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Estrogen receptor (ER) and human epidermal growth factor 2 (HER2) expression guide the use of neoadjuvant chemotherapy (NACT) in patients with early breast cancer. We evaluate the independent predictive value of adding a multigene profile (CIT256 and PAM50) to immunohistochemical (IHC) profile regarding pathological complete response (pCR) and conversion of positive to negative axillary lymph node status. The cohort includes 458 patients who had genomic profiling performed as standard of care. Using logistic regression, higher pCR and node conversion rates among patients with Non-luminal subtypes are shown, and importantly the predictive value is independent of IHC profile. In patients with ER-positive and HER2-negative breast cancer an odds ratio of 9.78 (95% CI 2.60;36.8), P < 0.001 is found for pCR among CIT256 Non-luminal vs. Luminal subtypes. The results suggest a role for integrated use of up-front multigene subtyping for selection of a neoadjuvant approach in ER-positive HER2-negative breast cancer., (© 2023. The Author(s).)

Purpose: Quality of life and symptomatology in patients with malignancies admitted to comprehensive cancer centres are rarely investigated. Thus, this study aimed to investigate symptomatology and health-related quality of life of inpatients with cancer., Methods: A prospective, cross-sectional study was carried out on two occasions 5 weeks apart in haematology and oncology departments at a comprehensive cancer centre. Assessment included demographic data, WHO performance status (PS), EORTC QLQ-C30 and pain scales of brief pain inventory. Comparisons were analysed using Wilcoxon two-sample test, rank tests and Fisher's exact test., Results: One hundred twenty-four patients were analysed, mean age=59 years (SD=13.7), 42% admitted to haematological department; lung cancer was the most frequent diagnosis (15%). Low health-related quality of life and severe symptom burden, especially fatigue and appetite loss, were observed among the inpatients. In addition, role and social functions appeared to be more impaired in haematology patients than in those admitted to oncology (P=0.0372 and 0.0167, respectively). On the other hand, pain and constipation were more severely affected in oncology patients (P=0.0194 and 0.0064, respectively)., Conclusions: Patients in the wards of haematology and oncology had pronounced symptomatology and low quality of life. A more systematic focus on the amelioration of problems with functioning and symptoms among inpatients with malignant diseases is warranted.

Aims: This prospective, cross-sectional study aimed to assess cancer pain and its management in an inpatient setting at a comprehensive cancer centre in Denmark., Methods: One hundred and eighty-eight inpatients with cancer were invited to participate (May/June 2011). Demographics, diagnoses, World Health Organization performance status, health-related quality of life, pain and data regarding analgesic treatment were registered., Results: One hundred and thirty-four (71.3%) patients agreed to participate in the study. Most frequent diagnoses were leukaemia (27.6%) and lung cancer (14.2%). A high prevalence of pain was observed, 65.7%. Thirty-two per cent reported moderate to severe pain when it was at its worst, 96% reported no or mild pain when it was at its least. Nearly 22% reported moderate to severe pain when the pain was categorised as average. Breakthrough pain episodes were reported by 30.5%. Adjuvant medication was sparsely used and not always correctly indicated. Out of 88 patients with pain, 62.5% were left untreated according to the Electronic Medication System. Higher health-related quality of life was associated with lower pain intensity. The use of opioids with or without adjuvants was associated with higher pain intensity and higher number of breakthrough pain episodes., Conclusions: Approximately two thirds of inpatients reported pain and one third had breakthrough pain. A substantial number of patients with pain were left untreated. Opioid-treated patients reported highest pain intensity and number of breakthrough episodes; however, analgesic medication seemed to be underused. Measures to improve pain assessment and management are highly required., (© 2013 The Acta Anaesthesiologica Scandinavica Foundation.)

