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Approximately 30% of patients with localized prostate cancer (PCa) who undergo radical prostatectomy will develop biochemical recurrence. In these patients, the only potentially curative treatment is postoperative radiotherapy (PORT) with or without hormone therapy. However, the optimal radiotherapy dose is unknown due to the limited data available.To determine whether the postoperative radiotherapy dose influences biochemical failure-free survival (BFFS) in patients with PCa.Retrospective analysis of patients who underwent radical prostatectomy for PCa followed by PORT-either adjuvant radiotherapy (ART) or salvage radiotherapy (SRT)-between April 2002 and July 2015. From 2002 to 2010, the prescribed radiation dose to the surgical bed was 66-70 Gy in fractions of 2 Gy; from 2010 until July 2015, the prescribed dose was 70-72 Gy. Patients were grouped into three categories according to the total dose administered: 66-68 Gy, 70 Gy, and 72 Gy. The primary endpoint was BFFS, defined as the post-radiotherapy prostate-specific antigen (PSA) nadir + 0.2 ng/mL. Secondary endpoints were overall survival (OS), cancer-specific survival (CSS), and metastasis-free survival (MFS; based on conventional imaging tests). Treatment-related genitourinary (GU) and gastrointestinal (GI) toxicity was evaluated according to Radiation Therapy Oncology Group/European Organization for Research and Treatment of Cancer criteria. Finally, we aimed to identify potential prognostic factors. BFFS, OS, CSS, and MFS were calculated with the Kaplan-Meier method and the log-rank test. Univariate and multivariate Cox regression models were performed to explore between-group differences in survival outcome measures.A total of 301 consecutive patients were included. Of these, 93 (33.6%) received ART and 186 (66.4%) SRT; 22 patients were excluded due to residual macroscopic disease or local recurrence in the surgical bed. In this subgroup (The findings of this retrospective study suggest that postoperative radiotherapy dose intensification in PCa is not superior to conventional radiotherapy treatment.

Approximately 30% of patients who undergo radical prostatectomy for prostate cancer develop disease progression. The only potentially curative treatment in these patients is postoperative radiotherapy with or without hormonotherapy. One of the standards of care in nonsurgical patients is hypofractionated radiotherapy. However, the current evidence based is insufficient to define the optimal dose and fractionation schedule for postoperative radiotherapy. In this context, the aim of this editorial is to assess the main efficacy and toxicity data for postoperative hypofractionated radiotherapy and discuss the potential to implement this fractionation in routine clinical practice.

Introduction: Cancer patients are more susceptible to infections, and infection can be more severe than in patients without cancer diagnosis. We conducted this retrospective study in patients admitted for SARS-CoV-2 infection in order to find differences in inflammatory markers and mortality in cancer patients compared to others. Methods: We reviewed the electronic records of patients admitted for SARS-CoV-2 infection confirmed by PCR from March to September 2020. Data on socio-demographics, comorbidities, inflammatory makers, and cancer-related features were analyzed. Results: 2,772 patients were admitted for SARS-CoV-2, to the Hospital Universitario Ramón y Cajal in Madrid during this period. Of these, 2,527 (91%) had no history of neoplastic disease, 164 (5.9%) patients had a prior history of cancer but were not undergoing oncological treatment at the time of infection, and 81 (2.9%) were in active treatment. Mortality in patients without a history of cancer was 19.5%, 28.6% for patients with a prior history of cancer, and 34% in patients with active cancer treatment. Patients in active oncology treatment with the highest mortality rate were those diagnosed with lung cancer (OR 5.6 95% CI: 2.2–14.1). In the multivariate study, active oncological treatment (OR 2.259 95% CI: 1.35–3.77) and chemotherapy treatment (OR 3.624 95% CI: 1.17–11.17), were statistically significant factors for the risk of death for the whole group and for the group with active oncological treatment, respectively. Conclusion: Cancer patients on active systemic treatment have an increased risk of mortality after SARS-CoV-2 infection, especially with lung cancer or chemotherapy treatment.

The treatment for nonmetastatic castration-resistant prostate cancer (nmCRPC) is a highly unmet medical need. The classic treatment approach for these patients—androgen deprivation therapy (ADT) alone—until metastatic progression is now considered suboptimal. Several randomized phase III clinical trials have demonstrated significant clinical benefits—including significantly better overall survival (OS)—for treatments that combine ADT with apalutamide, enzalutamide, and darolutamide. As a result, these approaches are now included in treatment guidelines and are considered a standard of care. In the present article, we discuss the changing landscape of the management of patients with nmCRPC.

