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1.
Article in English | MEDLINE | ID: mdl-38845275

ABSTRACT

BACKGROUND: No standard criteria for dose reduction exists for high-dose melphalan for autologous stem cell transplantation (ASCT) for multiple myeloma (MM) due to limited and conflicting evidence. OBJECTIVE: To evaluate efficacy and safety of standard dose (200 mg/m2 = Mel200) versus reduced dose 140 mg/m2 = Mel140) of melphalan in patients with MM undergoing ASCT. DESIGN: A single-center retrospective review of adults with MM for their first ASCT between January 1, 2010, and November 1, 2022, who received Mel200 or Mel140 as conditioning. Primary endpoint was progression-free survival (PFS). Secondary safety and efficacy endpoints included overall survival (OS), incidence of febrile neutropenia and acute kidney injury, and time to engraftment. Subgroup analyses were performed based on patient age and renal function. RESULTS: A total of 322 patients were included in the study, 240 in the Mel200 group and 82 in the Mel140 group. Baseline demographics were similar except patients receiving Mel140 were on average older and had worse kidney function. PFS at 2 years was not different between groups (P = .2335). No difference existed in 2 year PFS or OS for patients < 65 years of age versus ≥ 65 years of age or for patients with CrCl 30-59 mL/min versus CrCl ≥ 60 mL/min within either Mel200 group or Mel140 group (all P > .05). No differences existed between groups across all secondary outcomes. CONCLUSION: Reduced doses melphalan showed no differences in safety or efficacy outcomes versus standard dose even when analyzed based on age and renal function. Larger randomized controlled trials need to be performed to validate these findings.

2.
Am J Pharm Educ ; 88(1): 100599, 2024 Jan.
Article in English | MEDLINE | ID: mdl-37806556

ABSTRACT

OBJECTIVE: To examine the impact of a critical care pharmacy elective (CCPE) on student performance in other courses in the Doctor of Pharmacy curriculum that emphasize clinical reasoning and decision making. METHODS: This is a retrospective, cohort study including all students from the 2019-2021 graduating classes enrolled in required courses, Pharmacotherapy and Integrated Patient Cases (IPCs). Students were divided for comparison based on completion of the CCPE. The primary outcome was outstanding performance, defined by a final course grade ≥90%, in Pharmacotherapy and IPC. Baseline characteristics and outcomes were analyzed using descriptive statistics and the χ2 test or two-sided t test for categorical and continuous variables, respectively. Binary logistic regression models were constructed to identify variables associated with the primary outcome. RESULTS: Of 377 students included, 129 (34%) completed the CCPE. Baseline characteristics were similar between both groups, except more females completed the CCPE. Students that completed the CCPE were not more likely to demonstrate outstanding performance in Pharmacotherapy III (20% vs 30%) or Pharmacotherapy IV (27% vs 24%), but were more likely in IPC (34% vs 23%). In the adjusted analysis, CCPE students were almost twice as likely to exhibit outstanding performance in IPC. CONCLUSION: Students that completed the CCPE were more likely to demonstrate outstanding performance in IPC, but not in either of the Pharmacotherapy courses. Students may benefit from practicing clinical reasoning earlier in the curriculum to build-up to effective and efficient clinical decision-making. Implications of course structure on student performance should be further explored.


Subject(s)
Education, Pharmacy , Pharmacy , Students, Pharmacy , Female , Humans , Cohort Studies , Educational Measurement , Retrospective Studies , Curriculum , Clinical Decision-Making
3.
J Pharm Technol ; 39(4): 191-194, 2023 Aug.
Article in English | MEDLINE | ID: mdl-37529151

