Indications For Adjuvant Radiotherapy Research Articles

Променева терапія раку шлунка. Від наукових досліджень до практики

Abstract. Significant decrease (almost thrice) of the quantity of patients, who received radiation therapy, was noted for the last 5 years. Radiation of the stomach was not absolutely performed in neoadjuvant and adjuvant regimes. The main indications to therapy were cancer of the cardiac portion of the stomach with patency disturbances and pain syndrome.Effect of palliative treatment was achieved in 60 % of cases. Absence of modern planning systems inhibitsadministration of the stomach cancer radiation therapy. Groups of patients with evident indications to radiation therapy of the gastric cancer were identified. When planning therapy it is advisable to use well-known data with the landmarks regionto bone formations in epigastric region.The purpose of this work is to estimate efficiency and indications to radiation therapy of the stomach cancer in two periods – 1997-2003 and 2016-2017 years; to detect tendencies in radiation therapy indications on the basis of the previous experience and present state of surgery.Material and methods. In the course of study a retrospective analysis of the patients’ case historiessuffering fromgastric cancer aftera complex treatment was conducted.Results.Having analyzed radiotherapy results of the gastric carcinoma during 1997-2003 years in neoadjuvant and adjuvant regimes, it has been established that a significant life extension of theoperated patients was not achieved. In2015-2107, radiotherapy was performed exceptionally for the purpose of palliative care, and improvement was achieved (reduction of pain syndrome and obstruction) in 60% pf patients.Conclusions. Radiotherapy of the stomach cancer is indicated with palliative purpose. There are possibilities and indications for adjuvant radiation therapy of the stomach cancer.

Adjuvant Radiation Therapy for Vulvar Squamous Cell Carcinoma: Does p16-Positivity Influence Locoregional Control?

Vulvar squamous cell carcinoma (VSCC) is a relatively rare malignancy. Human papillomavirus (HPV) has been implicated as a causative factor for a subset of these patients. The purpose of this study is to evaluate if p16-positivity, which is surrogate for HPV infection, predicts for better response rates and survival in women who undergo surgery followed by adjuvant radiation therapy (RT). A retrospective chart review was undertaken of all women treated with adjuvant radiation therapy from 2000-2016 for VSCC at our institution. Available tissue blocks were stained for p16. Each tumor was assigned an H-score according to the College of American Pathologists criteria. P16-positivity was defined as diffuse, strong immunoreactivity within invasive tumor with an H-score of 200+. P16 +/- groups were compared using Chi-squared and t-test. These were correlated with outcomes via Kaplan-Meier with log-rank technique. Time to an event was defined as the time from completion of RT. Thirty-nine women were identified. Median follow up was 25.6 months and 43.3 months for living patients. Ten women (25.6%) had p16+ pathology. The median age at diagnosis was 59.3 years for women with p16+ tumors and 70.2 years for women with p16- tumors (p=0.04). The distribution of stage did not differ by p16-status. The median maximal vulvar dose was 54.4Gy (range: 42.6-63.0Gy). The indication for adjuvant RT was close/positive margins in 19 women (48.7%), positive nodes in 8 (20.5%), and both in 12 (30.8%). The average pathologic tumor size was 2.1cm for p16+ tumors and 3.4cm for p16- tumors (p=0.028). Average margin size was not statistically different. There was a trend towards differences in the average number of pathologically involved lymph nodes, 0.5 vs 1.26 for p16+ vs p16-, p=0.077. Vulvar control rates differed by p16 status at 2 years: 88.9% vs 52.3% for p16+ vs p16-, p=0.041. This translated to a strong trend in differences in two-year locoregional control as well: 77.8% vs 47.4% for p16+ vs p16-, respectively, p=0.064. In women with only one indication for adjuvant RT, this benefit was more pronounced for women with p16+ tumors vs p16-: 2-year locoregional control 100% vs 48.5%, p=0.041. Two-year overall survival was not significantly different between p16+/- cohorts (88.9% vs 64.6%, p=0.405). Survival was impacted by risk factors necessitating adjuvant RT, however. Women with either close/positive margins or positive nodes had a 2-year survival of 80.4% vs 50.0% for women with both risk factors (p=0.044). p16+/- status did not statistically influence survival for women with one risk factor, but survival was numerically different at 2 years (100% vs 73.2%). The p16 positivity appears to be a prognostic factor for locoregional control rates in VSCC treated with vulvectomy and adjuvant radiation therapy for close/positive margins or positive lymph nodes. This benefit was pronounced especially in women with only close/positive margins or positive lymph nodes.