Brachytherapy (BT) is widely used for salvage therapy in patients with biochemical failure (BF) after radiotherapy for prostate cancer (PCa). Although low-dose-rate (LDR) and high-dose-rate (HDR) BT are both used for salvage therapy, it is not clear whether there are any differences between these two approaches in terms of efficacy or toxicity in this setting. Therefore, we review the institutional experience of the members of the Urological Tumour Working Group (URONCOR) of the Spanish Society of Radiation Oncology (SEOR) to compare these two techniques.Between 2001 and 2016, 119 patients with biopsy-proven, locally-recurrent PCa underwent salvage BT (LDR, n = 44; HDR, n = 75) after primary radiotherapy. Relapse-free survival (RFS) and cause-specific survival (CSS) after salvage therapy were analyzed. Toxicity was assessed according to the RTOG scale.Median follow-up after salvage BT was 52 months. Overall, the 5-year prostate-specific antigen (PSA) RFS rate was 71% (95% CI, 65.9%-75.9%). No significant between-group differences in RFS were observed (p = 0.063). Five-year CSS for the LDR- and HDR-BT groups were 96.5% and 93%, respectively. Overall, 38 patients (32%) developed biochemical progression (Phoenix definition) after salvage BT: 14 patients (32%) in the LDR group and 24 (32.5%) in the HDR group. On the multivariate analysis, the following variables were significantly associated with progression, time to BF from primary radiotherapy30 months (p = 0.014); and post-salvage nadir PSA (p = 0.000). There were no significant between-group differences in toxicity. Overall, there were 13 cases of urethral stricture, 22 cases of urinary incontinence, and 13 cases of haematuria. Toxicity ≥grade 3 was observed in 23.5% of patients.These findings show that both HDR-BT and LDR-BT yield comparable efficacy and toxicity outcomes in patients undergoing salvage treatment for locally-recurrent prostate cancer after primary radiotherapy. Predictors of worse outcomes after salvage BT were post-salvage nadir PSA and time to BF from initial radiotherapy.

Lessons Learned Background Refractory and metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) generally does not respond to PD-1 inhibitor monotherapy. Cemiplimab is a human anti–PD-1 monoclonal antibody. An expansion cohort enrolled patients with R/M HNSCC in a phase I study combining cemiplimab plus radiation therapy (RT), cyclophosphamide, and granulocyte macrophage colony-stimulating factor (GM-CSF). Methods Patients with R/M HNSCC refractory to at least first-line therapy and for whom palliative RT is clinically indicated received cemiplimab plus RT, cyclophosphamide, and GM-CSF. The co-primary objectives were the safety, tolerability, and efficacy of cemiplimab plus RT, cyclophosphamide, and GM-CSF in 15 patients with R/M HNSCC. Results Fifteen patients were enrolled. Patients discontinued treatment due to progression of disease. The most common treatment-emergent adverse events (TEAEs) of any grade were fatigue (40.0%), constipation (26.7%), and asthenia, dyspnea, maculo-papular rash, and pneumonia (each 20%). The only grade ≥3 TEAE that occurred in two patients was pneumonia (13.3%). By investigator assessment, there was one partial response (6.7%); disease control rate was 40.0% (95% confidence interval [CI], 16.3–67.7; five patients with stable disease); seven patients had progressive disease, and two were not evaluable. Median progression-free survival by investigator assessment was 1.8 months (95% CI, 1.7–4.7). Conclusion The regimen demonstrated tolerability but not efficacy above that which can be achieved with anti–PD-1 inhibitor monotherapy for R/M HNSCC.

Background: Health-related quality of life (HRQoL) is greatly affected by prostate cancer (PCa) and associated treatments. This study aimed to measure the impact of radiotherapy on HRQoL and to further validate the Spanish version of the 16-item Expanded Prostate Cancer Index Composite (EPIC-16) in routine clinical practice.Methods: An observational, non-interventional, multicenter study was conducted in Spain with localized PCa patients initiating treatment with external beam radiotherapy (EBRT) or brachytherapy (BQT). Changes from baseline in EPIC-16, University of California-Los Angeles Prostate Cancer Index (UCLA-PCI), and patient-perceived health status were longitudinally assessed at end of radiotherapy (V2) and 90 days thereafter (V3). Psychometric evaluations of the Spanish EPIC-16 were conducted.Results: Of 516 patients enrolled, 495 were included in the analysis (EBRT, n = 361; BQT, n = 134). At baseline, mean (standard deviation [SD]) EPIC-16 global scores were 11.9 (7.5) and 10.3 (7.7) for EBRT and BQT patients, respectively; scores increased, i.e., HRQoL worsened, from baseline, by mean (SD) of 6.8 (7.6) at V2 and 2.4 (7.4) at V3 for EBRT and 4.2 (7.6) and 3.9 (8.2) for BQT patients. Changes in Spanish EPIC-16 domains correlated well with urinary, bowel, and sexual UCLA-PCI domains. EPIC-16 showed good internal consistency (Cronbach’s alpha = .84), reliability, and construct validity.Conclusion: EPIC-16 scores worsened after radiotherapy in different HRQoL domains, regardless of patient-perceived health status. UCLA-PCI scores mostly recovered for EBRT patients at V3, while scores for BQT patients did not. The Spanish EPIC-16 questionnaire demonstrated sensitivity, strong discriminative properties and reliability, and validity for use in clinical practice.

