These abstracts represent the balance of studies featured during the poster presentation at the 16th Annual Conference of the Hematology/Oncology Pharmacy Association (HOPA) in April 2020 in Tampa, FL. The other abstracts were previously published in the June, August, and October issues of the journal.
In This Article
- Impact of Treatment Sequence on Overall Survival in Patients with Metastatic Pancreatic Cancer Treated with Irinotecan Liposomal in the Real-World Setting
- Fixed-Dose 3-mg Rasburicase for Hyperuricemia in Patients with Tumor Lysis Syndrome at a Community Hospital
- The Impact of Pegaspargase Premedication on Hypersensitivity Reactions in Pediatric Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma Patients
- Evaluation of an Oncology Transitions-of-Care Pilot Program
- The Role of Pharmacists in Increasing Patient Access to Targeted Therapies
CLINICAL/TRANSACTIONAL TRACK: COMPLETED RESEARCH
Impact of Treatment Sequence on Overall Survival in Patients with Metastatic Pancreatic Cancer Treated with Irinotecan Liposomal in the Real-World Setting
Presenter: Kishore Ramnani
Co-Authors: George Kim, George Washington University, Division of Hematology & Oncology, Washington, DC; Andy Surinach, Genesis Research, Hoboken, NJ; Frank A. Corvino, Genesis Research, Hoboken, NJ; Paul Cockrum, Ipsen, Cambridge, MA
Background: The real-world evidence is limited about the impact of treatment sequence on outcomes for patients with metastatic pancreatic cancer treated with liposomal irinotecan in combination with fluorouracil and leucovorin.
Objective: To assess clinical characteristics and overall survival (OS) in patients who received liposomal irinotecan in the third-line setting or beyond, after treatment with fluorouracil and gemcitabine-based treatment (Sequence 1), and patients who received liposomal irinotecan as second-line treatment, after gemcitabine-based frontline treatment (Sequence 2).
Methods: Using the Flatiron Health longitudinal database, data were extracted and analyzed for adults with metastatic pancreatic cancer treated with liposomal irinotecan between November 2015 and October 2018. Lines of treatment were derived from structured medication administration and order data. Kaplan-Meier methods were used to estimate the OS from liposomal irinotecan initiation.
Results: A total of 121 patients in Sequence 1 and 129 patients in Sequence 2 were included in this study. Sequence 1 patients had a median age of 66 years (interquartile range [IQR], 60-73) at liposomal irinotecan initiation and the median age of Sequence 2 patients was 72 years (IQR, 65-77) at initiation. A total of 65.1% (N = 84) Sequence 2 patients were initially diagnosed with stage IV pancreatic cancer compared with 55.4% (N = 67) of Sequence 1 patients. ECOG scores were similar between the 2 cohorts: 52.1% (N = 63) of Sequence 1 patients had a score of 0-1 compared with 52.7% (N = 68) of Sequence 2 patients. Sequence 1 patients had a median OS of 4.1 months (95% confidence interval [CI], 3.5-5.4) with liposomal irinotecan treatment initiation, whereas Sequence 2 patients had a median OS of 6.3 months (95% CI, 4.2-7.5).
Conclusion: This real-world analysis showed similar results to a recent single-center study of patients treated with liposomal irinotecan, and the NAPOLI-1 trial.1,2 As expected, Sequence 2 patients had a longer OS than Sequence 1 patients. Further real-world studies are needed to understand the impact of treatment sequences on survival outcomes in patients receiving liposomal irinotecan.
- Glassman DC, Palmaira RL, Covington CM, et al. Nanoliposomal irinotecan with fluorouracil for the treatment of advanced pancreatic cancer, a single institution experience. BMC Cancer. 2018;18:693.
- Wang-Gillam A, Li CP, Bodoky G, et al; for the NAPOLI-1 study group. Nanoliposomal irinotecan with fluorouracil and folinic acid in metastatic pancreatic cancer after previous gemcitabine-based therapy (NAPOLI-1): a global, randomised, open-label, phase 3 trial. Lancet. 2016;387:545-557. Erratum in: Lancet. 2016;387:536.
