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Postmastectomy radiation therapy (PMRT) delivered to an immediate reconstruction increases the risk of surgical complications. Although acellular dermal matrix (ADM) has been used with immediate tissue expander (TE) reconstruction to improve cosmetic outcomes and minimize capsular contracture, there is a paucity of data on this approach in the setting of PMRT. Thirty-two patients with stage I to III breast cancer were treated with mastectomy, immediate TE-ADM reconstruction, and PMRT between 2009 and 2012 in a prospective single-arm study. The primary objective was the "success" rate, determined by the number of patients at 2 years after PMRT having an intact final reconstruction, no major complications, and a cosmetic outcome rated by a physician as excellent or good. The median follow-up was 24 months. Final reconstruction status was known in 31 of 32 patients (96.9%; 1 patient left the country) and completed in 29 of 31 patients (93.5%; implant, n = 26; flap, n = 1; both, n = 2; none, n = 2). At 2 years, 6 patients were unevaluable (metastatic disease, n = 3; withdrawn consent, n = 1; left the country, n = 2). Of 26 evaluable patients, the success rate was 65.4% (17 of 26). Lack of success was the result of "fair" cosmesis (n = 2), infection (n = 2), severe capsular contracture (n = 1), major revision (n = 2), and no final reconstruction (n = 2). Most patients had good-to-excellent 2-year overall cosmesis based on patient perception (15; 62.5%) and physician evaluation (19; 79.2%). To the best of our knowledge, this is the first dedicated prospective trial evaluating long-term cosmetic and complication outcomes in patients treated with immediate TE-ADM reconstruction followed by PMRT. Most patients (65.4%) met the success criteria in this prospective single-arm series. The great majority (93.5%) achieved final reconstruction; most had good-to-excellent overall cosmetic outcomes (79.2%). The results with longer follow-up will be of interest, and further investigation of strategies to optimize reconstruction with PMRT are warranted. [ABSTRACT FROM AUTHOR]

Older patients make up the majority of patients with pancreatic cancer, with a median age of 71 years at diagnosis. However, older patients are underrepresented in clinical trials in pancreatic cancer. This study investigates trends in age distribution of patients enrolled in clinical trials for advanced pancreatic cancer over time, and examines outcomes and toxicity in older patient subgroups from two studies conducted by Eastern Cooperative Oncology Group and American College of Radiology Imaging Network (ECOG-ACRIN) in this disease. 16,042 patients from 38 phase III clinical trials for locally advanced or metastatic pancreatic adenocarcinoma published between 1997 and 2016 were identified and included in this analysis. Outcomes and toxicity by age were examined in two of the trials, ECOG-ACRIN trials E2297 and E6201, which included a total of 1146 patients. The median age across the trials was 62.7 years; median ages for individual trials ranged from 57 years to 66 years. Weighted linear regression showed no significant change in median age over time. Combined analysis of the two ECOG-ACRIN trials demonstrated higher rates of fatigue, thrombocytopenia, and infection in those ≥75 years compared with those <75 years, but despite this showed no difference in overall survival (OS) or progression-free survival (PFS) (OS: 5.7 vs. 5.6 months and PFS: 2.8 vs 3.5 months). Enrollment of older adults in phase III pancreatic cancer clinical trials has not increased over time, despite increasing number of older patients seen in clinic. Increased efforts are needed to enhance enrollment of older patients in clinical trials, and to promote trials specifically for older patients, in order to improve the evidence base for treating this patient population. [ABSTRACT FROM AUTHOR]

Prescribed nature walks frequently yield improvements to mood and cognition as observed in experimental studies. Research that uses real life settings such as self-determined time exercising outdoors for restorative health benefits may more accurately elicit effects than time-specified study protocols. This study examined in situ psycho-cognitive outcomes of routine walks in urban greenspace to test the concept that self-set exposure duration and not context alone is related to magnitude of psycho-cognitive benefit. Pre-post measurements taken on a diverse participant pool of individuals walking in urban parks and recruited on random days over a two-week period found significant associations between outdoor activity duration and cognitive and mood improvements. Greater outdoor walking duration linearly predicted stronger processing speeds but non-linearly in tests of other cognitive domains. Results of fixed effects model for mean mood change following green exercise show outdoor walking influenced mood change at highest levels of significance, even after accounting for individual level variability in duration. Mood improved for all durations of outdoor walking under a random effects model with high significance. Untethering fixed intervals of outdoor exercise from formal study design revealed briefer but more frequent nature engagement aligned with nature affinity. The influence of unmeasured factors, e.g., nature affinity or restorative conditioning, for prescriptive durations of urban green exercise merits further investigation toward designing wellbeing interventions directed at specific urban populations. [ABSTRACT FROM AUTHOR]

Purpose: To determine whether total energy (TE) reaching the microwave (MW) applicator or net energy (NE) exiting the applicator (after correcting for reflectivity) correlates better with hepatic MW ablation zone dimensions than manufacturer-provided chart predictions.Materials and Methods: Single-applicator, nonoverlapping ablations of 93 liver tumors (0.7-5.9 cm) were performed in 52 adult patients. TE and NE were recorded for each ablation. Long axis diameter (LAD), short axis diameter (SAD), and volume (V) of each ablation zone were measured on magnetic resonance imaging or computed tomography after the procedure and retrospectively compared with TE; NE; and manufacturer-provided chart predictions of LAD, SAD, and V using correlation and regression analyses.Results: For treated tumors, mean (± SD) TE and NE were 49.8 kJ (± 22.7) and 36.4 kJ (± 19.4). Mean LAD, SAD, and V were 5.8 cm (± 1.3), 3.7 cm (± 0.8), and 44.1 cm(3) (± 25.4). Correlation coefficients (95% confidence interval) with LAD, SAD, and V were 0.46 (0.28, 0.61), 0.52 (0.36, 0.66), and 0.52 (0.36, 0.66) for TE; 0.42 (0.24, 0.58), 0.55 (0.39, 0.68), and 0.53 (0.36, 0.66) for NE; and 0.51 (0.34, 0.65), 0.63 (0.49, 0.74), and 0.60 (0.45, 0.73) for chart predictions. Using regression analysis and controlling for TE, SAD was 0.34 cm larger in patients with cirrhosis than in patients without cirrhosis.Conclusions: Correcting for reflectivity did not substantially improve correlation of energy values with MW ablation zone size parameters and did not outperform manufacturer-provided chart predictions. Correlations were moderate and variable using all methods. The results suggest a disproportionate influence of tissue factors on MW ablation results. [ABSTRACT FROM AUTHOR]

