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Background: The initial quality assurance programme of the EORTC Radiotherapy Cooperative Group in trial 22881/10882 is described. The implications of its results for quality assurance in future trials are discussed.Methods: In the EORTC trial 22881/10882 patients with stage I or II breast cancer are treated with tumor excision, axillary dissection, 50 Gy whole breast irradiation and then randomized to receive a boost dose of 15 Gy or no boost following complete tumor excision or between 10 Gy or 25 Gy in case of incomplete excision. To avoid or diminish protocol deviations and to quantify inevitable variations an extensive initial quality assurance programme was conducted. The programme consisted of a dummy run procedure an individual case review procedure, in vivo dosimetry studies and phantom dosimetry studies.Results: This combination of quality assurance procedures allows a good estimation of patient to patient and inter-institutional variations, and early detection of (potential) systematic protocol deviations of 3 types: 1. Deviations due to ambiguities in the protocol prescriptions. 2. Deviations not known to the institution, such as mistakes in implementation of treatment planning algorithms resulting in a systematic overdosage or underdosage. 3. Inability of an institution to cope with (precise) protocol prescriptions for technical or logistic reasons.Discussion: The first 2 types of deviations may be corrected or avoided by direct discussions and recommendations. With respect to the third type it is up to the trial coordinator to accept participation or not, depending upon the relative importance of the particular deviation(s) for the trial end points. To be effective, such a quality assurance programme must be implemented as early as possible in the course of a clinical trial. [ABSTRACT FROM AUTHOR]

Abstract Reliable models are required to assess the impacts of climate change on forest ecosystems. Precise and independent data are essential to assess this accuracy. The flux measurements collected by the EUROFLUX project over a wide range of forest types and climatic regions in Europe allow a critical testing of the process-based models which were developed in the LTEEF project. The ECOCRAFT project complements this with a wealth of independent plant physiological measurements. Thus, it was aimed in this study to test six process-based forest growth models against the flux measurements of six European forest types, taking advantage of a large database with plant physiological parameters. The reliability of both the flux data and parameter values itself was not under discussion in this study. The data provided by the researchers of the EUROFLUX sites, possibly with local corrections, were used with a minor gap-filling procedure to avoid the loss of many days with observations. The model performance is discussed based on their accuracy, generality and realism. Accuracy was evaluated based on the goodness-of-fit with observed values of daily net ecosystem exchange, gross primary production and ecosystem respiration (gC m-2 d-1 ), and transpiration (kg H2 O m-2 d-1 ). Moreover, accuracy was also evaluated based on systematic and unsystematic errors. Generality was characterized by the applicability of the models to different European forest ecosystems. Reality was evaluated by comparing the modelled and observed responses of gross primary production, ecosystem respiration to radiation and temperature. The results indicated that: Accuracy . All models showed similar high correlation with the measured carbon flux data, and also low systematic and unsystematic prediction errors at one or more sites of flux measurements. The results were similar in the case of several models when the water fluxes were considered.... [ABSTRACT FROM AUTHOR]

