Assessment of drug therapy satisfaction amongst the elderly: A patient reported outcomes measures approach.

BACKGROUND: Understanding elderly experiences enhance healthcare outcomes and patient satisfaction. Recognizing caregivers' role and implementing supportive measures enhance care. OBJECTIVES: Quantify drug satisfaction using patient-reported outcomes measures approach. Assess caregiver burden using short version of Burden Scale for Family Caregivers. METHODS: Six-month cross-sectional study in Department of Geriatrics. Elderly (≥60), minimum one comorbidity, admitted for >48 h, and consenting to participate were enrolled. Patient satisfaction assessed using Treatment Satisfaction with Medicines Questionnaire (SATMED-Q). SPSS version 27 used to calculate odds ratio. RESULTS: 282 participants enrolled. SATMED-Q score 47.41 ± 10.34, indicating overall satisfaction. Treatment satisfaction range 47.07 % to 100 %. Age [OR 0.964, 95 % CI 0.932-0.996 (p = 0.029)] and education [OR 1.500, 95 % CI 1.129-1.992 (p = 0.005)] influenced satisfaction. 268 [95.03 %] had caregivers, 14 [4.96 %] did not. Caregiver burden score 9.25 ± 9.11. CONCLUSION: Insights obtained from assessing satisfaction and caregiver burden enables physicians to improve welfare of elderly and caregivers.

Auxiliary delivered school based oral health promotion among 12-14-year-old children from a low resource setting-A cluster randomized trial.

OBJECTIVES: This community intervention study compared the changes in oral health knowledge, attitude, practices (KAP), and oral health indicators among 12-14-year-old children who received a school based oral health promotion delivered by auxiliaries in a rural setting in India. METHODS: The interventions in this school based cluster randomized trial were delivered using schoolteachers and school health nurses. Oral health education (once in 3 months), weekly classroom based sodium fluoride mouth rinsing and biannual oral health screening/ referral were provided for 1 year. The control arm did not receive these interventions. Oral health indicators and self-administered KAP questionnaire were evaluated at baseline and 1-year follow-up. Oral health indicators included oral hygiene index simplified, DMFT/DMFS net caries increments, prevented fraction, number of sites with gingival bleeding, changes in care index, restorative index, treatment index, and dental attendance. RESULTS: The improvement in total KAP score, oral hygiene, and gingival bleeding from baseline to follow up was higher in the intervention arm (p < 0.05). The prevented fraction for net caries increment were 23.33% and 20.51% for DMFT and DMFS, respectively. Students in the intervention group had a higher dental attendance (OR 2.92, p < 0.001). The change in treatment index, restorative index, and care index were significantly higher in the intervention arm (p < 0.001). CONCLUSIONS: Inclusion of available primary care auxiliaries like school health nurses and teachers in oral health promotion is a novel, effective, and sustainable strategy to improve oral health indicators and utilization in rural areas in low resource settings.

Hepatitis B Surface Antibody Levels among Health-Care Personnel Vaccinated against Hepatitis B in a Teaching Hospital in South India.

Background: Hepatitis B virus infection is a global health priority, and health-care personnel (HCP) have 10 times higher prevalence than the general population. Seromonitoring identifies those with low titers and vaccine nonresponders with increased risk. Objective: The objective of the study was to assess hepatitis B surface antibody (anti-HBs) titers and associated factors among HCP vaccinated against hepatitis B in a teaching hospital in Kerala. Methods: A cross-sectional study was done among 454 vaccinated HCP, and anti-HBs antibody titers were assessed by enzyme-linked immunosorbent assay method. Results: Participants included 162 (35.7%) doctors, 132 (29.3%) nursing and laboratory personnel, and 160 (35.3%) supporting staff. The mean age was 38.06 ± 11.33 years, and 72% were female. Majority (92.5%, 420) were seroprotected and 78.9% (358) with high (>100 mIU) titers. Moderate (10-100 mIU) and low (<10 mIU) level seroprotection was seen in 13.7% (62) and 7.5% (34), respectively. Incomplete vaccination, >10 years since vaccination, and age >40 years were independent predictors for poor seroprotection, while increasing doses and boosters were positively associated. Conclusions: Majority of vaccinated HCP were seroprotected. Incomplete schedules, older age, and prolonged time since vaccination can lead to decline in titers, and periodical seromonitoring should guide hepatitis B revaccination strategies.

Higher mortality rates associated with rheumatoid arthritis in Saskatchewan, Canada, 2001-2019.