Purpose: Toxicity, pathologic complete response, and long-term outcomes are reported for the neoadjuvant therapies assessed in a randomized phase 2 Eastern Cooperative Oncology Group and American College of Radiology Imaging Network trial for operable esophageal adenocarcinoma, staged as II-IVa by endoscopy/ultrasonography (EUS).Methods and Materials: A total of 86 eligible patients began treatment. For arm A, preoperative chemotherapy was cisplatin, 30 mg/m(2), and irinotecan, 50 mg/m(2), on day 1, 8, 22, 29 during 45 Gy radiation therapy (RT), 1.8 Gy per day over 5 weeks. Adjuvant therapy was cisplatin, 30 mg/m(2), and irinotecan, 65 mg/m(2) day 1, 8 every 21 days for 3 cycles. Arm B therapy was cisplatin, 30 mg/m(2), and paclitaxel, 50 mg/m(2), day 1, 8, 15, 22, 29 with RT, followed by adjuvant cisplatin, 75 mg/m(2), and paclitaxel, 175 mg/m(2), day 1 every 21 days for 3 cycles. Stratification included EUS stage and performance status.Results: In arm A, median overall survival was 35 months, and 5-, 6-, and 7-year survival rates were 46%, 39%, and 35%, respectively, whereas for arm B, they were 21 months and 27%, 27%, and 23%, respectively. Median progression- or recurrence-free survival (PFS) was 39.8 months with a 3-year PFS of 50% for arm A and 12.4 months (P=.046) with 3-year PFS of 28% for arm B. Eighty percent of the observed incidents of progression occurred within 19 months. Survival did not differ significantly by EUS and performance status strata.Conclusions: Long-term survival was similar for both arms and did not appear superior to results achieved with other standard regimens. [ABSTRACT FROM AUTHOR]

Purpose Deep inspiration breath hold (DIBH) is used to decrease cardiac irradiation during radiation therapy (RT) for breast cancer. The patients most likely to benefit and the impact on treatment time remain largely unknown. We sought to identify predictors for the use of DIBH and to quantify differences in dosimetry and treatment time using a prospective registry. Methods and materials A total of 150 patients with left breast cancer were enrolled. All patients were simulated with both free breathing (FB) and DIBH. RT was delivered by either modality. Alternate scans were planned with use of deformable registration to include identical RT volumes. DIBH patients were monitored by a real-time surface tracking system, AlignRT (Vision RT, Ltd, London, United Kingdom). Baseline characteristics and treatment times were compared by Fisher exact test and Wilcoxon rank sum test. Dosimetric endpoints were analyzed by Wilcoxon signed rank test, and linear regression identified predictors for change in mean heart dose (∆MHD). Results We treated 38 patients with FB and 110 with DIBH. FB patients were older, more likely to have heart and lung disease, and less likely to receive chemotherapy or immediate reconstruction (all P < .05). Treatment times were not significantly different, but DIBH patients had greater variability in times ( P = .0002). Of 146 evaluable patients, DIBH resulted in > 20 cGy improvement in MHD in 107 patients but a > 20 cGy increase in MHD in 14. Both MHD and lung V20 were significantly lower in DIBH than in paired FB plans. On multivariate analysis, younger age (4.18 cGy per year; P < .0001), higher body mass index (6.06 cGy/kg/m 2 ; P = .0018), and greater change in lung volumes (130 cGy/L; P = .003) were associated with greater ∆MHD. Conclusions DIBH improves cardiac dosimetry without significantly impacting treatment time in most patients. Greater inspiratory lung volumes augment this benefit. Because the improvement with DIBH was not uniform, patients should be scanned with both FB and DIBH. [ABSTRACT FROM AUTHOR]

Background: The Supplemental Nutrition Assistance Program (SNAP) aims to alleviate hunger among its beneficiaries by providing benefits to purchase nutritious foods. Objective: We conducted a comprehensive dietary analysis of low- income adults and examined differences in dietary intake between SNAP participants and nonparticipants. Design: The study population comprised 3835 nonelderly adults with a household income ≤130% of the federal poverty level from the 1999-2008 NHANES. The National Cancer Institute method was used to estimate the distributions of usual intake for dietary outcomes. Relative differences in dietary intake by SNAP participation were estimated with adjustment for sociodemographic characteristics and household food security. Results: Few low-income adults consumed recommended amounts of whole grains, fruit, vegetables, fish, and nuts/seeds/legumes. Conversely, many low-income adults exceeded recommended limits for processed meats, sweets, and bakery desserts and sugar-sweetened beverages. Approximately 13-22% of low-income adults did not meet any food and nutrient guidelines; virtually no adults met all of the guidelines. Compared with nonparticipants, SNAP participants consumed 39% fewer whole grains (95% CI: -57%, -15%), 44% more 100% fruit juice (95% CI: 0%, 107%), 56% more potatoes (95% CI: 18%, 106%), 46% more red meat (95% CI: 4%, 106%), and, in women, 61% more sugar-sweetened beverages (95% CI: 3%, 152%). SNAP participants also had lower dietary quality scores than did nonparticipants, as measured by a modified Alternate Healthy Eating Index. Conclusion: Although the diets of all low-income adults need major improvement, SNAP participants in particular had lower-quality diets than did income-eligible nonparticipants. [ABSTRACT FROM AUTHOR]

Purpose: Postorchiectomy adjuvant radiotherapy (RT) for Stage I seminoma can be associated with long-term toxicity, and management strategies with a lower treatment burden achieve the same excellent cure rate. Because studies suggest that radiation oncologists in the United States continue to recommend RT for these patients, we sought to identify factors associated with management recommendations. Methods and Materials: We conducted a one-time internet-based survey among 491 randomly selected American radiation oncologists self-described as specializing in genitourinary oncology. Results: Response rate was 53% (n = 261). Forty-nine percent of respondents worked in university-affiliated practices. Sixty-two percent of respondents always/usually recommended adjuvant RT for patients with Stage I seminoma, whereas 21% always/usually recommended surveillance and 3% always/usually recommended chemotherapy. One third (33%) expressed concerns that patients who experienced relapse during surveillance could not be salvaged. Although 88% of physicians were aware of an increased risk of second malignant neoplasms (SMN) after adjuvant RT, 85% underestimated its magnitude. Compared with physicians not typically recommending RT, physicians who always/usually recommended RT were more likely to believe that patients might not be salvaged at relapse during surveillance (p = 0.008) and were less aware of the association between RT and SMN (p = 0.04). Conclusions: Respondents who always/usually recommend postorchiectomy RT for patients with Stage I seminoma are more likely to underestimate late RT morbidity and to believe that surveillance is associated with increased mortality. Given the equivalent efficacy and reduced morbidity of surveillance compared with RT, our findings underscore the need for ongoing physician education to increase appropriate clinical implementation of surveillance strategies. [Copyright &y& Elsevier]