CLINICAL/TRANSACTIONAL TRACK: COMPLETED RESEARCH
Fixed-Dose 3-mg Rasburicase for Hyperuricemia in Patients with Tumor Lysis Syndrome at a Community Hospital
Presenter/Author: Sarah Maryon Hayes, PharmD, BCOP, North Memorial Health Care, Robbinsdale, MN
Background: Rasburicase is a recombinant urate oxidase enzyme approved by the US Food and Drug Administration (FDA) for the treatment of patients with hyperuricemia secondary to tumor lysis syndrome (TLS). Previous 2 retrospective studies have supported the use of 3-mg fixed dosing, as opposed to the FDA-approved dose of 0.15 mg/kg of rasburicase.
Objective: To evaluate the efficacy of using a fixed-dose 3-mg rasburicase in patients with TLS at a North Memorial Health Care community hospital.
Method:In 2018, our community hospital implemented a new policy for patients who are not receiving hematopoietic stem-cell transplant (HSCT). This policy established the use of a 3-mg fixed dose of rasburicase for this patient population after a review of the published literature and a 3-year retrospective analysis of rasburicase use at our institution. Repeated 3-mg doses of rasburicase were considered for patients with uric acid levels of >8 mg/dL, as measured 24 hours after the initial rasburicase administration. Fourteen months after the policy implementation, we evaluated the outcomes of our new policy and compared them with those reported in the literature. We also compared the efficacy of rasburicase therapy and the resolution of TLS laboratory results before and after the policy implementation. Treatment success was defined as repeated uric acid levels of <8 mg/dL (per Cairo-Bishop criteria), measured 24 hours after the administration of rasburicase.
Results: Based on the average pre-policy dose, the estimated cost-savings to our hospital was $47,000 annually. For reference, on average, patients required a serum uric acid reduction of 4.42 mg/dL (standard deviation, 3.0 mg/dL) to reach 7 mg/dL. Before the policy implementation, the average dose of rasburicase was 6.1 mg (range, 3-11.6 mg), with an average uric acid reduction of 7.5 mg/dL per dose (range, 1.7-16.9 mg/dL; N = 42 doses). After the 3-mg flat-dose policy was adopted, we observed an average uric acid reduction of 5.5 mg/dL per dose (range, 1-11.8 mg/dL; N = 30 doses). Before our policy implementation, only 12% of the patients required multiple doses of rasburicase compared with 16% of patients who required more than 1 dose after the policy implementation. Treatment failure occurred in 55% of patients whose initial uric acid level was >12 mg/dL, and only 9% of patients with baseline uric acid <12 mg/dL. These rates were similar to the pre-policy status, when patients were given 6-mg, 7.5-mg, or even larger doses of rasburicase. Our follow-up investigation after the policy implementation showed the efficacy of using fixed-dose 3-mg rasburicase for patients with hyperuricemia related to TLS.
Conclusion: The efficacy of 3-mg flat dosing, in a combination of patients who did or did not have HSCT, has previously been reported in the literature. Here we report the effectiveness of this strategy for patients with TLS for patients with all cancer types, including solid malignancies, in a community setting.
CLINICAL/TRANSACTIONAL TRACK: COMPLETED RESEARCH
The Impact of Pegaspargase Premedication on Hypersensitivity Reactions in Pediatric Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma Patients
Presenters: Jonathan Angus, PharmD, BCOP, Pediatric Hematology/Oncology Clinical Pharmacist, and Sarah Menig, PharmD, BCOP, Pediatric Hematology/Oncology Clinical Pharmacist, Seattle Children’s Hospital
Co-Authors: Sarah Tucker, PharmD, BCOP, Pediatric Hematology/Oncology Clinical Pharmacist, Seattle Children’s Hospital; Kristoffer Martinson, PharmD, Pediatric Hematology/Oncology Clinical Pharmacist, Seattle Children’s Hospital; Kasey Leger, MD, MSc, Assistant Professor of Pediatrics, University of Washington School of Medicine, Seattle
Background: Asparagine depletion with pegaspargase is an essential component of the multi-agent treatment of pediatric acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma. However, hypersensitivity reactions occur in up to 24% of patients. Premedication for asparaginase drugs, in an effort to reduce allergic reactions, is controversial because of concerns for masking reactions indicative of neutralizing antibody formation. Monitoring of serum asparaginase activity (SAA) levels as a surrogate for neutralizing antibody formation allows screening for inactivation or accelerated clearance.
