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J R Yarnold - One of the best experts on this subject based on the ideXlab platform.

  • late normal tissue effects in the arm and shoulder following lymphatic Radiotherapy results from the uk start standardisation of Breast Radiotherapy trials
    Radiotherapy and Oncology, 2017
    Co-Authors: Js Haviland, M Sydenham, J M Liss, Mariella Mannino, Clare Griffi, Nuria Porta, J R Yarnold
    Abstract:

    Background and purpose: Adjuvant lymphatic Radiotherapy (LNRT) is recommended for selected axillary node positive women with early Breast cancer. We investigated whether hypofractionated LNRT is safe combined with similarly-hypofractionated Breast/chest wall Radiotherapy (RT). Material and methods: The Standardisation of Breast Radiotherapy (START) pilot, A and B trials randomised women with early Breast cancer to schedules of 2.67-3.3 Gy versus 2.0 Gy fractions (control). RT adverse effects were assessed by patients using the EORTC QLQ-BR23 and protocol-specific questions, and by physicians. Rates of arm/shoulder effects were compared between schedules for patients given LNRT. Results: 864/5861 (14.7%) patients received LNRT (385 START-pilot, 318 START-A, 161 START-B). Prevalences of moderate/marked arm/shoulder effects were low up to 10 years. There were no significant differences between the hypofractionated and control groups for patient- and physician-assessed symptoms in START-A or START-B. In START-pilot, adverse effect rates were higher after 13 fractions of 3.3 Gy, consistent with effects reported in the Breast/chest wall (significant for shoulder stiffness, HR 3.07, 95%Ci 1.62-5.83, p = 0.001). Conclusions: The START trial results suggest that appropriately-dosed hypofractionated LNRT is safe in the long-term, according to patient and physician-assessed arm and shoulder symptoms. These findings are consistent with those reported after the same schedules delivered to the Breast/chest wall. (C) 2017 The Author(s). Published by Elsevier Ireland Ltd.

  • acute skin toxicity associated with a 1 week schedule of whole Breast Radiotherapy compared with a standard 3 week regimen delivered in the uk fast forward trial
    Radiotherapy and Oncology, 2016
    Co-Authors: Murray A Brunt, Charlotte E Coles, J R Yarnold, D Wheatley, Navita Somaiah, Stephen Kelly, A Harnett, Andrew Goodman, Amit Bahl, Mark Churn
    Abstract:

    Abstract Background and purpose FAST-Forward is a phase 3 clinical trial testing a 1-week course of whole Breast Radiotherapy against the UK standard 3-week regimen after primary surgery for early Breast cancer. Two acute skin toxicity substudies were undertaken to test the safety of the test schedules with respect to early skin reactions. Material and methods Patients were randomly allocated to 40Gy/15 fractions (F)/3-weeks, 27Gy/5F/1-week or 26Gy/5F/1-week. Acute Breast skin reactions were graded using RTOG (first substudy) and CTCAE criteria v4.03 (second substudy) weekly during treatment and for 4weeks after treatment ended. Primary endpoint was the proportion of patients within each treatment group with grade ⩾3 toxicity (RTOG and CTCAE, respectively) at any time from the start of Radiotherapy to 4weeks after completion. Results 190 and 162 patients were recruited. In the first substudy, evaluable patients with grade 3 RTOG toxicity were: 40Gy/15F 6/44 (13.6%); 27Gy/5F 5/51 (9.8%); 26Gy/5F 3/52 (5.8%). In the second substudy, evaluable patients with grade 3 CTCAE toxicity were: 40Gy/15F 0/43; 27Gy/5F 1/41 (2.4%); 26Gy/5F 0/53. Conclusions Acute Breast skin reactions with two 1-week schedules of whole Breast Radiotherapy under test in FAST-Forward were mild.