Purpose: Long-term comparative effectiveness research on localized prostate cancer treatments is scarce, and evidence is lacking especially for brachytherapy. The aim of this study was to assess the long-term impact of the side effects of radical prostatectomy, brachytherapy, and external radiation therapy on patients with localized prostate cancer at 10 years, using propensity score analyses. Methods and Materials: This was a prospective observational study of a cohort of men who received a diagnosis of clinically localized prostate cancer (clinical stage T1 or T2, low and intermediate risk group) and were treated with radical prostatectomy (n = 139), brachytherapy (n = 317), or external radiation therapy (n = 194). Treatment decisions were jointly made by patients and physicians. Patient-reported outcome (PRO) evaluation included the Expanded Prostate Cancer Index Composite and Short Form-36, administered centrally by telephone interviews before and annually after treatment. The Expanded Prostate Cancer Index Composite covers urinary, bowel, sexual, and hormonal domains. To assess PRO changes over time, while accounting for correlation among repeated measures, generalized estimating equation models adjusted by propensity scores were constructed. Results: The PRO completion rate at 10 years was 85.8%. Generalized estimating equation models showed that the pattern of radical prostatectomy side effects, with substantial urinary incontinence and sexual dysfunction, remained until 10 years after treatment (standard deviation [SD], -1.1 and -1.3, respectively). Brachytherapy produced late deterioration in urinary continence (SD, -0.4) and sexual function (SD, -0.9) that appeared midterm, but the differences from radical prostatectomy remained statistically significant at 10 years (P < .001 after adjusting by propensity score). External radiation therapy showed similar results to brachytherapy, but with bowel bother (SD, -0.3). Conclusions: Although late deterioration in radiation therapy groups attenuated differences from radical prostatectomy, relevant PRO differences still remained after 10 years. Our findings support that brachytherapy is the treatment option that causes the least impact on PROs; it is therefore an alternative to be considered when making evidence-based decisions on localized prostate cancer treatment. (C) 2021 The Authors. Published by Elsevier Inc.

Purpose/Objective(s) SBRT-SG 05 is a collaborative (SBRT-SG, GICOR and SEOR) prospective multicenter phase II trial testing SBRT and androgen deprivation therapy (ADT) in oligorecurrent prostate cancer patients. Materials/Methods Prostate cancer patients (hormone-sensitive or castration-resistant) in an oligorecurrent stage defined as less than 5 bone or lymph node metastases by Choline PET-CT or/and WB-DWI-MRI, after primary treatment, were assigned to receive ADT and SBRT (Vertebral metastases: 1 × 16-18Gy or 3 × 8-9Gy; lymph node metastases: 3 × 10-11 Gy or 6 × 7,5Gy; non-spinal bone metastases: 1 × 16Gy or 3 × 10Gy). Inclusion criteria included: more than 1 year from primary treatment to biochemical recurrence and PSA doubling time greater than 2 months. A minimum of 24 months of LhRh analogues from the time of the enrollment was required and concomitant treatment with chemotherapy, abiraterone or enzalutamide was not allowed. Oncologic outcomes defined by PCWG3 were evaluated separately for hormone-sensitive and castration-resistant patients, using Kaplan-Meier competing risks, and Cox regression. Toxicity was prospectively evaluated according to CTCAE.v4 criteria. Results From 07/2014 to 12/2019, 81 patients from 14 Spanish centers were recruited with a total of 117 oligometastases treated, 67 in lymph nodes, 43 in non-‐spinal bones and 7 in spinal bones. 14 patients were recruited in a castration-resistance status. Median follow-up was 41 months, (range 18 - 72 months). 13 hormone-sensitive (19,4%) and 8 castration-resistant (57,1%) oligorecurrent patients presented distant disease progression. Median distant progression-free survival (DPFS) was 54,2 months (IC95% = 48,2 – 60,3). 18 of the patients who progressed (85,7%) were treated with SBRT for the new lesions, 7 of them presented a subsequent distant progression (38,9%), with a median of second DPFS of 24,4 months (95% CI = 23,7 – 25,2). In the castration resistant subgroup, median DPFS was 33,5 months (range 14,8 – 52,1), 42,9% of them were free from distant disease progression at last follow-up, without the need to start second generation hormonal treatment. Tolerance and toxicity profiles were excellent, none of the patients developed toxicity ≥G3 or symptoms related to local progression of the disease. Conclusion Combination of SBRT and ADT is a safe treatment approach with favorable clinical outcomes for hormone-sensitive and castration-resistant prostate cancer patients. Validation studies are needed in castration-resistant patients. ClinicalTrials.gov Identifier: NCT02192788