OBJECTIVES: To estimate provincial all-cause mortality rates of Saskatchewan people with rheumatoid arthritis (RA) for comparison with the general population over time and between different geographic regions. METHODS: Saskatchewan provincial administrative health databases (2001-2019) were utilized as data sources. Two RA case definitions were employed: (1) ≥ 3 physician billing diagnoses, at least 1 from a specialist (rheumatologist, general internist or orthopaedic surgeon) within 2 years; (2) ≥ 1 hospitalization diagnosis (ICD-9 code 714, and ICD-10-CA codes M05, M06). Data from these definitions were combined to create an administrative data RA cohort. All-cause mortality rates across geographic regions, between rural/urban residences and between sexes were examined. RESULTS: Over an 18-year span, between fiscal-year 2001-2002 and fiscal-year 2018-2019, age- and sex-adjusted mortality rates ranged from 17.10 to 21.04 (95% CI 14.77, 19.44; 18.03, 24.05)/1000 RA person-years, compared with mortality rates for the general Saskatchewan population without RA, which ranged from 9.37 to 10.88 (95% CI 9.23, 9.51; 10.72, 11.05)/1000 person-years. Fiscal-year mortality rate ratios ranged from 1.82 to 2.13 (95% CI 1.56, 2.13; 1.83, 2.46). Provincial mortality rates were higher in men than in women for both general and RA populations. Northern Saskatchewan mortality rates were significantly higher in the general population but did not achieve significance compared with other provincial regions for the RA population. Regression analysis identified age, male sex, RA and geographic region as factors contributing to increased mortality. A trend towards lower mortality rates over time was observed. CONCLUSION: Higher mortality rates were observed in the RA population overall. Men had higher mortality rates, as did residents of Northern Saskatchewan compared with residents of other regions for the general population.

RéSUMé: OBJECTIFS: Estimer les taux de mortalité provinciaux, toutes causes confondues, des habitants de la Saskatchewan atteints de polyarthrite rhumatoïde (PR) pour les comparer aux taux dans la population générale au fil du temps et entre différentes régions géographiques. MéTHODE: Nos données sont extraites des bases de données administratives sur la santé de la Saskatchewan (2001­2019). Deux définitions de cas ont été employées pour la PR : 1) ≥ 3 factures de diagnostic médical, dont au moins une d'un(e) spécialiste (rhumatologue, interniste général[e] ou chirurgien[ne] orthopédiste) en l'espace de deux ans; 2) ≥ 1 diagnostic d'hospitalisation (code CIM-9 714 et codes CIM-10-CA M05 et M06). Les données de ces définitions ont été combinées pour créer une cohorte de personnes atteintes de PR dans les données administratives. Les taux de mortalité toutes causes confondues entre les régions géographiques, entre les lieux de résidence urbains et ruraux et entre les sexes ont été examinés. RéSULTATS: En l'espace de 18 ans, entre les exercices 2001-2002 et 2018-2019, les taux de mortalité rajustés selon l'âge et le sexe ont varié entre 17,10 et 21,04 (IC de 95 % : 14,77-19,44; 18,03-24,05)/1000 personnes-années pour les personnes atteintes de PR, tandis que les taux de mortalité de la population générale de la Saskatchewan non atteinte de PR se sont situés entre 9,37 et 10,88 (IC de 95 % : 9,23-9,51; 10,72-11,05)/1000 personnes-années. Les rapports de taux de mortalité par exercice ont varié entre 1,82 et 2,13 (IC de 95 % : 1,56-2,13; 1,83-2,46). Les taux de mortalité provinciaux des hommes étaient supérieurs à ceux des femmes, tant dans la population générale que chez les personnes atteintes de PR. Les taux de mortalité dans le Nord de la Saskatchewan étaient sensiblement plus élevés que dans les autres régions de la province pour la population générale, mais pas sensiblement plus élevés pour la population atteinte de PR. Selon les analyses de régression, l'âge, le sexe masculin, la PR et la région géographique étaient des facteurs contribuant à une mortalité accrue. Une tendance à la baisse des taux de mortalité au fil du temps a été observée. CONCLUSION: Dans la population atteinte de PR, des taux de mortalité plus élevés ont été observés globalement. Dans la population générale, les taux de mortalité des hommes et ceux des résidents du Nord de la Saskatchewan étaient plus élevés que ceux des résidents des autres régions.

Thermal deactivation of α-amylase immobilized magnetic chitosan and its modified forms: A kinetic and thermodynamic study.

