Oral Anticancer Therapy Research Articles

O.32.1 - How Patient-Centered is Education and Counselling of Patients on Oral Anticancer Therapy?: Presenter(s): Ilyse Kenis, KU Leuven, Belgium

O.32.1 - How Patient-Centered is Education and Counselling of Patients on Oral Anticancer Therapy?: Presenter(s): Ilyse Kenis, KU Leuven, Belgium

Abstract P6-05-51: Best Quality of Care from a Distance (BQual-D): Maintaining high quality care for hormone receptor positive (HR+) metastatic breast cancer (MBC) during the COVID pandemic, patient participation and satisfaction with the program

Abstract Background During the COVID pandemic, we designed and implemented a program, called BQual-D, to maintain high quality care for patients with HR+, HER2 negative MBC who were taking oral anti-cancer therapy and needed to shelter at home. This program augmented available clinical resources with (1) trained nurse coaches to manage side effects, improve adherence, monitor for cancer progression and screen for psychological distress via telehealth, and (2) a care coordinator to arrange blood testing at local labs to facilitate timely medication dose adjustments. BQual-D served patients from August 2020 through April 2021. Here, we describe survey results assessing patient (pt) satisfaction with BQual-D. Methods Pt’s satisfaction surveys included questions rated on a Likert scale (1 “strongly disagree” to 5 “strongly agree”) with questions regarding the following: satisfaction with the quality of the nurse coaching calls; perception that the nurse coach listened to what they were trying to convey; whether or not their needs were met by the nurse coaching calls; whether they felt that they received adequate explanation regarding the nurse coaching calls; whether they would recommend the nurse coaching calls to a friend; perception of whether or not the nurse coach was negative or critical towards them; whether or not they would do it over (i.e., if they would return to the nurse coaching calls); whether or not they felt that the nurse coach was friendly or warm toward them; they were able to more effectively deal with care and symptoms; they felt free to express themselves; they were able to focus on what was of real concern to them; the nurse seemed to understand what they were thinking and feeling. Patients were also asked how much the calls helped with their care and symptoms. Descriptive statistics are reported (i.e., frequencies and means). Results 84 pts were screened and contacted for the BQual-D program. Of the 64 pts who responded, 52 (81.3%) were interested and enrolled in BQual-D; 12 (18.8%) declined. Among those who enrolled, 1 voluntarily withdrew, and 7 withdrew due to change in treatment. Participants had a mean age of 65 (range 36 – 88 yrs) and the following racial distribution - Caucasian/White (38, 73.1%), Black or African American (12, 23.1%), American Indian (1, 1.9%) and American Indian or Alaskan Native (1, 1.9%). Satisfaction surveys were received from 32 (50%) pts. Results of surveys regarding patient satisfaction with the nurse coach were generally positive. Pts agreed or strongly agreed that they were satisfied with the quality of the nurse coaching calls (94%), the nurse coach listened to what they were trying to convey (94%), their needs were met by the nurse coaching calls (91%), they understood the purpose of the call (90%), and they would recommend the nurse coaching calls to a friend (88%). The majority (74%) agreed or strongly agreed that they were able to more effectively deal with their care and symptoms after the nurse coach calls. When asked how much the calls helped their care and symptoms, 61% indicated that they made things a lot better, 19% indicated that they made things somewhat better, 16% indicated that they made no difference. One patient indicated that the calls made things somewhat worse. Conclusions During the COVID pandemic, when sheltering at home was encouraged, patient satisfaction with BQual-D, which provided additional health resources (nurse coaches, care coordinator) to support pts on oral therapy for HR+ MBC, was high. Resources needed to implement BQual-D should be explored as a way of providing additional support for pts to minimize the requirement for in-person visits. Funding: Supported by a grant from Pfizer. Citation Format: Gretchen Kimmick, Smrithi Divakaran, Heather Moore, Cynthia Rose, Pamela Gentry, Michael Willis, Susan Dent, Sarah L. Sammons, Jeremy Force, Kelly Westbrook, Carey Anders, Rebecca Shelby. Best Quality of Care from a Distance (BQual-D): Maintaining high quality care for hormone receptor positive (HR+) metastatic breast cancer (MBC) during the COVID pandemic, patient participation and satisfaction with the program. [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr P6-05-51.

Oral Bioactive Self-Nanoemulsifying Drug Delivery Systems of Remdesivir and Baricitinib: A Paradigmatic Case of Drug Repositioning for Cancer Management.

