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The NRG/RTOG 9413 study showed that whole pelvic radiotherapy (WPRT) plus neoadjuvant hormonal therapy (NHT) improved progression-free survival in patients with intermediate-risk or high-risk localised prostate cancer compared with prostate only radiotherapy (PORT) plus NHT, WPRT plus adjuvant hormonal therapy (AHT), and PORT plus AHT. We provide a long-term update after 10 years of follow-up of the primary endpoint (progression-free survival) and report on the late toxicities of treatment. The trial was designed as a 2 × 2 factorial study with hormonal sequencing as one stratification factor and radiation field as the other factor and tested whether NHT improved progression-free survival versus AHT, and NHT plus WPRT versus NHT plus PORT. Eligible patients had histologically confirmed, clinically localised adenocarcinoma of the prostate, an estimated risk of lymph node involvement of more than 15% and a Karnofsky performance status of more than 70, with no age limitations. Patients were randomly assigned (1:1:1:1) by permuted block randomisation to receive either NHT 2 months before and during WPRT followed by a prostate boost to 70 Gy (NHT plus WPRT group), NHT 2 months before and during PORT to 70 Gy (NHT plus PORT group), WPRT followed by 4 months of AHT (WPRT plus AHT group), or PORT followed by 4 months of AHT (PORT plus AHT group). Hormonal therapy was combined androgen suppression, consisting of goserelin acetate 3·6 mg once a month subcutaneously or leuprolide acetate 7·5 mg once a month intramuscularly, and flutamide 250 mg twice a day orally for 4 months. Randomisation was stratified by T stage, Gleason Score, and prostate-specific antigen concentration. NHT was given 2 months before radiotherapy and was continued until radiotherapy completion; AHT was given at the completion of radiotherapy for 4 months. The primary endpoint progression-free survival was analysed by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00769548. The trial has been terminated to additional follow-up collection and this is the final analysis for this trial. Between April 1, 1995, and June 1, 1999, 1322 patients were enrolled from 53 centres and randomly assigned to the four treatment groups. With a median follow-up of 8·8 years (IQR 5·07–13·84) for all patients and 14·8 years (7·18–17·4) for living patients (n=346), progression-free survival across all timepoints continued to differ significantly across the four treatment groups (p=0·002). The 10-year estimates of progression-free survival were 28·4% (95% CI 23·3–33·6) in the NHT plus WPRT group, 23·5% (18·7–28·3) in the NHT plus PORT group, 19·4% (14·9–24·0) in the WPRT plus AHT group, and 30·2% (25·0–35·4) in the PORT plus AHT group. Bladder toxicity was the most common grade 3 or worse late toxicity, affecting 18 (6%) of 316 patients in the NHT plus WPRT group, 17 (5%) of 313 in the NHT plus PORT group, 22 (7%) of 317 in the WPRT plus AHT group, and 14 (4%) of 315 in the PORT plus AHT group. Late grade 3 or worse gastrointestinal adverse events occurred in 22 (7%) of 316 patients in the NHT plus WPRT group, five (2%) of 313 in the NHT plus PORT group, ten (3%) of 317 in the WPRT plus AHT group, and seven (2%) of 315 in the PORT plus AHT group. In this cohort of patients with intermediate-risk and high-risk localised prostate cancer, NHT plus WPRT improved progression-free survival compared with NHT plus PORT and WPRT plus AHT at long-term follow-up albeit increased risk of grade 3 or worse intestinal toxicity. Interactions between radiotherapy and hormonal therapy suggests that WPRT should be avoided without NHT. National Cancer Institute.

[...]there was an absence of any evaluation as to the reliability of patient masking in the study.6,7 Third, the absence of physician masking is a concern. Many patients with prostate cancer will die of other competing medical comorbidities and interventions for prostate cancer must be carefully considered for the risks and benefits that they confer. [...]all prostate interventions should provide a substantial benefit before they are recommended as standard of care. In summary, genitourinary oncologists need to carefully review and consider the validity of the current data supporting the use of SpaceOAR before routinely using this device. [...]individuals who select patients for SpaceOAR implantation should be vigilant at reporting toxicity to MAUDE to ensure that the oncology community is aware of these events.

Dual translocated (or “dual hit”) lymphomas are highly aggressive B cell neoplasms associated with an extremely poor prognosis. The optimal treatment for these lymphomas remains undefined. We present two cases of follicular lymphoma with transformation to Burkitt-like lymphoma. In both cases dual translocations involving both the bcl-2 and c-myc loci were present. Each patient underwent intensive induction immunochemotherapy followed by autologous stem cell transplantation and radiation therapy. The first patient received post-transplant mediastinal radiation and developed recurrence in multiple areas outside of the radiation field. The second patient received total body irradiation as part of the conditioning regimen, and is without recurrence 18 months after transplant, and 24 months after diagnosis of the dual translocated lymphoma. We review dual translocation B cell lymphoma in the setting of transformation from follicular lymphoma, and suggest a potential role for total body irradiation in the management of this highly aggressive non-Hodgkin lymphoma.

With a median follow-up of 13 years, a randomized comparison of radiotherapy with or without antiandrogen therapy in patients with a rising PSA level after prostatectomy showed that 2 years of antiandrogen therapy resulted in a significantly higher overall survival rate. Patients with localized prostatic cancer are often treated with radical prostatectomy. More than 30% of such patients will subsequently have recurrence. This recurrence manifests first as a rising serum level of prostate-specific antigen (PSA), 1 – 3 termed biochemical recurrence. Large, retrospective studies suggest that salvage radiation therapy after biochemical recurrence may be associated with long-term freedom from cancer recurrence. 4 , 5 However, 50% of the patients who are treated with salvage radiation therapy will have further disease progression, particularly when there are aggressive disease features. 4 – 7 The combination of radiation therapy and either androgen-deprivation therapy or antiandrogen therapy prolongs survival among some . . .