The stability and thermodynamic properties of an enzyme are the main factors that governing its applications in industry. With that intention we have immobilized the α-amylase onto synthesized chitosan-magnetite (CSM) composite and its modified forms by gluteraldehyde (CSM-GLA), glyoxal (CSM-GLY) and epichlorohydrin (CSM-ECH). In this study all the immobilized enzymes exhibited improved pH stability about 60-80% of relative activity at pH 9 compared to the free enzyme. The temperature stability at 60 °C is up to 50% of relative activity for covalently immobilized enzymes as enzyme become more rigid by covalent binding and so protected from the conformational changes caused by the environment. The thermal deactivation of the free and immobilized enzymes follows the first order kinetics. The t1/2 and D-values were prolonged considerably in case of covalently immobilized enzymes, indicating better thermal stability than that of free and adsorbed ones. The Ed values 18.71, 32.00, 27.19 and 20.46 KJmol-1 for CSM-E, CSM-GLY-E, CSM-GLA-E and CSM-ECH-E described the high stability and resistance to heat inactivation. The Km values 0.525 ± 0.04, 0.57 ± 0.06, 0.65 ± 0.04 mg/mL and Vmax values 25 ± 0.06, 19.6 ± 0.02, 16.39 ± 0.01 µmol mg-1 min-1for CSM-GLY-E, CSM-GLA-E and CSM-ECH-E showing better substrate affinity. The immobilized enzymes have exhibited about 60% of relative activity after 90 days of storage and very good reuse potential.

Self-perception on oral health and related behaviours among antenatal mothers attending a public antenatal clinic - Kerala.

BACKGROUND AND AIMS: Antenatal oral care has been given least priority on a global scale. The study assesses self-perception of oral health knowledge and related behaviors among antenatal mothers. METHOD: A cross-sectional study was done among 400 pregnant women attending antenatal care clinic of a tertiary care center in Kerala, India. Details regarding knowledge, attitude, and practice were obtained, after getting an informed consent. The dental caries experience and gingival status were measured. To test the significance (p ≤ 0.05) between variables, Chi-square test was used. RESULTS: Poor oral health knowledge was observed among 75.5% of the pregnant mothers. Oral health problems were reported by 63.2% of them. Low priority for oral health (59.4%) and fear for fetal safety (17.5%) were the reasons for delaying dental services. Oral examination showed that more than half of the study subjects had a high prevalence of dental caries (67.5%) and low gingival bleeding status (26.2%). The study highlights that more than half of the study population (60.8%) were influenced by the elderly in the family to avoid certain food items. A better oral health knowledge was observed among the upper middle class (OR - 2.8) who had visited dentists within the last six months (OR - 3.6) and child bearing mothers (OR- 0.46) (p ≤ 0.05).

The Diminishing Impact of Margin Definitions and Width on Local Recurrence Rates following Breast-Conserving Therapy for Early-Stage Invasive Cancer: A Meta-Analysis.

BACKGROUND: The optimal tumor-free margin definition and width following breast-conserving therapy (BCT) for early-stage invasive cancers has been evaluated in previous meta-analyses and guidelines. We performed an updated meta-analysis to assess how improvements in treatment over time have affected the impact of margins on local recurrence (LR) rates over time. METHODS: A systematic literature review identified 38 eligible studies comprising 54,502 patients treated between 1968 and 2010. Inclusion criteria included patients treated with BCT and minimum follow-up of 50 months, pathologic definitions of margin status explicitly stated, and LR data in relation to margin status. Data were pooled using a Bayesian logistic regression model to evaluate the risk of LR in relation to both margin status and study enrollment periods. RESULTS: Median follow-up was 7.25 years. Absolute LR rates decreased over time for each margin width cohort, with maximum differences between negative margin groups of less than 1% for the most recent enrollment period. However, relative rates of LR between different margin groups remained stable over time. CONCLUSIONS: With an additional 22,000 patients compared with the previous meta-analysis, this updated meta-analysis supports the consensus guideline of "no tumor on ink" for the majority of patients. Additionally, while concerns exist regarding a benefit with wider margins from previous studies, the analysis demonstrates the impact of margin width on LR rates has declined substantially over time, with very small differences between the narrowest and widest margin groups in the most recent cohort. Hence, older studies appear to have limited value to inform current management guidelines.

Validation of RTOG 0813 Proximal Bronchial Tree Constraints for Pulmonary Toxicity With Stereotactic Body Radiation Therapy for Central Non-small Cell Lung Cancer.

