Benzodiazepines vs barbiturates for alcohol withdrawal: Analysis of 3 different treatment protocols.

INTRODUCTION: Alcohol withdrawal treatment varies widely. Benzodiazepines are the standard of care, with rapid onset and long durations of action. Recent drug shortages involving IV benzodiazepines have required incorporation of alternative agents into treatment protocols. Phenobarbital has similar pharmacokinetics to select benzodiazepines frequently used for alcohol withdrawal. The objective of this study is to describe the effectiveness and safety of our institutional protocols during three time periods utilizing benzodiazepines and barbiturates for the acute treatment of alcohol withdrawal in the emergency department. METHODS: Adult patients presenting to the ED for acute alcohol withdrawal from April 1st, 2016 to January 31st, 2018 were reviewed. Patients who received at least one dose of treatment were included. Treatments were based on availability of medication and given protocol at time of presentation. The primary outcome was the rate of ICU admission. RESULTS: 300 patient encounters were included. Overall baseline characteristics were equal across groups, except for age. There was no difference in rate of ICU admission from the ED between groups (D:8, L&P:11, P:13 patients, p = 0.99). Rate of mechanical ventilation was no different across all groups (D:1, L&P:3, P:3 patients, p = 0.55). CONCLUSION: During benzodiazepine shortages, phenobarbital is a safe and effective treatment alternative for alcohol withdrawal. Incorporating phenobarbital into a benzodiazepine based protocol or as sole agent led to similar rates of ICU admission, length of stay, and need for mechanical ventilation in patients treated for alcohol withdrawal in the emergency department.

Risk Factors Associated with Unplanned Hospital Readmissions in Adults with Cancer.

PURPOSE/OBJECTIVES: To identify risk factors associated with 30-day unplanned hospital readmissions in adults with cancer. DESIGN: Case-control study. SETTING: A teaching hospital in an urban center in the Mid-Atlantic region of the United States. SAMPLE: 302 adults with solid tumors. METHODS: The Conceptual Model of Re-Hospitalization was used as a theoretic framework. Univariate logistic regression and multivariate logistic regression were conducted to identify risk factors for hospital readmission. MAIN RESEARCH VARIABLES: Risk factors included patient, clinical, hospitalization, and discharge-planning characteristics. FINDINGS: From November 2011 to November 2012, 29% of patients were readmitted within 30 days after discharge, and a higher percentage of those readmissions occurred within the first week of discharge. Several predictors for hospital readmission were identified in the univariate logistic analysis, but the most relevant in the final multivariate logistic model were moderate to high risk for falls and advanced stage disease (metastatic). CONCLUSIONS: Hospital readmission is an indicator of quality care. Learning about risk factors allows opportunities to prevent hospital readmission by identifying those at high risk and implementing optimal discharge-planning systems and early referrals to palliative care. IMPLICATIONS FOR NURSING: Oncology nurses are best positioned to develop strategic plans aimed at improving discharge planning and transitions of care that will decrease unplanned hospital readmissions.

Gender disparities in leadership and scholarly productivity of academic hospitalists.

BACKGROUND: Gender disparities still exist for women in academic medicine but may be less evident in younger cohorts. Hospital medicine is a new field, and the majority of hospitalists are <41 years of age. OBJECTIVE: To determine whether gender disparities exist in leadership and scholarly productivity for academic hospitalists and to compare the findings to academic general internists. DESIGN: Prospective and retrospective observational study. SETTING: University programs in the United States. MEASUREMENTS: Gender distribution of (1) academic hospitalists and general internists, (2) division or section heads for both specialties, (3) speakers at the 2 major national meetings of the 2 specialties, and (4) first and last authors of articles from the specialties' 2 major journals RESULTS: We found equal gender representation of hospitalists and general internists who worked in university hospitals. Divisions or sections of hospital medicine and general internal medicine were led by women at 11/69 (16%) and 28/80 (35%) of university hospitals, respectively (P = 0.008). Women hospitalists and general internists were listed as speakers on 146/557 (26%) and 291/580 (50%) of the presentations at national meetings, respectively (P < 0.0001), first authors on 153/464 (33%) and 423/895 (47%) publications, respectively (P < 0.0001), and senior authors on 63/305 (21%) and 265/769 (34%) articles, respectively (P < 0.0001). CONCLUSIONS: Despite hospital medicine being a newer field, gender disparities exist in leadership and scholarly productivity.

Accomplishing much in a short time: use of a rapid improvement event to redesign the assessment and treatment of patients with alcohol withdrawal.

