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AIM AND BACKGROUND: We describe a successful implementation of a departmental incident learning system (ILS) across a regionally expanding academic radiation oncology department, dovetailing with a structured integration of the safety and quality program across clinical sites. MATERIALS AND METHODS M: Over 6 years between 2011 and 2017, a long-standing departmental ILS was deployed to 4 clinical locations beyond the primary clinical location where it had been established. We queried all events reported to the ILS during this period and analyzed trends in reporting by clinical site. The chi-square test was used to determine whether differences over time in the rate of reporting were statistically significant. We describe a synchronous development of a common safety and quality program over the same period. RESULTS: There was an overall increase in the number of event reports from each location over the time period from 2011 to 2017. The percentage increase in reported events from the first year of implementation to 2017 was 457% in site 1, 166.7% in site 2, 194.3% in site 3, 1025% in site 4, and 633.3% in site 5, with an overall increase of 677.7%. A statistically significant increase in the rate of reporting was seen from the first year of implementation to 2017 (p

Many eligible women with invasive breast cancer do not receive recommended adjuvant radiation (RT), despite its role in local control and overall survival. We examined trends in RT use over 10 years, and the impact of sociodemographic factors on the receipt of standard-of-care RT, using the National Cancer Database (NCDB). Women under age 70 with invasive breast cancer who underwent BCS from 2004 to 2014 were analyzed. Receipt of RT was evaluated in the whole cohort and by time period to identify temporal trends. Multiple logistic regression models were used to assess associations between factors such as race, insurance status, ethnicity, and receipt of RT. A total of 501,733 patients met eligibility criteria. The percentage of patients undergoing adjuvant RT increased from 86.7% in 2004 to 92.4% in 2012, and then decreased in 2013 and 2014 to 88.9%. On univariate analysis, patients of white race were significantly more likely to receive RT compared with patients of black race (90.4% vs 86.9%, p

Purpose The associations among radiation fractionation, body mass index (BMI), and acute skin toxicity with adjuvant radiation for breast cancer is of increasing interest. This study evaluated the rate of grade ≥2 dermatitis and moist desquamation (MD) in patients with a high BMI who were treated to the breast or chest wall to understand the role of radiation target, fractionation regimen, and BMI. Methods and materials We retrospectively evaluated 280 patients treated with adjuvant radiation for breast cancer after up-front surgery. We collected information on patient demographics, disease and treatment characteristics, and acute skin toxicities. Multiple logistic regression models were used to evaluate for predictors of grade ≥2 dermatitis and MD. Results Patients undergoing post-mastectomy radiation therapy (PMRT) had the highest rate of MD (24%). The rate was lower (8.7%) among lumpectomy patients, but those receiving conventional fractionation had a higher rate of MD (10.9%) compared with hypofractionated therapy (1.8%; P = .05). Among lumpectomy patients, chemotherapy use (odds ratio, 3.74; P = .04) and regional nodal irradiation (odds ratio, 3.29; P = .03) were also significant predictors of MD. Despite an elevated average BMI among lumpectomy patients, hypofractionated therapy resulted in lower rates of skin toxicity. Conclusions We identified multiple risk factors for acute skin toxicity, including the use of PMRT and conventionally fractionated regimens. Elevated BMI, regional nodal irradiation, and chemotherapy use were associated with an increased risk of MD. Our findings highlight the need to explore the use of less toxic hypofractionated regimens in patients who are at the highest risk of acute skin toxicity, including those with a higher BMI and those receiving PMRT.

Purpose To develop a multidisciplinary algorithmic approach to management of women aged ≥70 years with clinically staged T1N0 hormone receptor–positive breast cancer, including geriatric assessments predicting life expectancy and the likelihood of functional decline in the near future, in the context of a program-wide quality improvement initiative, to better select patients for therapeutic interventions. Methods and Materials Two geriatric assessment tools, the Combined Lee-Schonberg Index and the Vulnerable Elderly Scale, were introduced into our clinical workflow to predict long-term mortality and likelihood of functional decline. Scores from these tools, along with patient preferences and clinical features, were incorporated into a preoperative algorithm addressing the use of sentinel lymph node biopsy (SLNB), and a postoperative algorithm addressing the use of adjuvant radiation therapy (RT). Results The algorithms were approved for use in August 2015. Twenty-four patients were identified by in-clinic screening and have been managed using the algorithms as a guide. Mean patient age was 80 years (range, 71-89 years). Per the preoperative algorithm, consideration of omission of SLNB was an option in 11 of 24 patients (46%), and in total 18 of 24 (75%) opted against SLNB. Per the postsurgical algorithm, consideration of omission of adjuvant RT was an option for 19 of 24 patients (79%), and in total 17 of 24 (71%) opted to forego RT. Conclusion Incorporation of simple geriatric assessments seems to have had a marked impact on decision making regarding both surgical and adjuvant therapies for women aged ≥70 years with early-stage hormone-positive breast cancer compared with historical patterns, with ≥71% omission of both SLNB and adjuvant RT in patients managed according to an institutional quality improvement initiative.