  • do patient reported outcome measures agree with clinical and photographic assessments of normal tissue effects after Breast Radiotherapy the experience of the standardisation of Breast Radiotherapy start trials in early Breast cancer
    Clinical Oncology, 2016
    Co-Authors: Js Haviland, P Hopwood, Judith Mills, M Sydenham, J M Liss, J R Yarnold
    Abstract:

    Abstract Aims In Radiotherapy trials, normal tissue effects (NTE) are important end points and it is pertinent to ask whether patient-reported outcome measures (PROMs) could replace clinical and/or photographic assessments. Data from the Standardisation of Breast Radiotherapy (START) trials are examined. Materials and methods NTEs in the treated Breast were recorded by (i) annual clinical assessments, (ii) photographs at 2 and 5 years, (iii) PROMs at 6 months, 1, 2 and 5 years after Radiotherapy. Hazard ratios for the Radiotherapy schedules were compared. Measures of agreement of assessments at 2 and 5 years tested concordance. Results PROMs were available at 2 and/or 5 years for 1939 women, of whom 1870 had clinical and 1444 had photographic assessments. All methods were sensitive to the dose difference between schedules. Patients reported a higher prevalence for all NTE end points than clinicians or photographs ( P Conclusions All three methods produced similar conclusions for the comparison of trial schedules, despite low concordance between the methods on an individual patient basis. Careful consideration should be given to the different contributions of the measures of NTE in future Radiotherapy trials.

  • the uk heartspare study randomised evaluation of voluntary deep inspiratory breath hold in women undergoing Breast Radiotherapy
    Radiotherapy and Oncology, 2013
    Co-Authors: Frederick R Bartlett, P M Evans, Js Haviland, E Donovan, Ruth Colgan, Karen Carr, H Mcnair, I Locke, J R Yarnold
    Abstract:

    Purpose To determine whether voluntary deep-inspiratory breath-hold (v-DIBH) and deep-inspiratory breath-hold with the active breathing coordinator™ (ABC-DIBH) in patients undergoing left Breast Radiotherapy are comparable in terms of normal-tissue sparing, positional reproducibility and feasibility of delivery. Methods Following surgery for early Breast cancer, patients underwent planning-CT scans in v-DIBH and ABC-DIBH. Patients were randomised to receive one technique for fractions 1-7 and the second technique for fractions 8-15 (40 Gy/15 fractions total). Daily electronic portal imaging (EPI) was performed and matched to digitally-reconstructed radiographs. Cone-beam CT (CBCT) images were acquired for 6/15 fractions and matched to planning-CT data. Population systematic (Σ) and random errors (σ) were estimated. Heart, left-anterior-descending coronary artery, and lung doses were calculated. Patient comfort, radiographer satisfaction and scanning/treatment times were recorded. Within-patient comparisons between the two techniques used the paired t-test or Wilcoxon signed-rank test. Results Twenty-three patients were recruited. All completed treatment with both techniques. EPI-derived Σ were ≤1.8 mm (v-DIBH) and ≤2.0 mm (ABC-DIBH) and σ ≤2.5 mm (v-DIBH) and ≤2.2 mm (ABC-DIBH) (all p non-significant). CBCT-derived Σ were ≤3.9 mm (v-DIBH) and ≤4.9 mm (ABC-DIBH) and σ ≤ 4.1 mm (v-DIBH) and ≤ 3.8 mm (ABC-DIBH). There was no significant difference between techniques in terms of normal-tissue doses (all p non-significant). Patients and radiographers preferred v-DIBH (p = 0.007, p = 0.03, respectively). Scanning/treatment setup times were shorter for v-DIBH (p = 0.02, p = 0.04, respectively). Conclusions v-DIBH and ABC-DIBH are comparable in terms of positional reproducibility and normal tissue sparing. v-DIBH is preferred by patients and radiographers, takes less time to deliver, and is cheaper than ABC-DIBH. © 2013 Elsevier Ireland Ltd. All rights reserved.

  • hypofractionated whole Breast Radiotherapy for women with early Breast cancer myths and realities
    International Journal of Radiation Oncology Biology Physics, 2011
    Co-Authors: J R Yarnold, Charlotte E Coles, Soren M Bentzen, Js Haviland
    Abstract:

    JOHN YARNOLD, F.R.C.R.,* SOREN M. BENTZEN, D.SC.,y CHARLOTTE COLES, PH.D.,z AND JOANNE HAVILAND, M.SC.{ *Section of Radiotherapy, Institute of Cancer Research and Royal Marsden Hospital, Sutton, United Kingdom; yDepartment of Human Oncology, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin; zOncology Centre, Cambridge University Hospitals NHS Foundation Trust, Cambridge, United Kingdom; {Institute of Cancer Research Clinical Trials and Statistics Unit, Section of Clinical Trials, Sutton, United Kingdom

Frederik Wenz - One of the best experts on this subject based on the ideXlab platform.