Le grand débat : cancers du sein pN1mi – pour l’irradiation des aires ganglionnaires

Standard of care in breast cancer management is well-defined. However, some gray zones still exist, in particular adjuvant radiotherapy indications in case of pN1mi breast cancer. Here we propose to define their prognosis, to underpin the benefit of adjuvant treatments in such patients’ management and to define lymphedema risk, which is the most common late side effect of locoregional treatments.

The Prognostic Significance of p16 Status in Patients With Vulvar Cancer Treated With Vulvectomy and Adjuvant Radiation

Vulvar squamous cell carcinoma (VSCC) is a relatively rare malignancy. Human papillomavirus has been implicated as a causative factor for a subset of these patients. The purpose of this study was to evaluate whether p16-positivity (a human papillomavirus surrogate) predicts for better response rates in women who undergo surgery followed by adjuvant radiation therapy (RT). We retrospectively analyzed data from women with VSCC who were treated with adjuvant RT. p16-Positivity was defined as diffuse strong immunoreactivity within the tumor. Time to event outcomes was performed with Kaplan-Meier and cumulative incidence methodologies. Thirty-nine women were identified. Ten had positive results for p16 (p16+), and 29 had negative results (p16-). The median follow-up was 25.7months. The median age at diagnosis was 59years for women with p16+tumors and 74years for women with p16- tumors (P=.022). The distribution of stage did not differ by p16 status. The indications for adjuvant RT were close/positive margins in 19 women, positive nodes in 9 women, and both in 11 women. There were 21 recurrences: 15 vulvar, 3 isolated nodal, 2 synchronous vulvar/nodal, and 1 distant metastasis. In-field relapse rates at 3years were lower in p16+patients (32.5%) than in p16- patients (59.1%, P=.072). This trend was also observed in progression-free survival (P=.062). A p16+status and a lower International Federation of Gynecology and Obstetrics stage were associated with fewer in-field relapses and improved progression-free survival in multivariable analyses. The p16 status was not a predictor of overall survival. p16-Positivity appears to be a prognostic factor for in-field relapse rates in patients with VSCC appropriately treated with adjuvant RT.

Neoadjuvant chemotherapy for breast cancer-background for the indication of locoregional treatment.

Neoadjuvant chemotherapy (NACT) has been widely adopted into the multidisciplinary management of breast cancer. The prognostic impact of treatment response has been clearly demonstrated. However, the impact of treatment response on the indication for adjuvant radiotherapy is unclear. This review summarizes important implications of NACT and treatment response on the risk of recurrence and locoregional multidisciplinary management from the standpoint of radiation oncology.

ESGO Survey on Current Practice in the Management of Cervical Cancer

The aim of this survey was to acquire an overview of the current management of cervical cancer with an emphasis on the early disease stages. A hyperlink to the survey was sent to the European Society of Gynaecological Oncology Office database. The survey contained 6 groups of questions regarding the characteristics of respondents, pretreatment workup, management of the early stages of cervical cancer, adjuvant treatment, fertility-sparing treatment, and surveillance. In total, 566 responses were collected. The most frequent imaging method used in the workup was magnetic resonance imaging (74%), followed by computed tomography (54%) and positron emission tomography/computed tomography (25%). Conization or simple hysterectomy was a preferred procedure in stage T1a1 lymphovascular space invasion (LVSI)-positive for 79% of respondents, in stage T1a2 LVSI-negative for 58%, and in stage T1a2 LVSI-positive for 28%. Sentinel lymph node biopsy alone was reported in stage T1a1 by 17% and in stage T1b1 less than 2 cm by 9%, whereas systematic lymphadenectomy by 29% and 90% of respondents. Macrometastases, micrometastases, and isolated tumor cells in lymph nodes were considered indications for adjuvant treatment by 96%, 93%, and 68% of respondents, respectively. Neoadjuvant chemotherapy was reported by 28% and 19% of respondents in fertility-sparing and nonsparing management in stage T1b1. Over 60% of respondents recommend primary surgery for their patients with T1b2 N0 disease and 81% of them use a combination of adverse prognostic factors as indication for adjuvant radiotherapy in pN0 disease. The results of this survey indicate considerable differences in the workup and treatment of cervical cancer in current clinical practice.