Purpose: Oxaliplatin is a platinum analog and radiosensitizer active in colorectal cancer. We performed a Phase I trial to test the safety and preliminary efficacy of adding oxaliplatin to standard preoperative chemoradiation therapy for rectal cancer. Methods and Materials: Eligible patients had T3 to T4 rectal adenocarcinoma. Patients received standard-dose radiation (50.4 Gy for 5.5 weeks) with concurrent infused 5-fluorouracil (5-FU) at 200 mg/m2 per day, 7 days per week. Oxaliplatin was given three times at 14-day intervals at 55, 70, or 85 mg/m2 during the 5.5-week radiation period, before resection. Adjuvant therapy consisted of four cycles of 5-FU (500 mg/m2 per week) with leucovorin (500 mg/m2 per week) given every 6 weeks. The main goals were to identify the maximum tolerated dose of oxaliplatin and the dose-limiting toxicities when given with 5-FU and RT. Secondary goals were to determine resectability, pathologic response, sphincter preservation, and overall survival rates. Results: Twenty-one patients were enrolled, 5 at the 55 mg/m2 oxaliplatin dose level, 5 at 70 mg/m2, and 11 at 85 mg/m2. All patients were able to complete the preoperative chemoradiation regimen with no dose adjustments. No dose-limiting toxicities or differences in the type or extent of toxicity were noted among the groups. Nineteen patients underwent surgery (three abdominopelvic resections and 16 low anterior resections), for an 84% sphincter preservation rate. The pathologic complete response rate was 26% (5 patients), and minimal microscopic residual tumor was found in 21% (4 additional patients). Conclusions: Oxaliplatin was well tolerated at 85 mg/m2 given every 2 weeks in combination with standard preoperative chemoradiation for rectal cancer. The rates of major pathologic response and sphincter preservation are promising. [Copyright &y& Elsevier]

Neurologic death is the most serious consequence of intracranial disease among patients with brain metastases. Identifying patients with brain metastases at increased risk of neurologic death can improve care and guide further research. We sought to delineate factors predictive of neurologic death among patients with brain metastases. We identified 1218 patients with newly diagnosed brain metastases managed at Brigham and Women's Hospital/Dana-Farber Cancer Institute from 2008–2015. Factors predictive of neurologic death were assessed via univariable and multivariable Fine and Gray competing risks regression. On multivariable analysis, neurologic death was associated with number of brain metastases (hazard ratio [HR] 1.01 per 1 metastasis increase, 95% confidence interval [CI] 1.01–1.02, P < 0.001) and 3 primary tumor sites (reference=non-small cell lung cancer): melanoma (HR 4.67, 95% CI 3.27–6.68, P < 0.001), small cell lung cancer (HR 2.33, 95% CI 1.47–3.68, P < 0.001), and gastrointestinal cancer (HR 2.21, 95% CI 1.28–3.82, P = 0.005). Conversely, a reduction in neurologic death was found in patients with good Karnofsky performance status (90–100 vs. 30-80, HR 0.67, 95% CI 0.48–0.95, P = 0.03) and progressive extracranial metastases at diagnosis of intracranial disease (HR 0.50, 95% CI 0.38–0.67, P = 0.001). Among patients with breast primaries, HER2+ patients displayed increased neurologic death relative to the reference of HR+/HER2– (univariable analysis only: HR 2.41, 95% CI 1.00–5.84, P = 0.05). Patients with melanoma, small cell lung cancer, gastrointestinal cancer, and HER2+ breast cancer primaries, as well as greater intracranial versus extracranial disease burden, harbor significant risk of neurologic death. Future research investigating novel intracranial approaches should focus on these populations. [ABSTRACT FROM AUTHOR]

Myxopapillary ependymoma (MPE) is a rare, typically slow-growing subtype of spinal ependymomas. There are no standard guidelines for radiotherapy and long-term outcomes after radiation, particularly patterns of relapse, for pediatric and young adult (YA) patients with MPE remain under-characterized. This is an Institutional Review Board-approved multi-institutional retrospective cohort study of 60 pediatric and YA patients diagnosed with MPE and received radiotherapy between 2000-2020. Clinical and treatment characteristics, and long-term outcomes were recorded. Site(s) of progression was compared to radiation fields. Survival outcomes were analyzed using Kaplan-Meier method. Cumulative incidence of local in-field progression (CILP) after initial radiotherapy was analyzed using Gray's method with out-of-field-only progression as a competing risk. Univariate analyses were performed using Cox proportional hazard's model. The median age at radiation was 14.8 years (range: 7.1-26.5). At time of radiotherapy, 45 (75.0%) and 35 (58.3%) patients had gross residual and multifocal disease, respectively. Forty-eight (80.0%), seven (11.7%) and five (8.3%) patients received involved field radiotherapy, craniospinal irradiation, and whole spine radiation, respectively. Median follow-up from end of radiotherapy was 6.2 years (range: 0.6-21.0). Five-year overall survival, progression-free survival, and CILP were 100%, 60.8% and 4.1%, respectively. Both local recurrences were at sites of gross residual disease. Of the eighteen out-of-field first recurrences after radiotherapy, all were superior to the initial treatment field and nine had intracranial relapse. On univariate analyses, distant-only recurrence before radiation (HR: 4.00, 95% CI: 1.54-10.43, p = 0.005) was significantly associated with shorter time to progression. While the risk of recurrence within the radiation field is low, pediatric and YA patients with high-risk MPE remain at risk for recurrences in the spine above the radiation field and intracranially after radiotherapy. Future prospective studies are needed to investigate the appropriate radiation field and dose based on the extent of metastases. [ABSTRACT FROM AUTHOR]

Background Global temperature and the frequency of extreme weather events are projected to increase and affect indoor exposure to outdoor particulate matter (PM); however, no studies have quantitatively examined the effect of climate change on particle infiltration and indoor PM exposure. Obective To quantify the relationship between future changes in ambient temperature and fine particle (PM 2.5 ) infiltration in the Greater Boston area. Methods We assembled a large database of outdoor and indoor PM 2.5 data from 340 homes, and used the indoor-outdoor sulfur ratio ( S r ) as a surrogate for PM 2.5 infiltration. We employed linear mixed-effects models to examine the relationship between S r and ambient temperature for all homes in the database and a subgroup of naturally ventilated homes. We used projected temperature data from 1981 to 2000 and 2046–2065 to predict future changes in S r . Results The summer-winter difference in S r was calculated to be 30% and 54% for all homes and in the naturally ventilated subgroup, respectively. The largest future difference in S r (21%) was linked to differences in prevalence of air conditioning. Furthermore, S r was predicted to increase by 7% for naturally ventilated homes and 2% for all homes in summer, corresponding to an average increase of 2–3 °C in future temperature. Conclusions We found that increases in future temperature due to climate change will be associated with increased PM 2.5 infiltration, particularly in summer. The predicted temperature-related changes in S r can be used to characterize future health risk due to elevated indoor PM 2.5 exposure through increased particle infiltration. [ABSTRACT FROM AUTHOR]

Purpose: Although chemoradiation using 5-fluorouracil (5-FU) and mitomycin-C (MMC) is the standard of care in the treatment of anal cancer, many patients are unable to tolerate MMC. This Phase II clinical trial was performed to determine whether cisplatin could replace MMC in the treatment of anal cancer. Methods and Materials: Thirty-three patients with localized anal cancer were enrolled. One patient registered but never received any assigned therapy and was excluded from all analyses. Between February 1, 1993, and July 21, 1993, 19 patients were accrued to Cohort 1. Radiation consisted of 45 Gy to the primary tumor and pelvic nodes, followed by a boost to the primary and involved nodes to 59.4 Gy. A planned 2-week treatment break was used after 36 Gy. Concurrent chemotherapy consisted of 5-FU 1,000 mg/m2/day on Days 1 to 4 and cisplatin 75 mg/m2 on Day 1. A second course of 5-FU and cisplatin was given after 36 Gy, when the patient resumed radiation therapy. Between April 4, 1996, and September 23, 1996, an additional 13 patients (Cohort 2) were accrued to the study and received the same treatment except without the planned treatment break. Results: Complete response was seen in 78% (90% CI, 63–89) of patients and was higher in patients who did not get a planned treatment break (92% vs. 68%). The overall Grade 4 toxicity rate was 31%. One treatment-related death (Grade 5) occurred in a patient who developed sepsis. The 5-year overall survival was 69%. Conclusions: Radiation therapy, cisplatin, and 5-FU resulted in an overall objective response (complete response + partial response) of 97%. Although the 5-year progression-free survival was only 55%, the overall 5-year survival was 69%. Given the excellent salvage provided by surgery, this study affirms that cisplatin-based regimens may be an alternative for patients who cannot tolerate the severe hematologic toxicities associated with mitomycin-based chemoradiation regimens. [ABSTRACT FROM AUTHOR]