PURPOSE: Clinical validation of protocol-specified dosimetric constraints for the proximal bronchial tree (PBT) is limited for central non-small cell lung cancer treated with stereotactic body radiation therapy. We sought to validate Radiation Therapy Oncology Group (RTOG) PBT constraints with a large institutional data set. METHODS AND MATERIALS: Lesions ≤2 cm from the PBT treated with definitive stereotactic body radiation therapy from 2009 to 2016 were identified from a prospective registry of 1462 patients. Every PBT dose and volume combination, ranging from 0 cGy to 8000 cGy in increments of 10 cGy and volumes ranging from 0.03 cm3 to 50 cm3 in increments of 0.03 cm3, was analyzed. The sensitivity and specificity of these endpoints for identifying pulmonary toxicity were calculated. Pulmonary toxicity was classified as pneumonitis or nonpneumonitis toxicity (NPT) (fistula, stenosis, necrosis, hemoptysis, clinically significant pleural effusion). The optimal dosimetric predictor was chosen by calculation of F-score (highest sensitivity and specificity). RESULTS: The study included 132 patients, with 26.0-month median follow-up. Eight grade ≥2 NPT (2 grade 5) and 8 grade 2 pneumonitis toxicities were observed. The PBT dosimetric endpoint with the highest F-score for identification of grade 2 to 5 NPT was D0.03cc ≤5000 cGy and that for grade 3 to 5 NPT was D0.33cc ≤4710 cGy, with sensitivity and specificity of 87.5% and 76.6% and 100.0% and 85.7%, respectively. Applying the RTOG 0813 PBT constraints to our data set achieved a sensitivity and specificity of 33.3% and 92.1% for D4cc ≤1800 cGy and 37.5% and 92.7% for D0.03cc ≤5250 cGy for identification of grade 2 to 5 NPT. A PBT dosimetric correlation for pneumonitis toxicity could not be identified. CONCLUSIONS: This novel dosimetric analysis validates current RTOG constraints and emphasizes high-dose, small-volume constraints as better predictors for NPT. We demonstrated that a slightly lower maximum point dose PBT constraint may be optimal for identification of NPT. Validation of these findings in a larger cohort of patients with longer follow-up is necessary.

Outcomes with intraoperative radiation therapy for early-stage breast cancer.

Adjuvant radiation therapy has been associated with improved local control following breast-conserving surgery. Traditionally, treatment has been delivered with whole breast irradiation over 3-6 weeks or partial breast irradiation over 1-3 weeks. However, intraoperative radiation therapy (IORT) has emerged as a technique that delivers a single dose of radiotherapy at the time of surgery for early-stage breast cancers. We report initial outcomes and acute toxicities with intraoperative radiation from a single institution. Patients with DCIS or Stage I-II breast cancer who underwent lumpectomy and sentinel lymph node biopsy (nodal sampling excluded in some cases) were included. All patients in this analysis were treated with IORT as at the time of surgery, 20 Gy in 1 fraction with 50 kV x-ray. Patients were treated at a single institution between 2011 and 2019. Follow-up was per standard institutional protocol. Two hundred and one patients were included in the analysis, with a median follow-up of 23 months (range: 0-73 months). Median age was 71 years old. Overall, 4 (2.0%) patients had DCIS, 186 (92.5%) patients had Stage 1 disease, and 11 patients had (5.5%) Stage 2 disease. All patients were estrogen receptor-positive, 175 (87.9%) progesterone receptor-positive, and 1 (0.5%) HER2 amplified. The crude rate of local recurrence was 2.0% (n = 4) and distant metastasis rate was 0.5% (n = 1). The rate of arm lymphedema was 0.5% (n = 1) and chronic telangiectasia rate was 1.1% (n = 2). Intraoperative radiation therapy, in a cohort of low-risk patients, demonstrated low rates of recurrence and reproducibility in a multi-disciplinary setting. Further follow-up, analysis of patient satisfaction and cosmesis, and comparison to whole breast irradiation and partial breast techniques is necessary in order to further validate these findings.

Initial outcomes with image-guided partial breast irradiation delivered with intensity-modulated radiation therapy.

Patients were treated at a single institution to a dose of 30 Gy in five fractions delivered every other day using image-guided intensity modulated radiation therapy (IMRT) partial breast irradiation. A total of 34 patients were treated with a median follow-up of 4.6 months. The rate of acute Grade 1 dermatitis was 23.5% (n = 8), and Grade 1 fatigue was 17.6% (n = 6), with no Grade 2 or higher acute toxicities. The rate of chronic Grade 1 dermatitis was 25.0% (n = 6), Grade 1 fat necrosis 4.2% (n=1), with no patients demonstrating other chronic toxicities. Image-guided APBI delivered with IMRT is associated with low rates of acute and chronic toxicity though additional follow-up is warranted.