Although the use of postmastectomy radiation therapy (PMRT) is widely accepted in certain clinical situations, areas of controversy persist for some clinical scenarios. In addition, with significant shifts in the management of breast cancer, including omission of axillary nodal dissection in select sentinel node-positive patients and increased use of neoadjuvant chemotherapy, new clinical challenges have arisen regarding the role of PMRT. This article reviews the data to support current recommendations for postmastectomy radiation and explores areas of controversy and the studies that guide clinicians in these scenarios.

Stereotactic body radiotherapy (SBRT) is an emerging treatment option for borderline resectable and locally advanced, unresectable pancreatic cancer (PCA). However, no standardized guidelines for treatment exist and patterns of SBRT use for PCA are unclear. Radiation oncologists known to use SBRT in the setting of PCA were invited to complete a 26-item Web-based survey on practice patterns. Thirty of the 36 (83 %) invited radiation oncologists completed the survey. Of the responders, 86 % treat with 6–8 Gy ×5 fractions. The majority (93 %) of responders use four-dimensional computed tomography (4D-CT) for simulation, with 50 % using gating for breathing motion. Two thirds of radiation oncologists use fiducials for tumor localization. Most (79 %) responders noted an improvement in patient-reported pain after SBRT. Approximately, 59 % report difficulty obtaining insurance clearance for pancreas SBRT in the absence of a clinical trial. The largest variations in practice were related to gross tumor volume (GTV) to planning target volume (PTV) expansions and management of respiratory motion. SBRT is increasingly used for PCA. The data presented here indicate that the majority of radiation oncologists treat with 6–8 Gy ×5 fractions and use fiducials with 4D-CT simulation for localization and planning. Although the majority of the surveyed physicians prefer SBRT to standard radiation, it may be underutilized due to the difficulty of obtaining insurance approval outside of a clinical trial. Our investigation documents current pancreas SBRT practice patterns and highlights the need for prospective clinical trials as a means to develop consensus guidelines for this emerging treatment.

Purpose This guideline systematically reviews the evidence for treatment of pancreatic cancer with radiation in the adjuvant, neoadjuvant, definitive, and palliative settings and provides recommendations on indications and technical considerations. Methods and Materials The American Society for Radiation Oncology convened a task force to address 7 key questions focused on radiation therapy, including dose fractionation and treatment volumes, simulation and treatment planning, and prevention of radiation-associated toxicities. Recommendations were based on a systematic literature review and created using a predefined consensus-building methodology and system for grading evidence quality and recommendation strength. Results The guideline conditionally recommends conventionally fractionated or stereotactic body radiation for neoadjuvant and definitive therapy in certain patients and conventionally fractionated regimens for adjuvant therapy. The task force suggests a range of appropriate dose-fractionation schemes and provides recommendations on target volumes and sequencing of radiation and chemotherapy. Motion management, daily image guidance, use of contrast, and treatment with modulated techniques are all recommended. The task force supported prophylactic antiemetic medication, and patients may also benefit from medications to reduce acid secretion. Conclusions The role of radiation in the management of pancreatic cancer is evolving, with many ongoing areas of active investigation. Radiation therapy is likely to become even more important as new systemic therapies are developed and there is increased focus on controlling local disease. It is important that the nuances of available data are discussed with patients and families and that care be coordinated in a multidisciplinary fashion.

Clinically apparent pulmonary toxicities are quite rare after radiation for breast cancer, and thus data regarding pulmonary toxicity from breast radiation is relatively limited and heterogeneous. The pulmonary toxicity profile includes the acute/subacute toxicity radiation pneumonitis (RP), as well as late toxicities of pulmonary fibrosis and secondary lung cancers. Here we review available data regarding the range of pulmonary toxicities observed after adjuvant breast radiation, as well as techniques for minimization.

