Search

Objective: To review the pharmacology, pharmacokinetics, efficacy, safety, dosing, and administration of mogamulizumab for the treatment of T-cell lymphomas. Data Sources: A literature search of PubMed (1966 to September 2019) was conducted using the keywords mogamulizumab, KW-0761, and lymphoma. Data were also obtained from package inserts and meeting abstracts. Study Selection and Data Extraction: All relevant published articles, package inserts, and unpublished meeting abstracts on mogamulizumab for the treatment of T-cell lymphomas were reviewed. Data Synthesis: Mogamulizumab is an anti-CC chemokine receptor 4 (CCR4) monoclonal antibody that has demonstrated activity in various T-cell lymphomas. It was approved by the US Food and Drug Administration (FDA) for the treatment of adult patients with relapsed or refractory mycosis fungoides (MF) or Sézary syndrome (SS) who have been treated with at least 1 prior line of therapy. Mogamulizumab demonstrated significant improvement in progression-free survival compared with vorinostat in patients with relapsed or refractory MF or SS. Serious adverse events associated with mogamulizumab include infusion-related reactions, cutaneous drug eruption, and autoimmune complications. Mogamulizumab administration in the preallogeneic hematopoietic stem cell transplant setting can increase the risk for severe posttransplant graft-versus-host disease. Relevance to Patient Care and Clinical Practice: Mogamulizumab is a first-in-class CCR4 inhibitor, providing a new option in the treatment of relapsed or refractory cutaneous T-cell lymphomas. Although not currently FDA approved for this indication, mogamulizumab may have some utility for the treatment of relapsed adult T-cell leukemia/lymphoma. Conclusion: The recent approval of mogamulizumab represents an important addition to the armamentarium of pharmacotherapies for T-cell lymphomas.

Objectives: Pegfilgrastim is a granulocyte colony-stimulating factor (G-CSF) used as primary prophylaxis in patients receiving myelosuppressive chemotherapy regimens that have greater than 20% risk of developing febrile neutropenia (FN). Historically, pegfilgrastim has been administered 24 to 72 hours after chemotherapy, necessitating a return to clinic to receive the provider-administered injection. An alternative option is the pegfilgrastim on-body injector (OBI). With the OBI device, patients have their pegfilgrastim administered 27 hours after receiving chemotherapy while remaining at home, avoiding an additional clinic appointment. Concerns with pegfilgrastim OBI include lack of experience with the device in both the patient and provider, device-related failures, and the success of delivery. This study evaluates pegfilgrastim OBI failure rates through associated patient outcomes among cancer patients receiving chemotherapy requiring G-CSF. Methods: A retrospective electronic chart review was conducted of adult patients with cancer who received chemotherapy and pegfilgrastim OBI from July 1, 2016, to July 31, 2018. The primary objective of this study was the incidence of FN in patients receiving pegfilgrastim OBI. Results: There were no reported cases of hospitalization due to FN in patients who received pegfilgrastim OBI. Dose delays and dosage modifications were not observed in our review. The OBI device failure rate was found to be low (1.92%). Conclusion: The low device failure rate from this study suggests that the OBI is a viable option for administration of pegfilgrastim in patients receiving chemotherapy requiring G-CSF.

Training in environmental health (EH) engages and inspires youth to tackle health promotion and policy change. Yet, there is little guidance on how to successfully nurture and sustain youth engagement. This paper compares four case studies of youth engagement to promote EH in rural and urban communities using the Youth Empowerment Solutions (YES!) framework. Of the case studies in rural (Central Appalachia) and urban (Cincinnati, Ohio) communities, two employ citizen science approaches using PhotoVoice and environmental sampling, one engages youth in a science communication camp, and one focuses on policy advocacy. We compare and contrast these case studies using the YES! Critical Components and Empowerment levels. The case studies were discussed at the 2020 Partnerships in Environmental Public Health Meeting, where participants identified challenges and possible solutions for promoting and maintaining authentic youth engagement in EH research and advocacy. Analysis of the case studies indicated that youth engagement activities focusing on the individual were more common than those targeting the organizational setting or the community. Youth demonstrate agency to impact EH issues in their communities by engaging in hands-on opportunities to practice citizen science and advocacy. Overcoming challenges to authentic young engagement is important to sustain this work.