Oral anticancer therapy mostly faces the challenges of low aqueous solubility, poor and irregular absorption from the gastrointestinal tract, food-influenced absorption, high first-pass metabolism, non-targeted delivery, and severe systemic and local adverse effects. Interest has been growing in bioactive self-nanoemulsifying drug delivery systems (bio-SNEDDSs) using lipid-based excipients within nanomedicine. This study aimed to develop novel bio-SNEDDS to deliver antiviral remdesivir and baricitinib for the treatment of breast and lung cancers. Pure natural oils used in bio-SNEDDS were analyzed using GC-MS to examine bioactive constituents. The initial evaluation of bio-SNEDDSs were performed based on self-emulsification assessment, particle size analysis, zeta potential, viscosity measurement, and transmission electron microscopy (TEM). The single and combined anticancer effects of remdesivir and baricitinib in different bio-SNEDDS formulations were investigated in MDA-MB-231 (breast cancer) and A549 (lung cancer) cell lines. The results from the GC-MS analysis of bioactive oils BSO and FSO showed pharmacologically active constituents, such as thymoquinone, isoborneol, paeonol and p-cymenene, and squalene, respectively. The representative F5 bio-SNEDDSs showed relatively uniform, nanosized (247 nm) droplet along with acceptable zeta potential values (+29 mV). The viscosity of the F5 bio-SNEDDS was recorded within 0.69 Cp. The TEM suggested uniform spherical droplets upon aqueous dispersions. Drug-free, remdesivir and baricitinib-loaded bio-SNEDDSs (combined) showed superior anticancer effects with IC50 value that ranged from 1.9-4.2 µg/mL (for breast cancer), 2.4-5.8 µg/mL (for lung cancer), and 3.05-5.44 µg/mL (human fibroblasts cell line). In conclusion, the representative F5 bio-SNEDDS could be a promising candidate for improving the anticancer effect of remdesivir and baricitinib along with their existing antiviral performance in combined dosage form.

Knowledge of and willingness for dispensing oral anticancer drug therapy among community pharmacists: a cross-sectional study from Jordan

Abstract Objectives This study aimed to assess the knowledge of and willingness for dispensing oral anticancer drugs (OADs) among community pharmacists in Jordan. Methods A cross-sectional survey was conducted among pharmacists in community pharmacies. Key findings Five hundred pharmacists completed the questionnaire. The mean age of respondents was 30.4 ± 6.2 years (range 21–61). Most pharmacists had a bachelor’s degree in pharmacy (80.8%) and were staff pharmacists (61.6%). Two hundred and ten (42.0%) pharmacists indicated not receiving adequate education on OADs at the undergraduate level. The majority of respondents (79.8%) did not attend continuing education events in oncology in the past 2 years. Further, 44.6% of pharmacists never dispensed OADs in their pharmacies. The mean score of knowledge of OADs was 1.7 ± 1.9 out of 12 points (range 0–9). The vast majority of pharmacists surveyed (97.6%) had poor knowledge of OADs. Almost half of the pharmacists (49.8%) agreed or strongly agreed to be comfortable answering questions regarding cancer treatments. More than half of respondents (52.2%) feel comfortable providing patient education on OADs. Half of the respondents (49.6%) disagreed that their current pharmacy settings are equipped with the necessary tools to handle OADs. Conclusions A large number of community pharmacists in Jordan lack the foundational knowledge regarding OADs. A substantial proportion of pharmacists never dispensed OADs and were not satisfied with the level of undergraduate education received regarding oncology and oral cancer therapies. Nevertheless, most pharmacists were willing to handle OADs and were positive about receiving further training/education on dispensing OADs. Collectively, efforts are needed to improve pharmacy education on oral chemotherapy and cancer care along with continuous training for pharmacists in their community settings.

Mitigating the Risk of Drug Interactions in Cancer Patients Taking Oral Anticancer Agents: The Role of a Multidisciplinary Team-Based Medication Reconciliation.

Polypharmacy in cancer patients is a recognized issue and should be an integral part of comprehensive patient assessment and management. Despite this, a systematic review of concomitant drugs or a search for potential drug-drug interactions (DDIs) is not always performed. Here, we present the results of a medication reconciliation model performed by a multidisciplinary team to identify clinically meaningful potential DDIs (defined by the presence of DDIof major severity or contraindication) in cancer patients undergoing oral antineoplastic drugs. From June to December 2022, we performed a non-interventional, prospective, cross-sectional, single-center study of adult cancer patients, initiating or undergoing treatment with oral antineoplastic drugs, referred by their oncologists for therapeutic review regarding potential DDIs. DDIs were assessed by a multidisciplinary team of hospital pharmacists and medical oncologists, through research in three different drug databases as well as in the summary of product characteristics. A report detailing all potential DDIs was created for each request and provided to the patient's medical oncologist for further examination. Overall, 142 patients' medications were reviewed. Regardless of the severity or clinical importance, 70.4% of patients had at least one potential DDI. We found 184 combinations of oral anticancer and regular therapy agents with potential DDIs, 55 of whom were considered of major severity by at least one DDI database. As expected, the number of potential DDIs increased with the number of active substances in regular therapy (p <0.001), but we did not find an increased relation between age and the total number of potential DDIs (p =0.109). Thirty-nine (27.5%) patients had at least one clinically meaningful DDI identified. After adjustment through multivariable logistic regression, only the female sex (odds ratio (OR) 3.01,p= 0.029), the number of active comorbidities (OR 0.60,p= 0.029), and the presence of proton pump inhibitors in chronic medication (OR 2.99,p= 0.033) remained as predictors of potential meaningful DDI. Although drug interactions are a concern in oncology, a systematic DDI review is rarely conducted in medical oncology consultations. The availability of a medication reconciliation service, carried out by a multidisciplinary team with dedicated time for this task, is an added value for safety enhancement in cancer patients.