Objectives: The primary objective was to determine if implementation of a standardized premedication protocol reduced the incidence of hypersensitivity reactions to pegaspargase. Secondary objectives included grades of hypersensitivity reactions observed, and the incidence of patients with inadequate SAA levels, defined as SAA levels of <0.1 IU/mL on days 3 to 8 and/or days 10 to 14.
Method: Seattle Children’s Hospital implemented universal pegaspargase premedication with diphenhydramine and hydrocortisone, prolongation of pegaspargase infusion to 2 hours, and serial SAA level monitoring. A retrospective chart review was conducted, including children/adolescents with ALL or lymphoblastic lymphoma who received their second or higher dose of pegaspargase between June 15, 2015, and August 1, 2018. Because the majority of pegaspargase reactions occur with the second or third dose, patients receiving ≥3 doses before the implementation date of December 15, 2016, were included in the pre-intervention group, and those who received dose 1 or 2 after implementation were included in the post-intervention group. Patients who received dose 2 pre- and dose 3 post-intervention were excluded.
Results: Hypersensitivity reactions occurred in 12 of 65 (18.5%) patients pre-intervention and in 16 of 74 (21.6%) post-intervention (P = .64). Overall, 20 of 28 (71.4%) hypersensitivity reactions were classified as grade 3; and 4 of 28 (14.3%) reactions were grade 4. There were no differences in reaction severity pre- and post-intervention. Of 72 patients who had evaluable asparaginase activity levels after at least 1 dose of pegaspargase, 4 (5.6%) patients had an inadequate SAA level; 2 of these were silent inactivation, and 2 patients had hypersensitivity symptoms.
Conclusion: In contrast to Cooper et al, who showed that a reduction in pegaspargase had clinically significant reactions with dual H1 and H2 histamine blockade before pegaspargase, our premedication protocol with diphenhydramine and hydrocortisone did not reduce the incidence of hypersensitivity reactions. Our data suggest that the addition of a corticosteroid to pegaspargase premedication protocols in patients without a history of reaction may not be beneficial. Optimal premedication strategies capable of reducing the incidence of hypersensitivity reactions to pegaspargase should continue to be investigated to preserve this essential treatment modality.
PRACTICE MANAGEMENT TRACK: COMPLETED RESEARCH
Evaluation of an Oncology Transitions-of-Care Pilot Program
Presenter: Rachel S.L. McDevitt, PharmD, BCOP, Clinical Pharmacist Specialist, Ambulatory Oncology, University of Michigan Rogel Cancer Center
Co-Authors: Allison Schepers, PharmD, BCOP, Clinical Pharmacist Specialist, Inpatient Oncology, University of Michigan Rogel Cancer Center; Maya Manning, PharmD Candidate 2021, University of Michigan College of Pharmacy
Background: Transitions-of-care coordination has previously been shown to benefit patient outcomes and enable pharmacists to expand their roles and positively affect patient care.1,2 However, oncology patients are routinely excluded from these programs. Patients with gastrointestinal (GI) malignancies have particularly high hospital admission and readmission rates, making this population an ideal pilot population.3-5
Objective: To create a pharmacist-run transitions-of-care program for oncology patients.
Method: This evaluation was a prospective single-arm study. Enrollment required an admission to the medical oncology service with a diagnosis of upper or lower GI malignancy between March 2019 and May 2019. At patient discharge, the inpatient pharmacist sent a message in the electronic medical record to the outpatient pharmacist with action items for postdischarge. Patients were seen by the outpatient pharmacist in person (preferred) or via telephone after hospital discharge. To evaluate the success of the program, action items sent from the inpatient to outpatient pharmacist, the number and types of outpatient pharmacist interventions, and readmission rates were analyzed.
Results: Over the 3-month pilot period, 29 patients were enrolled in the study. Most patients had 2 unique action items communicated from the inpatient to outpatient pharmacist. The most common action items were related to symptom management, antibiotics, oncologic treatment, and other chronic disease states (ie, diabetes, blood pressure, diet, medication reconciliation). Of the 29 patients enrolled, 15 patients received outpatient pharmacist follow-up and 14 patients did not receive outpatient pharmacist follow-up. The most common reason for not receiving outpatient follow-up was because the patient had been discharged to hospice. Other reasons included language barriers or logistical/scheduling issues. Most patients had outpatient pharmacist follow-up within 1 week of discharge (53%) and in person (67%). The average number of outpatient pharmacist interventions per patient was 2.8 (range, 0-6), and 93% of patients had at least 1 intervention. The most common intervention was medication discontinuation. The 30-day readmission rate for all patients was 20%, which is less than historical data (26%) for patients with GI malignancies.3-5 In this small pilot study, 30-day readmission rate was reduced by 50% for patients who received outpatient pharmacist follow-up compared with patients who did not receive pharmacist follow-up, for logistical reasons (20% vs 40%).
