Search

Simple Summary: The use of oral anticancer agents (OAAs) is increasing, and even more people need to monitor and manage their treatment pathway. A clear map of self-care outcomes studied so far can provide insights for clinical practice and future studies. The study revealed that all included articles considered, as intervention, treatment adherence and, as outcomes, mortality, survival, disease recurrence and quality of life. Adherence to OAA treatment has been found to reduce mortality and increase survival. However, important outcomes such as economic, social or psychological outcomes should be assessed in future studies to provide a complete picture of improvements that can be derived from self-care behaviours. Background/Objectives: The use of oral anticancer agents (OAA) dates to the late 20th century in cancer treatment. It is crucial that patients implement self-care behaviours to keep their disease stable and manage their OAA treatment. The three dimensions of self-care according to Riegel et al., self-care maintenance, self-care monitoring, and self-care management, may be implemented to avoid negative outcomes. This paper seeks to identify outcomes associated with self-care in breast cancer patients during treatment with OAA and to compare which of these outcomes fall into the core outcome categorizations in oncology (minimal set of outcomes that research on a given health issue should measure). Methods: A systematic review with narrative synthesis was conducted. This study included patients with breast cancer taking any kind of OAA and described outcomes of self-care. The search was performed on MEDLINE, Web of Science and CINAHL/PsycINFO; Results: Of 4173 records, eight studies were selected and reviewed. The core outcomes mainly considered were mortality, survival, disease recurrence and quality of life. All studies focused only on pharmacological adherence outcome; none of them focused on other dimensions of self-care. Conclusions: This systematic review highlighted that there is a great lack of research on outcomes related to self-care in patients with breast cancer taking OOA. Even though pharmacological adherence to OAA is important, other behaviours are also important to improve patients' outcomes, but they have not been studied. Further research is needed to study how self-care behaviours can impact patients' outcomes. [ABSTRACT FROM AUTHOR]

Purpose: Patients on oral anticancer agent (OAA) therapies have the autonomy to manage their cancer treatments in home settings. However, patients may not have adequate knowledge, confidence, or ability to effectively manage OAA-related consequences, which can significantly impact their treatment and health outcomes. This study aims to identify the associations between medication beliefs, patient activation, and self-rated health (SRH) among oncology patients taking OAAs and explore the potential mediation effects of patient activation on the relationship between medication beliefs and SRH. Methods: A secondary data analysis was conducted on cross-sectional data from 114 patients who were diagnosed with breast, colorectal, lung, or prostate cancer. Patients completed a self-reported survey including items of SRH, Beliefs about Medicines Questionnaire (BMQ), and Patient Activation Measure (PAM-13). Descriptive statistics, bivariate correlation, hierarchical multiple linear regression, and mediation analysis were conducted. Results: The results indicate that patients taking OAAs have ambivalent attitudes toward medication. Both medication necessity (r = − 0.27) and concerns (r = − 0.21) were negatively associated with SRH, while patient activation was positively associated with SRH (r = 0.38). Patient activation had a negative association with medication concerns (r = − 0.36) and fully mediated the relationship between medication concerns and SRH in patients taking OAAs (indirect effect = − 0.154, 95% confidence interval, − 0.276 to − 0.060). Conclusion: The findings highlight the significance of activating patients to better understand and manage their OAAs. It is crucial for oncology professionals to provide multifaceted interventions to promote patient activation with an effort to mitigate the negative impact of medication beliefs on patient-perceived health outcomes. [ABSTRACT FROM AUTHOR]

Introduction: Increased use of oral anticancer agents (OAAs) has empowered adults with chronic lymphocytic leukemia (CLL) and chronic myelogenous leukemia (CML) to manage their therapy, but this shift may complicate medication use, particularly among adults with multiple chronic conditions (MCC). Methods: This retrospective cohort study used 2013–2018 commercial and Medicare claims data to assess medication use in adults with CML or CLL. To be included, patients must have been at least 18 years old, diagnosed with and had 2+ claims for an OAA indicated for either CML or CLL, continuously enrolled 12 months before and after OAA initiation, and treated for (2+ fills) at least two select chronic conditions. Proportion of days covered (PDC) determined medication adherence and was compared for 12 months before and after OAA initiation by Wilcoxon signed-rank tests, McNemar's tests, and difference-in-differences models. Results: Among CLL patients, mean OAA adherence in the first year of therapy was 79.8% (SD: 21.1) and 74.7% (SD: 24.9) for commercial and Medicare patients, respectively; mean adherence for CML patients was 84.5% (SD: 15.8) and 80.1% (SD: 20.1) for commercial and Medicare patients, respectively. Adherence and the proportion adherent (PDC ≥ 80%) to comorbid therapies was generally unchanged following OAA initiation. Consistently unremarkable changes in MCC adherence were observed in 12-month difference-in-differences models, but significant decline was observed in MCC adherence after 6 months of OAA use. Conclusions: OAA initiation among adults with CML or CLL was not associated with significant, initial changes to adherence to medications for chronic diseases. [ABSTRACT FROM AUTHOR]

The development and use of oral anticancer agents (OAAs) continue to grow, and supporting individuals on OAAs is now a priority as they find themselves taking these drugs at home with little professional guidance. This mapping review provides an overview of the current evidence concerning OAA-supportive adherence interventions, identifying potential gaps, and making recommendations to guide future work. Four large databases and the grey literature were searched for publications from 2010 to 2022. Quantitative, qualitative, mixed-method, theses/dissertations, reports, and abstracts were included, whereas protocols and reviews were excluded. Duplicates were removed, and the remaining publications were screened by title and abstract. Full-text publications were assessed and those meeting the inclusion criteria were retained. Data extracted included the year of publication, theoretical underpinnings, study design, targeted patients, sample size, intervention type, and primary outcome(s). 3175 publications were screened, with 435 fully read. Of these, 314 were excluded with 120 retained. Of the 120 publications, 39.2% (n = 47) were observational studies, 38.3% (n = 46) were quasi-experimental, and 16.7% (n = 20) were experimental. Only 17.5% (n = 21) were theory-based. Despite the known efficacy of multi-modal interventions, 63.7% (n = 76) contained one or two modalities, 33.3% (n = 40) included 3, and 3.3% (n = 4) contained four types of modalities. Medication adherence was measured primarily through self-report (n = 31) or chart review/pharmacy refills (n = 28). Given the importance of patient tailored interventions, future work should test whether having four intervention modalities (behavioral, educational, medical, and technological) guided by theory can optimize OAA-related outcomes.

The development and use of oral anticancer agents (OAAs) continue to grow, and supporting individuals on OAAs is now a priority as they find themselves taking these drugs at home with little professional guidance. This mapping review provides an overview of the current evidence concerning OAA-supportive adherence interventions, identifying potential gaps, and making recommendations to guide future work. Four large databases and the grey literature were searched for publications from 2010 to 2022. Quantitative, qualitative, mixed-method, theses/dissertations, reports, and abstracts were included, whereas protocols and reviews were excluded. Duplicates were removed, and the remaining publications were screened by title and abstract. Full-text publications were assessed and those meeting the inclusion criteria were retained. Data extracted included the year of publication, theoretical underpinnings, study design, targeted patients, sample size, intervention type, and primary outcome(s). 3175 publications were screened, with 435 fully read. Of these, 314 were excluded with 120 retained. Of the 120 publications, 39.2% (n = 47) were observational studies, 38.3% (n = 46) were quasi-experimental, and 16.7% (n = 20) were experimental. Only 17.5% (n = 21) were theory-based. Despite the known efficacy of multi-modal interventions, 63.7% (n = 76) contained one or two modalities, 33.3% (n = 40) included 3, and 3.3% (n = 4) contained four types of modalities. Medication adherence was measured primarily through self-report (n = 31) or chart review/pharmacy refills (n = 28). Given the importance of patient tailored interventions, future work should test whether having four intervention modalities (behavioral, educational, medical, and technological) guided by theory can optimize OAA-related outcomes. [ABSTRACT FROM AUTHOR]