A Predictive Model for Postoperative Margin Status in Localized Prostate Cancer

Positive surgical margins are a risk factor for recurrence following radical prostatectomy for prostate cancer. Accordingly, positive margins are an indication for adjuvant radiation therapy. The ability to accurately predict the risk of post-operative margin status based on pre-operative clinical characteristics may direct therapeutic management for clinically localized prostate cancer and potentially help avoid treatment with combined surgery and radiation. Based on a large, modern cohort of patients who underwent definitive surgical management for clinically localized prostate cancer, we have designed a novel predictive algorithm for post-operative margin status which incorporates initial prostate-specific antigen (iPSA) level, percent positive biopsy cores (PPC), Gleason score (GS), clinical tumor staging, and post-operative margin status. Records from 1,023 patients treated for clinically localized prostate cancer with radical prostatectomy were analyzed for age, primary and total GS on biopsy, iPSA, PPC, and clinical T stage. A multivariate analysis was performed via logistic regression modelling to create a predictive algorithm. Mean patient age was 59.0 years old. Regarding D’Amico risk stratification, 35.2% were low-risk, 51.5% were intermediate-risk, and 13.2% were high-risk. Post-operatively, 256 patients had positive margins and 767 patients had negative margins. On multivariate analysis, age and primary Gleason score were not statistically significant predictors for positive margins. Total GS, iPSA, PPC, and clinical T stage were all found to be statistically significant predictors. For total GS, odds ratio (OR) was 1.401 (p-value 1.14 x10-4). For iPSA, OR was 1.044 (p-value 5.66x10-5). For PPC, OR was 1.014 (p-value 6.91x10-5). For clinical stage T2a, OR relative to stage T1 was 1.440 (p-value 5.35x10-2). For clinical stage >T2a, OR relative to stage T1 was 2.349 (p-value 3.64x10-2). The area under the curve (AUC) for this model, corrected by bootstrapping, was calculated to be 0.6935. The AUC for this model indicates acceptable predictive performance in terms of sensitivity and specificity for a large, modern cohort of patients. This model may therefore serve to aid in therapeutic decision-making for patients with clinically localized prostate cancer. It does remain to be externally validated. Future modelling will incorporate data from pre-operative magnetic resonance imaging.

Clinical significance of the lymph node ratio in N1 breast cancer.

PurposeThe purpose of this study was to evaluate the prognostic value of the lymph node ratio (LNR), which was defined as the proportion of involved nodes of all dissected nodes, in pN1 breast cancer.Materials and MethodsWe retrospectively analyzed the clinical data of patients with pN1 breast cancer (N = 144) treated at Keimyung University Dongsan Medical Center, Daegu, Korea between 2001 and 2010. The median age was 46 years (range, 27 to 66 years). The LNR was 0.01–0.15 (low LNR) in 130 patients and >0.15 (high LNR) in 14 patients. Sixty-five patients (45.1%) had T1 tumors, 74 (51.4%) had T2 tumors, and 5 (3.5%) had T3 tumors. Eighty-eight patients (61.1%) underwent total mastectomy and 56 (38.9%) underwent partial mastectomy. Fifty-nine patients (41.0%) underwent radiotherapy and 12 (8.3%) underwent regional radiotherapy. The median follow-up period was 65 months.ResultsThe 5- and 10-year disease-free survival (DFS) rates were 92.7% and 82.4%, respectively. Univariate analyses revealed that high LNR (p = 0.004), total mastectomy (p = 0.006), no local radiotherapy (p = 0.036), and stage T2 or T3 (p = 0.010) were associated with worse DFS. In multivariable analysis, only high LNR (p = 0.015) was associated with worse DFS.ConclusionHigh LNR is an independent prognostic factor in pN1 breast cancer and could be an indication for adjuvant radiotherapy in these patients.