End-of-Life Care for Patients With Metastatic Renal Cell Carcinoma in the Era of Oral Anticancer Therapy.

New therapies including oral anticancer agents (OAAs) have improved outcomes for patients with metastatic renal cell carcinoma (mRCC). However, little is known about the quality of end-of-life (EOL) care and systemic therapy use at EOL in patients receiving OAAs or with mRCC. We retrospectively analyzed EOL care for decedents with mRCC in two parallel cohorts: (1) patients (RCC diagnosed 2004-2015) from the University of North Carolina's Cancer Information and Population Health Resource (CIPHR) and (2) patients (diagnosed 2007-2015) from SEER-Medicare. We assessed hospice use in the last 30 days of life and existing measures of poor-quality EOL care: systemic therapy, hospital admission, intensive care unit admission, and > 1 ED visit in the last 30 days of life; hospice initiation in the last 3 days of life; and in-hospital death. Associations between OAA use, patient and provider characteristics, and EOL care were examined using multivariable logistic regression. We identified 410 decedents in the CIPHR cohort (53.4% received OAA) and 1,508 in SEER-Medicare (43.5% received OAA). Prior OAA use was associated with increased systemic therapy in the last 30 days of life in both cohorts (CIPHR: 26.5% v 11.0%; P < .001; SEER-Medicare: 23.4% v 11.7%; P < .001), increased in-hospital death in CIPHR, and increased hospice in the last 30 days in SEER-Medicare. Older patients were less likely to receive systemic therapy or be admitted in the last 30 days or die in hospital. Patients with mRCC who received OAAs and younger patients experienced more aggressive EOL care, suggesting opportunities to optimize high-quality EOL care in these groups.

278MO Adherence optimisation, benefits, and limitations of oral anti-cancer therapy: A systematic review of patient preferences

Oral anti-cancer (OAC) therapies are now commonplace in cancer treatment. Variable adherence and irregular toxicity monitoring remain concerning, particularly for treatments with curative intent. This study reviews literature on patient preferences considering: 1) factors contributing to patient adherence; 2) benefits and limitations; 3) concordance between patient and clinician perspectives.

Relationships among illness understanding, information preferences, and adherence to oral anticancer therapy.

250 Background: Patients prescribed oral anticancer therapy receive less support for adherence and symptom monitoring from oncologists compared to infusional cancer therapy, which can result in lower quality care and worse disease outcomes. Identifying factors related to adherence can guide efforts to develop patient-centered interventions. The goal of this analysis was to examine associations among patients’ illness understanding, information preferences, and oral anticancer therapy adherence. Methods: We conducted a secondary analysis of a randomized trial testing the efficacy of a mobile application to improve assessment of symptoms and treatment adherence. Eligible patients included adults diagnosed with cancer prescribed oral anticancer therapy. To assess adherence, participants stored their medication for three months in a Medication Event Monitoring System (MEMS) bottle that electronically records the date and time the bottle is opened. At baseline, participants completed the Prognosis and Treatment Perceptions Questionnaire, which assesses patients’ illness understanding and information preferences in communicating with oncologists. We conducted linear regression to examine associations among patients’ illness understanding, information preferences, and medication adherence. Results: The study included 181 patients prescribed oral anticancer therapy (Mean age = 53.30 years; 53.6% female; 87.8% white). The most common cancer types were hematologic (33.1%), lung (18.2%), and breast (14.4%) malignancies. Two-thirds (66.9%) were prescribed oral targeted therapies, and 35.5% self-identified as terminally ill. Controlling for intervention effects, patients who reported wanting as many details as possible related to their cancer and treatment had higher MEMS adherence over the three-month study period (B = 12.84, 95%CI: 3.65, 22.03, p =.006) versus those who preferred to know fewer details. Also, patients who reported that it was extremely important for them to know their prognosis had higher adherence (B = 9.93, 95%CI: 1.73, 18.13, p =.018) versus those who rated knowing about prognosis as less important, though this relationship was moderated by illness understanding. Specifically, in the subgroup of patients reporting that they were not terminally ill, the association between wanting to know about prognosis and MEMS adherence remained significant (p =.006), which was not the case for patients identifying as terminally ill (p =.776). Conclusions: In this sample, patients’ desire for information about their cancer and prognosis was strongly associated with higher adherence to oral anticancer therapy over the following three months. Yet, this association may be stronger among those who do not identify as terminally ill. Targeted interventions that support patients who prefer fewer details about their illness and prognosis may improve medication adherence.

