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Objective: Patients and partners both cope individually and as a dyad with challenges related to a breast cancer diagnosis. The objective of this study was to evaluate the effect of a psychological attachment-oriented couple intervention for breast cancer patients and partners in the early treatment phase., Methods: A randomised controlled trial including 198 recently diagnosed breast cancer patients and their partners. Couples were randomised to the Hand in Hand (HiH) intervention in addition to usual care or to usual care only. Self-report assessments were conducted for both patients and partners at baseline, postintervention (5 months), and follow-up (10 months), assessing cancer-related distress, symptoms of anxiety and depression, and dyadic adjustment. Patients' cancer-related distress was the primary outcome., Results: Cancer-related distress decreased over time in both patients and partners, but the intervention did not significantly affect this decrease at postintervention (P = .08) or follow-up (P = .71). A significant positive effect was found on dyadic adjustment at follow-up for both patients (P = .04) and partners (P = .02)., Conclusions: There was no significant effect of the HiH intervention cancer-related distress. The results suggest that most couples can cope with cancer-related distress in the context of usual care. However, the positive effect on dyadic adjustment implies that the HiH intervention benefitted both patients and partners. Future studies should investigate how to integrate a couple focus in usual cancer care to improve dyadic coping in the early treatment phase., (© 2017 The Authors. Psycho-Oncology Published by John Wiley & Sons Ltd.)

Background: Women with breast cancer experience different symptoms related to surgical or adjuvant therapy. Previous findings and theoretical models of mind-body interactions suggest that psychological wellbeing, i.e. levels of distress, influence the subjective evaluation of symptoms, which influences or determines functioning. The eight-week mindfulness-based stress reduction (MBSR) program significantly reduced anxiety and depression in breast cancer patients in a randomized controlled trial (NCT00990977). In this study we tested the effect of MBSR on the burden of breast cancer related somatic symptoms, distress, mindfulness and spiritual wellbeing and evaluated possible effect modification by adjuvant therapy and baseline levels of, distress, mindfulness and spiritual wellbeing., Material and Methods: A population-based sample of 336 women Danish women operated for breast cancer stages I-III were randomized to MBSR or usual care and were followed up for somatic symptoms, distress, mindfulness skills and spiritual wellbeing post-intervention and after six and 12 months. Effect was tested by general linear regression models post-intervention, and after six and 12 months follow-up and by mixed effects models for repeated measures of continuous outcomes. Effect size (Cohen's d) was calculated to explore clinical significance of effects among intervention group. Finally, modification of effect of MBSR on burden of somatic symptoms after 12 months' follow-up by adjuvant therapy and baseline levels of, distress, mindfulness and spiritual wellbeing were estimated., Results: General linear regression showed a significant effect of MBSR on the burden of somatic symptoms post-intervention and after 6 months' follow-up. After 12 months' follow-up, no significant effect of MBSR on the burden of somatic symptoms was found in mixed effect models. A statistically significant effect of MBSR on distress was found at all time-points and in the mixed effect models. Significant effects on mindfulness were seen after six and 12 months and no significant effect was observed for spiritual wellbeing. No significant modification of MBSR effect on somatic symptom burden was identified., Conclusion: This first report from a randomized clinical trial on the long-term effect of MBSR finds an effect on somatic symptom burden related to breast cancer after six but not 12 months follow-up providing support for MBSR in this patient group.