Missed Opportunities for Loco‐Regional Treatment of Elderly Women with Breast Cancer

Factors associated with surgery, adjuvant radiotherapy, and chemotherapy and whether there were missed opportunities for treatment in elderly patients were determined in an Asian setting. All 5616 patients, diagnosed with breast cancer in University Malaya Medical Centre from 1999 to 2013 were included. In 945 elderly patients (aged 65years and above), multivariable logistic regression was performed to identify factors associated with treatment, following adjustment for age, ethnicity, tumor, and other treatment characteristics. The impact of lack of treatment on survival of the elderly was assessed while accounting for comorbidities. One in five elderly patients had comorbidities. Compared to younger patients, the elderly had more favorable tumor characteristics, and received less loco-regional treatment and chemotherapy. Within stage I-IIIa elderly breast cancer patients, 10% did not receive any surgery. These patients were older, more likely to be Malays, have comorbidities, and bigger tumors. In elderlies with indications for adjuvant radiotherapy, no irradiation (30%) was associated with increasing age, comorbidity, and the absence of systemic therapy. Hormone therapy was optimal, but only 35% of elderly women with ER negative tumors received chemotherapy. Compared to elderly women who received adequate treatment, those not receiving surgery (adjusted hazard ratio: 2.30, 95%CI: 1.10-4.79), or radiotherapy (adjusted hazard ratio: 1.56, 95%CI: 1.10-2.19), were associated with higher mortality. Less than 25% of the survival discrepancy between elderly women receiving loco-regional treatment and no treatment were attributed to excess comorbidities in untreated patients. While the presence of comorbidities significantly influenced loco-regional treatment decisions in the elderly, it was only able to explain the lower survival rates in untreated patients up to a certain extent, suggesting missed opportunities for treatment.

Indications for adjuvant radiation therapy in breast cancer: a review of the evidence and recommendations for clinical practice.

Radiation therapy (RT) plays an important role in the curative management of all stages of breast cancer. The optimal application of adjuvant RT is an area of continuous investigation, and the indications for treatment are refined with each new trial. This article reviews the evidence for adjuvant RT across five distinct clinical scenarios, with additional discussion of RT targets, techniques, and doses where appropriate.

Cancer of the corpus uteri.

Cancer of the corpus uteri.

Positive surgical margins in radical prostatectomy patients do not predict long-term oncological outcomes: results from the Shared Equal Access Regional Cancer Hospital (SEARCH) cohort.

To assess the impact of positive surgical margins (PSMs) on long-term outcomes after radical prostatectomy (RP), including metastasis, castrate-resistant prostate cancer (CRPC), and prostate cancer-specific mortality (PCSM). Retrospective study of 4,051 men in the Shared Equal Access Regional Cancer Hospital (SEARCH) cohort treated by RP from 1988 to 2013. Proportional hazard models were used to estimate hazard ratios (HRs) of PSMs in predicting biochemical recurrence (BCR), CRPC, metastases, and PCSM. To determine if PSMs were more predictive in certain patients, analyses were stratified by pathological Gleason score, stage, and preoperative prostate-specific antigen (PSA) level. The median (interquartile range) follow-up was 6.6 (3.2-10.6) years and 1 127 patients had >10 years of follow-up. During this time, 302 (32%) men had BCR, 112 (3%) developed CRPC, 144 (4%) developed metastases, and 83 (2%) died from prostate cancer. There were 1,600 (40%) men with PSMs. In unadjusted models, PSMs were significantly associated with all adverse outcomes: BCR, CRPC, metastases and PCSM (all P ≤ 0.001). After adjusting for demographic and pathological characteristics, PSMs were associated with increased risk of only BCR (HR 1.98, P < 0.001), and not CRPC, metastases, or PCSM (HR ≤1.29, P > 0.18). Similar results were seen when stratified by pathological Gleason score, stage, or PSA level, and when patients who underwent adjuvant radiotherapy were excluded. PSMs after RP are not an independent risk factor for CRPC, metastasis, or PCSM overall or within any subset. In the absence of other high-risk features, PSMs alone may not be an indication for adjuvant radiotherapy.

