Use Of Oral Anticancer Agents Research Articles

Patient Adherence to Oral Anticancer Agents: A Mapping Review of Supportive Interventions.

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.

Risk factors predicting clinical oncology pharmacists’ medication modifications.

54 Background: Pharmacists provide an important role in oncology practice, especially as the use of oral anticancer agents (OAAs) has increased. A program supporting the integration of clinical oncology pharmacists into community practices, Pharmacists Optimizing Oncology Care Excellence in Michigan (POEM), is examining their roles and impact. The purpose of this study was to identify patient characteristics that were associated with medication modification interventions from clinical oncology pharmacists. These results will provide insight into how pharmacists support patient care as well as how to focus pharmacists’ care when their time may be limited. Methods: This multicenter, retrospective analysis was conducted with data from October 2020 – April 2023 documenting clinical care provided to patients taking OAA(s) and receiving a patient-focused intervention. POEM pharmacists received support in the development of collaborative practice agreements, billing, and clinical oncology education. Data included patient demographics, and encounter and intervention characteristics. First, we predicted medication modification interventions including each OAA in machine learning Regression Tree analyses. Second, we used zero-inflated Poisson regression to quantify predictors of receipt of medication modification interventions. We examined cross-tabulations for age and rurality and medication modifications. Results: In these analyses, 1836 met study inclusion, and 1029 medication modifications were made for 623 patients. In Tree analyses, Group 1 was patients receiving trametinib (n=1 patient) and cabozantinib (n=2), and Group 2 was patients receiving alpelisib (n=28 patients) and osimertinib/palbociclib (n=1). Groups 1 and 2 were associated with statistically significantly more medication modifications (predicted value was 6.7 and 3.8, respectively). Age (65-69 and >80) and rurality (rural/small town and micropolitan) were statistically significant predictors of receiving a medication modification as well as the number of medication modifications. For example, individuals residing in rural/small towns compared to metropolitan were less likely to have no medication modifications (-0.668 SE 0.22, p=0.003). They were also more likely to have greater numbers of medication modifications (0.545 SE 0.10, p<0.001). Age (Χ2=10.2, 3df, 0=0.017) and rurality (X2=78.81, 6df, p<0.001) were statistically significantly associated with more medication modifications. Conclusions: Individuals who took alpelisib, were older, and living in more rural communities were more likely to receive medication modifications from clinical oncology pharmacists. Developing sustainable models for interprofessional pharmacist care in community oncology practices appear to be an important strategy to address disparities in care, particularly for patients from rural areas.

Impact of initiating oral anticancer agents for leukemia on adherence to medications for multiple chronic conditions.

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). 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. 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. OAA initiation among adults with CML or CLL was not associated with significant, initial changes to adherence to medications for chronic diseases.

Impact of Initiating Oral Anticancer Agent Therapy for Chronic Lymphocytic Leukemia Among Adults with Multiple Chronic Conditions