Background: Breast cancer is the most common cancer among Danish women. Locally advanced breast cancer occurs in a relatively large proportion of all new primary breast cancer diagnoses and for unexplained reasons 20-30% of women with breast cancer wait more than eight weeks from the initial breast cancer symptom(s) before seeking medical advice., Material and Methods: In this study, we performed a retrospective review of the medical records of patients referred to The Department of Breast Surgery, Rigshospitalet in Copenhagen in the period between 2006 and 2011, to characterize women presenting with breast cancer either larger than 5 cm or locally advanced breast cancer/inoperable breast cancer (LABC/IOBC). The aim of the study was to characterize these women concerning age, social status, co-morbidity, defined anamnestic parameters concerning breast history and delay in seeking medical advice, to explore whether common traits among these parameters could be identified which could account for the late diagnosis., Results: We identified 157 cases. The median age of our cohort was 67 years (range 30-98) and did not differ from all women with breast cancer, but with a high risk of severe medical co-morbidity, psychiatric co-morbidity or dementia. However, 42% did not reveal any history of a psychiatric or somatic co-morbidity did not take psychoactive drugs and had no previous benign breast disorder. They were living in their own homes, were married, did not suffer from dementia, could have a first-degree relative with a history of breast cancer, but still presented with breast cancer characterized as LABC/IOBC, without any apparent reason. Among these 42%, more than half had neglected their obvious symptoms of breast cancer.

Background: The aim of this study was to assess the diagnostic and therapeutic impact of preoperative positron emission tomography and computed tomography (PET/CT) in the initial staging of patients with early-stage breast cancer., Patients and Methods: A total of 103 consecutive patients with newly diagnosed operable breast cancer with tumors ≥2 cm were independently examined preoperatively with conventional assessment (mammography, breast/axillary ultrasound, chest X-ray and blood samples) and PET/CT with no prior knowledge of the other., Results: PET/CT identified a primary tumor in all but three patients (97%). PET/CT solely detected distant metastases (ovary, bones and lung) in 6 patients and new primary cancers (ovary, lung) in another two patients, as well as 12 cases of extra-axillary lymph node involvement. In 15 patients (15%), extra-axillary malignancy was detected by PET/CT only, leading to an upgrade of initial staging in 14% (14/103) and ultimately a modification of planned treatment in 8% (8/103) of patients., Conclusions: PET/CT is a valuable tool to provide information on extra-axillary lymph node involvement, distant metastases and other occult primary cancers. Preoperative (18)F-fluorodeoxyglucose-PET/CT has a substantial impact on initial staging and on clinical management in patients with early-stage breast cancer with tumors ≥2 cm.

Purpose: To evaluate docetaxel or vinorelbine, both with trastuzumab, as first-line therapy of human epidermal growth factor receptor 2-positive advanced breast cancer., Patients and Methods: Patients naive to chemotherapy for advanced disease were randomly assigned to docetaxel 100 mg/m(2) day 1 or vinorelbine 30 to 35 mg/m(2) on days 1 and 8, both combined with trastuzumab (8-mg/kg loading dose and 6-mg/kg maintenance dose) on day 1 every 3 weeks. The primary end point was time to progression (TTP)., Results: A total of 143 patients were randomly allocated to docetaxel, and 141 patients were assigned to vinorelbine. The median TTP for docetaxel and vinorelbine respectively was 12.4 months versus 15.3 months (hazard ratio [HR] = 0.94; 95% CI, 0.71 to 1.25; P = .67), median overall survival was 35.7 months versus 38.8 months (HR = 1.01; 95% CI, 0.71 to 1.42; P = .98), and the 1-year survival rate was 88% in both arms. Median time to treatment failure for study chemotherapy was 5.6 months versus 7.7 months (HR = 0.50; 95% CI, 0.38 to 0.64; P < .0001). The investigator-assessed overall response rate among 241 patients with measurable disease were 59.3% in both arms. More patients in the docetaxel arm discontinued therapy due to toxicity (P < .001). Significantly more treatment-related grade 3 to 4 febrile neutropenia (36.0% v 10.1%), leucopenia (40.3% v 21.0%), infection 25.1% v 13.0%), fever (4.3% v 0%), neuropathy (30.9% v 3.6%), nail changes (7.9% v 0.7%), and edema (6.5% v 0%) were reported with docetaxel., Conclusion: The study failed to demonstrate superiority of any drug in terms of efficacy, but the vinorelbine combination had significantly fewer adverse effects and should be considered as an alternative first-line option.