ABSTRACT

Background: Recent literature demonstrates support for using methicillin-resistant Staphylococcus aureus (MRSA) nasal swab polymerase chain reaction (NaPCR) screening as an antimicrobial stewardship tool aiding early de-escalation of anti-MRSA antimicrobials. However, immunocompromised patients have been underrepresented in previous studies despite increased risk of morbidity and mortality from multidrug-resistant organisms (MDRO). Objective: The purpose of this study was to determine the negative predictive value (NPV) of the MRSA NaPCR in hospitalized, immunocompromised adult patients with suspected pneumonia. Methods: A single-center, retrospective, observational review was conducted of hospitalized, immunocompromised adult patients that had an MRSA NaPCR obtained between March 1, 2020 and January 10, 2021. For inclusion, bacterial cultures must have been collected within 2 weeks after MRSA NaPCR. The primary outcome was the NPV of MRSA NaPCR in hospitalized, immunocompromised patients with suspected pneumonia. Secondary outcomes include NPV in other infections. Results: Between March 1, 2020 and January 10, 2021, 59 patients with 78 unique cultures, including 28 respiratory cultures, were included in the study. The NPV of the MRSA NaPCR for pneumonia was 91.7%. The NPV for bloodstream infections was 100% and for urinary tract infections was 100%, but interpretation of these results should be cautioned due to the small sample sizes. Conclusion: The NPV of MRSA NaPCR in pneumonia remains high in this study. The MRSA NaPCR has utility as a de-escalation tool in hospitalized, immunocompromised adult patients, but larger studies are warranted to evaluate all immunocompromised patient populations.

4.
J Adv Pract Oncol ; 13(1): 77-85, 2022 Jan.
Article in English | MEDLINE | ID: mdl-35173991

ABSTRACT

Multiple myeloma (MM) is a hematologic malignancy characterized by proliferation of plasma cells with or without production of monoclonal immunoglobulins. Management of patients with MM begins with induction therapy, typically a proteasome inhibitor (PI) with dexamethasone and an immunomodulator (IMID), followed by autologous hematopoietic stem cell transplantation in eligible patients. Although various treatments are available, MM is considered incurable, and patients with progression after multiple treatment lines, including CD38 monoclonal antibodies, have a median overall survival of 8.6 months. Belantamab mafodotin-blmf (Blenrep) is a first-in-class antibody-drug conjugate directed against B-cell maturation antigen (BCMA) that obtained U.S. Food and Drug Administration accelerated approval in August 2020 for patients with multiply relapsed/refractory MM. This article provides information on the mechanism of action, efficacy, safety, monitoring, and current place in therapy for belantamab mafodotin-blmf.

5.
Curr Pharm Teach Learn ; 14(2): 145-152, 2022 02.
Article in English | MEDLINE | ID: mdl-35190155

ABSTRACT

INTRODUCTION: To describe the impact of the SARS-CoV-2 pandemic on teaching, research, practice, and work-life integration for pharmacy faculty at research-intensive institutions. METHODS: An online survey related to transition to remote work, impact on faculty responsibilities, demographics, and other elements was sent to nine research-intensive United States public schools/colleges of pharmacy. Respondents were asked to describe challenges in moving to remote instruction as a result of the pandemic. The 75-item survey asked respondents to rate the degree to which factors were challenging and levels of concern with the abrupt transition. Responses were analyzed using descriptive statistics and comparison of means using paired samples t-tests between spring and fall semesters, for the types of students taught, and for faculty discipline. RESULTS: Surveys were completed by 279 faculty (36% response rate), with 62% self-identifying as pharmacy practice faculty. The highest reported challenges were family/home responsibilities (41%), assisting children with schoolwork (28%), and availability of childcare (22%). Concerns most identified by respondents were increased workload, potential for academic dishonesty, and inability to effectively conduct hands-on activities. Practice faculty encountered barriers using telehealth and delivering virtual experiential education, while both practice and research faculty reported concerns with research progress. CONCLUSIONS: The pandemic has led to substantial challenges and increased workload in many areas. As the pandemic persists, administration should consider reported barriers and concerns to inform expectations. Evaluation of novel instructional design, assessment methods, and best practices in the virtual learning environment is highly encouraged to ensure student competencies are met.


Subject(s)
COVID-19 , Education, Pharmacy , Pharmacy , Child , Education, Pharmacy/methods , Faculty , Humans , Pandemics , SARS-CoV-2 , Schools, Pharmacy , United States
6.
J Oncol Pharm Pract ; 28(3): 542-550, 2022 Apr.
Article in English | MEDLINE | ID: mdl-33663290