Background: We sought to determine whether patients with high-volume, low-risk prostate cancer are suitable candidates for ultrasound-guided brachytherapy, monotherapy alone, without supplemental external beam radiation. Materials and Methods: The study cohort comprised 200 consecutive patients who received ultrasound.guided monotherapy from November 02, 1998 to March 26, 2010. Real.time intraoperative treatment planning was performed for all patients. 145. Gy with I125 was prescribed to the prostate with no margin. The primary endpoint was time to prostate-specific antigen. (PSA) failure using the phoenix definition. Cox multivariable regression analysis was used to determine the factors significantly associated with time to PSA failure. Results: Median follow-up was 59 months (range 1.2–146.8 months). The median PSA was 5.0 ng/ml. For the overall cohort, both 5- and 8-year PSA failure-free survival was 92.3% (95% confidence interval [95% CI]: 86.5–95.7%). Low-risk patients per the NCCN criteria had 5- and 8-year PSA failure-free survival of 93.6%. On cox multivariable analysis, only baseline PSA (adjusted hazard ratio: 1.29 [95% CI: 1.02–1.65], P = 0.036) was associated with outcome. Among patients with < 33% cores positive, 33–< 50% cores positive, and ≥50% cores positive, the 5-year PSA failure-free survival was 92.3% (95% CI: 85.1–96.1%), 91.0% (95% CI: 68.5–97.6%), and 93.3% (95% CI: 61.2–99.0%), respectively. Conclusions: Our analysis indicates that patients with a high number of cores positive for cancer can be adequately treated with modern brachytherapy as monotherapy and be spared the additional morbidity and cost of supplemental external beam radiation or androgen deprivation therapy.

The optimal approach to managing incident learning system (ILS) reports remains unclear. Here, we describe our experience with prospective coding of events reported to the ILS with comparisons of risk scores on the basis of event type and process map location.Reported events were coded by type, origin, and method of discovery. Events were given a risk priority number (RPN) and near-miss risk index (NMRI) score. We compared workflow versus near-miss events with respect to origin and detection in the process map and by risk scores. A χDuring 2016, 1351 events were reported. Of these events, 1300 (96.2%) were workflow and 51 (3.8%) near-miss events. Workflow events were more likely to both originate (1041 of 1300 events; 81.2%) compared with near-miss events (31 of 51 events; 62.7%; P = .005) and be detected in pre-treatment (997 of 1300 events; 76.7%) compared with near-miss events (24 of 51 events; 47%; P.001). Average occurrence (scale: 1-10) was 6.14 for workflow versus 3.33 for near-miss events (P.001), average severity was 2.94 versus 7.35 (P.001), and average detectability was 1.33 versus 4.67 (P.001). Mean overall RPN was 22.4 for workflow versus 108.4 for near-miss events (P = .07) and mean NMRI was 1.16 versus 3.19, respectively. Events that originated and were detected in treatment delivery had the greatest mean overall RPN (38.2 and 32.1, respectively) and NMRI scores (1.62 and 1.6, respectively).Our experience demonstrates that workflow event reports are far more common than near-misses and that near-miss events are more likely to both originate and be discovered in later treatment phases. The frequency of workflow reports highlights the imperative need for safety and operational teams to work collaboratively to maximize the benefit of ILS. We suggest a potential utility of the RPN system to guide mitigation strategies for future near-miss events.

