Diet Quality of Pregnant American Indian Women in the Northern Plains.

INTRODUCTION: We examined diet quality and intake of pregnancy-specific micronutrients among pregnant American Indian women in the Northern Plains. METHODS: We conducted an analysis of nutrition data from the Prenatal Alcohol and SIDS and Stillbirth (PASS) Network Safe Passage Study and the PASS Diet Screener study (N = 170). Diet intake, including dietary supplementation, was assessed by using three 24-hour recalls conducted on randomly selected, nonconsecutive days. Diet intake data were averaged across the participant's recalls and scored for 2 dietary indices: the Healthy Eating Index 2010 (HEI-2010) and the Alternate Healthy Eating Index for Pregnancy (AHEI-P). We also assessed nutrient adequacy with Dietary Reference Intakes for pregnancy. RESULTS: On average, participants were aged 26.9 (standard deviation [SD], 5.5) years with a pre-pregnancy body mass index of 29.8 (SD, 7.5) kg/m2. Mean AHEI-P and HEI-2010 scores (52.0 [SD, 9.0] and 49.2 [SD, 11.1], respectively) indicated inadequate adherence to dietary recommendations. Micronutrient intake for vitamins D and K, choline, calcium, and potassium were lower than recommended, and sodium intake was higher than recommended. CONCLUSION: Our findings that pregnant American Indian women are not adhering to dietary recommendations is consistent with studies in other US populations. Identifying opportunities to partner with American Indian communities is necessary to ensure effective and sustainable interventions to promote access to and consumption of foods and beverages that support the adherence to recommended dietary guidelines during pregnancy.

Carrying out streamlined routine data analyses with reports for observational studies: introduction to a series of generic SAS ® macros.

For a typical medical research project based on observational data, sequential routine analyses are often essential to comprehend the data on hand and to draw valid conclusions.  However, generating reports in SAS ® for routine analyses can be a time-consuming and tedious process, especially when dealing with large databases with a massive number of variables in an iterative and collaborative research environment. In this work, we present a general workflow of research based on an observational database and a series of SAS ® macros that fits this framework, which covers a streamlined data analyses and produces journal-quality summary tables. The system is generic enough to fit a variety of research projects and enables researchers to build a highly organized and concise coding for quick updates as research evolves. The result reports promote communication in collaborations and will escort the research with ease and efficiency.

Relative validation of a short questionnaire to assess the dietary habits of pregnant American Indian women.

The objective of this study was to compare a short dietary screener developed to assess diet quality with interviewer-administered telephone 24-hour dietary recalls in a population of pregnant Northern Plains (NP) American Indian women. Participants were recruited from NP clinical sites of the Prenatal Alcohol and SIDS and Stillbirth (PASS) Network, as part of a large, prospective, multidisciplinary study. Prenatal PASS participants who enrolled prior to 24 weeks gestation were eligible to participate. Repeated 24-hour dietary recalls were collected using the Nutrition Data System for Research (NDSR) software and a short dietary screener was administered intended to capture usual dietary intake during pregnancy. The available recalls were averaged across days for analysis. Items were grouped from the recalls to match the food group data estimates for the screener (e.g., total vegetables, total fruit, total dairy, total and whole grains). Deattenuated Pearson correlation coefficients were calculated between the two data sources after correcting for the within-person variation in the 24-hour recall data. A total of 164 eligible women completed the screener and at least two 24-hour dietary recalls and were included in the analyses. Pearson deattenuated correlation coefficients between the diet screener and the dietary recalls for the majority of food groups were 0.40 or higher. This short diet screener to assess usual diet appears to be a valid instrument for use in evaluating diet quality among pregnant American Indian women.

Socioeconomic Factors Are Associated With Readmission After Lobectomy for Early Stage Lung Cancer.