Abstract Background A large variety of oral anticancer agents have become available and while at first glance these therapies appear to provide only benefits, patients have expressed their need for educational interventions and raised safety issues. Although both patients and providers have recognized patient education’s importance, and an interplay with safety has been acknowledged, no systematic reviews of the literature that summarize all of the current evidence related to patient education’s outcomes for patients who receive oral anticancer agents have been performed to date. Accordingly, this systematic review will attempt to fill the gap in the literature as well as to map (1) contents, (2) methodologies, (3) settings, (4) timing/duration, and (5) healthcare professionals involved. Methods This protocol is being reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. A systematic review will be performed. Studies that targeted eligible adult patients (≥ 18 years old) in hospital, outpatient, and home settings, and reported patient education’s outcomes for those taking oral anticancer agents will be included. Searches will be conducted in PubMed/MEDLINE, CINAHL, Embase, and Scopus, and gray literature will be also sought. Two researchers will screen the search results independently and blindly in two phases: (1) title/abstract screening and (2) full-text screening using the Rayyan AI platform. An electronic data extraction form will be implemented and piloted, and then, two trained data extractors will extract the data cooperatively. Thereafter, a quality appraisal will be conducted using the Critical Appraisal Tools from The Joanna Briggs Institute. The results will be analyzed, grouped, clustered into categories, and discussed until a consensus is reached. Emerging evidence will be synthesized narratively and reported in accordance with the synthesis without meta-analysis guidelines. Discussion The systematic review’s results will be relevant to (1) policymakers and management at an institutional level, and (2) for clinical practice, in an evidence-based paradigm, potentially leading to a quality improvement with respect to safety and patient satisfaction. Systematic review registration PROSPERO CRD42022341797

Abstract Background More than 60% of cancer cases occur in older adults, and many are treated with oral anticancer agents. Yet, the treatment tolerability in older adults has not been fully understood due to their underrepresentation in oncology clinical trials, creating challenges for treatment decision-making and symptom management. The objective of this study was to investigate the tolerance of capecitabine, an example of oral chemotherapy, among older adults with cancer and explore factors associated with capecitabine-related side effects and treatment changes, to enhance supportive care. Methods A secondary analysis used combined data from electronic health records and a pilot study of patient-reported outcomes, with a total of 97 adult patients taking capecitabine during 2016–2017, including older adult patients aged 65 years or older (n = 43). The data extracted included patient socio-demographics, capecitabine information, side effects, and capecitabine treatment changes (dose reductions and dose interruptions). Bivariate correlations, negative binomial regression, and multiple linear regression were conducted for data analysis. Results Older adults were more likely to experience fatigue (86% vs. 51%, p = .001) and experienced more severe fatigue (β = 0.44, p = 0.03) and hand-foot syndrome (HFS) (β = 1.15, p = 0.004) than younger adults. The severity of fatigue and HFS were associated with the number of outpatient medications (β = 0.06, p = 0.006) and the duration of treatment (β = 0.50, p = 0.009), respectively. Correlations among side effects presented different patterns between younger and older adults. Although more older adults experienced dose reductions (21% vs. 13%) and dose interruptions (33% vs. 28%) than younger adults, the differences were not statistically different. Female sex, breast cancer diagnosis, capecitabine monotherapy, and severe HFS were found to be associated with dose reductions (p-values

Background: A large variety of oral anticancer agents have become available and while at first glance these therapies appear to provide only benefits, patients have expressed their need for educational interventions and raised safety issues. Although both patients and providers have recognized patient education's importance, and an interplay with safety has been acknowledged, no systematic reviews of the literature that summarize all of the current evidence related to patient education's outcomes for patients who receive oral anticancer agents have been performed to date. Accordingly, this systematic review will attempt to fill the gap in the literature as well as to map (1) contents, (2) methodologies, (3) settings, (4) timing/duration, and (5) healthcare professionals involved. Methods: This protocol is being reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. A systematic review will be performed. Studies that targeted eligible adult patients (≥ 18 years old) in hospital, outpatient, and home settings, and reported patient education's outcomes for those taking oral anticancer agents will be included. Searches will be conducted in PubMed/MEDLINE, CINAHL, Embase, and Scopus, and gray literature will be also sought. Two researchers will screen the search results independently and blindly in two phases: (1) title/abstract screening and (2) full-text screening using the Rayyan AI platform. An electronic data extraction form will be implemented and piloted, and then, two trained data extractors will extract the data cooperatively. Thereafter, a quality appraisal will be conducted using the Critical Appraisal Tools from The Joanna Briggs Institute. The results will be analyzed, grouped, clustered into categories, and discussed until a consensus is reached. Emerging evidence will be synthesized narratively and reported in accordance with the synthesis without meta-analysis guidelines. Discussion: The systematic review's results will be relevant to (1) policymakers and management at an institutional level, and (2) for clinical practice, in an evidence-based paradigm, potentially leading to a quality improvement with respect to safety and patient satisfaction. Systematic review registration: PROSPERO CRD42022341797 [ABSTRACT FROM AUTHOR]

Background. Many factors contribute to oral anti-cancer therapy adherence, including counselling and educational support. Objective. We systematically review the literature evaluating the effectiveness of interpersonal communication-, counselling- and education-based interventions on patient adherence to oral anticancer therapy. Methods. Using search terms pertaining to medication adherence, oral anticancer therapy, and communication, education, and counselling, we conducted a systematic search for full-text, original research articles prior to 3/13/20. Two reviewers independently reviewed each paper for inclusion and charted study information. Results. Twenty-four articles were included. All considered the use of oral anticancer therapy between two defined time points. Four studies also considered the length of time a patient persisted on therapy. Half (n = 12) of the studies reported a statistically significant relationship between the intervention and medication adherence, with no consistent pattern among intervention structure/content and effectiveness. Programmes offering in-person counselling and those targeting patients with chronic myeloid leukemia (CML), tended to report positive findings. Most studies faced substantial risk of bias, and only two reported using a behavioural theory to guide interventional content. Conclusions. Findings highlight the infancy of evidence base and need for rigorous and large-scale studies grounded in established behavioural theories to advance patient-targeted educational and counselling practices supporting adherence to oral anti-cancer therapy. [ABSTRACT FROM AUTHOR]

Objective: To test the Self-Care Oral Anticancer Agents Index (SCOAAI)'s psychometric properties (structural validity, convergent validity, predictive validity, and internal consistency) in a sample of patients with solid tumour on Oral anticancer agents (OAA)., Methods: A methodological research in five in- or out-patient Italian facilities. Structural validity was tested by confirmatory factor analysis, and internal consistency was assessed through Cronbach's alpha and composite reliability. The Mann-Whitney U-test was used to test associations between SCOAAI scores and patient's emergency room admission, re-hospitalization, mortality, and quality of life measured three months after baseline., Results: We enrolled 356 patients; mostly were male (52.24%), and mean age was 59.10 years. Analyses demonstrated the SCOAAI's factorial validity and internal consistency. Moreover, patients that experienced emergency room admissions (U = 3484.5; P = .002) and re-hospitalization (U = 2446.0; P = .001) showed lower self-care maintenance scores; those who experienced emergency room admission (U = 3263.5; P = .019) and died at follow-up (U = 700.5; P = .025) had lower self-care monitoring scores; while patients that experienced re-hospitalisation (U = 2931.5; P = .040) and emergency room admission (U = 3285.0; P = .012) had lower self-care management scores. Patients with adequate self-care (≥ 70) reported significantly higher quality of life (self-care maintenance U = 1228.500, P < .001; self-care monitoring U = 3512.500, P < .001; self-care management U = 3287.500, P < .001)., Conclusion: According to our findings the SCOAAI is a valid and reliable tool. Patients with inadequate self-care can experience more emergency room accesses, re-hospitalization, death, and lower quality of life., Implications for Nursing Practice: Adequate self-care behaviors can improve patient's outcomes and should be assessed by healthcare providers during the disease pathway., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2025 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: More than 60% of cancer cases occur in older adults, and many are treated with oral anticancer agents. Yet, the treatment tolerability in older adults has not been fully understood due to their underrepresentation in oncology clinical trials, creating challenges for treatment decision-making and symptom management. The objective of this study was to investigate the tolerance of capecitabine, an example of oral chemotherapy, among older adults with cancer and explore factors associated with capecitabine-related side effects and treatment changes, to enhance supportive care.Methods: A secondary analysis used combined data from electronic health records and a pilot study of patient-reported outcomes, with a total of 97 adult patients taking capecitabine during 2016-2017, including older adult patients aged 65 years or older (n = 43). The data extracted included patient socio-demographics, capecitabine information, side effects, and capecitabine treatment changes (dose reductions and dose interruptions). Bivariate correlations, negative binomial regression, and multiple linear regression were conducted for data analysis.Results: Older adults were more likely to experience fatigue (86% vs. 51%, p = .001) and experienced more severe fatigue (β = 0.44, p = 0.03) and hand-foot syndrome (HFS) (β = 1.15, p = 0.004) than younger adults. The severity of fatigue and HFS were associated with the number of outpatient medications (β = 0.06, p = 0.006) and the duration of treatment (β = 0.50, p = 0.009), respectively. Correlations among side effects presented different patterns between younger and older adults. Although more older adults experienced dose reductions (21% vs. 13%) and dose interruptions (33% vs. 28%) than younger adults, the differences were not statistically different. Female sex, breast cancer diagnosis, capecitabine monotherapy, and severe HFS were found to be associated with dose reductions (p-values < 0.05).Conclusions: Older adults were less likely to tolerate capecitabine treatment and had different co-occurring side effects compared to younger adults. While dose reductions are common among older adults, age 65 years or older may not be an independent factor of treatment changes. Other socio-demographic and clinical factors may be more likely to be associated. Future studies can be conducted to further explore older adults' tolerance to a variety of oral anticancer agents to generate more evidence to support optimal treatment decision-making and symptom management. [ABSTRACT FROM AUTHOR]