Background: The TARGIT-A trial compared risk-adapted radiotherapy using single-dose targeted intraoperative radiotherapy (TARGIT) versus fractionated external beam radiotherapy (EBRT) for breast cancer. We report 5-year results for local recurrence and the first analysis of overall survival., Methods: TARGIT-A was a randomised, non-inferiority trial. Women aged 45 years and older with invasive ductal carcinoma were enrolled and randomly assigned in a 1:1 ratio to receive TARGIT or whole-breast EBRT, with blocks stratified by centre and by timing of delivery of targeted intraoperative radiotherapy: randomisation occurred either before lumpectomy (prepathology stratum, TARGIT concurrent with lumpectomy) or after lumpectomy (postpathology stratum, TARGIT given subsequently by reopening the wound). Patients in the TARGIT group received supplemental EBRT (excluding a boost) if unforeseen adverse features were detected on final pathology, thus radiotherapy was risk-adapted. The primary outcome was absolute difference in local recurrence in the conserved breast, with a prespecified non-inferiority margin of 2·5% at 5 years; prespecified analyses included outcomes as per timing of randomisation in relation to lumpectomy. Secondary outcomes included complications and mortality. This study is registered with ClinicalTrials.gov, number NCT00983684., Findings: Patients were enrolled at 33 centres in 11 countries, between March 24, 2000, and June 25, 2012. 1721 patients were randomised to TARGIT and 1730 to EBRT. Supplemental EBRT after TARGIT was necessary in 15·2% [239 of 1571] of patients who received TARGIT (21·6% prepathology, 3·6% postpathology). 3451 patients had a median follow-up of 2 years and 5 months (IQR 12-52 months), 2020 of 4 years, and 1222 of 5 years. The 5-year risk for local recurrence in the conserved breast was 3·3% (95% CI 2·1-5·1) for TARGIT versus 1·3% (0·7-2·5) for EBRT (p=0·042). TARGIT concurrently with lumpectomy (prepathology, n=2298) had much the same results as EBRT: 2·1% (1·1-4·2) versus 1·1% (0·5-2·5; p=0·31). With delayed TARGIT (postpathology, n=1153) the between-group difference was larger than 2·5% (TARGIT 5·4% [3·0-9·7] vs EBRT 1·7% [0·6-4·9]; p=0·069). Overall, breast cancer mortality was much the same between groups (2·6% [1·5-4·3] for TARGIT vs 1·9% [1·1-3·2] for EBRT; p=0·56) but there were significantly fewer non-breast-cancer deaths with TARGIT (1·4% [0·8-2·5] vs 3·5% [2·3-5·2]; p=0·0086), attributable to fewer deaths from cardiovascular causes and other cancers. Overall mortality was 3·9% (2·7-5·8) for TARGIT versus 5·3% (3·9-7·3) for EBRT (p=0·099). Wound-related complications were much the same between groups but grade 3 or 4 skin complications were significantly reduced with TARGIT (four of 1720 vs 13 of 1731, p=0·029)., Interpretation: TARGIT concurrent with lumpectomy within a risk-adapted approach should be considered as an option for eligible patients with breast cancer carefully selected as per the TARGIT-A trial protocol, as an alternative to postoperative EBRT., Funding: University College London Hospitals (UCLH)/UCL Comprehensive Biomedical Research Centre, UCLH Charities, National Institute for Health Research Health Technology Assessment programme, Ninewells Cancer Campaign, National Health and Medical Research Council, and German Federal Ministry of Education and Research., (Copyright © 2014 Vaidya et al. Open Access article distributed under the terms of CC BY-NC-ND. Published by Elsevier Ltd. All rights reserved.)

Background: Discussion regarding the necessity to identify patients with both the need and motivation for psychosocial intervention is ongoing. Evidence for an effect of mindfulness-based interventions among cancer patients is based on few studies with no systematic enrollment., Methods: We used Danish population-based registries and clinical databases to determine differences in demographics, breast cancer and co-morbidity among 1208 women eligible for a randomized controlled trial (www.clinicaltrials.gov identifier: NCT00990977) of mindfulness-based stress reduction MBSR., Results: Participants (N = 336) were found to be younger (p < 0.001) and have a less recent diagnosis at invitation than decliners (N = 872; p < 0.001). After adjustment for age and time since diagnosis at invitation, a statistically significant difference was also found between the two groups in use of psychologist sessions (p < 0.05), whereas neither breast cancer variables nor co-morbidity was significantly different. Self-reported data obtained by use of validated psychometric scales from 169 decliners and 336 women who agreed to enroll in the trial showed statistically significant differences in level of education, distress, anxiety, depression, well being and symptom burden. No differences were observed with regard to marital status, children living at home, affiliation to the work market, psychiatric caseness or any lifestyle measure., Conclusion: Our findings indicate that participants are younger, have a less recent diagnosis and have a higher level of education than those who refuse. This should be taken into account in designing and evaluating trials of psychosocial interventions and in planning mindfulness-based interventions., (Copyright © 2012 John Wiley & Sons, Ltd.)