Purpose: To describe patterns of failure (POF) after reirradiation (reRT) with intensity modulated radiation therapy (IMRT) for recurrent/second primary squamous cell carcinoma of the head and neck.Methods: From 08/2004-02/2013, 75 consecutive patients received reRT with IMRT. Gross tumor was generally treated with a 5mm planning target volume (PTV) margin. For postoperative cases, a 5mm PTV was added to the clinical target volume which included the postoperative bed. Elective neck coverage was not standard. POF were characterized by correlating the recurrent tumor location on CT-imaging with the reRT IMRT plan.Results: Patients received definitive reRT (55%) or postoperative reRT (45%) to a median 60Gy (range, 59.4-70Gy). Most patients (88%) received concurrent chemotherapy including induction (16%). The median overall survival was 1.8years. Isolated local-regional recurrence (LRR) was the most common failure-type (2-year cumulative incidence [CI] 22.5% [95% C.I. 13.6-32.7%]), but concurrent LRR and distant-failure occurred frequently (2-year CI LRR+distant-failure 19.6% [95% C.I. 11.3-29.5%]); isolated distant-failure was rare (2-year CI 5.7% [95% C.I. 1.8-12.8%]). The 2-year in-field control was 65% (95% C.I. 52-81%) reflecting encouraging control within the irradiated target. Patients with gross disease were more likely to recur in-field (p=0.02), whereas postoperative patients were more likely to recur out-of-field/marginally than in-field (p=0.02).Conclusions: POF after reRT differ when treating gross disease or postoperatively and should be considered when delineating reRT targets. Aggressive local therapy resulted in favorable in-field control, yet there remains a high competing risk of regional and distant micrometastatic disease. Better systemic agents are needed to control clinically occult local-regional and distant disease. [ABSTRACT FROM AUTHOR]

Purpose To compare clinical outcomes of image-based versus non-image-based interstitial brachytherapy (IBBT) for vaginal cancer. Methods and materials Of 72 patients with vaginal cancer treated with brachytherapy (BT), 47 had image guidance (CT = 31, MRI = 16) and 25 did not. Kaplan–Meier (KM) estimates were generated for any recurrence, local control (LC), disease-free interval (DFI), and overall survival (OS) and Cox models were used to assess prognostic factors. Results Median age was 66 and median follow-up time was 24 months. Median cumulative EQD2 dose was 80.8 Gy in the non-IBBT group and 77 Gy in the IBBT group. For non-IBBT versus IBBT, the 2-year KM LC was 71% vs. 93% ( p = 0.03); DFI was 54% vs. 86% ( p = 0.04); and OS 52% vs. 82% ( p = 0.35). On multivariate analysis, IBBT was associated with better DFI (HR 0.24, 95% CI 0.07–0.73). Having any 2 or more of chemotherapy, high-dose-rate (HDR) BT or IBBT (temporally correlated variables) significantly reduced risk of relapse (HR = 0.33, 95% CI = 0.13–0.83), compared to having none of these factors. Conclusion Over time, the use of chemotherapy, HDR, and IBBT has increased in vaginal cancer. The combination of these factors resulted in the highest rates of disease control. Image-guided brachytherapy for vaginal cancer patients maximizes disease control. [ABSTRACT FROM AUTHOR]

Purpose: The objective of this cross-sectional study was to characterize long-term breast pain in patients undergoing breast-conserving surgery and radiation (BCT) and to identify predictors of this pain.Methods and Materials: We identified 355 eligible patients with Tis-T2N0M0 breast cancer who underwent BCT in 2007 to 2011, without recurrent disease. A questionnaire derived from the Late Effects Normal Tissue Task Force (LENT) Subjective, Objective, Management, Analytic (SOMA) scale was mailed with 7 items detailing the severity, frequency, duration, and impact of ipsilateral breast pain over the previous 2 weeks. A logistic regression model identified predictors of long-term breast pain based on questionnaire responses and patient, disease, and treatment characteristics.Results: The questionnaire response rate was 80% (n=285). One hundred thirty-five patients (47%) reported pain in the treated breast, with 19 (14%) having pain constantly or at least daily; 15 (11%) had intense pain. The pain interfered with daily activities in 11 patients (8%). Six patients (4%) took analgesics for breast pain. Fourteen (10%) thought that the pain affected their quality of life. On univariable analysis, volume of breast tissue treated to ≥105% of the prescribed dose (odds ratio [OR] 1.001 per cc, 95% confidence interval [CI] 1.000-1.002; P=.045), volume treated to ≥110% (OR 1.009 per cc, 95% CI 1.002-1.016; P=.012), hormone therapy use (OR 1.95, 95% CI 1.12-3.39; P=.02), and other sites of pain (OR 1.79, 95% CI 1.05-3.07; P=.03) predicted for long-term breast pain. On multivariable analysis, volume ≥110% (OR 1.01 per cc, 95% CI 1.003-1.017; P=.007), shorter time since treatment (OR 0.98 per month, 95% CI 0.96-0.998; P=.03), and hormone therapy (OR 1.84, 95% CI 1.05-3.25; P=.03) were independent predictors of pain.Conclusion: Long-term breast pain was common after BCT. Although nearly half of patients had pain, most considered it tolerable. Dosimetric inhomogeneity independently predicted for pain and should be minimized to the greatest extent possible. [ABSTRACT FROM AUTHOR]

Background and purpose The goals of this study were to determine the rate and risk factors of rectal bleeding (RB) after external beam radiotherapy and vaginal brachytherapy (EBRT + VB), and to compare these data to previously unreported RB rates from PORTEC-2 patients receiving EBRT or VB alone. Materials and methods Retrospective chart review identified 212 endometrial cancer patients receiving adjuvant EBRT + VB between 2006 and 2013. Patient-reported RB data were also obtained from PORTEC-2 patients randomized to EBRT ( n = 166) or VB ( n = 182). The two populations were compared using an RB scale of symptom severity. Results After a median 35 months, 17.9% of EBRT + VB patients ( n = 38) experienced any RB with 1.9% ( n = 4) having bleeding requiring intervention. Age ⩽70 years was the only predictor of RB (OR 2.8; 95% CI 1.1–8.7; p = 0.027). Rates of patient-reported RB after EBRT were similar with 15.0% ( n = 25) having any RB and 0.6% ( n = 1) having “very much” bleeding. On regression analysis, any EBRT (either EBRT alone or EBRT + VB) increased the risk of RB compared to those who received VB alone (OR 3.0; p = 0.0028; 95% CI 1.4–6.7). The rates of more severe RB were low and did not significantly differ between treatments. Conclusions Significant RB is rare after radiation. EBRT has higher rates of rectal bleeding than VB. The addition of VB to EBRT does not significantly alter bleeding rates. [ABSTRACT FROM AUTHOR]