Purpose: This study was performed to characterize the impact of obesity on the risk of breast cancer recurrence and death as a result of breast cancer or other causes in relation to adjuvant treatment., Patients and Methods: Information on body mass index (BMI) at diagnosis was available for 18,967 (35%) of 53,816 women treated for early-stage breast cancer in Denmark between 1977 and 2006 with complete follow-up for first events (locoregional recurrences and distant metastases) up to 10 years and for death up to 30 years. Information was available on prognostic factors and adjuvant treatment for all patients. Univariate analyses were used to compare the associations of known prognostic factors and risks of recurrence or death according to BMI categories. Cox proportional hazards regression models were used to assess the influence of BMI after adjusting for other factors., Results: Patients with a BMI of 30 kg/m(2) or more were older and had more advanced disease at diagnosis compared with patients with a BMI below 25 kg/m(2) (P < .001). When data were adjusted for disease characteristics, the risk of developing distant metastases after 10 years was significantly increased by 46%, and the risk of dying as a result of breast cancer after 30 years was significantly increased by 38% for patients with a BMI of 30 kg/m(2) or more. BMI had no influence on the risk of locoregional recurrences. Both chemotherapy and endocrine therapy seemed to be less effective after 10 or more years for patients with BMIs greater than 30 kg/m(2)., Conclusion: Obesity is an independent prognostic factor for developing distant metastases and for death as a result of breast cancer; the effects of adjuvant therapy seem to be lost more rapidly in patients with breast cancer and obesity.

We investigated if delayed breast implant reconstruction after breast cancer impairs prognosis. Using data from the Danish Breast Cancer Cooperative Group register, we identified all women <70 years who underwent breast reconstruction with implants after mastectomy after invasive breast cancer during 1978 to 1992, on average 2.2 years (range, 3 days-9.4 years) after mastectomy. The reconstructed women were closely matched to breast cancer patients without reconstruction on age and calendar time of diagnosis, tumor size, regional lymph node involvement, and adjuvant radiation therapy. Overall, 580 reconstructed women and 1158 individually matched controls were followed-up for disease-free survival within the first 10 years and for overall survival for an average of 20.1 year (range, 12.8-27.5 years). Disease-free survival was significantly improved hazard ratio 0.78; 95% confidence interval 0.64-0.95 and overall survival was nonsignificantly improved (hazard ratio, 0.90; 95% confidence interval 0.76-1.06) among the breast reconstructed women. This is likely because of differences in socioeconomic and health factors.

Objectives: To evaluate the effect on breast cancer mortality during the first 10 years of the mammography service screening programme that was introduced in Copenhagen in 1991., Design: Cohort study., Setting: The mammography service screening programme in Copenhagen, Denmark., Participants: All women ever invited to mammography screening in the first 10 years of the programme. Historical, national, and historical national control groups were used., Main Outcome Measures: The main outcome measure was breast cancer mortality. We compared breast cancer mortality in the study group with rates in the control groups, adjusting for age, time period, and region., Results: Breast cancer mortality in the screening period was reduced by 25% (relative risk 0.75, 95% confidence interval 0.63 to 0.89) compared with what we would expect in the absence of screening. For women actually participating in screening, breast cancer mortality was reduced by 37%., Conclusions: In the Copenhagen programme, breast cancer mortality was reduced without severe negative side effects for the participants.