Background: Increased use of oral anticancer agents (OAA) has empowered adults with chronic lymphocytic leukemia (CLL) to manage their therapy independently. However, comorbid chronic disease is common among patients with CLL, and initiating OAA therapy increases the treatment burden on adults with both cancer and multiple chronic conditions (MCC). The objective of this research was to examine adherence to OAAs in adult patients with CLL newly initiating OAA treatment and assess the extent to which such initiation impacted adherence to medications for existing comorbid chronic conditions. Methods: This retrospective cohort study used commercial (MarketScan) and Medicare (20% sample) claims data for 2013-2018 to assess medication use in adults with CLL. To be included, patients must have been: 1) at least 18 years old; 2) diagnosed with and had 2+ claims for an OAA indicated for either CLL; 3) continuously enrolled 12 months before and after OAA initiation; and 4) treated for (2+ fills before and after OAA initiation) at least 2 select chronic conditions (diabetes, hypertension, or hyperlipidemia plus at least 1 other chronic condition). Proportion of days covered (PDC) determined medication adherence for all included medication classes and was compared for the 12 months before and after OAA initiation by Wilcoxon signed-rank tests and McNemar's tests. Multivariable logistic regression identified predictors of OAA adherence in the first year of therapy while controlling for available demographic and clinical characteristics. Difference-in-differences models assessed the change in adherence to select comorbid chronic disease medications before and after OAA initiation. Results: The final analysis included 246 (commercial) and 805 (Medicare) adults with CLL and MCC. 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, translating to 68.3% (commercial) and 59.1% (Medicare) being adherent (PDC>80%). An increase in comorbidity burden was associated with a lower odds of OAA adherence and was the sole significant predictor in the Medicare models: OR=0.87 (95% CI: 0.82-0.92) for Medicare members and OR=0.83 (95% CI: 0.73-0.95) with commercial coverage. Among adults with commercial coverage, the odds of OAA adherence were lower for residents of the South (OR=0.39; 95% CI: 0.16-0.94; compared to the Northeast), but higher among those using a greater number of medications overall (OR=1.08; 95% CI: 1.01-1.16). No significant changes in mean adherence to MCC medications were observed, irrespective of payer, when comparing values before and after OAA initiation (Figure Panel A), including when accounting for OAA adherence in the first year of therapy. However, compared to the first 6 months post-OAA initiation, mean PDCs in the second half of the year noticeably declined, irrespective of comorbidity or payer cohort, with PDC declines ranging from 3.0 (antihypertensives, Medicare) to 11.1 (antihypertensives, Medicare) percentage points (Figure Panel B). Conclusion: Using nationally representative claims data, this study found that initial OAA adherence was generally good among adults with CLL, with a majority of patients reaching accepted thresholds of adequate anticancer medication use. Additionally, few differences in adherence were observed in multivariable analyses using a range of patients’ characteristics, irrespective of payer or cancer type. Importantly, limited evidence of changes in adherence to oral antidiabetic, antihypertensive, or lipid-lowering agents were found in the first year following OAA initiation. However, these findings do not negate the need for careful monitoring of medication use in these populations over the course of time as some eventual declines in comorbid chronic disease medication adherence were observed. Figure 1View largeDownload PPTFigure 1View largeDownload PPT Close modal

CN36 Informal caregivers’ contributions to self-care for patients treated with oral anticancer agents: A qualitative study

The use of oral anticancer agents (OAAs) is increasing worldwide. OAAs can be managed by patients at home, but potential side effects must be considered. For adequate management of OAAs, patients should perform appropriate self-care behaviors. Informal caregivers could support and contribute to patient self-care. This study aimed to explore informal caregivers’ contributions to self-care for patients undergoing OAAs.

Smartphone-based application and nurses' interventions for symptoms monitoring in patients treated with oral anticancer agents: A 1-year follow-up in a tertiary cancer center.

The increasing use of oral anticancer agents over the past years has necessitated changes in monitoring toxicities to ensure patients' adherence and tolerance at home. The aim of this study was to describe nurses' interventions and medical changes after alerts triggered by a web-based platform designed to support the management of oral anticancer agents-related toxicities. This retrospective study included patients undergoing oral anticancer agents in a cancer center from September 2018 to September 2019 (excluding hormonal therapy). In this cancer center, the standard of care included symptoms' collections for 1 month thanks to a web platform based on patient-reported outcomes. Patients had to fill a weekly questionnaire (Q1 to Q4). The web-based platform triggered orange alerts when patients reported moderate symptoms and red alerts when severe toxicities were declared. The rate of orange and red alerts, the rate of patients with medical changes consecutively to an orange or a red alert, and the different types of nurses' interventions and medical changes were assessed. A total of 524 patients were extracted but the final number of 436 patients were included in this study and 1488 questionnaires were filled in. More than 90% of patients declared that they took their medication as prescribed. Up to 60% of patients recorded all grade symptoms, including 8% of patients who recorded Grades 3-4 symptoms during the month, mostly anorexia, fatigue, and diarrhea. The web platform system triggered 700 orange and 212 red alerts: 305/700 (44%) of orange alerts resulted in nurses' interventions, most frequently phone counseling (78%), and 65/212 (31%) of red alerts resulted in medical changes, most frequent treatment interruptions (48%). Implementing an e-health (electronic-health) system can be helpful for monitoring symptoms in patients under oral anticancer agents, enhancing that this organization should be a standard of care in every cancer centers.