The use of Lean tools for quality improvement and process refinement is gaining acceptance in many health care institutions. Traditionally, these tools are used to apply incremental changes to established processes in order to reduce waste and improve quality. In this article, the authors describe a novel Lean methodology, the Rapid Improvement Event (RIE), used in a unique way to develop a new treatment protocol for a specific medical condition: alcohol withdrawal. The RIE allowed for the collaboration of a multidisciplinary group of providers invested in the success of a new protocol for alcohol withdrawal that spans areas from the emergency department to the inpatient ward at an inner-city safety net hospital. It also allowed for the definition of measures for its success once it is implemented.

A phase II study of capecitabine, oxaliplatin, and cetuximab with or without bevacizumab as frontline therapy for metastatic colorectal cancer. A Fox Chase extramural research study.

OBJECTIVES: Dual inhibition of vascular endothelial growth factor (VEGF) and epidermal growth factor receptor (EGFR) demonstrated initial promise in clinical trials. This phase II study tested the efficacy and safety of capecitabine, oxaliplatin, and cetuximab with or without bevacizumab as first-line treatment for metastatic colorectal cancer patients. METHODS: Patients were randomized to receive capecitabine 850 mg/m2 PO twice daily for 14 days, oxaliplatin 130 mg/ m2 IV day 1, and cetuximab 400 mg/m2 IV loading dose followed by 250 mg/m2 IV days 1, 8, and 15 with (arm A) or without (Arm B) bevacizumab 7.5 mg/kg IV day 1 every 21 days. Tumor samples were collected and retrospectively analyzed for KRAS mutation status. The primary endpoint was response rate, with time to progression (TTP) and overall survival (OS) as secondary objectives. RESULTS: Twenty-three patients (12 in arm A, 11 in arm B) were enrolled onto the study. Median follow-up was 25.9 months. Both treatments were well tolerated, with expected higher rates of grade 1/2 hypertension and bleeding in arm A. The overall response rate was 54% (36.4% in arm A and 72.7% in arm B). Median time to progression was 8.7 months in arm A and 14.4 months in arm B. The median survival was 18.0 months in arm A and 42.5 months in arm B. The study was prematurely terminated after other studies reported inferior outcomes with dual antibody therapy. CONCLUSIONS: Although terminated early, the study supports the detrimental effect of combining VEGF and EGFR inhibition in metastatic colorectal cancer.

Phase II multicenter trial of albumin-bound paclitaxel and capecitabine in first-line treatment of patients with metastatic breast cancer.

BACKGROUND: Capecitabine, a tumor-activated oral fluoropyrimidine, and albumin-bound paclitaxel (ab-paclitaxel) have substantial single-agent activity in patients with metastatic breast cancer (MBC). Taxane and antimetabolite doublets have improved efficacy compared with single agents. This phase II open-label trial was designed to test the safety and efficacy of capecitabine and ab-paclitaxel in previously untreated MBC. PATIENTS AND METHODS: Patients received capecitabine (825 mg/m(2) orally twice daily, approximately 12 hours apart, on days 1 to 15) and ab-paclitaxel (125 mg/m(2) intravenously on days 1 and 8 of each cycle with no premedication) every 3 weeks. The primary endpoint was overall objective response rate (ORR), with evaluation performed after every 2 cycles. Entry criteria included measurable MBC, human epidermal growth factor receptor 2 (HER2) negativity, Eastern Cooperative Oncology Group (ECOG) performance status 0-2, no previous chemotherapy for metastatic disease, and > 6 months since adjuvant fluoropyrimidine or paclitaxel treatment. RESULTS: Fifty patients received at least 1 dose of study drug, with 46 patients evaluable for efficacy evaluation. Three hundred seventy-four cycles of therapy were delivered. Eighty percent of patients completed 8 cycles. The ORR was 61% (complete response [CR], 4%; partial response [PR], 57%), and 7 patients had sustained (≥ 24 weeks) stable disease for a clinical benefit rate of 76.1%. The median progression-free survival (PFS) was 10.6 months, and the median overall survival was 19.9 months. The most common adverse events (AEs) that were ≥ grade 3 were pain, hand-foot syndrome, and neutropenia. CONCLUSION: The combination of weekly ab-paclitaxel plus daily capecitabine orally at these doses and scheduling was well tolerated and showed substantial efficacy.

An interdisciplinary approach to manage cancer cachexia.