Background: 10-year results from several studies showed improved disease-free survival and distant metastasis-free survival, reduced breast cancer-related mortality, and variable effects on overall survival with the addition of partial or comprehensive regional lymph node irradiation after surgery in patients with breast cancer. We present the scheduled 15-year analysis of the European Organisation for Research and Treatment of Cancer (EORTC) 22922/10925 trial, which aims to investigate the impact on overall survival of elective internal mammary and medial supraclavicular (IM-MS) irradiation., Methods: EORTC 22922/10925, a randomised, phase 3 trial done across 46 radiation oncology departments from 13 countries, included women up to 75 years of age with unilateral, histologically confirmed, stage I-III breast adenocarcinoma with involved axillary nodes or a central or medially located primary tumour. Surgery consisted of mastectomy or breast-conserving surgery and axillary staging. Patients were randomly assigned (1:1) centrally using minimisation to receive IM-MS irradiation at 50 Gy in 25 fractions (IM-MS irradiation group) or no IM-MS irradiation (control group). Stratification was done for institution, menopausal status, site of the primary tumour within the breast, type of breast and axillary surgery, and pathological T and N stage. Patients and investigators were not masked to treatment allocation. The primary endpoint was overall survival analysed according to the intention-to-treat principle. Secondary endpoints were disease-free survival, distant metastasis-free survival, breast cancer mortality, any breast cancer recurrence, and cause of death. Follow-up is ongoing for 20 years after randomisation. This study is registered with ClinicalTrials.gov, NCT00002851., Findings: Between Aug 5, 1996, and Jan 13, 2004, we enrolled 4004 patients, of whom 2002 were randomly assigned to the IM-MS irradiation group and 2002 to the no IM-MS irradiation group. At a median follow-up of 15·7 years (IQR 14·0-17·6), 554 (27·7%) patients in the IM-MS irradiation group and 569 (28·4%) patients in the control group had died. Overall survival was 73·1% (95% CI 71·0-75·2) in the IM-MS irradiation group and 70·9% (68·6-72·9) in the control group (HR 0·95 [95% CI 0·84-1·06], p=0·36). Any breast cancer recurrence (24·5% [95% CI 22·5-26·6] vs 27·1% [25·1-29·2]; HR 0·87 [95% CI 0·77-0·98], p=0·024) and breast cancer mortality (16·0% [14·3-17·7] vs 19·8% [18·0-21·7]; 0·81 [0·70-0·94], p=0·0055) were lower in the IM-MS irradiation group than in the control group. No significant differences in the IM-MS irradiation group versus the control group were seen for disease-free survival (60·8% [95% CI 58·4-63·2] vs 59·9% [57·5-62·2]; HR 0·93 [95% CI 0·84-1·03], p=0·18), or distant metastasis-free survival (70·0% [67·7-72·2] vs 68·2% [65·9-70·3]; 0·93 [0·83-1·04], p=0·18). Causes of death between groups were similar., Interpretation: The 15-year results show a significant reduction of breast cancer mortality and any breast cancer recurrence by IM-MS irradiation in stage I-III breast cancer. However, this is not converted to improved overall survival., Funding: US National Cancer Institute, Ligue Nationale contre le Cancer, and KWF Kankerbestrijding., (Copyright © 2020 Elsevier Ltd. All rights reserved.)

Background: Since the introduction of breast-conserving treatment, various radiation doses after lumpectomy have been used. In a phase 3 randomised controlled trial, we investigated the effect of a radiation boost of 16 Gy on overall survival, local control, and fibrosis for patients with stage I and II breast cancer who underwent breast-conserving treatment compared with patients who received no boost. Here, we present the 20-year follow-up results., Methods: Patients with microscopically complete excision for invasive disease followed by whole-breast irradiation of 50 Gy in 5 weeks were centrally randomised (1:1) with a minimisation algorithm to receive 16 Gy boost or no boost, with minimisation for age, menopausal status, presence of extensive ductal carcinoma in situ, clinical tumour size, nodal status, and institution. Neither patients nor investigators were masked to treatment allocation. The primary endpoint was overall survival in the intention-to-treat population. The trial is registered with ClinicalTrials.gov, number NCT02295033., Findings: Between May 24, 1989, and June 25, 1996, 2657 patients were randomly assigned to receive no radiation boost and 2661 patients randomly assigned to receive a radiation boost. Median follow-up was 17.2 years (IQR 13.0-19.0). 20-year overall survival was 59.7% (99% CI 56.3-63.0) in the boost group versus 61.1% (57.6-64.3) in the no boost group, hazard ratio (HR) 1.05 (99% CI 0.92-1.19, p=0.323). Ipsilateral breast tumour recurrence was the first treatment failure for 354 patients (13%) in the no boost group versus 237 patients (9%) in the boost group, HR 0.65 (99% CI 0.52-0.81, p<0.0001). The 20-year cumulative incidence of ipsilatelal breast tumour recurrence was 16.4% (99% CI 14.1-18.8) in the no boost group versus 12.0% (9.8-14.4) in the boost group. Mastectomies as first salvage treatment for ipsilateral breast tumour recurrence occurred in 279 (79%) of 354 patients in the no boost group versus 178 (75%) of 237 in the boost group. The cumulative incidence of severe fibrosis at 20 years was 1.8% (99% CI 1.1-2.5) in the no boost group versus 5.2% (99% CI 3.9-6.4) in the boost group (p<0.0001)., Interpretation: A radiation boost after whole-breast irradiation has no effect on long-term overall survival, but can improve local control, with the largest absolute benefit in young patients, although it increases the risk of moderate to severe fibrosis. The extra radiation dose can be avoided in most patients older than age 60 years., Funding: Fonds Cancer, Belgium., (Copyright © 2015 Elsevier Ltd. All rights reserved.)