To compare adjuvant radiotherapy (ART) to salvage radiotherapy (SRT) after radical prostatectomy (RP) in a cohort of prostate cancer (PCa) patients. The primary aim was to comparatively assess 2- and 5-year biochemical relapse-free survival (BRFS). A secondary aim was to identify predictors of survival. Data were acquired from the RECAP database, a population-based prostate cancer registry in Spain. Inclusion criteria included RP (with or without lymphadenectomy) followed by ART or SRT. A total of 702 patients were analyzed. Pre-RT PSA values (> 0.5 vs. ae0.5 ng/ml), pathological stage (T1-2 vs. T3-4), post-surgical Gleason score (ae7 vs. 8-10), margin status (positive vs. negative), hormonal treatment (yes vs. no), and RT dose ( 66 Gy) were evaluated to assess their impact on BRFS. The mean patient age in the ART and SRT groups, respectively, was 64 years (range 42-82) and 64.8 years (range 42-82). Median follow-up after RT in the whole sample was 34 months (range 3-141). A total of 702 patients were included: 223 (31.8%) received ART and 479 (68.2%) SRT. BRFS rates (95% CI) in the ART and SRT groups at months 24 and 60 were, respectively: 98.1% (95.9-100.0%) vs. 91.2% (88.2-94.2%) and 84.5% (76.4-92.6%) vs. 74.0% (67.4-80.7%) (p = 0.004). No significant differences in OS were observed (p = 0.053). The following variables were significant predictors of biochemical recurrence in the SRT group: (1) positive surgical margin status (p = 0.049); (2) no hormonotherapy (p = 0.03); (3) total prostate dose ae66 Gy (p = 0.004); and pre-RT PSA ae0.5 ng/ml (p = 0.013). This is the first nationwide study in Spain to evaluate a large cohort of PCa patients treated with RP followed by postoperative RT. ART yielded better 2- and 5-year BRFS rates, although OS was equivalent. These findings are consistent with most other published studies and support ART in patients with adverse prognostic characteristics after radical prostatectomy. Prospective trials are needed to compare immediate ART to early SRT to better determine their relative benefits.

PurposeTo retrospectively assess outcomes and to identify prognostic factors in patients diagnosed with intermediate-risk (IR) prostate cancer (PCa) treated with primary external beam radiotherapy (EBRT).Materials and methodsData were obtained from the multi-institutional Spanish RECAP database, a population-based prostate cancer registry in Spain. All IR patients (NCCN criteria) who underwent primary EBRT were included. The following variables were assessed: age; prostate-specific antigen (PSA); Gleason score; clinical T stage; percentage of positive biopsy cores (PPBC); androgen deprivation therapy (ADT); and radiotherapy dose. The patients were stratified into one of three risk subcategories: (1) favourable IR (FIR; GS 6,T2b or GS 3+4,T1c), (2) marginal IR (MIR; GS 3+4, T2a-b), and (3) unfavourable IR (UIR; GS 4+3 or T2c). Biochemical relapse-free survival (BRFS), disease-free survival (DFS), cancer-specific survival (CSS), and overall survival (OS) were assessed.ResultsA total of 1754 patients from the RECAP database were included and stratified by risk group: FIR, n=781 (44.5%); MIR, n=252 (14.4%); and UIR, n=721 (41.1%). Mean age was 71years (range 47-86). Mean PSA was 10.4ng/ml (range 6-20). The median radiotherapy dose was 74Gy, with mean doses of 72.5Gy (FIR), 73.4Gy (MIR), and 72.8Gy (UIR). Most patients (88%) received ADT for a median of 7.1months. By risk group (FIR, MIR, UIR), ADT rates were, respectively, 88.9, 86.5, and 86.9%. Only patients with24months of follow-up post-EBRT were included in the survival analysis (n=1294). At a median follow-up of 52months (range 24-173), respective 5- and 10-year outcomes were: OS 93.6% and 79%; BRFS 88.9% and 71.4%; DFS 96.1% and 89%; CSS 98.9% and 94.6%. Complication rates (grade 3) were: acute genitourinary (GU) 2%; late GU 1%; acute gastrointestinal (GI) 2%; late GI 1%. There was no significant association between risk group and BRFS or OS. However, patients with favourable-risk disease had significantly better 5- and 10-year DFS than patients with UIR: 98.7% vs. 92.4% and 92% vs. 85.8% (p=0.0005). CSS was significantly higher (p=0.0057) in the FIR group at 5 (99.7% vs. 97.3%) and 10 years (96.1% vs. 93.4%). On the multivariate analyses, the following were significant predictors of survival: ADT (BRFS and DFS); dose74Gy (BRFS); age (OS).ConclusionsThis is the first nationwide study in Spain to report long-term outcomes of patients with intermediate-risk PCa treated with EBRT. Survival outcomes were good, with a low incidence of both acute and late toxicity. Patients with unfavourable risk characteristics had significantly lower 5- and 10-year disease-free survival rates. ADT and radiotherapy dose74Gy were both significant predictors of treatment outcomes.

