Oral Anticancer Drugs Research Articles

Key factors underlying the willingness of patients with cancer to participate in medication redispensing.

Redispensing medication unused by patients to other patients could reduce the environmental burden of medication waste. Simultaneously, associated financial loss could be reduced, particularly for expensive medication such as oral anticancer drugs. An important determinant for successful medication redispensing is patient participation. To identify key factors underlying the willingness of patients with cancer to participate in the redispensing of unused oral anticancer drugs. Semi-structured interviews via telephone or video call were conducted with adult patients diagnosed with cancer from two Dutch hospitals. The interview guide was framed using the COM-B model for behavioural change, to elicit patients' capability, opportunity and motivation to participate in medication redispensing. Questions were related to patients' willingness to accept redispensed medication, reasons thereof, perceived concerns and needs. Inductive thematic analysis was applied. Seventeen patients (aged 38-82 years, 71% female), with nine different types of cancer participated. The majority of participants supported medication redispensing. Four categories of key factors underlying the willingness of patients with cancer to participate in medication redispensing were identified. First, the driver for participation was having positive societal impact, relating to affordability and sustainability of healthcare. Second, having trust in product quality was a requirement, influenced by preconceived beliefs, quality assurance and patients' knowledge of this process. Third, a facilitator for participating in medication redispensing was adequate provision of information. This concerned awareness of medication waste, information about medication redispensing, support from healthcare providers and other patients, and insight into medication dispensing history. Last, a convenient process for returning unused medication to pharmacies would facilitate participation in medication redispensing. The willingness of patients with cancer to participate in medication redispensing relates to a drive for achieving positive societal impact, provided that medication is of high quality, there is adequate information provision and a convenient process.

CONTACT-Patient-Centred Care Questionnaire to assess care for patients treated with oral anticancer drugs: Development and psychometric validation.

Instruments to measure quality of patient-centred care (PCC) for the rapidly growing population of patients treated with oral anticancer drugs (OACD) are lacking. The aim of this study was to develop a valid and reliable instrument to assess PCC in the context of OACD. The CONTACT-Patient-Centred Care Questionnaire (CONTACT-PCCQ) was developed based on a validated set of key elements (KEs) for patient-centred education and counselling in patients taking OACD, and face validity was evaluated by means of cognitive interviews. In 16 Belgian hospitals, adult patients treated with OACD were asked to complete the questionnaire. Construct validity was investigated through exploratory factor analyses (EFAs) and internal consistency of the subscales was examined using Cronbach's alpha. The initial 86-item instrument was completed by 464 patients. Each EFA confirmed the a priori PCC-based structure of the subscales. However, EFA revealed more than one factor for two of the subscales. Therefore, multiple subsections within these subscales were created. Based on factor loadings and item content, six items were removed. This resulted in a final 80-item instrument with seven subscales and five subsections. Cronbach's alpha for the subscales and subsections ranged between 0.732 and 0.918, which implies adequate internal consistency. A final instrument with 80 items divided into seven subscales, covering all six dimensions of PCC, was obtained. The CONTACT-PCCQ has acceptable psychometric properties, supporting its use as a measure to assess care experiences of patients treated with OACD.

Evaluation of a pharmacist-led video consultation to identify drug interactions among patients initiating oral anticancer drugs.