Conclusion: A pharmacist-driven oncology transitions-of-care program was successfully established; the inpatient and outpatient pharmacists communicated effectively, and the program resulted in medication interventions. Next steps would involve expansion to other oncology specialties.
- Bethishou L, Herzik K, Fang N, et al. The impact of the pharmacist on continuity of care during transitions of care: a systematic review. J Am Pharm Assoc (2003). 2020;60:163-177.e2.
- Pedersen CA, Schneider PJ, Scheckelhoff DJ. ASHP national survey of pharmacy practice in hospital settings: monitoring and patient education—2015. Am J Health Syst Pharm. 2016;73:1307-1330.
- Manzano JGM, Gadiraju S, Hiremath A, et al. Unplanned 30-day readmissions in a general internal medicine hospitalist service at a comprehensive cancer center. J Oncol Pract. 2015;11:410-415.
- Brooks GA, Abrams TA, Meyerhardt JA, et al. Identification of potentially avoidable hospitalizations in patients with GI cancer. J Clin Oncol. 2014;32:496-503.
- Numico G, Cristofano A, Mozzicafreddo A, et al. Hospital admission of cancer patients: avoidable practice or necessary care? PLoS One. 2015;10:e0120827.
PRACTICE MANAGEMENT TRACK: COMPLETED RESEARCH
The Role of Pharmacists in Increasing Patient Access to Targeted Therapies
Presenters/Co-Authors: Jennifer Espiritu, PharmD, BCOP, Department of Pharmacy, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA; Francheska Ocasio Serrano, BS, CPhT, Department of Pharmacy, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA
Background: The advent of targeted therapy has revolutionized cancer treatment. Next-generation sequencing has allowed us to identify patient-specific mutations and initiate targeted agents accordingly. A majority of these agents have gained US Food and Drug Administration (FDA) approval in their primary disease states, but off-label coverage outside of those indications is challenging. In addition, expansions of the FDA-approved indications for these agents are increasing at such an accelerated pace that payers are unable to update their coverage policies in a timely manner, causing delays in treatment initiation. A solution is needed to ensure that insurance barriers do not hinder appropriate treatment of patients.
Objectives: The primary objective was to determine if pharmacist involvement in the insurance approval process resulted in increased coverage of medications for indications that were initially or historically denied from coverage. The secondary objective was to examine specific payer rationale for denial of coverage in these instances.
Method: We conducted a retrospective analysis of insurance outcomes between March 2019 and October 2019 at Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA. Patients who had a pharmacist involved in their insurance approval processes were identified through an examination of pharmacy intervention records. Information regarding the patients’ medication, indication, payer type, initial denial reason, appeal methods, and appeal outcome was collected.
Results: A total of 14 patients had a pharmacist involved in their insurance approval processes during the 8-month study period. In 12 (86%) instances, pharmacist assistance was requested for appeals after an initial denial of coverage. For 2 (14%) instances, pharmacist assistance was prospectively requested for off-label claims. A total of 11 (79%) patients had letters of medical necessity written by a pharmacist, 2 (14%) patients had pharmacists provide literature to their payers for coverage reconsideration, and 1 (7%) patient had a pharmacist conduct a peer-to-peer discussion on their physician’s behalf. Of the 12 appeals, 9 (75%) denials were overturned and 3 (25%) denials were upheld. The most common reason for initial insurance denials was absence of a traditional mutation for targeted therapy (5; 42%) followed by unfamiliarity of the current literature (3; 25%); out-of-date coverage policies (2; 17%); and other reasons (2; 17%).
Conclusion: Pharmacists are a valuable asset to help navigate the coverage complexities associated with patient-specific, mutation-driven, targeted therapies. We have a unique combination of clinical expertise and practical reimbursement knowledge that puts us in a prime position to ensure that patients are able to gain access to necessary medications and challenge unreasonable coverage determinations.