Abstract Background Improving oral anticancer agent (OAA) initiation and adherence is the important quality‐of‐care issues, particularly since one fourth of anticancer agents being developed will be administered orally. Our objective was to identify provider‐ and patient‐level characteristics associated with OAA initiation and adherence among individuals with metastatic renal cell carcinoma (mRCC). Methods We used state cancer registry data linked to multi‐payer claims data to identify patients with mRCC diagnosed in 2004–2015. Provider data were obtained from North Carolina Health Professions Data System and the National Plan & Provider Enumeration System. We estimated risk ratios (RRs) and corresponding 95% confidence limits (CLs) using modified Poisson regression to evaluate factors associated with OAA initiation and adherence. Results Among the 207 (out of 687) patients who initiated an OAA following mRCC diagnosis and survived 90 days, median proportion of days covered was 0.91. Patients with a modal provider specializing in hematology/medical oncology were much more likely to initiate OAAs than those seen by other specialties. Additionally, patients with a female provider were more likely to initiate OAAs than those with a male provider. Compared to patients treated by providers practicing in both urban and rural areas, patients with providers practicing solely in urban areas were more likely to initiate OAAs, after controlling for patient‐level factors (RR = 1.37; 95% CL: 1.09–1.73). Medicare patients were less likely to be adherent than those with private insurance (RR = 0.61; 95% CL: 0.42–0.87). Conclusions Our results suggest that provider‐ and patient‐level factors influence OAA initiation in patients with mRCC but only insurance type was associated with adherence.

Improvements in chronic myeloid leukemia (CML), chronic lymphocytic leukemia (CLL), and multiple myeloma (MM) treatment options have increased the 5-year survival rates for patients with these hematologic malignancies. In addition to cancer management, these patients may need help to manage multiple chronic conditions (MCC). The overall objective of this study is to examine the impact and implementation of a model that coordinates care between oncology and primary care pharmacists for people taking an oral anti-cancer agent (OAAs) and medications for comorbid chronic conditions. This is a multi-center, prospective, single-arm pilot study that will recruit up to 40 patients from Michigan Medicine and Vanderbilt University Medical Center (VUMC). Eligible participants will be 18 years of age or older, prescribed an OAA, have a diagnosis of either CML, CLL or MM, and be diagnosed with and taking medication for at least two specified chronic conditions. The Pharmacists Coordinated Care Oncology Model (PCOM) is a two-month intervention that builds upon current pharmacist clinical responsibilities. Generally, participants will complete a patient-reported outcome measure at 2 and 6 weeks post-OAA initiation that is sent to their oncology pharmacist, and they will also receive a comprehensive medication review at week 4 from a primary care pharmacist for their chronic medications. The pharmacists will communicate about the results via electronic medical record (EMR) and intervene if necessary. The primary endpoints are (1) dose-adjusted OAA proportion of days covered (PDC), and (2) PDC for chronic condition medications. PDCs will be determined via prescription records. The association of OAA and chronic medication PDCs will be quantified via correlation and chi-squared tests. The association between symptom experience and OAA adherence will be examined via correlation analyses. For implementation, characteristics of patient participants, feasibility, acceptability, adoption, fidelity, and trialability will be described. Data will be collected via EMR and pharmacist and patient interviews. Median/IQR for acceptability, adoption and fidelity will be reported, and patient interviews will be analyzed using a grounded theory approach and pharmacist interviews will be analyzed using thematic analyses.

Purpose: Due to polypharmacy and the rising popularity of complementary and alternative medicines (CAM), oncology patients are particularly at risk of drug–drug interactions (DDI) or herb–drug interactions (HDI). The aims of this study were to assess DDI and HDI in outpatients taking oral anticancer drug. Method: All prescribed and non-prescribed medications, including CAM, were prospectively collected by hospital pharmacists during a structured interview with the patient. DDI and HDI were analyzed using four interaction software programs: Thériaque®, Drugs.com®, Hédrine, and Memorial Sloan Kettering Cancer Center (MSKCC) database. All detected interactions were characterized by severity, risk and action mechanism. The need for pharmaceutical intervention to modify drug use was determined on a case-by-case basis. Results: 294 patients were included, with a mean age of 67 years [55–79]. The median number of chronic drugs per patient was 8 [1–29] and 55% of patients used at least one CAM. At least 1 interaction was found for 267 patients (90.8%): 263 (89.4%) with DDI, 68 (23.1%) with HDI, and 64 (21.7%) with both DDI and HDI. Only 13% of the DDI were found in Thériaque® and Drugs.com® databases, and 125 (2.5%) were reported with similar level of risk on both databases. 104 HDI were identified with only 9.5% of the interactions found in both databases. 103 pharmaceutical interventions were performed, involving 61 patients (20.7%). Conclusion: Potentially clinically relevant drug interaction were frequently identified in this study, showing that several databases and structured screening are required to detect more interactions and optimize medication safety. [ABSTRACT FROM AUTHOR]

Background: Healthcare professionals are faced with the new challenges of preventing and managing drug-related problems (DRPs) with oral anticancer therapy (OAT): side-effects, drug-drug interactions (DDIs), non-adherence, or medication errors. This study aims to assess the impact of ONCORAL, a real-life multidisciplinary care plan for cancer patients based on community and hospital follow-up, for the first OAT cycle., Methods: A prospective cohort study was conducted between October 1, 2021 and October 1, 2022 including all outpatients starting OAT treatment. During the first OAT cycle, the program consists of 6 weekly scheduled face-to-face or phone consultations to prevent and manage DRPs. Nurse and pharmacist interventions (NPIs) are realized to optimize treatments (primary outcomes). Secondary outcomes included the relative dose intensity (RDI) of the first cycle., Results: A total of 562 NPIs were performed by the ONCORAL team: that is, 87.1% of the 209 patients included, for a mean of 3.1 ± 2.2 NPIs/patient. NPIs-concerned DRPs detected by the nurse and pharmacist (346, 61.6%), symptoms and/or adverse effects reported as PROs by the patient or family (138, 24.6%), or pathway issues (78, 13.9%). Seventy-three DDIs were detected and managed during medication review, in a quarter of patients (n = 54/209), leading to the discontinuation of a daily concomitant medication in 30 cases. The mean RDI at the end of the first cycle, calculated for 209 patients, was 83.1 ± 23.9% (17.56-144.23)., Conclusion: In these ambulatory cancer patients, the interest in tailored monitoring of DRPs as a whole, including the prevention and management of drug interactions in addition to symptoms and adverse effects, is highlighted., (© The Author(s) 2024. Published by Oxford University Press.)