Context Distressing symptoms interfere with the quality of life in patients with lung cancer. Algorithm-based clinical decision support (CDS) to improve evidence-based management of isolated symptoms seems promising, but no reports yet address multiple symptoms. Objectives This study examined the feasibility of CDS for a Symptom Assessment and Management Intervention targeting common symptoms in patients with lung cancer (SAMI-L) in ambulatory oncology. The study objectives were to evaluate completion and delivery rates of the SAMI-L report and clinician adherence to the algorithm-based recommendations. Methods Patients completed a web-based symptom assessment and SAMI-L created tailored recommendations for symptom management. Completion of assessments and delivery of reports were recorded. Medical record review assessed clinician adherence to recommendations. Feasibility was defined as 75% or higher report completion and delivery rates and 80% or higher clinician adherence to recommendations. Descriptive statistics and generalized estimating equations were used for data analyses. Results Symptom assessment completion was 84% (95% CI = 81–87%). Delivery of completed reports was 90% (95% CI = 86–93%). Depression (36%), pain (30%), and fatigue (18%) occurred most frequently, followed by anxiety (11%) and dyspnea (6%). On average, overall recommendation adherence was 57% (95% CI = 52–62%) and was not dependent on the number of recommendations ( P = 0.45). Adherence was higher for anxiety (66%; 95% CI = 55–77%), depression (64%; 95% CI = 56–71%), pain (62%; 95% CI = 52–72%), and dyspnea (51%; 95% CI = 38–64%) than for fatigue (38%; 95% CI = 28–47%). Conclusion The CDS systems, such as SAMI-L, have the potential to fill a gap in promoting evidence-based care. [ABSTRACT FROM AUTHOR]

Purpose To evaluate the response rate (RR) and time to local recurrence (TTLR) among patients who received salvage radiation therapy for relapsed or refractory aggressive non-Hodgkin lymphoma (NHL) and investigate whether RR and TTLR differed according to disease characteristics. Methods and Materials A retrospective review was performed for all patients who completed a course of salvage radiation therapy between January 2001 and May 2011 at Brigham and Women's Hospital/Dana-Farber Cancer Institute. Separate analyses were conducted for patients treated with palliative and curative intent. Predictors of RR for each subgroup were assessed using a generalized estimating equation model. For patients treated with curative intent, local control (LC) and progression-free survival were estimated with the Kaplan-Meier method; predictors for TTLR were evaluated using a Cox proportional hazards regression model. Results Salvage radiation therapy was used to treat 110 patients to 121 sites (76 curative, 45 palliative). Salvage radiation therapy was given as part of consolidation in 18% of patients treated with curative intent. Median dose was 37.8 Gy, with 58% and 36% of curative and palliative patients, respectively, receiving 39.6 Gy or higher. The RR was high (86% curative, 84% palliative). With a median follow-up of 4.8 years among living patients, 5-year LC and progression-free survival for curative patients were 66% and 34%, respectively. Refractory disease (hazard ratio 3.3; P =.024) and lack of response to initial chemotherapy (hazard ratio 4.3; P =.007) but not dose ( P =.93) were associated with shorter TTLR. Despite doses of 39.6 Gy or higher, 2-year LC was only 61% for definitive patients with refractory disease or disease that did not respond to initial chemotherapy. Conclusions Relapsed or refractory aggressive NHL is responsive to salvage radiation therapy, and durable LC can be achieved in some cases. However, refractory disease is associated with a shorter TTLR, suggesting that radiation dose escalation, addition of radiosensitizers, or a combination of both may be indicated in these patients. [ABSTRACT FROM AUTHOR]

Purpose: To determine the maximum tolerated dose and tolerability of (1) afatinib in combination with postoperative radiation therapy (PORT) for patients with intermediate-risk squamous cell carcinoma of the head and neck (SCCHN) and (2) afatinib in combination with PORT and weekly docetaxel for high-risk SCCHN.Methods and Materials: An open-label, multicenter, 2-cohort, phase 1 dose-escalation trial was conducted using a 3 + 3 design. Eligible patients had definitive surgery for SCCHN, including the oral cavity, oropharynx, larynx, or hypopharynx and had intermediate- or high-risk pathologic features. Afatinib was given for a 1-week lead in before PORT and daily during 6 to 6.5 weeks of PORT with or without weekly docetaxel. The starting dose was 30 mg and could be escalated to 40 mg or de-escalated to 20 mg. The primary objective was to determine the maximum tolerated dose of afatinib with PORT or PORT + docetaxel.Results: Between April 2013 and November 2017, 27 patients were enrolled and started study treatment, including 16 intermediate-risk patients and 11 high-risk patients, all with Eastern Cooperative Oncology Group performance status of 0 to 1. Most patients (n = 25) had oral cavity cancer and were treated to a median total dose of 60 Gy in the intermediate-risk arm and 65 Gy in the high-risk arm. There was 1 grade 4 event, but no deaths. The maximum tolerated dose was not established owing to dose-limiting toxicities (DLTs) in both arms. In the high-risk arm, DLTs were grade 3 mucositis (n = 3) and grade 3 diarrhea/hypokalemia (n = 1). In the intermediate-risk arm, DLTs were grade 3 mucositis (n = 4) and grade 3 diarrhea (n = 2).Conclusions: Afatinib in combination with PORT for mucosal SCCHN was difficult to tolerate because of grade 3 toxicity, mostly mucositis, in a cohort of patients requiring high-dose PORT to the oral cavity. This regimen may be better tolerated for a non-oral cavity site or if given in a different schedule. [ABSTRACT FROM AUTHOR]

Background Brain metastases commonly manifest in patients with cancer, with ∼20%–50% presenting with 1 intracranial lesion. Among patients with 1, small brain metastasis and controlled or absent extracranial disease, it remains unclear whether aggressive intracranial management using neurosurgical resection plus cavity stereotactic radiosurgery/stereotactic radiotherapy (SRS/SRT) rather than SRS/SRT alone is beneficial. In patients with controlled or absent extracranial disease and 1 brain metastasis ≤2 cm in size, we evaluated the effect of surgery plus SRS/SRT compared with SRS/SRT on oncologic outcomes, including overall survival. Methods We retrospectively identified 86 patients with controlled or absent extracranial disease and 1 brain metastasis ≤2 cm in size who had been treated from 2000 to 2015 at our institution. We examined differences in the rates of local and distant failure, use of salvage treatment, and other oncologic outcomes, including all-cause mortality. Results The baseline characteristics were similar between the 2 cohorts. The median follow-up period for the surviving patients was 38 months. On multivariable analysis , surgical resection plus cavity SRS/SRT was associated with a lower risk of all-cause mortality (hazard ratio, 0.44; 95% confidence interval, 0.19–1.00; P = 0.05) compared with SRS/SRT alone. The 1- and 2-year rates of overall survival were 100% and 88% versus 74% and 52% for surgery plus cavity SRS/SRT versus SRS/SRT alone, respectively. Conclusions Aggressive, local therapy, including neurosurgical resection, might benefit patients with 1 brain metastasis in the context of controlled or absent systemic disease, even if the lesion in question is small. Further studies are needed to evaluate these associations. [ABSTRACT FROM AUTHOR]