ABSTRACT

PURPOSE: To determine the impact of Clostridioides difficile infection (CDI) treatment duration on CDI recurrence in hematology/oncology patients receiving concurrent non-CDI antibiotics. PATIENTS AND METHODS: This multi-site, retrospective study examined hematology/oncology patients age ≥18 years hospitalized with active CDI who received ≥1 dose of concurrent non-CDI antibiotics between September 2013 and June 2019. All patients were classified by two definitions for statistical analysis: standard (10-14 days) versus prolonged (>14 days) duration of CDI treatment and non-extended (≤24 hours after stopping non-CDI antibiotics) versus extended (>24 hours after stopping non-CDI antibiotics) CDI treatment. Primary outcome was CDI recurrence within 180 days of completing CDI treatment. Secondary outcomes included hospital length of stay (LOS) as well as mortality and incidence of vancomycin-resistant enterococcus (VRE) infections at 180 days. RESULTS: Of the 198 patients included, 112 were classified as prolonged versus 86 standard duration and 138 were classified as extended versus 60 non-extended duration. After accounting for demographic differences, no difference existed in the primary outcome of CDI recurrence in either prolonged versus standard or extended versus non-extended analysis (all p > 0.05). Patients who received prolonged versus standard CDI treatment had longer LOS (p < 0.0001) while no difference existed in extended versus non-extended (p > 0.05). No difference in mortality existed in prolonged versus standard (p > 0.05) while those who received extended versus non-extended CDI treatment had significantly lower mortality (p = 0.0008). CONCLUSIONS: Neither prolonging CDI treatment beyond standard duration nor extending duration beyond end of non-CDI antibiotics was associated with decreased CDI recurrence rate.


Subject(s)
Clostridioides difficile , Clostridium Infections , Hematology , Neoplasms , Adolescent , Anti-Bacterial Agents/therapeutic use , Clostridium Infections/drug therapy , Duration of Therapy , Humans , Neoplasms/drug therapy , Retrospective Studies
7.
Diagn Microbiol Infect Dis ; 101(2): 115444, 2021 Oct.
Article in English | MEDLINE | ID: mdl-34186321

ABSTRACT

Benefit of follow-up blood cultures (FUBC) in cancer patients with gram-negative bacteremia (GNB) is unknown. Multicenter, retrospective review was performed in adult cancer patients with GNB between January and December 2018. Primary outcome was FUBC incidence. Chi-square, t-tests/Wilcoxon rank-sum, and bivariate regression (logistic/Poisson) analyses compared secondary outcomes (catheter removal, ID consultation, antibiotic duration, length stay, mortality) between patients with versus without FUBC. Of 52 patients with GNB, majority (35/52; 67%) received ≥1 FUBC (mean per patient 3.6, SD 4.3, range 0-29). Majority FUBC had no growth (157/173; 90.8%). Rates of catheter removal and ID consultation were similar between groups (P > 0.05). Patients with FUBC had greater LOS (mean 21 vs 15 days; coefficient = 0.31, CI 0.17-0.45), longer duration of antibiotics (mean 13 vs 11 days, coefficient 0.19, P = 0.013), but no mortality difference (P = 1). FUBC are frequently performed yet infrequently positive in cancer patients with GNB, but were associated with increased LOS and antibiotic duration.


Subject(s)
Bacteremia/diagnosis , Blood Culture/statistics & numerical data , Gram-Negative Bacterial Infections/diagnosis , Neoplasms/epidemiology , Adult , Aged , Aged, 80 and over , Anti-Bacterial Agents/therapeutic use , Bacteremia/drug therapy , Bacteremia/epidemiology , Female , Follow-Up Studies , Gram-Negative Bacteria/isolation & purification , Gram-Negative Bacterial Infections/drug therapy , Gram-Negative Bacterial Infections/epidemiology , Humans , Incidence , Length of Stay , Male , Middle Aged , Retrospective Studies , Young Adult
8.
Support Care Cancer ; 29(3): 1527-1534, 2021 Mar.
Article in English | MEDLINE | ID: mdl-32725375