The objective of this study was to evaluate medical adherence for patients with ovarian cancer who initiated treatment with a PARP inhibitor therapy, and to identify factors associated with nonadherence. We used the MarketScan Database to identify ovarian cancer patients who initiated PARP inhibitor therapy between January 1, 2008 and December 31, 2017. The primary outcome was adherence defined as ≥ 80% proportion of days covered (PDC). A secondary outcome included adherence assessed using the medication possession ratio (MPR). Multivariable logistic regression analysis was performed to assess relation between PDC and explanatory variables. Sensitivity analysis was performed to evaluate impact of dose-adjustments and toxicity-related delays on adherence. Among 170,976 patients diagnosed with ovarian cancer, 151 patients met inclusion criteria. The median time from diagnosis to initiating therapy was 33 months. Overall, 40 (26.5%) were non-adherent based on a PDC less than 80%. Non-adherent patients were more likely to receive niraparib and have a longer duration of therapy (p < 0.05). We found no significant impact of age, comorbidities, insurance plan, or year of PARP inhibitor initiation on non-adherence. In a sensitivity analysis to assess different definition of adherence, non-adherence ranged from 11.3% to 41.1%. When accounting for possible dose-adjustments, 21.2% of patients were non-adherent. This population based study of ovarian cancer patients found that a quarter of patients may be sub-optimally adherent to PARP inhibitor therapy. Future research should focus on identification of patients at risk for nonadherence and interventions to lower nonadherence among these patients. • A quarter of patients may be suboptimally adherent to PARPi regimen. • Adherence did not differ when adjusting for dose-adjustments and delays in therapy. • Risk of adherence may differ based on type of PARPi and indication for treatment. [ABSTRACT FROM AUTHOR]

Background: Improving oral anticancer agent (OAA) initiation and adherence is the important quality‐of‐care issues, particularly since one fourth of anticancer agents being developed will be administered orally. Our objective was to identify provider‐ and patient‐level characteristics associated with OAA initiation and adherence among individuals with metastatic renal cell carcinoma (mRCC). Methods: We used state cancer registry data linked to multi‐payer claims data to identify patients with mRCC diagnosed in 2004–2015. Provider data were obtained from North Carolina Health Professions Data System and the National Plan & Provider Enumeration System. We estimated risk ratios (RRs) and corresponding 95% confidence limits (CLs) using modified Poisson regression to evaluate factors associated with OAA initiation and adherence. Results: Among the 207 (out of 687) patients who initiated an OAA following mRCC diagnosis and survived 90 days, median proportion of days covered was 0.91. Patients with a modal provider specializing in hematology/medical oncology were much more likely to initiate OAAs than those seen by other specialties. Additionally, patients with a female provider were more likely to initiate OAAs than those with a male provider. Compared to patients treated by providers practicing in both urban and rural areas, patients with providers practicing solely in urban areas were more likely to initiate OAAs, after controlling for patient‐level factors (RR = 1.37; 95% CL: 1.09–1.73). Medicare patients were less likely to be adherent than those with private insurance (RR = 0.61; 95% CL: 0.42–0.87). Conclusions: Our results suggest that provider‐ and patient‐level factors influence OAA initiation in patients with mRCC but only insurance type was associated with adherence. [ABSTRACT FROM AUTHOR]

Yun Jiang,1 Karen E Wickersham,2 Xingyu Zhang,1 Debra L Barton,1 Karen B Farris,3 John C Krauss,4 Marcelline R Harris1 1University of Michigan School of Nursing, Ann Arbor, MI, USA; 2University of South Carolina College of Nursing, Columbia, SC, USA; 3University of Michigan College of Pharmacy, Ann Arbor, MI, USA; 4University of Michigan Medical School, Michigan Medicine, Ann Arbor, MI, USACorrespondence: Yun JiangUniversity of Michigan School of Nursing, 400 North Ingalls Street, Ann Arbor, MI 48109, USAEmail jiangyu@umich.eduPurpose: There are growing concerns about patients’ adherence to oral anticancer agents (OAAs), and the need for patients to engage in self-management of OAA-related side effects. We assessed associations among adherence, severity of side effects, and effectiveness of self-management of side effects in patients taking capecitabine.Methods: Adherence to capecitabine at 6 weeks was measured by the Medication Event Monitoring System among 50 patients with gastrointestinal cancers. Severity of side effects related to capecitabine and effectiveness of self-management of side effects were captured using the Modified Self-Care Diary at the time of enrollment and weekly for 6 weeks. Spearman’s correlation, Mann–Whitney U-tests, and multiple linear regression were conducted, p

BACKGROUND: As medication experts, pharmacists play a critical role in educating and advising members of the cancer care team to optimize the use of oral anticancer agents, which can be convenient options for patients but are associated with novel adverse effects that are different from conventional cytotoxic chemotherapy. Because of increased demand for pharmacy services, including postgraduate year 2 (PGY2) oncology residents in these efforts may help expand pharmacy services. OBJECTIVE: To assess the feasibility and barriers to instituting a new PGY2 oncology pharmacy resident-led medication reconciliation and patient education service for patients with leukemia who are receiving oral anticancer therapy. METHODS: This single-center pilot study was conducted from September 1, 2019, to January 31, 2020, in a 1000-bed academic medical center and outpatient infusion clinic. Eligible inpatients and ambulatory patients with leukemia were identified through notification from the treating provider or the inpatient pharmacist, via e-mail from the prior authorization nurse, or via PGY2 oncology pharmacy resident chart review. Data collection included baseline demographics, diagnosis, patient identification method, oral anticancer therapies, interventions made, and the length of the encounter. Patients with altered mental status and those who declined patient education were excluded. RESULTS: Of the 28 patients identified during the pilot study period, 26 met the eligibility criteria and received the PGY2 oncology pharmacy resident-led pharmacy services. The PGY2 oncology pharmacy resident made a median of 3 interventions per patient. The interventions included medication reconciliation in all patients (N = 26; 100%), medication education (N = 26; 100%), identification of drug-drug interactions (N = 5; 19.2%), supportive care optimization (N = 5; 19.2%), and the identification of barriers to medication access (N = 1; 3.8%). The barriers to the implementation of this new PGY2 oncology pharmacy resident-led service included patient identification, time commitment, and complex coordination of care. CONCLUSION: The use of pharmacy extenders in a layered learning model can be an effective way to expand clinical pharmacy services and optimize patient care. Based on the experience gained in this pilot study, we are exploring restructuring the current full-time equivalents to expand the role of the pharmacist in the clinic. Further directions for expansion include telehealth services, longitudinal patient follow-up, and collaborative practice agreements to facilitate smoother workflow. [ABSTRACT FROM AUTHOR]

OBJECTIVES: To describe patient satisfaction with an interactive voice response (IVR) system to assess adherence and symptom management in patients newly prescribed an oral anticancer agent (OAA). SAMPLE & SETTING: Patients prescribed a new OAA were recruited from six comprehensive cancer centers in the United States. METHODS & VARIABLES: Cross-sectional analysis and descriptive statistics were used to summarize patient demographics and satisfaction with the IVR system and symptom management toolkit. RESULTS: Participants had a mean age of 61.82 years, and gastrointestinal cancer was most prevalent. Participants were either "very" or "highly" satisfied with the IVR weekly calling system to assess symptoms, the IVR system daily OAA adherence reminders, and the symptom management toolkit. IMPLICATIONS FOR NURSING: Nurses often triage patient-reported issues with OAAs. Nurses are well positioned to lead IVR system symptom management interventions and to be actively involved in the development, implementation, and dissemination of IVR technologies through research and practice. [ABSTRACT FROM AUTHOR]