1592 Background: The past decade has seen a dramatic increase in the number of oral anti-cancer drug (OACD) approvals in the United States. Though polypharmacy and drug-drug interactions (DDIs) likely contribute to OACD toxicity, the prevalence of these features in patients on OACDs remains largely unknown. We aimed to evaluate a one-time 30-minute pharmacist-led video consultation among metastatic cancer patients initiating OACDs to identify medication list inaccuracies as well as the prevalence, characteristics, and severity of OACD-related potential DDIs. Methods: We conducted a single-arm, prospective telehealth intervention study among 29 patients initiating OACDs to evaluate a one-time 30-minute pharmacist-led video consultation. The video visits focused on identifying and discussing polypharmacy and potential DDIs, and pharmacists then communicated recommendations to each patient's oncologist. We estimated the prevalence, characteristics (QTc prolongation, absorption interactions, etc.), and severity of OACD-related potential DDIs. Lexicomp and Micromedex were used to assess potential DDIs and measure severity on a standardized scale (A – D, X). In addition, we assessed the prevalence of medication list inaccuracies, polypharmacy, and patient satisfaction. Results: Twenty-five patients completed the intervention (86% completion rate) of whom 40% were 75 years of age or older and 60% were men. The majority were white (68%) and non-Hispanic (76%). Sixteen patients (68%) had a solid tumor diagnosis. Nearly half (48%) were insured by Medicare. The median number of medications per patient was 9 with a range of 4 – 21, and 96% of patients had at least 5 prescriptions listed. The median number of medication list errors was 2 with a range of 0 – 16, with at least 1 error for 76% and more than 1 error for 52% of patients. Pharmacists identified potential OACD-related interactions in 9 cases (40%). These included change in drug absorption or metabolism (7), QTc prolongation (1), hypotension (1), and bleeding (1). Interactions were classified as either category C (8) or D (2), requiring close monitoring or a change in treatment, respectively. All patients expressed a high level of satisfaction with the video visit. Conclusions: Polypharmacy, medication list errors, and potential DDIs are prevalent among patients initiating OACDs despite use of an electronic medical record requiring medication reconciliation. Our study suggests that a one-time remote 30-minute pharmacist-led video consultation can effectively identify and address OACD-related potential DDIs, which may decrease medication complexity and improve adherence in this population.

Cyclin-dependent kinase 4/6 inhibitor treatment use in women treated for advanced breast cancer: Integrating ASCO/NCODA patient-centered standards in a community pharmacy.

Outpatients treated with oral anti-cancer drugs, including selective cyclin-dependent kinase 4/6 inhibitors (CDK4/6i), may benefit from a pharmacy practice setting adapted to support proper oral anti-cancer drug monitoring. This real-world study aimed to characterize patient-centered pharmacy practice aligned with American Society of Clinical Oncology (ASCO)/National Community Oncology Dispensing Association (NCODA) standards and to describe its impact on CDK4/6i treatment use. This retrospective study included women with confirmed hormone receptor-positive/human epidermal growth factor 2 negative locally advanced or metastatic breast cancer treated with either palbociclib, abemaciclib or ribociclib combined with letrozole or fulvestrant. Pharmacists collected patient characteristics, clinical activities, and treatment patterns using data from the pharmacy chart. CDK4/6i treatment adherence rates were estimated based on medication claims data. Time-to-treatment discontinuation, a proxy for time-to-event, was assessed using the Kaplan-Meier estimate. Of the 195 patients assessed for eligibility, 65 were included in this study. The median observation duration was 13.6 months. An average of seven pharmaceutical care activities (range 2.8-21.7) per patient was documented for each treatment cycle. The mean proportion of days covered was 89.6%. The median time-to-treatment discontinuation was estimated at 44.2 months in patients treated with CDK4/6i + letrozole and 17.0 months in patients treated with CDK4/6i + fulvestrant. The average relative dose intensity was 85%, and the benefits of treatment were maintained regardless of the relative dose intensity levels. A structured patient-centered pharmacy practice model integrating the ASCO/NCODA patient-centered standards and ongoing communication with patients and healthcare providers ensure timely refills, close monitoring, and allows patients to achieve high adherence and persistence rates comparable to those reported in clinical trials.