ABSTRACT

PURPOSE: High-dose methotrexate (HD-MTX) requires urine alkalinization to pH ≥ 7 for adequate excretion to prevent toxicity. Due to shortages of IV sodium bicarbonate (IV-NaHCO3), few reports have demonstrated utility of oral bicarbonate (PO-NaHCO3); however, the addition of acetazolamide (Acet) has not been well described. Our study compares outcomes between alkalinization methods of IV-NaHCO3 monotherapy versus IV-NaHCO2 + Acet and PO-NaHCO3 + Acet. METHODS: A single-center, IRB exempt, retrospective review was conducted from Jan 2016 to Sept 2019 of adults receiving HD-MTX ≥ 500 mg/m2. The primary outcome was time from start of alkalinization to pH ≥ 7. Secondary outcomes included time from start of alkalinization to initiation of HD-MTX, time to MTX clearance, length of stay (LOS), percentage of urine pH assessments < 7, and incidence of MTX toxicity. Statistical analysis was performed using SAS9.4 with alpha 0.05. RESULTS: Overall demographics (n = 196 HD-MTX cycles for 55 patients) include a mean age 55 years, HD-MTX dose ~ 5400 mg/m2, and 69% with a diagnosis of lymphoma. Adjusting for baseline demographic differences among groups, median time from first dose alkalinization to pH ≥ 7 and to start of HD-MTX was longer for those receiving IV-NaHCO3 (n = 41) vs either IV-NaHCO3 + Acet (n = 70) or PO-NaHCO3 + Acet (n = 76) (p = 0.0001). HD-MTX clearance to a level < 0.1 µmol/L was not improved with the addition of Acet. No difference existed among groups for pH results < 7, LOS, or incidence of MTX toxicity (p > 0.05). CONCLUSIONS: Addition of Acet to NaHCO3 reduces time to pH ≥ 7 and initiation of HD-MTX but does not appear to improve LOS, MTX toxicities, or time to MTX clearance.


Subject(s)
Acetazolamide/therapeutic use , Bicarbonates/therapeutic use , Methotrexate/therapeutic use , Sodium Bicarbonate/therapeutic use , Urine/chemistry , Acetazolamide/pharmacology , Administration, Intravenous , Administration, Oral , Bicarbonates/pharmacology , Female , Humans , Male , Methotrexate/pharmacology , Middle Aged , Retrospective Studies , Sodium Bicarbonate/pharmacology
9.
J Adv Pract Oncol ; 12(8): 810-832, 2021 Nov.
Article in English | MEDLINE | ID: mdl-35295545

ABSTRACT

Chemotherapeutic agents and radiation therapy are associated with numerous potential adverse events (AEs). Many of these common AEs, namely chemotherapy- or radiation-induced nausea and vomiting, hypersensitivity reactions, and edema, can lead to deleterious outcomes (such as treatment nonadherence or cessation, or poor clinical outcomes) if not prevented appropriately. The occurrence and severity of these AEs can be prevented with the correct prescribing of prophylactic medications, often called "premedications." The advanced practitioner in hematology/oncology should have a good understanding of which chemotherapeutic agents are known to place patients at risk for these adverse events as well as be able to determine appropriate prophylactic medications to employ in the prevention of these adverse events. While several guidelines and literature exist regarding best practices for prophylaxis strategies, differences among guidelines and quality of data should be explored in order to accurately implement patient-specific recommendations. Herein, we review the existing literature for prophylaxis and summarize best practices.

11.
Hosp Pharm ; 55(1): 64-68, 2020 Feb.
Article in English | MEDLINE | ID: mdl-31983769

ABSTRACT

Introduction: Due to the renal handling mechanism of magnesium, prolonging the time for infusion of intravenous (IV) magnesium has been postulated to decrease magnesium requirements; however, a paucity of clinical evidence exists to support prolonging infusion rates. Objective: To assess if there is a difference in magnesium replacement required in the medicine population at an academic medical center when prolonged infusion rates (0.5 g/h) are compared to short infusion rates of > 0.5 g/h. Methods: A retrospective chart review was performed before and after implementation of the hypomagnesemia protocol (November 2015). Patients who received at least one dose of IV magnesium during hospitalization were selected from general medicine units. Primary aim was to determine if a difference exists in percent of days IV magnesium repletion required between patients receiving prolonged versus short infusion rates. Secondary objectives were to determine if a difference exists in total grams of magnesium received, percent of days magnesium levels were maintained in the optimal (1.4-2.7) and desired (2-2.7) therapeutic ranges, and incidence of hypomagnesemia (< 1.4 g/dL) and hypermagnesemia (> 2.7 g/dL). For safety, incidence of hypotension (systolic blood pressure < 90/60 mm Hg) during the magnesium infusion was recorded. Results: Totally, 45 patients were included in each cohort for a total of 90 patients to meet power. No differences existed between protocol groups for any demographic variables (all P > .05). Median infusion rate for the short infusion cohort was 1.8 g/h (range 1-2 g/h). Percent of days IV magnesium was replaced was 34.8% versus 37.8% (P = .39) in the short and prolonged infusion groups, respectively. No difference existed between groups for secondary outcomes (all P > .05). Conclusion: Prolonged magnesium infusion rates did not decrease magnesium replacement requirements. These results have been used to propose revision of our current magnesium infusion protocol to reduce infusion length.