BACKGROUND: Data regarding risk factors for readmissions after surgical resection for lung cancer are limited and largely focus on postoperative outcomes, including complications and hospital length of stay. The current study aims to identify preoperative risk factors for postoperative readmission in early stage lung cancer patients. METHODS: The National Cancer Data Base was queried for all early stage lung cancer patients with clinical stage T2N0M0 or less who underwent lobectomy in 2010 and 2011. Patients with unplanned readmission within 30 days of hospital discharge were identified. Univariate analysis was utilized to identify preoperative differences between readmitted and not readmitted cohorts; multivariable logistic regression was used to identify risk factors resulting in readmission. RESULTS: In all, 840 of 19,711 patients (4.3%) were readmitted postoperatively. Male patients were more likely to be readmitted than female patients (4.9% versus 3.8%, p < 0.001), as were patients who received surgery at a nonacademic rather than an academic facility (4.6% versus 3.6%; p = 0.001) and had underlying medical comorbidities (Charlson/Deyo score 1+ versus 0; 4.8% versus 3.7%; p < 0.001). Readmitted patients had a longer median hospital length of stay (6 days versus 5; p < 0.001) and were more likely to have undergone a minimally invasive approach (5.1% video-assisted thoracic surgery versus 3.9% open; p < 0.001). In addition to those variables, multivariable logistic regression analysis identified that median household income level, insurance status (government versus private), and geographic residence (metropolitan versus urban versus rural) had significant influence on readmission. CONCLUSIONS: The socioeconomic factors identified significantly influence hospital readmission and should be considered during preoperative and postoperative discharge planning for patients with early stage lung cancer.

Cholangiocarcinoma size on magnetic resonance imaging versus pathologic specimen: Implications for radiation treatment planning.

PURPOSE: The accuracy of abdominal magnetic resonance imaging (MRI) in measuring gross tumor volume in patients with resectable cholangiocarcinoma (CC) is unknown. CC is a highly difficult tumor to visualize and treatment with dose-escalated radiation therapy requires clear tumor delineation. We aim to investigate the concordance between imaging and pathologic size in patients with resected CC to determine the usefulness of MRI for image guided treatment modalities. METHODS AND MATERIALS: The records of 51 patients with resected CC who underwent preoperative MRI were evaluated. Each preoperative MRI was individually reviewed by a diagnostic radiologist (P.M.), who was blinded to pathologic measurements. A combination of dynamic multiphase contrast-enhanced T1- and T2-weighted images, original imaging reports, and pathologic reports were reviewed for greatest tumor dimensions. A general linear regression model was used to examine the outcome MRI minus pathology using MRI report, T1-weighted measurement, or T2-weighted measurement. A multivariable regression model was fit to assess the association of other factors with pathologic underestimation. RESULTS: The median age was 69 years. Eleven tumors were categorized distal/extrahepatic, 17 hilar, and 23 intrahepatic CC. The median tumor size on pathology report was 3.00 cm (range, 0.3-19). The median tumor size from the MRI report was 3 cm (range, 0.80-16.20) and median tumor size on independent radiological review was 3 cm (range, 0.90-17) on the T1-weighted and 3 cm (range, 0.90-17) on the T2-weighted MRI sequences. When compared with pathologic tumor size, the MRI report dimension was found to underestimate tumor size by 4.1 mm (P = .04). On multivariable analysis, pathologic size underestimation was influenced by increasing tumor size (slope, -0.20; P < .001); however, underestimation was not affected by tumor location or MRI sequence. CONCLUSIONS: MRI underestimates tumor size, which was more pronounced with larger tumors, but not influenced by tumor location. The potential for gross tumor volume underestimation should be considered when planning highly conformal radiation therapy treatment of CC.

Nodal Upstaging Is More Common with Thoracotomy than with VATS During Lobectomy for Early-Stage Lung Cancer: An Analysis from the National Cancer Data Base.