Purpose: The European Organisation for Research and Treatment of Cancer conducted a randomized trial investigating the role of radiotherapy (RT) after local excision (LE) of ductal carcinoma-in-situ (DCIS) of the breast. We analyzed the efficacy of RT with 10 years follow-up on both the overall risk of local recurrence (LR) and related to clinical, histologic, and treatment factors., Patients and Methods: After complete LE, women with DCIS were randomly assigned to no further treatment or RT (50 Gy). One thousand ten women with mostly (71%) mammographically detected DCIS were included. The median follow-up was 10.5 years., Results: The 10-year LR-free rate was 74% in the group treated with LE alone compared with 85% in the women treated by LE plus RT (log-rank P < .0001; hazard ratio [HR] = 0.53). The risk of DCIS and invasive LR was reduced by 48% (P = .0011) and 42% (P = .0065) respectively. Both groups had similar low risks of metastases and death. At multivariate analysis, factors significantly associated with an increased LR risk were young age (< or = 40 years; HR = 1.89), symptomatic detection (HR = 1.55), intermediately or poorly differentiated DCIS (as opposed to well-differentiated DCIS; HR = 1.85 and HR = 1.61 respectively), cribriform or solid growth pattern (as opposed to clinging/micropapillary subtypes; HR = 2.39 and HR = 2.25 respectively), doubtful margins (HR = 1.84), and treatment by LE alone (HR = 1.82). The effect of RT was homogeneous across all assessed risk factors., Conclusion: With long-term follow-up, RT after LE for DCIS continued to reduce the risk of LR, with a 47% reduction at 10 years. All patient subgroups benefited from RT.

The aim of this study was to evaluate prognostic factors for isolated loco-regional recurrence in patients treated for invasive stage I or II breast cancer. The study population comprised 3602 women who had undergone primary surgery for early stage breast cancer, who were enrolled in European Organisation for Research and Treatment of Cancer (EORTC) trials 10801, 10854, or 10902, by breast conservation (55%) and mastectomy (45%). The median follow-up time varied from 5.3 (range: 0.6-9.5) to 11.9 years (range: 0.6-17.4). Main outcome was the occurrence of isolated loco-regional recurrence. The results of multivariate analysis showed that younger age and breast conservation were risk factors for isolated loco-regional recurrence (breast cancer under 35 years of age versus over 50 years of age: hazard ratio 2.80 (95% CI 1.41-5.60)); breast cancer age 35-50 years versus over 50 years: hazard ratio 1.72 (95% CI 1.17-2.54); breast conservation (hazard ratio: 1.82 (95% CI 1.17-2.86)). After perioperative chemotherapy, less isolated loco-regional recurrences were observed (hazard ratio 0.63 (95% CI 0.44-0.91)). No significant interaction effects were observed. It is concluded that young age and breast conserving therapy are both independent predictors for isolated loco-regional recurrence. As an isolated loco-regional recurrence is a potentially curable condition, women treated with breast conservation or diagnosed with breast cancer at a young age should be monitored closely to detect local recurrence at an early stage.

Background: Breast-conserving therapy (BCT) has been shown to be as effective as mastectomy in the treatment of tumors 2 cm or smaller. However, evidence of its efficacy, over the long term, in patients with tumors larger than 2 cm is limited. From May 1980 to May 1986, the European Organization for Research and Treatment of Cancer carried out a randomized, multicenter trial comparing BCT with modified radical mastectomy for patients with tumors up to 5 cm. In this analysis, we investigated whether the treatments resulted in different overall survival, time to distant metastasis, or time to locoregional recurrence., Methods: Of 868 eligible breast cancer patients randomly assigned to the BCT arm or to the modified radical mastectomy arm, 80% had a tumor of 2.1-5 cm. BCT comprised lumpectomy with an attempted margin of 1 cm of healthy tissue and complete axillary clearance, followed by radiotherapy to the breast and a supplementary dose to the tumor bed. The median follow-up was 13.4 years. All P values are two-sided., Results: At 10 years, there was no difference between the two groups in overall survival (66% for the mastectomy patients and 65% for the BCT patients; P =.11) or in their distant metastasis-free rates (66% for the mastectomy patients and 61% for the BCT patients; P =.24). The rate of locoregional recurrence (occurring before or at the same time as distant metastasis) at 10 years did show a statistically significant difference (12% of the mastectomy and 20% of the BCT patients; P =. 01)., Conclusions: BCT and mastectomy demonstrate similar survival rates in a trial in which the great majority of the patients had stage II breast cancer.