Purpose: We analyzed the prevalence and severity of potential drug-drug interactions (PDDIs) in Korean patients receiving oral anticancer agents (OAAs) during two different periods.Methods: A cross-sectional study was conducted using the national insurance reimbursement database. The subjects were adult outpatients diagnosed with cancer and prescribed OAAs at least once in 2010 or 2014. PDDIs were identified using a database and the PDDI severity was categorized as category X (contraindications) or D (consideration of therapy modification). The associated factors for the occurrence of PDDIs were also analyzed.Results: Among the 118,258 patients prescribed OAAs in 2014, approximately 59% were middle-aged, and approximately half were diagnosed with breast cancer. The number of comorbidities increased over time, and majority were diagnosed with gastrointestinal disorders, hyperlipidemia, and psychonervous disorders. The PDDIs due to protein kinase inhibitors (PKIs) with gastrointestinal/metabolic and neurological drugs increased 3.1- and 4.9-fold, respectively, over the 5 years, and 24.0% of the PDDIs fell into category X. Tamoxifen, the most commonly prescribed OAAs, caused the PDDIs with antidepressants through QTc prolongation or pharmacokinetic interaction. The PKIs prescription, cancer type like breast or hematologic cancer, and number of comorbidities or co-prescribing drugs were independently associated with the occurrence of PDDIs.Conclusions: The risk of PDDIs in patients receiving OAAs increases, particularly with the concomitant use of PKIs with gastrointestinal or psychiatric drugs and endocrine agents with antidepressants. Considering the potential risk of chronic concomitant use of these drug classes in outpatients, healthcare professionals should be made aware of the potential interactions. [ABSTRACT FROM AUTHOR]

Introduction: The global prevalence of cancer is rising. Use of oral anticancer medications has expanded exponentially. Knowledge about these medications as well as safe handling guidelines has not kept abreast with the rapidity these medications are applied in clinical practice. They pose serious hazards on all personal involved in handling these medications as well as on patients and their caregivers. We addressed the gaps in knowledge and safe handling of oral anticancer agents among pharmacists in institutional based cancer care. Materials and Methods: We used a 41 item questionnaire to explore three domains, pharmacists’ knowledge, safe handling practice and confidence and self-improving strategies towards these agents among pharmacists in multicentre specialized cancer care. Results: Participants included 120 pharmacists dedicated to handle and dispense oral anticancer agents. About 20% of Pharmacists have adequate knowledge about oral anticancer agents. Less than 50% apply safe handling principles adequately. Only a quarter are confident in educating cancer patients and their caregivers about Oral Anti-Cancer Agents. Conclusions: Pharmacists’ knowledge about Oral Anticancer agents needs to be improved. Safe handling and dispensing practice of these medications should be optimized. Pharmacists’ confidence towards educating patients and their caregiver needs to be addressed. Enhancing safety of oral anticancer agents should be a priority. Involving all key players, research and quality improving projects are needed to improve all aspects of the safety of oral anticancer agents.

Abstract: Therapeutic drug monitoring (TDM) could be helpful in oral targeted therapies. Data are sparse to evaluate its impact on treatment management. This study aimed to determine a threshold value of plasma drug exposure associated with the occurrence of grade 3–4 toxicity, then the potential impact of TDM on clinical decision. Consecutive outpatients treated with sunitinib were prospectively monitored between days 21 and 28 of the first cycle, then monthly until disease progression. At each consultation, the composite AUCƬ,ss (sunitinib + active metabolite SU12662) was assayed. The decisions taken during each consultation were matched with AUCƬ,ss and compared to the decisional algorithm based on TDM. A total of 105 cancer patients and 288 consultations were matched with the closest AUCƬ,ss measurement. The majority (60%) of the patients had metastatic renal clear‐cell carcinoma (mRCC). Fifty‐five (52%) patients experienced grade 3–4 toxicity. Multivariate analysis identified composite AUCƬ,ss as a parameter independently associated with grade 3–4 toxicity (P < 0.0001). Using the ROC curve, the threshold value of composite AUCƬ,ss predicting grade ≥3 toxicity was 2150 ng/mL/h (CI 95%, 0.6–0.79%; P < 0.0001). At disease progression in patients with mRCC, AUCƬ,ss tended to be lower than the one assayed during the first cycle (1678 vs. 2004 ng/mL/h, respectively, P = 0.072). TDM could have changed the medical decision for sunitinib dosing in 30% of patients at the first cycle of treatment, and in 46% of the patients over the whole treatment course. TDM is routinely feasible and may both contribute to improve toxicity management and to identify sunitinib underexposure at the time of disease progression. [ABSTRACT FROM AUTHOR]

Adequate information on oral anticancer agent (OACA) use is an essential element of optimal cancer care. The present study aimed to get insight into the experiences of patients with information on OACA treatment and their characteristics regarding information dissatisfaction. Patients of four Dutch university hospitals using OACA participated in this observational study and completed the Satisfaction with Information about Medicines Scale (SIMS), EORTC Quality of Life Questionnaire-C30, Brief Illness Perception Questionnaire, and Beliefs about Medicines Questionnaire-Specific. Logistic regression analyses were used to determine factors associated with dissatisfaction with information. Patients (n = 208) using capecitabine (35%), lenalidomide (15%), imatinib (14%), temozolomide (12%), sunitinib (11%), thalidomide (5%), dasatinib (4%), erlotinib (2%), and nilotinib (2%) participated. Information on the following SIMS-items was inadequate: how OACA elicit their effect, how long it takes before treatment works, how to conclude that treatment is effective, the risk of side effects and its management, interference with sex life, drowsiness, interference with other medication and alcohol and what to do in case of a missed dose. Younger age, hematological malignancy, dyspnoea, positive perception of consequences of the cancer, low perception of treatment control, and indifferent attitude towards OACA were associated with dissatisfaction with information. In conclusion, a considerable number of patients would have appreciated receiving more information on specific issues relating to the consequences of OACA treatment such as the effects and side effects of OACA and the interference of treatment with various aspects of their daily life. Oncologists, hematologists, lung-oncologists and pharmacists may reconsider the provision of information on OACA treatment. [ABSTRACT FROM AUTHOR]

Ru(II) and Os(II) complexes of 2-pyridinecarbothioamide ligands were introduced as orally administrable anticancer agents (S.M. Meier, M. Hanif, Z. Adhireksan, V. Pichler, M. Novak, E. Jirkovsky, M.A. Jakupec, V.B. Arion, C.A. Davey, B.K. Keppler, C.G. Hartinger, Chem. Sci. , 2013 , 4 , 1837–1846 ). In order to identify structure-activity relationships, a series of N -phenyl substituted pyridine-2-carbothiamides (PCAs) were obtained by systematically varying the substituents at the phenyl ring. The PCAs were then converted to their corresponding Ru II ( η 6 - p -cymene) complexes and characterized spectroscopically and by X-ray diffraction as well as in terms of stability in water and HCl. The cytotoxic activity of the PCA ligands and their respective organoruthenium compounds was evaluated in a panel of cell lines (HCT116, H460, SiHa and SW480). The lipophilic PCAs 1 – 4 showed cytotoxicity in the low micromolar range and 6 was the most potent compound of the series with an IC 50 value of 1.1 μM against HCT116 colon cancer cells. These observations were correlated with calculated octanol/water partition coefficient (clog P ) data and quantitative estimated druglikeness. A similar trend as for the PCAs was found in their Ru complexes, where the complexes with more lipophilic ligands proved to be more cytotoxic in all tested cell lines. In general, the PCAs and their organoruthenium derivatives demonstrated excellent drug-likeness and cytotoxicity with IC 50 values in the low micromolar range, making them interesting candidates for further development as orally active anticancer agents. [ABSTRACT FROM AUTHOR]

Background Patient adherence is important with the increasing use of oral anticancer drugs. Recent studies reported different capecitabine adherence rates based on self-reporting and microelectronic monitoring of the medication bottle. Patient’s awareness of being monitored may confound these results. Prescription records provide a larger and more objective dataset for adherence investigation. We report the use of computer algorithm and manual review of prescription and medical documentation to determine the rate of capecitabine adherence. Methods Two years of capecitabine prescription records from five ambulatory cancer centres were reviewed. Prescription data were extracted using a custom Java-based software tool to compare the predicted vs. actual dispensing date. The difference between the dates was the primary adherence measure (altered treatment date incident) and estimated using a computer algorithm and by manual review of medical charts. Results Of 4412 refill prescriptions, 45.2% was associated with an altered treatment date incident based on the initial computer algorithm. This was reduced to 29.5% after adjusting for clinic scheduling processes and 10.2% after manual chart review to adjust for valid reasons for delay. The reasons for altered treatment date incident were not identified in 52.2% of prescriptions. Conclusions Adherence rate of capecitabine based on refill data seem to be high and consistent with other findings based on patient self-report. Population analysis of prescription data with custom computer algorithm may identify trends in capecitabine adherence with some efficiency. Manual review would likely be required to verify these results. The accuracy of using altered prescription refill dates as an adherence measure requires further studies. [ABSTRACT FROM AUTHOR]