Adjuvant radiation for soft tissue sarcomas.

Over recent decades, limb-preservation surgery in combination with radiotherapy achieves local control rates exceeding 90% for extremity soft tissue sarcoma (STS). Local control is not as successful for retroperitoneal sarcoma (approximately 60%) despite aggressive surgical approaches including en bloc resection of uninvolved adjacent organs combined with intensity modulated radiotherapy (IMRT). This review will discuss the indications for adjuvant radiation therapy (RT) for primary presentation of soft tissue sarcoma: "What," referring to the type and manner of planning and delivery of RT; "When," referring to the timing and scheduling of RT; and "Why," referring to the rationale for the use of RT will be addressed. From a practical stand point, this Educational Chapter on "adjuvant RT" will focus on pre- and postoperative RT in the context of gross total resection for extremity and retroperitoneal soft tissue sarcoma, the two most frequent paradigms for the use of adjuvant RT.

Are breast cancer patients treated with radiotherapy younger now than ten years ago?

AimThe aim of the present study was to analyze the age of breast cancer patients managed with curative approach at the time of treatment with radiotherapy. BackgroundBreast cancer is the most frequent neoplasm in women. Little is known with regard to the age of patients at diagnosis, and some authors have suggested that breast cancer is now affecting women who are younger than before. Materials and methodsWe performed a descriptive study of our series of breast cancer patients from 1998 to 2011. The age of patients, city of residence, year of treatment and uni- or bilateral location were extracted from the administrative database of the Radiation Oncology Department. The demographical and reference populational data were extracted from the Catalan Institute of Statistics. Results3382 patients were obtained. The mean age was 57.79 years. No statistical differences were observed in the mean age during the period of study (p>0.05), nor in patients with bilateral neoplasias with regard to unilateral tumours (p>0.5). Patients aged less than 30, 40, 50 and 65 years were 0.3%, 6.3%, 27.0% and 69.1%, respectively. The proportion of patients aged less, equal or more than 40 and 50 years was not statistically different. ConclusionsBreast cancer patients treated with adjuvant radiotherapy after radical surgery have not experienced significant changes in their mean age at treatment. The subgroups of patients that remain out of the mammographic screening programmes were unchanged as well. The observed differences can be explained by demographical disparities and by a probable increase in the indications for adjuvant radiotherapy.

Place de la radiothérapie après chimiothérapie première dans le cancer du sein

Indications for adjuvant radiotherapy in breast cancer are defined from the clinical data and the pathological extent of disease in the surgical specimen. Neoadjuvant chemotherapy could modify the pathological characteristics of the tumour, inducing a pathologic complete response in 15 to 50% of cases, challenging the classical indications of adjuvant radiotherapy. The benefit of adjuvant radiotherapy after neoadjuvant chemotherapy was not prospectively evaluated. Nonetheless, from retrospective series, some recommendations with a low level of proof could be given: (i) after lumpectomy, radiotherapy of the mammary gland must be performed even in case of pathologic complete response; (ii) after mastectomy, postoperative radiotherapy is recommended in case of cT3-T4, cN1-3 (clinical or radiological) or pathologically involved nodes; (iii) irradiation of the lymph nodes areas is more questionable, but could be also proposed in case of cN1 or pN1. These recommendations are in accordance with those recently published by the National Cancer Institute and the French National Cancer Institute.