In an overview, Swedish mammography screening trials demonstrated a 29% reduction in breast cancer mortality in women aged 50-69 and no effect on total mortality. Three Danish regions introduced mammography screening in the 1990s. The authors developed a method to evaluate the effect of mammography service screening on breast cancer mortality and validated it applying it to total mortality, where no effect was expected. Study groups and historical and national control groups were analysed using Poisson regression. Total mortality in the screening regions and periods was close to that expected in the absence of screening. A small (3%) excess risk, also seen in a non-screening area, probably results from regional differences changing over time. The effect of this is inseparable from the screening effect. The design is adequate for analysing the effect of mammography service screening on breast cancer mortality.

Analyses of data from cancer registries have shown a 10% unit difference in 5-year relative survival between Danish and Swedish patients with breast cancer. This study investigates the effect of age and patho-anatomic variables on this survival difference. Hospital records were collected for women over 40 years of age diagnosed in 1989 or 1994 in east Denmark and south Sweden; patho-anatomical variables and survival were compared between 2289 Danish and 1715 Swedish women. Tumours were smaller, node-negative axillae more frequent and well-differentiated tumours almost 10% more frequent in Sweden. A superior 5-year relative survival in Sweden was found in the 50- to 79-year age group. The adjusted hazard rate ratio between countries was 1.7 in 1989 and 1.3 in 1994. Conditional survival after surviving the first 5 years was similar for the two countries. Adjusting for patho-anatomical variables reduced but did not eliminate the higher risk of death among the Danish patients. Higher population death rates could explain some but not all of the residual elevated risk for Danish women.

Concern has been raised about the potential delay in breast cancer diagnosis in the augmented breast. We linked a cohort of 2955 women, who received cosmetic breast implants in Denmark during the period 1973-1997 with the Danish Cancer Registry and the Danish Breast Cancer Cooperative Group register. We identified 23 incident cases of invasive breast cancer diagnosed subsequent to breast implantation. We randomly selected 11 controls for each case from the Danish Breast Cancer Cooperative Group's register, and obtained detailed information on all study subjects about surgery, histopathology and stage of breast cancer at diagnosis, intended adjuvant treatment according to trial protocols and overall survival. We found that women with breast implants on average were diagnosed with breast cancer at the same stage as controls. Significantly more women with breast implants had tumour cells in the surgical margins according to the Danish Breast Cancer Cooperative Group's data. There was no significant difference in overall survival between the two groups after an average of 6.4 years of follow-up. Based on this limited number of women with breast cancer subsequent to breast augmentation, breast implants do not appear to delay the diagnosis of breast cancer, and no evidence of impaired survival after breast cancer diagnosis in augmented women was found.

Introduction: Biennial service mammography screening for breast cancer has been offered to women aged 50-69 years in the municipality of Copenhagen since 1991. We report the results of the first three invitation rounds., Material and Methods: Data were collected from the Copenhagen service mammography screening database and other Danish registers., Results: The average participation rate during the first three invitation rounds was 66%. The breast cancer detection rate was 10/1,000 screened in the first invitation round and 5/1,000 in the consecutive rounds. The probability of a false positive mammography was 6% at the prevalent screen, and this was reduced to 3% at incidence screens. Fifty-two cases of interval cancer were seen after the first invitation round. The expected number was 152, which gives a proportional interval cancer rate of 0.34. The sensitivity was 86% and the specificity 94% after the first round., Discussion: The detection rate of breast cancer was high, especially in the prevalence round. The trend in the incidence of breast cancer at the subsequent rounds was similar to that before screening, which indicates that mammography screening does not lead to any greater over-diagnosis. The rate of false positive mammography was high at the initial screening round, but was acceptable at subsequent rounds, and a false positive mammography does not seem to have affected participation in subsequent rounds. The Copenhagen screening programme conforms to international quality assurance guidelines for process evaluation.