  • development and validation of a predictive risk model for acute skin toxicity in patients undergoing Breast Radiotherapy
    Ejso, 2017
    Co-Authors: Tim Rattay, Frederik Wenz, Kerstie Johnson, Gillian C Barnett, Charlotte E Coles, Jenny Changclaude, Petra Seibold, Paul R Symonds, Catharine M L West, Christopher J Talbot
    Abstract:

    BackgroundClinically significant side-effects from Radiotherapy affect around a quarter of Breast cancer patients and may have a considerable impact on Breast cosmesis and quality of life. If patients at high risk of radiation toxicity could be identified at Breast cancer diagnosis, this could be taken into account when discussing treatment options. The aim of this study was to develop a predictive model for acute skin toxicity in patients undergoing Breast Radiotherapy.MethodsUsing multivariate logistic regression and backwards elimination, the risk model for acute skin toxicity (moderately brisk reaction and/or ≥1 acute desquamation) was first developed in patient cohorts treated by Breast-conserving surgery and whole Breast Radiotherapy in three European centres (Leicester, Heidelberg/Mannheim, Cambridge; total n=2,012) with a biologically effective dose (BED) range from 47.1 to 67.2 Gy. It was externally validated in Breast cancer patients enrolled in the multi-centre REQUITE cohort study (n=2,062; BED range 44.6 to 75.4 Gy).ResultsThe final model with the variables age, BED, cup size or BMI, and presence/absence of diabetes, smoking, and hypertension proved to give best prediction of acute skin toxicity with a c-statistic (AUC) of 0.79 in the development and 0.75 in the validation cohort and was well calibrated (Hosmer-Lemeshow p=0.53). ConclusionsA predictive model for radiotoxicity has the potential to give clinicians important information when planning treatment to reduce side-effects and optimise quality of life. The addition of prognostic genetic markers investigated as part of the REQUITE study is likely to improve model performance. Similar models can be developed for other toxicity endpoints, such as Breast fibrosis, and should also be validated for patients undergoing chest wall Radiotherapy and Breast reconstruction.

  • evaluation of the radiance planning system for Breast fibrosis after intraoperative Radiotherapy as a boost in Breast conserving surgery
    Journal of Clinical Oncology, 2016
    Co-Authors: Xuerui Li, Elena Sperk, Frank Schneider, Sven Clausen, Christel Weiss, Frederik Wenz
    Abstract:

    e12534Background: Intraoperative Radiotherapy (IORT) is a convenient and effective treatment for some Breast cancer patients. IORT as a boost followed by conventional external Radiotherapy has less radiation-induced fibrosis than whole Breast Radiotherapy, but the percentage of higher-grade fibrosis (II -III ) still ranges between 25 - 38% after IORT as a boost. Currently, it is not possible to plan the radiation therapy process beforehand for IORT. Radiance planning System is a new simulation and planning tool for IORT. The purpose of this project is to validate the planning software Radiance System for IORT boost patients by creating dose-volume-histograms for the skin at risk and to find the affecting factors for fibrosis after IORT as a boost. Methods: 42 cases were enrolled into replanning and analysis and distributed into two groups: 14 cases with fibrosis in group A and 28 cases without fibrosis in group B. The replanning data including Breast volume, seroma volume, skin volume, skin dose, applic...

  • radiation related quality of life parameters after targeted intraoperative Radiotherapy versus whole Breast Radiotherapy in patients with Breast cancer results from the randomized phase iii trial targit a
    Radiation Oncology, 2013
    Co-Authors: Grit Welzel, U Kraustiefenbacher, Angela Boch, Elena Sperk, Frank Hofmann, Axel Gerhardt, Marc Suetterlin, Frederik Wenz
    Abstract:

    Background: Intraoperative Radiotherapy (IORT) is a new treatment approach for early stage Breast cancer. This study reports on the effects of IORT on radiation-related quality of life (QoL) parameters. Methods: Two hundred and thirty women with stage I-III Breast cancer (age, 31 to 84 years) were entered into the study. A single-center subgroup of 87 women from the two arms of the randomized phase III trial TARGIT-A (TARGeted Intra-operative Radiotherapy versus whole Breast Radiotherapy for Breast cancer) was analyzed. Furthermore, results were compared to non-randomized control groups: n = 90 receiving IORT as a tumor bed boost followed by external beam whole Breast Radiotherapy (EBRT) outside of TARGIT-A (IORT-boost), and n = 53 treated with EBRT followed by an external-beam boost (EBRT-boost). QoL was collected using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaires C30 (QLQ-C30) and BR23 (QLQBR23). The mean follow-up period in the TARGIT-A groups was 32 versus 39 months in the non-randomized control groups. Results: Patients receiving IORT alone reported less general pain (21.3 points), Breast (7.0 points) and arm (15.1 points) symptoms, and better role functioning (78.7 points) as patients receiving EBRT (40.9; 19.0; 32.8; and 60.5 points, respectively, P < 0.01). Patients receiving IORT alone also had fewer Breast symptoms than TARGIT-A patients receiving IORT followed by EBRT for high risk features on final pathology (IORT-EBRT; 7.0 versus 29.7 points, P < 0.01). There were no significant differences between TARGIT-A patients receiving IORT-EBRT compared to non-randomized IORT-boost or EBRT-boost patients and patients receiving EBRT without a boost. Conclusions: In the randomized setting, important radiation-related QoL parameters after IORT were superior to EBRT. Non-randomized comparisons showed equivalent parameters in the IORT-EBRT group and the control groups.

  • are mammographic changes in the tumor bed more pronounced after intraoperative Radiotherapy for Breast cancer subgroup analysis from a randomized trial targit a
    Breast Journal, 2013
    Co-Authors: Dorothee Engel, Frederik Wenz, Marc Suetterlin, E Blank, A Schnitzer, Joachim Brade, Stefan O Schoenberg, K Wasser
    Abstract:

    : Intraoperative Radiotherapy (IORT) with low-energy x-rays is increasingly used in Breast-conserving therapy (BCT). Previous non-randomized studies have observed mammographic changes in the tumor bed to be more pronounced after IORT. The purpose of this study was to reassess the postoperative changes in a randomized single-center subgroup of patients from a multicenter trial (TARGIT-A). In this subgroup (n = 48) 27 patients received BCT with IORT, 21 patients had BCT with standard whole-Breast Radiotherapy serving as controls. Overall 258 postoperative mammograms (median follow-up 4.3 years, range 3-8) were retrospectively evaluated by two radiologists in consensus focusing on changes in the tumor bed. Fat necroses showed to be significantly more frequent (56% versus 24%) and larger (8.7 versus 1.6 sq cm, median) after IORT than those in controls. Scar calcifications were also significantly more frequent after IORT (63% versus 19%). The high incidence of large fat necroses in our study confirms previous study findings. However, the overall higher incidence of calcifications in the tumor bed after IORT represents a new finding, requiring further attention.

  • can the risk of secondary cancer induction after Breast conserving therapy be reduced using intraoperative Radiotherapy iort with low energy x rays
    Radiation Oncology, 2011
    Co-Authors: E Blank, Muhammad Hammad Aziz, Frank Schneider, Sven Clausen, Carsten Herskind, Muhammad Afzal, Frederik Wenz
    Abstract:

    Background Radiation induced secondary cancers are a rare but severe late effect after Breast conserving therapy. Intraoperative Radiotherapy (IORT) is increasingly used during Breast conserving surgery. The purpose of this analysis was to estimate secondary cancer risks after IORT compared to other modalities of Breast Radiotherapy (APBI - accelerated partial Breast irradiation, EBRT - external beam Radiotherapy).

Js Haviland - One of the best experts on this subject based on the ideXlab platform.

  • Patient-Reported Outcomes Over 5 Years After Whole- or Partial-Breast Radiotherapy: Longitudinal Analysis of the IMPORT LOW (CRUK/06/003) Phase III Randomized Controlled Trial.
    2019
    Co-Authors: Is Bhattacharya, Js Haviland, Am Kirby, Cc Kirwan, Hopwood P, Jm Bliss, Ce Coles, Import Trialists
    Abstract:

    PURPOSE:IMPORT LOW demonstrated noninferiority of partial-Breast and reduced-dose Radiotherapy versus whole-Breast Radiotherapy for local relapse and similar or reduced toxicity at 5 years. Comprehensive patient-reported outcome measures collected at serial time points are now reported. PATIENTS AND METHODS:IMPORT LOW recruited women with low-risk Breast cancer after Breast-conserving surgery. Patients were randomly assigned to 40 Gy whole-Breast Radiotherapy (control), 36 Gy whole-Breast and 40 Gy partial-Breast Radiotherapy (reduced-dose), or 40 Gy partial-Breast Radiotherapy only (partial-Breast) in 15 fractions. European Organisation for Research and Treatment of Cancer Quality of Life Questionnaires Core 30 and Breast Cancer-Specific Module, Body Image Scale, protocol-specific items, and the Hospital Anxiety and Depression Scale were administered at baseline, 6 months, and 1, 2, and 5 years. Patterns of moderate/marked adverse effects (AEs) were assessed using longitudinal regression models, and baseline predictors were investigated. RESULTS:A total of 41 of 71 centers participated in the patient-reported outcome measures substudy; 1,265 (95%) of 1,333 patients consented, and 557 (58%) of 962 reported no moderate/marked AEs at 5 years. Breast appearance change was most prevalent and persisted over time (approximately 20% at each time point). Prevalence of Breast hardness, pain, oversensitivity, edema, and skin changes reduced over time ( P < .001 for each), whereas Breast shrinkage increased ( P < .001). Analysis by treatment group showed average number of AEs per person was lower in partial-Breast (incidence rate ratio, 0.77; 95% CI, 0.71 to 0.84; P < .001) and reduced-dose (incidence rate ratio, 0.83; 95% CI, 0.76 to 0.90; P < .001) versus whole-Breast group and decreased over time in all groups. Younger age, larger Breast size/surgical deficit, lymph node positivity, and higher levels of anxiety/depression were baseline predictors of subsequent AE reporting. CONCLUSION:Most AEs reduced over time, with fewer AEs in the partial-Breast and reduced-dose groups. Baseline predictors for AE reporting were identified. These findings will facilitate informed discussion and shared decision making for future patients receiving moderately hypofractionated Breast Radiotherapy

  • late normal tissue effects in the arm and shoulder following lymphatic Radiotherapy results from the uk start standardisation of Breast Radiotherapy trials
    Radiotherapy and Oncology, 2017
    Co-Authors: Js Haviland, M Sydenham, J M Liss, Mariella Mannino, Clare Griffi, Nuria Porta, J R Yarnold
    Abstract:

    Background and purpose: Adjuvant lymphatic Radiotherapy (LNRT) is recommended for selected axillary node positive women with early Breast cancer. We investigated whether hypofractionated LNRT is safe combined with similarly-hypofractionated Breast/chest wall Radiotherapy (RT). Material and methods: The Standardisation of Breast Radiotherapy (START) pilot, A and B trials randomised women with early Breast cancer to schedules of 2.67-3.3 Gy versus 2.0 Gy fractions (control). RT adverse effects were assessed by patients using the EORTC QLQ-BR23 and protocol-specific questions, and by physicians. Rates of arm/shoulder effects were compared between schedules for patients given LNRT. Results: 864/5861 (14.7%) patients received LNRT (385 START-pilot, 318 START-A, 161 START-B). Prevalences of moderate/marked arm/shoulder effects were low up to 10 years. There were no significant differences between the hypofractionated and control groups for patient- and physician-assessed symptoms in START-A or START-B. In START-pilot, adverse effect rates were higher after 13 fractions of 3.3 Gy, consistent with effects reported in the Breast/chest wall (significant for shoulder stiffness, HR 3.07, 95%Ci 1.62-5.83, p = 0.001). Conclusions: The START trial results suggest that appropriately-dosed hypofractionated LNRT is safe in the long-term, according to patient and physician-assessed arm and shoulder symptoms. These findings are consistent with those reported after the same schedules delivered to the Breast/chest wall. (C) 2017 The Author(s). Published by Elsevier Ireland Ltd.