Purpose To explore seromarker levels for associations with outcomes in locally advanced pancreatic cancer (LAPC) patients who received chemotherapy and stereotactic body radiation therapy (SBRT). Methods and Materials Serum from LAPC patients in 2 prospective trials of hypofractionated SBRT (5-6.6 Gy × 5) was collected before SBRT. Proximity ligation assay quantified the expression levels of 36 pancreatic cancer–specific candidate seromarkers: Axl, BMP2, CA 125, CA 19-9, CEA, CXCL-1/6/9/10, EGFR, Gas6, Her2, IGF-2, IGFBP-2/3/7, IL-6/6Ra/7/8/12, mesothelin, MMP-1/2/3/7, osteopontin, PDGFRa, PDK1, PF4, RegIV, SPARC, TGF-β, VEGF-A/D, and YKL40. Seromarker values were log transformed owing to log-normal distribution of the values, and Cox regression analysis was performed to assess for any association with overall survival. The Benjamini-Hochberg method was used to control for a false discovery rate (FDR) of only 10%. Results Sixty-four patients with LAPC were included. No clinical factors (including surgical resection, receipt of pre-SBRT chemotherapy, receipt of post-SBRT chemotherapy, performance status, and age) or potential biomarkers in the panel were associated with improved survival in this cohort after application of the FDR correction. Potential prognostic factors for improved survival for future investigation included surgical resection (P=.007, adjusted P=.153) and the serum expression of IL-8 (P=.006, adjusted P=.153), CA 19-9 (P=.031, adjusted P=.377), and MMP-1 (P=.036, adjusted P=.377). Conclusions These data explore the expression of a panel of proteins in pre-SBRT serum of LAPC patients in the context of a conservative FDR correction. None of the clinical factors or expression levels of the serum proteins were found to be associated with survival; however, IL-8, CA 19-9, and MMP-1 were highlighted as possible candidates warranting inclusion in future seromarker studies in the ongoing efforts to identify tools for risk stratification and treatment allocation in LAPC.

Purpose To determine which specific comorbidities predispose men to excess mortality by androgen deprivation therapy (ADT) given before and during brachytherapy for prostate cancer. Methods and Materials We analyzed 5972 men with T1c–T3b prostate cancer treated with brachytherapy-based radiation with or without neoadjuvant ADT. Cox multivariable analysis with propensity scoring was used to determine if ADT was associated with increased all-cause mortality (ACM) in men divided into groups stratified by cardiac comorbidities. Tests for interaction between risk group and outcome were performed. Results ADT was associated with increased ACM in men with a history of myocardial infarction or congestive heart failure, regardless of whether they underwent revascularization (adjusted hazard ratio [AHR], 2.1 [95% confidence interval {CI}, 1.02–4.17; p = 0.04]) or not (AHR, 1.8 [95% CI, 1.05–3.20; p = 0.03]), but this effect was not seen in men with less severe comorbidity. However, among men with diabetes, there was a significant interaction with risk group (p = 0.01) such that ADT was associated with excess mortality in men with low-risk disease (AHR = 2.21 [1.04–4.68]; p = 0.04) but not in men with intermediate or high-risk disease (AHR, 0.64 [0.33–1.22]; p = 0.17). Conclusions ADT was associated with excess ACM in all patients with a history of congestive heart failure or myocardial infarction, regardless of whether they were revascularized, and in diabetics with low-risk disease. ADT for gland downsizing before brachytherapy should be avoided in these men.

The National Comprehensive Cancer Network guidelines currently endorse salvage local therapy as a reasonable alternative to observation or androgen-deprivation therapy for select men with a biopsy-proven local recurrence after definitive radiation for prostate cancer. Patients being considered for salvage therapy should have had localized disease at presentation, a prostate-specific antigen10 at recurrence, a life expectancy10 years at recurrence, and a negative metastatic workup. In this systematic review, we synthesize the current literature describing the oncologic efficacy and toxicity profile of salvage brachytherapy, prostatectomy, cryotherapy, and high-intensity focused ultrasound. We found 5-year biochemical control rates to be similar across treatments, in the range of 52%-56%, although patient selection and definition of failure was variable. Toxicity profiles were also distinct between local salvage modalities.

Mentoring in academic medicine has been described on a multitude of levels in medical literature, but seldom with respect to medical students. In fact, although some fields have addressed mentoring in the context of medical student education, radiation oncology has yet to do so in a comprehensive fashion. Furthermore, the projected domestic and worldwide epidemiologic trends in cancer cases, coupled with the frequent use of radiation-based cancer treatment regimens, make this an opportune moment to initiate such a discussion. Herein, the authors consider mentoring in the context of radiation oncology and related fields from the perspective of a medical student. They present a paradigm for promoting mentorship through traditional classroom-based and nontraditional socially and research-based initiatives. It is the authors' hope that both radiation oncology and other specialties will benefit from the initiation of this discussion, as well as build on the suggestions detailed here as we prepare the next generation of radiation oncologists.

