Adherence enhancing interventions for oral anticancer agents: A systematic review

e20596 Background: With the increasing number of orally administered anticancer agents, evaluation of treatment adherence is critical to assess efficacy and adverse events. When patients enrolled in registration clinical trials do not adhere to the investigational agent(s), conclusions made regarding efficacy and safety may be inaccurate and translate poorly to broader use. We performed a systematic review of adherence reporting in phase III trials of oral anticancer agents. Methods: We selected all oral anticancer agents approved by the FDA between 1996 and 2012. A PubMed search for generic name, with limits to "title" and "clinical trials", was performed. Publications from phase III trials were identified from the results. Medication adherence data were abstracted searching for the roots “compli” and “adher” and were categorized as follows: 1) mentioned or not, 2) methods described or not and 3) results reported or not. Results: Overall, publications or reports with 24 agents were identified. The search strategy yielded 5383 articles, of which 504 reporting on phase III trials were included for analysis. Of these, 106 (21%) mentioned either adherence or compliance to medications. Only 33 (7%) publications described methods of measuring adherence (e.g., diaries, interviews, pill counts), while 37 (7%) reported medication adherence results. Trials specifically identifying quantitative or qualitative rates of adherence in phase III trials involved abiraterone, anastrozole, capecitabine, dasatinib, exemestane, imatinib, lapatinib, letrozole, tamoxifen, thalidomide, topotecan, and toremifene (50% of agents). Within the 37 trials reporting adherence, 12 were qualitative (e.g., excellent, poor), 23 were quantitative, and 2 used pharmacokinetically-defined adherence measures. Conclusions: Medication adherence is infrequently reported in phase III trials of oral anti-cancer agents, leading to a knowledge gap in translation to clinical use. Our study underscores the need for standard metrics on measuring and reporting adherence to oral anticancer agents.

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Assessment of adherence with oral anticancer agents in oncology clinical trials: A systematic review

Journal of Oncology Pharmacy Practice ◽

10.1177/1078155214567163 ◽

2015 ◽

Vol 22 (1) ◽

pp. 105-113 ◽

Cited By ~ 5

Author(s):

JJ Bergsbaken ◽

JC Eickhoff ◽

BA Buss ◽

MS Mably ◽

JM Kolesar

Keyword(s):

Systematic Review ◽

Clinical Trials ◽

Anticancer Agents ◽

Oncology Clinical Trials ◽

Oral Anticancer Agents

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Real-World Utilization of Oral Anticancer Agents Costs in Older Adults with Metastatic Renal Cell Carcinoma in the United States

Kidney Cancer ◽

10.3233/kca-210119 ◽

2021 ◽

pp. 1-13

Author(s):

Lauren E. Wilson ◽

Lisa Spees ◽

Jessica Pritchard ◽

Melissa A. Greiner ◽

Charles D. Scales ◽

...

Keyword(s):

United States ◽

Anticancer Agents ◽

Patient Characteristics ◽

The United States ◽

Socioeconomic Indicators ◽

Economic Implications ◽

Southern Us ◽

Race Ethnicity ◽

Nationally Representative ◽

Oral Anticancer Agents

Background: Substantial racial and socioeconomic disparities in metastatic RCC (mRCC) have persisted following the introduction of targeted oral anticancer agents (OAAs). The relationship between patient characteristics and OAA access and costs that may underlie persistent disparities in mRCC outcomes have not been examined in a nationally representative patient population. Methods: Retrospective SEER-Medicare analysis of patients diagnosed with mRCC between 2007–2015 over age 65 with Medicare part D prescription drug coverage. Associations between patient characteristics, OAA receipt, and associated costs were analyzed in the 12 months following mRCC diagnosis and adjusted to 2015 dollars. Results: 2,792 patients met inclusion criteria, of which 32.4%received an OAA. Most patients received sunitinib (57%) or pazopanib (28%) as their first oral therapy. Receipt of OAA did not differ by race/ethnicity or socioeconomic indicators. Patients of advanced age (> 80 years), unmarried patients, and patients residing in the Southern US were less likely to receive OAAs. The mean inflation-adjusted 30-day cost to Medicare of a patient’s first OAA prescription nearly doubled from $3864 in 2007 to $7482 in 2015, while patient out-of-pocket cost decreased from $2409 to $1477. Conclusion: Race, ethnicity, and socioeconomic status were not associated with decreased OAA receipt in patients with mRCC; however, residing in the Southern United States was, as was marital status. Surprisingly, the cost to Medicare of an initial OAA prescription nearly doubled from 2007 to 2015, while patient out-of-pocket costs decreased substantially. Shifts in OAA costs may have significant economic implications in the era of personalized medicine.

