Whole Versus Partial Bladder Radiation: Use of an Image-guided Hypofractionated IMRT Bladder-preservation Protocol.

OBJECTIVES: To report our institutional experience using definitive chemoradiation via whole bladder (WB) and partial bladder (PB) treatment in muscle-invasive bladder cancer. Combining intensity-modulated radiation therapy with image-guidance can improve the therapeutic ratio. MATERIALS AND METHODS: Retrospective analysis of 26 patients with clinical stage T2-4 N0-2 M0 urothelial cancer treated in 2009 to 2012; 16 received WB radiation and 10 received PB radiation. PB/tumor boost volume included visibly thickened bladder wall or tumor localized on cystoscopy. WB radiation delivered 45 to 50.4 Gy to bladder/lymph nodes, then sequential 19.8 to 21.6 Gy tumor boost (1.8 Gy/fx). PB radiation was 45 to 50 Gy to lymph nodes (1.8 to 2 Gy/fx) and simultaneous integrated boost to 55 to 62.5 Gy to tumor only (2.2 to 2.5 Gy/fx). The primary endpoint was local control, defined as no muscle-invasive recurrence. Secondary endpoints were overall survival, toxicity, and cost. RESULTS: Mean age was 77 and median follow-up was 20 months. Freedom from local recurrence was 86% at 2 years (PB 100%, WB 77%). Overall survival was 80% at 1 year (PB 88%, WB 75%), and 55% at 2 years (PB 70%, WB 48%, P=0.38). Failure was predominantly distant. Toxicities were minimal (3 late grade 3 ureteral, 1 acute grade 4 renal), and all resolved. No cystectomies were performed for toxicity. Hypofractionation reduces treatment time and costs by one third. CONCLUSIONS: Image-guided hypofractionated PB radiation provides local control with similar survival to WB therapy, with minimal toxicity. Hypofractionation also offers time and cost advantages. Our results need to be validated in a larger, multi-institutional cohort.

Dosimetric distribution to tooth-bearing areas in intensity-modulated radiation therapy for head and neck cancer: a pilot study.

OBJECTIVES: Dosimetric distribution of intensity-modulated radiotherapy (IMRT) to tooth-bearing areas for common head and neck (H&N) cancer sites were analyzed to facilitate minimization of osteoradionecrosis (ORN) risk through preradiation dental treatment planning. STUDY DESIGN: Fifty-four patients received IMRT with prescribed doses ranging from 6000 centigrays (cGy) (adjuvant) to 6930 cGy (primary) to treat base of tongue (BOT), tonsil, larynx, nasopharynx, and hypopharynx cancers. The average maximal radiation dose delivered was recorded in tooth-bearing areas (anteriors, premolars, and first, second, and third molars) of the maxilla and mandible. RESULTS: All tooth-bearing areas in laryngeal cancer cases received less than 2500 cGy. Maxillary and mandibular molar regions for BOT, tonsil, and hypopharynx cancers received 5000 cGy or higher. In nasopharynx cancers, maxillary teeth received higher doses than mandibular teeth. CONCLUSIONS: Among 5 H&N subsites, mandibular molar regions for BOT, tonsil, and hypopharynx cancers received higher IMRT doses on average, posing the greatest ORN risk.

Tomotherapy improves local control and changes failure patterns in locally advanced malignant pleural mesothelioma.

PURPOSE: The purpose of the study was to determine whether intensity modulated radiation therapy delivered via helical tomotherapy improves local control (LC) after pleurectomy/decortication (P/D) for malignant pleural mesothelioma compared with 3-dimensional conformal radiation therapy (3D-CRT). METHODS AND MATERIALS: Forty-five consecutive patients were treated with adjuvant radiation to 45 Gy in 1.8 Gy fractions after P/D between 2006 and 2014; 23 received 3D-CRT, and 22 received tomotherapy. Kaplan-Meier analysis was used to calculate overall survival, time to in-field or local failure (LF), and time to out-of-field failure. The Student t test and Fisher exact test were used to detect between-group differences. RESULTS: Median follow-up time was 19.4 months and 12.7 months for the 3D-CRT and tomotherapy groups, respectively. Eighty-two percent of patients had T3/T4 disease, and 64% had positive nodes; 17.4% and 41% of patients in the 3D-CRT and tomotherapy groups had nonepithelioid histology, respectively. Mean planning target volume dose, percentage of planning target volume receiving 100% of the prescription dose, and lung doses were significantly greater with tomotherapy (P < .05), but toxicity rates (including radiation pneumonitis rates) were equivalent. LC was significantly improved with tomotherapy on Kaplan-Meier analysis with outcomes censored at 2 years (P < .05); uncensored, this became a trend (P = .06). Median time to LF was 19 months with tomotherapy and 10.9 months in 3D-CRT (the latter interval being less than the median follow-up in the tomotherapy group). On univariate analysis, treatment modality was the only significant predictor of LC (P < .05). Isolated LF was significantly more frequent with 3D-CRT (P < .05). Conversely, isolated out-of-field failure was significantly more frequent with tomotherapy (P < .05). Overall survival and out-of-field control were not significantly different. CONCLUSION: Tomotherapy after P/D for malignant pleural mesothelioma is associated with improved target coverage that translates into improved LC compared with 3D-CRT. This is related to a change in failure patterns, with isolated LF being more common in the 3D-CRT group and isolated out-of-field failures predominating in the tomotherapy group.