Nipah Virus Infection in Kozhikode, Kerala, South India, in 2018: Epidemiology of an Outbreak of an Emerging Disease.

BACKGROUND: An outbreak of the rare and highly pathogenic Nipah virus infection occurred in Kozhikode, Kerala, India, during May 2018. METHODOLOGY: Outbreak control activities included laboratory case confirmation and isolation. Contact surveillance was initiated and close contacts were home quarantined for the maximum incubation period of the disease. Field visits and verbal autopsy of the deaths were done to elicit the details of exposure. RESULTS: Of the 18 confirmed cases, 16 succumbed (case fatality rate, 88.8%). The mean incubation period was 9 days. The transmission was person to person wherein the primary case served as a point source for 15 other cases including 2 health-care workers. The mean age of the affected cases was 41 years with male preponderance. More than 2600 contacts were under surveillance. The outbreak was contained within 3 weeks and declared closed by July the same year. CONCLUSION: Early detection of the outbreak and prompt isolation of cases along with strengthening of infection control practices and barrier nursing helped in containing the outbreak.

Long-term complications and reconstruction failures in previously radiated breast cancer patients receiving salvage mastectomy with autologous reconstruction or tissue expander/implant-based reconstruction.

Salvage mastectomy (SM) is the standard of care for patients with local recurrence (LR) after breast conservation therapy (BCT), often with immediate reconstruction. Complications of reconstruction are a concern for these patients, and long-term data are limited. We sought to compare rates of complications requiring re-operation (CRR) and reconstruction failure (RF) between autologous reconstruction (AR) and tissue expander/implant reconstruction (TE/I). Patients with locally recurrent breast cancer after BCT, treated with SM and immediate AR or TE/I between 2000 and 2008, were identified. CRR was defined as unplanned return to operating room for wound infection, dehiscence, necrosis (including flap, skin, or fat), hematoma, or hernia (for AR) and extrusion, leak, or capsular contracture (for TE/I). RF was defined as conversion to another reconstruction technique or to flat chest wall. This study included 103 patients with 107 reconstructions. Median follow-up was 6.6 years. CRR and RF were significantly higher with TE/I (n = 34) compared to AR (n = 73) at 5 years (50.9% vs 25.5%; P = 0.02) and (42.1% vs 5.8%; P < 0.001). On univariate analysis (UVA), TE/I (HR = 2.14; P = 0.02) and diabetes (HR = 5.10; P = 0.007) were significant predictors for CRR. On UVA, TE/I (HR = 7.30; P < 0.001) and older age at reconstruction (HR = 1.03; P = 0.003) were significant predictors for RF. In this population of previously irradiated patients, TE/I was associated with significantly higher CRR and RF. Complications continue to occur up to 10 years after TE/I. AR should be considered in appropriately selected patients, though TE/I may remain a reasonable option in patients without high-risk factors for surgical complications.

Long-Term Outcomes After Autologous or Tissue Expander/Implant-Based Breast Reconstruction and Postmastectomy Radiation for Breast Cancer.

PURPOSE: The toxicity profile of breast reconstruction with postmastectomy radiation therapy (PMRT) varies by technique and timing, and long-term data are limited. We compared rates of complications requiring reoperation (CRR) and reconstruction failure (RF) between immediate autologous reconstruction (I-AR), immediate tissue expander/implant reconstruction (I-TE/I), delayed autologous reconstruction (D-AR), and delayed tissue expander/implant reconstruction (D-TE/I) in patients receiving PMRT. METHODS AND MATERIALS: Patients who received autologous reconstruction (AR) or tissue expander/implant reconstruction (TE/I) and PMRT between 2000 to 2008 were included. Reconstruction was immediate if performed on the same day as mastectomy followed by PMRT (I-AR or I-TE/I) or delayed if after PMRT (D-AR and D-TE/I). CRR was defined as an unplanned return to the operating room for infection, dehiscence, necrosis, hematoma, or hernia (with AR) and extrusion, leak, or contracture (with TE/I). RF was defined as unplanned conversion to another reconstruction technique or to flat chest wall. Cumulative incidence of CRR and RF was calculated using Kaplan-Meier and compared using the log-rank test. Logistic regression was used to identify variables associated with CRR and RF. RESULTS: Two hundred four patients were included. Median follow-up was 8 years. There were 127 AR cases (63%) and 77 TE/I cases (38%). At 5 years, CRR was 18%, 38%, 34%, and 70% (P = .010) and RF was 4%, 22%, 7%, and 56% (P < .0001) for I-AR, I-TE/I, D-AR, and D-TE/I, respectively. On multivariate analysis, TE/I (hazard ratio [HR] 2.0; P = .011), body mass index ≥30 (HR 3.9; P = .002), and smoking (HR 2.7; P = .001) were significant predictors for CRR, and TE/I (HR 6.6; P < .0001), diabetes (HR 4.1; P = .044), and hypertension (HR 3.5; P = .005) were significant for RF. When excluding RF because of infection, the rate of RF was not significantly different among the 4 groups (P = .23). CONCLUSIONS: With PMRT, TE/I reconstruction in the immediate and delayed setting is associated with higher CRR and RF compared with AR. Patient factors should guide selection of technique. Efforts to reduce rates of RF with TE/I should focus on minimizing risks for infection.