Ökonomische Aspekte bei der Versorgung von Patient*innen mit neuen oralen Tumortherapeutika: Erkenntnisse aus der AMBORA-Studie

IntroductionThe number of prescriptions and costs of oral anticancer drugs are increasing. Therapy discontinuation due to, for example, side effects, progression, or death, often lead to medication wastage. While evidence exists for the economic value of wasted injectable chemotherapeutics, there is a lack of data for oral anticancer drugs in Germany. MethodsThe multicenter AMBORA trial investigated 202 patients, who had been newly started on new oral anticancer drugs, over 12 weeks and analyzed the outpatient prescription data of patients who discontinued treatment. The amount of medicines wasted and their costs were determined using the pharmacy retail price. Defined daily doses and prescription data from the AOK Bayern, a German statutory health care insurance company, were used to extrapolate these costs. ResultsWithin 12 weeks, 24.8 % of the AMBORA patients discontinued oral anticancer treatment (50 of 202). Prescription data of 34 patients were evaluable. In total, 1,693 tablets/capsules with a value of 112,212 euros were wasted. The approximate extrapolation to the prescription volume of the AOK Bayern resulted in an estimated wastage of 3.49 million euros in 12 weeks. DiscussionMedication wastage due to discontinuation of new oral anticancer drug therapy leads to a considerable financial burden. Regarding rising prescription numbers and therapy costs in oncology, measures to reduce wastage of oral anticancer drugs should be initiated. ConclusionClinical pharmacological / pharmaceutical care including medication reconciliation and review, side effect management and patient counseling to optimize adherence and medication intake behavior, contributes to a reduction of therapy discontinuations, thereby reducing drug wastage. To further reduce drug wastage small (initiation) packages, which are currently not always available for an economic prescription, play an important role. The practice of partial prescription fills, which is already practiced internationally, should also be further discussed in Germany.

Improved home management of oral pediatric anticancer drugs as a result of an intervention comprising practical training, written instructions and movie clips: A pilot study.

Long term treatment of pediatric patients with oral anticancer drugs (OADs) requires the parents/caregivers to prepare the drug at home. The handling procedures in the home setting are, however, not regulated by Swedish law and the parents are often left without guidance on how to handle OADs in a safe way. The aim of this study was to increase understanding of how OADs are handled by parents/caregivers in the home setting before and after an intervention. Parents of pediatric cancer patients were observed and videotaped during their handling of OADs in the home setting before and after the intervention. During the intervention, the parents were provided with written instructions, movie clips and practical training on handling the OADs. Four checklists were used to compare and score the four handling procedures (measuring an oral suspension, cutting tablets, dissolving tablets, and opening capsules) for each parent before and after the intervention. The intervention significantly improved the OAD handling procedures among the studied parents. The median score for correct handling was 19% (IQR: 3.6 to 30%) before the intervention and 89.5% (IQR: 71.5 to 94.5%) after the intervention (p < 0.0001). An intervention comprising practical training and information presented in different forms improved the handling of OADs at home by parents. There is an urgent need to implement this method in all oncology centers in Sweden, educate HCPs to standardize the presentation of information. There is also a great need to provide parents with age-appropriate oral drug formulations from the local hospital pharmacies in Sweden.

Acalabrutinib in the management of chronic lymphocytic leukaemia

Chronic lymphocytic leukaemia (CLL) is the most common leukaemia worldwide. This article explores the management of CLL with a particular focus on the role of acalabrutinib in managing patients with CLL under NICE guidelines. Acalabrutinib is a potent bruton tyrosine kinase (BTK) inhibitor. Its use requires careful assessment, monitoring and early intervention to minimise side effects and maintain patients on treatment. Continuity of patient care and promotion of adherence and compliance is essential, particularly in light of the indefinite treatment duration. Patient education is central to therapeutic adherence of oral anti-cancer drugs, and nurses are ideally positioned to educate and support patients with CLL in collaboration with pharmacy colleagues. The benefits of nurse/pharmacy-led oral therapy clinics include continuity of care, consistency in information provision, efficient use of time with patients and carers, improved therapeutic relationships and an enhanced patient experience.

Assessment of Patient Reported Outcomes (PROs) in Outpatients Taking Oral Anticancer Drugs Included in the Real-Life Oncoral Program.