  • do patient reported outcome measures agree with clinical and photographic assessments of normal tissue effects after Breast Radiotherapy the experience of the standardisation of Breast Radiotherapy start trials in early Breast cancer
    Clinical Oncology, 2016
    Co-Authors: Js Haviland, P Hopwood, Judith Mills, M Sydenham, J M Liss, J R Yarnold
    Abstract:

    Abstract Aims In Radiotherapy trials, normal tissue effects (NTE) are important end points and it is pertinent to ask whether patient-reported outcome measures (PROMs) could replace clinical and/or photographic assessments. Data from the Standardisation of Breast Radiotherapy (START) trials are examined. Materials and methods NTEs in the treated Breast were recorded by (i) annual clinical assessments, (ii) photographs at 2 and 5 years, (iii) PROMs at 6 months, 1, 2 and 5 years after Radiotherapy. Hazard ratios for the Radiotherapy schedules were compared. Measures of agreement of assessments at 2 and 5 years tested concordance. Results PROMs were available at 2 and/or 5 years for 1939 women, of whom 1870 had clinical and 1444 had photographic assessments. All methods were sensitive to the dose difference between schedules. Patients reported a higher prevalence for all NTE end points than clinicians or photographs ( P Conclusions All three methods produced similar conclusions for the comparison of trial schedules, despite low concordance between the methods on an individual patient basis. Careful consideration should be given to the different contributions of the measures of NTE in future Radiotherapy trials.

  • the uk standardisation of Breast Radiotherapy start trials of Radiotherapy hypofractionation for treatment of early Breast cancer 10 year follow up results of two randomised controlled trials
    Lancet Oncology, 2013
    Co-Authors: Js Haviland, R K Agrawal, P Hopwood, Roger J Owen, J A Dewar, Jane Barrett, Peter Barrettlee, Jane H Dobbs, P A Lawton
    Abstract:

    Summary Background 5-year results of the UK Standardisation of Breast Radiotherapy (START) trials suggested that lower total doses of Radiotherapy delivered in fewer, larger doses (fractions) are at least as safe and effective as the historical standard regimen (50 Gy in 25 fractions) for women after primary surgery for early Breast cancer. In this prespecified analysis, we report the 10-year follow-up of the START trials testing 13 fraction and 15 fraction regimens. Methods From 1999 to 2002, women with completely excised invasive Breast cancer (pT1–3a, pN0–1, M0) were enrolled from 35 UK Radiotherapy centres. Patients were randomly assigned to a treatment regimen after primary surgery followed by chemotherapy and endocrine treatment (where prescribed). Randomisation was computer-generated and stratified by centre, type of primary surgery (Breast-conservation surgery or mastectomy), and tumour bed boost Radiotherapy. In START-A, a regimen of 50 Gy in 25 fractions over 5 weeks was compared with 41·6 Gy or 39 Gy in 13 fractions over 5 weeks. In START-B, a regimen of 50 Gy in 25 fractions over 5 weeks was compared with 40 Gy in 15 fractions over 3 weeks. Eligibility criteria included age older than 18 years and no immediate surgical reconstruction. Primary endpoints were local-regional tumour relapse and late normal tissue effects. Analysis was by intention to treat. Follow-up data are still being collected. This study is registered as an International Standard Randomised Controlled Trial, number ISRCTN59368779. Findings START-A enrolled 2236 women. Median follow-up was 9·3 years (IQR 8·0–10·0), after which 139 local-regional relapses had occurred. 10-year rates of local-regional relapse did not differ significantly between the 41·6 Gy and 50 Gy regimen groups (6·3%, 95% CI 4·7–8·5 vs 7·4%, 5·5–10·0; hazard ratio [HR] 0·91, 95% CI 0·59–1·38; p=0·65) or the 39 Gy (8·8%, 95% CI 6·7–11·4) and 50 Gy regimen groups (HR 1·18, 95% CI 0·79–1·76; p=0·41). In START-A, moderate or marked Breast induration, telangiectasia, and Breast oedema were significantly less common normal tissue effects in the 39 Gy group than in the 50 Gy group. Normal tissue effects did not differ significantly between 41·6 Gy and 50 Gy groups. START-B enrolled 2215 women. Median follow-up was 9·9 years (IQR 7·5–10·1), after which 95 local-regional relapses had occurred. The proportion of patients with local-regional relapse at 10 years did not differ significantly between the 40 Gy group (4·3%, 95% CI 3·2–5·9) and the 50 Gy group (5·5%, 95% CI 4·2–7·2; HR 0·77, 95% CI 0·51–1·16; p=0·21). In START-B, Breast shrinkage, telangiectasia, and Breast oedema were significantly less common normal tissue effects in the 40 Gy group than in the 50 Gy group. Interpretation Long-term follow-up confirms that appropriately dosed hypofractionated Radiotherapy is safe and effective for patients with early Breast cancer. The results support the continued use of 40 Gy in 15 fractions, which has already been adopted by most UK centres as the standard of care for women requiring adjuvant Radiotherapy for invasive early Breast cancer. Funding Cancer Research UK, UK Medical Research Council, UK Department of Health.