Background: Prostate volume can affect whether patients qualify for brachytherapy (desired size ≥20 mL and ≤60 mL) and/or active surveillance (desired PSA density ≤0.15 for very low risk disease). This study examines variability in prostate volume measurements depending on imaging modality used (ultrasound versus MRI) and volume calculation technique (contouring versus ellipsoid) and quantifies the impact of this variability on treatment recommendations for men with favorable-risk prostate cancer. Methods: We examined 70 patients who presented consecutively for consideration of brachytherapy for favorable-risk prostate cancer who had volume estimates by three methods: contoured axial ultrasound slices, ultrasound ellipsoid (height × width × length × 0.523) calculation, and endorectal coil MRI (erMRI) ellipsoid calculation. Results: Average gland size by the contoured ultrasound, ellipsoid ultrasound, and erMRI methods were 33.99, 37.16, and 39.62 mLs, respectively. All pairwise comparisons between methods were statistically significant (all p

Background The Radiation Therapy Oncology Group 96-01 randomized trial demonstrated the benefit of adding androgen deprivation therapy (ADT) to salvage radiotherapy for an increasing prostate-specific antigen (PSA) after prostatectomy, but it is unknown whether modern patients followed with ultrasensitive PSA and salvaged at a low PSA (ie, ≤ 0.5) also benefit from ADT. Patients and Methods The cohort comprised 108 patients who received radical prostatectomy (RP), were followed by ultrasensitive PSA, and received salvage radiotherapy at a PSA of 0.5 or less. Sixty patients had negative margins, and 48 patients had positive margins at RP. Cox multivariable regression analysis was performed to identify factors associated with time to secondary PSA failure and included PSA at salvage, year of treatment, Gleason score, ADT use, margin status, T stage, and PSA doubling time. Occurrence of distant metastases was documented. Results Median follow-up after radiation was 63.09 months. A total of 24 patients had a distant metastasis. In all patients, ADT use was associated with a decreased risk of recurrence (hazard ratio [HR], 0.44; 95% confidence interval [CI], 0.25-0.79; P = .006). On subgroup analysis, ADT was associated with a decreased risk of failure among patients with negative margins (HR, 0.27; 95% CI, 0.12-0.61; P = .002), but not among men with positive margins (HR, 0.78; 95% CI, 0.29-2.10; P = .63). Conclusions Even patients followed with ultrasensitive PSA and salvaged early with a PSA ≤ 0.5 seem to benefit from the addition of ADT to salvage radiation. However, this benefit seemed to be limited to men with negative margins; thus, men with positive margins and PSA ≤ 0.5 may be good candidates for salvage radiation alone.

Surgery and radiation therapy represent the only curative options for many patients with solid malignancies. However, despite the recommendations of their physicians, some patients refuse these therapies. This study characterized factors associated with refusal of surgical or radiation therapy as well as the impact of refusal of recommended therapy on patients with localized malignancies.We used the Surveillance, Epidemiology, and End Results program to identify a population-based sample of 925,127 patients who had diagnoses of 1 of 8 common malignancies for which surgery and/or radiation are believed to confer a survival benefit between 1995 and 2008. Refusal of oncologic therapy, as documented in the SEER database, was the primary outcome measure. Multivariable logistic regression was used to investigate factors associated with refusal. The impact of refusal of therapy on cancer-specific mortality was assessed with Fine and Gray's competing risks regression.In total, 2441 of 692,938 patients (0.4%) refused surgery, and 2113 of 232,189 patients (0.9%) refused radiation, despite the recommendations of their physicians. On multivariable analysis, advancing age, decreasing annual income, nonwhite race, and unmarried status were associated with refusal of surgery, whereas advancing age, decreasing annual income, Asian American race, and unmarried status were associated with refusal of radiation (P.001 in all cases). Refusal of surgery and radiation were associated with increased estimates of cancer-specific mortality for all malignancies evaluated (hazard ratio [HR], 2.80, 95% confidence interval [CI], 2.59-3.03; P.001 and HR 1.97 [95% CI, 1.78-2.18]; P.001, respectively).Nonwhite, less affluent, and unmarried patients are more likely to refuse curative surgical and/or radiation-based oncologic therapy, raising concern that socioeconomic factors may drive some patients to forego potentially life-saving care.