Introduction Ado-trastuzumab emtansine (T-DM1) is an antibody-drug conjugate indicated for the treatment of HER2-positive breast cancer. The 2012 American Society of Clinical Oncology guidelines on chemotherapy dosing in obesity recommend using full weight-based cytotoxic chemotherapy doses to treat obese patients with cancer. These guidelines were published prior to the advent of anticancer antibody-drug conjugates. There is a need to investigate the safety of T-DM1 in obese patients. Methods This retrospective chart review included adult patients with breast cancer receiving T-DM1. The primary endpoint was a composite of the incidence of T-DM1 treatment modifications secondary to an adverse event. Secondary outcomes included the incidence of dose reductions, dose delays, treatment discontinuations, and adverse events. Results A total of 119 patients with HER2-positive breast cancer who received T-DM1 therapy were included in this study: 44 obese patients and 75 non-obese patients. The composite outcome of treatment modifications due to toxicity was significantly higher in obese patients compared to non-obese patients (45% vs 25%, p = 0.024). Treatment delays were significantly higher in obese patients (36% vs 16%, p = 0.011). All-grade adverse events with a higher incidence in obese patients included left ventricular ejection fraction decrease (11% vs 5%), bilirubin increase (32% vs 12%), thrombocytopenia (61% vs 55%), and peripheral neuropathy (34% vs 27%). Conclusions This study suggests obese patients receiving T-DM1 may require more treatment modifications secondary to adverse events compared to non-obese patients. Larger studies are needed to determine if obese patients are at higher risk for specific T-DM1-induced adverse events.

Background: Trastuzumab emtansine (T-DM1) is an anti-HER2 antibody-drug conjugate indicated for the treatment of HER2-positive breast cancer. One of the most severe adverse events reported with T-DM1 is hepatotoxicity. The objective of our meta-analysis is to investigate the risk of hepatic adverse events in patients with breast cancer receiving T-DM1 compared with controls. Methods: We conducted a systematic review and meta-analysis of randomized clinical trials (RCTs) comparing T-DM1 with a control treatment in patients with HER2-positive breast cancer. Phase II/III RCTs with available event number or event rate of hepatic toxicity with an assessable sample size were included. Relative risk (RR) and corresponding 95% confidence intervals (CI) for all grade and high-grade (grade 3/4) aspartate aminotransferase (AST) and alanine aminotransferase (ALT) elevations were calculated. Results: Seven RCTs were deemed eligible and were included in the meta-analysis. The RR for all-grade AST and ALT elevations were 3.24 (95% CI 2.16–4.86; p < 0.00001) and 2.90 (95% CI 1.98–4.23; p < 0.00001), respectively. The RR for high-grade AST and ALT elevations were 2.73 (95% CI 1.07–6.93; p = 0.03) and 2.17 (95% CI 1.34–3.50; p = 0.002), respectively. Conclusions: Our meta-analysis demonstrates that T-DM1-based therapy is associated with an increased risk of AST and ALT elevations.

Bing-Neel syndrome is a rare complication of Waldenström macroglobulinemia, characterized by infiltration of lymphoplasmacytic cells to the central nervous system. Multiple treatment modalities exist including purine analogs, bendamustine, high-dose methotrexate, or high-dose cytarabine. Of interest, ibrutinib, a Bruton tyrosine kinase inhibitor has also displayed efficacy in Bing-Neel syndrome. Current literature is limited for the treatment of Bing-Neel syndrome considering its rarity, and while ibrutinib is indicated for the treatment of Waldenström macroglobulinemia, it is utilized off-label for treatment of Bing-Neel syndrome. Additionally, debate exists regarding the recommended dosing strategy for ibrutinib for this indication with disease remission demonstrated at 560 mg and 420 mg. We present a case report that provides additional evidence for this debate with a patient who received 560 mg of ibrutinib initially and maintained disease control despite a dose reduction to 420 mg for tolerability. Ultimately, more data are needed to develop standardized Bing-Neel syndrome treatment strategies with specific consideration to the use of ibrutinib in this condition.

IntroductionSeveral regimens for treating hematologic malignancies are given inpatient due to multiple factors. Many clinicians are evaluating methods to deliver traditionally inpatient regimens in the outpatient setting to increase patient satisfaction, improve access to therapy, and reduce costs. A regimen traditionally administered inpatient, dexamethasone, cytarabine, and cisplatin (DHAP) is a common and effective salvage regimen for relapsed/refractory non-Hodgkin’s lymphoma. DHAX, which substitutes oxaliplatin for cisplatin, has been identified as a reasonable alternative to DHAP and offers the potential for tolerable administration in the outpatient setting as well.Case descriptionA 74-year-old patient with double hit relapsed/refractory diffuse large B cell lymphoma was given rituximab, dexamethasone, high-dose cytarabine, and oxaliplatin (R-DHAX) in our outpatient clinic; however, this regimen is traditionally administered in the inpatient setting. Our main obstacle being cytarabine doses traditionally given 12 h apart. The outpatient regimen given to our patient was rituximab and oxaliplatin on day 1, cytarabine dose one late afternoon on day 2, cytarabine dose two early morning on day 3, and dexamethasone on days 1–4. Doses of oxaliplatin and cytarabine were reduced due to thrombocytopenia experienced with Cycle 1. He did not experience any increased toxicities or complications associated with the regimen moving forward.DiscussionThis illustrates a unique administration of R-DHAX in an infusion center that operates during typical outpatient clinic hours. Both DHAP and DHAX, with or without rituximab, administered in the outpatient setting may be options to consider in relapsed/refractory non-Hodgkin’s lymphoma.