Purpose: Sources of funding and principal investigator (PI) leadership for clinical trials using radiation therapy (RT) are not well characterized but are important mediators of innovation, particularly because funding for trials from the National Institutes of Health (NIH) has decreased and industry funding has increased. We sought to determine characteristics of trials using RT that are associated with industry funding, NIH funding, and radiation oncologist (RO) PI leadership.Methods and Materials: www.ClinicalTrials.gov was queried for all open, interventional trials that administered RT. Logistic regression was used to identify associations between trial characteristics, receipt of funding type (NIH, industry, or other), and PI leadership.Results: The authors identified 1469 oncology trials, of which 41% were based in the United States, 56% were based internationally, and 3% were based in the United States and internationally. Of these, 22% were RT monotherapy, 53% were bimodality (40% RT + drug, 13% RT + surgery), and 24% were trimodality. Although ROs led 60% of all trials, industry-sponsored trials were significantly less likely to have RO PIs (35% RO vs 65% non-RO PI; adjusted odds ratio [aOR], 0.45; 95% confidence interval [CI], 0.28-0.73), to fund trials that did not incorporate drug therapy (aOR, 0.19; 95% CI, 0.10-0.35), or to fund phase III trials (aOR, 0.25; 95% CI, 0.11-0.60) because industry-sponsored trials favored smaller phase I trials. NIH-funded trials were not associated with PI type and, although not statistically significant, favored larger phase III trials (unadjusted OR, 2.06; 95% CI, 0.99-4.29). ROs were less likely to lead trials incorporating drug therapy (aOR, 0.30; 95% CI, 0.22-0.41).Conclusions: ROs are less likely than other specialties to lead trials that use RT in combination with drug therapy or surgery and more likely to lead trials supported by nonindustry, non-NIH funding. This suggests a need for ROs to lead multimodality trials and to consider opportunities to interact with industry. As NIH resources decrease, alternative funding is needed to support innovation, particularly in in RT-alone trials. [ABSTRACT FROM AUTHOR]

Purpose: Programmed death-1 (PD-1) inhibitors are approved for the treatment of patients with recurrent and metastatic squamous cell carcinoma of the head and neck (SCCHN). Ongoing and planned randomized phase 3 trials are testing the benefit of combining PD-1/programmed death-ligand 1 (PD-L1) inhibitors with chemoradiation for patients with locoregionally confined SCCHN. Few studies have investigated relationships among potential predictive pathologic biomarkers such as PD-L1, PD-L2, and PD-1 in this population and associations between these markers and clinical characteristics.Methods and Materials: We retrospectively reviewed records and pathology from 81 patients with locoregional oropharynx SCCHN treated with curative intent. Samples were analyzed for PD-L1, PD-L2, PD-1, CD8, and CD56 expression using immunohistochemistry. Human papilloma virus (HPV) status was determined by p16-immunohistochemistry and confirmed by in situ hybridization or polymerase chain reaction-based HPV typing. Correlations between HPV status, clinical features, and recurrence status with immune markers in both tumor and tumor-associated stroma were determined. Hazard ratios were estimated via Cox proportional hazards model.Results: Tumor PD-L1 expression was inversely associated with age (P = .01) and the highest levels of expression (>30% of tumor cells) were observed in HPV-associated tumors. There was a correlation between tumor and stromal PD-L1 expression (P = < .0001). PD-1 and CD8 expression within tumor deposits was associated with HPV status (P = 0.003 and P = .008, respectively) and decreased local recurrence (P = .001 and P < .001, respectively). In addition to the association between tumor and stromal PD-1 (P < .0001), PD-1 was also correlated with tumor PD-L1 expression (P < .001). CD56+ natural killer cell infiltrates correlated with PD-L1 expression.Conclusions: In patients with untreated oropharyngeal SCCHN, HPV-associated tumors displayed the highest levels of PD-L1 expression and PD-1+ and CD8+ immune cells. Locally recurrent tumors had lower levels of PD-L1, PD-1, and CD-8 positivity. Whereas almost all SCCHN tumors had CD56+ infiltrating natural killer cells, most tumors didn't have PD-L2 expression. These associations may help predict which patients may benefit most from immunotherapeutic approaches. [ABSTRACT FROM AUTHOR]

Objectives: To characterize specific serious toxicities of reRT with intensity modulated radiation therapy (IMRT) for squamous cell carcinoma of the head and neck (SCCHN) and identify treatment-related predictors of toxicity for patient counseling and decision-making.Materials/methods: 75 consecutive patients with recurrent or 2nd primary SCCHN received reRT from 8/2004-02/2013. All patients had prior definitive or postoperative RT. Objective endpoints of "serious toxicity" were defined as: hospitalization during reRT, tracheotomy after reRT, hemorrhage, soft tissue complication requiring operative intervention, or other CTCAE grade ≥4 toxicity.Results: Patients received definitive (n=41,55%) or postoperative (n=34,45%) reRT (median dose 60Gy, range 59.4-70Gy). Most patients (88%) had concurrent chemotherapy. With a median follow-up of 1.4years, 39 (52%) patients had at least one serious toxicity: hospitalization during reRT (24%), surgically-managed soft tissue complication (19%), and/or urgent tracheotomy (18%). There were no grade 5 acute toxicities but there were 4 fatal hemorrhages (median 8.3months) including 2 attributed to local-regional recurrence (LRR). Most patients (69%) had a percutaneous endoscopic gastrostomy (PEG) tube at last follow-up; those with a LRR had higher PEG tube-dependence rates (86% vs. 53%, p=0.001). LRR, site of reRT, and laryngeal RT dose, were marginally associated with toxicity-risk.Conclusions: Patients considering reRT should be counseled on the high rate of PEG tube-dependence, and events of urgent tracheotomy, hospitalization, hemorrhage, and operative intervention, which typically occur months after reRT completion. Further study of baseline patient function and cumulative radiation dose to the larynx and other organs-at-risk may improve estimates of serious toxicity-risk after reRT. [ABSTRACT FROM AUTHOR]