Nomograms were established to predict biochemical recurrence (BCR) after radiotherapy (RT) with a low weight of the characteristic variables of RT and androgen deprivation therapy (ADT). Our aim is to provide a new stratified tool for predicting BCR at 4 and 7 years in patients treated using RT with radical intent. A retrospective, nonrandomized analysis was performed on 5044 prostate cancer (PCa) patients with median age 70 years, who received RT—with or without ADT—between November 1992 and May 2007. Median follow-up was 5.5 years. BCR was defined as a rise in serum prostate-specific antigen (PSA) of 2 ng/ml over the post-treatment PSA nadir. Univariate association between predictor variables and BCR was assessed by the log-rank test, and three linked nomograms were created for multivariate prognosis of BCR-free survival. Each nomogram corresponds to a category of the Gleason score—either 6,7, or 8–10—and all of them were created from a single proportional hazards regression model stratified also by months of ADT (0, 1–6, 7–12, 13–24, 25–36, 36–60). The performance of this model was analyzed by calibration, discrimination, and clinical utility. Initial PSA, clinical stage, and RT dose were significant variables (p

Purpose To assess long-term quality of life (QoL) impact of treatments in localized prostate cancer patients treated with radical prostatectomy, external beam radiotherapy or brachytherapy. Material and methods Observational, prospective cohort study with pre-treatment QoL evaluation and follow-up until five years after treatment. 704 patients with low or intermediate risk localized prostate cancer were consecutively recruited in 2003–2005. QoL was measured by the EPIC questionnaire, with urinary irritative–obstructive, incontinence, bowel, sexual, and hormonal scores (ranging 0–100). Results Brachytherapy's QoL impact was restricted to the urinary domain, Generalized Estimating Equation models showed score changes at five years of −12.0 (95% CI=−15.0, −9.0) in incontinence and −5.3 (95% CI=−7.5, −3.1) in irritative–obstructive scales. Compared to brachytherapy, radical prostatectomy fared +3.3 (95% CI=+0.0, +6.5) points better in irritative–obstructive but −17.1 (95% CI=−22.7, −11.5) worse in incontinence. Sexual deterioration was observed in radical prostatectomy (−19.1; 95% CI=−25.1, −13.1) and external radiotherapy groups (−7.5; 95% CI=−12.5, −2.5). Conclusions Brachytherapy is the treatment causing the least impact on QoL except for moderate urinary irritative–obstructive symptoms. Our study provides novel long-term valuable information for clinical decision making, supporting brachytherapy as a possible alternative to radical prostatectomy for patients seeking an attempted curative treatment, while limiting the risk for urinary incontinence and sexual impact on QoL.

Background Incidence of human papillomavirus (HPV)-related oropharyngeal carcinomas is increasing worldwide. The purpose of this study was to report the incidence in our region, and to determine the influence of HPV status on survival among a heavy smoking population. Methods p16 expression was analyzed in 102 patients with stage II to IV treated with chemoradiation. Overall survival (OS), locoregional control, and disease-free survival (DFS) were compared for HPV+ and HPV− status. Results The majority of patients were smokers (86%). p16 positivity was found in 26.7%. Patients who were HPV+ were younger (56 vs 59 years old; p = .052). No differences were observed regarding tumor stage, sex, or smoking between HPV+ and HPV−. Three-year OS was 67.4% for patients who were HPV+ versus 49.7% for HPV− (hazard ratio [HR], 0.55; p = .095). Conclusion Incidence of HPV-related oropharyngeal carcinoma in Spain is similar to that reported in other European countries. In this sample of heavy smokers, we observed a nonsignificant trend for better outcomes in patients who were HPV+. © 2013 Wiley Periodicals, Inc. Head Neck 36: 782–786, 2014

BackgroundSalivary gland-type tumors originating in the nasopharynx are rare, and only a few articles about mucoepidermoid carcinomas (MEC) in this location have been reported. We describe one case of nasopharyngeal MEC and, based on a review of the literature, discuss different therapeutic approaches that can be taken regarding the result of histological findings, radiological tests and extent of disease.Case presentationA 47-year-old woman diagnosed with mucoepidermoid carcinoma of nasopharynx, T1 N3 M0 (stage IV-B) was treated in 2007 with a combination of radiotherapy and chemotherapy to a maximum dose of 70Gy and concomitant Cisplatin during the radiation. One year later, with the head and neck disease under control, mediastinal nodes relapse appeared which were treated with exclusive radiotherapy to a maximum dose of 65Gy. One year after the first relapse, a second relapse was detected in the right lung, next to the previously treated mediastinal regions, and the patient initiated a treatment with exclusive chemotherapy based on TPF scheme.ConclusionFor limited or resectable MEC, combined surgery with radiotherapy, or radiochemotherapy, should be considered the main treatment policy. On the other hand, in poorly differentiated, unresectable tumors or nasopharyngeal MEC, radiochemotherapy could be currently the main treatment approach.