INTRODUCTION: Questions remain regarding differences in nodal evaluation and upstaging between thoracotomy (open) and video-assisted thoracic surgery (VATS) approaches to lobectomy for early-stage lung cancer. Potential differences in nodal staging based on operative approach remain the final significant barrier to widespread adoption of VATS lobectomy. The current study examines differences in nodal staging between open and VATS lobectomy. METHODS: The National Cancer Data Base was queried for patients with clinical stage T2N0M0 or lower lung cancer who underwent lobectomy in 2010-2011. Propensity score matching was performed to compare the rate of nodal upstaging in VATS with that in open approaches. Additional subgroup analysis was performed to assess whether rates of upstaging differed by specific clinical setting. RESULTS: A total of 16,983 lobectomies were analyzed; 4935 (29.1%) were performed using VATS. Nodal upstaging was more frequent in the open group (12.8% versus 10.3%; p < 0.001). In 4437 matched pairs, nodal upstaging remained more common for open approaches. For a subgroup of patients who had seven lymph or more nodes examined, propensity matching revealed that nodal upstaging remained more common after an open approach than after VATS (14.0% versus 12.1%; p = 0.03). For patients who were treated in an academic/research facility, however, the difference in nodal upstaging between an open and VATS approach was no longer significant (12.2% versus 10.5%, p = 0.08). CONCLUSIONS: For early-stage lung cancer, nodal upstaging was observed more frequently with thoracotomy than with VATS. However, nodal upstaging appears to be affected by facility type, which may be a surrogate for expertise in minimally invasive surgical procedures.

Ureteroscopy versus Shock Wave Lithotripsy: Factors Influencing Patient Treatment Preferences.

INTRODUCTION: Shock wave lithotripsy and ureteroscopy are considered first line treatment options for patients with urolithiasis. However, these interventions have significant variation in rates of stone-free success, procedure related complications and need for reoperation. We examined patient preferences in treatment selection for urolithiasis and factors associated with choice of treatment. METHODS: Patients with a history of urolithiasis were self-administered or mailed a questionnaire with a clinical scenario of a stone in the ureter and outcome statistics derived from a Cochrane Review for ureteroscopy and shock wave lithotripsy comparing stone-free success rates, complication rates, need for ureteral stent placement and need for additional surgery. Subjects were asked to choose ureteroscopy or shock wave lithotripsy and to indicate the relative importance that each of the 4 outcome parameters had on their treatment selection. RESULTS: A total of 163 patients returned complete surveys and a majority preferred ureteroscopy to shock wave lithotripsy (63% vs 37%, p=0.001) for the clinical scenario presented. For factors influencing procedure preference success was indicated as extremely important by 94% (152 of 163) of respondents, followed by complications, need for second surgery and, finally, need for stent. CONCLUSIONS: A majority of patients preferred ureteroscopy to shock wave lithotripsy after reviewing the evidence-based rates of stone-free success, complications and need for second surgery. Shared decision making and patient centered care should be the focus of surgical treatment selection when there is no consensus regarding a superior treatment for urolithiasis.

Novel risk stratification score for predicting early distant brain failure and salvage whole-brain radiotherapy after stereotactic radiosurgery for brain metastases.

BACKGROUND: The purpose of this study was to evaluate predictors of early distant brain failure (DBF) and salvage whole-brain radiotherapy (WBRT) after treatment with stereotactic radiosurgery (SRS) for brain metastases and create a clinically relevant risk score to stratify patients' risk for these events. METHODS: The records of 270 patients with brain metastases who were treated with SRS between 2003 and 2012 were reviewed. Pretreatment patient and tumor characteristics were analyzed with univariate and multivariate analyses. The cumulative incidences of first DBF and salvage WBRT were calculated. Significant factors were used to create a score for stratifying early (6-month) DBF risk. RESULTS: No prior WBRT, a total lesion volume < 1.3 cm(3), primary breast cancer or malignant melanoma histology, and multiple metastases (≥2) were found to be significant predictors of early DBF. Each factor was ascribed 1 point because of similar hazard ratios. Scores of 0 to 1, 2, and 3 to 4 were considered to indicate low, intermediate, and high risk, respectively. This correlated with 6-month cumulative incidences of DBF of 16.6%, 28.8%, and 54.4%, respectively (P < .001). For patients without prior WBRT, the 6-month cumulative incidence of salvage WBRT was 2%, 17.7%, and 25.7%, respectively (P < .001). CONCLUSIONS: Early DBF after SRS requiring salvage WBRT remains a significant clinical problem. Patient stratification for early DBF can better inform the decision for the initial treatment strategy for brain metastases. The provided risk score may help to predict early DBF and subsequent salvage WBRT if SRS is initially used. External validation is needed before clinical implementation.