12.
Pharmacy (Basel) ; 8(1)2020 Jan 02.
Article in English | MEDLINE | ID: mdl-31906486

ABSTRACT

Recently, the required training and credentials for as well as the various roles of the hematopoietic cell transplant (HCT) pharmacist have been endorsed by the leading organizations in cellular therapy, the American Society of Transplant and Cellular Therapy and the European Society of Blood and Bone Marrow Transplantation. While these documents establish the roles a HCT pharmacist can fulfill within the multi-disciplinary team, few reports have evaluated the impact of the HCT pharmacist on clinical, financial, or quality outcomes. Further, a paucity of information has been reported on types of practice models, such as the use of collaborative practice agreements, or described effective methods to overcome the barriers to the increased utilization of HCT pharmacists. Herein, a brief summary of available information is provided to aid readers in understanding the state of the science for pharmacists practicing in this specialty with the goal to stimulate further research to justify the roles of HCT pharmacists and the correlation of such research to various outcome measures. Practitioners are encouraged to build upon this existing knowledge to create the novel integration and elevation of pharmacy practice to improve outcomes for patients, providers, and payors.

13.
J Oncol Pharm Pract ; 26(3): 647-654, 2020 Apr.
Article in English | MEDLINE | ID: mdl-31474214

ABSTRACT

OBJECTIVES: The emergence of immune checkpoint inhibitors has transformed treatment paradigms for various malignancies. Patients with cancer are at increased risk of complications and hospitalizations from influenza; therefore, it is recommended that they receive inactivated influenza vaccination. However, efficacy and safety of inactivated influenza vaccination in patients receiving immune checkpoint inhibitors is uncertain. The objective of this prospective case series was to evaluate the incidence of immune-mediated adverse events (imAEs) following inactivated influenza vaccination in patients receiving immune checkpoint inhibitors. Changes in cytokine and chemokine levels were also evaluated. METHODS: Patients receiving immune checkpoint inhibitors during the 2017-2018 influenza season were eligible for study participation. Peripheral blood samples were collected prior to administration of inactivated influenza vaccine and two post-vaccination time points. Evaluation of new or worsening imAEs occurred via patient questionnaire and review of medical records for 60 days following inactivated influenza vaccination. Baseline imAEs were evaluated from review of medical records for 60 days prior to inactivated influenza vaccination. Serum cytokines and chemokines were measured using a multiplex Luminex assay. RESULTS: Twenty-four patients were enrolled in this study. Seven patients experienced any grade imAE (one patient having 2) within 60 days following inactivated influenza vaccination. The majority were Grades 1-2, including rash (n = 3), hypothyroidism, myalgia, and colitis (n = 1 each). Two patients experienced severe imAEs (grade 3 nephritis and grade 4 diabetes). No significant changes (p > 0.05) in serum cytokine or chemokine concentrations were observed. CONCLUSIONS: Although small, our study suggests that inactivated influenza vaccine may be safely administered to patients receiving immune checkpoint inhibitors. The majority of imAEs following inactivated influenza vaccination were Grades 1-2 and did not require changes in immune checkpoint inhibitor therapy.


Subject(s)
Influenza Vaccines/adverse effects , Neoplasms/immunology , Programmed Cell Death 1 Receptor/antagonists & inhibitors , Vaccination/adverse effects , Adult , Aged , Aged, 80 and over , Cytokines/blood , Female , Humans , Male , Middle Aged , Neoplasms/drug therapy , Prospective Studies
14.
J Oncol Pharm Pract ; 25(2): 326-332, 2019 Mar.
Article in English | MEDLINE | ID: mdl-29059026