Simple SummaryPatients receiving oral anticancer agents (OAAs) have a substantial symptom burden. Given the trend toward patient-centered care, the use of patient-reported outcomes (PROs) seems appropriate to secure medication management, and to improve clinical decision-making. The aim of this study was to assess symptoms potentially related to adverse events experienced by cancer outpatients treated by OAAs using PROs. In total, 407 questionnaires were completed by 63 patients, in which 2333 symptoms were reported. Almost three-quarters (74.6%) reported at least one high-level symptom. The symptoms most commonly experienced were fatigue, various psychological disorders and general pain. This initiative is the first step in the implementation of symptom assessment by PROs in patients treated by OAAs. The results highlight the need for close coordination between community and hospital health professionals, and the integration of patient self-reporting systems in oncologic clinical practice.Background In previous studies, patient-reported outcomes (PROs) have been shown to improve survival in cancer patients. The aim of the present study was to assess symptoms potentially related to adverse events experienced by cancer outpatients treated by oral anticancer agents (OAAs) using PROs. Methods Between September 2018 and May 2019, outpatients starting OAAs were included in a 12-week follow-up to assess 15 symptoms listed in the National Cancer Institute PRO Common Terminology Criteria for Adverse Events, using a 5-point scale of severity or frequency. Patients were requested to alert a referral nurse or pharmacist when they self-assessed high-level (level 3 or 4) symptoms. Results 407 questionnaires were completed by 63 patients in which 2333 symptoms were reported. Almost three-quarters (74.6%) reported at least one high-level symptom. The symptoms that were most commonly experienced were fatigue (>9 in 10 patients; 13.2% of symptoms declared), various psychological disorders (>9 in 10 patients; 28.6% of symptoms declared) and general pain (>8 in 10 patients; 9.4% of symptoms declared). Conclusion PROs are appropriate to detect potential adverse events in cancer outpatients treated by OAAs. This study is the first step for integrating the patient’s perspective in a digital e-health device in routine oncology care.

A Remote Monitoring System to Optimize the Home Management of Oral Anticancer Therapies (ONCO-TreC): Prospective Training-Validation Trial.

BackgroundA platform designed to support the home management of oral anticancer treatments and provide a secure web-based patient–health care professional communication modality, ONCO-TreC, was tested in 3 cancer centers in Italy.ObjectiveThe overall aims of the trial are to customize the platform; assess the system’s ability to facilitate the shared management of oral anticancer therapies by patients and health professionals; and evaluate system usability and acceptability by patients, caregivers, and health care professionals.MethodsPatients aged ≥18 years who were candidates for oral anticancer treatment as monotherapy with an Eastern Cooperative Oncology Group performance status score of 0 to 1 and a sufficient level of familiarity with mobile devices were eligible. ONCO-TreC consisted of a mobile app for patients and a web-based dashboard for health care professionals. Adherence to treatment (pill count) and toxicities reported by patients through the app were compared with those reported by physicians in medical records. Usability and acceptability were evaluated using questionnaires.ResultsA total of 40 patients were enrolled, 38 (95%) of whom were evaluable for adherence to treatment. The ability of the system to measure adherence to treatment was high, with a concordance of 97.3% (95% CI 86.1%-99.9%) between the investigator and system pill count. Only 60% (3/5) of grade 3, 54% (13/24) of grade 2, and 19% (7/36) of grade 1 adverse events reported by physicians in the case report forms were also reported in the app directly by patients. In total, 94% (33/35) of patients had ≥1 app launch each week, and the median number of daily accesses per patient was 2. Approximately 71% (27/38) and 68% (26/38) of patients used the app for messages and vital sign entering, respectively, at least once during the study period.ConclusionsONCO-TreC is an important tool for measuring and monitoring adherence to oral anticancer drugs. System usability and acceptability were very high, whereas its reliability in registering toxicity could be improved.Trial RegistrationClinicalTrials.gov NCT02921724; https://www.clinicaltrials.gov/ct2/show/NCT02921724

Molecular and Thermodynamic Modeling of the Protein-Ligand Interaction. Application to Computer-Assisted Design of Anti-Competitive Inhibitors of Human Histone Deacetylase 2 (HDAC2)