Introduction: In 2012, the updated U.S. Department of Agriculture school meals standards and a competitive food law similar to the fully implemented version of the national Smart Snack standards went into effect in Massachusetts. This study evaluated the impact of these updated school meal standards and Massachusetts' comprehensive competitive food standards on school food revenues and school lunch participation.Methods: Revenue and participation data from 11 Massachusetts school districts were collected from 2011 to 2014 and analyzed in 2015 using multilevel modeling. The association between the change in compliance with the competitive food standards and revenues/participation was assessed using linear regression.Results: Schools experienced declines in school food revenues of $15.40/student in Year 1 from baseline (p=0.05), due to competitive food revenue losses. In schools with 3 years of data, overall revenues rebounded by the second year post-implementation. Additionally, by Year 2, school lunch participation increased by 15% (p=0.0006) among children eligible for reduced-price meals. Better competitive food compliance was inversely associated with school food revenues in the first year only; an absolute change in compliance by 10% was associated with a $9.78/student decrease in food revenues over the entire school year (p=0.04). No association was seen between the change in compliance and school meal participation.Conclusions: Schools experienced initial revenue losses after implementation of the standards, yet longer-term school food revenues were not impacted and school meal participation increased among children eligible for reduced-price meals. Weakening the school meal or competitive food guidelines based on revenue concerns appears unwarranted. [ABSTRACT FROM AUTHOR]

Purpose To compare the performance of various tumor response criteria (TRC) in the assessment of patients with advanced gastrointestinal stromal tumor (GIST) treated with sunitinib after failure of imatinib. Methods Sixty-two participants with advanced GIST in two clinical trials received oral sunitinib after prior failure of imatinib (median duration 24 weeks; interquartile range 14–56) and were followed with contrast-enhanced computed tomography at baseline and thereafter at median intervals of 6 weeks (IRQ 6–9). Tumor response was prospectively determined using Response Evaluation Criteria in Solid Tumors (RECIST) 1.0, and retrospectively reassessed for comparison using RECIST 1.1, Choi criteria, and modified Choi (mChoi) criteria using the original target lesions. For mChoi criteria, progressive disease was defined as 20% increase in sum of the longest dimension, similar to RECIST 1.1. Clinical benefit rate (CBR; complete response, partial response, or stable disease ≥ 12 weeks) and progression-free survival were compared between various TRCs using kappa statistics. Results While partial response as the best response was more frequent by Choi and mChoi criteria (50% each) than RECIST 1.1 (15%) and RECIST 1.0 (13%), CBR was similar between various TRCs (overall CBR 60%–77%, 77%–94% agreement between all TRC pairs). Time to best response was shorter for Choi and mChoi criteria (median 11 weeks each) compared to RECIST 1.1 and RECIST 1.0 (median 25 and 24 weeks, respectively). PFS was similar for RECIST 1.1, RECIST 1.0, and mChoi (median 35 weeks each), and shortest for Choi criteria (median 23 weeks). Conclusions CBR was similar among the various TRCs, although Choi criteria led to earlier determination of disease progression. Therefore, RECIST 1.1 and mChoi criteria may be preferred for response assessment in patients with advanced GIST. [ABSTRACT FROM AUTHOR]

Background: The U.S Department of Agriculture (USDA) recently made substantial changes to the school meal standards. The media and public outcry have suggested that this has led to substantially more food waste. Purpose: School meal selection, consumption, and waste were assessed before and after implementation of the new school meal standards. Methods: Plate waste data were collected in four schools in an urban, low-income school district. Logistic regression and mixed-model ANOVA were used to estimate the differences in selection and consumption of school meals before (fall 2011) and after implementation (fall 2012) of the new standards among 1030 elementary and middle school children. Analyses were conducted in 2013. Results: After the new standards were implemented, fruit selection increased by 23.0% and entrée and vegetable selection remained unchanged. Additionally, post-implementation entrée consumption increased by 15.6%, vegetable consumption increased by 16.2%, and fruit consumption remained the same. Milk selection and consumption decreased owing to an unrelated milk policy change. Conclusions: Although food waste levels were substantial both pre- and post-implementation, the new guidelines have positively affected school meal selection and consumption. Despite the increased vegetable portion size requirement, consumption increased and led to significantly more cups of vegetables consumed. Significantly more students selected a fruit, whereas the overall percentage of fruit consumed remained the same, resulting in more students consuming fruits. Contrary to media reports, these results suggest that the new school meal standards have improved students’ overall diet quality. Legislation to weaken the standards is not warranted. [ABSTRACT FROM AUTHOR]

Abstract: Purpose: To compare the safety of image-guided percutaneous cryoablation and radiofrequency ablation in the treatment of hepatocellular carcinoma in patients with cirrhosis. Materials and methods: This retrospective HIPAA-compliant study received institutional review board approval. Forty-two adult patients with cirrhosis underwent image-guided percutaneous ablation of hepatocellular carcinoma from 2003 to 2011. Twenty-five patients underwent 33 cryoablation procedures to treat 39 tumors, and 22 underwent 30 radiofrequency ablation procedures to treat 39 tumors. Five patients underwent both cryoablation and radiofrequency ablation procedures. Complication rates and severity per procedure were compared between the ablation groups. Potential confounding patient, procedure, and tumor-related variables were also compared. Statistical analyses included Kruskal–Wallis, Wilcoxon rank sum, and Fisher's exact tests. Two-sided P-values <0.05 were considered significant. Results: The overall complication rates, 13 (39.4%) of 33 cryoablation procedures versus eight (26.7%) of 30 radiofrequency ablation procedures and severe/fatal complication rates, two (6.1%) of 33 cryoablation procedures versus one (3.3%) of 30 radiofrequency ablation procedures, were not significantly different between the ablation groups (both P =0.26). Severe complications included pneumothoraces requiring chest tube insertion during two cryoablation procedures. One death occurred within 90 days of a radiofrequency ablation procedure; all other complications were managed successfully. Conclusion: No significant difference was seen in the overall safety of image-guided percutaneous cryoablation and radiofrequency ablation in the treatment of hepatocellular carcinoma in patients with cirrhosis. [Copyright &y& Elsevier]

Objective: To examine whether short-term participation in the Supplemental Nutrition Assistance Program (SNAP) affects food security and dietary quality among low-income adults recruited from a Massachusetts-wide emergency food hotline. Methods: A 3-month, longitudinal study was conducted among 107 adults recruited at the time of SNAP application assistance. Outcomes included household food security (10-item US Department of Agriculture Food Security Survey Module), dietary intake (eg, grains, fruit) and diet quality (modified Alternate Healthy Eating Index). Data were analyzed using paired t tests and multivariable linear regression. Results: Supplemental Nutrition Assistance Program participation was not associated with improved household food security over 3 months (P = .25). Compared with non-participants, SNAP participants increased refined grain intake by 1.1 serving/d (P = .02), from baseline to follow-up. No associations were observed with other foods, nutrients, or dietary quality. Conclusion and Implications: Policies that simultaneously improve household food security and dietary quality should be implemented to support the health of low-income Americans participating in this crucial program. [ABSTRACT FROM AUTHOR]