An observational retrospective subgroup analysis of verteporfin photodynamic therapy-naive and previously treated patients in the focus trial.

PURPOSE: To perform a retrospective post hoc subgroup analysis of the FOCUS trial to assess the visual acuity outcomes and treatment benefits for patients receiving combination therapy who, at the time of enrollment, were naive to verteporfin photodynamic therapy (PDT) or had previously received PDT. METHODS: In this retrospective post hoc analysis of 24-month data from the FOCUS trial, PDT-naive and previously PDT-treated patients (n = 162) were included. Patients were randomized in a 2:1 ratio to receive 0.5 mg of ranibizumab monthly plus PDT or PDT alone. We retrospectively identified patients who had or had not received prior PDT for a post hoc subgroup analysis of 12- and 24-month outcomes. RESULTS: For the PDT-naive patients, mean change in the visual acuity at 24 months was +4.1 letters for the ranibizumab plus PDT group and -11.5 letters for the PDT monotherapy group, a treatment benefit over control group of 15.6 letters (95% confidence interval: 7.1-24.2). For the previously treated patients, mean change in the visual acuity at 24 months was +5.2 letters for the ranibizumab plus PDT group and -4.3 letters for the PDT monotherapy group, a treatment benefit over control group of 9.5 letters (95% confidence interval: 2.3-16.8). CONCLUSION: In the FOCUS subanalysis, the PDT-naive patients showed a trend toward greater treatment benefit over control subjects compared with patients previously treated with PDT. However, this study was not designed to address this question, and the confidence intervals were wide. Furthermore, the mean change in the visual acuity from baseline to 24 months was similar for both the PDT-naive and previously treated patients receiving combination therapy.

Racial variation in the incidence, care, and outcomes of severe sepsis: analysis of population, patient, and hospital characteristics.

RATIONALE: Higher rates of sepsis have been reported in minorities. OBJECTIVES: To explore racial differences in the incidence and associated case fatality of severe sepsis, accounting for clinical, social, health care service delivery, and geographic characteristics. METHODS: Retrospective population-based cohort study using hospital discharge and U.S. Census data for all persons (n = 71,102,655) living in 68 hospital referral regions in six states. MEASUREMENTS AND MAIN RESULTS: Age-, sex- and race-standardized severe sepsis incidence and inpatient case fatality rates, adjusted incidence rate ratios, and adjusted intensive care unit (ICU) admission and case fatality rate differences. Of 8,938,111 nonfederal hospitalizations, 282,292 had severe sepsis. Overall, blacks had the highest age- and sex-standardized population-based incidence (6.08/1,000 vs. 4.06/1,000 for Hispanics and 3.58/1,000 for whites) and ICU case fatality (32.1 vs. 30.4% for Hispanics and 29.3% for whites, P < 0.0001). Adjusting for differences in poverty in their region of residence, blacks still had a higher population-based incidence of severe sepsis (adjusted rate ratio, 1.44 [95% CI, 1.42-1.46]) than whites, but Hispanics had a lower incidence (adjusted rate ratio, 0.91 [0.90-0.92]). Among patients with severe sepsis admitted to the ICU, adjustments for clinical characteristics and the treating hospital fully explained blacks' higher ICU case fatality. CONCLUSIONS: Higher adjusted black incidence and the lower Hispanic incidence may reflect residual confounding, or it could signal biologic differences in susceptibility. Focused interventions to improve processes and outcomes of care at the hospitals that disproportionately treat blacks could narrow disparities in overall mortality from severe sepsis.

Annual rates of arterial thromboembolic events in medicare neovascular age-related macular degeneration patients.

