Oral Chemotherapy Agents Research Articles

Identification of patients on chronic prescription opioids at risk for opioid use disorder using pharmacy claims data.

Using pharmacy claims data from a single commercial health plan to identify opportunities for opioid use disorder (OUD) focused screening and interventions communicated via targeted prescriber messaging. Participants included members ≥18 years using more than 90 morphine milligram equivalents (MMED) daily based on all opioid claims, had >1 paid claim for an opioid product, and had ≥90 days of total opioid therapy. Members were excluded with ≥1 claims for an oral chemotherapy agent (except methotrexate). Intervention was completed with a secure communication to the primary outpatient opioid prescriber that included resources for diagnosis, treatment, and best practices for opioid prescribing. The main outcome measure was any documented change to opioid use following the intervention. Seven hundred forty-five members were identified; a subset (n = 20) was further assessed, and all had identified OUD risk factors; providers were subsequently sent a communication. Sixteen providers acknowledged receipt and 11 patients (55%) had at least one documented intervention following communication receipt. Provision of targeted, evidence-based recommendations to providers for patients identified to be at risk of OUD from pharmacy claims data can result in increased recognition and intervention. Future efforts to explore feasibility of provider education detailing efforts and continued evaluation of efficacy are needed.

Safety and efficacy of PEG-rhG-CSF as primary prophylaxis against neutropenia induced by combination chemotherapy regimens involving oral chemotherapy agents in gastrointestinal cancer patients: A prospective, exploratory, non-randomized controlled study.

e24107 Background: The safety and efficacy of PEGylated recombinant human granulocyte colony-stimulating factor (PEG-rhG-CSF) for prevention of chemotherapy-induced neutropenia (CIN) in patients undergoing oral chemotherapy remain unclear. This study investigated the safety and efficacy of PEG-rhG-CSF as primary prophylaxis against CIN in gastrointestinal (GI) cancer patients receiving combination chemotherapy regimens involving oral chemotherapy agents. Methods: This is a prospective, single-center, open-label, exploratory, non-randomized controlled study. GI cancer patients receiving two consecutive cycles of IV oxaliplatin (150mg/m2 on day 1) combined with oral capecitabine 1000mg/m2 or tegafur gimeracil oteracil potassium capsule 40-60mg twice daily on days 1-14 every 3 weeks. PEG-rhG-CSF (6mg) was administered subcutaneously 24 hours post-oxaliplatin treatment in the PEG-rhG-CSF group, while the control group did not receive it. The primary endpoint was safety, and secondary endpoints included CIN incidence and neutropenic complications. The study was registered with the Chinese Clinical Trial Registry (registration number ChiCTR2100054854). Results: Between March 2022 and January 2023, a total of 49 patients was screened, and 43 patients completed the treatment (26 in PEG-rhG-CSF group and 17 in control group). The average age was 61.4 years, with 90.7% males and 83.7% having gastric cancer. Baseline characteristics were similar between the two groups. The overall adverse events (AE) did not differ statistically (88.5% vs. 88.2%, p = 1.000), with grade £2 fatigue and nausea being the most common AEs. Grade 3 platelet reduction showed no significant difference between the two groups (7.69% vs. 17.65%, p = 0.432). Four cases of bone pain (15.4%) and five cases of injection site reactions below grade 3 (19.2%) were observed in the PEG-rhG-CSF group. Grade ≥2 CIN was significantly lower in the PEG-rhG-CSF group (3.84% vs. 58.82%, p < 0.001). One case in the PEG-rhG-CSF group required antibiotic treatment due to febrile neutropenia. Regarding neutropenic complications, the PEG-rhG-CSF group exhibited lower proportion of chemotherapy delay (3.85% vs. 35.29%, p < 0.001) and dose reduction (1.92% vs. 23.53%, p = 0.002). Rescue treatment with rhG-CSF for grade 3/4 CIN was significantly less frequent in the PEG-rhG-CSF group (1.92% vs. 23.53%, p = 0.002). Conclusions: Primary prophylaxis with PEG-rhG-CSF in GI cancer patients undergoing oral capecitabine/tegafur gimeracil oteracil potassium may be safe, without an increased chemotherapy-related AEs, and is associated with a reduced grade ≥2 CIN. Clinical trial information: ChiCTR2100054854.

Factors affecting medication adherence in patients using oral chemotherapy: A descriptive study.