Background: Histone deacetylases (HDACs) are promising drug targets for a variety of therapeutic applications. Here we report in silico design and evaluation of novel amine-based hydroxamic acid derivatives (DAHAs), HDAC2 inhibitors with favorable predicted pharmacokinetic profiles. Methods: By using in situ modifications of the crystal structure of suberoylanilide hydroxamic acid SAHA-HDAC2 complex (PDB entry 4LXZ), 3D models of HDAC2-DAHAx complexes were prepared for a training set of 18 DAHAs with experimentally determined inhibitory potencies (half-maximal inhibitory concentrations IC50exp In the search for active conformations of the DAHA1-18, a linear QSAR model was prepared, which correlated computed gas-phase enthalpies of formation (∆∆HMM) of HDAC2-DAHAx complexes with the IC50exp. Further, taking into account the solvent effect and entropy changes upon ligand, binding resulted in a superior QSAR model correlating computed complexation Gibbs free energies (∆∆Gcom). The successive pharmacophore model (PH4) generated from the active conformations of DAHAs served as a virtual screening tool of novel analogs included in a virtual combinatorial library (VCL) of compounds containing hydroxamic acid scaffolds. The PH4 model to identify new DAHA analogs screened the VCL filtered by Lipinski’s rule-of-five. Results: Gas-phase QSAR model: -log10(IC50exp) = pIC50exp -0.2870 x ∆∆HMM +6.5764, R2= 0.83, superior aqueous phase QSAR model: pIC50exp =-0.4005 x ∆∆Gcom + 6.4402, R2=0.93 and PH4 pharmacophore model : pIC50exp = 1.0107 x pIC50pre - 0.0607, R2 = 0.92. The VCL of more than 198 thousand DAHAs was filtered down to 150,713 analogs Lipinski’s rule. The PH4 screening retained 110 new and potent DAHAs with predicted inhibitory potencies pIC50pre up to 520-fold lower than .that of DAHA1 (IC50exp =260nM). Predicted pharmacokinetic profiles of the new analogs were compared to current per oral anti-cancer drugs. Conclusions: This computational approach, which combines molecular modeling, pharmacophore model, analysis of HDAC2-DAHAs interaction energies, in silico screening of VCL of DAHAs, and ADME properties resulted in a set of proposed new HDAC2 inhibitors.

Identifying homogeneous healthcare use profiles and treatment sequences by combining sequence pattern mining with care trajectory clustering in kidney cancer patients on oral anticancer drugs: A case study

We evaluated the ability of a coupled pattern-mining and clustering method to identify homogeneous groups of subjects in terms of healthcare resource use, prognosis and treatment sequences, in renal cancer patients beginning oral anticancer treatment. Data were retrieved from the permanent sample of the French medico-administrative database. We applied the CP-SPAM algorithm for pattern mining to healthcare use sequences, followed by hierarchical clustering on principal components (HCPC). We identified 127 individuals with renal cancer with a first reimbursement of an oral anticancer drug between 2010 and 2017. Clustering identified three groups of subjects, and discrimination between these groups was good. These clusters differed significantly in terms of mortality at six and 12months, and medical follow-up profile (predominantly outpatient or inpatient care, biological monitoring, reimbursement of supportive care drugs). This case study highlights the potential utility of applying sequence-mining algorithms to a large range of healthcare reimbursement data, to identify groups of subjects homogeneous in terms of their care pathways and medical behaviors.

Shifting the linear range of the calibration curves for the quantification of oral molecular-targeted anticancer drugs and the active metabolite in human plasma using LC-ESI-MS/MS

Shifting the linear range of the calibration curves for the quantification of oral molecular-targeted anticancer drugs and the active metabolite in human plasma using LC-ESI-MS/MS

Association between adherence to oral therapies in cancer patients and clinical outcome: A systematic review of the literature.