Background: RTOG 0518 evaluated the potential benefit of zoledronic acid therapy in preventing bone fractures for patients with high grade and/or locally advanced, non-metastatic prostate adenocarcinoma receiving luteinizing hormone-releasing hormone (LHRH) agonist and radiotherapy (RT). Methods: Eligible patients with T-scores of the hip (<−1.0, but >−2.5 vs >−1.0) and negative bone scans were prospectively randomized to either zoledronic acid, 4 mg, concurrently with the start of RT and then every six months for a total of 6 infusions (Arm 1) or observation (Arm 2). Vitamin D and calcium supplements were given to all patients. Secondary objectives included quality of life (QOL) and bone mineral density (BMD) changes over a period of three years. Results: Of 109 patients accrued before early closure, 96 were eligible. Median follow-up was 36.3 months for Arm 1 and 34.8 months for Arm 2. Only two patients experienced a bone fracture (one in each arm) resulting in no difference in freedom from any bone fracture ( P =0.95), nor in QOL. BMD percent changes from baseline to 36 months were statistically improved with the use of zoledronic acid compared to observation for the lumbar spine (6% vs −5%, P <0.0001), left total hip (1% vs −8%, P =0.0002), and left femoral neck (3% vs −8%, P =0.0007). Conclusions: For patients with advanced, non-metastatic prostate cancer receiving LHRH agonist and RT, the use of zoledronic acid was associated with statistically improved BMD percent changes. The small number of accrued patients resulted in decreased statistical power to detect any differences in the incidence of bone fractures or QOL.

In our rapidly advancing scientific and technological world, many take great pride and comfort in believing that we are on the threshold of new ways of thinking, living, and understanding ourselves. But despite dramatic discoveries that appear in every way to herald the future, legacies still carry great weight. Even in swiftly developing fields such as health and medicine, most systems and policies embody a sequence of earlier ideas and preexisting patterns.In History and Health Policy in the United States, seventeen leading scholars of history, the history of medicine, bioethics, law, health policy, sociology, and organizational theory make the case for the usefulness of history in evaluating and formulating health policy today. In looking at issues as varied as the consumer economy, risk, and the plight of the uninsured, the contributors uncover the often unstated assumptions that shape the way we think about technology, the role of government, and contemporary medicine. They show how historical perspectives can help policymakers avoid the pitfalls of partisan, outdated, or merely fashionable approaches, as well as how knowledge of previous systems can offer alternatives when policy directions seem unclear.Together, the essays argue that it is only by knowing where we have been that we can begin to understand health services today or speculate on policies for tomorrow.

\"Delta-radiomics\" investigates variations in quantitative image metrics over time and can yield important clinical information. We hypothesized that in patients undergoing active radiation therapy (RT) for prostate cancer (PCa), there would exist observable variation in the quantitative metrics that describe the T -weighted (T ) intensity histogram in the prostate and surrounding organs at risk (OAR) over time. We investigated the feasibility of acquisition and subsequent analysis of the delta-radiomic profiles of these regions of interest (ROI) in serial T magnetic resonance (MR) images obtained on a 1.5 Tesla (T) Magnetic Resonance Linear Accelerator (MRL). Principally, we sought to illustrate the significance of longitudinal radiomic data acquisition for tissue response monitoring and provide a framework for future hypothesis driven research. Patients with PCa undergoing treatment with RT were compiled from an ongoing prospective observational imaging trial using a 1.5 T MRL (NCT30500081). Contiguous axial slices of prostate parenchyma were contoured and temporally normalized to sections of Sartorius muscle which served as a control. Similarly, contiguous sections of rectal and bladder wall adjacent to the prostate were contoured and temporally normalized to regions of these organs further removed from the planning target volume (PTV). First order statistical descriptors of the T intensity histogram were extracted and evaluated for changes over time using linear mixed effects regression modeling and post-hoc contrasts. Benjamini-Hochberg corrections were employed to reduce the effects of multiple testing and control for the false discovery rate (FDR). Four patients with a median age of 69 comprised this exploratory cohort. One patient had low-risk disease, two had intermediate (one favorable, one unfavorable), and one had high risk disease. Three out of four patients underwent definitive radiation to 75.6 Gray (Gy) in 42 fractions and one received hypofractionated therapy to a total dose of 70 Gy over 28 fractions, and all received treatment on a conventional linear accelerator. The most significant acute toxicity event was grade 2 GU dysfunction observed in two patients. Follow up ranged from 1 month to 10 months post treatment, and no long-term complications were reported in patients who completed treatment at least one month prior. Bladder wall adjacent to the prostate demonstrated significant variation in the mean and median metric values after the first week of treatment. In addition, rectal wall adjacent to the prostate exhibited significant variation in the mean, median, and standard deviation metric values by the second week of treatment. No significant variation in any radiomic feature was observed in the Sartorius control. This exploratory study is one of the earliest examining the delta-radiomic characteristics of the T intensity histogram in OAR extracted from images acquired on a 1.5 T MRL in patients actively being treated with RT for PCa. We demonstrated a feasible approach to longitudinal radiomic data acquisition providing limitless opportunity for future research. Analysis of the delta-radiomic profiles in OAR revealed significant variation in metrics after only one week of RT in bladder and rectal wall adjacent to the prostate. These findings must be further investigated and validated with expanded data sets with long-term follow up and correlation to clinical outcomes including toxicity and tumor control.