The utilization of oral chemotherapy agents for cancer treatment has witnessed a steady rise in recent years. The pivotal determinant for the success of oral chemotherapy lies in the adherence of cancer patients to the prescribed treatment. This study aims to explore oral chemotherapy adherence and identify factors influencing medication adherence among cancer patients. A total of 103 cancer patients participated in this descriptive study. Data were collected using the Oral Chemotherapy Adherence Scale, the Turkish Translation of the Beliefs about Medicines Questionnaire (BMQ-T) and The Functional Living Index-Cancer. Of the participants, 66% reported good adherence to oral chemotherapy. Key findings indicate that access to health services (β = -1.473, p = 0.009), cancer stage (β = -1.570, p = 0.015) and the BMQ-T subscale of General Overuse (β = .696, p = 0.041) were independent predictors of medication adherence. The study observed medication non-adherence in one-third of patients undergoing oral chemotherapy. Primary contributors to non-adherence included difficulties in accessing health services, advanced cancer stage and the belief that drugs are over-recommended by doctors. These results underscore the need for a heightened focus on preventable factors, such as improving access to health services and addressing beliefs about drug overuse, to enhance medication adherence in patients receiving oral chemotherapy.

Patient-reported outcomes in patients with gastrointestinal cancer on oral chemotherapy.

732 Background: Over the last several years, patient reported outcomes (PROs) have been demonstrated to address patient symptoms, improve outcomes, and reduce health care utilization. We aim to provide an electronic PRO (ePRO) tool for gastrointestinal (GI) oncology patients with the goals of improving adherence, reducing toxicity, and enhancing patient access to the clinical team. Methods: Patients are provided an ePRO tool consisting of a cellphone app integrated into the electronic health record with questions on adherence and 10 questions on symptoms adapted from the NCI PRO-CTCAE for local use. Emails are sent to the clinical team for nonadherence, new or worsening symptoms, or patient requested callback. Outcomes including time to first symptom assessment, emergency department (ED) visit and/or hospitalization at 30 and 90 days from enrollment will be compared with historical controls. Other outcomes including adherence and patient-reported access to the clinic will be assessed. Results: Six patients have been enrolled between May 1, 2023 and September 4, 2023. Five patients were newly starting oral chemotherapy agents and one patient had already been on therapy. Types of cancers included colon cancers (2), rectal cancer (1), pancreatic cancer (1), GIST (1), and cholangiocarcinoma (1). Types of oral chemotherapy included capecitabine (4), olaparib (1), and imatinib (1). Five patients have submitted a total of ten responses. Of the five who completed the ePROs, patients responded a median of one time (range 1-5). Reported symptoms were fatigue (4), pain (2), nausea (1), diarrhea (1), other symptoms (2) and a request callback (1). Seven (70%) responses have prompted emails alerts for clinical symptoms and one (10%) for adherence concerns. All alerts were resolved; average time to alert response 1.6 calendar days (range 1-3). Among historical controls, time to first symptom assessment after a new oral chemotherapy prescription was seven days, 30-day rate for ED and/or hospitalizations was 12%, and 90-day rate of ED visits and/or hospitalizations was 28%. Conclusions: Early data suggests a new process to manage ePROs can provide timely responses to email alerts. Of the responses thus far, 70% prompted email alerts due to clinical symptoms and 10% reported nonadherence, suggesting a high need for ongoing ePRO tools. Results are forthcoming on outcomes including time to symptom assessment/clinical action, ED visit/hospitalization and access.

Oral Chemotherapy Adherence in Pediatric Acute Lymphoblastic Leukemia (ALL): A Report from the Dana-Farber Cancer Institute (DFCI) ALL Consortium Protocol 16-001