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Primary care oncology model (PCOM): Implementation of a model integrating primary and oncology care for patients taking oral anticancer agents.

Journal of Clinical Oncology ◽

10.1200/jco.2021.39.15_suppl.tps1587 ◽

2021 ◽

Vol 39 (15_suppl) ◽

pp. TPS1587-TPS1587

Author(s):

Emily R. Mackler ◽

Karen B. Farris ◽

Katie S. Gatwood ◽

Amna Rizvi-Toner ◽

Alex Wallace ◽

...

Keyword(s):

Primary Care ◽

Anticancer Agents ◽

Chronic Conditions ◽

Lymphocytic Leukemia ◽

Chronic Obstructive ◽

Multiple Chronic Conditions ◽

Hiv Intervention ◽

Patient Reported ◽

Chronic Medications ◽

Oral Anticancer Agents

TPS1587 Background: Non-adherence to oral anticancer agents (OAA) has been reported among 30% of individuals. Often, individuals with cancer are not just managing their new OAA but also medications to treat multiple chronic conditions (MCC). Multiple factors contribute to the extent patients on OAAs and MCC medications adhere to therapy. The objective of this study is to improve medication, symptom, and disease management of patients with hematological malignancies and MCC through care coordination between pharmacists. Methods: Design. This is a multi-center prospective single arm pilot study at two academic medical centers in Michigan and Tennessee. Subjects. Ninety participants will be recruited, 60 from site 1 and 30 from site 2. Inclusion criteria are: adults > 18 years, diagnosed with and initiating oral treatment for chronic myeloid leukemia, chronic lymphocytic leukemia, or multiple myeloma, diagnoses of at least 2 chronic conditions, where one is type 2 diabetes, hypertension, congestive heart failure, depression/anxiety, gastroesophageal reflux disease, hyperlipidemia, or chronic obstructive pulmonary disease, taking at least two chronic medications, and able to provide electronic consent. Exclusion criteria are: inability to speak English, and diagnosis of type 1 diabetes or HIV. Intervention. Participants will complete two Patient Reported Outcome Measures (PROMs) for their OAA that will be reviewed by the oncology pharmacist, with follow-up to the care team if needed. Participants will be scheduled for a Comprehensive Medication Review with a primary care pharmacist for up to two visits for their chronic medications. The intervention over 2 months, and the oncology and primary care pharmacists communicate via electronic health record about medications, symptoms, and disease control. Outcomes. The primary endpoints are (a) dose-adjusted adherence by proportion days covered (PDC) for the OAA and (b) PDC for chronic condition medications, assessed using 6 months of prescription claims. Data will be collected from patients using REDCap surveys and abstracted data will be entered into REDCap. Implementation by pharmacists and patient acceptability will be examined. Analysis. The association of OAA and chronic medication adherence (PDC) will be examined via correlation. Participant demographics,clinical characteristics, and the symptom experience from the PROM will be described. Using CMR results, medication problems, recommendations, and changes will be provided. Program implementation will be assessed and patient perceptions obtained from post-CMR interviews. A joint display for the quantitative and qualitative data for feasibility, appropriateness, and acceptability from pharmacists will be completed. Results: Screening and recruitment has begun. Clinical trial information: NCT04595851 and NCT04663100.

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