Association of Disease Recurrence With Survival Outcomes in Patients With Cutaneous Squamous Cell Carcinoma of the Head and Neck Treated With Multimodality Therapy.

Importance: It has previously been demonstrated that immunosuppressed patients with cutaneous squamous cell cancer of the head and neck (cSCC-HN) treated with surgery and postoperative radiotherapy have significantly inferior disease-related outcomes compared with immunocompetent patients, but data on outcomes after disease recurrence are limited. Objectives: To report survival outcomes in patients with cSCC-HN after disease recurrence after surgery and postoperative radiotherapy and to investigate the association of immune status with disease-related outcomes. Design, Setting, and Participants: A multi-institutional study of 205 patients treated at the Cleveland Clinic, Washington University in St Louis, and the University of California, San Francisco, in which patients who underwent surgical resection and postoperative radiotherapy for primary or recurrent stage I to IV (nonmetastatic) cSCC-HN between January 1, 1995, and December 31, 2014, were identified. Patients with any disease recurrence, defined as local, regional, and/or distant failure, were included. Patients were categorized as immunosuppressed if they received a diagnosis of chronic hematologic malignant neoplasm or HIV or AIDS, or were treated with immunosuppressive therapy for organ transplantation 6 months or more before diagnosis. Statistical analysis was conducted from January 1, 1995, to December 31, 2015. Main Outcomes and Measures: Overall survival calculated using the Kaplan-Meier method and compared using the log-rank test. Results: Of the 205 patients in the original cohort, 72 patients (63 men and 9 women; median age, 71 years [range, 43-91 years]) developed disease recurrence after surgery and postoperative radiotherapy. Forty patients (55.6%) were immunosuppressed, and 32 patients (44.4%) were immunocompetent. Locoregional recurrence was the most common first pattern of failure for both groups (31 immunosuppressed patients [77.5%]; 21 immunocompetent patients [65.6%]). After any recurrence, 1-year overall survival was 43.2% (95% CI, 30.9%-55.4%), and median survival was 8.4 months. For patients for whom information on salvage treatment was available (n = 45), those not amenable to surgical salvage had significantly poorer median cumulative incidence of survival compared with those who were amenable to surgical salvage (4.7 months; 95% CI, 3.7-7.0 months vs 26.1 months; 95% CI, 6.6 months to not reached; P = .01), regardless of their immune status. Conclusions and Relevance: Results of this study suggest that patients with cSCC-HN who experience disease recurrence after definitive treatment with surgery and postoperative radiotherapy have poor survival, irrespective of immune status. Survival rates are low for patients with recurrent disease that is not amenable to surgical salvage. The low rate of successful salvage underscores the importance of intensifying upfront treatment to prevent recurrence.

Investigation of brachial plexus dose that exceeds RTOG constraints for apical lung tumors treated with four- or five-fraction stereotactic body radiation therapy.