Background: Successful treatment of pediatric acute lymphoblastic leukemia (ALL) requires 2 years of risk-directed therapy, much of which is built on a backbone of oral chemotherapy including 6-mercaptopurine (6MP) and dexamethasone (DEX). Studies conducted in the Children's Oncology Group (COG) demonstrate that poor adherence to 6MP during the maintenance phase confers increased relapse risk; however, little is known about the rates of 6MP adherence in non-COG ALL regimens. DFCI ALL Consortium protocols utilize 3-week cycles including 14-day pulses of 6MP with weekly intravenous or intramuscular methotrexate. This treatment approach requires more frequent contact between families and healthcare providers and reduces the number of oral chemotherapy agents prescribed. Whether this higher-touch regimen might reduce the frequency of non-adherence as compared to published COG data is not known. Additionally, there remains a paucity of data investigating incidence of non-adherence to DEX, 6MP, and to any medications during the first year of therapy. Methods: Oral chemotherapy adherence was prospectively evaluated as an embedded ancillary study on the DFCI ALL Consortium Protocol 16-001. Eligible participants included English-, Spanish-, or French-speaking caregivers of patients (<22 years) receiving 6MP and DEX (both liquid and tablet formations) and did not utilize a pillbox. Adherence to 6MP and DEX were measured using Medication Event Monitoring Systems (MEMS) caps, which record the date and time of medicine bottle opening. MEMS caps were used to measure adherence for three consecutive cycles during the first year of therapy, and again for three consecutive cycles during the second year of therapy. Caregivers completed surveys reporting sociodemographic determinants of health (SDOH), medication-taking behaviors, and chemotherapy comprehension. MEMS-based medication adherence rates were calculated as a percentage based upon the ratio of the number of days with MEMS cap openings to the number of days 6MP and/or DEX were prescribed. Adherent patients were defined as those with ≥95% adherence based on prior COG trials that observed an excess risk of relapse below this threshold (Bhatia JAMA Onc 2015). Results: Between 2018 - 2022, 252/429 (59%) eligible patients consented to study participation, and adherence data was successfully collected for 207 (82%). Sixty-six (26%) participants were enrolled from Canadian hospital centers, and 186 (74%) participants were enrolled from US hospital centers. Participant age included 159 (77%) <10 years of age, 31 (15%) 10 - 14 years, and 17 (8%) 15 - 21 years (see Table 1). Thirty-four (16%) patients identified as Hispanic, 13 (6%) non-Hispanic Black, 18 (9%) non-Hispanic Other, and 142 (69%) non-Hispanic White. 57 (31%) patients relied on public insurance at time of diagnosis, 61 (34%) patients reported a primary household language other than English, and 36 (20%) patients lived in lone-parent households. A third, 61 (34%) and 62 (34%), of caregivers reported being unsure of what would happen if their child stopped taking 6MP or DEX, respectively. Over the course of six cycles, MEMS-measured adherence rates to 6MP (N = 180) and DEX (N = 195) were 73% (range 21 - 100) and 86% (range 10 - 100), respectively. Preliminary data suggest that adherence rates to 6MP improved during year 2 of treatment (cycles 4-6 of monitoring) (Table 2). In unadjusted analyses, there was a non-significant association between patient age and likelihood of adherence to oral medication: adherence to 6MP was 71% in those <10 years, 80% in those 10 - 14 years, and 71% in those 15 years or older (Jonckheere-Terpstra test p = 0.66). Conclusion: Among a diverse cohort of patients treated with a DFCI ALL Consortium regimen, adherence to oral chemotherapy is suboptimal with rates of 73% to 6MP and 86% to DEX. This finding recapitulates published data from COG ALL trials, suggesting more frequent contact with healthcare providers in the DFCI Consortium protocol does not mitigate non-adherence. Numerical differences between age groups suggest patients ages 10 - 14 years (N=31) have higher adherence compared to patients both younger and older. These preliminary findings suggest that there may be a behavioral component when it comes to medication adherence - with barriers among young children differing from those in both younger and older adolescents.

Tolerability of capecitabine in difference racial/ethnic groups.

e18833 Background: Capecitabine (cap) is an oral chemotherapy agent used for treatment of solid malignancies. The recommended dose of cap generally ranges from 1000mg/m2 to 1250mg/m2 twice daily, but many patients require a dose reduction during treatment due to AE. It is unclear whether patients of different race have better tolerability of cap than others. In Asian populations for example, potential differences in tolerance have been attributed to low dietary folate intake. Race is a social construct; however it has been used to identify groups of patients within a population. We aimed to understand the tolerability of cap among patients of different racial/ethnic groups. Methods: In this retrospective chart review, we studied patients treated with cap at Tufts Medicine (three centers in MA, USA) between 2017-2021. Patients treated with cap alone, concurrent with other chemo, or concurrent with radiation for solid tumors were included. Patients were excluded if race/ethnicity data was not available. We collected demographic information, cap dose, AE, and dose reductions during the treatment period. Dose intensity (DI) was calculated (Total administered cap dose during treatment period (mg)/Recommended cap dose (mg/m2) * BSA (m2)). ANOVA was used to determine difference between groups. Results: 202 patients were included: 134 (66.3%) White, 35 (17.3%) Asian, 22 (10.9%) African American/Black, and 11 (5.4%) other race. 10 (5%) identified as Hispanic ethnicity. Most common cancer types treated were 46 (22.8%) breast, 44 (21.8%) colon, and 39 (19.3%) rectal. Average DI by race/ethnicity is outlined in Table 1. There was no statistically significant difference in DI among patients of different racial groups (p = 0.232). AEs leading to dose reduction or cap discontinuation occurred in 93 (46%) of patients, the most common outlined in Table 1. Conclusions: We found no significant difference in cap DI or toxicity among patients of different racial groups. The study is limited by the small sample size and that it is retrospective. The patients presented are racially diverse but live in one geographic area, which could impact environmental factors such as dietary folate intake. Our findings suggest that there is no difference in tolerated DI among all patients. Clinicians should not empirically reduce the dose of cap based on race and should assess tolerance on an individual basis. [Table: see text]

Adherence to Capecitabine Among Patients With Gastrointestinal Cancer: A Prospective Cohort Study