Surgery and Adjuvant Radiation Provides Excellent Control of Advanced, High-Grade Skin Adnexal Carcinoma of the Head and Neck: Non-Squamous Cell Malignancies of the Head and Neck (thyroid, skin cancers, salivary gland and sinus cancers)

Skin adnexal carcinoma is a rare cutaneous malignancy that arises from sebaceous and sweat glands. It is most often diagnosed in the head and neck. These carcinomas are believed to behave more aggressively than cutaneous squamous cell carcinomas (SCC) with a propensity for local recurrence. Limited data is available to define the role of adjuvant radiation therapy (RT). We retrospectively reviewed all cases of non-melanoma skin cancer treated with a curative intent operation and adjuvant RT at a tertiary care institution from 2000-2012. We excluded Merkel Cell carcinoma, basal cell carcinoma, SCC (and associated variants) from this analysis. Surviving patients with less than 6 months of follow-up were excluded. A total of eight cases met the inclusion criteria. Median age was 67 (range 52 - 88). The histologies reported on the pathology report were as follows: adnexal carcinoma (n =3), skin appendage carcinoma (n = 1), sclerosing sweat duct carcinoma (n = 1), mucinous carcinoma (n = 1), porocarcinoma (n = 1), and trichilemmal carcinoma (n = 1). All patients with a grade or differentiation assigned on the pathology report (n = 5) were determined to be either high grade or poorly differentiated. A PET/CT scan was obtained for the patient with mucinous carcinoma to confirm that the cutaneous tumor was not a metastasis. Staging based on AJCC 7th ed for non-melanoma skin cancer were as follows: II (n = 4), III (n = 2), IVA (n = 1), and IVB (n = 1). All patients had a surgical extirpation of the primary tumor; 50% (n = 4) of patients had a neck dissection, 25% (n = 2) had sampling of lymph nodes (LNs) adjacent to the primary site, and 25% (n = 2) had clinically negative necks observed. Adjuvant therapy consisted of RT to the primary site alone (n = 2) or to the primary site and draining lymphatics (n = 6). One patient received concurrent chemotherapy (weekly cisplatin). Median dose of radiation to the primary site was 60 Gy (range, 50 - 60). Median dose to the neck was 50 Gy (range, 46 - 58). Indication for adjuvant RT was involved LNs (n = 4), perineural invasion (n = 2), positive margin (n = 1), high grade (n = 5), and/or recurrent disease (n = 5). Median follow-up among living patients was 4.0 years (0.6 - 11.4 years). Locoregional control was 100%. There was a single distant failure in a patient with stage III cancer that was not salvageable. Progression free survival was 88% at 5 years. There was a single acute grade 3 toxicity, gastrostomy tube placement, which was subsequently removed after treatment was completed. There were no late toxicities ≥ grade 2 recorded. Surgery and adjuvant radiation for advanced, high grade skin adnexal carcinoma of the head and neck offers excellent locoregional control with an acceptable level of toxicity.

Using the lymph nodal ratio to predict the risk of locoregional recurrence in lymph node-positive breast cancer patients treated with mastectomy without radiation therapy

BackgroundTo evaluate the prognostic value of axillary lymph node ratio (LNR) as compared to the number of involved nodes (pN stage) in patients with axillary lymph node-positive breast cancer treated with mastectomy without radiation.MethodsWe performed a retrospective analysis of the clinical data of patients with stage II-III node-positive breast cancer (N=1068) between 1998 and 2007. Locoregional recurrence-free survival (LRFS) and overall survival (OS) were compared based on the LNR and pN staging.ResultsA total of 780 cases were classified as pN1, 183 as pN2, and 105 as pN3. With respect to LNR, 690 cases had a LNR from 0.01-0.20, 269 cases a LNR from 0.21-0.65, and 109 cases a LNR > 0.65. The median follow-up time was 62 months. Univariate analysis showed that both LNR and pN stage were prognostic factors of LRFS and OS (p<0.05). Multivariate analysis indicated that LNR was an independent prognostic factor of LRFS and OS (p<0.05). pN stage had no significant effect on LRFS or OS (p>0.05). In subgroup analysis, the LNR identified groups of patients with different survival rates based on pN stage.ConclusionsLNR is superior to pN staging as a prognostic factor in lymph node-positive breast cancer after mastectomy, and should be used as one of the indications for adjuvant radiation therapy.