We compared biochemical control and quality of life with intermittent (6 months) versus continuous (36 months) androgen deprivation therapy (ADT) in a non-inferiority randomized phase 3 trial in patients with biochemical failure (BF) after external beam radical radiotherapy (EBRT). Patients were stratified according to the Gleason score (GS) and were classified as low risk with a GS < 6 and 7 (3 + 4) and high risk with a GS of 7 (4 + 3) and > 7. Patients were followed with PSA determinations and quality-of-life assessments (QLQ C-30 and QLQ PR-25) every 6 months for a period of 3 years. BF after radiation was defined as a PSA level of nadir +2 ng/ml. Disease progression (DP) after ADT was defined as PSA >4 ng/ml (BF) and/or metastases. Seventy-seven patients were included in this multicenter phase 3 trial from 2005 to 2009. Thirty-eight and 39 patients were included in the intermittent and continuous groups, respectively. The median follow-up for both groups was 48 months (40-68). DP after ADT in the intermittent group was seen in three patients (distant metastases in one patient) versus 0 in the continuous group. The QLQ-C30 and QLQ PR-25 scores did not show any statistically difference between the two ADT groups. No significant differences were seen in DP and QLQ between intermittent (6 months) and continuous (36 months) ADT in patients with BF after EBRT.

Purpose Earlier studies evaluating the effect on quality of life (QoL) of localized prostate cancer interventions included patients receiving adjuvant hormone therapy, which could have affected their outcomes. Our objective was to compare the QoL impact of the three most common primary treatments on patients who were not receiving adjuvant hormonal treatment. Patients and Methods This was a prospective study of 435 patients treated with radical prostatectomy, external-beam radiotherapy, or brachytherapy. QoL was assessed before and after treatment with the Short Form-36 and the Expanded Prostate Cancer Index Composite. Differences between groups were tested by analysis of variance. Distribution of outcome at 3 years was examined by stratifying according to baseline status. Generalized estimating equation models were constructed to assess the effect of treatment over time. Results Compared with the brachytherapy group, the prostatectomy group showed greater deterioration on urinary incontinence and sexual scores but better urinary irritative-obstructive results (−18.22, −13.19, and +6.38, respectively, at 3 years; P < .001). In patients with urinary irritative-obstructive symptoms at baseline, improvement was observed in 64% of those treated with nerve-sparing radical prostatectomy. Higher bowel worsening (−2.87, P = .04) was observed in the external radiotherapy group, with 20% of patients reporting bowel symptoms. Conclusion Radical prostatectomy caused urinary incontinence and sexual dysfunction but improved pre-existing urinary irritative-obstructive symptoms. External radiotherapy and brachytherapy caused urinary irritative-obstructive adverse effects and some sexual dysfunction. External radiotherapy also caused bowel adverse effects. Relevant differences between treatment groups persisted for up to 3 years of follow-up, although the difference in sexual adverse effects between brachytherapy and prostatectomy tended to decline over long-term follow-up. These results provide valuable information for clinical decision making.

Non-melanoma skin tumours (NMSC) are one of the most frequent types of cancer, accounting for nearly one third of newly diagnosed tumours. NMSC are frequently diagnosed in elderly patients and while mortality rates are low, NMSC can be associated with significant morbidity in terms of cosmetic and functional impairment.Surgical excision is nowadays considered the standard treatment for NMSC, although this approach might not be suitable for all the patients. Good rates of local control and cosmetic outcome are achieved by using high-dose-rate (HDR) plesiotherapy.Nine consecutive patients with 11 NMSC were treated with custom-made moulds and HDR plesiotherapy reaching a fi nal dose of 44-48 Gy in 11-12 fractions of 4 Gy over 4 weeks.No local or distant relapses have been observed after a mean follow-up of 15 months (range 4-36 months). Acute toxicity was acceptable and cosmetic result was considered as excellent/good in 7 patients.This modality of treatment offers an alternative for those patients not candidates for surgical procedures because of medical contraindications or risk of disfigurement or functional impairment.

Radiation enteritis is a complication of radiation therapy for pelvic tumours. It appears after a variable period of time and is often progressive.We analyse our experience of 77 cases (52 females and 25 males) diagnosed with radiation enteritis or proctitis between 1986 and 2006.The most frequent location of radiation injury is ileum (55 patients, 71%), followed by rectum (22 patients, 28%). Twenty-eight patients (36%) were medically managed and 49 (64%) required surgical treatment. In 41 (53%) of the patients the affected region was resected, in 5 (7%) a by-pass was performed and in 3 (4%) a terminal colostomy. Surgical mortality was 4% (3 cases) and the complication rate 9% (7 cases). Twelve patients (16%) presented recurrence of radiation-related illness. Excluding those cases deceased because of tumoral progression, 5-year survival rate was 90% and 10-year survival rate 83%.Radiation enteritis must be initially conservatively managed, but in those cases without response, surgery is indicated. Surgical treatment should not be delayed fearing postoperative complications, which are more susceptible to appear in deteriorated patients. If technically possible, the affected region should be resected, because complications may appear later at this damaged location.