Adherence to capecitabine, an effective oral chemotherapy agent, is essential in achieving treatment response in cancer. In this study, we aimed to investigate factors associated with non-adherence to capecitabine in a sample of patients with gastrointestinal cancer. We enrolled 98 patients with colon, rectal or gastric cancers who were undergoing treatment with capecitabine as part of their single or multi-agent chemotherapy regimen. The patients were followed during cohort time up to four consecutive cycles of their chemotherapy. For adherence measurement, the participants were asked to bring back the leftover medicines at the time of follow-up visits and were considered adherent if they had taken ≥95% of their prescribed dose. The mean adherence rate was 97.7%, and the patients were adherent to capecitabine in 93.1% of their cycles. The patients who underwent neoadjuvant chemotherapy were significantly less adherent to capecitabine (60%) as compared with adjuvant (95.2%) and palliative chemotherapy (94.6%) [P=0.004]. Multivariable logistic regression revealed that neoadjuvant chemotherapy and the presence of nausea and mucositis were inversely associated with adherence rate. We did not find any association between adherence and any of our laboratory findings. Our findings suggest a high adherence rate to capecitabine among patients with gastrointestinal cancers. Neoadjuvant chemotherapy and the presence of nausea and mucositis may play a significant role in non-adherence to capecitabine.

The impact of adverse drug reactions on medication adherence and outpatient treatment outcomes in female breast cancer: A review protocol.

Discover the impact of adverse drug reactions of hormonal and chemotherapy on medication adherence and outpatient treatment outcomes in the breast cancer patient population. A systematic review following the reporting guidance from the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols (PRISMA-P) guided by the Joanna Briggs Institute methodology will be conducted. A literature search will be conducted using the following databases: PubMed, CINAHL, Web of Science, Medline and Scopus. Studies published in English before 2022 that report adverse drug reactions with medication adherence and outpatient treatment outcomes as primary outcome measures, following the initiation of one or more oral hormonal, endocrine and chemotherapy agents in female patients with diagnoses of breast cancer will be identified. Observational studies will be included for review, and two reviewers will independently screen study titles, abstracts and full text for inclusion. The quality assessment will be conducted using the Joanna Briggs Institute tools. A meta-analysis will be conducted where sufficient data are available. This is a systematic review study protocol, and results are not available at the time of the submission. All results will be reported on the completion of this study. This systematic review will highlight the impact of medication non-adherence on the breast cancer patient population, support determining strategies to address this issue and identify areas for further research. This protocol article will identify the impact of adverse drug reactions on medication non-adherence and treatment outcomes in the female breast cancer patient population. A unique contribution of our study is to support determining strategies to address this ongoing public health issue and identify areas for further research. This protocol has been registered with the International Prospective Register of Systematic Reviews (PROSPERO) database (registration number CRD 42021291364).

Commentary: Futility in Psychiatry.

While other medical professions have grappled with end-of-life care, the areas of palliative psychiatry, and more particularly, futility in psychiatry, have not been thoroughly addressed. The 3 cases presented in this issue illustrate how patients can succumb to a medical condition while presenting with primary psychosis (a patient with treatment-resistant schizophrenia who starves himself), secondary psychosis (a patient with small cell cancer of the lung who develops psychotic symptoms in the context of a paraneoplastic neurological syndrome), or a factitious disorder (a patient with self-induced aplastic anemia from ingesting an oral chemotherapy agent). The descriptions of these challenging cases show how collaborative teamwork among psychiatric and medical treatment teams, including the provision of palliative care, can help patients and families, even if a fatal outcome appears certain.

Impact of the oral chemotherapy pharmacist on direct cost avoidance and cost savings of oral oncolytics at an integrated health system.

e18839 Background: The impact of oncology pharmacists on patient care have been well-documented including enhanced medication safety and efficacy, increased medication adherence, improved provider and clinic burden, and increased patient and provider satisfaction. There is a scarcity of articles relating to pharmacists’ drug cost savings or cost avoidance of oncologic drugs in an oral chemotherapy management clinic within an integrated healthcare system. Cost savings and cost avoidance studies are needed to reinforce this practice and gain support and funding from hospital administration. Methods: This retrospective, observational study analyzed interventions made by oncology pharmacists in the Pharmacist-Managed Oral Chemotherapy Clinic at Kaiser Permanente San Diego and determine the direct drug cost savings and cost avoidance effects over one year. Cost savings and cost avoidance were calculated by comparing the costs of drug utilization if no interventions were implemented versus costs of drug saved from accepted interventions for dose reduction, dose delay, temporary dose hold, therapy discontinuation, therapy conversion, formulary alternative conversion, and brand to generic conversion. Secondary outcomes included the highest and average cost avoidance per intervention, intervention type, medication, medication class, and cancer type. Additionally, interventions that did not lead to direct drug cost savings such as adverse drug reaction management, drug interaction identification, and supportive care recommendation were also recorded. The secondary endpoint was oncologist satisfaction via a six-question satisfaction survey. All documented oncology pharmacist interventions that were made in the Oral Chemotherapy Clinic from January 1 to December 31, 2021 were reviewed for study inclusion. From a report generated monthly from the electronic health record (EHR), retrospective chart review was conducted to verify whether each cost-savings intervention was truly recommended by an oncology pharmacist and if the intervention was accepted by the treating oncologist. The Average Wholesale Price (AWP) of drugs listed on Lexicomp as of November 1, 2021 was used to calculate the drug cost savings and cost avoidance. During this period, there were no changes to practice and no increased efforts to identify interventions. Results: As of September 2021, 156 interventions were identified, with a total cost savings and cost avoidance of $2,245,856. Once all data have been collected for the remainder of 2021, descriptive statistics will be used to analyze and stratify the data as appropriate. Conclusions: Pharmacist interventions in the Oral Chemotherapy Clinic led to significant overall cost savings to the health care system. It is reasonable to expect that higher cost savings will be achieved as more oral chemotherapy agents are managed by pharmacists.