Introduction: As the incidence of and survival from breast cancer continue to raise, interventions to reduce anxiety and depression before, during and after treatment are needed. Previous studies have reported positive effects of a structured 8-week group mindfulness-based stress reduction program (MBSR) among patients with cancer and other conditions., Purpose: To test the effect of such a programme on anxiety and depression among women with breast cancer in a population-based randomised controlled study., Methods: A total of 336 women who had been operated on for breast cancer (stage I-III) were randomised to usual care or MBSR+usual care. Questionnaires including the Symptom Checklist-90r anxiety and depression subscales and the Center for Epidemiological Studies-Depression scale were administered before randomisation and immediately, 6 and 12 months after the intervention., Results: Intention-to-treat analyses showed differences between groups in levels of anxiety (p=0.0002) and depression (SCL-90r, p<0.0001; CES-D, p=0.0367) after 12 months. Graphical comparisons of participants with higher levels of anxiety and depression at baseline showed a significantly greater decrease in the intervention group throughout follow-up and no differences among least affected participants. Medium-to-large effects were found for all outcomes in the intervention group in analyses of change scores after 12 months' follow-up., Conclusion: The 8-week group based MBSR intervention had clinically meaningful, statistically significant effects on depression and anxiety after 12 months' follow-up, and medium-to-large effect sizes. Our findings support the dissemination of MBSR among women with breast cancer. (Clintrials.gov No.: NCT00990977)., (Copyright © 2012 Elsevier Ltd. All rights reserved.)

Background: After breast-conserving surgery, 90% of local recurrences occur within the index quadrant despite the presence of multicentric cancers elsewhere in the breast. Thus, restriction of radiation therapy to the tumour bed during surgery might be adequate for selected patients. We compared targeted intraoperative radiotherapy with the conventional policy of whole breast external beam radiotherapy., Methods: Having safely piloted the new technique of single-dose targeted intraoperative radiotherapy with Intrabeam, we launched the TARGIT-A trial on March 24, 2000. In this prospective, randomised, non-inferiority trial, women aged 45 years or older with invasive ductal breast carcinoma undergoing breast-conserving surgery were enrolled from 28 centres in nine countries. Patients were randomly assigned in a 1:1 ratio to receive targeted intraoperative radiotherapy or whole breast external beam radiotherapy, with blocks stratified by centre and by timing of delivery of targeted intraoperative radiotherapy. Neither patients nor investigators or their teams were masked to treatment assignment. Postoperative discovery of predefined factors (eg, lobular carcinoma) could trigger addition of external beam radiotherapy to targeted intraoperative radiotherapy (in an expected 15% of patients). The primary outcome was local recurrence in the conserved breast. The predefined non-inferiority margin was an absolute difference of 2.5% in the primary endpoint. All randomised patients were included in the intention-to-treat analysis. This trial is registered with ClinicalTrials.gov, number NCT00983684., Findings: 1113 patients were randomly allocated to targeted intraoperative radiotherapy and 1119 were allocated to external beam radiotherapy. Of 996 patients who received the allocated treatment in the targeted intraoperative radiotherapy group, 854 (86%) received targeted intraoperative radiotherapy only and 142 (14%) received targeted intraoperative radiotherapy plus external beam radiotherapy. 1025 (92%) patients in the external beam radiotherapy group received the allocated treatment. At 4 years, there were six local recurrences in the intraoperative radiotherapy group and five in the external beam radiotherapy group. The Kaplan-Meier estimate of local recurrence in the conserved breast at 4 years was 1.20% (95% CI 0.53-2.71) in the targeted intraoperative radiotherapy and 0.95% (0.39-2.31) in the external beam radiotherapy group (difference between groups 0.25%, -1.04 to 1.54; p=0.41). The frequency of any complications and major toxicity was similar in the two groups (for major toxicity, targeted intraoperative radiotherapy, 37 [3.3%] of 1113 vs external beam radiotherapy, 44 [3.9%] of 1119; p=0.44). Radiotherapy toxicity (Radiation Therapy Oncology Group grade 3) was lower in the targeted intraoperative radiotherapy group (six patients [0.5%]) than in the external beam radiotherapy group (23 patients [2.1%]; p=0.002)., Interpretation: For selected patients with early breast cancer, a single dose of radiotherapy delivered at the time of surgery by use of targeted intraoperative radiotherapy should be considered as an alternative to external beam radiotherapy delivered over several weeks., Funding: University College London Hospitals (UCLH)/UCL Comprehensive Biomedical Research Centre, UCLH Charities, National Institute for Health Research Health Technology Assessment programme, Ninewells Cancer Campaign, National Health and Medical Research Council, and German Federal Ministry of Education and Research (BMBF)., (Copyright 2010 Elsevier Ltd. All rights reserved.)