Adherence to therapy is a key factor in successful treatment. The aim of this systematic review is to assess the extent to which patients with better adherence to oral therapy have better clinical outcomes among cancer patients. All studies published in PubMed up to 20 October 2020, which considered the use of oral anticancer drugs for cancer patients and which correlated treatment adherence with a clinical outcome, were considered. From the 42 studies considered in the systematic review, 14 were for oncological indications and 28 for haematological indications. There was considerable variance in calculation methods, outcomes considered, and in the definitions of adherence. However, it emerged that most studies reported a significant correlation between adherence to therapy and clinical outcome. As adherence to therapy is a key factor in achieving a better clinical outcome, future studies with large samples, robust endpoints and the use of at least two methods of assessing adherence would be desirable in order to produce more robust evidence.

An Easily Expandable Multi-Drug LC-MS Assay for the Simultaneous Quantification of 57 Oral Antitumor Drugs in Human Plasma.

Simple SummaryOral antitumor therapy has significantly improved clinical outcomes in multiple tumor entities. However, following a standard dosing regime, strong interindividual variability in patients’ plasma concentrations can be observed for many oral antitumor drugs. This results in risks of reduced therapeutic effect and increased side effects. Monitoring these variable plasma concentrations is an important tool in evaluating multiple factors influencing drug exposure and, if necessary, adjusting therapeutic doses. Here, we developed a method for the simultaneous measurement of 57 oral antitumor drug plasma concentrations. Detection and quantification were achieved using liquid chromatography coupled to an Orbitrap mass spectrometer, which can be easily expanded to newly approved oral antitumor drugs in the future. Applicability of the method was proven by measuring 71 plasma samples from 39 patients undergoing oral antitumor therapy. In summary, the developed method provides an important tool for exposure measurements of oral antitumor drugs.Oral anticancer drugs have led to significant improvements in the treatment of multiple tumor entities. However, in patients undergoing oral antitumor therapy, plasma concentrations are highly variable, resulting in risks of reduced therapeutic effects or an increase in side effects. One important tool to reduce this variability is therapeutic drug monitoring. In this work we describe a method to simultaneously quantify the plasma concentrations of 57 oral antitumor agents. Quantification of these drugs was achieved using liquid chromatography coupled to an Orbitrap mass spectrometer. The method was fully validated according to the FDA guidelines and constitutes a simple and robust way for exposure monitoring of a wide variety of oral anticancer drugs. Applicability to clinical routine was demonstrated by the analysis of 71 plasma samples taken from 39 patients. In summary, this new multi-drug method allows simultaneous quantification of 57 oral antitumor drugs, which can be applied to exposure monitoring in clinical studies, taking into account the broad variety of oral antitumor drugs prescribed in clinical routine.

Developing a Nationwide Infrastructure for Therapeutic Drug Monitoring of Targeted Oral Anticancer Drugs: The ON-TARGET Study Protocol.

Simple SummaryRelationships between drug concentrations in blood and efficacy and/or toxicity have been reported for up to 80% of oral anticancer drugs (OADs). Most OADs exhibit highly variable drug concentrations at the approved dose. This may result in a significant proportion of patients with suboptimal drug concentrations. Therapeutic Drug Monitoring (TDM), which is dose optimization based on measured drug concentrations, can be used to personalize drug dosing with the overall goal to improve the benefit-risk ratio of anticancer drug treatment. The ON-TARGET study aims to investigate the feasibility of TDM in patients receiving either axitinib or cabozantinib for the treatment of renal-cell carcinoma with the main objective to improve severe tyrosine kinase inhibitor associated toxicity. Additionally, the feasibility of volumetric absorptive microsampling (VAMS), a novel minimally invasive and easy to handle blood sampling technique, for TDM sample collection is investigated.Exposure-efficacy and/or exposure-toxicity relationships have been identified for up to 80% of oral anticancer drugs (OADs). Usually, OADs are administered at fixed doses despite their high interindividual pharmacokinetic variability resulting in large differences in drug exposure. Consequently, a substantial proportion of patients receive a suboptimal dose. Therapeutic Drug Monitoring (TDM), i.e., dosing based on measured drug concentrations, may be used to improve treatment outcomes. The prospective, multicenter, non-interventional ON-TARGET study (DRKS00025325) aims to investigate the potential of routine TDM to reduce adverse drug reactions in renal cell carcinoma patients receiving axitinib or cabozantinib. Furthermore, the feasibility of using volumetric absorptive microsampling (VAMS), a minimally invasive and easy to handle blood sampling technique, for sample collection is examined. During routine visits, blood samples are collected and sent to bioanalytical laboratories. Venous and VAMS blood samples are collected in the first study phase to facilitate home-based capillary blood sampling in the second study phase. Within one week, the drug plasma concentrations are measured, interpreted, and reported back to the physician. Patients report their drug intake and toxicity using PRO-CTCAE-based questionnaires in dedicated diaries. Ultimately, the ON-TARGET study aims to develop a nationwide infrastructure for TDM for oral anticancer drugs.