Standardization of informed consent for oral chemotherapeutic agents.

e18665 Background: Informed consent is an essential prerequisite to the administration of any oral or parenteral chemotherapeutic agent. Obtaining informed consent for treatment is the oncologist’s responsibility and all the information the oncologist and patient share and agree to in this process should be documented in the patient’s medical record. Informed consents at Inova Schar Cancer Institute are created through an electronic consent, a web-based solution that creates procedure-specific consent forms that can be used for treatments and procedures for patients and is integrated in our electronic medical record system. While the oncology nurse administering parenteral chemotherapy ensures that the consent is signed before infusion starts, no clear plan existed at our institution for patients starting oral chemotherapeutic agents. In addition, with the transition to telemedicine visits during covid-19 pandemic, patients are often not in clinic at time of discussion of the new treatment plan with the oncologist or for chemotherapy teaching session therefore creating a barrier to obtain consent on the computer pad. The aim of this study is to standardize methods to obtain written informed consent for oral chemotherapy agents with 100% compliance. Methods: Our first Plan-Do-Study-Act (PDSA) cycle conducted in the breast medical oncology clinic included the following steps: 1) the oncologist or the registered pharmacist (RPH) creates the electronic consent 2) after completion of chemotherapy teaching session, the RPH ensures that the patient and the physician have signed the consent and also signs as witness. In this first cycle we also tested the “mobile sign” modality that allows to text the informed consent to the patients so they can sign directly on their mobile phone if the teaching is conducted remotely. Results: Baseline chart audit of seven patients who were started on oral chemotherapy regimen during the month of December 2021 revealed that all the patients received chemotherapy teaching, but none provided written informed consent. After implementation of above steps for two weeks, chart audit of five patients showed that all signed informed consent that was also completed by physician’s and witness’s signature. Two patients were successfully consented through the “mobile sign” modality. Conclusions: Our study identified failure to obtain written informed consent for oral chemotherapeutic agents with some barriers created by increasing use of telemedicine. As all our patients receive chemotherapy teaching sessions, we identified this as best timing to obtain informed consent as patients have received comprehensive education on the chemotherapy agent. We also explore the option of “mobile sign” if the teaching session is conducted virtually. Our preliminary results showed 100% compliance in obtaining informed consent and feasible use of “mobile sign” option. We plan for long term chart audits to confirm above results.

A novel oral paclitaxel and HM10381 (oraxel)-treated metastatic breast cancer: A phase I study (KX-ORAX-CN-007).

1104 Background: This phase I study assessed the pharmacokinetics, safety, antitumor activity of oral paclitaxel and HM10381 (Oraxel) in patients with metastatic breast cancer. Methods: Oraxol (oral paclitaxel 205 mg/m2 plus HM30181A 15 mg) daily for 3 consecutive days weekly for up to 16 weeks was administered to patients. The primary objective endpoint was pharmacokinetic analysis. The secondary endpoint were objective response rate (ORR) and safety. For pharmacokinetic analysis, timed blood samples were collected. Results: Twenty-four female patients were enrolled from Apr 2019 to Aug 2019. The median age was 53 years (range: 35 to 70 years). The mean lines and median line of treatment were 2.5 and 2, respectively. Previous breast cancer treatments included chemotherapy in 23 (96%) patients, hormonal therapy in 20 (83%) patients. Prior taxanes therapy was reported in 20 (83%) patients. There were 15 patients in efficacy dataset. The best ORR (Investigator) was PR in 40%, SD in 53%, and PD in 7%. The best overall response rate (ICRRC) was PR in 36%, SD in 57%, and PD in 7% of patients. There were no hypersensitivity-type reactions. Adverse events of interest neutropenia, neurotoxicity, and diarrhea were reported as 20 (83%)，7 (29%) and 11 (46%), retrospectively. A total of 15 (63%) patients experienced Grade ≥3 TEAEs, including neutrophil count decreased in 11 (46%) patients, WBC count decreased in 8 (33%) patients. Treatment related SAE was reported in 1 (4.17%) patient experienced febrile neutropenia, pneumonia, and septic shock. The PK data indicated that the efficacy response is not associated with oral paclitaxel exposure parameters AUC or Cmax. Conclusions: The study showed that Oraxol as novel oral chemotherapy agent shows promising antitumor activity in patients with metastatic breast cancer, manageable toxicity, and no hypersensitivity-type reactions. Clinical trial information: NCT04993040.

