Paving the Way for Dose Banding of Chemotherapy: An Analytical Approach

Reinhardt, Heike; Trittler, Rainer; Eggleton, Alison; Wöhrl, Stefan; Epting, Thomas; Buck, Marion; Kaiser, Sabine; Jonas, Daniel E; Duyster, Justus; Jung, Manfred; Hug, Martin; Engelhardt, Monika

doi:10.6004/jnccn.2017.0048

Cited by 11 publications

(12 citation statements)

References 8 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…As early as 2001, due to the absence of rationale to BSA-dosing for most cytotoxic and in order to simplify drug preparation, some authors have proposed to round dose (i.e., dose-banding) chemotherapy [ 34 ]. This approach is already applied in several institutions for some drugs [ 35 , 36 ]. However, due to this very easily-applicable TDM, it seems that 5-FU is probably not the best drug candidate for such an approach.…”

Section: Discussionmentioning

confidence: 99%

5-FU therapeutic drug monitoring as a valuable option to reduce toxicity in patients with gastrointestinal cancer

et al. 2018

View full text Add to dashboard Cite

Aims5-FU is used as the main backbone of chemotherapy regimens for patients with colorectal and other gastrointestinal cancers. Despite development of new strategies that allowed enhancing clinical effectiveness and tolerability of 5-FU, 10–30% of patients treated with 5-FU-based regimens experience severe treatment-related toxicity. In our study, we evaluated the 5-FU exposure-toxicity relationship and investigated the efficacy of PK-guided dosing in increasing tolerability of 5-FU-based chemotherapy.Results50.7% of patients required dose adjustments after cycle 1. Percentage of patients within 5-FU AUC range was 49.3%, 66.9%, 61.0% at cycle 1, 2 and 3 respectively (p = 0.002 cycle 1 vs cycle 2). At all 3 cycles, lower incidences of grade I/II toxicities were observed for patients below or within range compared with those above range (19.4% vs 41.3%, p < 0.001 respectively).ConclusionsOur analysis confirms that the use of BSA-guided dosing results in highly variable 5-FU exposure and strongly suggests that PK-guided dosing can improve tolerability of 5-FU based chemotherapy in patients with gastrointestinal cancers, thus supporting 5-FU therapeutic drug monitoring.Methods155 patients with gastrointestinal cancers, who were to receive 5-FU-based regimens were included in our study. At cycle 1, the 5-FU dose was calculated using patient’s Body Surface Area (BSA) method. A blood sample was drawn on Day 2 to measure 5-FU concentration. At cycle 2, the 5-FU dose was adjusted using a PK-guided dosing strategy targeting a plasma AUC range of 18–28 mg·h/L, based on cycle 1 concentration. Assessments of toxicity was performed at the beginning of every cycle.

show abstract

Section: Discussionmentioning

confidence: 99%

5-FU therapeutic drug monitoring as a valuable option to reduce toxicity in patients with gastrointestinal cancer

et al. 2018

View full text Add to dashboard Cite

show abstract

“…Errors with the potential for immediate patient safety consequences, including the prescribing of an incorrect antineoplastic drug as well as chemotherapy dosing or timing errors (eg, an insufficient gap between cycles), were subject to in‐depth analysis. Administrative errors (eg, missing patient consent) and minor dose deviations of up to ±5% were excluded …”

Section: Methodsmentioning

confidence: 99%

“…Administrative errors (eg, missing patient consent) and minor dose deviations of up to ±5% were excluded. 12,13 To evaluate each error, the incorrect chemotherapy order, previous orders, and the amended order after pharmaceutical intervention were analyzed. Patient's medical records were accessed as supporting material when appropriate.…”

