Single-center, retrospective evaluation of safety and efficacy of direct oral anticoagulants versus low-molecular-weight heparin and vitamin K antagonist in patients with cancer.

INTRODUCTION: The safety and efficacy of direct oral anticoagulants in cancer patients is currently unclear. Low-molecular-weight heparin remains the standard of care for cancer patients with venous thromboembolism, with warfarin, a vitamin K antagonist, as an alternative. Clear recommendations do not exist for patients with both active cancer and non-valvular atrial fibrillation. The objectives of this study were to report safety and efficacy outcomes of direct oral anticoagulants, low-molecular-weight heparin, and vitamin K antagonist in cancer patients with venous thromboembolism or non-valvular atrial fibrillation. METHODS: Retrospective chart review of adult cancer patients from 2012 to 2015 who received an antineoplastic agent and an anticoagulant. RESULTS: A total of 258 patients were reviewed: 80 patients in direct oral anticoagulant group, 95 patients in low-molecular-weight heparin group, and 83 patients in vitamin K antagonist group. Sixty-seven percent of patients were on an anticoagulant for acute or chronic venous thromboembolism. Major bleeding events were similar across the groups (15% direct oral anticoagulant vs 17% low-molecular-weight heparin vs 18% vitamin K antagonist). The most common type of major bleeding event was gastrointestinal bleeding. A total of five fatal bleeding events occurred. Venous thromboembolism recurrence rates were higher in both direct oral anticoagulant (18%) and low-molecular-weight heparin (12%) groups while lower in vitamin K antagonist group (10%) compared to previous studies. CONCLUSIONS: Cancer patients receiving direct oral anticoagulants, low-molecular-weight heparin, or vitamin K antagonist had similar rates of major bleeding events, with gastrointestinal bleeding being the most common event. Venous thromboembolism recurrence rates were higher in direct oral anticoagulant and low-molecular-weight heparin groups than prior studies. Randomized trials are warranted to establish clear safety and efficacy in this population.

Use of a pharmacy protocol to convert standard rituximab infusions to rapid infusion shortens outpatient infusion clinic visits.

STUDY OBJECTIVE: To evaluate the impact of a pharmacy protocol that converts standard rituximab infusions to a rapid 90-minute infusion on the duration of outpatient infusion center clinic visits. DESIGN: Prospective interventional study. SETTING: Outpatient infusion clinic at an academic medical center. PATIENTS: Sixty-four adults who received at least one rituximab infusion that was eligible for conversion to rapid infusion between August 2010 and July 2011 and who did not receive concurrent chemotherapy or colony-stimulating agents during the same clinic visit. Of the 64 patients, 37 received the rapid infusion (intervention cohort); 27 received the nonrapid infusion (control cohort). INTERVENTION: Using a hospital-approved protocol, pharmacists converted rituximab infusions that met eligibility criteria (noninitial rituximab infusion, rituximab given in the previous 90 days, age 18 yrs or older, dose 375 mg/m(2) or less per infusion, dose 1000 mg or less per infusion, and no history of a grade 3 or higher reaction) to a rapid 90-minute infusion. MEASUREMENTS AND MAIN RESULTS: The durations of rituximab infusion time and clinic visit time were evaluated and compared between the intervention cohort and the control cohort. Use of the pharmacy protocol to convert standard rituximab infusion to rapid rituximab infusion reduced infusion time by 110.5 minutes/infusion (median 94.5 min [interquartile range (IQR) 90-105 min] for rapid infusion vs 205 min [IQR 138-263 min] for nonrapid infusion; p<0.001) and reduced clinic visit time by 92 minutes/outpatient encounter (median 233 min [IQR 208-277] min for rapid infusion vs 325 min [IQR 275-415 min] for nonrapid infusion; p<0.001). This resulted in a reduction of the duration of outpatient clinic visits by an estimated 255-299 hours in 1 year. CONCLUSION: Use of a pharmacist protocol that converted standard rituximab infusions to a rapid 90-minute infusion decreased the duration of outpatient infusion clinic visits for rituximab infusion.