  • the uk heartspare study randomised evaluation of voluntary deep inspiratory breath hold in women undergoing Breast Radiotherapy
    Radiotherapy and Oncology, 2013
    Co-Authors: Frederick R Bartlett, P M Evans, Js Haviland, E Donovan, Ruth Colgan, Karen Carr, H Mcnair, I Locke, J R Yarnold
    Abstract:

    Purpose To determine whether voluntary deep-inspiratory breath-hold (v-DIBH) and deep-inspiratory breath-hold with the active breathing coordinator™ (ABC-DIBH) in patients undergoing left Breast Radiotherapy are comparable in terms of normal-tissue sparing, positional reproducibility and feasibility of delivery. Methods Following surgery for early Breast cancer, patients underwent planning-CT scans in v-DIBH and ABC-DIBH. Patients were randomised to receive one technique for fractions 1-7 and the second technique for fractions 8-15 (40 Gy/15 fractions total). Daily electronic portal imaging (EPI) was performed and matched to digitally-reconstructed radiographs. Cone-beam CT (CBCT) images were acquired for 6/15 fractions and matched to planning-CT data. Population systematic (Σ) and random errors (σ) were estimated. Heart, left-anterior-descending coronary artery, and lung doses were calculated. Patient comfort, radiographer satisfaction and scanning/treatment times were recorded. Within-patient comparisons between the two techniques used the paired t-test or Wilcoxon signed-rank test. Results Twenty-three patients were recruited. All completed treatment with both techniques. EPI-derived Σ were ≤1.8 mm (v-DIBH) and ≤2.0 mm (ABC-DIBH) and σ ≤2.5 mm (v-DIBH) and ≤2.2 mm (ABC-DIBH) (all p non-significant). CBCT-derived Σ were ≤3.9 mm (v-DIBH) and ≤4.9 mm (ABC-DIBH) and σ ≤ 4.1 mm (v-DIBH) and ≤ 3.8 mm (ABC-DIBH). There was no significant difference between techniques in terms of normal-tissue doses (all p non-significant). Patients and radiographers preferred v-DIBH (p = 0.007, p = 0.03, respectively). Scanning/treatment setup times were shorter for v-DIBH (p = 0.02, p = 0.04, respectively). Conclusions v-DIBH and ABC-DIBH are comparable in terms of positional reproducibility and normal tissue sparing. v-DIBH is preferred by patients and radiographers, takes less time to deliver, and is cheaper than ABC-DIBH. © 2013 Elsevier Ireland Ltd. All rights reserved.

J S Vaidya - One of the best experts on this subject based on the ideXlab platform.

  • targeted intraoperative Radiotherapy tumor bed boost during Breast conserving surgery after neoadjuvant chemotherapy in hormone receptor positive her2 negative Breast cancer
    Journal of Clinical Oncology, 2017
    Co-Authors: Hanschristian Kolberg, J S Vaidya, Gyoergy Loevey, L Akpolatbasci, M Stephanou, Peter A Fasching, M Untch, Max Bulsara, Cornelia Liedtke
    Abstract:

    e12090Background: Targeted intraoperative Radiotherapy (TARGIT – IORT) as a tumor bed boost during Breast conserving surgery is an established option for women with early Breast cancer. In a previous study our group could show a beneficial effect of TARGIT-IORT on overall survival after neoadjuvant chemotherapy compared to an external boost in an unselected cohort. In this study we present an analysis of the hormone receptor positive HER2 negative subgroup. Methods: In this non-randomized cohort study involving 46 hormone receptor positive HER2 negative patients after NACT we compared outcomes of 21 patients who received a tumour bed boost with IORT (TARGIT-IORT) during lumpectomy versus 25 patients treated in the previous 13 months with external (EBRT) boost. All patients received whole Breast Radiotherapy. Disease free survival (DFS) and overall survival (OS) were compared. Results: There were no statistical differences between the two groups regarding tumor size, grading, nodal status and pCR rates. Me...