Medication Adherence Among Adults With Comorbid Chronic Conditions Initiating Oral Anticancer Agent Therapy for Multiple Myeloma.

Increased use of oral anticancer agents (OAAs) has empowered adults with multiple myeloma (MM) to manage their oncolytic therapy, but such a shift may result in issues with medication use, particularly among patients being concurrently treated for pre-existing, multiple chronic conditions. This retrospective cohort study used 2013-2018 commercial and Medicare claims data to assess medication use in adults with MM. To be included, adults (18 years and older) must have been diagnosed with and had 2+ claims for an OAA, had continuous enrollment for 12 months before and after OAA initiation, and have been previously diagnosed with and had prescription fills for 2+ select chronic conditions. The proportion of days covered metric assessed medication adherence and was compared for 12 months before and after the OAA initiation by Wilcoxon signed-rank tests, McNemar's tests, and difference-in-differences models. The mean OAA adherence in the first year of therapy was 58.3% (standard deviation: 24.5) and 65.1% (standard deviation: 27.01) for commercial and Medicare patients, respectively. Adherence and the proportion adherent (proportion of days covered ≥ 80%) to comorbid therapies generally declined in the first year after OAA initiation. Changes in medication use were particularly noticeable among those on antihypertensive therapy: adjusted analyses uncovered a 2.5% (Medicare) and 5.2% (commercial) difference in adherence to these medications between those initially adherent and nonadherent to OAA therapy (both P < .05). Initiating OAA therapy in adults with MM may complicate an already complex treatment regimen, resulting in poor overall medication adherence in patients with multiple comorbid conditions.

Abstract P4-12-01: Adherence with adjuvant endocrine therapy with or without Palbociclib in the PALLAS trial