Adherence to oral anti-cancer therapies in older patients is similar to that of younger patients.

The use of oral anti-cancer therapies is becoming increasingly common in the management of cancers, raising the question of adherence. The objective of this study was to assess adherence to oral anti-cancer therapies, as well as the impact of various factors that may influence it. Patients starting oral chemotherapy (tyrosine kinase inhibitor or cytotoxic) were followed up for 3 months using a medication diary, which was given to the patient by the pharmacist during a multidisciplinary consultation. Adherence was assessed using the diary, as well as by counting the tablets they brought back. One hundred and fifty patients were included in the study. The main oral chemotherapy agents prescribed were palbociclib (23.3%), everolimus (18.7%), and capecitabine (13.3%). The adherence at the end of the 3 months, by means of dose intensity (i.e. percent of the dose prescribed that has been taken), was 95.5%. No significant difference in adherence was found based on age, sex, family circumstances, health status, co-medication, type of oral therapy, tumor location, number of previous treatment lines, or presence of toxicity. The main reasons for non-adherence were forgetting (50%) and toxicity (21%). Fifty-seven patients prematurely discontinued the study: 40.3% for toxicity and 36.8% for disease progression. Adherence in this study is high in comparison to literature, which can be explained by close multidisciplinary follow-up. Moreover, no significant difference was observed between younger and older patients.

Novel Tool to Monitor Adherence to Oral Oncolytics: A Pilot Study.

Nonadherence is a significant issue in cancer care, especially as more oral therapies become available. Measuring and optimizing adherence to such therapies is challenging. In this study, we tested a novel technology that records real-time medication-taking behavior from a smart prescription bottle and can communicate with patients via text message to intervene in cases of nonadherence. We conducted a 28-patient pilot study to assess the feasibility of this technology in measuring and improving adherence in patients taking capecitabine, an oral chemotherapy agent with a complex, cyclical regimen. The study had a preintervention stage, during which patients were monitored, and an intervention stage, during which the text messaging intervention was enabled. During preintervention, patients had an average self-adherence of 89%, and during post intervention, they had an average adherence of 90%. We defined three categories of patients by change in adherence: category 1 (> 8%), category 2 (-8% to 8%), and category 3 (< -8%). Patients in category 1 tended to live in regions with lower average household income (mean = $58,937 in US dollars [USD]) than those in category 2 (mean = $77,482 USD) and category 3 (mean = $90,972 USD). Of poststudy survey respondents, most indicated that they would want to continue using this technology and that they would recommend it to others. This novel technology is able to monitor, measure, and intervene for patients taking capecitabine in real time. Adherence overall was high, and some patients appeared to benefit more from text-message interventions. Future work should focus on patients deemed high risk for nonadherence.

Impact of a Pharmacist-Led Hypertension Management Program for Oral Chemotherapy in a Specialty Pharmacy Setting.

Oral chemotherapy agents are a growing area of oncology treatment, but some are associated with a high incidence of hypertension. Management of hypertension in oncology patients may be insufficient due to a variety of reasons. A pharmacist-led hypertension management service within the specialty pharmacy setting has the potential to help patients on oral chemotherapy achieve and maintain adequate blood pressure control. The objective of this study was to assess the impact of a pharmacist-led hypertension management program on the blood pressure control of patients on oral chemotherapy. This retrospective, single-center study compared data from two groups of patients receiving oral chemotherapy agents from a health systems specialty pharmacy within an academic medical center, before and after the establishment of a pharmacist-led hypertension management program. Twenty-one of 50 (0.42) patients in the control group had blood pressure overall at goal, compared to 19 of 29 (0.66) patients in the intervention group who had blood pressures at goal at the end of the specified 3-month time period (p = 0.04). In cases where a pharmacist intervention was necessary per the hypertension management program's protocol, the rate of provider acceptance of recommendations regarding modifying or initiating antihypertensive therapy was high. When followed with a pharmacist-led hypertension management program, patients on oral chemotherapy showed improved blood pressure control and reduced mean blood pressure readings over time.

Sustaining safety and delivery of oral chemotherapy utilizing lean methodology.

