Evaluation of Extended-Release Oxycodone Administered through Enteral Tubes for the Management of Pain in Patients with Head and Neck Cancer: A Case Series.

An abuse-deterrent, microsphere-in-capsule extended-release formulation of oxycodone myristate (Xtampza® ER, Collegium Pharmaceutical Inc, Canton, Massachusetts), was approved by the FDA in 2016 for the management of pain. The advantage of this formulation of oxycodone is that the microspheres can be administered via enteral tubes without compromising the long-acting formulation. This case series characterizes the experiences of five head and neck cancer patients initiated on oxycodone myristate through enteral tube administration for control of cancer-related pain. The primary outcome of patient reported subjective improvement in pain within one week occurred in all five patients. The median time to pain control was 4 days. The safety profile of oxycodone myristate was consistent with the package insert with no new findings reported. Oxycodone myristate can be an appropriate long-acting opioid analgesic option for patients requiring enteral tube administration of medications to achieve adequate cancer-related pain control.

Biotin-induced thyroid stimulating hormone aberrations in the setting of immunotherapy.

INTRODUCTION: Immune checkpoint inhibitors are associated with immune-mediated thyroid disease and other endocrinopathies. Biotin is an over-the-counter supplement known to interfere with lab assays, including thyroid function tests. Biotin-induced complications with lab monitoring during immunotherapy have not been previously reported. CASE REPORT: We present a case of a 68-year old woman with hypothyroidism after initiating immune checkpoint blockade therapy and abnormal laboratory monitoring values while concurrently taking biotin supplements.Management & outcome: The patient was initiated on levothyroxine with subsequent dose increases over a period of weeks with resolution of symptoms and normalization of free thyroxine levels. Thyroid stimulating hormone (TSH) levels appeared to remain elevated until biotin supplements were held and levels normalized. DISCUSSION: The purpose of this report is to provide the first known incidence of biotin complicating the routine monitoring of immune checkpoint inhibitors with elevated TSH levels and to alert providers to elicit accurate medication histories regarding over-the-counter supplements.

Evaluation of pharmacist interventions in a head and neck medical oncology clinic.

INTRODUCTION: Head and neck cancers (HNC) are a complex and heterogeneous group of cancers, often necessitating a multidisciplinary approach across the care continuum. Oncology pharmacists are uniquely qualified to play a vital role on a multidisciplinary team and provide specialized care to optimize medication therapy. METHODS: This was a retrospective chart review evaluating the role of a board-certified oncology pharmacist in the head and neck oncology clinic at an academic, comprehensive cancer center from April 2017 through March 2018. The primary objective of the study was to describe the types of interventions made by the oncology pharmacists. Secondary objectives included quantifying time spent on patient education and number of prescriptions sent to pharmacies. RESULTS: The pharmacist had 873 encounters with 151 patients, resulting in 2080 interventions. Approximately 57% of the interventions were performed in the clinic. Patient education (58%), facilitation of new prescriptions or refill requests (49.9%), and supportive care management (32.6%) were the most frequent interventions. The oncology pharmacist spent 154.1 h on patient education and sent 811 prescriptions to pharmacies, with 63.6% of prescriptions sent to the institution's cancer center pharmacy. CONCLUSION: The incorporation of an oncology pharmacist in the HNC team optimized patient care through comprehensive and timely interventions across the care continuum. Our study is the first to highlight the vital role oncology pharmacists have in improving the overall quality of care of HNC patients. Future directions include exploring the impact of oncology pharmacist interventions on select Quality Oncology Practice Initiative measures by the American Society of Clinical Oncology.

Cost-effectiveness Analysis of Nivolumab for Treatment of Platinum-Resistant Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck.

Background: The CheckMate 141 trial found that nivolumab improved survival for patients with recurrent or metastatic head and neck cancer (HNC). Despite the improved survival, nivolumab is much more expensive than standard therapies. This study assesses the cost-effectiveness of nivolumab for the treatment of HNC. Methods: We constructed a Markov model to simulate treatment with nivolumab or standard single-agent therapy for patients with recurrent or metastatic platinum-refractory HNC. Transition probabilities, including disease progression, survival, and probability of toxicity, were derived from clinical trial data, while costs (in 2017 US dollars) and health utilities were estimated from the literature. Incremental cost-effectiveness ratios (ICERs), expressed as dollar per quality-adjusted life-year (QALY), were calculated, with values of less than $100 000/QALY considered cost-effective from a health care payer perspective. We conducted one-way and probabilistic sensitivity analyses to assess model uncertainty. Results: Our base case model found that treatment with nivolumab increased overall cost by $117 800 and improved effectiveness by 0.400 QALYs compared with standard therapy, leading to an ICER of $294 400/QALY. The model was most sensitive to the cost of nivolumab, though nivolumab only became cost-effective if the cost per cycle decreased from $13 432 to $3931. The model was not particularly sensitive to assumptions about survival. If one assumed that all patients alive at the end of the CheckMate 141 trial were cured of their disease, nivolumab was still not cost-effective (ICER $244 600/QALY). Conclusion: While nivolumab improves overall survival, at its current cost it would not be considered a cost-effective treatment option for patients with HNC.

A retrospective review of the frequency and nature of acute hypersensitivity reactions at a medium-sized infusion center: comparison to reported values and inconsistencies found in literature.

PURPOSE: To evaluate acute hypersensitivity reactions at the UCSD Moores Cancer Center in San Diego, compare our findings to those reported previously in the literature, and examine the effectiveness of the objective grading scale as represented by the Common Terminology Criteria for Adverse Events (CTCAE). PATIENTS AND METHODS: Using the available pharmacy and electronic medical record data from 2006-2010, we examined our reported hypersensitivity reactions (HSRs) using the CTCAE v.3.0 and v.4.0. A thorough literature review was also performed to compare our findings with those previously reported. RESULTS: We found 222 cases of HSRs, of which 50% were due to immunotherapeutics. Most were grade 1 or 2 by any CTCAE criteria. The clinical presentation of HSRs varied between drug classes. Using different versions of grading schema led to inconsistencies in ~50% of all HSRs. Fifty-two percent of all cases not due to blood products were rechallenged on the same day. The reported literature HSR frequencies for each causative agent showed a striking variability, possibly indicating that previous studies used a wide variety of grading and reporting systems for adverse events. CONCLUSION: HSRs are common in clinical practice, and most are mild or moderate. There are inconsistencies in reporting HSRs between studies. The existence of several grading schema and subjective definitions of hypersensitivity could be contributing to poor clinical generalizability. Along with an improved system of reporting HSRs to minimize underreporting, a standard system of objectively assessing HSRs is necessary for purposes of research and clinical practice.