Nonclinical Factors Associated with 30-Day Mortality after Lung Cancer Resection: An Analysis of 215,000 Patients Using the National Cancer Data Base.

BACKGROUND: Clinical variables associated with 30-day mortality after lung cancer surgery are well known. However, the effects of nonclinical factors, including insurance coverage, household income, education, type of treatment center, and area of residence, on short-term survival are less appreciated. We studied the National Cancer Data Base, a joint endeavor of the Commission on Cancer of the American College of Surgeons and the American Cancer Society, to identify disparities in 30-day mortality after lung cancer resection based on these nonclinical factors. STUDY DESIGN: We performed a retrospective cohort analysis of patients undergoing lung cancer resection from 2003 to 2011 using the National Cancer Data Base. Data were analyzed using a multivariable logistic regression model to identify risk factors for 30-day mortality. RESULTS: During our study period, 215,645 patients underwent lung cancer resection. We found that clinical variables, such as age, sex, comorbidity, cancer stage, preoperative radiation, extent of resection, positive surgical margins, and tumor size were associated with 30-day mortality after resection. Nonclinical factors, including living in lower-income neighborhoods with a lesser proportion of high school graduates, and receiving cancer care at a nonacademic medical center were also independently associated with increased 30-day postoperative mortality. CONCLUSIONS: This study represents the largest analysis of 30-day mortality for lung cancer resection to date from a generalizable national cohort. Our results demonstrate that, in addition to known clinical risk factors, several nonclinical factors are associated with increased 30-day mortality after lung cancer resection. These disparities require additional investigation to improve lung cancer patient outcomes.

Locoregional prostate cancer treatment pattern variation in independent cancer centers: policy effect, patient preference, or physician incentive?

Surveillance, Epidemiologic, and End Results (SEER) registry data abstracted from a priority 2 or higher reporting source from 2006 to 2008 were used to compare treatment patterns in 45-64-year old men diagnosed with locoregional prostate cancer (LRPC) across states with or without radiation therapy-directed certificate of need (CON) laws and across independent cancer centers (ICCs) compared to large multi-specialty groups (LMSGs). Adjusted treatment percentages for the five most common LRPC treatments (surgery, external beam radiation therapy (EBRT), combination brachytherapy with EBRT, brachytherapy, and observation) were compared using cross-sectional logistic regression between CON-unregulated and -regulated states and between LMSGs and ICCs. LRPC EBRT rates were no different across CON regions, but are increased in ICCs compared to LMSGs (37.00% vs. 13.23%, P < 0.001). Variation in LRPC treatment patterns by reporting source merits further scrutiny under the Affordable Care Act of 2010, considering the intent of incentivized accountable care organizations (ACOs) established by the Patient Protection and Affordable Care Act of 2010 (PPACA) and the implications of early descriptions of these new healthcare provider organizations on prostate cancer treatment patterns.

18F-FDG-PET/CT parameters as imaging biomarkers in oral cavity squamous cell carcinoma, is visual analysis of PET and contrast enhanced CT better than the numbers?