Abstract Background: As the development and use of oral anticancer agents increases, it is critical to understand patient adherence to both standard and investigational agents. The open label, phase 3 multicenter PALLAS trial investigates whether adding 2 years of the CDK4/6 inhibitor palbociclib (P) to adjuvant endocrine therapy (ET) improves invasive disease-free survival (iDFS) over adjuvant ET alone in patients (pts) with HR- positive, HR2-negative, stage II-III breast cancer. Pts were randomly assigned to either Palbociclib (125 mg/day, 3 weeks on, 1 week off, in a 28-day cycle) plus ongoing provider/patient-choice adjuvant ET (P+ET) versus ET alone. We examined patient-reported adherence to ET +/- P during the first two years of study treatment. Methods: Adherence outcomes were measured in English-speaking pts in the U.S., UK, Ireland and Australia, Spanish-speaking pts in Spain and Mexico, and German-speaking pts in Germany and Austria. Adherence measures included drug diaries completed at each cycle, pill counts (for P only) collected at each study visit, and the Morisky Medication Adherence Scale-4 item and the McHorney Adherence Estimator questionnaires completed at cycles 2, 3, 6, 12, 18, and 24 (22 months). Mean adherence for each cycle was defined as the average proportion of prescribed pills taken (via drug diary) across all patients who initiated that cycle. Persistence was defined as the duration of drug initiation to treatment cessation (via drug diary). Generalized estimating equations were used to model the “most adherent” pts on the Morisky (score = 5 vs score &amp;lt;5) and “low risk” for adherence problems on the McHorney (score=0 vs score &amp;gt;0) to compare the average difference between arms over time for ET, adjusting for baseline demographic and clinical variables. Results: 81% (N=4688) of PALLAS pts were included in this analysis. Median persistence to ET was 23.6 months in P + ET (n=2169), 23.7 months in ET alone (2136) and 20.4 months for P (n=2194). The number of pts who initiated each cycle for ET declined over time and was similar between arms; the decline was more marked for P (Table 1). Mean adherence range as measured by drug diary was 98.2-99.3% for ET in P+ET and 98.0 - 99.4% in ET alone; and for P, ranged from 93.4 - 98.8%. The adherence and persistence results were nearly identical whether measured by drug diary or pill count for P. The observed percent “most adherent” for P measured by the Morisky scale ranged from 71.9% - 79.6% and the percent “low risk” for adherence problems measured by the McHorney scale, 64.0% - 73.4%. The percent of pts “most adherent” and “low risk” for adherence problems to ET was higher, on average over time, in the P+ET group compared to ET alone (75% vs 68%, p&amp;lt;0.01; 75% vs 72%, p=.05, respectively). Conclusions: Self-reported mean adherence for both P + ET and ET alone was strikingly high for pts who remained on therapy; persistence was also high with ET during the 2-year treatment period. Current analyses suggest that nonadherence to either P or ET was likely not a major contributor to the iDFS results seen in the overall PALLAS trial. These results illustrate the importance of measuring and monitoring patient adherence to oral study agents. Support: AFT, Pfizer; ClinicalTrials.gov (NCT02513394) and EudraCT (2014-005181-30). https://acknowledgments.alliancefound.org Table 1.Adherence and persistence in PALLAS over the 24 month treatment periodPalbocicilb + ETETPalbociclibETETTreatment cycleMean Adherence (SD)N*Mean Adherence (SD)NMean Adherence (SD)N193.4 (13.8)229098.7 (6.1)230999.0 (5.2)2343294.7 (13.3)218198.8 (6.4)220398.4 (7.1)2206397.4 (10.1)211298.7 (7.3)214298.8 (6.3)2168497.6 (10.2)203598.6 (7.8)211099.0 (5.7)2154597.6 (11.1)197598.3 (7.9)209398.1 (8.3)2148698.1 (8.7)189998.7 (6.6)203798.5 (8.2)2116798.1 (9.3)185599.0 (6.3)201298.6 (7.3)2102898.0 (9.1)181098.2 (8.2)199798.1 (8.2)2092998.4 (7.4)173399.0 (6.4)196298.8 (6.8)20511098.3 (8.6)171499.2 (4.9)194699.0 (5.5)20381198.3 (8.0)169198.5 (7.3)193798.2 (8.2)20311298.7 (6.2)161299.1 (5.3)191098.7 (7.5)19861398.5 (7.7)159698.9 (6.4)189398.8 (7.1)19691497.9 (9.3)157698.4 (7.3)188298.0 (9.1)19611598.5 (6.9)151499.2 (4.6)185499.0 (6.0)19281698.2 (8.7)148699.1 (4.6)183599.1 (5.7)19131798.1 (9.8)147998.3 (7.8)182698.5 (6.4)19031898.7 (6.8)141699.3 (4.1)176899.2 (5.3)18601998.7 (7.3)140899.3 (3.8)175699.4 (3.1)18482098.4 (8.9)139798.9 (5.3)174298.7 (5.8)18382198.5 (7.5)130199.0 (6.1)167698.8 (7.1)17842297.8 (9.7)124698.8 (6.2)164799.2 (5.7)17692398.1 (8.8)118098.2 (8.5)161998.4 (8.0)17552498.8 (7.2)108699.0 (6.3)146898.9 (7.1)16192598.8 (6.7)99699.2 (5.2)143298.8 (7.1)15892697.9 (11.2)84599.1 (5.7)140998.6 (8.8)1578ET=Endocrine therapy * Number of pts who initiated the treatment cycle. Citation Format: Eileen Shinn, David Zahrieh, Angela DeMichele, Nick Zdenkowski, Julie Lemieux, Jun Mao, Vesna Bjelic-Radisic, Michelle Naughton, Georg Pfeiler, Karen Gelmon, Ingrid Mayer, Daniel Egle, Gabriele Zoppoli, Tiffany Traina, Miguel Martin Jiménez, Silvia Antolin Novoa, Tufia Haddad, Arlene Chan, Alistair Edward Ring, Antonio Wolff, Jose JuanPonce Lorenzo, Dhanusha Sabanathan, Hal Burstein, Zbigniew Ireneusz Nowecki, Gunda Pristauz-Telsnigg, Adam Brufsky, Meritxell Bellet-Ezquerra, Theodoros Foukakis, Yelena Novik, Gabor Rubovszky, Karoline Muehlbacher, Otto Metzger, Theodora Goulioti, Ernest Law, Ann Partridge, Lisa Carey, Alex Zoroufy, Dominik Hlauschek, Christian Fesl, Erica Mayer, Michael Gnant. Adherence with adjuvant endocrine therapy with or without Palbociclib in the PALLAS trial [abstract]. In: Proceedings of the 2021 San Antonio Breast Cancer Symposium; 2021 Dec 7-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2022;82(4 Suppl):Abstract nr P4-12-01.