Previous studies have suggested that minor alleles for ERCC4 rs744154, TNF rs361525, CASP10 rs13010627, PGR rs1042838, and BID rs8190315 may influence breast cancer risk, but the evidence is inconclusive due to their small sample size. These polymorphisms were genotyped in more than 30,000 breast cancer cases and 30,000 controls, primarily of European descent, from 30 studies in the Breast Cancer Association Consortium. We calculated odds ratios (OR) and 95% confidence intervals (95% CI) as a measure of association. We found that the minor alleles for these polymorphisms were not related to invasive breast cancer risk overall in women of European descent: ECCR4 per-allele OR (95% CI) = 0.99 (0.97-1.02), minor allele frequency = 27.5%; TNF 1.00 (0.95-1.06), 5.0%; CASP10 1.02 (0.98-1.07), 6.5%; PGR 1.02 (0.99-1.06), 15.3%; and BID 0.98 (0.86-1.12), 1.7%. However, we observed significant between-study heterogeneity for associations with risk for single-nucleotide polymorphisms (SNP) in CASP10, PGR, and BID. Estimates were imprecise for women of Asian and African descent due to small numbers and lower minor allele frequencies (with the exception of BID SNP). The ORs for each copy of the minor allele were not significantly different by estrogen or progesterone receptor status, nor were any significant interactions found between the polymorphisms and age or family history of breast cancer. In conclusion, our data provide persuasive evidence against an overall association between invasive breast cancer risk and ERCC4 rs744154, TNF rs361525, CASP10 rs13010627, PGR rs1042838, and BID rs8190315 genotypes among women of European descent.

The study aimed to evaluate intraoperative immunohistochemistry (IHC) staining of sentinel nodes in primary breast cancer surgery. We analysed retrospectively 1209 consecutive sentinel node procedures and compared the rate of late positive metastases in sentinel node biopsy (SNB) and the duration of the surgical procedures before (n=706) and after (n=503) introducing intraoperative IHC on frozen section. We also did a cost analysis. Intraoperative IHC staining led to a lowering of the late positive SNB rate. Introducing IHC gave a decrease in the late positive rate from 93 to 52% (p<0.0001) for isolated tumour cell metastasis, from 56 to 36.4% (p<0.02) for micrometastasis, and from 16 to 5% (p<0.01) for macrometastasis. The surgical procedures were slightly prolonged for lumpectomies but not for mastectomies after introducing intraoperative IHC staining. The cost analysis showed an overall cost saving of approximately 40%. In conclusion, intraoperative IHC staining of the SNB lowered the late positive rate and gave an overall cost saving.

An investigation of the impact of axillary surgery on arm morbidity in patients who underwent sentinel lymph node biopsy (SLNB), axillary clearance in a one-step procedure, and axillary clearance in a two-step procedure, respectively, was performed. Over a period of 2 years 438 patients with invasive breast carcinoma or carcinoma in situ underwent SLNB at our clinic. Of these 393 were interviewed on symptoms of swelling, numbness, pain, reduced strength, reduced mobility and fatigue more than 1 year postoperatively. Using a standardised symptom score system postoperative morbidity was registered and differences between the patients were compared in a logistic regression analysis. Of the 393 patients who received the questionnaire 370 responded (94%). The mean follow-up was 23.5 months (range 12-37). SLNB resulted in significantly lower arm morbidity than axillary clearance. Doing stepwise logistic regression of the data the two-step axillary clearance represented the most important influential factor of the development of arm morbidity symptoms of swelling and numbness.