Abstract: Although breast cancer patients with localized disease exhibit an excellent long-term prognosis, up to 40% of patients treated with local resection alone may harbor occult nodal metastatic disease leading to increased locoregional recurrence and decreased survival. Given the potential for targeted drug delivery to result in more efficacious locoregional control with less morbidity, the current study assessed the ability of drug-loaded polymeric expansile nanoparticles (eNP) to migrate from the site of tumor to regional lymph nodes, locally deliver a chemotherapeutic payload, and prevent primary tumor growth as well as lymph node metastases. Expansile nanoparticles entered tumor cells and paclitaxel-loaded eNP (Pax-eNP) exhibited dose-dependent cytotoxicity in vitro and significantly decreased tumor doubling time in vivo against human triple negative breast cancer in both microscopic and established murine breast cancer models. Furthermore, migration of Pax-eNP to axillary lymph nodes resulted in higher intranodal paclitaxel concentrations and a significantly lower incidence of lymph node metastases. These findings demonstrate that lymphatic migration of drug-loaded eNP provides regionally targeted delivery of chemotherapy to both decrease local tumor growth and strategically prevent the development of nodal metastases within the regional tumor-draining lymph node basin. [Copyright &y& Elsevier]

Purpose: To evaluate outcomes of patients treated for aggressive non-Hodgkin lymphoma (NHL) with combined modality therapy based on [18F]fluoro-2-deoxy-2-d-glucose positron emission tomography (FDG-PET) response. Methods and Materials: We studied 59 patients with aggressive NHL, who received chemotherapy and radiation therapy (RT) from 2001 to 2008. Among them, 83% of patients had stage I/II disease. Patients with B-cell lymphoma received R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone)-based chemotherapy, and 1 patient with anaplastic lymphoma kinase-negative anaplastic T-cell lymphoma received CHOP therapy. Interim and postchemotherapy FDG-PET or FDG-PET/computed tomography (CT) scans were performed for restaging. All patients received consolidated involved-field RT. Median RT dose was 36 Gy (range, 28.8-50 Gy). Progression-free survival (PFS) and local control (LC) rates were calculated with and without a negative interim or postchemotherapy FDG-PET scan. Results: Median follow-up was 46.5 months. Thirty-nine patients had negative FDG-PET results by the end of chemotherapy, including 12 patients who had a negative interim FDG-PET scan and no postchemotherapy PET. Twenty patients were FDG-PET-positive, including 7 patients with positive interim FDG-PET and no postchemotherapy FDG-PET scans. The 3-year actuarial PFS rates for patients with negative versus positive FDG-PET scans were 97% and 90%, respectively. The 3-year actuarial LC rates for patients with negative versus positive FDG-PET scans were 100% and 90%, respectively. Conclusions: Patients who had a positive interim or postchemotherapy FDG-PET had a PFS rate of 90% at 3 years after combined modality treatment, suggesting that a large proportion of these patients can be cured with consolidated RT. [ABSTRACT FROM AUTHOR]

Purpose: Technological advances in radiation therapy (RT) delivery have the potential to reduce errors via increased automation and built-in quality assurance (QA) safeguards, yet may also introduce new types of errors. Intensity-modulated RT (IMRT) is an increasingly used technology that is more technically complex than three-dimensional (3D)–conformal RT and conventional RT. We determined the rate of reported errors in RT delivery among IMRT and 3D/conventional RT treatments and characterized the errors associated with the respective techniques to improve existing QA processes. Methods and Materials: All errors in external beam RT delivery were prospectively recorded via a nonpunitive error-reporting system at Brigham & Women’s Hospital/Dana Farber Cancer Institute. Errors are defined as any unplanned deviation from the intended RT treatment and are reviewed during monthly departmental quality improvement meetings. We analyzed all reported errors since the routine use of IMRT in our department, from January 2004 to July 2009. Fisher’s exact test was used to determine the association between treatment technique (IMRT vs. 3D/conventional) and specific error types. Effect estimates were computed using logistic regression. Results: There were 155 errors in RT delivery among 241,546 fractions (0.06%), and none were clinically significant. IMRT was commonly associated with errors in machine parameters (nine of 19 errors) and data entry and interpretation (six of 19 errors). IMRT was associated with a lower rate of reported errors compared with 3D/conventional RT (0.03% vs. 0.07%, p = 0.001) and specifically fewer accessory errors (odds ratio, 0.11; 95% confidence interval, 0.01–0.78) and setup errors (odds ratio, 0.24; 95% confidence interval, 0.08–0.79). Conclusions: The rate of errors in RT delivery is low. The types of errors differ significantly between IMRT and 3D/conventional RT, suggesting that QA processes must be uniquely adapted for each technique. There was a lower error rate with IMRT compared with 3D/conventional RT, highlighting the need for sustained vigilance against errors common to more traditional treatment techniques. [ABSTRACT FROM AUTHOR]

Purpose: The median survival time of patients with locally advanced adenocarcinoma of the pancreas is 8–10 months. Radiation therapy has been used to improve local control and palliate symptoms. This randomized study was undertaken to determine whether the addition of 5-fluorouracil (5-FU) and mitomycin-C (MMC) to radiation therapy improves outcome in this patient population. Patients and Methods: One hundred fourteen patients were randomized to receive 59.4 Gy external beam radiotherapy in 1.8 Gy fractions alone or in combination with 5-FU (1,000 mg/m2/day for 4 days by continuous infusion Days 2–5 and 28–31) and MMC (10 mg/m2 on Day 2). Results: One hundred four patients were evaluable for efficacy. Hematologic and nonhematologic toxicities were more common in the combination arm. The response rates were 6% in the radiation therapy arm and 9% in the combination arm. There were no differences in median disease-free survival time (DFS) or overall survival time (OS) between the combination and radiation therapy alone arms: 5.1 vs. 5.0 months, respectively, for DFS (p = 0.19) and 8.4 vs. 7.1 months, respectively, for OS (p = 0.16). Conclusion: The addition of 5-FU and MMC to radiotherapy increased toxicity without improving DFS or OS in patients with locally advanced pancreatic cancer. Alternative drugs for radiosensitization may improve outcome. [Copyright &y& Elsevier]

• Biophilic environments had larger restorative impact than non-biophilic environment. • Biophilic environments reduced stress and anxiety. • Effects on physiological response are immediate after biophilic exposure. • Restorative effects differ among three different types of biophilic environments. Previous research has demonstrated the positive associations between outdoor nature contact and stress reduction. However, similar effects of incorporating natural elements into indoor environment (i.e. biophilic design) have been less well studied. We hypothesize that exposure to biophilic indoor environments help people recover from stress and anxiety and those effects differ among different types of biophilic elements. To test these hypotheses, we conducted a between-subjects experiment with 100 participants using virtual reality (VR). Participants were randomly assigned to experience one of four virtual offices (i.e. one non-biophilic base office and three similar offices enhanced with different biophilic design elements) after stressor tasks. Their physiological indicators of stress reaction, including heart rate variability, heart rate, skin conductance level and blood pressure, were measured by bio-monitoring sensors. Their anxiety level was measured by using State-Trait Anxiety Inventory test (short version). We found that participants in biophilic indoor environments had consistently better recovery responses after stressor compare to those in the non-biophilic environment, in terms of reduction on stress and anxiety. Effects on physiological responses are immediate after exposure to biophilic environments with the larger impacts in the first four minutes of the 6-minute recovery process. Additionally, these restorative effects differ among three different types of indoor biophilic environments. This research provides evidence that biophilic design elements that impact stress recovery and anxiety. It also demonstrated the potential that virtual reality may be a way to bring nature and its therapeutic benefits to patients in hospitals. [ABSTRACT FROM AUTHOR]