PURPOSE: This study was designed to seek associations between positron emission tomography/computed tomography (PET/CT) parameters, contrast enhanced neck computed tomography (CECT) and pathological findings, and to determine the potential prognostic value of PET/CT and CECT parameters in oral cavity squamous cell carcinoma (OCSCC). MATERIALS AND METHOD: 36 OCSCC patients underwent staging PET/CT and 30/36 of patients had CECT. PET/CT parameters were measured for the primary tumor and the hottest involved node, including maximum, mean, and peak standardized uptake values (SUV max, SUV mean, and SUV peak), metabolic tumor volume (MTV), total lesion glycolysis (TLG), standardized added metabolic activity (SAM), and normalized standardized added metabolic activity (N SAM). Qualitative assessment of PET/CT and CECT were also performed. Pathological outcomes included: perineural invasion, lymphovascular invasion, nodal extracapsular spread, grade, pathologic T and N stages. Multivariable logistic regression models were fit for each parameter and outcome adjusting for potentially confounding variables. Multivariable Cox proportional hazards models were used for progression free survival (PFS), locoregional recurrence free survival (LRFS), overall survival (OS) and distant metastasis free survival (DMFS). RESULTS: In multivariable analysis, patients with high (≥ median) tumor SUV max (OR 6.3), SUV mean (OR 6.3), MTV (OR 19.0), TLG (OR 19.0), SAM (OR 11.7) and N SAM (OR 19.0) had high pathological T-stage (T3/T4) (p<0.05). Ring/heterogeneous pattern on CECT qualitative assessment was associated with worse DMFS and OS. CONCLUSION: High PET/CT parameters were associated with pathologically advanced T stage (T3/T4). Qualitative assessment of CECT has prognostic value. PET/CT parameters did not predict clinical outcome.

Do 18F-FDG PET/CT parameters in oropharyngeal and oral cavity squamous cell carcinomas indicate HPV status?

OBJECTIVE: The aim of this study was to explore the relationship of PET/CT parameters with human papillomavirus (HPV) status of oropharyngeal (OP) and oral cavity (OC) squamous cell carcinomas (SCCs). PATIENTS AND METHODS: We retrospectively reviewed 39 patients with OC and OP-SCC who underwent staging 18F-FDG PET/CT. PET/CT parameters were measured for the primary tumor and the hottest involved node, including SUV max, SUV mean, SUV peak, metabolic tumor volume, total lesion glycolysis, standardized added metabolic activity (SAM), and normalized SAM. Patient characteristics were compared between HPV positive (HPV+) and negative (HPV-) groups. Receiver operating characteristic analysis was used to dichotomize PET/CT parameters into high and low. Logistic regression models predicting HPV status were fit for each PET/CT parameter. RESULTS: The HPV+ group was composed of 18 patients all with OP-SCC; the HPV- group consisted of 21 patients, 4 OP cancer patients and 17 OC cancer patients. The HPV+ group had a higher proportion of N2 stage (94% vs 43%; P < 0.001). Nodal PET/CT parameters were higher in the HPV+ group (P < 0.01); this difference was not present for the primary lesion. After adjusting for sex and age, the association of higher nodal SUV max (odds ratio [OR], 9.67), SUV mean (OR, 10.48), SUV peak (OR 9.67), metabolic tumor volume (OR, 14.52), total lesion glycolysis (OR, 11.84), and SAM, normalized SAM (OR, 16.21) with HPV+ status remained statistically significant (P < 0.05). CONCLUSIONS: Nodal PET/CT parameters predict HPV status. High nodal FDG uptake should raise suspicion for positive HPV status in the evaluation of the primary lesion.

Postoperative radiotherapy is associated with better survival in non-small cell lung cancer with involved N2 lymph nodes: results of an analysis of the National Cancer Data Base.

INTRODUCTION: Use of postoperative radiotherapy (PORT) in non-small-cell lung cancer remains controversial. Limited data indicate that PORT may benefit patients with involved N2 nodes. This study evaluates this hypothesis in a large retrospective cohort treated with chemotherapy and contemporary radiation techniques. METHODS: The National Cancer Data Base was queried for patients diagnosed 2004-2006 with resected non-small-cell lung cancer and pathologically involved N2 (pN2) nodes also treated with chemotherapy. Multivariable Cox proportional hazards model was used to assess factors associated with overall survival (OS). Inverse probability of treatment weighting (IPTW) using the propensity score was used to reduce selection bias. OS was compared between patients treated with versus without PORT using the adjusted Kaplan-Meier estimator and weighted log-rank test based on IPTW. RESULTS: Two thousand and one hundred and fifteen patients were eligible for analysis. 918 (43.4%) received PORT, 1197 (56.6%) did not. PORT was associated with better OS (median survival time 42 months with PORT versus 38 months without, p = 0.048). This effect was significant in multivariable and IPTW Cox models (hazard ratio: 0.87, 95% confidence interval: 0.78-0.98, p = 0.026, and hazard ratio: 0.89, 95% confidence interval: 0.79-1.00, p = 0.046, respectively). No interaction was seen between the effects of PORT and number of involved lymph nodes (p = 0.615). CONCLUSIONS: PORT was associated with better survival for patients with pN2 nodes also treated with chemotherapy. No interaction was seen between benefit of PORT and number of involved nodes. These findings reinforce the benefit of PORT for N2 disease in modern practice using the largest, most recent cohort of chemotherapy-treated pN2 patients to date.