[This corrects the article DOI: 10.1016/j.rpor.2015.04.003.].

Purpose: To report treatment outcomes in a cohort of extreme-risk prostate cancer patients and identify a subgroup of patients with worse prognosis. Materials and methods: Extreme-risk prostate cancer patients were defined as patients with at least one extreme-risk factor: stage cT3b–cT4, Gleason score 9–10 or PSA > 50 ng/ml; or patients with 2 or more high-risk factors: stage cT2c–cT3a, Gleason 8 and PSA > 20 ng/ml. Overall survival (OS), cause-specific survival (CSS), clinical-free survival (CFS), and biochemical non-evidence of disease (bNED) survival are the four outcomes of interest in a population of 1341 patients. Results: With a median follow-up of 71.5 months, 5- and 10-year bNED survival, CFS, CSS and OS for the entire cohort were 77.1 % and 57.0, 89.2 and 78.9 %, 97.4 and 93.6 %, and 92.0 and 71.3 %, respectively. On multivariate analysis, PSA and clinical stage were associated with bNED survival. PSA and Gleason score predicted for CFS, whereas only Gleason score predicted for OS. When a simplified model was performed using the “number of risk factors” variable, this model provided the best distinction between patients with ≥2 extreme-risk factors and patients with 2 high-risk factors, showing a hazard ratio (HR) of 1.737 (p = 0.0003) for bNED survival, HR 1.743 (p = 0.0448) for OS and an HR of 3.963 (p = 0.0039) for the CSS endpoint. Conclusions: Patients presenting at diagnosis with two extreme-risk criteria have almost fourfold higher risk for prostate cancer mortality. Such patients should be considered for more aggressive multimodal treatments.

PURPOSE: To assess variability in the use of Tomita and modified Bauer scores in spine metastases. MATERIALS AND METHODS: Clinical data and imaging from 90 patients with biopsy-proven spinal metastases, were provided to 83 specialists from 44 hospitals. Spinal levels involved and the Tomita and modified Bauer scores for each case were determined twice by each clinician, with a minimum of 6-week interval. Clinicians were blinded to every evaluation. Kappa statistic was used to assess intra and inter-observer agreement. Subgroup analyses were performed according to clinicians' specialty (medical oncology, neurosurgery, radiology, orthopedic surgery and radiation oncology), years of experience (⩽7, 8-13, ⩾14), and type of hospital (four levels). RESULTS: For metastases identification, intra-observer agreement was "substantial" (0.600.80) at the other levels. Inter-observer agreement was "almost perfect" at lumbar spine, and "substantial" at the other levels. Intra-observer agreement for the Tomita and Bauer scores was almost perfect. Inter-observer agreement was almost perfect for the Tomita score and substantial for the Bauer one. Results were similar across specialties, years of experience and type of hospital. CONCLUSION: Agreement in the assessment of metastatic spine disease is high. These scoring systems can improve communication among clinicians involved in oncology care., This study was funded by the Kovacs Foundation, a not-for-profit Spanish institution specializing in neck and back pain research, and with no links to the health industry.

The purpose of the study was to describe infrastructures, treatment modalities, and workload in radiation oncology (RO) in Spain, referred particularly to prostate cancer (PC). An epidemiologic, cross-sectional study was performed during 2008-2009. A study-specific questionnaire was sent to the 108 RO-registered departments. One hundred and two departments answered the survey, and six were contacted by telephone. Centers operated 236 treatment units: 23 (9.7 %) cobalt machines, 37 (15.7 %) mono-energetic linear accelerators, and 176 (74.6 %) multi-energy linear accelerators. Sixty-one (56.4 %) and 33 (30.5 %) departments, respectively, reported intensity-modulated radiation therapy (IMRT) and image-guided RT (IGRT) capabilities; three-dimensional-conformal RT was used in 75.8 % of patients. Virtual simulators were present in 95 departments (88.0 %), 35 use conventional simulators. Fifty-one departments (47.2 %) have brachytherapy units, 38 (35.2 %) perform prostatic implants. Departments saw a mean of 24.9 new patients/week; the number of patients treated annually was 102,054, corresponding to 88.4 % of patients with a RT indication. In 56.5 % of the hospitals, multidisciplinary teams were available to treat PC. Results provide an accurate picture of current situation of RO in Spain, showing a trend toward the progressive introduction of new technologies (IMRT, IGRT, brachytherapy).