The latest dramatic progress in the technologies of the computer industry is likely to increasingly influence the oncologist's daily routine. Besides well known and established telemedical services such as videoconferencing, the most influential trends are the spread of digital hospital infrastructures with unlimited, secured access to all relevant patient information. This article seeks to summarise the most imminent influences of telemedical developments on the future of the oncologist: the effects of telemedical services and electronic infrastructures on clinical workflow and on medical quality management. In addition, the history of telemedicine, recent technologies and the performance of electronic patient records are described.

A quality assurance programme was activated in 1982 in the EORTC Cooperative Group of Radiotherapy. Definitions and contents of quality assurance and quality control, definitions of errors and deviations (systematic, occasional) are given. The methodology and steps of the quality assurance programme adopted over the past ten years are briefly described. The need for an interaction between national and international networks is emphasized. Consensus statements on quality assurance in radiotherapy provided during the January 1993 Geneva meeting conclude this introduction to the detailed reports on the quality assurance programme of the EORTC Cooperative Group of Radiotherapy.

In a prospective randomized clinical trial conducted by the European Organization for Research and Treatment of Cancer (EORTC), mastectomy was compared with breast-conserving therapy in 903 stage I and stage II breast cancer patients entering the study between 1980 and 1986. The main participating centers were: Guy's Hospital, London; The Netherlands Cancer Institute, Amsterdam; University Hospital, Leuven; Radiotherapy Institute, Rotterdam; Breast Unit, Tijgerberg, S.A. The data were collected in the EORTC Data Center, Brussels. Treatment in the study arm consisted of lumpectomy, axillary clearance, and radiotherapy to the breast (50 Gy external irradiation in 5 weeks followed by boost with iridium implant of 25 Gy). Important in this study is the large number of TNM stage II patients (755). Most patients were stage II because of the size of the tumor (2-5 cm). The patient and tumor characteristics in the study and control groups were well balanced. So far the survival curves and local recurrence rates are not statistically different for the two study arms. Tumor size was found in univariate analysis to be a significant risk factor for local recurrence in the breast-conserving therapy group but not in the mastectomy group. Results of salvage treatment for local recurrence were not better for the breast-conserving therapy group compared with the mastectomy group. Measurements of quality of life and cosmesis show a clear benefit for the breast-conserving therapy group.

A consensus on a quality assurance programme of the treatment of early breast cancer was reached in a multidisciplinary meeting of surgeons, pathologists, radiotherapists, physicists and radiographers. Guidelines for treatment preparation and execution have been set up, including careful location and excision with marking of the primary tumour. The target volumes for irradiation of the whole breast and boost area have been defined. Radiation dose prescription rules, specification and checking procedures are given, together with measures to achieve a homogeneous dose within the target volume. The rules for a quality assurance programme in each clinic are designed for checking equipment and treatment method.

The EORTC trial 22881/10882 is a randomised trial with the aim to assess the role of the boost dose in breast conserving therapy in stage I and II breast cancer. In order to detect potential protocol deviations concerning irradiation technique and in the dose specification procedure of participating institutions before actual patient accrual, a Dummy Run was performed. Three transverse sections of a patient were sent to 16 participating institutions with a request to make a three-plane treatment plan according to the protocol prescriptions. A treatment chart and beam data were also requested for recalculation of the dose. Additional information was asked in a questionnaire. On evaluation, the techniques differed considerably with respect to photon beam energy, varying between 60Co gamma-rays and 8 MV X-rays, and the use of wedge filters. Two institutions did not apply wedges, whereas wedge angles in the other institutions varied between 6 degrees and 45 degrees. Twelve institutions used collimator rotation and/or a table wedge to diminish the amount of irradiated lung volume. The dose was specified in a point according to the protocol prescription in 11 institutions and to the 90, 95 or 100% isodose curve in four. Twelve institutions applied lung density corrections during treatment planning, while nine reported problems with their planning system in off-axis dose distribution calculation and/or the simulation of collimator rotation. Recalculation of the dose at the isocentre showed agreement within 2% compared with the stated dose. The dose reported in the tumour excision area varied between 93 and 100%.(ABSTRACT TRUNCATED AT 250 WORDS)