Socioeconomic risk factors for long-term mortality after pulmonary resection for lung cancer: an analysis of more than 90,000 patients from the National Cancer Data Base.

BACKGROUND: Several clinical variables, such as tumor stage and age, are well established factors associated with long-term survival after surgical resection of lung cancer. Our aim was to examine the impact of other clinical and demographic variables, controlling for known predictors of long-term survival, in order to investigate how outcomes varied according to important nonclinical factors. STUDY DESIGN: The National Cancer Data Base, jointly supported by the Commission on Cancer of the American College of Surgeons and the American Cancer Society, was used to identify patients undergoing pulmonary resection for lung cancer and perform a retrospective cohort study. The cohort consisted of patients diagnosed with nonsmall cell lung cancer from 2003 to 2006, who underwent resection; overall survival data are available only for patients diagnosed through 2006. A Cox proportional hazards survival model was used to examine factors associated with risk of mortality. RESULTS: A total of 92,929 patients were identified as diagnosed during the study period and undergoing surgical resection for lung cancer. On multivariable analysis, several socioeconomic factors such as lack of insurance, lower income, less education, and treatment at community centers vs academic or research programs predicted worse overall survival after controlling for disease characteristics known to be predictors of worse survival, such as tumor stage, histology, age, and extent of resection. CONCLUSIONS: Diminished long-term survival after pulmonary resection was associated with a number of socioeconomic factors. To date, this represents the largest database analysis of long-term mortality in patients undergoing surgical resection for lung cancer. The disparities in survival outcomes reported here require further detailed investigation.

Neighborhood influences on girls' obesity risk across the transition to adolescence.

BACKGROUND AND OBJECTIVES: The neighborhoods in which children live, play, and eat provide an environmental context that may influence obesity risk and ameliorate or exacerbate health disparities. The current study examines whether neighborhood characteristics predict obesity in a prospective cohort of girls. METHODS: Participants were 174 girls (aged 8-10 years at baseline), a subset from the Cohort Study of Young Girls' Nutrition, Environment, and Transitions. Trained observers completed street audits within a 0.25-mile radius around each girl's residence. Four scales (food and service retail, recreation, walkability, and physical disorder) were created from 40 observed neighborhood features. BMI was calculated from clinically measured height and weight. Obesity was defined as BMI-for-age ≥ 95%. Logistic regression models using generalized estimating equations were used to examine neighborhood influences on obesity risk over 4 years of follow-up, controlling for race/ethnicity, pubertal status, and baseline BMI. Fully adjusted models also controlled for household income, parent education, and a census tract measure of neighborhood socioeconomic status. RESULTS: A 1-SD increase on the food and service retail scale was associated with a 2.27 (95% confidence interval, 1.42 to 3.61; P < .001) increased odds of being obese. A 1-SD increase in physical disorder was associated with a 2.41 (95% confidence interval, 1.31 to 4.44; P = .005) increased odds of being obese. Other neighborhood scales were not associated with risk for obesity. CONCLUSIONS: Neighborhood food and retail environment and physical disorder around a girl's home predict risk for obesity across the transition from late childhood to adolescence.

Necrotizing sialometaplasia-like change of the esophageal submucosal glands is associated with Barrett's esophagus.