Section: General Parameters and Error Causesmentioning

confidence: 99%

Avoiding chemotherapy prescribing errors: Analysis and innovative strategies

Reinhardt

Otte

Eggleton

et al. 2019

Cancer

Self Cite

View full text Add to dashboard Cite

Background At Freiburg University Medical Center, chemotherapy prescriptions are processed via a computerized physician order entry (CPOE) tool and clinically checked by a designated chemotherapy surveillance team. Any error detected is reported instantly, corrected, and prospectively recorded. The objective of the current study was to gain insight into the causes, potential consequences, and future preventability of chemotherapy prescribing errors. Methods A detailed analysis of 18,823 consecutive antineoplastic orders placed in 2013 through 2014 was performed. In cooperation with information technology (IT) specialists, the intercepted errors were analyzed for effective future prevention using IT measures. Potential error consequences were determined by case discussions between pharmacists and physicians. Results Within 24 months, a total of 406 chemotherapy prescribing errors were intercepted that affected 375 (2%) of the total orders. Errors were classified as clinically relevant in 279 of the chemotherapy orders (1.5%). In these cases, reduced therapeutic efficacy (0.44%), the need for increased monitoring (0.48%), prolonged hospital stay (0.55%), and fatality (0.02%) were avoided as potential consequences. The most efficient conventional measures for error prevention comprised checking the order history and patient’s medical record, and a detailed knowledge of chemotherapy protocols. Of all the errors analyzed, 61% would be avoided through further software development. The improvements identified are implemented through a validated next‐generation CPOE tool. Conclusions The upgraded CPOE tool can be shared across other hospitals to raise safety standards and spread potential benefits across a wider patient population. The current analysis also highlighted that approximately 30% to 40% of errors cannot be avoided electronically. Therefore, pharmacovigilance initiatives remain indispensable.

show abstract

“…In Europe and other regions, IV bags may be routinely prepared at centralized hospital pharmacy locations using aseptic techniques and then distributed to clinical oncology sites for patient administration. The practice of dose banding allows for the advance preparation of specific doses of drugs with sufficient stability [15,16]. Standardization of chemotherapy doses through dose banding has been shown to decrease drug spending [17] and improve overall safety in drug ordering [18].…”

Section: Physicochemical Stability Of the Bevacizumab Biosimilar Abpmentioning

confidence: 99%

Physicochemical stability of the bevacizumab biosimilar, ABP 215, after preparation and storage in intravenous bags

Seckute¹,

Castellanos²

2020

GaBI J

View full text Add to dashboard Cite

Study Objectives: To evaluate extended in-use stability of bevacizumab biosimilar, ABP 215, after dilution into intravenous bags, extended storage, and simulated infusion to enable advanced preparation and storage. Methods: Two lots of ABP 215 were diluted to high- (16.5 mg/mL) and low- (1.4 mg/mL) dose concentrations in two types of intravenous bag under ambient light conditions. Dosed intravenous bags were stored at 2°C–8°C for 35 days, followed by 30°C for 2 days, and each bag was infused on Day 37. Analysis of purity and physicochemical stability was performed using size-exclusion high-performance liquid chromatography (SE-HPLC), cation-exchange high-performance liquid chromatography (CEX-HPLC), reduced capillary electrophoresis-sodium dodecyl sulphate (rCE-SDS), subvisible particle detection assays, visual inspection, and by measuring protein concentration and potency. Results: No meaningful changes were seen in ABP 215 purity when analysed by SE-HPLC, CEX-HPLC and rCE-SDS following dilution, storage and infusion of two lots, bags, and doses. Protein concentration remained consistent throughout the study for all samples and no significant loss in potency was detected. No potentially proteinaceous particles or increases in subvisible particles were observed. Discussion: This study investigated the in-use stability of ABP 215 following dilution, extended storage, and infusion, that represent worst-case handling conditions. ABP 215 exhibited consistent product quality and activity, with no significant degradation observed under the conditions tested. Conclusion: ABP 215 retains physicochemical stability after dilution over the recommended dosing concentrations, extended storage, and simulated infusion. This supports the advance preparation and storage of ABP 215 in intravenous bags for infusion.

show abstract

Paving the Way for Dose Banding of Chemotherapy: An Analytical Approach

Cited by 11 publications

References 8 publications

5-FU therapeutic drug monitoring as a valuable option to reduce toxicity in patients with gastrointestinal cancer

5-FU therapeutic drug monitoring as a valuable option to reduce toxicity in patients with gastrointestinal cancer

Avoiding chemotherapy prescribing errors: Analysis and innovative strategies

Physicochemical stability of the bevacizumab biosimilar, ABP 215, after preparation and storage in intravenous bags

Contact Info

Product

Resources

About