Cancer cachexia occurs in about 33% of newly diagnosed patients with cancer and may lead to delayed, missed, or decreased treatments. An interdisciplinary team approach to manage cancer cachexia may result in fewer missed treatments and improved outcomes. The palliative care program of an urban community cancer center developed an interdisciplinary clinic to treat cancer cachexia with the goal of using an interdisciplinary approach to improve symptom management, nutrition, function, and quality of life (QOL) for patients with cancer at high risk for malnutrition. The Cancer Appetite and Rehabilitation Clinic team completes medical, nutritional, speech, swallowing, and physical therapy evaluations and then develops an individualized program directed to meet patients' needs and improve overall QOL. Patient outcomes are measured by symptom management and nutritional and functional parameters. Early intervention and aggressive symptom management may improve performance status and overall QOL. Results from this project will be used to expand this innovative program. The process of developing and implementing this clinic may help oncology nurses and other healthcare professionals to improve management of cancer cachexia and overall cancer care.

Esthesioneuroblastoma (Olfactory Neuroblastoma) with Ectopic ACTH Syndrome: a multidisciplinary case presentation from the Joan Karnell cancer center of Pennsylvania Hospital.

The case of a patient with recurrent esthesioneuroblastoma complicated by ectopic adrenocorticotropic hormone production is presented, including the workup and management of this uncommon complication of an uncommon disease.

Drug-induced hematologic syndromes.

Objective. Drugs can induce almost the entire spectrum of hematologic disorders, affecting white cells, red cells, platelets, and the coagulation system. This paper aims to emphasize the broad range of drug-induced hematological syndromes and to highlight some of the newer drugs and syndromes. Methods. Medline literature on drug-induced hematologic syndromes was reviewed. Most reports and reviews focus on individual drugs or cytopenias. Results. Drug-induced syndromes include hemolytic anemias, methemoglobinemia, red cell aplasia, sideroblastic anemia, megaloblastic anemia, polycythemia, aplastic anemia, leukocytosis, neutropenia, eosinophilia, immune thrombocytopenia, microangiopathic syndromes, hypercoagulability, hypoprothrombinemia, circulating anticoagulants, myelodysplasia, and acute leukemia. Some of the classic drugs known to cause hematologic abnormalities have been replaced by newer drugs, including biologics, accompanied by their own syndromes and unintended side effects. Conclusions. Drugs can induce toxicities spanning many hematologic syndromes, mediated by a variety of mechanisms. Physicians need to be alert to the potential for iatrogenic drug-induced hematologic complications.

Phase II study of paclitaxel, carboplatin, and cetuximab as first line treatment, for patients with advanced non-small cell lung cancer (NSCLC): results of OPN-017.

BACKGROUND: Cetuximab has demonstrated synergy with taxanes in preclinical models; as well as single agent activity. We assessed the activity of cetuximab with carboplatin and paclitaxel given on a 4-week schedule, in advanced, chemo-naive non-small cell lung cancer. PATIENTS AND METHODS: This phase II, single arm, multi-institution study featured standard dosage of cetuximab 400 mg/m day 1, then 250 mg/m with paclitaxel (100 mg/m/wk, for 3 weeks), and carboplatin (area under curve = 6) day 1 of each 28 day cycle. After 4 to 6 cycles, in the absence of disease progression or excess toxicity, cetuximab was continued weekly. Primary end point was response rate. RESULTS: Fifty-three patients (median age 63, 51% male) participated. Response rate was 57% (3 complete response and 27 partial response). At a median follow-up of 12.5 months, the estimated overall survival is 13.8 months (95% CI: 9.08-16.02) with an event-free survival rate of 5.53 months (95% CI: 4.77-7.99), 18.9% remain free from progression at 1 year. Improved survival was associated with female gender, absence of prior radiation, PS 0 and epidermal growth factor receptor expression. Toxicities included rash (28% grade 3), nail changes (3.7% grade 3), hypomagnesemia (7.5% grade 3 and 3.7% grade 4), and neutropenia (25% grade 3 and 13% grade 4) in addition to other typical side effects anticipated with paclitaxel/carboplatin. There were no grade 5 toxicities. CONCLUSION: Combination of cetuximab/paclitaxel/carboplatin in non-small cell lung cancer was well tolerated and clinically active with manageable toxicities. This unique schedule, integrating weekly paclitaxel and cetuximab has not yet been tested in a randomized trial.

Promising survival in patients with recurrent non-small cell lung cancer treated with docetaxel and gemcitabine in combination as second-line therapy.