The esophageal submucosal glands (SMG) protect the squamous epithelium from insults such as gastroesophageal reflux disease by secreting mucins and bicarbonate. We have observed metaplastic changes within the SMG acini that we have termed oncocytic glandular metaplasia (OGM), and necrotizing sialometaplasia-like change (NSMLC). The aim of this study is to evaluate the associated clinicopathological parameters of, and to phenotypically characterize the SMG metaplasias. Esophagectomy specimens were retrospectively assessed on hematoxylin and eosin sections and assigned to either a Barrett's esophagus (BE) or non-BE control group. Clinicopathologic data was collected, and univariate analysis and multivariate logistic regression models were performed to assess the adjusted associations with NSMLC and OGM. Selected cases of SMG metaplasia were characterized. SMG were present in 82 esophagi that met inclusion criteria. On univariate analysis, NSMLC was associated with BE (p = 0.002). There was no relationship between NSMLC and patient age, sex, tumor size, or treatment history. OGM was associated with BE (p = 0.031). No relationship was found between OGM and patient age, sex, or tumor size. On multivariate analysis, BE was independently associated with NSMLC (odds ratio [OR] 4.95, p = 0.003). Treatment history was also independently associated with OGM (p = 0.029), but not NSMLC. Both NSMLC and OGM were non-mucinous ductal type epithelia retaining a p63-smooth muscle actin co-positive myoepithelial cell layer. NSMLC and OGM were present in endoscopic mucosal resection specimens. Our study suggests that SMG metaplasia is primarily a reflux-induced pathology. NSMLC may pose diagnostic dilemmas in resection specimens or when only partially represented in mucosal biopsies or endoscopic resection specimens.

The influence of radiation therapy dose escalation on overall survival in unresectable pancreatic adenocarcinoma.

PURPOSE: Radiation therapy (RT) dose escalation in unresectable pancreatic adenocarcinoma (PAC) remains investigational. We examined the association between total RT dose and overall survival (OS) in patients with unresectable PAC. METHODS AND MATERIALS: National cancer data base (NCDB) data were obtained for patients who underwent definitive chemotherapy and RT (chemo-RT) for unresectable PAC. Univariate (UV) and multivariate (MV) survival analysis were performed along with Kaplan-Meier (KM) estimates for incremental RT dose levels. RESULTS: A total of 977 analyzable patients met inclusion criteria. Median tumor size was 4.0 cm (0.3-40 cm) and median RT dose was 45 Gy. Median OS was 10 months (95% CI, 9-10 months). On MV analysis RT dose <30 Gy [HR, 2.38 (95% CI, 1.85-3.07); P<0.001] and RT dose ≥30 to <40 Gy [HR, 1.41 (95% CI, 1.04-1.91); P=0.026] were associated with lower OS when compared with dose ≥55 Gy. Patients receiving RT doses from 40 to <45, 45 to <50, 50 to <55, and ≥55 Gy did not differ in OS. CONCLUSIONS: Lack of benefit to OS with conventionally delivered RT above 40 Gy is shown. Optimal RT dose escalation methods in unresectable PAC remain an important subject for investigation in prospective clinical trials.

Pharmacoeconomic analysis of palifermin to prevent mucositis among patients undergoing autologous hematopoietic stem cell transplantation.

Trials have shown benefits of palifermin in reducing the incidence and severity of oral mucositis in patients with hematological malignancies undergoing autologous hematopoietic stem cell transplantation (HSCT) with total body irradiation (TBI)-based conditioning regimens. Similar outcome data are lacking for patients receiving non-TBI-based regimens. We performed a retrospective evaluation on the pharmacoeconomic benefit of palifermin in the setting of non-TBI-based conditioning and autologous HSCT. Between January 2002 and December 2010, 524 patients undergoing autologous HSCT for myeloma (melphalan 200 mg/m²) and lymphoma (high-dose busulfan, cyclophosphamide, and etoposide) as preparative regimen were analyzed. Use of patient-controlled analgesia (PCA) was significantly lower in the palifermin-treated groups (myeloma: 13% versus 53%, P < .001; lymphoma: 46% versus 68%, P < .001). Median total transplant charges were significantly higher in the palifermin-treated group, after controlling for inflation (myeloma: $167,820 versus $143,200, P < .001; lymphoma: $168,570 versus $148,590, P < .001). Palifermin treatment was not associated with a difference in days to neutrophil engraftment, length of stay, and overall survival and was associated with an additional cost of $5.5K (myeloma) and $14K (lymphoma) per day of PCA avoided. Future studies are suggested to evaluate the cost-effectiveness of palifermin compared with other symptomatic treatments to reduce transplant toxicity using validated measures for pain and quality of life.