Improvement in time to oral anticancer agent follow-up.

235 Background: Use of oral anticancer agents (OAAs) for cancer treatment continues to grow and creates a need for oncology practices to adapt their ambulatory infusion model of care to one that supports patients taking anti-cancer treatment at home. Historically, our practice has had success with care managers supporting infusion treatment patients. A recently published randomized trial has shown considerable benefits of dedicated pharmacist follow-up for patients taking OAAs. As a result, our practice added a dedicated oncology pharmacist to provide education and follow-up for our OAA patients. Methods: This is a single-center, retrospective evaluation of time to first follow up for patients taking OAAs pre-intervention (11/1/20 - 2/28/21) versus post-intervention (3/1/21 - 4/30/21). The intervention consists of structured symptom and adherence monitoring by a dedicated oncology pharmacist as part of our care management team for all patients prescribed an OAA. In the pre-intervention group, OAA monitoring was divided between care team members without a dedicated OAA program. The population consists of 139 patients newly started on OAAs over the 6-month period. “On-time” follow up defined by our practice is follow up that is &lt;10 days from the OAA start date. There were 20 patients (10 per group) excluded from data analysis due to being deceased before follow-up could be assessed (n= 3), transferring oncology care elsewhere (n= 5), or never starting the OAA (n= 12). Results: Pre-intervention, initial follow up occurred via pharmacist or nurse care manager visit (n=47), provider visit (n=29), or unplanned admission (n=3). Post-intervention, all but two initial follow up visits were performed by the designated oncology pharmacist, and there were no unplanned admissions prior to first follow up. The median time to first follow up visit was 8 days (range 2 to 31 days) in the pre-intervention group (n=79) and 7 days (range 3 to 15 days) in the post-intervention group (n=40). Follow up visits occurred within 10 days of OAA initiation for 67.1% of patients in the pre-intervention group and 95% of patients in the post-intervention group (p=&lt;0.001). Follow up occurred within 14 days of initiation for 82.3% of pre-intervention patients and 97.5% of post-intervention patients (p=0.018). Conclusions: Post-intervention assessment showed improvement in the time to follow up for patients taking OAAs. Future analyses will include outcomes, such as interventions at the time of follow-up, length on therapy, and unplanned admissions.

Intervention combining nurse navigators (NNs) and a mobile application versus standard of care (SOC) in cancer patients (pts) treated with oral anticancer agents (OAA): Results of CapRI, a single-center, randomized phase III trial.

2000 Background: Various interventions aiming to improve a safe use of oral anti-cancer agents have previously been reported. These retrospective studies involved nurse-led follow-up and use of health technologies. However, the potential impact of these combined strategies is limited by a lack of rigorous methodology. Methods: We performed a randomized phase 3 trial comparing an intervention combining NNs and a mobile application vs. SOC in cancer pts treated with OAA (excluding hormonal therapy) in our tertiary cancer center. Pts initiating OAA (all types of cancer, PS &lt; 3, life expectancy &gt; 6 months), were randomized in a 1:1 basis. The intervention combined a nursing-led follow-up and a mobile application for patients. NNs provided regular phone follow-ups to manage symptoms and assess toxicities, adherence and supportive care needs. Pts had access to a mobile application to record tracking data, contact NNs via secure messaging or a dedicated phone line. The intervention lasted 6 months. The primary endpoint was the Relative Dose Intensity (RDI). Secondary endpoints included adherence, toxicity, response and survival, quality of life, pts experience (PACIC Score), end-of-life support, and economic estimation of the use of healthcare resources. Results: From October 2016 to May 2019, 609 pts (median age: 62 years, 20-92; PS2: 11.8%) were included. 39% were receiving oral chemotherapy, and 61% other OAA. The RDI was significantly higher in the CAPRI arm (93.4% ±0.26 vs. 89.4% ±0.19, p = 0.04). The CAPRI intervention also improved PACIC scores (mean: 2.94±0.83 vs. 2.67±0.89, p = 0.01), the number of unplanned hospitalizations (15.1% vs. 22.0%, p = 0.04), hospitalization duration (mean: 2.82±6.96 days vs. 4.44±9.60, p = 0.02), and treatment-related grade≥3 toxicities (27.6% vs. 36.9%, p = 0.02). Conclusions: Compared to SOC, the CAPRI intervention improved RDI, pts experience, hospitalizations and their duration, as well as the rate of treatment-related grade≥3 toxicities. This type of intervention should represent a new standard in pts receiving OAA. Clinical trial information: NCT02828462.