Objective: To validate a computer version of the Danish Prostatic Symptom Score (DAN-PSS) questionnaire and compare it with the paper version., Material and Methods: Ninety-three male patients (aged 25-87 years), referred to a department of urology for lower urinary tract symptoms (LUTS), filled in a personal computer (PC) version and a paper version of the DAN-PSS questionnaire. Subsequently they answered a questionnaire concerning their preferences and computer experience., Results: A fair correlation between the total scores from the paper and PC versions was found. The differences were independent of both total score and age. In the PC version all LUTS questions were answered while 9.8% were left blank in the paper version. The sexual questions were answered by 71% of patients in the paper version and by 87.5% in the PC version. For the questions in the PC version a learning curve was observed in terms of the time taken to answer the questions. Previous computer experience did not influence answering time, difference in score between paper and PC versions or total score. Almost all patients preferred the PC version to the paper version., Conclusion: The PC scores are reasonably reliable judging by comparison with previously validated traditional paper scores. The PC questionnaire had a higher response rate and was preferred by the majority of patients.

Flow cytometry was used to study the incidence of aneuploidy and to determine the significance of multiple sampling from colorectal tumors. DNA ploidy pattern has been proposed as a supplementary prognostic marker, but discrepancies in findings are major. DNA clonal heterogeneity, defined as two or more DNA aneuploid stemlines in the same tumor, is well established. However, most studies have been based on only one biopsy from each tumor. In our study multiple biopsies were taken from 163 patients (88 males and 75 females) electively operated for colorectal cancer. Tumor cells were harvested by fine needle aspiration from fresh frozen biopsies sampled at different sites of each tumor. DNA aneuploidy was detected in tumors from 145 patients (89%), and 18 patients (11%) had a solitary DNA diploid cell population. In a 79 month follow-up period 105 patients had died. Statistical analysis showed that distinction between diploidy and aneuploidy did not predict survival. However, grouping subpopulations into DNA diploid plus near diploid (DNA index (DI) 0. 97-1.15), DNA aneuploid with all aneuploid subpopulations in the interval 1.15-2.06, and DNA aneuploid with subpopulations with DI < 0.97 and/or DI > 2.06, showed a significant difference in survival in a Cox multivariate analysis including Dukes' stage P = 0.049 comparing the second group to the first and P = 0.01 comparing the third group to the first. In 21 (13%) patients only one subpopulation was found, 57 (35%) had two, 44 (27%) had three, and 41 (25%) had four or more different subpopulations. The association of DNA ploidy to survival is shown to be dependent on the number of biopsies analysed., (Copyright 1999 Wiley-Liss, Inc.)

The DAN-PSS-1 system, a self-administered quality-of-life questionnaire comprising 12 questions related to voiding problems and the perceived bother of each individual symptom, was compared to other extensively used score systems and furthermore included in different clinical situations so as to validate the system. The system was internally consistent (alpha cr = 0.73), the median test-retest reliability of answers to each question was 83.5% (range 0-99.7%). A high degree of construct validity demonstrated in the correlation with the Madsen-Iversen score system (rs = 0.51) and with the patients' answers to questions about how bothersome their symptoms were (rs = 0.71). The discriminant validity of the DAN-PSS-1 was excellent with an area under the ROC curve of 0.94. Finally, the DAN-PSS-1 was sensitive to changes following intervention, with scores decreasing 100% after transurethral prostatectomy and 65% after four months of treatment with an alpha-blocker. The DAN-PSS-1 is reliable, valid and responsive, and therefore can be recommended for assessing the severity of symptoms among patients presenting with lower urinary tract complaints suggestive of BPH and during follow-up.

Routine procedures for urological investigations, treatment and follow-up of patients with monosymptomatic dipstick haematuria were studied by a questionnaire. This consisted of 13 questions and was filled in by the chief urologist in 45 (80%) of all surgical departments in Denmark. Dipstick testing was used by 98% of all departments, but only in 31% of these were the personnel reading the tests especially trained in the procedure. Cystourethroscopy and excretory urography were used in respectively 98% and 93% of the departments, although many different evaluation schedules were employed. Thirty-eight departments confirmed the initial dipstick result, of these 21 (55%) omitted further investigations in case of a negative result. Persistent monosymptomatic haematuria resulted in repeated urological examination in 36 departments (80%). The paper discusses the use of dipstick testing versus urine microscopy and gives recommendations for the investigation and follow-up of patients with monosymptomatic dipstick haematuria.