Aims To identify predictors affecting total hospital length of stay(TLOS) and receiving lower limb prosthesis of amputees after surgery in a Singapore tertiary hospital. Materials and Methods A retrospective study of 96 patients was undertaken with various levels of lower limb amputation admitted to Singapore General Hospital (SGH) from January 2009 to December 2014. Patients were divided into two groups: 40-59 and 60 to 80 years old. We correlate clinical variables with TLOS and receiving prosthesis at 6 months from surgery. Results For the cohort of age 40-59, presence of IHD (B=22.4), wound infection (B=17.8) and those needing inpatient rehabilitation(B=36.8) correlate to increased TLOS. Premorbid independence (B=28.6) and presence of care-giver (B=23.3) led to a reduction of TLOS. For successful receiving of prosthesis at 6months from surgery, diabetes (B=0.69) and CRF (B=0.31)were negative predictors. In the older cohort, presence of care-giver (B=18.6) predicted shorter TLOS whereas those needing inpatient rehabilitation contributed to longer TLOS(B=25.61). Those who needed for inpatient rehabilitation had statistically signifi cant higher chance of receiving prosthesis later(B=0.53). Conclusion IHD, wound infection and need for inpatient rehabilitation, premorbid independence and care-giver availability are important predictors of TLOS. For receiving of prosthesis at 6months, predictors include needing inpatient rehabilitation, diabetes and CRF.

Residents in rural Kentucky (KY) and suburban Ohio (OH) expressed concerns about radon exposure and lung cancer. Although 85% of lung cancer cases are caused by tobacco smoke, radon exposure accounts for 10&ndash, 15% of lung cancer cases. Academic and community members from the University of KY and the University of Cincinnati developed and pilot-tested a family-centered, youth-engaged home radon testing toolkit. The radon toolkit included radon information, and how to test, interpret, and report back findings. We educated youth as citizen scientists and their teachers in human subjects protection and home radon testing using the toolkit in the classroom. Youth citizen scientists explained the study to their parents and obtained informed consent. One hundred students were trained in human subjects protection, 27 had parental permission to be citizen scientists, and 18 homeowners completed surveys. Radon values ranged from &lt, 14.8 Bq/m3 to 277.5 Bq/m3. Youth were interested and engaged in citizen science and this family-centered, school-based project provided a unique opportunity to further the healthy housing and quality education components of the Sustainable Development Goals for 2030. Further research is needed to test the impact of student-led, family-centered citizen science projects in environmental health as part of school curricula.

Objectives Pancreatic cancer is a lethal disease mostly affecting elderly people. Clinical trials on treatment contain disproportionately fewer elderly patients compared with everyday practice. This retrospective study evaluates differences in the rates of chemotherapy delivered and associated survival in different age groups. Methods Data were collected from the Cancer Information Resource Files on patients diagnosed with pancreatic cancer from 1993 to 2008. Patients were divided into 3 age groups, namely, A with younger than 50 years, B with 50 to 70 years old, and C with older than 70 years. Results Complete data were available on 16,694 patients. Forty-four percent were in group C. Results Chemotherapy was given to 38% of patients in group C versus 69% of patients in group A. A multivariate analysis revealed a similar chemotherapy benefit in all groups, as follows: group C (hazard ratio [HR], 0.51), group A (HR, 0.74), and group B (HR, 0.55). Conclusions We found that elderly patients with pancreatic cancer receive treatment less frequently compared with younger patients. However, elderly patients receiving chemotherapy derive similar benefits. Randomized clinical trials are needed to evaluate pancreatic cancer treatment in the elderly patients, particularly given the increasing occurrence of pancreatic cancer in later life.

Purpose Biological contamination of insulin pens in a hospital setting was studied. Methods This prospective study, conducted at two hospitals within a multihospital system, examined 125 insulin pens that had been returned to the inpatient pharmacies after patient discharge and were refrigerated for up to 48 hours before laboratory testing. Insulin was removed from the 125 pens and examined microscopically for the presence of nucleated cells and red blood cells (RBCs). Positive samples were examined by a pathologist to determine the cell types present. An immunochromatographic assay was used to determine the presence of free hemoglobin in the insulin. The 10 control samples were negative on microscopic examination. Results Out of 125 insulin pens, 7 (5.6%) tested positive for cells or hemoglobin. Microscopic examination revealed six positive samples containing a total of nine cells, including macrophages, squamous cells, and an RBC. The sample containing the RBC was not the same sample that tested positive for hemoglobin. Based on findings of intact cells and hemoglobin in insulin pens after administration, the potential exists for transmission of infectious agents from patient to patient if a single pen cartridge is used to administer insulin to multiple patients, even if a new needle is used for each individual. Conclusion Examination of 125 insulin pens used in hospitals revealed hemoglobin in 1 pen and at least one cell in another 6 pens. The nine detected cells consisted of four squamous epithelial cells, four macrophages, and one RBC.

1525 Background: Impact of race on prognosis of colon cancer (CCa) is controversial and the potential reasons for that are not clearly understood. We analyzed data from Cancer Information Reference...