ABSTRACT

BACKGROUND: Patients immediately post-hematopoietic cell transplantation are at high risk for bacteremia. Judicious prophylactic antimicrobial utilization must balance anticipated benefits (reduction infections) versus risk (bacterial resistance, Clostridium difficile) . OBJECTIVE: To compare infectious outcomes (primary: incidence bacteremia; secondary: febrile neutropenia, C. difficile, susceptibility of bacteremia, time to discharge and 30-day mortality) between hematopoietic cell transplantation who received fluoroquinolone prophylaxis to those who did not. METHODS: A local institutional review board-approved retrospective study was conducted on all hematopoietic cell transplantation patients ( n = 171) comparing those who received fluoroquinolone prophylaxis ( n = 105) to those who did not ( n = 66). Data included infectious outcomes and mortality for the first 30 days post-hematopoietic cell transplantation. Chi-squared was performed for categorical variables (GraphPad Software Inc., 2015). Secondary analysis compared outcomes within autologous and allogeneic sub-groups. RESULTS: Bacteremia was significantly lower for the overall cohort receiving fluoroquinolone (median duration eight days) versus those without fluoroquinolone (15.2% vs. 31.8%; P < 0.01). No difference was seen in C. difficile infection ( P = 0.81) or 30-day mortality (2.9% vs. 4.5%; P = 0.67). In the autologous sub-group ( n = 115), bacteremia was significantly lower in the fluoroquinolone cohort (8.5% vs. 27.3%; P = 0.0069), while no differences were seen in C. difficile infection ( P = 1) or 30-day mortality ( P = 1). In the allogeneic sub-group ( n = 56), there was no difference between those with and without fluoroquinolone in bacteremia (29.4% vs. 40.9%; P = 0.4) or C. difficile ( P = 0.72); however, there was a trend toward improved 30-day mortality (2.9% vs. 9.1%; P = 0.55). CONCLUSIONS: Fluoroquinolone prophylaxis reduces incidence of bacteremia in autologous hematopoietic cell transplantation without increasing C. difficile after hematopoietic cell transplantation.


Subject(s)
Anti-Bacterial Agents/therapeutic use , Bacteremia/prevention & control , Fluoroquinolones/therapeutic use , Hematopoietic Stem Cell Transplantation/adverse effects , Postoperative Complications/prevention & control , Adolescent , Adult , Aged , Bacteremia/mortality , Female , Humans , Male , Middle Aged , Postoperative Complications/mortality , Retrospective Studies , Transplantation, Autologous , Young Adult
15.
J Adv Pract Oncol ; 10(7): 730-735, 2019.
Article in English | MEDLINE | ID: mdl-33391856

ABSTRACT

Cytomegalovirus (CMV) is a double-stranded DNA virus that infects (seropositive on screening) more than half of adults by age 40. However, reactivation of detectable viral load (CMV reactivation) typically occurs only in immunocompromised patients. Notably, CMV reactivation after allogeneic hematopoietic cell transplant (HCT) can increase treatment-related mortality almost 2-fold compared to patients who do not have reactivation. Historically, prevention of CMV reactivation mainly included the preemptive strategy of serial monitoring of viral load and initiating an antiviral once the viral load became elevated in an effort to prevent end-organ disease. The major limitations of the antiviral agents utilized in preemptive therapy are myelosuppression and renal toxicity. In 2017, a first-in-class viral terminase complex subunit inhibitor, letermovir, became the only U.S. Food & Drug Administration-approved medication to prevent CMV reactivation after allogeneic HCT (e.g., as prophylaxis). In a phase III trial, patients who were randomized to letermovir prophylactically had decreased rates of CMV viremia leading to preemptive therapy. The purpose of this article is to describe the need for safe and effective medication to prevent CMV reactivation, the clinical efficacy of letermovir, and the impact oncology advanced practitioners can play in reducing CMV reactivation in patients undergoing allogeneic HCT.