PURPOSE/OBJECTIVESS: We sought to determine the rate of brachial plexopathy (BPX) in patients exceeding RTOG dose constraints for treatment of apical lung tumors. MATERIALS/METHODS: Patients with apical lung tumors treated with four- or five-fraction SBRT were identified from a prospective registry. Dosimetric data were obtained for ipsilateral subclavian vein (SCV) and anatomic BP (ABP) contours. Cumulative equivalent dose in 2 Gy equivalents (EQD2) was calculated for the SCV contour in patients with a history of prior ipsilateral RT. Five-fraction SBRT RTOG constraints of D0.03cc ≤32.0 Gy and D3cc ≤30.0 Gy were used. BPX was graded according to Common Terminology Criteria for Adverse Events 3.0. RESULTS: A total of 64 patients met inclusion criteria. Median follow-up was 21 months. Six patients (9.4%) had prior ipsilateral conventional fractionated RT with varying degrees of overlap with subsequent SBRT field. Eleven patients without prior ipsilateral RT exceeded D0.03cc ≤32.0 Gy to SCV (mean 43.8 Gy ± 5.8). No BPX was observed in these patients. Out of the six patients who had prior ipsilateral RT, three patients exceeded D0.03cc ≤32.0 Gy to SCV (44.2 Gy ± 11.3), with two of these patients developing Grade 2 BPX within one year of SBRT. The EQD2 cumulative maximum point dose to BP was 122.6 Gy and 184.7 Gy for the two patients who developed Grade 2 BPX. The D0.03cc was >10 Gy higher to the ABP contour than the SCV contour in 14 patients. CONCLUSION: Without a history of prior ipsilateral RT, no BPX was observed at 21 month follow-up in 11 patients who exceeded the RTOG five-fraction BP constraint. This observation is hypothesis generating and more experience with longer follow-up is necessary to validate these findings. For tumors located in close proximity to apical structures, there was substantial variation in dose between the ABP and SCV contours.

Effect of Tumor Location and Dosimetric Predictors for Chest Wall Toxicity in Single-Fraction Stereotactic Body Radiation Therapy for Stage I Non-Small Cell Lung Cancer.

PURPOSE: Dosimetric parameters to limit chest wall toxicity (CWT) are not well defined in single-fraction (SF) stereotactic body radiation therapy (SBRT) phase 2 trials. We sought to determine the relationship of tumor location and dosimetric parameters with CWT for SF-SBRT. METHODS AND MATERIALS: From a prospective registry of 1462 patients, we identified patients treated with 30 Gy or 34 Gy. Gross tumor volume was measured as abutting, ≤1 cm, 1 to 2 cm, or >2 cm from the chest wall. CWT was prospectively graded according to Common Terminology Criteria for Adverse Events version 3.0, with grade 2 requiring medical therapy, grade 3 requiring procedural intervention, and grade 4 being disabling pain. Grade 1 CWT or radiographic rib fracture was not included. Logistic regression analysis was used to identify the parameters associated with CWT and calculate the probability of CWT with dose. RESULTS: This study included 146 lesions. The median follow-up time was 23.8 months. The 5-year local control, distant metastasis, and overall survival rates were 91.8%, 19.2%, and 28.7%, respectively. Grade 2 to 4 CWT was 30.6% for lesions abutting the chest wall, 8.2% for ≤1 cm from the chest wall, 3.8% for 1 to 2 cm from the chest wall, and 5.7% for >2 cm from the chest wall. Grade ≥3 CWT was 1.4%. Tumor abutment (odds ratio [OR]: 6.5; P = .0005), body mass index (OR: 1.1; P = .02), rib D1cc (OR: 1.01/Gy; P = .03), chest wall D1cc (OR: 1.08/Gy; P = .03), and chest wall D5cc (OR: 1.10/Gy; P = .01) were significant predictors for CWT on univariate analysis. Tumor abutment was significant for CWT (OR: 7.5; P = .007) on multivariate analysis. The probability of CWT was 15% with chest wall D5cc at 27.2 Gy and rib D1cc at 30.2 Gy. CONCLUSIONS: The rate of CWT with SF-SBRT is similar to the rates published for fractionated SBRT, with most CWT being low grade. Tumor location relative to the chest wall is not a contraindication to SF-SBRT, but the rates increase significantly with abutment. Rib D1cc and chest wall D1cc and D5cc may be used as predictors of CWT.

Suboptimal Outcomes in Cutaneous Squamous Cell Cancer of the Head and Neck with Nodal Metastases.

BACKGROUND/AIM: There are limited data regarding survival, failure patterns, and factors associated with disease recurrence in patients with cutaneous squamous cell cancer of the head and neck (cSCC-HN) with nodal metastases. PATIENTS AND METHODS: A retrospective analysis of patients with cSCC-HN metastatic to cervical and/or parotid lymph nodes treated with surgery and post-operative radiation therapy was performed. RESULTS: This study included 76 patients (57 immunocompetent and 18 immunosuppressed) with a median follow-up of 18 months. Overall survival, disease-free survival (DFS), and disease recurrence (DR) at 2 years was 60%, 49%, and 40%, respectively. Immunosuppressed patients had significantly lower 2-year DFS (28% vs. 55%; p=0.003) and higher DR (61% vs. 34%; p=0.04) compared to immunocompetent patients. Analysis of immunocompetent patients demonstrated extracapsular extension (ECE) as the only factor associated with DR (p<0.0001). CONCLUSION: Patients with nodal metastases from cSCC-HN have suboptimal outcomes. ECE and immunosuppression were significantly associated with DR.