CN74 - Providing a nurse-led telephone intervention for patients treated with oral anticancer medication: Symptom management and adherence monitoring

BackgroundMany interventions to improve a safe use of oral anti-cancer agents have been reported during the last decade. Frequently, these interventions involve nurse-led follow-up, but there is limited data to suggest the proportion of adherence and toxicity related to treatment that nurses can detect. MethodsCAPRI, a randomized phase III trial comparing: an intervention combining Nurse Navigators (NNs) and a mobile application vs. Standard of care in cancer patients treated with oral anticancer agents was initiated in 2016 at Gustave Roussy (Villejuif, France). Nurses conduct regular telephone follow-up (1/week for the 1st month, 2/month for the following 3 months, then 1/3 weeks). During follow-up, they assess adherence, symptoms and supportive care needs. PROMS (Patient Reported Outcome Measure) (e.g. pain, appetite) are also recorded by the patient via the mobile application. A coding grid was developed to extract from the nurses intervention reports the information identified during follow-up and to categorize the actions implemented by them. All regular follow-ups over a 24-month period were studied. ResultsNurses carried out 2279 regular follow-ups concerning 237 patients, of which 1880 could be carried out (patient available). They detected treatment-related symptoms/toxicities (or worsening) in 582 (31%) of the regular follow-ups involving 193 patients. Interventions performed in these situations are advice given to the patient (55%), advice or indications after the oncologist’s request (23%), referral to a primary care professional (14%) or to a health facility (8%). Twenty-six regular follow-ups concerning 18 patients identified adherence issues. Actions implemented by nurses encompassed: patient advice (n=14), request for advice from the referring oncologist (n=10), introduction of a homecare nurse (n=2). ConclusionsClose and proactive nurse-led follow-up might help not only detecting and managing toxicities, but also identifying adherence issues in cancer patients receiving oral anti-cancer agents. Clinical trial identification2016-A00254-47. Legal entity responsible for the studyGustave Roussy. FundingFondation Philanthropia - Lombard Odier, Agence Nationale de la Recherche IHU-MMO, ARS Ile de France, Novartis, AstraZeneca. DisclosureAll authors have declared no conflicts of interest.

Patient experience of an intervention combining nurse navigators and e-Health technologies for use of oral anticancer agents.

e23149 Background: An intervention (named CAPRI) combining Nurse Navigators (NN) and a mobile application dedicated to patients treated with oral anticancer agents was implemented in 2016 at Gustave Roussy (Villejuif, France). NN provide regular telephone follow-ups to manage patients' symptoms and assess toxicities, adherence to treatment and supportive care needs. Patients can have access to a mobile application to record tracking data, contact NN via secure messaging, view therapy and side effect information or store documents. Methods: A questionnaire was addressed to patients after using for 5 months the CAPRI intervention in order to assess their experience with the device. In parallel, interviews were conducted with patients. To determine patient utilization of the mobile application, data were extracted over a 24-month period. Results: 148 patients completed the evaluation (response rate = 81%). 15 interviews were conducted. Patients' experience with CAPRI intervention is very positive: The open-ended comments on the questionnaires and interviews with patients highlighted the importance of listening, having a contact person who is easily reachable, available and empathetic. 83% of patients preferred contacting NN by phone rather than through the mobile application. Only 50% (n = 74) of patients reported having tried to connect to the mobile application and 38% reported monitoring data at least once. Conclusions: Patients' experience is highly positive about the intervention. However, the application is poorly used, patients seems to prefer human contact. In perspective, results from the randomized trial currently conducted will evaluate the impact of the intervention on clinical criteria.[Table: see text]