Chemoradiation therapy sequencing for resected pancreatic adenocarcinoma in the National Cancer Data Base.

BACKGROUND: Pancreatic adenocarcinoma (PAC) has low overall survival (OS) rates and high recurrence rates following surgical resection. The role for preoperative radiation therapy (prRT) for PAC versus postoperative RT (poRT) remains uncertain. The authors used the National Cancer Data Base (NCDB) to report prRT outcomes for the largest multi-institutional patient cohort to date. METHODS: NCDB data were obtained for all patients who underwent resection and external beam radiation (RT) for PAC from 1998 to 2002. Patients with metastatic (M1) disease, intraoperative RT, RT both before and after surgery, missing OS, or missing RT variables were excluded. Univariate (UV) and multivariate (MV) analysis were run using treatment characteristics, tumor characteristics, and patient demographics. The difference in patients' known characteristics was described by a chi-square test or analysis of variance. RESULTS: A total of 5414 patients were identified. Of these, 277 received prRT and 5137 received poRT. Overall, 92.9% received chemotherapy and 7.1% received RT alone; 56% (2990 of 5307) of patients had stage III disease, according to American Joint Commission on Cancer (AJCC) staging manual, 5th edition. Median tumor size was 3 cm (range: 0-9.9 cm); 82% (199 of 244) of patients with prRT had negative surgical margins; 72% (3383 of 4699) of patients with poRT had negative margins. Forty-one percent (71 of 173) of patients with prRT were lymph node (LN)-positive; 65% (3159 of 4833) of patients with poRT were LN-positive. Median OS for patients with prRT was 18 months (95% CI = 18-19 months) and for patients with poRT, 19 months (95% CI = 17-22 months). CONCLUSIONS: Receipt of prRT was associated with lower stage, higher rates of negative margins, and lower rates of lymph node positivity at resection. However, there was no significant difference in median OS versus that of the poRT group.

The association between C-reactive protein (CRP) level and biochemical failure-free survival in patients after radiation therapy for nonmetastatic adenocarcinoma of the prostate.

BACKGROUND: C-reactive protein (CRP) has been associated with outcomes in patients with metastatic adenocarcinoma of the prostate. Associations between prostate adenocarcinoma-specific endpoints and CRP in patients who are treated for localized disease remain unknown. METHODS: In total, 206 patients who received radiation therapy for adenocarcinoma of the prostate had at least 1 CRP measured in follow-up and were analyzed. The primary outcome was biochemical failure-free survival. In addition, associations were examined between CRP and prostate-specific antigen (PSA). RESULTS: On univariate analysis, higher CRP levels were associated significantly with shorter biochemical failure-free survival for patients who received radiation therapy after undergoing radical prostatectomy. For patients who were managed with definitive radiation therapy alone, higher CRP levels also were associated significantly with shorter biochemical failure-free survival on univariate and multivariable analyses (hazard ratio, 2.03; 95% confidence interval, 1.19-3.47; P = .009). In addition, CRP levels were associated significantly with PSA after radical prostatectomy for patients who had Gleason scores ≥ 8 (P = .037), for high-risk patients (P = .008), and for those with pretreatment PSA levels > 20 ng/mL (P = .05). In patients who received definitive radiation therapy, CRP levels also were associated with PSA both for those with pretreatment PSA levels > 20 ng/mL (P < .001), and for the intermediate-risk (P = .029) and high-risk (P = .009) subgroups. CONCLUSIONS: A higher CRP level was associated with shorter biochemical failure-free survival on univariate and multivariable analyses in patients who received definitive radiation therapy. CRP was also associated with PSA in exploratory subgroups. These findings warrant further exploration in a prospectively enrolled patient cohort.