Preoperative chemoradiotherapy (preopCRT) for locally advanced rectal cancer is associated with grade 3 or higher acute gastrointestinal (GI) toxicity. This study was conducted to determine whether intensity-modulated radiation therapy (IMRT) significantly reduces acute GI toxicity, compared to 3-dimensional conformal RT (3D-CRT) in preopCRT for rectal cancer.A retrospective analysis was conducted of 48 patients treated between January 2002 and August 2010 with preopCRT for rectal cancer. 3D-CRT or IMRT was administered at a planned dose of 45-50.4 Gy to patients positioned prone on a bowel-displacement device. Data regarding patient and tumor characteristics, treatment, acute toxicity, and tumor response were collected. Comparisons of acute toxicity and treatment response between 3D-CRT and IMRT were performed with the Chi-square or Fisher's exact test.There were no significant differences in radiation dose, median age, race, gender, stage, type of concurrent chemotherapy, pathologic complete response (pCR), or type of surgery (lower anterior or abdominal perineal resection) between 3D-CRT and IMRT. There was a significant reduction in grade 2 or higher GI toxicity (3D-CRT, 60.7%; IMRT, 30%; P = .036) and grade 2 or higher diarrhea (3D-CRT, 42.8%; IMRT, 10%; P = .014). Two patients who underwent 3D-CRT required a treatment break (grade 3 diarrhea and grade 3 dehydration). Radiation duration was significantly less (IMRT, 35 days; 3D-CRT, 39 days; P ≤ .0001). pCR rates were 16.7% for 3D-CRT and 21.4% for IMRT (nonsignificant [NS]); pCR+microscopic residual rates were 57.1% for IMRT and 27.8% for 3D-CRT (P = .093).Maximal bowel displacement with IMRT yields favorable acute GI toxicity and pathologic downstaging profiles, as compared to 3D-CRT in preoperative CRT for rectal cancer and warrants further prospective investigation.

Objective To report the relative incidence of the perceived reduction in penile size across prostate cancer treatment modalities and to describe its effect on quality of life and treatment regret. Materials and Methods The incidence of patient complaints about reduced penile size was calculated for 948 men in the Comprehensive, Observational, Multicenter, Prostate Adenocarcinoma (COMPARE) registry who experienced biochemical failure (per registry definition) and were assessed a median of 5.53 years after prostatectomy or radiotherapy (RT) consisting of either external beam RT or brachytherapy, with or without androgen deprivation therapy (ADT). Multivariate logistic regression analysis was used to determine the factors associated with treatment regret and interference with emotional relationships. Results Of 948 men, 25 (2.63%) complained of a reduced penile size. The incidence of reduced penile size stratified by treatment was 3.73% for surgery (19 of 510), 2.67% for RT plus ADT (6 of 225), and 0% for RT without ADT (0 of 213). The surgery (P = .004) and RT plus ADT (P = .016) groups had significantly more shortened penis complaints than the RT alone group. The rate of a shortened penis after surgery and after RT plus ADT was similar (P = .47). On multivariate analysis adjusting for age, treatment type, and baseline comorbidity, a perceived reduction in penile size was associated with interference with close emotional relationships (odds ratio 2.36, 95% confidence interval 1.02-8.26; P = .04) and increased treatment regret (odds ratio 3.37, 95% confidence interval 1.37-8.26; P = .0079). Conclusion Complaints about a reduced penile size were more common with RT plus ADT or surgery than RT alone and were associated with greater interference with close emotional relationships and increased treatment regret. Physicians should discuss the possibility of this rarely mentioned side effect with their patients to help them make more informed treatment choices.