A mixed-methods study to identify key priorities around improving team-based care coordination for patients receiving combination IV and oral systemic anti-cancer therapy.

52 Background: When combination medical therapy incorporates both IV and oral anti-cancer agents, patients may experience compound side effects and face challenges with treatment adherence. To assess how community cancer programs may improve care coordination for patients receiving combination IV/oral systemic therapy, the Association of Community Cancer Centers (ACCC) conducted a mixed-methods study that involved healthcare professionals (HCPs), patients and caregivers. Methods: The study followed a sequential quantitative-qualitative design to answer questions around the barriers or challenges associated with combination IV/oral systemic therapy. The quantitative phase included an online survey of HCPs (by ACCC) and a survey of patients and caregivers (by Edge Research, in collaboration with several patient advocacy organizations). In the quantitative phase, the survey results were contextualized through two HCP focus groups and individual HCP interviews. Results: Comparing and contrasting the patient survey (n = 113) and HCP survey (n = 157) results revealed insights around the following themes: Top Challenges: Patients felt their top challenges were side effects (57.5%); inconvenience going to medical appointments (37.2%); and financial burden (36.3%). HCPs perceived top challenges as cost of care to the patient (24.0%); coordination and delivery of oral agents (22.1%); and health insurance coverage (21.9%). In focus groups, HCPs explained how they were investing significant staffing resources to prevent and mitigate financial toxicity, especially for patients receiving oral therapies. Methods of Communication: 35.4% of patients “highly preferred” using email to communicate with HCPs about their combination regimens. However, HCPs felt that email was one of the least effective methods of communicating with patients. In focus groups, HCPs agreed that email is convenient when communicating about non-urgent matters. However, they were concerned that some patients may use email to communicate about urgent issues. Treatment-related AEs: When patients experienced treatment-related AEs, 30.1% said their clinicians tried a dose modification or hold. HCPs had mixed perceptions regarding the effectiveness of dose holidays. Those who felt this was highly effective included: advanced practice providers (42.9%), nurses (28.1%); oncologists (16.7%); and pharmacists (16.7%). Conclusions: This study identifies opportunities to improve care coordination for patients receiving combination IV/oral systemic anti-cancer regimens. These findings may inform the creation and dissemination of effective practices and quality improvement projects. These results may also help cancer programs tailor resources and incorporate proactive steps to address some of the key challenges patients may face.

Disparities in receipt of financial assistance for patients prescribed oral anti-cancer medications at an integrated specialty pharmacy.

217 Background: An increasing number of patients with cancer are prescribed oral anti-cancer medications and face significant challenges in affording them. Financial assistance programs may be a critical resource to mitigate this financial burden but there are often barriers to accessing them. This study evaluated factors associated with receipt of financial assistance among patients with cancer prescribed oral anti-cancer medications. Methods: We conducted a retrospective cohort study including all patients prescribed an oral anti-cancer therapy through the University of California, San Francisco (UCSF) Specialty Pharmacy between January 1,2021 and December 31, 2021. The unit of analysis was patient-drug. Information on financial assistance, including sponsor, type, and amount secured was extracted through Vivor – a financial navigation and grant tracking tool – and linked to clinical and prescription data extracted from the institutional electronic medical record. We employed a multivariate logistic regression analysis to identify variables associated of receipt of financial assistance.Results: Of 1,357 unique patient/drug combinations, 488 (36%) received some form of financial assistance. Mean age of patients was 67 years (SD = 14, range 21-97). Patients were predominantly male (69%), lived in an urban area (42%), were retired (41%), and identified as Non-Hispanic White (61%). A minority of patients (13%) were non-English speaking. The most common type of assistance received was from a foundation (35%), followed by free drug program (24%) and copayment card (23%). Healthwell Foundation (28%) and Patient Access Network Foundation (26%) were the most common sponsors for foundation-based support. Receipt of assistance varied (Χ2 = 60.8, p &lt; 0.001) by disease state. Multivariate logistic regression indicated that patients who identified as Hispanic/Latinx ethnicity (OR 0.49, p = 0.038) or were non-English speaking (OR 0.38, p = 0.015) were less likely to receive financial assistance. Conclusions: There were disparities in receipt of financial assistance by ethnicity and primary language spoken. Some patients may not be equitably connected to existing financial resources and may be disproportionately at risk for the financial, clinical, and psychosocial implications of a high out-of-pocket cost burden. Future studies should develop and implement standardized workflows to ensure equitable access to existing financial resources for patients with cancer.

Self-emulsifying Drug Delivery System for Oral Anticancer Therapy: Constraints and Recent Development.