Randomized controlled trial to evaluate the effects of progressive resistance training compared to progressive muscle relaxation in breast cancer patients undergoing adjuvant radiotherapy: the BEST study

BackgroundCancer-related fatigue (CRF) is one of the most common and distressing side effects of cancer and its treatment. During and after radiotherapy breast cancer patients often suffer from CRF which frequently impairs quality of life (QoL). Despite the high prevalence of CRF in breast cancer patients and the severe impact on the physical and emotional well-being, effective treatment methods are scarce.Physical activity for breast cancer patients has been reported to decrease fatigue, to improve emotional well-being and to increase physical strength. The pathophysiological and molecular mechanisms of CRF and the molecular-biologic changes induced by exercise, however, are poorly understood.In the BEST trial we aim to assess the effects of resistance training on fatigue, QoL and physical fitness as well as on molecular, immunological and inflammatory changes in breast cancer patients during adjuvant radiotherapy.Methods/designThe BEST study is a prospective randomized, controlled intervention trial investigating the effects of a 12-week supervised progressive resistance training compared to a 12-week supervised muscle relaxation training in 160 patients with breast cancer undergoing adjuvant radiotherapy. To determine the effect of exercise itself beyond potential psychosocial group effects, patients in the control group perform a group-based progressive muscle relaxation training. Main inclusion criterion is histologically confirmed breast cancer stage I-III after lumpectomy or mastectomy with indication for adjuvant radiotherapy. Main exclusion criteria are acute infectious diseases, severe neurological, musculosceletal or cardiorespiratory disorders. The primary endpoint is cancer-related fatigue; secondary endpoints include immunological and inflammatory parameters analyzed in peripheral blood, saliva and urine. In addition, QoL, depression, physical performance and cognitive capacity will be assessed.DiscussionThe BEST study is the first randomized controlled trial comparing progressive resistance training with muscle relaxation training in breast cancer patients during adjuvant radiotherapy. Based on the analysis of physiological, immunological and inflammatory parameters it will contribute to a better understanding of the physiological and psychosocial effects and the biological mechanisms of resistance training. The ultimate goal is the implementation of optimized intervention programs to reduce fatigue, improve quality of life and potentially the prognosis after breast cancer.Trial registrationClinicalTrials.gov NCT01468766

Hypofractionated helical intensity-modulated radiotherapy of the prostate bed after prostatectomy with or without the pelvic lymph nodes - the PRIAMOS trial

BackgroundWhile evidence on safety and efficacy of primary hypofractionated radiotherapy in prostate cancer is accumulating, data on postoperative hypofractionated treatment of the prostate bed and of the pelvic lymph nodes is still scarce. This phase II trial was initiated to investigate safety and feasibility of hypofractionated treatment of the prostate bed alone or with the pelvic lymph nodes.Methods/designA total of 80 prostate cancer patients with the indication for adjuvant radiotherapy will be enrolled, where 40 patients with a low risk of lymph node involvement (arm 1) and another 40 patients with a high risk of lymph node involvement (arm 2) will each receive 54 Gy in 18 fractions to the prostate bed. Arm 2 will be given 45 Gy to the pelvic lymph nodes additionally. Helical Tomotherapy and daily image guidance will be used.DiscussionThis trial was initiated to substantiate data on hypofractionated treatment of the prostate bed and generate first data on adjuvant hypofractionated radiotherapy of the pelvic lymph nodes.Trial registrationClinicalTrials.gov; NCT01620710

Parallel uncertainty for adjuvant radiotherapy indications in cutaneous squamous cell carcinoma (CSCC) with perineural invasion (PNI) among radiation oncologists and Mohs surgeons

Parallel uncertainty for adjuvant radiotherapy indications in cutaneous squamous cell carcinoma (CSCC) with perineural invasion (PNI) among radiation oncologists and Mohs surgeons