Evaluation of community pharmacist ability to ensure the safe use of oral anticancer agents: a nationwide survey in Japan

A recent study of community pharmacists in Canada reported that they required additional education. We conducted a survey of community pharmacists to evaluate the adequacy of education and training in oral anticancer agents in Japan. Between May and June 2014, community pharmacists were asked to complete a questionnaire by using two different survey strategies, one online and one via postal mail. Three hundred community pharmacists responded to an online survey and 283 community pharmacists responded to a mailed survey. Only 6-10% of respondents felt that they had received adequate education in oncology or oral chemotherapy. Although 81% of Japanese pharmacists had attended at least one continuing education event related to oncology in the past 2 years, only 54% felt comfortable dispensing oral anticancer agents and only 40% felt comfortable educating patients about oral chemotherapy. In a multivariate analysis, confidence in educating patients about oral chemotherapy was associated with an understanding of chemotherapy cycles and doses (odds ratio = 4.89, 95% confidence interval [2.53-9.45]) and the number of continuing education events they had attended (odds ratio = 1.67, 95% confidence interval [1.35-2.08]). This is the first report to evaluate whether community pharmacists are equipped to ensure the safe use of oral anticancer agents in Japan. The results are similar to those previously reported for Canadian pharmacists, namely a low rate of positive responses for education in oncology and oral chemotherapy, demonstrating a similar need for additional education and training in oral chemotherapy.

Long-term survival in metastatic malignant struma ovarii treated with oral chemotherapy: A case report.

Malignant struma ovarii is a rare type of ovarian tumor. Metastasis from malignant struma ovarii is rare and has only been documented in 5–6% of cases. The natural history and optimal treatment strategy for malignant struma ovarii remains controversial due to its rarity. The current report presents the case of a 45-year-old female who presented with a tumor of the rib bone. Following resection, the postoperative diagnosis was a metastasizing thyroid carcinoma. No abnormality was detected in the thyroid gland, however, computed tomography revealed a tumor in the left ovary. The patient underwent a left salpingo-oophorectomy and a wedge resection of the right ovary. The postoperative diagnosis was determined as a mature cystic teratoma with malignant struma ovarii (thyroid type, follicular carcinoma) of the left ovary and mature cystic teratoma of the right ovary. Four years subsequent to the initial diagnosis, multiple lung metastases were detected. The following chemotherapies were administered sequentially and intermittently: Tegafur-uracil, paclitaxel/carboplatin and oral etoposide. During this period, the metastatic lesions extended into the bone and progressed slowly. The patient continues to survive with the disease and 24 years have passed since the initial diagnosis, 20 years following the diagnosis of multiple lung metastates. The present report describes a rare case of malignant struma ovarii in which surgical resection and pathological examination of a metastatic rib tumor resulted in the identification of the primary ovarian lesion. The clinical behavior of malignant struma ovarii does not necessarily indicate a histological malignancy, therefore, prediction of future metastasis is difficult and the optimal treatment strategy for malignant struma ovarii is controversial. The present case indicates that the long-term use of oral anticancer agents may facilitate the maintenance of tumor dormancy.

Adherence and patients’ experiences with the use of oral anticancer agents

A rapidly growing number of oral anticancer agents has become available in oncology and hematology. Though these introductions have several benefits, medication adherence is an issue of concern. Little is known about the factors influencing adherence to treatment with oral anticancer agents in daily practice. Material and methods. In this observational, multicenter study including 216 patients, carried out between October 2010 and March 2012, the use of oral anticancer drugs was assessed by means of a telephonic pill count, a questionnaire and a review of the patient's medical file and pharmacy medication records. Parameters collected were patients’ demographics, treatment characteristics, beliefs and attitude towards disease and medicines, self-reported adherence, side effects, quality of life and satisfaction about information. Patients off treatment filled out a questionnaire about the reasons for discontinuation. Optimal adherence was defined as ≥ 95%–≤ 105%. Results. The mean adherence rate (AR) (n = 177) was 99.1% with 20.3% of patients having a sub-optimal AR (< 95%, > 105%) consisting both of under- and over-adherence. Multivariate analyses showed that being on a cyclic dosing regimen (rather than a continuous regimen), not living alone and being highly educated increased the chances of optimal adherence (ORs = 4.88, 4.59 and 2.53, respectively). In addition, optimal adherence was found to be less common in patients reporting treatment control (OR = 0.77). One third of 79 patients off treatment reported their experienced side effects as one of the reasons for discontinuation. Discussion. Although most patients are fully adherent to oral anticancer agents, there is a substantial number tending to non-adherence. Patients living alone and those on a continuous dosing regimen are most likely to adhere sub-optimally. Interventions to improve adherence should specifically address these patients and be tailored to the needs of the individual patient.