Oral anticancer therapy faces several drawbacks: low aqueous solubility, poor and irregular absorption from gastrointestinal sites, high first-pass metabolism, food-influenced absorption, non-targeted delivery, severe systemic and local adverse effects, etc. Enhancement of oral bioavailability could reduce the drug load and associated adverse effects. Self-emulsifying drug delivery systems (SEDDS) can enhance in-vivo solubility and drug absorption from the gastrointestinal tract, bypass liver metabolism by lymphatic absorption and inhibit efflux transport. All these phenomena ultimately result in improved oral bioavailability. Anticancer drug delivery using the SEDDS has shown promising results for bioavailability and pharmacodynamic response. A handful of research studies have produced evidence of the successful loading of anticancer agents in SEDDS-based formulations. Various potent and established chemotherapeutic agents such as docetaxel, paclitaxel, etoposide, 5 Fluorouracil, doxorubicin etc., have been successfully formulated and evaluated. Improved bioavailability and reduction of dose might be possible by SEDDS. It could be effective for low-dose drugs. But, excessive surfactant- cosurfactant concentration, lacking predictive in-vitro models and adequate IVIVC, and unavailability of toxicity data are certain challenges for future researchers. No clinical trials have been recorded with anticancer drug-loaded SEDDS. Overcoming the challenges and further progression to clinical studies are required to avail the benefits of anticancer SEDDS.

Predictors of adherence to oral anticancer medications: An analysis of 2010-2018 US nationwide claims.

BACKGROUND: Various factors, including patient demographic and socioeconomic characteristics, patient out-of-pocket (OOP) costs, therapy-related factors, clinical characteristics, and health-system factors, can affect patient adherence to oral anticancer medications (OAMs). OBJECTIVE: To determine the proportion of patients initiating oral anticancer therapy who were adherent to OAMs and to identify significant predictors of adherence to OAMs, including patient OOP costs and patient demographics. METHODS: A retrospective cohort study was conducted using data from Optum Clinformatics Data Mart commercial claims database for 2010-2018. Patients with a new pharmacy claim for an OAM between July 1, 2010, and December 31, 2017, were followed for 6 months to ascertain their medication adherence, which was defined as a proportion of days covered value of at least 0.8. Average monthly patient OOP costs for OAM prescriptions were categorized as lower OOP costs (quartiles 1-3) and higher OOP costs (quartile 4). Separate multivariable logistic regressions were conducted to identify predictors of OAM nonadherence for each cancer type. RESULTS: Out of 37,938 patients with cancer, 51.9% were adherent to OAMs, with adherence ranging from 32.8% among those with liver cancer to 70.4% among those with brain tumor. The average monthly OOP costs of OAMs also differed by cancer type, ranging from $749 (SD = $1,014) among patients with blood cancer to $106 (SD = $439) among those with prostate cancer. Higher patient OOP costs were associated with higher odds of OAM nonadherence for many cancer types, including renal cancer (adjusted odds ratio [AOR] = 3.91; 95% CI = 2.80-5.47) and breast cancer (AOR = 1.26; 95% CI = 1.13-1.41). Additionally, patients with inpatient hospitalizations during the 6 months following OAM initiation had significantly higher odds of OAM nonadherence for all cancer types except for stomach cancer. Among patients with stomach cancer, male sex was associated with lower odds of OAM nonadherence (AOR = 0.60; 95% CI = 0.37-0.97). Among patients with renal or stomach cancer, those who had Medicare low-income subsidy had higher odds of OAM nonadherence compared with those with commercial insurance coverage. Among patients with blood cancers, Black and Hispanic patients had higher odds of OAM nonadherence compared with White patients (AOR = 1.48; 95% CI = 1.25-1.75 and AOR = 1.38; 95% CI = 1.13-1.68, respectively). CONCLUSIONS: Overall adherence to OAMs was suboptimal, and for several cancer types, adherence was worse among patients with higher OOP costs, those who were hospitalized, and those who received Medicare low-income subsidy. Policies addressing cost and access to OAMs and health-system strategies to address barriers to the effective use of OAMs are needed to improve patient access to these vital medications. DISCLOSURES: This study was funded by joint funding from the Pharmacy Quality Alliance and the National Pharmaceutical Council (NPC). Drs Vyas and Kogut were partially supported by this joint funding. Mr Descoteaux was supported by this joint funding for performing data analysis. The content is solely the responsibility of the authors and does not necessarily represent the official views of PQA or NPC. Dr Campbell completed this work during his employment at Pharmacy Quality Alliance; he is now an employee of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ.

Adherence to oral anticancer therapy of oncology patients attending the pharmaceutical office of a public hospital in the lower Amazon region.