Whether androgen deprivation therapy (ADT) causes excess cardiovascular deaths in men with prostate cancer is highly controversial and was the subject of a joint statement by multiple medical societies and a US Food and Drug Administration safety warning.To perform a systematic review and meta-analysis of randomized trials to determine whether ADT is associated with cardiovascular mortality, prostate cancer-specific mortality (PCSM), and all-cause mortality in men with unfavorable-risk, nonmetastatic prostate cancer.A search of MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials databases for relevant randomized controlled trials in English between January 1, 1966, and April 11, 2011.Inclusion required nonmetastatic disease, intervention group with gonadotropin-releasing hormone agonist-based ADT, control group with no immediate ADT, complete information on cardiovascular deaths, and median follow-up of more than 1 year.Extraction was by 2 independent reviewers. Summary incidence, relative risk (RR), and CIs were calculated using random-effects or fixed-effects models.Among 4141 patients from 8 randomized trials, cardiovascular death in patients receiving ADT vs control was not significantly different (255/2200 vs 252/1941 events; incidence, 11.0%; 95% CI, 8.3%-14.5%; vs 11.2%; 95% CI, 8.3%-15.0%; RR, 0.93; 95% CI, 0.79-1.10; P = .41). ADT was not associated with excess cardiovascular death in trials of at least 3 years (long duration) of ADT (11.5%; 95% CI, 8.1%-16.0%; vs 11.5%; 95% CI, 7.5%-17.3%; RR, 0.91; 95% CI, 0.75-1.10; P = .34) or in trials of 6 months or less (short duration) of ADT (10.5%; 95% CI, 6.3%-17.0%; vs 10.3%; 95% CI, 8.2%-13.0%; RR, 1.00; 95% CI, 0.73-1.37; P = .99). Among 4805 patients from 11 trials with overall death data, ADT was associated with lower PCSM (443/2527 vs 552/2278 events; 13.5%; 95% CI, 8.8%-20.3%; vs 22.1%; 95% CI, 15.1%-31.1%; RR, 0.69; 95% CI, 0.56-0.84; P.001) and lower all-cause mortality (1140/2527 vs 1213/2278 events; 37.7%; 95% CI, 27.3%-49.4%; vs 44.4%; 95% CI, 32.5%-57.0%; RR, 0.86; 95% CI, 0.80-0.93; P.001).In a pooled analysis of randomized trials in unfavorable-risk prostate cancer, ADT use was not associated with an increased risk of cardiovascular death but was associated with a lower risk of PCSM and all-cause mortality.

Purpose To report the mature data of a prospective Phase II trial designed to evaluate the efficacy of an epidermal growth factor receptor inhibitor cetuximab (CTX) added to the concurrent therapy of weekly paclitaxel/carboplatin (PC) and daily radiation therapy (RT). Methods and Materials From 2005 to 2009, a total of 43 patients were enrolled in the study. The median follow-up was 31 months (range, 9–59 months). All patients had Stage III/IV disease at presentation, and 67% had oropharyngeal primaries. The weekly IV dose schedules were CTX 250 mg/m2 (400 mg/m2 IV loading dose 1 week before RT), paclitaxel 40 mg/m2, and carboplatin AUC 2. RT was given at 1.8 Gy per day to 70.2 Gy. Intensity-modulated RTwas used in 70% of cases. Results All patients completed the planned RT dose, 74% without any treatment breaks. The planned CTX and PC cycles were completed in 70% (91% with at least seven of planned nine cycles) and 56% (93% with at least seven of planned eight cycles) of patients, respectively. Toxicity included Grade 3 mucositis (79%), rash (9%), leucopenia (19%), neutropenia (19%), and RT dermatitis (16%). The complete response (CR) rate at the completion of therapy was 84%. The estimated 3-year local regional control rate was 72%. Six patients with an initial CR subsequently experienced a local recurrence, 10 patients experienced distant progression. The median overall survival and disease-free survivals have not been reached. The 3-year actuarial overall survival and disease-free survival were 59% and 58%, respectively. Conclusions The addition of CTX to weekly PC and daily RT was well tolerated and resulted in encouraging local control and survival rates.

Objective Stereotactic body radiotherapy (SBRT) is an emerging treatment option for borderline resectable and locally advanced, unresectable pancreatic cancer (PCA). However, no standardized guidelines for treatment exist and patterns of SBRT use for PCA are unclear.

38 Background: The relative incidence of reduced penis size across prostate cancer treatment modalities is not well-known. Methods: The incidence of physician-reported patient complaints about reduced penis size was calculated for 948 men in the COMPARE registry who experienced PSA failure and were assessed a median of 5.45 (2.6-8.9 IQ range) years after prostatectomy or radiation (RT) consisting of either external beam or brachytherapy. Multivariable logistic regression was used to determine factors associated with poorer sexual function and incontinence. Results: Of 948 men, 25 (2.63%) complained of a reduced penis size. The incidence of reduced penis size by treatment was: surgery (19/510=3.73%), RT plus androgen deprivation therapy (ADT) (6/225=2.67%), RT without ADT (0/213=0%). Surgery (p=0.004) and RT+ADT (p=0.016) had significantly more short penis complaints than RT alone. Rates of shortened penis for surgery and for RT+ADT were similar (p=0.47). On multivariable analysis adjusting for age and treatment type, short penis was associated with poorer sexual function (Odds ratio: 2.430, 95% CI: 1.046-5.643) (p=0.0389) and more incontinence (Odds ratio: 4.671, 95% CI: 1.985-10.994) (p=0.0004). Conclusions: Complaints about reduced penis size were more common with RT+ADT or surgery than with RT alone, and were associated with poorer sexual function and incontinence issues.