Are community pharmacists equipped to ensure the safe use of oral anticancer therapy in the community setting? Results of a cross-country survey of community pharmacists in Canada

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. 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. 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. A substantial portion of community pharmacists in Canada lack a solid understanding of oral anticancer agents and thus are poorly equipped to play a major role in ensuring their appropriate use. More education and training on oral anticancer agents are urgently required.

Safe Handling and Administration Considerations of Oral Anticancer Agents in the Clinical and Home Setting

The use of hormonal, chemotherapeutic, and targeted biologic oral agents has exponentially increased since the early 2000s. Oral therapies have the advantage of persistent exposure of the cytotoxic drug to tumor cells and the tumor environment. The use of oral anticancer agents provides therapeutic drug treatment for patients with cancer in the comfort of their home or alternative settings, such as retirement homes and assisted living or extended-care facilities. Practices to ensure safe storage, handling, administration, and disposal of oral agents are necessary to prevent additional exposure of hazardous substances to the environment, professionals, patients, family members, and caretakers. Providers should consider potential barriers to adherence and compliance, and develop strategies to ensure optimal therapeutic benefit prior to initiation of oral agents.

The use of capecitabine in daily practice: a study on adherence and patients&amp;#39; experiences

BackgroundAdherence to pharmacological therapy is a complex and multifactorial issue that can substantially alter the outcome of treatment. Especially when using long-term medication, cancer patients have adherence rates similar to those of patients with other diseases. The consequences of poor adherence are poor health outcomes and increased health care costs. Only few studies have focused on the use of oral anticancer agents in daily practice. Information about the reasons for nonadherence is essential for the development of interventions that may improve adherence. This report presents the CAPER-capecitabine protocol, which is designed to study the adherence to capecitabine and the influence of patient attitudes towards medication and self-reported side effects. Furthermore, the relationships between patient characteristics, disease characteristics, side effects, quality of life, patient beliefs and attitudes towards disease and medication, dose adjustments, reasons for discontinuation, and plasma concentration of three of the main metabolites, including the active compound 5-fluorouracil, will be explored.MethodsIn this multicenter, prospective, observational cohort study, 90 patients aged 18 years or older starting treatment with capecitabine will be included and followed for a period up to five cycles. The main study parameters are adherence, patient attitudes towards medication, and the number and grade of patient-reported side effects. At baseline and during week 2 of cycles 1, 3 and 5, patients will be asked to donate blood and fill out a questionnaire. Blood samples will be analyzed for plasma concentration of the metabolites, 5′-deoxy-5-fluorouridine, 5-fluorouracil, and α-fluoro-β-alanine. The CAPER-capecitabine trial is closely related to the CAPER-erlotinib trial.DiscussionThe aim of the present study is to get more insight into patient experiences with the use of capecitabine in daily practice and the various aspects that govern adherence. We hypothesize that patient attitudes towards medication and the side effects experienced play an important role in the way patients use capecitabine. We expect that our findings will be useful for health care professionals in developing interventions to support patients in improving adherence and persistence with the use of capecitabine.

Prevalence of the Coprescription of Clinically Important Interacting Drug Combinations Involving Oral Anticancer Agents in Singapore: A Retrospective Database Study

BackgroundThere 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. ObjectiveTo assess the prevalence of the coprescription of potentially interacting drug combinations involving OAAs in Singapore. MethodsA 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. ResultsFifty-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. ConclusionAlthough 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.

Use and costs of oral anticancer agents in the Netherlands in the period 2000–2008

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. 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). 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. 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.