To develop and test the content validity of the Self-Care of Oral Anticancer Agents Index (SCOAAI). SCOAAI items were developed according to the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) criteria. The Middle Range Theory of Self-Care of Chronic Illnesses informed item generation. A four-phase procedure was followed; Phase 1: items were created based on a previous systematic review and a qualitative study; Phase 2: the SCOAAI comprehensibility and comprehensiveness were established through qualitative interviews with clinical experts and with patients (Phase 3); and Phase 4: the SCOAAI was then administered through an online survey to a group of clinical experts for the Content Validity Index (CVI) calculation. The first version of the SCOAAI included 27 items. Five clinical experts and 10 patients tested the comprehensiveness and comprehensibility of instructions, items, and response options. Fifty-three experts (71.7% female, mean experience with patients on oral anticancer agents 5.8 years [standard deviation ±.2]; 66% nurses) participated in the online survey for content validity testing. The final version of the SCOAAI includes 32 items. Item CVI ranges between 0.79 and 1; the average Scale CVI is 0.95. Future studies will test the psychometric properties of the tool. The SCOAAI showed excellent content validity, confirming its usefulness for assessing self-care behaviors for patients on oral anticancer agents. By implementing this instrument, nurses could define and implement targeted interventions for improving self-care and obtaining more positive outcomes (eg, better quality of life, reduced hospitalizations and emergency department visits). [ABSTRACT FROM AUTHOR]

To adequately manage oral anticancer agents (OAAs) therapy, appropriate self-care behaviours must be implemented. Informal caregivers could support and contribute to patient self-care. This study aimed to explore and describe the caregiver contribution to self-care and their related experience of caring among informal caregivers of patients on OAAs. Qualitative descriptive design. We conducted semi-structured interviews, which were transcribed, read in depth, and analysed with deductive and inductive content analysis, according to Mayring. Adult informal caregivers (>18 years) of elderly patients (>65 years) with solid malignancies undergoing OAAs therapy for at least 3 months were included. Twenty-three caregivers were interviewed with mean age of 57,2 (SD ± 15,8). A total of 18 codes from the qualitative content analysis were found, of which ten were referred to caregiver contribution and classified into the three dimensions of self-care maintenance (i.e. behaviours to maintain illness stable), self-care monitoring (i.e., tracking symptoms and side effects), and self-care management (i.e., management of worsening symptoms), according to the Middle Range Theory of Self-Care of Chronic Illnesses. The eight codes on caregiver experience were aggregated into two main themes: negative aspects (i.e., burden, emotional state, self-denial, social isolation) and positive aspects of caregiving. Healthcare professionals should consider the importance of caregiver role in supporting their loved one treated with OAAs, also taking into account their needs to prevent burdensome situations. A holistic view in which a patient-centred approach is established should be encouraged through the communication and education of the dyad. • Caregivers contribute to the patient's self-care mainly with actions to keep the disease stable (self-care maintenance). • Caregiver contribution may involve negative outcomes for the caregiver, such as burden, anxiety, or social problems. • Healthcare professionals should consider the importance of caregivers in supporting their loved one, in a dyad perspective. [ABSTRACT FROM AUTHOR]

Background: Healthcare provider (HCP) activities and attitudes towards patients strongly influence medication adherence. The aim of this study was to assess current clinical practices to support patients in adhering to treatment with oral anticancer agents (OACA) and to explore clues to improve the management of medication adherence.Methods: A cross-sectional, observational study among HCPs in (haemato-)oncology settings in Belgium and the Netherlands was conducted in 2014 using a composite questionnaire. A total of 47 care activities were listed and categorised into eight domains. HCPs were also asked about their perceptions of adherence management on the items: insight into adherence, patients' communication, capability to influence, knowledge of consequences and insight into causes. Validated questionnaires were used to assess beliefs about medication (BMQ) and shared decision making (SDM-Q-doc).Results: In total, 208 HCPs (29% male) participated; 107 from 51 Dutch and 101 from 26 Belgian hospitals. Though a wide range of activities were reported, certain domains concerning medication adherence management received less attention. Activities related to patient knowledge and adverse event management were reported most frequently, whereas activities aimed at patient's self-efficacy and medication adherence during ongoing use were frequently missed. The care provided differed between professions and by country. Belgian physicians reported more activities than Dutch physicians, whereas Dutch nurses and pharmacists reported more activities than Belgian colleagues. The perceptions of medication adherence management were related to the level of care provided by HCPs. SDM and BMQ outcomes were not related to the care provided.Conclusions: Enhancing the awareness and perceptions of medication adherence management of HCPs is likely to have a positive effect on care quality. Care can be improved by addressing medication adherence more directly e.g., by questioning patients about (expected) barriers and discussing strategies to overcome them, by asking for missed doses and offering (electronic) reminders to support long-term medication adherence. A multidisciplinary approach is recommended in which the role of the pharmacist could be expanded. [ABSTRACT FROM AUTHOR]

Introduction: The global prevalence of cancer is rising. Use of oral anticancer medications has expanded exponentially. Knowledge about these medications as well as safe handling guidelines has not kept abreast with the rapidity these medications are applied in clinical practice. They pose serious hazards on all personal involved in handling these medications as well as on patients and their caregivers. We addressed the gaps in knowledge and safe handling of oral anticancer agents among pharmacists in institutional based cancer care. Materials and Methods: We used a 41 item questionnaire to explore three domains, pharmacists' knowledge, safe handling practice and confidence and self-improving strategies towards these agents among pharmacists in multicentre specialized cancer care. Results: Participants included 120 pharmacists dedicated to handle and dispense oral anticancer agents. About 20% of Pharmacists have adequate knowledge about oral anticancer agents. Less than 50% apply safe handling principles adequately. Only a quarter are confident in educating cancer patients and their caregivers about Oral Anti-Cancer Agents. Conclusions: Pharmacists' knowledge about Oral Anticancer agents needs to be improved. Safe handling and dispensing practice of these medications should be optimized. Pharmacists' confidence towards educating patients and their caregiver needs to be addressed. Enhancing safety of oral anticancer agents should be a priority. Involving all key players, research and quality improving projects are needed to improve all aspects of the safety of oral anticancer agents. [ABSTRACT FROM AUTHOR]

The introduction of oral-targeted therapy for cancer improves survival while adherence also presents as a challenge to patients. Current studies on oral anticancer agents are primarily limited to patients from developed countries with breast cancer and chronic myeloid leukemia receiving oral chemotherapy and hormonal therapy. This study explored experience of oral-targeted therapy adherence among Chinese patients with nonsmall cell lung cancer and its contributing factors by using a qualitative research. Semi-structured interviews with 16 patients and 7 family caregivers at a tertiary tumor hospital in China were conducted to understand their experience and perceptions of oral-targeted therapy. Thematic analysis was applied to generate the themes and to identify underlying factors associated with the adherence. The lung cancer survivors struggled with ambivalence between survival and relief during taking targeted anticancer medication and showed diverse models of nonadherence, including intentionally or unintentionally intermittent medication and overadherence. Three main themes were identified: (1) cancer-related distresses, (2) inadequate social support, and (3) forgetfulness, together with seven subthemes, representing factors impeding patients' medication adherence. The themes demonstrate complicated and interrelated factors from personal, interpersonal, sociocultural, and structural forces contributing to patients' poor adherence. The findings suggest the imperativeness of reinforcing community- or home-based oral-targeted medication management in which nurses play a principal role to implement strategies of patient education, symptom management, reminder prompts, and monitoring to improve adherence. [ABSTRACT FROM AUTHOR]