16.
Biol Blood Marrow Transplant ; 24(10): 2065-2071, 2018 10.
Article in English | MEDLINE | ID: mdl-29906570

ABSTRACT

Evidence supports olanzapine for prophylaxis of chemotherapy-induced nausea/vomiting (CINV) for highly emetogenic chemotherapy; however, most studies focus on solid malignancies and single-day regimens. A randomized, double-blinded, placebo-controlled trial was conducted to compare the addition of olanzapine to triplet therapy (fosaprepitant, ondansetron, dexamethasone [FOND-O]) versus triplet therapy alone (FOND) in preventing CINV in hematology patients receiving single-day and multiple-day highly emetogenic chemotherapy and hematopoietic cell transplant (HCT) regimens (NCT02635984). The primary objective of this study was to compare complete response (CR; no emesis and minimal nausea, <25 mm on a 100-mm visual analog scale) during the overall assessment period (chemotherapy days plus 5 days after). Secondary objectives were the number of emesis, number of rescue medications, percent achieving minimal nausea, and percent achieving complete protection (CP; no emesis, rescue antiemetic, or significant nausea), all of which are reported as acute (chemotherapy days), delayed (5 days after chemotherapy), and overall phases. Olanzapine 10 mg or matching placebo were given on each chemotherapy day and 3 days after. Adults with hematologic malignancy receiving HCT regimens of melphalan, BEAM (carmustine, etoposide, cytarabine, melphalan), busulfan (Bu)/cyclophosphamide (Cy), Bu/fludarabine (Flu), Bu/melphalan, FluCy, FluCy-total body irradiation (TBI), etoposide-TBI, and ICE (ifosfamide, carboplatin, etoposide) or 7+3 chemotherapy regimens were included. An estimated 98 patients were required using alpha = .05 and 80% power. No significant differences existed in baseline characteristics between FOND-O (n = 51) and FOND (n = 50) arms. Mean duration of olanzapine was 7.7 days (range, 4 to 11). Discontinuation for possible adverse events occurred in 3 placebo and 0 olanzapine patients. CR was significantly higher for FOND-O in overall (55% versus 26%, P = .003) and delayed (60.8% versus 30%, P = .001) but not acute (P = .13) phases. Significantly more patients receiving FOND-O achieved no more than minimal nausea in overall (P = .001) and delayed phases (P = .0002), as well as fewer overall mean emesis counts (P = .005). CP rates were not different in any assessment phase (P ≥ .05 each). Within the HCT subgroup (n = 64), the CR, CP, and no significant nausea rates were significantly better for FONDO-O in overall and delayed phases (all P < .05). Analysis within the HCT subgroup revealed significant improvement in outcomes in delayed and overall phases with FOND-O in the autologous but not allogeneic cohort. Addition of olanzapine to an NK-1-based triplet antiemetic regimen significantly improved clinically relevant outcomes in the HCT population.


Subject(s)
Antiemetics/administration & dosage , Antineoplastic Combined Chemotherapy Protocols , Hematologic Neoplasms/therapy , Hematopoietic Stem Cell Transplantation , Induction Chemotherapy , Morpholines/administration & dosage , Nausea/drug therapy , Olanzapine/administration & dosage , Ondansetron/administration & dosage , Vomiting/drug therapy , Adult , Aged , Antineoplastic Combined Chemotherapy Protocols/administration & dosage , Antineoplastic Combined Chemotherapy Protocols/adverse effects , Carmustine/administration & dosage , Carmustine/adverse effects , Cytarabine/administration & dosage , Cytarabine/adverse effects , Female , Humans , Male , Melphalan/administration & dosage , Melphalan/adverse effects , Middle Aged , Nausea/chemically induced , Podophyllotoxin/administration & dosage , Podophyllotoxin/adverse effects , Vomiting/congenital
17.
Support Care Cancer ; 26(8): 2809-2814, 2018 Aug.
Article in English | MEDLINE | ID: mdl-29508140

ABSTRACT

PURPOSE: Hematopoietic cell transplant (HCT) recipients often require intravenous (IV) magnesium repletion due to poor dietary intake, gastrointestinal loss, and use of concomitant magnesium wasting medications. Prolonging the IV magnesium infusion rate has been postulated to reduce renal clearance and improve retention; however, limited evidence supports this hypothesis. METHODS: We reviewed autologous and allogeneic HCT recipients (n = 82) who received IV magnesium at our institution between 2014 and 2016: 41 patients received IV magnesium at a prolonged rate of 0.5 g/h and 41 patients at > 0.5 g/h (mean 2.07 g/h). Primary outcome was percent of days in which magnesium levels were in desired therapeutic range (2-2.7 mg/dL) during hospitalization. RESULTS: Baseline characteristics were similar between cohorts: no difference existed between groups in incidence of gastrointestinal graft-versus-host disease or the percentage of patients who received magnesium replacement in maintenance fluids, received concomitant oral magnesium supplementation, or received parenteral nutrition. Percent of days in desired therapeutic range was not different between groups (p = 0.3). No difference existed between groups with respect to total amount of IV magnesium repletion (22.5 vs. 21.4 g, p = 0.81) or number of days of IV replacement (7.2 vs. 6.2 days, p = 0.41). In terms of safety, there was no difference between groups with respect to incidence of hypomagnesemia or hypermagnesemia (p = 0.43 each). CONCLUSIONS: Overall, prolonging the infusion rate did not correlate with improved magnesium retention based on amount and frequency of magnesium repletion or attainment of goal levels in HCT patients.