218 Background: An oral chemotherapy safety event in 2017 prompted analysis of related workflows utilizing lean quality improvement methodology. Three kaizen workshops utilizing lean methodology with primary objectives to 1) develop safety standards for oral chemotherapy as rigorous as those for intravenous chemotherapy; 2) improve efficiency; and 3) design workflows that enable data collection and process control were conducted. Since 2017, our goal has been to sustain developed workflows to ensure oral chemotherapy patients have the right oral chemotherapy agent, at the right dose, at the right time, with independent and efficient safety checks by all care providers. Methods: After multidisciplinary teams participated in three kaizen workshops to develop workflows, education plans were developed and results were incorporated into the lean management system. The lean production method of Training Within Industry (TWI) was used to train physician, nursing, and pharmacy teams to the workflows. Results were communicated to key stakeholders weekly to monitor progress on workflow creation, spread, and process metrics designed to signal defects in the workflow. When processes were deemed ‘out of control,’ clinical team members provided regular and targeted interventions. Safety data were collected and correlated to surrogate outcomes for long-term impact assessment. Results: Interventions resulted in the following outcomes: 62 consecutive weeks with 99% reduction in oral chemotherapy defects reaching pharmacy. 86 consecutive weeks with 51% error reduction processing oral chemotherapy though a single EMR workflow. 57 consecutive weeks with 62% error reduction processing oral chemotherapy though a single EMR workflow. No serious safety events have occurred since 2017. Conclusions: Comprehensive quality improvement in our oral chemotherapy process has resulted in sustained safety, efficiency, and a data collection to signal when process defects occur. Multidisciplinary teams utilizing established lean methodology were critical to success.

Improving oral chemotherapy compliance and documentation in a safety-net oncology clinic.

263 Background: Barriers to safe delivery of oral chemotherapy in a safety net hospital population include lack of health insurance, delays in medication delivery, and language barriers. Baseline chart review at the Lyndon B. Johnson Hospital oncology clinic revealed sparse documentation of oral chemotherapy education and compliance. Our team conducted the present quality improvement project to improve documentation of toxicity assessment, patient education, and compliance with the oral chemotherapy agents capecitabine, palbociclib, and sorafenib by 25% from October through December 2020. Methods: A set of standardized questions designed to assess for the above domains were generated in the form of an auto-populated electronic medical record phrase ("dot phrase," see Figure 1). Using weekly timed email notifications, physicians were reminded to incorporate these questions in their documentation during clinic visits. Chart review was performed to assess usage frequency of the dot phrase. A post-intervention survey was administered to assess providers' experience with use of the dot phrase, and assess barriers to consistent documentation. Results: 41 patients over 3 months were identified as taking the oral chemotherapy drugs capecitabine (68%), palbociclib (29%) or sorafenib (3%). 63% were non-English speakers. 49% had breast cancer, 39% GI cancers, and 12% other cancers. 12% of clinic visits correctly incorporated use of the dot phrase. Education on the dosing and schedule for oral chemo was addressed for 48% of patients, documentation of adverse effects was performed for 34% of patients, and assessment of medication adherence was documented for 22% of patients. While 73% of providers felt that documentation of oral chemotherapy compliance is important, 70% cited failure to remember to incorporate the dot phrase in real time as the primary reason for failure to use the dot phrase for oral chemotherapy documentation. Conclusions: Despite providers' view of documentation of oral chemotherapy toxicities and compliance as important, low uptake of the dot phrase was observed. The main barrier to use of the dot phrase was providers' forgetting to incorporate the dot phrase prior to and during their clinic charting. Future efforts should focus on automated reminders and regular assessments to increase compliance to this important quality domain. [Table: see text]

Cancer Disparities and Black American Representation in Clinical Trials Leading to the Approval of Oral Chemotherapy Drugs in the United States Between 2009 and 2019.

PURPOSE:Over the past 10 years, oral chemotherapy made up about half (45.6%) of all US Food and Drug Administration (FDA)–approved oncolytic and hematologic medications. Given the disparity in incidence and mortality rate because of certain cancers among Black Americans (BAs) in the United States, a review of BA’s representation in the clinical trials that lead to the development and FDA approval of oral chemotherapy drugs becomes imperative. The objective of this study was to evaluate the reporting of race and inclusion of BA in clinical trials that led to the approval of oral chemotherapy medications by the FDA from 2009 to 2019 in the United States. Additionally, we evaluated the inclusion of BAs in clinical trials of three cancer types with the highest disparity rates among BAs (lung, breast, and prostate).METHODS:A retrospective review of all FDA-approved oral chemotherapy drug from 2009-2019 was obtained using the FDA’s Hematology/Oncology Approvals & Safety Notifications website. Reports of racial and demographics inclusion were obtained from the clinical trials registry.RESULTS:Primary outcome: 142 clinical trials led to FDA approval of 81 oral chemotherapy agents between 2009 and 2019, among which 74 (52%) reported on at least one race and were included in our analysis. 35,933 participants were enrolled in these 74 clinical trials, among which 25,684 (71.47%), 6,061 (16.87%), 889 (2.47%), and 826 (2.30%) were White, Asian, Black, and Hispanic, respectively. BAs were also under-represented in the clinical trials of three cancer types with the highest disparity rates among this population.CONCLUSION:BAs were under-represented in clinical trials leading to FDA approval of oral chemotherapy drugs. There should be more BAs in cancer clinical trials to increase the generalizability of the results, improve outcomes, and eventually close the health disparity gap among this patient population.