Most patients are eligible for an alternative to conventional whole breast irradiation for early-stage breast cancer: A National Cancer Database Analysis.

We evaluated the proportion of patients eligible for alternatives to standard whole breast irradiation (WBI) following breast-conserving surgery using the National Cancer Database (NCDB). Using the 2016 dataset, Stage I-III patients were identified. Eligibility for hypofractionated WBI (HFRT), accelerated partial breast irradiation (APBI) and endocrine therapy (ET-alone) was defined using eligibility from large clinical trials as well as consensus guidelines. For patients with pN0 breast cancer, 20.6% and 37.0% were eligible for ET-alone based on the CALGB 9343/PRIME-II trials, respectively. In terms of HFRT, 72.5% and 50.4% were eligible based on IMPORT LOW/ASTRO HFRT guidelines, respectively. Based on IMPORT LOW/GEC-ESTRO trial/ASTRO guidelines/ABS guidelines/GEC-ESTRO guidelines, 72.5%, 86.1%, 39.0%, 72.5%, 45.7%, respectively, were eligible for APBI. Of those who qualify for HFRT per ASTRO guidelines, approximately 90% were eligible for APBI and 50% for ET-alone. This analysis shows that a large proportion of patients with node-negative breast cancer are eligible for HFRT, APBI and/or ET-alone after breast-conserving surgery.

Evaluating Candidacy for Hypofractionated Radiation Therapy, Accelerated Partial Breast Irradiation, and Endocrine Therapy After Breast Conserving Surgery: A Surveillance Epidemiology and End Results (SEER) Analysis.

PURPOSE/OBJECTIVE(S): After breast conserving surgery, adjuvant radiation therapy represents the standard of care for most patients. However, multiple options exist beyond standard fractionated whole breast irradiation including hypofractionated whole breast irradiation (HFRT), accelerated partial breast irradiation (APBI), and endocrine therapy (ET) alone, which can limit treatment duration, and potentially reduce morbidity and cost. Limited data are available on the percentage of patients eligible for these alternatives; therefore, a Surveillance Epidemiology and End Results (SEER) analysis was performed to assess candidacy for these alternative options in women with early stage breast cancer. MATERIALS AND METHODS: Women treated for breast cancer between the years of 2010 and 2012 were identified in the SEER database. Patients with unknown staging, metastatic disease, T3/T4 disease, and ≥N1 disease were excluded. Patients were defined as eligible for HFRT based on the American Society for Radiation Oncology (ASTRO) consensus guidelines and randomised trial testing intensity modulated and partial organ radiotherapy following breast conservation surgery for early breast cancer (IMPORT LOW) trial criteria, APBI based on the ASTRO, American Brachytherapy Society and the Groupe Européen de Curiethérapie of European Society for Therapeutic Radiotherapy and Oncology (GEC-ESTRO) consensus guidelines, and GEC-ESTRO APBI and IMPORT LOW trial criteria, and ET alone based on the Cancer and Leukemia Group B 9343 and Post-operative Radiotherapy in Minimum Risk Elderly II inclusion criteria. RESULTS: A total of 108,484 women with early stage breast cancer who met the aforementioned inclusion criteria were identified. Of these patients, 86,896 (80.1%) were eligible for HFRT based on ASTRO consensus guidelines and 81,459 (75.0%) based on IMPORT LOW trial criteria. Regarding APBI, 44,797 (41.2%), 81,020 (74.6%), 81,020 (74.6%) were eligible according to ASTRO, ABS, GEC-ESTRO consensus guidelines, respectively, 97,301 (89.7%) patients according to the GEC-ESTRO trial criteria, and 81,459 (75.0%) patients according to the IMPORT LOW trial criteria. For ET alone, 23,006 (21.2%) were eligible according to Cancer and Leukemia Group B 9343 criteria and 42,104 (38.8%) according to Post-operative Radiotherapy in Minimum Risk Elderly II criteria. CONCLUSIONS: This SEER analysis demonstrates that a substantial proportion of women with early stage breast cancer are eligible for HFRT, APBI, or ET alone after breast conserving surgery according to consensus guidelines and prospective trial criteria. With incorporation of additional pathologic, dosimetric, and chemotherapy data, quality assurance pathways may use such data to help ensure patients are receiving appropriate risk stratified treatment recommendations.