Treatment given near the end of life in castration-resistant prostate cancer.

Chemotherapy treatment options are limited for patients with castration-resistant prostate cancer (CRPC). The purpose of this study is to report treatment use and adverse effects (AEs) within the last three months of life in patients with CRPC. Of the 88 patients identified, 32% received treatment within 3 months of death, and documented AEs occurred in 25% of patients. Of those, neutropenia (18.3%), nausea/vomiting (18.3%), and febrile neutropenia (13.6%) were the most frequent. Results of this study show high treatment utility towards the end-of-life in patients with CRPC, with one fourth of patients experiencing AEs. Attention to health-related quality of life becomes increasingly important as new treatments appear to have small impact on survival, and AEs of those treatments may significantly impact patient quality of life.

Incidence of myelodysplastic syndromes in patients receiving concurrent myelosuppressive chemotherapy and pegfilgrastim.

BACKGROUND: The World Health Organization classifies myelodysplastic syndromes (MDS) as a group of hematologic malignancies where at least one myeloid lineage contains ≥10% cells with myelodysplasia. Therapy-related MDS (t-MDS) may result from treatment with myelosuppressive chemotherapy and/or radiation. Myeloid growth factors, such as pegfilgrastim, have also been investigated as a possible risk factor for development of t-MDS. National guidelines and myeloid growth factor prescribing information recommend administering myeloid growth factors after a minimum of 24 h following myelosuppressive chemotherapy. Some evidence suggests that administering myeloid growth factors and myelosuppressive chemotherapy concurrently may increase the risk of developing t-MDS. OBJECTIVE: To evaluate the incidence of t-MDS in patients who received pegfilgrastim and chemotherapy on the same day compared to patients receiving pegfilgrastim at least 1 day following completion of their chemotherapy. METHODS: A retrospective chart review was performed to identify all patients who received myelosuppressive chemotherapy and pegfilgrastim on the same day between January 2003 and December 2007. Any initial diagnosis of t-MDS was clinically confirmed. RESULTS: A total of 227 patients received myelosuppressive chemotherapy and pegfilgrastim on the same day. Median time to follow-up was 3.47 years (IQR 1.15). Two patients had a confirmed diagnosis of t-MDS. The incidence of t-MDS in patients receiving concurrent myelosuppressive chemotherapy and pegfilgrastim in our study population is 0.88%. CONCLUSION: Administering pegfilgrastim at least 1 day after myelosuppressive chemotherapy may help reduce the risk of t-MDS, but more studies with longer follow-up are needed to confirm this finding.

Chemotherapy given near the end of life by community oncologists for advanced non-small cell lung cancer.

PURPOSE: To characterize the chemotherapy given near the end of life to advanced non-small cell lung cancer (NSCLC) patients treated in the community oncology setting using a medical records database. METHODS: We conducted a retrospective chart review of expired advanced (stage IIIb/IV) NSCLC patients treated with chemotherapy. Patients who initiated chemotherapy in 2000-2003 were eligible. Patient demographics, all chemotherapy including dose and schedule, and disease-related events were collected. RESULTS: We report data from 10 community practices including 417 patients treated for advanced NSCLC in 2000-2003. The mean age was 67 years (median, 62 years) and 54% were male. Forty percent of patients were >69 years of age and 35% had an Eastern Cooperative Oncology Group performance status score of > or =2. First-line chemotherapy included combination therapy in 84% of patients. Second-line therapy was given to 56% of patients. Twenty-six percent of patients received third-line therapy, while 10% received fourth-line therapy and 5% received fifth-line therapy or greater. Patients received a mean of 6.1 cycles of chemotherapy. For patients receiving chemotherapy at the time of death, the mean line of therapy being given was second line. Chemotherapy was given within 1 month and 2 weeks of death to 43% and 20% of patients, respectively. CONCLUSION: The availability of new chemotherapeutic agents has caused a subsequent increase in the length of time patients are receiving chemotherapy with advanced NSCLC. This would suggest an increased use of chemotherapy near the end of life, which was identified in this study.