PURPOSE: To evaluate efficacy and toxicity after salvage brachytherapy (BT) in prostate local recurrence after radiation therapy. METHODS AND MATERIALS: Between 1993 and 2007, we retrospectively analyzed 56 consecutively patients (pts) undergoing salvage brachytherapy. After local biopsy-proven recurrence, pts received 145 Gy LDR-BT (37 pts, 66%) or HDR-BT (19 pts, 34%) in different dose levels according to biological equivalent doses (BED2 Gy). By the time of salvage BT, only 15 pts (27%) received ADT. Univariate and multivariate analyses were performed to identify predictors of biochemical control and toxicities. Acute and late genitourinary (GU) and gastrointestinal (GI) toxicities were graded using Common Terminology Criteria for Adverse Events (CTCv3.0). RESULTS: Median follow-up after salvage BT was 48 months. The 5-year FFbF was 77%. HDR and LDR late grade 3 GU toxicities were observed in 21% and 24%. Late grade 3 GI toxicities were observed in 2% (HDR) and 2.7% (LDR). On univariate analysis, pre-salvage prostate-specific antigen (PSA) > 10 ng/ml (p = 0.004), interval to relapse after initial treatment

e15145Background: Data of outcomes of elderly patients ( ≥ 70) with stage II and III rectal cancer treated with multimodal treatment (neoadjuvant chemoradiotherapy, surgery and adjuvant chemotherap...

737 Background: There is some evidence relating delay of surgery (DS) by more than 8 weeks after the end of chemoradiotherapy and achievement of complete pathological response (ypCR). However, the relationship with overall survival (OS) seems to be negative. Methods: Records of 171 patients diagnosed from January 2003 to December 2011 with rectal adenocarcinoma T3/T4 and/or positive node staged by ultrasound or MRI were collected retrospectively from the Pathology Department database. Results: Of the 171 patients, 62% were male, median age at diagnosis 69.3 years (31.3 years -85.3 years). All of them received 50.4 Gy with different concomitant regimens (capecitabine, continuous infusion of fluoracil or bolus of fluoracil-leucovorin). 72.5% of the cohort received adjuvant chemotherapy. 13% of patients achieved ypCR, independently of DS (13.7% in DS vs 11.8%, p 0.722). OS was significantly worse among DS patients (67.9 months vs 54.8 months, p 0.016). In addition, more sphincter preservations (SP) were not achieved (60.8% in DS vs 57.1%, p 0.881). Conclusions: In contrast with published literature, in our cohort DS failed to show higher rates of ypCR. Neither an improvement in OS or SP was observed with DS. It is recommended that clinical trials be designed in order to establish ideal surgical timing.

The treatment of rectal cancer has evolved over the last few decades from surgery alone to treatments with trimodal therapy for high-risk patients. The involvement of a multidisciplinary team of radiologists, pathologists, surgeons, radiotherapists and medical oncologists is now fundamental for decision-making and outcomes. The evolution of different diagnostic and therapeutic techniques has optimised the therapeutic rate. Future studies will determine the optimal regimen for inducing complete responses in locally advanced disease and whether the intensification of local treatments could enable the use of more conservative treatments, as for other tumour locations. The study of biomarkers will be essential in this respect.

The concept of radiation therapy for the treatment of benign diseases refers to the use of moderate to high-energy ionising radiation as part of the treatment of non-malignant, but not necessarily harmless, diseases. The usefulness of radiation therapy, based on the anti-inflammatory properties of ionising radiation, has long been known. Apart from the treatment of intracranial benign tumours, such as meningiomas and neurinomas, the prevention of cardiovascular restenosis or treatment of skeletal degenerative diseases are, without doubt, the main fields of action for radiation therapy in benign conditions. Nonetheless, many other non-cancer entities may benefit from ionising radiation therapy treatment. The purpose of this review is to highlight and update indications for treatment with radiation therapy in benign conditions, focusing on skeletal degenerative processes, vascular conditions and soft tissue diseases.

Stereotactic Body Radiation Therapy With Volumetric Modulated Arc Therapy and Flattening Filter-Free Beams in Lowor Intermediate-Risk Prostate Cancer: Early Experience and Quality of Life Assessment in Phase 1-2 Trial F. Ferrer, O. Garin, H.A. Letelier, R. De Blas, A. Boladeras, E. Garcia, E. Zardoya, R. Pineiro, A. Hervas, M. Castells, V. Macias, M. Galdeano, C. Gutierrez, M. Ventura, D. Najjari, E. Martinez, J.F. Suarez, C. Picon, J. Pera, and F. Guedea; Catalan Institute of Oncology, L’Hospitalet-Barcelona, Spain, Health Services Research Group IMIM (Hospital del Mar Research Institute), Barcelona, Spain, Escuela de Medicina, Universidad de Valparaiso, Valparaiso, Chile, Ramon y Cajal Hospital, Madrid, Spain, Bellvitge Hospital, L’Hospitalet-Barcelona, Spain, Salamanca Hospital, Salamanca, Spain, University of Barcelona, L’Hospitalet-Barcelona, Spain

e14539 Background: The role of adjuvant chemotherapy (AC) after chemo-Rt and surgery in stage II and III of rectal cancer is not well defined. Neither the regimen nor the duration is clear. Besides...

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