Abstract PS13-26: Effect of an outpatient pharmacy team to improve management and adherence to oral chemotherapy

Abstract Introduction Oral chemotherapy agents have become increasingly common for the treatment of various malignancies, specifically in the metastatic setting. In metastatic breast cancer, oral chemotherapy is now considered the standard of care for first-line treatment due to progression-free survival and overall survival benefits. Oral agents are also considered to be a convenient and less toxic therapy option, improving quality of life. However, these benefits are offset by challenges in the delay to initiation of therapy, adherence, and toxicity management which may lead to high co-pays, delays in treatment, increased clinic visits, and non-adherence. These issues can be augmented at a safety net hospital charged to care for the most vulnerable patients. Close monitoring and follow-up are critical but can be complex and pose an additional burden on the treating oncologist. Pharmacists can serve as an extender to the oncologist and may help mitigate many of these clinical and operational barriers through adherence strategies, toxicity management, care coordination, and optimization of dosing schedules and regimens. Methods/Materials We conducted a quality improvement (QI) initiative aimed to decrease the average number of treatment day delays experienced by patients receiving oral chemotherapy for the treatment of MBC during the first six cycles of chemotherapy. A secondary aim was to improve adherence and patient-provider satisfaction. A protocol was designed and implemented utilizing pharmacists to provide assistance with obtaining the medications through a specialty pharmacy, oral chemotherapy counseling, toxicity assessments, and strategies to help optimize oral adherence (OPTIMAL protocol). Pharmacists conducted live in-person visits and telemedicine visits at weekly to monthly intervals to supplement the ongoing routine care of the oncology provider. All treatment and supportive care recommendations, in addition to any identified barriers, were communicated to the provider. Results A baseline assessment of 63 patients receiving oral oncolytic therapy from December 1st, 2018 through November 26th, 2019 was completed. Patients experienced most delays during cycle 1, with an average of 14.5 days of delay (range 1 - 34 days). The most common reasons for delay throughout the first six cycles of therapy were toxicity development, receipt of medication from the pharmacy, and patient adherence. A separate analysis of patients on CDK4/6 inhibitors (n=8) identified an average treatment day delay of 7.7 days (range 3.2 - 15.3 days) during the first six cycles of chemotherapy. Over a 7-month period, fifteen patients were enrolled in the OPTIMAL protocol and experienced an average treatment day delay of 2.9 days (range 0 - 6.8 days) during the first six cycles. Pharmacists made 206 documented interventions amongst the patients on the protocol, encompassing medication reconciliations, therapy counseling, and clinical recommendations. Eleven patients reported treatment-related toxicities, resulting in six therapy modifications and two-dose modifications. Four patients experienced progression on oral oncolytic therapy and subsequently went on to other treatment options. Conclusion Our protocol to incorporate pharmacists in initial and follow-up clinic visits at an outpatient breast cancer clinic within a safety net hospital was associated with decreased treatment day delays. Pharmacists performed a large number of meaningful clinical and operational interventions to facilitate medication treatment in a, particularly vulnerable population. This intervention supports the valuable and versatile role pharmacists can play in co-managing patients with the rest of the healthcare team. Citation Format: Jasmine Patel, David Michael Hughes, Kathryn Quinn, Tsion Fikre, Naomi Ko. Effect of an outpatient pharmacy team to improve management and adherence to oral chemotherapy [abstract]. In: Proceedings of the 2020 San Antonio Breast Cancer Virtual Symposium; 2020 Dec 8-11; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2021;81(4 Suppl):Abstract nr PS13-26.

Navigating herbal dietary supplements: Oral chemotherapy drug interactions in a community cancer center.

e19239 Background: The number of FDA-approved oral chemotherapy medications has continued to increase as has their incorporation into cancer treatment plans. Oncology pharmacists play an integral role in assessing and navigating drug interactions for patients. At Southcoast Centers for Cancer Care (SCCC), oncology pharmacists meet with patients to review/counsel on newly initiated oral therapy. One of the areas assessed during the visit is the use of herbal nutritional supplements. Pharmacists utilize available institutional resources to assess potential interactions and collaborate with the University of Rhode Island (URI), Drug Information Services (DIS), when information is not readily available. Methods: Patient responses about utilization of herbal dietary supplements during pharmacist-patient counseling sessions were assessed. All positive responses triggered a drug-supplement interaction screen. Number of patients taking herbal dietary supplements was tabulated and their use was characterized. Results: From October 2016-June 2019, 187 patients were counseled. Of these, 44/187 (24%) were taking herbal dietary supplements. SCCC pharmacists consulted the URI DIS on 10/44 (23%) patients to assist in identifying, researching, and recommending a care plan. The most frequently used supplements were melatonin and marijuana/CBD oil. The most frequently used supplements that required further consultation included curcumin. Conclusions: Consistent with findings from the general population taking prescription medications, we found that approximately 25% of patients taking oral chemotherapeutic medications were also actively taking herbal dietary supplements. Little data exists regarding oral chemotherapy agents and herbal dietary supplement interactions. Careful questioning/review/research of potential interactions is needed to prevent interactions and maximize effectiveness of oral chemotherapy.