Earlier Intervention to Reduce Time to Receipt for Oral Anti-Cancer Drugs

Earlier Intervention to Reduce Time to Receipt for Oral Anti-Cancer Drugs

Pharmacoepidemiology for oncology clinical practice: Foundations, state of the art and perspectives

Since the early 2000s, the arrival of the so-called targeted therapies and immunotherapies have prolonged survival rates in many cancers. In parallel, post-marketing surveillance of anticancer drugs through pharmacoepidemiology has gradually developed. This paper provides (i) a detailed argumentation of the foundations for pharmacoepidemiology of anticancer drugs, (ii) an overview of pharmacoepidemiological studies currently available in this field, and (iii) some perspectives to improve pharmacoepidemiology for oncology practice. First of all, according to the existing literature, the development of pharmacoepidemiological studies for the clinical evaluation of anticancer drugs appears particularly justified based on common limitations of clinical trials in oncology regarding essential methodological principles such as adequate control groups, randomisation or double blinding. Many descriptive field cohort studies have investigated together treatment patterns, effectiveness, and safety to compare results from clinical trials with those of everyday practice. The utilisation of anticancer drugs has also been extensively described through cross-sectional or cohort studies by often using medico-administrative or medical databases. Such studies are useful to quantify and characterise use over time in the population, including clinically unvalidated use, and to evaluate adherence and persistence to increasingly available oral anticancer drugs. Despite their importance to increase knowledge, comparative effectiveness or safety studies remain uncommon. In a context of rapidly emerging therapies and personalised treatments, this may be due to methodological challenges especially related to the choice of a comparator or the consideration of confounding by indication. In the future, efforts must be pursued to provide real-time access to high-quality, large-scale clinical, biological and treatment data, and to improve record-linkage between hospital and outpatient databases. More research is also needed to better evaluate all medications, not only anticancer, as part of an overall cancer care pathway and to bring the evaluation of anticancer drugs closer to patients and society (social pharmacology).

Exploring the factors influencing adherence to oral anticancer drugs in patients with digestive cancer: a qualitative study

PurposeThe aim of this study was to explore the beliefs, perceptions and representations of patients in order to identify the determinants of oral anticancer drugs adherence and to take action in current practice to improve patient support in digestive oncology.MethodsWe constructed a semi-directed interview guide which aimed to explore the patient’s relationship with medication, their health history, their experiences at the time of the announcement of treatment, their confidence, their fears, their motivations to adhere to their treatment and the constraints linked to their treatment. The data were analysed and discussed using a thematic approach.ResultsSeventeen patients agreed to participate in the study. The median age was 60 years. Ten patients had colorectal cancer, 3 patients had hepatocellular carcinoma, 3 patients had gastrointestinal stromal tumour and 1 patient had neuroendocrine pancreatic tumour. We identified five categories of factors influencing adherence: demographic and socioeconomic, disease-related, treatment-related, care system-related, and patient representation and pathways’ factors. A majority of patients emphasised the importance of family support in the adherence process and the convenience of per os treatment compared to other intravenous treatments. However, several negative determinants emerged such as the toxicity of the treatment, fears of forgetting to take the medication, difficulties with the galenic formulation and negative beliefs of the family.ConclusionThis study demonstrates the need to address the different dimensions of the patient in order to understand his or her behaviour with regard to adherence and to identify the levers for improvement.