PURPOSE: Smoking, age, and nutrition have been associated with the development of neovascular age-related macular degeneration (AMD) and can increase the risk of arterial thromboembolic events (ATEs). This study assesses annual rates of ATEs in new-onset neovascular AMD patients compared with matched controls. DESIGN: Retrospective study. PARTICIPANTS: New-onset neovascular AMD patients and age-, race-, gender-, and database length-matched controls from the 5% Medicare database. METHODS: We conducted a retrospective analysis of the 5% Medicare database from 2001 to 2003. New-onset neovascular AMD patients were included if they were > or =65 years old, had 2 diagnoses of neovascular AMD, and had at least 1 year of data before the first diagnosis of AMD within the dataset. A control group was constructed in a 3:1 ratio from those without a diagnosis of a major eye disorder and matched by age, race, gender, and length of data. Annual prevalence rates were determined for myocardial infarctions (MIs) and ischemic cerebral vascular accidents (CVAs). MAIN OUTCOME MEASURES: Rates of MIs and ischemic CVAs in new-onset neovascular AMD patients and matched controls from 2001 to 2003. RESULTS: There were 15771 new-onset neovascular AMD patients identified and matched with 46 408 controls. Average age was 80.5 years, with 64% > or =80; 65% were female; and 95.9% were white. Inpatient MI rates for neovascular AMD patients and controls were 2.2% and 2.2%, respectively (P = 0.74). Inpatient ischemic CVA rates for neovascular AMD patients and controls were 3.5% and 3.6%, respectively (P = 0.59). Myocardial infarction rates and ischemic CVA rates for both groups increased with age. Subgroups of patients with comorbidities known to be risk factors for ATEs (i.e., hypertension, hyperlipidemia, diabetes, and arrhythmias) had a higher rate of events. Patients with previous ATEs were also at a higher risk of subsequent events, at 7.4% for inpatient MI and 35.1% for inpatient ischemic stroke. CONCLUSION: Despite the shared risk factors associated with neovascular AMD and ATEs, Medicare beneficiaries with neovascular AMD had a rate of ATEs similar to that of matched controls. Rates of ATEs increased in patients with comorbidities and for patients with previous events.

Use of drotrecogin alfa (activated) in older patients with severe sepsis.

Drotrecogin alfa (activated) has been approved by the United States Food and Drug Administration for treatment of patients at high risk of death from severe sepsis. Severe sepsis is common, and its occurrence increases dramatically with age. Clinical use data, however, suggest that drotrecogin alfa (activated) may be underused in older patients, possibly due to concern over the drug's anticoagulant effects and perceived high cost. In addition, clinicians often treat older patients less aggressively than younger patients. We reviewed a subgroup analysis of patients aged 75 years and older from a large clinical trial evaluating efficacy and safety of drotrecogin alfa (activated), as well as cost-effectiveness data from real-world clinical use of the drug in older patients. We also explored ethical dilemmas of treating older patients with sepsis. Drotrecogin alfa (activated) is safe, effective, and cost-effective in older patients with severe sepsis and should be considered for elderly intensive care patients who are high risk of death and who have no contraindications to treatment.

A new weapon against severe sepsis related to necrotizing fasciitis.

Necrotizing fasciitis is a life-threatening infection. The purpose of this article is to review necrotizing fasciitis and nursing care as this disease may progress to sepsis.

Overview of inpatient coding.

The main classification-based and nomenclature-based coding systems used in the United States, as well as the process and importance of documenting in the patient record, are discussed. Hospital pharmacists usually have limited knowledge of and exposure to coding and reimbursement in the inpatient system. Coding allows for reporting of mortality data to the World Health Organization (WHO), reporting morbidity data in the U.S., and providing data for reimbursement from third-party payers to hospitals for services provided. Coded information is also the primary source for administrative management of medical services and a source of epidemiologic and statistical data from inpatient stays. In order to better understand inpatient coding and reimbursement, this article will discuss the International Classification of Diseases, 9th Revision, Clinical Modification (ICD-9-CM) coding system; the Healthcare Common Procedure Coding System (HCPCS); the process and importance of appropriate chart documentation; and the development of the International Classification of Diseases, 10th Revision, Clinical Modification (ICD-10-CM) coding system. Coding in the inpatient setting enables hospital billing and provides statistical data for epidemiology and financial planning. The ICD-9-CM is a clinically modified version of the international ICD-9 system used for coding both diagnoses and procedures in the United States. Coding is derived from documentation found in the patient's chart. Appropriate documentation is key for quality and continuity of care and compensation for resources utilized. In the future the ICD-9-CM will be replaced by the 10th revision, ICD-10, which is already in use in many countries in Europe.