Introduction:Oral anticancer therapy has the benefit of allowing cancer patients to carry out their treatment at home, without being inconvenienced or being at risk of nosocomial infection. However, non-adherence is a public health problem that contributes to the clinical decline of the patient and there are no studies submitted on the adherence of cancer patients to oral anti-anticancer agents in Santarém, PA.Objective:In view of this, the general objective of this work was to evaluate this oral medication adherence.MethodsThe methodology consisted of a cross-sectional documentary study with a quantitative approach of patients seen at the pharmaceutical office. The Morisky–Green test was used to analyse the degree of adherence and descriptive and inferential statistics were used (p < 0.05).Results:Patients’ adherence to antitumour therapy was not 100%, the majority belonging to females; men were the most adherent, showing adverse reactions to anti-anticancer agents (p = 0.0096); comorbidity (p = 0.0202) negatively impacted adherence.Conclusion:It is necessary to adopt new clinical procedures that can contribute to the management of these variables that prevent adherence, in order to improve the effectiveness of the treatment of these patients. There are circumstances that go beyond the aspects inherent to the patient, so it is also relevant to research the external factors that influence the individual’s behaviour, such as the duration of therapy and the consequences of the treatment in the patient’s routine.

Abstract 495: Outcomes of an expanded access program for patients with gastrointestinal stromal tumors in low- and middle-income countries

Abstract Background: Gastrointestinal Stromal Tumors (GIST) treatment was revolutionized by the introduction of the tyrosine kinase inhibitor imatinib. More recently, sunitinib, has prolonged survival in patients (pts) with metastatic disease resistant to imatinib. 10-year survival for high-risk pts treated with adjuvant imatinib is 79%. Median overall survival for pts with unresectable or metastatic GIST is 4.8 years. In order to bring access to these life-saving medications to pts in low- and middle- income countries (LMICs), The Max Foundation (TMF) developed its Max Access Solutions (MAS) program in 2017, after administering Novartis’ imatinib (Glivec) International Patient Assistance Program (GIPAP) since 2002. We analyzed the outcomes of pts enrolled in these programs from 2002-2020 for both adjuvant (n=2100) or metastatic (n=9,867) GIST across 67 countries. Methods: Demographic data and treatment indications were reported by treating physicians. The clinical status of each enrolled pt was reviewed with TMF every 3-4 months. Pts who were lost to follow-up (LTFU) (n=2282) with metastatic or unresectable disease were presumed to be deceased. Alternatively, for patients treated in the adjuvant setting an imputation based informed censoring model was used to estimate events for LTFU patients (n=477). Kaplan-Meier analysis was used to estimate the distribution of progression-free (PFS) and overall survival (OS). Results: The median age at diagnosis was 54 and 55 years in the adjuvant and metastatic groups, respectively. Males comprised 59.5% of all metastatic/unresectable cases and females 51.3% of adjuvant cases. Median OS for pts treated with imatinib for unresectable or metastatic disease was 5.8 years (CI: (5.6, 6.1)) and PFS was 3.5 years (CI: (3.5, 3.7)). Pts treated with imatinib in the adjuvant setting had a 10-year OS of 72% and PFS of 70%. Median OS of pts with metastatic disease treated with sunitinib was 2 years (CI: (1.5, 2.5)); PFS was 1.2 years (CI: (0.9, 1.6)). Multivariate analysis showed that male sex was a negative prognostic factor in both the metastatic and adjuvant setting. Other variables including World Bank Income groups and frequency of contact were not associated with increased mortality or progression in any group. Discussion: This is the largest known cohort of GIST outcomes and the first study to present outcomes from predominantly low- and middle-income countries. Additionally, studies in LMICs are challenged by high rates of lost to follow-up which can falsely prolong or shorten survival times due to censoring. Therefore, we employed an informed censoring model to better reflect survival in the adjuvant setting. We demonstrate that access to a targeted oral anti-cancer therapy results in outcomes similar to those in high resource countries and provides a model to help close the global gap in cancer outcomes. Citation Format: Edward Lloyd Briercheck, J. Michael Wrigglesworth, Philip Stevenson, Alicia A. Annamalay, Pat Garcia-Gonzalez, Michael Wagner. Outcomes of an expanded access program for patients with gastrointestinal stromal tumors in low- and middle-income countries [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2022; 2022 Apr 8-13. Philadelphia (PA): AACR; Cancer Res 2022;82(12_Suppl):Abstract nr 495.

Trends in Medicare oral anticancer drug utilization among relapsed and refractory chronic myeloid leukemia patients.