Background Despite recommendations for adherence reporting in clinical trials involving an oral anticancer agent, the frequency and methods of adherence reporting are inconsistent. The purpose of this systematic review is to determine the frequency and type of adherence measures used in oncology and hematology clinical trials of oral anticancer agents and their association with study characteristics including quality, cancer type, stage and treatment type. Design PubMed was searched of all randomized controlled clinical trials assessing self-administered pharmacological interventions in patients with cancer and published over two years, between 1 January 2011 and 31 December 2012 were evaluated. Results We identified 70 publications in the PubMed database, comprising 45,118 total patients. Adherence reporting was present in 14 of 70 trials (20%); quantitative reporting was present in three of 70 trials (4%). Method of adherence assessment varied and included medication count, medication diaries and patient self-report. There was no association between adherence reporting and study quality or other study characteristics, although there was a trend towards increased reporting in breast cancer studies, with 46% of the studies reporting adherence (p = 0.0621). In a preliminary analysis, hematology studies (mean Jadad score 2.19 ± 1.47) were found to have significantly lower quality when compared to non-hematology trials (mean Jadad score 3.39 ± 1.37, p = 0.0034). Conclusion This systematic review demonstrates adherence reporting in clinical trials of oral anticancer agents is infrequent. When reported, adherence was not associated with overall study quality or other study characteristics. Given the potential effects of non-adherence on study power and validity, adherence reporting should be encouraged in oncology and hematology clinical trials. [ABSTRACT FROM AUTHOR]

Purpose: Adherence to oral medication is important in oncology. Few studies have evaluated adherence with cancer agents such as capecitabine, which is given on a complicated schedule. Furthermore, little guidance exists regarding the best methods for monitoring adherence with oral cancer drugs. The purpose of our study was to evaluate adherence to capecitabine using several accepted measures. Patients and methods: Patients treated with capecitabine for gastrointestinal cancers were included in this prospective cohort study. Adherence was evaluated during two consecutive cycles of capecitabine using three assessment methods: self-report, pill count, and use of a microelectronic monitoring system. The primary endpoint was proportion of patients adherent to capecitabine (>80% of adherence according to the three methods of measurement); the secondary objective was to compare the three methods of measurement. Results: Nineteen patients were accrued to this study. Further accrual was stopped after the first planned analysis, because 18 and 19 patients were adherent by self-report and pill count, respectively. The overall adherence rates were 99, 100, and 61% with self-report, pill count, and microelectronic monitoring system cap, respectively. Ten (53%) patients were classified as nonadherent (<80% of adherence according to at least one method of measurement), but four of them transferred their pills into another medication container suggesting that measurement of adherence using microtronic monitoring system technology may not be useful. [ABSTRACT FROM AUTHOR]

Background: The use of oral anticancer agents increased steadily in the last decades. Although oral anticancer agent adherence is important for a successful treatment, many patients are insufficiently adherent. Purpose: To evaluate adherence influencing factors in patients taking oral anticancer agents. Methods: A systematic literature search was performed in Medline and Embase. Titles and abstracts and in case of relevance, full-texts were screened according to predefined inclusion criteria. The risk of bias was assessed. Both were carried out independently by two reviewers. Relevant data on study characteristics and results were extracted in standardized tables by one reviewer and checked by a second. A meta-analysis was not performed because of clinical and methodological heterogeneity between the studies to avoid misleading results. Data were synthesized in narrative way using a standardized procedure. Results: Twenty-two relevant studies were identified. The study quality was moderate. Especially the risk of bias regarding the measurement of influencing factors and adherence was mostly unclear. Social support, intake of aromatase inhibitors, and lower out-of-pocket costs for OACA seem to have a positive effect on adherence. Depression and the number of different medications seem to have a negative effect on adherence. Low age and very high age seem to be associated with lower adherence. The remaining factors showed either mostly no influence or were heterogeneous regarding the effect direction and statistical significance. Conclusions: There are some factors that seem to have influence on adherence in patients taking OACA. However, due to the heterogeneity no general conclusions can be made also for these factors that can be applied to all indications, medications, settings, countries etc. The results should rather be considered as indications for factors that can have an influence on adherence to OACA. [ABSTRACT FROM AUTHOR]

Older adults treated with oral anticancer agents may have several needs related to managing their treatment at home. Moreover, the experiences of older adults engaging in self-care have been poorly investigated. This study aimed to explore and describe self-care behaviours in older adults treated with oral anticancer agents. This is a qualitative study using content analysis with both a deductive and an inductive approach. Guided by the Middle-Range Theory of Self-Care of Chronic Illness, we explored the three theoretical dimensions of self-care maintenance (i.e., behaviours to maintain illness stability), self-care monitoring (i.e., behaviours to monitor signs and symptoms) and self-care management (i.e., responses to signs and symptoms). Patients over 70 years of age who were treated with oral anticancer agents for at least 3 months were interviewed. We enrolled 22 participants (13 males), age range: 70–87 years. Nine categories emerged within the three identified dimensions—self-care maintenance: medication adherence, dietary adaptations and physical activity; self-care monitoring: general health status, cancer monitoring, sign and symptom recognition and attending visits; and self-care management: oral anticancer agent side effects management and illness management. Self-care is a growing area in cancer research. However, it is poorly understood among older patients taking oral anticancer agents. Oncology nurses can play a pivotal role in evaluating and supporting self-care behaviours, educating patients to effectively implement correct self-care behaviours and ensuring positive outcomes for these patients. Further research is needed to establish appropriate interventions to improve self-care in older patients taking oral anticancer agents. • Self-care behaviours can lead to positive outcomes for older patients with cancer. • Most self-care behaviours regard adherence to treatments. • Pain is not managed adequately, and patients wait until symptom relief. [ABSTRACT FROM AUTHOR]

Purpose: Oral anticancer agents offer significant benefits over parenteral anticancer therapy in terms of patient convenience and reduced intrusiveness. Oral anticancer agents give many cancer patients freedom from numerous hospital visits, allowing them to obtain their medications from their local community pharmacy. However, a major concern with increased use of oral anticancer agents is shift of responsibility in ensuring the proper use of anticancer agents from the hospital/clinical oncology team to the patient/caregiver and other healthcare providers such as the community pharmacists who may not be appropriately trained for this. This study assessed the readiness of community pharmacists across Canada to play this increased role with respect to oral anticancer agents. Methods: Using a structured electronic mailing strategy, a standardized survey was mailed to practicing pharmacists in five provinces where community pharmacists were dispensing the majority of oral anticancer agents. In addition to collecting basic demographic and their practice setting, the survey assessed the pharmacists’ knowledge regarding cancer therapy and oral anticancer agents in particular, their education needs and access to resources on oral anticancer agents, the quality of prescriptions for oral anticancer agents received by them in terms of the required elements, their role in patient education, and steps to enhance patient and personal safety. Results: There were 352 responses to the survey. Only 13.6% of respondents felt that they had received adequate oncology education at the undergraduate level and approximately 19% had attended a continuing education event related to oncology in the past 2 years. Only 24% of the pharmacists who responded were familiar with the common doses of oral anticancer agents and only 9% felt comfortable educating patients on these medications. [ABSTRACT FROM AUTHOR]

Abstract: Background: The use of oral anticancer agents has increased in the last decades. Adherence is a crucial factor for the success of oral anticancer agent therapy. However, many patients are non-adherent. Objective: The objective was to evaluate the effectiveness of adherence interventions in patients taking oral anticancer agents. Methods: A systematic literature search was performed in Medline and Embase. Titles and abstracts and in case of potential relevance, full-texts were assessed for eligibility according to the predefined inclusion criteria. The study quality was evaluated. Both process steps were carried out independently by two reviewers. Relevant data on study design, patients, interventions and results were extracted in standardized tables by one reviewer and checked by a second reviewer. Results: Six controlled studies were included. Only one study was randomized. The study quality was moderate to low. One study showed statistically significant results in favor of the adherence intervention, two studies showed a tendency in favor of the intervention, one study showed an inconsistent result depending on the adherence definition and one study showed almost identical adherence rates in both groups. One study showed a tendency in favor of the control group. Conclusions: Although most of the interventions are not very effective, it appears that certain adherence enhancing interventions could have a promising effect. One crucial point is the consideration of the baseline adherence when choosing patients to avoid ceiling effects. The evidence is limited due to lack of sufficient studies and partly inconsistent results. Further high quality studies are needed. [Copyright &y& Elsevier]

