 66 years of age, and continuously enrolled in Medicare Parts A and B in the 12 months prior to cancer diagnosis. The diagnosis of pre-existing COPD in lung cancer patients was identified using ICD-9 codes. Healthcare utilization and costs were categorized as inpatient hospitalizations, skilled nursing facility (SNF) use, physician office visits, ER visits, and outpatient encounters for every stage of lung cancer. The adjusted analysis was performed using a generalized linear model for healthcare costs and a negative binomial model for healthcare utilization.

Results: Inpatient admissions in the COPD group increased for each stage of non-small cell lung cancer (NSCLC) compared to the non-COPD group per 100 person-months (Stage I: 14.67 vs 9.49 stays, p?<?.0001; Stage II: 14.13 vs 10.78 stays, p?<?.0001; Stage III: 28.31 vs 18.91 stays, p?<?.0001; Stage IV: 49.5 vs 31.24 stays, p?<?.0001). A similar trend was observed for outpatient visits, with an increase in utilization among the COPD group (Stage I: 1136.04 vs 796 visits, p?<?.0001; Stage II: 1325.12 vs 983.26 visits, p?<?.0001; Stage III: 2025.47 vs 1656.64 visits, p?<?.0001; Stage IV: 2825.73 vs 2422.26 visits, p?<?.0001). Total direct costs per person-month in patients with pre-existing COPD were significantly higher than the non-COPD group across all services ($54,799.16 vs $41,862.91). Outpatient visits represented the largest cost category across all services in both groups, with higher costs among the COPD group ($41,203 vs $31,140.08).

Conclusion: Healthcare utilization and costs among lung cancer patients with pre-existing COPD was ～2–3-times higher than the non-COPD group.     

中西医结合治疗肺尘埃沉着病合并慢性阻塞性肺疾病患者的疗效

目的探讨噻托溴铵联合黄根片治疗肺尘埃沉着病合并慢性阻塞性肺疾病患者的临床疗效。方法选取2017年12月至2019年2月郴州市疾病预防控制中心收治的肺尘埃沉着病合并慢性阻塞性肺疾病患者157例为观察组,选取同期郴州市疾病预防控制中心收治的肺尘埃沉着病合并慢性阻塞性肺疾病患者143例为对照组。两组均予以吸氧、止咳祛痰平喘、肺灌洗、预防感染、康复训练等常规对症治疗。对照组患者吸入噻托溴铵粉雾剂,观察组在对照组基础上口服黄根片。比较治疗前后两组中医临床症状积分、肺功能、生命质量评分及血清白细胞介素(IL-1)、肿瘤坏死因子-α(TNF-α)水平。结果治疗前,两组中医临床症状积分、用力肺活量(FVC)、第一秒钟用力呼气容积(FEV1)、每分钟最大通气量(MVV)、生命质量评分及血清IL-1、TNF-α水平比较,差异无统计学意义(P>0.05);治疗后,两组FVC、FEV1及MVV高于治疗前(P<0.05),且观察组高于对照组(P<0.05);治疗后,两组各中医临床症状积分,症状、活动受限、疾病影响评分及生命质量总评分,血清IL-1、TNF-α水平低于治疗前(P<0.05),且观察组低于对照组(P<0.05)。结论噻托溴铵联合黄根片治疗肺尘埃沉着病合并慢性阻塞性肺疾病患者可改善其临床症状与肺功能,提高生命质量。     

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.