The aim of this study was to evaluate the sensitivity of urine dipstick for diagnosing microscopic haematuria. We prospectively reanalyzed 122 consecutive urine samples, that had been read positive for blood by dipstick testing in two hospital departments, with repeated dipstick testing and fractionated microscopy at the laboratory. Out of these 53/122 (43%) were negative at the new dipstick analysis and 67/122 (55%) were negative by urine microscopy. We further examined urine samples from 31 healthy employees at the laboratory. Urine was collected before and after accurate instruction in the procedure for midstream urine sample. A complete correlation between dipstick analysis and microscopy was found. Samples from 8/31 (25%) persons showed microscopic haematuria before instructions and 6/31 (19%) after. It is concluded that instruction in correct dipstick reading and urine sampling could reduce the number of patients with microscopic haematuria by approximately 50%.

We assessed the symptomatic outcome of transurethral prostatectomy with the newly developed self-administered questionnaire, Danish Prostate Symptom Score (DAN-PSS-1), in men suffering from uncomplicated benign prostatic hyperplasia (BPH). The questionnaire was filled in adequately by 53 men, median age 69 (range 52-82), preoperatively and 2, 4 and 6 months after transurethral prostatectomy (TUR-P). The DAN-PSS-1 symptom score showed a high degree of sensitivity as the preoperative total score was median 20 (quartiles 14-36) and decreased to 4, 0 and 1 (quartiles from 0-4) at the 2, 4, and 6-month control respectively. The symptoms related to voiding were relieved totally after 2 months while symptoms related to storage were first relieved completely at 4-month control. Bother from symptoms was relieved after 2 months, although some symptoms still remained. The questionnaire was internally consistent with a reliability coefficient, Cronbach's alpha (alphaCr), of 0.73. We conclude that the DAN-PSS-1 questionnaire is an efficient tool among others in the indication and evaluation of treatment of uncomplicated BPH.

Objective: To report our experience with a single layer continuous absorbable monofilament polyglyconate suture technique in colonic anastomosis., Design: Retrospective study., Setting: Teaching hospital, Denmark., Subjects: 105 consecutive patients operated on electively during the period January 1987-June 1990., Interventions: Single layer continuous monofilament polyglyconate end-to-end anastomosis., Main Outcome Measures: Clinical signs of anastomotic leak and stricture, wound infections, and duration of hospital stay postoperatively., Results: Of the 105 patients in the study, 1 developed an anastomotic leak (1%, 95% confidence interval 0 to 5.2%). Median duration of hospital stay was 8 days (range 4-72) and wound infections were recorded in 7 patients (7%, 95% confidence interval 2.7 to 13.2%). None of the patients had symptoms of anastomotic stricture at follow-up (median 19 months, range 2-48)., Conclusion: Single layered continuous colonic anastomosis with an absorbable monofilament suture is a safe technique, easily learned even by relatively inexperienced surgeons and less expensive than other methods.

Background: The aim of the study was to evaluate the prognostic significance of DNA ploidy of gastric carcinomas., Methods: The DNA content was analyzed by flow cytometry on archival paraffin-embedded material from tumors of 97 consecutive patients., Results: A multivariate analysis showed that the DNA ploidy pattern and lymph node metastasis were the only independent prognostic markers for survival (p = 0.01 and p = 0.02, respectively). The relative risk of death due to gastric cancer was three times greater for patients with DNA hypertetraploid tumors than for patients with DNA diploid tumors and twice as high for patients with lymph node metastasis as for patients without. Well and moderately differentiated carcinomas were more frequently aneuploid than tumors with poor differentiation (p = 0.047). There was no correlation between tumor ploidy pattern and location. In univariate analysis tumor growth through the serosal wall was predictive of poor survival (p = 0.003)., Conclusions: DNA ploidy is an independent prognostic indicator for cancer-specific survival in gastric cancer.

Three cases of amoebic liver abscess were initially diagnosed as pneumonia. All three patients had fever, respiratory pain at the right costal margin, increased erythrocyte sedimentation rate and white blood cell count, pulmonary infiltrate and pleural exudate. The first case was a relapse of an infection acquired at a visit to the tropics sixteen years previously. The second patient had spent a short holiday in Morocco seven months before the illness and the third patient was probably infected in Greenland. The correct diagnosis was confirmed by demonstration of a cavity in the liver, amoebic antibodies in the blood and good response to amoebicidal treatment which was combined with closed drainage in two cases.