e19058 Background: The treatment landscape for patients with relapsed and refractory (RR) chronic myeloid leukemia (CML) has changed significantly in recent years, with the introduction of targeted oral anticancer therapies. Current guidelines from the National Cancer Comprehensive Network (NCCN) recommend tyrosine-kinase inhibitors (TKIs) for second line and subsequent therapy. Recent real-world data evaluating treatment patterns in RR CML is limited. Study objective was to evaluate treatment patterns and trends in utilization of oral anticancer agents among Medicare beneficiaries diagnosed with RR CML, from 2017-2019. Methods: Retrospective study using Medicare Part D Prescription Drug Event Files, which contain records on prescription drug fills among Medicare beneficiaries enrolled in Fee-for-Service and Medicare Advantage plans. Beneficiaries diagnosed with RR CML (C9212 ICD-10) and prescribed oral anti-cancer therapy (Bosutinib, Dasatanib, Nilotinib, Ponatinib or Imatinib Mesylate) were identified and followed for at least 12 months, from index diagnosis until end of study period (December 31, 2019) or death. Trends in utilization by oral therapy, by number of beneficiary utilizers and prescription drug claims, were evaluated from 2017 to 2019. Results: Overall, 327 Medicare beneficiaries with a diagnosis of RR MM were prescribed an oral TKI therapy (Bosutinib, Dasatanib, Nilotinib, Ponatinib or Imatinib Mesylate) throughout the study period (2017-2019). The number of beneficiaries prescribed at least 1 oral therapy increased between 2017 and 2019, from 154 to 212 (Table). Total utilization also increased: from 210 prescription drug claims in 2017 to 296 in 2019. Throughout the study period, Imatinib Mesylate had the largest market share among all oral therapies, however the share decreased over time (from 35.7% in 2017 to 30.7% in 2019). Nilotinib had the largest gain in market share during this period, from 15.7% to 20.9%. Conclusions: Study findings suggest utilization of oral therapies are increasing over time, and shifting from Imatinib Mesylate to newer therapeutic agents. Given the high costs for these novel therapies, future research should examine trends in patient out-of-pocket spending, as well as factors impacting patient adherence.[Table: see text]

ASSOCIATIONS BETWEEN THERAPEUTIC REGIMEN-RELATED FACTORS AND MEDICATION ADHERENCE IN PATIENTS ON ORAL ANTICANCER THERAPY

Objective: Good adherence is critical for successful cancer treatment. Complex medication regimens have been found among the various therapy-related factors causing non-adherence. Methods: In a cross-sectional questionnaire-based study of outpatients, we assessed 75 patients suffering from cancer. The objective of this study is to find associations between therapeutic regimen-related factors and medication adherence in patients on oral anticancer therapy. Results: There was an increase in medication adherence as the length of therapy increased. About 10.76% of the patients with treatment duration &lt;4 years showed low adherence. Low adherence was not observed with treatment duration of more than 4 years. About 6.55% of those taking up to four drugs had low adherence as compared to 14.28% taking more than 4 drugs. About 8.69% of patients taking drugs up to thrice a day showed low adherence as compared to 16.66% taking more than thrice a day. The negative associations between medication regimen complexity and adherence observed in this study were in the predicted direction but did not achieve statistical significance (p&gt;0.05). The effect size was small (d=0.28) Conclusion: Complex prescription regimens reduce adherence to oral anticancer treatments, however, there are several other factors to consider than regimen simplification to increase adherence.

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

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

Abstract P4-10-06: Best quality care from a distance (BQual-D): Maintaining high quality care for hormone receptor positive (HR+) metastatic breast cancer (MBC) during the COVID pandemic, description of the program and provider satisfaction

Abstract Background: During the COVID pandemic, we designed and implemented a program, called BQual-D, to maintain high quality care for patients with HR+, HER2 negative MBC who were taking oral anti-cancer therapy and needed to shelter at home. This program augmented available clinical resources with (1) trained nurse coaches to manage side effects, improve adherence, monitor for cancer progression and screen for psychological distress via telehealth, and (2) a care coordinator to arrange blood testing at local labs to facilitate timely medication dose adjustments. BQual-D served patients from August, 2020 through April of 2021. Here, we describe survey results assessing provider satisfaction with BQual-D. Methods: Surveys assessing provider satisfaction were distributed in December, 2020 (Survey#1) and in April, 2021 (Survey#2). Provider demographics were collected with Survey#1. Eight questions assessed satisfaction with different aspects of the BQual-D program, including content of the nurse coach notes, communication with the program, timeliness of communication, frequency of notes, ease of reading the notes, ease of referring patients, and turnaround time for labs, which were rated on a Likert scale of 1 (strongly dissatisfied) to 10 (strongly satisfied), with an additional response choice of 0 (unable to assess). Providers were also asked if BQual-D led to changes in patient management (yes/no), the degree to which BQual-D supported the medical management of the patient (from 1=not at all to 7=significantly), the influence of BQual-D on patient wellbeing (positive effects, no change, negative effects), and the overall quality of care delivered by the program (from 1=excellent to 4=poor). Finally, we asked providers if they would continue to recommend their patients to BQual-D (yes, in the same way as the program has been deployed; yes but with improvements; or no). Results are described by frequencies and means. Results: Nineteen providers responded to Survey#1. Providers were physicians (31.6%), advanced practice providers (31.6%), nurses (31.6%) and a clinical pharmacist (5.3%). Respondents were 89.5% female, 94.7% White, and had a mean age of 44 years and mean 11 years in practice. Providers rated the quality of care provided by the BQual-D program as excellent (44%) or good (57%), all providers surveyed indicated that they would continue to recommend the program to patients, and 95% of providers indicated that the program had a positive effect on patients’ well-being. Half of the respondents indicated that BQual-D resulted in changes in or addition to patient management and 90% indicated that BQual-D significantly supported medical management. Providers were strongly satisfied (scores of 8-10 on the Likert scale) with overall communication with the BQual-D team (74%) and timeliness of communications (79%). Providers were also strongly satisfied with the content (68.4%), frequency (74%), and ease of reading (68%) program notes. Seven providers completed Survey#2, in which providers rated the overall quality of the program as excellent (57%) or good (43%); 86% indicated that they would continue to recommend the program to patients, and 86% indicated that the program had a positive effect on patients’ well-being. Conclusions: During the COVID pandemic, when sheltering at home was encouraged, provider satisfaction with BQual-D, which provided additional health resources (nurse coaches, care coordinator) to support patients on oral therapy for HR+ MBC, was high. Resources needed to implement BQual-D should be explored as a way of providing additional support for patients and providers in order to minimize the requirement for in-person visits. Funding: Supported by a grant from Pfizer. Citation Format: Gretchen Kimmick, Smrithi Davakaran, Heather Moore, Cynthia Rose, Pamela Gentry, Michael Willis, Susan Dent, Sarah Sammons, Jeremy Force, Kelly Westbrook, Carey Anders, Rebecca Shelby. Best quality care from a distance (BQual-D): Maintaining high quality care for hormone receptor positive (HR+) metastatic breast cancer (MBC) during the COVID pandemic, description of the program and provider satisfaction [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 P4-10-06.