  • long term results of targeted intraoperative Radiotherapy targit boost during Breast conserving surgery
    International Journal of Radiation Oncology Biology Physics, 2011
    Co-Authors: J S Vaidya, Frederik Wenz, Michael Baum, J S Tobias, Samuele Massarut, Mohammed Keshtgar, Basil S Hilaris, Christobel Saunders, Norman R Williams, Chris Brewgraves
    Abstract:

    Purpose We have previously shown that delivering targeted Radiotherapy to the tumour bed intraoperatively is feasible and desirable. In this study, we report on the feasibility, safety, and long-term efficacy of TARGeted Intraoperative Radiotherapy (Targit), using the Intrabeam system. Methods and Materials A total of 300 cancers in 299 unselected patients underwent Breast-conserving surgery and Targit as a boost to the tumor bed. After lumpectomy, a single dose of 20 Gy was delivered intraoperatively. Postoperative external beam whole-Breast Radiotherapy excluded the usual boost. We also performed a novel individualized case control (ICC) analysis that computed the expected recurrences for the cohort by estimating the risk of recurrence for each patient using their characteristics and follow-up period. Results The treatment was well tolerated. The median follow up was 60.5 months (range, 10–122 months). Eight patients have had ipsilateral recurrence: 5-year Kaplan Meier estimate for ipsilateral recurrence is 1.73% (SE 0.77), which compares well with that seen in the boosted patients in the European Organization for Research and Treatment of Cancer study (4.3%) and the UK STAndardisation of Breast Radiotherapy study (2.8%). In a novel ICC analysis of 242 of the patients, we estimated that there should be 11.4 recurrences; in this group, only 6 recurrences were observed. Conclusions Lumpectomy and Targit boost combined with external beam Radiotherapy results in a low local recurrence rate in a standard risk patient population. Accurate localization and the immediacy of the treatment that has a favorable effect on tumour microenvironment may contribute to this effect. These long-term data establish the long-term safety and efficacy of the Targit technique and generate the hypothesis that Targit boost might be superior to an external beam boost in its efficacy and justifies a randomized trial.

Chris Brewgraves - One of the best experts on this subject based on the ideXlab platform.

  • long term results of targeted intraoperative Radiotherapy targit boost during Breast conserving surgery
    International Journal of Radiation Oncology Biology Physics, 2011
    Co-Authors: J S Vaidya, Frederik Wenz, Michael Baum, J S Tobias, Samuele Massarut, Mohammed Keshtgar, Basil S Hilaris, Christobel Saunders, Norman R Williams, Chris Brewgraves
    Abstract:

    Purpose We have previously shown that delivering targeted Radiotherapy to the tumour bed intraoperatively is feasible and desirable. In this study, we report on the feasibility, safety, and long-term efficacy of TARGeted Intraoperative Radiotherapy (Targit), using the Intrabeam system. Methods and Materials A total of 300 cancers in 299 unselected patients underwent Breast-conserving surgery and Targit as a boost to the tumor bed. After lumpectomy, a single dose of 20 Gy was delivered intraoperatively. Postoperative external beam whole-Breast Radiotherapy excluded the usual boost. We also performed a novel individualized case control (ICC) analysis that computed the expected recurrences for the cohort by estimating the risk of recurrence for each patient using their characteristics and follow-up period. Results The treatment was well tolerated. The median follow up was 60.5 months (range, 10–122 months). Eight patients have had ipsilateral recurrence: 5-year Kaplan Meier estimate for ipsilateral recurrence is 1.73% (SE 0.77), which compares well with that seen in the boosted patients in the European Organization for Research and Treatment of Cancer study (4.3%) and the UK STAndardisation of Breast Radiotherapy study (2.8%). In a novel ICC analysis of 242 of the patients, we estimated that there should be 11.4 recurrences; in this group, only 6 recurrences were observed. Conclusions Lumpectomy and Targit boost combined with external beam Radiotherapy results in a low local recurrence rate in a standard risk patient population. Accurate localization and the immediacy of the treatment that has a favorable effect on tumour microenvironment may contribute to this effect. These long-term data establish the long-term safety and efficacy of the Targit technique and generate the hypothesis that Targit boost might be superior to an external beam boost in its efficacy and justifies a randomized trial.