ABSTRACT Purpose In recent years, the number of oral anticancer agents has increased substantially. Although these agents have quickly been incorporated in the treatment of a variety of malignancies, data on their incidence, prevalence and costs are lacking. The objective of the present study was to obtain insight into the use and the costs of oral anticancer agents (with Anatomical Therapeutic Chemical classification system (World Health Organisation) code L01) in the Netherlands between 2000 and 2008. Methods Incidence and prevalence were determined using community pharmacy dispensing records obtained from the PHARMO Record Linkage System database. The data of costs were provided by the Genees- en hulpmiddelen Informatie Project of the Dutch Health Care Insurance Board (CVZ, Diemen, The Netherlands). Results In the years 2000-2008, the use of oral anticancer agents has more than doubled from 64 to 140 users per 100 000 inhabitants. The increase is mainly caused by the prescription of capecitabine for various indications. There was a 50-fold rise in costs on oral anticancer agents from €2 m in 2000 to approximately €100 m in 2008. The share in the costs of tyrosine kinase inhibitors (TKIs) in 2008 was 67% (€70 m) with the oldest TKI, imatinib, having a share of more than 50% within the group of TKIs. Conclusions The increased use of oral anticancer agents is mainly due to the frequent prescription of capecitabine. The increased costs are caused by the registration of a variety of TKIs, in particular imatinib. The costs of new agents with an orphan drug status are very high as compared with those of capecitabine, a newer agent for which there are alternative treatment options. Copyright © 2011 John Wiley & Sons, Ltd. [ABSTRACT FROM AUTHOR]

Abstract: Background: There has been a recent increase in the availability and use of oral anticancer agents (OAAs). Drug–drug interactions (DDIs) involving OAAs pose a major concern in oncology practice due to these drugs'' narrow therapeutic indices and potential for compromised efficacy and fatal adverse events. Objective: To assess the prevalence of the coprescription of potentially interacting drug combinations involving OAAs in Singapore. Methods: A retrospective review of physicians'' electronic prescription records between the years 2007 and 2009 was performed in the largest cancer center in Singapore. An overall prevalence rate of potential DDIs and a prevalence rate for each individual DDI pair were calculated. Logistic regression was used to identify risk factors for potential DDIs. Results: Fifty-eight clinically significant DDIs were selected for evaluation from Drug Interaction Facts and Micromedex DrugDex. A total of 39,772 OAA prescriptions prescribed to 8837 patients were reviewed. Potential DDI coprescription was found in 5.4% of the patients on OAAs and in 4.7% of the OAA prescriptions. The drug pair prescribed to the largest number of patients was prednisolone and aspirin. About half (53.3%) of the observed DDIs were found on the same prescription. On multivariate analysis, older patients, males, and those taking prednisolone had a higher risk for potential DDIs. Conclusion: Although limited by the data available, the analysis of prescription records found that ∼5% of patients taking OAAs in Singapore were exposed to ≥1 potentially interacting drug combination. [Copyright &y& Elsevier]

Background: Drug-drug interactions (DDIs) can lead to adverse clinical outcomes, particularly in oncology, because of the narrow therapeutic index of chemotherapeutic agents and because patients with cancer are at a high risk due to polypharmacy and age-related organ dysfunction. In a previously published study, drug profiles were developed based on primary and tertiary literature reviews for a list of clinically significant DDIs involving 28 oral anticancer agents (OAAs). Objective: This study was based on a Delphi survey of oncology pharmacists; the survey results were used to develop a consensus list of clinically significant DDIs involving OAAs and nonanticancer agents. Methods: In this study, the DDI profiles previously developed were updated, and the DDI pairs that were listed both in the 2009 Drug Interaction Facts (DIF) and the Thomson Micromedex DrugDex System compendia and that also met the predetermined criteria for clinical significance were selected for further evaluation. In a 2-round, electronically administered Delphi survey of oncology pharmacists, a 5-point Likert scale (1–5, where 1 = strongly agree and 5 = strongly disagree) was used to evaluate the DDI pairs based on 8 clinical aspects (clinical importance; irreversible morbidity and mortality; quality of data; quantity of data; patient''s organ functions; comorbid conditions; awareness of interaction; and management burden). International pharmacists who specialized in oncology pharmacy practice and had ≥5 years of practice experience were eligible to participate. Results: Nine of the 23 surveyed pharmacists responded, giving a response rate of 39.1%. A total of 37 DDI pairs were selected from DIF and DrugDex and evaluated by the survey respondents, resulting in the identification, via consensus, of 12 clinically significant DDI pairs. The clinical aspects with the most DDIs that reached consensus of agreement were clinical importance (82.9%) and awareness of interaction (73.2%). Conclusion: An expert panel identified 12 clinically significant DDIs involving OAAs. [Copyright &y& Elsevier]

Adherence to medications is an important issue in oncology due to the increasing number of anticancer agents, such as targeted therapies, formulated for oral dosing. A prospective, crossover design was utilized in which patients on capecitabine were randomly assigned to one of two packaging methods for one cycle, and then switched over to the alternate packaging method in the subsequent cycle. Twenty-five patients were accrued to this study. Adherence rates were similar when using the daily pill boxes (17/21 = 81%) and when using the conventional pill bottles (18/21 = 86%). However, more patients were satisfied with the daily pill boxes (61% versus 11%, P = 0.027), preferred the daily pill boxes (61% versus 17%, P = 0.061), and thought the daily pill boxes were more helpful in reminding them to take their medications (50% versus 11%, P = 0.070). In conclusion, this small pilot study did not demonstrate that the use of daily pill boxes improved patient adherence with capecitabine, but patient satisfaction and preference for this packaging method were greater than for the conventional pill bottles. Further exploration of this intervention in a larger study is warranted. [ABSTRACT FROM AUTHOR]

Purpose. Imatinib (Glivec) has been established as a highly effective therapy for chronic myeloid leukemia and gastrointestinal tumors. The recommended daily dosage of 400–600 mg requires simultaneous intake of up to six of the current 100-mg capsules. Due to the need to swallow multiple capsules per dose, there is a potential negative impact on treatment adherence; therefore, a new imatinib 400-mg film-coated tablet has been developed. To improve dosing flexibility, particularly with regard to the pediatric population and the management of adverse events, a scored 100-mg film-coated tablet has also been introduced. Experimental design. A group of 33 healthy subjects were randomly assigned to one of six treatment sequences, in which they received imatinib as 4×100-mg capsules (reference), 4×100-mg scored tablets (test), and 1×400-mg tablet (test). Blood sampling was performed for up to 96 h after dosing, followed by a 10-day washout period prior to the next sequence. After the third dosing, subjects were monitored to assess delayed drug-related adverse events. Pharmacokinetic parameters were assessed using concentration-time curves for plasma imatinib and its metabolite CGP74588. Results. Median Tmax was 2.5 h for capsules and tablets. Mean AUC(0–inf) values were 27094, 26081 and 25464 ng·h/ml for 4×100-mg capsules, 4×100-mg tablets, and 1×400-mg tablets, respectively. Cmax values were 1748, 1638 and 1606 ng/ml, and t1/2 values were 15.8, 15.9 and 15.7 h. The test/reference ratios for AUC(0–inf), AUC(0–96 h), and Cmax were 0.98, 0.98 and 0.95 for 4×100-mg tablets versus 4×100-mg capsules, and 0.95, 0.95 and 0.92 for 1×400-mg tablet versus 4×100-mg capsules. The 95% confidence intervals were fully contained within the interval (0.80, 1.25). Eight mild and one moderate adverse event considered to be drug related were reported. These events showed no clustering by type of dosage form and were of little to no clinical significance. Conclusions. Film-coated 100-mg (scored) and 400-mg tablet dose forms of imatinib are bioequivalent to the commercial 100-mg hard-gelatin capsule, and are as safe and well tolerated. [ABSTRACT FROM AUTHOR]