Introduction: Service mammography has been offered biennially to women aged 50-69 years in the municipality of Copenhagen since 1991. The results were compared to breast cancer cases before initiation of screening. The comparison concerns prognostic factors and the treatment-related consequences., Material and Methods: Data from the Copenhagen service mammography screening were linked to data from the DBCG database., Results: Before screening, 16% of breast cancer cases had a tumour size of 10 mm or less, this percentage increased to 41 in the screen-detected cases. Sixty per cent of breast cancer cases showed no evidence of metastatic spread to axillary lymph nodes before screening; this percentage increased to 78 per cent in the screen-detected cases. Forty per cent of ductal carcinomas showed a malignancy grade I before screening, compared to 53% in the screen-detected cases. Thirteen per cent were treated with breast conserving therapy before screening, as opposed to 48% in the screen-detected cases. Forty-one per cent needed postoperative adjuvant treatment before screening, compared with 21% in the screen-detected cases., Discussion: A marked improvement was seen in the prognostic and treatment-related characteristics of the screen-detected breast cancer cases, as compared to breast cancer cases from the same area before screening was initiated.

Introduction: A biennial mammography screening programme started for all women aged 50-69 in the municipality of Copenhagen, Denmark, in April 1991. The aim of the present study was to evaluate the quality of the preoperative diagnostic assessment for women recalled for further examination. Quality indicators were: validity of the fine-needle aspiration cytology, rate of malignant to benign surgery, and frequency of one-step surgery for malignant lesions., Material and Method: Database registries during the first three screening rounds from April 1991 to March 1997 were studied retrospectively, for fine-needle aspiration cytology tests where surgical biopsy was also performed., Results: In the period 1991-1997, 4,111 women were recalled for clinical mammography and subsequently 1,086 women underwent surgery. The use of the triple test in the preoperative assessment increased from 50% in the first screening round to 72% in the third. Throughout the period of evaluation, the number of inadequate fine-needle aspiration cytology (FNAC) was reduced from 32% to 6%. Inadequate FNAC from malignant lesions declined from 27% to 6%. The sensitivity of FNAC increased from 67% to 90% and the accuracy from 60% to 81%. The malignant/benign ratio of surgery rose from 1.4 in the first screening round to 2.8 in the third. One-step surgery as definitive treatment was performed in 67% of malignant instances., Discussion: The preoperative diagnostic assessment improved during the evaluation period. The triple test was used more often over time, the validity of FNAC and the malignant/benign ratio of surgery increased.

Objectives: To evaluate the early outcome of an organised mammography screening programme in an area with little opportunistic screening., Setting: The municipality of Copenhagen, Denmark, during four invitation rounds 1991-99., Methods: The following outcome measures were used: rates of participation, recall, false positive, and cancer detection. Benign biopsy, distribution of tumour size, lymph node status, and malignancy grade., Results: A total of 106,933 screens were undertaken, and 824 invasive breast carcinomas or CIS were detected. The detection rate was 11.9 per 1000 participants in the first invitation round, and it continued to be high in subsequent rounds. The percentage of CIS cases was 11%. Coverage declined from 71% in the first round to 62% in the fourth, although 91% of those participating in the previous three rounds attended. The programme operated with a high recall rate. The false positive rate was also high, being 5.6% at first screen, and 1.8% later on. However, 90% of false positives were sorted out already at assessment. The percentage of screen detected invasive breast cancers with a tumour diameter < or = 10 mm was 39% compared with 16% of all invasive breast cancers in these age groups in Copenhagen before screening., Conclusion: Copenhagen is an area with a high incidence of breast cancer and with relatively little opportunistic screening. The start of a screening programme with a high recall rate in this area resulted in a detection rate above 1%. The Copenhagen programme met or exceeded most of the interim measures recommended in the European Guidelines.

Angiosarcoma developing in unusual sites such as the gastrointestinal tract is not uncommonly associated with a known eliciting factor. Thus, among hitherto reported cases of angiosarcoma of the small bowel, five were radiation-associated. One additional example of ileal angiosarcoma induced by therapeutic irradiation of endometrial carcinoma is herein reported as a reminder of this causal association. DNA analyses of the primary growth as well as the metastatic deposits showed at least four aneuploid cell clones indicating genetic instability. This observation corresponds to the consistently poor prognosis of radiation-associated angiosarcoma of the small bowel.