Patients' knowledge and awareness of safe handling of oral anticancer agents at Sultan Qaboos University Hospital in Oman.

Safe handling of oral anticancer agents is of great concern. There is a lack of clear, national guidelines on how patients can safely handle and dispose of unwanted medications. We aimed to evaluate the safe handling, storage, and disposal of oral anticancer drugs among cancer patients and caregivers at home. This cross-sectional survey of adult cancer patients (or their adult caregivers) used a closed-ended questionnaire from May 2019 to March 2020. A total of 257 patients (50 ± 15 years; range: 18-93 years) were enrolled; however, only 91% (233/257) reported self-administering oral anticancer medications. Caregivers were more likely to administer oral anticancer agents for patients ≥60 years than those <40 years old (63% vs. 8%; P = 0.001). Most patients (52%; 133/257) did not wash their hands after administering the drug; 74% (164/222) of the respondents reported that their medications were kept in a bedroom cabinet, while 18% (40/222) stored their medications in a refrigerator, and 5% (12/222) in a kitchen cabinet. A total of 55% (68/124) of patients returned their excess oral chemotherapy medications to the hospitals; however, 36% (45/124) disposed of their unused oral chemotherapy drugs in a household garbage container. While two-thirds of patients stored their oral anticancer medications properly, more than half used inappropriate handling procedures. Disposal practices were inconsistent and did not adhere to the reported international guidelines.

Impact of a hospital specialty pharmacy in partnership with a free-standing care coordination organization on time to delivery and receipt of oral anticancer drugs.

43 Background: Most oral anti-cancer drugs (OACD) prescriptions require extensive coordination between providers and payers, which can delay drug receipt. Specialty pharmacies are intended to facilitate communication between multiple entities to deliver OACDs with increased efficiency. In 2018, our cancer center partnered with Shields Health Solutions (SHS), a freestanding organization providing care coordination to implement a hospital-based specialty pharmacy. We evaluated the rate of failed drug receipt (FR) and time to drug receipt (TTR) before and after specialty pharmacy implementation. Methods: We prospectively collected data on all new OACD prescriptions for adult oncology patients at a large, urban cancer center from 1/1/2018 to 12/31/2019. In fall 2018, a specialty pharmacy was opened to facilitate drug procurement for patients. We collected patient demographic, clinical, and insurance data, OACD name, date prescribed, delivery date, and interactions with payers and financial assistance groups. For prescriptions received, TTR was the number of days from OACD prescription to patient receipt of the drug. FR was defined as failure to receive a prescribed OACD. We excluded OACD prescriptions for a washout period of two months during pharmacy initiation. We used multivariable logistic regression to examine factors associated with TTR &gt; 7 days and FR before and after specialty pharmacy implementation. Results: In total, 883 patients were prescribed 1145 new OACDs. The majority of prescribed drugs were targeted treatment (56%, N = 646) and 72% (N = 819) required prior authorization (PA). Of all prescriptions, 86% (N = 999) were successfully received with an overall median TTR of 7 days. Adjusted analyses showed that patients were more likely to receive their drugs in less than 7 days after specialty pharmacy implementation (OR: 1.4 95% CI 1.04 – 1.81), p = 0.03). In an unadjusted analysis, patients were more likely to receive their initial medications after specialty pharmacy implementation, compared to before specialty pharmacy implementation (89% vs. 84%, p = 0.04). Multivariable analysis showed a trend toward more patients receiving drugs after specialty pharmacy implementation (OR: 1.42, 95% CI 0.98 – 2.03, p = 0.06). Conclusions: The implementation of a hospital-based specialty pharmacy in partnership with SHS decreased TTR. This difference is in part attributable to improved care coordination and communication. A centralized approach may improve overall efficiency due to fewer clinical practice disruptions.