Summaries of Safety Labeling Changes Approved by the FDA: Boxed Warnings Highlights October - December 2016.

The FDA's MedWatch program safety labeling changes for boxed warnings are compiled quarterly for drugs and therapeutic biologics where important changes have been made to the safety information. Search of Drug Safety Labeling Changes (SLC) database was conducted on December 31, 2016 for date range "10/1/2016-12/31/2016", labeling section "Boxed Warning". These and other label changes are searchable in the Drug Safety Labeling Changes (SLC) database, where data are available to the public in downloadable and searchable formats. (Drug Safety Labeling Changes are available at: http://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/?source=govdelivery&utm_medium=email&utm_source=govdelivery) Boxed warnings are ordinarily used to highlight either: adverse reactions so serious in proportion to the potential benefit from the drug that it is essential that it be considered in assessing the risks and benefits of using the drug; OR serious adverse reactions that can be prevented/reduced in frequency or severity by appropriate use of the drug; OR FDA approved the drug with restrictions to ensure safe use because FDA concluded that the drug can be safely used only if distribution or use is restricted.

Summaries of Safety Labeling Changes Approved by the FDA: Boxed Warnings Highlights.

As part of the US Food and Drug Administration's MedWatch program, safety labeling changes are reviewed and compiled monthly for drugs and therapeutic biologics where important changes have been made to the safety information. Boxed warnings (http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm075096.pdf) are ordinarily used to highlight either adverse reactions so serious in proportion to the potential benefit from the drug that it is essential that it be considered in assessing the risks and benefits of using the drugs or serious adverse reactions that can be prevented/reduced in frequency or severity by appropriate use of the drug; or FDA approved the drug with restrictions to ensure safe use because FDA concluded that the drug can be safely used only if distribution or use is restricted. There were 4 revised boxed warning from January through March 2016.

Evolution of the Radiation Therapist Role in a Multidisciplinary Palliative Radiation Oncology Clinic.

BACKGROUND: Palliative radiation therapists (PRTs) have been integrated in varying capacities into outpatient palliative radiation therapy (RT) services across Canada for over 2 decades. At our institution, PRTs have developed an essential role over 11 years within a palliative radiation oncology (PRO) clinic that focuses on integrating symptom management with radiation oncology assessment for palliative RT. PRTs have had direct clinical, technical, research, and administrative involvement as the clinic evolved from a pilot in 2007 supporting one half-day per week to the current model of five full clinical days. METHODS: Using collaborative reflection, we explored the PRTs' experience and insight. Twelve PRTs who contributed to the PRO clinic for varying lengths of time from 2007 through to 2016 were invited to participate in the development of a collective expression of the PRT experience. Seven PRTs consented to completing an electronic survey consisting of fifteen open-ended questions regarding individual roles and perspectives relating to our PRO clinic. Survey answers were enhanced by semistructured interviews when needed for clarification. Responses were contextualized within the operational changes to our multidisciplinary clinical model, from pilot to integrated service. RESULTS/DISCUSSION: Five respondents answered all of the questions. From the narratives, PRT roles and responsibilities were outlined and their insights and reflections included to contextualize clinical changes. Four phases of the clinic were identified and elucidated. Beginning in January 2007, three PRTs staffed a multidisciplinary clinical pilot one half-day per week for single-fraction, symptomatic bone metastases. The clinic has now evolved through various iterations to the current model with four PRTs sharing a "navigator" role with two registered nurses five full clinic days per week. The range of PRT experiences, responsibilities, and challenges encountered reflected specific clinical and operational conditions. CONCLUSION: As our clinical service model evolved from short-term pilot to fully integrated departmental service, so did the PRT role. PRTs contributing to RT as part of a multidisciplinary model support and advance nontraditional involvement in the holistic care of patients with advanced cancer.

Peri-anal surface dose in anal canal VMAT radiotherapy.

INTRODUCTION: Skin bolus may routinely be used in the perineum to build up the surface dose in the treatment of anal cancer (ACC); this may contribute to significant acute skin toxicity. Skin bolus may not be needed with the introduction of modern radiotherapy techniques if these planning techniques would achieve adequate surface dose. Our study is to ascertain if appropriate skin dose can be achieved without the use of bolus when VMAT is used in the treatment of ACC. METHODS: The study includes 10 ACC patients treated with VMAT radiotherapy. Optically stimulated luminescence dosimeters (OSLD) are used to evaluate whether the calculated dose for the VMAT planning technique (VMAT-PT) accurately predicted the dose delivered to peri-anal target region without bolus. The OSLD recorded the dose at the anal verge or at the lower most extent of the tumour for each patient over two fractions. The OSLD was read after each of the two fractions, and the average value was reported. The mean dose over a volume centred on the anal marker was calculated in the treatment planning system (TPS). RESULTS: The mean TPS-calculated dose was 186.1 cGy. The mean of the OSLD-measured doses was 205.7 cGy for a single fraction. The mean of the measured doses was 10.6% higher than the mean of the calculated doses. CONCLUSIONS: The calculated dose for the VMAT-PT consistently under-predicted the dose delivered to the peri-anal target region without bolus. Routine use of skin bolus could be avoided with VMAT-PT when the patient is treated in a supine position.

Virtual Simulation of Bone Metastases by a Dedicated Palliative Radiation Therapist: A Retrospective Comparison Pilot Study.

PURPOSE: In interdisciplinary teams, members may take on responsibilities usually performed by others to enhance patient care. In the Rapid Access Palliative Radiotherapy Program, a dedicated radiation therapist (MRT[T]) participates in clinical assessments, team conferences, patient education, simulation, treatment delivery, and follow-up. The purpose of this study was to determine the feasibility of virtual simulation performed by an MRT(T) experienced in treating bone metastases within this specialized clinic. METHODS: After radiotherapy was planned by a radiation oncologist (RO) and administered, the 3-dimensional dataset was duplicated and anonymized. In a blinded fashion, patients were independently retrospectively simulated by one MRT(T) with access to the patient's clinical and radiological information. Resulting digitally reconstructed radiographs were compared with actual simulation films. Summary statistics were compiled to quantify differences in field size (FS) and isocenter placement. RESULTS: Twelve bone metastases were treated (6 spine, 4 hip, 2 shoulder) with either a direct posterior or parallel opposed arrangement. For 11 of the 12 sites, beam arrangements chosen by the MRT(T) and the RO were the same. Shielding was added to 3 of the 12 sites by the RO and 2 of the 12 by the MRT(T). For the sites with a similar field arrangement, there was no significant difference between mean blocked RO (133.6 cm2 [SD 52.6 cm]) and MRT(T) field sizes (129.3 cm2 [SD 47.4 cm]) (P = .52). On average, the MRT(T) plan resulted in 4.3 cm2 undercoverage compared with the treatment FS. Isocenter placement differed on average by 0.25 cm laterally, 0.02 cm anteriorly, and 0.15 cm inferiorly for MRT(T) versus RO fields. One of 11 sites virtually planned by the MRT(T) was a geographic miss of a soft-tissue mass. CONCLUSIONS: In this study, an MRT(T) member of a dedicated interdisciplinary team piloted virtual simulation for bone metastases treatment. Although average FS and isocenter placement did not significantly differ, optimal radiotherapy of complex bone metastases likely requires a collaborative approach.