Purpose Since 2018, several pegfilgrastim biosimilars were approved, which may affect insurance reimbursement. Guidelines recommend pegfilgrastim be administered the days following chemotherapy to prevent hematopoietic toxicity. To date, only the reference pegfilgrastim product has an available autoinjector-device. This has contributed to logistical issues in administering biosimilar agents per guideline recommendations. Administration on the same day as chemotherapy may be a potential alternative when logistical issues are present. This review will assess current evidence on this practice to inform clinical decisions. Data sources: A comprehensive literature search was performed in PubMed/Medline for studies examining the administration of pegfilgrastim on the same day as chemotherapy. Data summary: Several studies were identified, including a systematic review, retrospective reviews, and insurance claim data. Studies had significant limitations, and chemotherapy regimens and cancer types varied among studies. Studies showed inconsistent results in terms of incidence, duration, and severity of febrile neutropenia. In studies with patients with head and neck, urothelial, gynecologic, gastrointestinal, and prostate cancer, no difference in outcomes was detected or outcomes supported the feasibility of same-day administration. In patients with breast cancer, outcomes were worse with same-day administration. Outcomes were mixed in studies with non-Hodgkin’s lymphoma, non-small cell lung cancer, and various solid tumors. Conclusion Administration of pegfilgrastim on the same day as chemotherapy may be safe and an acceptable alternative, if logistics prohibit a patient from receiving administration the days after chemotherapy. Clinicians should consider patient risk factors and prescribed chemotherapy regimens, along with available evidence when contemplating administration of same-day pegfilgrastim.
Background : Venous thromboembolism (VTE) is a common consequence for patients with malignancy, and adversely impacts quality of life, morbidity and mortality. While historically low-molecular weight heparin (LMWH) was considered standard of care for treatment of cancer-associated thrombosis (CAT), more recent data support the safety and efficacy of direct oral anticoagulants (DOACs). However, management of CAT remains complex, and a national shortage of non-malignant hematologists limits access to thrombosis experts. Our non-malignant hematology group developed a pilot program to expedite referrals for oncology patients with CAT to aid in management and selection of appropriate therapies. Methods: With guidance from the Process Improvement team at Northwestern Medicine, the Cancer-Associated Thrombosis clinic was established in April 2020. Information about the clinic was disseminated via administrative meetings and e-mails from the clinical practice director. Patients were referred from the Robert H. Lurie Comprehensive Cancer Center for either: (1) newly diagnosed ("acute") venous thromboembolic event (VTE) that could be managed in an outpatient setting, or (2) "ongoing management" of an established VTE diagnosis. We aimed to see acute referrals within 24 business hours and ongoing management referrals within 2 weeks. Patients were seen initially by an advanced practice provider, with case discussion with an attending non-malignant hematologist and pharmacist review for anticoagulant eligibility and teaching. Patients were to be scheduled for follow-up with an attending hematologist within 3 months. Decision-making regarding anticoagulant choice was based on perceived bleeding risk, tumor type, drug interactions, and patient preferences. Herein we report our experience during the first year (April 2020-April 2021) of the CAT clinic. Results Sixty-three patients were seen in the first year, of whom 59% were women, with a median age of 63 years (range 30-90 years). 20.6% of patients had a prior history of VTE, and 6.3% had a prior history of bleeding. Tumor types from nine oncology sites were represented, of which gastrointestinal (33.3%); gynecological (22.2%); hematological malignancies (14.2%), and breast (7.9%) were the most common. Among 18 patients (28.5%) referred for acute VTE, the median time to appointment was 0 days, and among 45 patients (71.4%) referred for ongoing VTE management, the median time to appointment was 10 days. The most common VTE was pulmonary embolism (PE) (25.4%), followed by proximal deep vein thrombosis (DVT) (20.6%), concurrent PE and DVT (14.3%) and upper extremity DVT (11.1%). Additionally, 7.9% of thrombotic events involved splanchnic vein and 4.8% cerebral veins (1 isolated, 2 together with DVT and/or PE). DOACs were recommended in 29 (46%) of patients (19 apixaban, 9 rivaroxaban, 1 edoxaban), whereas enoxaparin was advised in 28 patients (44.4%). Four patients were advised to discontinue anticoagulation and 1 was advised to continue warfarin given prior DOAC failure and preference for an oral anticoagulant. Of 28 patients advised to use enoxaparin over a DOAC, the most common reasons included perceived bleeding risk/tumor type (50%), DOAC failure (21.4%), and drug-drug interactions (17.8%). Thirteen patients (21%) switched to a different anticoagulant (7 to a DOAC) in follow-up after the initial recommendation. Thirty-seven patients (59.7%) had a follow-up visit in the CAT clinic. During follow-up, 5 patients (7.9%) experienced recurrent or progressive VTE, and 7 (11.1%) patients had bleeding events. Fifteen patients (24.2%) died during follow-up. Conclusions The aim of this process improvement project was to improve access and assist with anticoagulant choice and management of CAT. Compared to a historical 3 month wait time for non-malignant hematology appointments at our institution, most acute CAT patients were scheduled within 24 hours, and patients requiring ongoing management were seen within 10 days. While DOACs are increasingly prescribed for treatment of CAT, we found that DOACs were not our recommended anticoagulant in over half of patients referred to our clinic, largely due to perceived risk of bleeding/tumor type. This highlights the complexity of management of CAT, and demonstrates the benefit of dedicated thrombosis expertise to aid in management of CAT. Disclosures Martin: Janssen: Research Funding; Penumbra: Other: Scientific Advisory Board. Kalhagen: Harborside: Other: Consulting; Incyte: Speakers Bureau. Zakarija: Bayer: Other: Consultancy Advisory Board. Stein: Pharmassentia: Other: Advisory Board and Steering Committee; Constellation Pharmaceuticals: Other: Advisory Board x 1.
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