249 Background: Prostate volume affects whether patients qualify for brachytherapy (desired size ≥20mL and ≤60mL) or active surveillance (desired PSA density ≤0.15). This study examines variability in prostate volume as determined by contoured axial ultrasound slices, ultrasound ellipsoid (HxWxL) calculation, and endorectal coil MRI (erMRI) ellipsoid calculation, and quantifies the impact of this variability on treatment recommendations for men with favorable-risk prostate cancer. Methods: The study examined 72 patients who presented consecutively for consideration of brachytherapy for favorable-risk prostate cancer who had 3 volume estimates from direct contouring on ultrasound axial slices (2.5mm thickness), the ultrasound ellipsoid method, and the erMRI ellipsoid method. Results: Average gland size by the contoured ultrasound, ellipsoid ultrasound, and eMRI methods were 34.22, 37.15, and 39.58 mLs, respectively. All pairwise comparisons between methods were significant (all p60 mL) or contoured ultrasound measures (7 patients 60 mL). 40 patients (55.56%) were very low risk (PSA density ≤0.15 ng/dl) as calculated using ellipsoid ultrasound volumes, while 35 (48.61%) and 39 patients (54.17%) were very low risk using contoured ultrasound and eMRI volumes, respectively. Conclusions: The ultrasound ellipsoid and erMRI ellipsoid methods appeared to overestimate ultrasound contoured volume by an average of 8.56% and 15.65% respectively. 32.35% of those who qualified for brachytherapy based on ellipsoid ultrasound volume would be disqualified based on ultrasound contoured and/or erMRI volume. As treatment recommendations increasingly rely on estimates of prostate size, clinicians must consider method of volume estimation.

435 Background: Pre- and post-treatment FDG-PET imaging parameters may be useful for predicting pR following neoadjuvant CRT for LARC Methods: Between 2006 and 2010, 18 patients (pts) receiving preoperative CRT (5FU or capecitabine with concurrent 50.4 Gy conformal radiation) for LARC underwent a pre- (0-14 days before) and post-CRT (4 to 6 weeks after) PET/CT. Total mesorectal excision was performed 6 weeks post CRT. pR was dichotomized into complete (pCRs) and partial responders as reference standard. Pts with pathologic microscopic disease were classified as pCRs for this analysis. Changes in FDG metabolic parameters between pre and post-CRT scans, including maximum Standardized Uptake Value (SUVmax), metabolic tumor volume (MTV) and total glycolytic activity (TGA), were investigated as predictive imaging biomarkers for pR. Fixed SUVmax percentage threshold (30%, 40% and 50%) and gradient-based segmentation (PET Edge) were used to calculate the MTV and TGA. Receiver Operator Curve analysis was performed Results: Median pt age was 57.5 years (31-87); 67% M; 61% AJCC 2010 stage II, 33% III and 6% IV. pCR achieved in 44%. The 30% SUVmax threshold MTV best correlated with PET Edge MTV (Pearson r 0.99). Using ROC analysis, % change in SUVmax and PET edge TGA between pre and post-CRT scans were comparable and the most accurate parameters for predicting pR. SUVmax % change yielded an area under the curve (AUC) of 0.7125 (95% CI 0.4318-0.9932), while the AUC for PET Edge TGA % change was 0.7000 (95% CI 0.4209-0.9791). Based on ROC analysis, a cutoff of 78.9% change of PET Edge TGA had a likelihood ratio of 2.4, with a sensitivity of 90% and a specificity of 62.5% for predicting pCR. A cutoff of 88.7% change of PET Edge MTV yielded a likelihood ratio of 2.00 with a sensitivity of 50% and a specificity of 75%. Conclusions: The % change pre- to post-CRT in SUVmax and PET Edge Total Glycolytic Activity appears to be the most suitable FDG metabolic parameters for predicting pR following neoadjuvant CRT for LARC. As such, these PET-FDG biomarkers of CRT response should be validated in future prospective trials.