Subject(s)
Hematopoietic Stem Cell Transplantation/methods , Infusion Pumps/standards , Magnesium Sulfate/therapeutic use , Transplantation Conditioning/methods , Female , Humans , Infusions, Intravenous , Magnesium Sulfate/administration & dosage , Magnesium Sulfate/pharmacology , Male , Middle Aged
18.
Biol Blood Marrow Transplant ; 24(4): 820-826, 2018 04.
Article in English | MEDLINE | ID: mdl-29292056

ABSTRACT

Empiric antimicrobials are frequently utilized in the pre-engraftment phase after hematopoietic cell transplantation (HCT). Recent evidence suggests an increased risk of acute kidney injury (AKI) from combination of vancomycin with piperacillin/tazobactam; however, this has not specifically been evaluated in the HCT population. A single-center, retrospective review was conducted from 2011 to 2017 on 110 autologous and 60 allogeneic HCT patients with the primary objective of comparing incidence of AKI for those who received vancomycin with piperacillin/tazobactam versus vancomycin with cefepime in the pre-engraftment phase. Demographics and outcomes were compared for all patients who received vancomycin with piperacillin/tazobactam versus vancomycin with cefepime as well as within the autologous and allogeneic subgroups. The primary endpoint of incidence of AKI, defined as increase in serum creatinine by .3 mg/dL or >50% from baseline (whichever was larger), was significantly higher for those who received vancomycin with piperacillin/tazobactam versus cefepime for the overall cohort (68% versus 27%; P < .001) resulting in an odds ratio (OR) of 5.16 (95% confidence interval [CI], 2.5 to 10.5) when adjusting for hypotension. Results were similar within the autologous (59% versus 22%; P < .001; OR, 4.63; 95% CI, 1.85 to 11.6) and allogeneic (79% versus 39%; P= .0021; OR, 5.41; 95% CI, 1.60 to 18.3) subgroups. Within the overall cohort between those who received vancomycin with piperacillin/tazobactam versus cefepime the time to onset of AKI was more commonly within 48 hours of concomitant antimicrobial use (53% versus 26%; P= .012), whereas resolution of AKI by discharge date was not different (39% versus 26%; P= .23). No difference in percentage of patients requiring at least 1 session of dialysis, duration of hospital stay, or 30-day mortality was found between overall cohorts. Further studies of HCT patients are warranted to fully elucidate the risk of various combination antimicrobial regimens on renal outcomes.


Subject(s)
Acute Kidney Injury , Cefepime/adverse effects , Hematopoietic Stem Cell Transplantation , Piperacillin, Tazobactam Drug Combination/adverse effects , Vancomycin/adverse effects , Acute Kidney Injury/etiology , Acute Kidney Injury/mortality , Acute Kidney Injury/therapy , Adolescent , Adult , Aged , Allografts , Autografts , Cefepime/administration & dosage , Disease-Free Survival , Female , Humans , Male , Middle Aged , Piperacillin, Tazobactam Drug Combination/administration & dosage , Retrospective Studies , Survival Rate , Vancomycin/administration & dosage
19.
Biol Blood Marrow Transplant ; 24(5): 914-922, 2018 05.
Article in English | MEDLINE | ID: mdl-29292057

ABSTRACT

Pharmacists are increasingly recognized as an essential member of the multidisciplinary team for hematopoietic cell transplant (HCT) patients. However, until recently, their educational background, required training, and potential roles have not been well described. Therefore, the purpose of this manuscript is to provide supporting evidence for the HCT Clinical Pharmacist Role Description, which has been endorsed by several organizations including the American Society for Blood and Marrow Transplantation. This document provides justification for the various roles pharmacists fulfill with respect to medication management, transitions of care, patient and provider education, policy development, quality improvement, and research. Furthermore, evidence supporting the value, financially and otherwise, HCT pharmacists provide is reviewed. Pharmacists in the HCT setting are encouraged to report on novel practice models and potential impact of their services to increase awareness and utilization of HCT pharmacists.


Subject(s)
Hematopoietic Stem Cell Transplantation , Pharmacists/standards , Education, Pharmacy , Humans , Professional Role , United States
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