INTRODUCTION: Lung cancer is the leading cause of cancer death in men and women, and current second-line chemotherapy regimens yield relatively poor response and survival rates. HYPOTHESIS: We hypothesized that the combination of weekly docetaxel (D) and gemcitabine (G) would show activity in the second-line setting. We therefore conducted a phase II trial evaluating this regimen in patients with relapsed or progressive non-small cell lung cancer (NSCLC) after first-line platinum-based therapy. METHODS: Patients with recurrent NSCLC, adequate physiologic indices, and exposure to one prior platinum-based regimen were eligible. Docetaxel 40 mg/m intravenous (IV) and gemcitabine (G) 800 mg/m IV weekly were administered on day 1 and 8 every 21 days. In the absence of dose-limiting toxicity, G was escalated on an intrapatient basis to 1 g/m/wk. The primary endpoint was response rate (RR); event-free (EFS) and overall survival were secondary endpoints. RESULTS: Thirty-five patients (median age 61 years; 20 [57%] male) were accrued. Most (88%) had previously received carboplatin/paclitaxel, 31.4% in combination with a third investigational agent, more than half (57.1%) had prior radiation. The median number of cycles was four. RR was 23%. Median EFS was 5.7 months and median overall survival was 12.5 months. Patients who had their cancer diagnosed more than or equal to 12 months before entering the trial had superior EFS (13.7 months versus 4.8 months). Toxicity was acceptable. There were no treatment-related deaths. CONCLUSIONS: A nonplatinum doublet with GD is feasible and effective in the treatment of recurrent, platinum-exposed NSCLC patients. RR and survival are promising.

Treating one of our own.

As a group, oncology nurses are aging, mirroring a large portion of the American public. Many practicing nurses are approaching middle age, and with increased age comes an increased risk for cancer. Many oncology nurses are cancer survivors, and the experience of treating a colleague is becoming more common, but few publications have addressed this topic. Pennsylvania Oncology Hematology Associates (POHA), a private medical oncology practice in Philadelphia, has encountered such a situation. This article captures the experience of one oncology nurse who underwent chemotherapy treatment for breast cancer at her place of employment. She discusses her cancer, chemotherapy treatments, and new level of understanding with patients. Her colleagues also share their reactions to witnessing the survivorship process. The nursing team at POHA has been inspired and humbled by the experience, and patient care has been enhanced. The courage of one individual's journey has demonstrated how a negative situation can be transformed into a positive one.

On how increasing numbers of newer cancer therapies further delay referral to hospice: the increasing palliative care imperative.

Delay in referral of cancer patients to hospice until very near the end of life may deny patients and families optimal palliative care. A variety of factors may contribute to these delays. This article describes how the proliferation of newer anticancer therapies, although desirable overall, may further increase these delays. It is important for hospice personnel to understand these changes in medical oncology and to work to optimize palliative care delivery concomitantly with disease-remitting therapies.

Single-arm, open label study of pemetrexed plus cisplatin in chemotherapy naïve patients with malignant pleural mesothelioma: outcomes of an expanded access program.

BACKGROUND: An expanded access program (EAP) provided patient access to pemetrexed prior to its commercial availability. The current report consists of US patients in the EAP who had chemotherapy naïve pleural mesothelioma. METHODS: Eligible patients had a histologic or cytologic diagnosis of malignant mesothelioma that was not amenable to curative treatment with surgery. Study treatment consisted of pemetrexed 500mg/m(2) in combination with cisplatin 75mg/m(2) once every 21 days. Vitamin B12, folic acid, and dexamethasone were administered as prophylaxis. Serious adverse events (SAEs) were reported by investigators and compiled in a pharmacovigilance database for all patients enrolled in the EAP. RESULTS: Of 1056 patients receiving at least one dose of pemetrexed in the EAP, 728 had chemotherapy naïve pleural mesothelioma. Median age of this group was 70 years (range 23-89 years) and 84% were male. Among 615 patients, overall response rate was 20.5%, including 12 complete responses (2.0%) and 114 partial responses (18.5%). An additional 290 patients (47.2%) had stable disease. Median survival for all 728 patients was 10.8 months (95% CI=9.8, 12.3; 60.3% censorship) and 1 year survival was 45.4%. The most commonly reported SAEs in the overall EAP irrespective of causality were dehydration (7.2%), nausea (5.2%), vomiting (4.9%), dyspnea (3.8%), and pulmonary embolism (2.4%). CONCLUSIONS: In this large cohort, 67.7% of patients treated with first-line chemotherapy experienced a response or stable disease. Survival time and toxicity from this EAP were promising for this difficult-to-treat disease.