The association between patient satisfaction with information and adherence to oral anticancer agents.

Adherence to anticancer agents is a critical factor in achieving adequate clinical response, and became a major challenge for patients and caregivers since the increased substitution of parenteral cytostatic by oral drugs. One of the factors that influences adherence is how well informed patients are about their therapy. This study assesses the association between patient satisfaction with information about oral anticancer agents and adherence. This study was conducted among patients (≥18 years) who began oral anticancer therapy. Patients satisfaction with information and adherence were assessed using validated questionnaires. Adherence was also assessed using refill data. Logistic regression was applied to assess the association between overall patient satisfaction with information and both self-reported adherence and adherence based on an MPR value of above 80%. In total, 124 patients were included in the study. The median (IQR) satisfaction with information was 15.0(4) on a scale of 0-17. Eighty-two percent of participants reported adherence, while the refill data demonstrated that 64.5% of patients had an adherence rate of 80% or higher. Overall satisfaction with information was not significantly associated with self-reported adherence (OR adj 0.98 [95% CI 0.85-1.15]) or refill-based adherence (OR adj 1.11 [95% CI 0.99-1.24]). The findings indicate no significant relationship between patient satisfaction with information and adherence. The population was highly satisfied with information about the oral anticancer agents, which indicates a high level of satisfaction with usual care. However, the refill data reveals that 35.5% of patients were not adherent.

Volumetric absorptive microsampling (VAMS) for the quantification of ten kinase inhibitors and determination of their in vitro VAMS-to-plasma ratio

Personalized dosing of kinase inhibitors (KI) might be beneficial in oral anti-cancer therapy to overcome individual pharmacokinetic variability. Volumetric absorptive microsampling (VAMS) has emerged as an attractive alternative compared to conventional invasive sampling methods enabling remote and frequent specimen collection. Therefore, an LC-MS/MS VAMS method was developed and validated to monitor drug exposure of ten KI from 20 µL dried capillary blood. The assay includes the KI cabozantinib, dabrafenib, nilotinib, and osimertinib with a calibration range of 6–1500 ng/mL and afatinib, axitinib, bosutinib, lenvatinib, ruxolitinib and trametinib within a range of 2–500 ng/mL. Using acetonitrile containing isotope labelled internal standards (IS) as solid-liquid extraction solvent, analytes and IS were detected by multiple reaction monitoring (MRM) after electro-spray ionization (ESI) in positive ionization mode after chromatographic separation using a phenyl-hexyl column. The method was validated according to the FDA and EMA guidelines for bioanalytical method validation and in accordance with the guideline of the International Association for Therapeutic Drug Monitoring and Clinical Toxicology for dried blood spot-based methods. The calibration model was linear and reproducible for all KI (R2> 0.994). Furthermore, the validation demonstrated that the VAMS method is accurate, precise, and sensitive. The method fulfilled the acceptance criteria for matrix effects, recovery, carry over, selectivity as well as for the haematocrit effect and all substances proved to be stable in dried condition for at least six weeks at room temperature. In vitro experiments using spiked venous blood were conducted to establish a VAMS-to-plasma conversion factor for each analyte for comparison of VAMS and plasma concentrations. The method was successfully used in a real-life setting demonstrating its applicability in clinical routine. VAMS concentrations of afatinib, cabozantinib, dabrafenib, nilotinib, ruxolitinib and trametinib were assessed in capillary blood samples collected from either trained healthcare professionals or patients at home.