The impact of the COVID-19 pandemic on perceived access to health care and preferences for health care provision in individuals (being) treated for breast cancer.

PURPOSE: To evaluate perceived access to health care and preferences for health care provision among patients (being) treated for breast cancer during the COVID-19 pandemic. METHODS: Longitudinal study within the prospective, multicenter UMBRELLA cohort of patients (being) treated for breast cancer. All cohort participants enrolled in UMBRELLA between October 2013 and November 2020 were sent a COVID-19-specific survey during the first and second wave of the COVID-19 pandemic, i.e., April 2020 and November 2020, respectively. RESULTS: In total, 1106 (69.3%) and 822 (50.9%) cohort participants completed the survey in the first and second wave, respectively. The proportion of patients experiencing that their treatment or follow-up care was affected due to COVID-19 decreased from 28.4% (n = 198) in April 2020 to 14.8% (n = 103) in November 2020. Throughout the pandemic, one or more hospital consultations were postponed in 10.0% (n = 82) of all patients and changed into a teleconsultation in 23.1% (n = 190). The proportion of patients who experienced a higher threshold to contact their general practitioner due to COVID-19 decreased from 29.9% (n = 204) in the first wave to 20.8% (n = 145) in the second wave. In-person consultations remained most preferred in 35.2% (n = 289) of all patients. Nearly half of all patients (48.3%, n = 396) indicated that telehealth would be a useful alternative for in-person consultations in future. CONCLUSION: Perceived access to health care has improved substantially throughout the pandemic. Digital care is well received by patients (being) treated for breast cancer.

(Ex-)breast cancer patients with (pre-existing) symptoms of anxiety and/or depression experience higher barriers to contact health care providers during the COVID-19 pandemic.

PURPOSE: To identify factors associated with (perceived) access to health care among (ex-)breast cancer patients during the COVID-19 pandemic. METHODS: Cross-sectional study within a large prospective, multicenter cohort of (ex-)breast cancer patients, i.e., UMBRELLA. All participants enrolled in the UMBRELLA cohort between October 2013 and April 2020 were sent a COVID-19-specific survey, including the Hospital Anxiety and Depression Scale (HADS) questionnaire. RESULTS: In total, 1051 (66.0%) participants completed the survey. During COVID-19, 284 (27.0%) participants reported clinically relevant increased levels of anxiety and/or depression, i.e., total HADS score ≥ 12. Participants with anxiety and/or depression reported statistically significant higher barriers to contact their general practitioner (47.5% vs. 25.0%, resp.) and breast cancer physicians (26.8% vs. 11.2%, resp.) compared to participants without these symptoms. In addition, a higher proportion of participants with anxiety and/or depression reported that their current treatment or (after)care was affected by COVID-19 compared to those without these symptoms (32.7% vs. 20.5%, resp.). Factors independently associated with symptoms of anxiety and/or depression during COVID-19 were pre-existent anxiety (OR 6.1, 95% CI 4.1-9.2) or depression (OR 6.0, 95% CI 3.5-10.2). CONCLUSION: During the COVID-19 pandemic, (ex-)breast cancer patients with symptoms of anxiety and/or depression experience higher barriers to contact health care providers. Also, they more often report that their health care was affected by COVID-19. Risk factors for anxiety and/or depression during COVID-19 are pre-existent symptoms of anxiety or depression. Extra attention-including mental health support-is needed for this group.

Impact of the COVID-19 Pandemic on Patient-Reported Outcomes of Breast Cancer Patients and Survivors.

BACKGROUND: The coronavirus disease 2019 (COVID-19) pandemic (officially declared on the March 11, 2020), and the resulting measures, are impacting daily life and medical management of breast cancer patients and survivors. We evaluated to what extent these changes have affected quality of life, physical, and psychosocial well-being of patients previously or currently being treated for breast cancer. METHODS: This study was conducted within a prospective, multicenter cohort of breast cancer patients and survivors (Utrecht cohort for Multiple BREast cancer intervention studies and Long-term evaLuAtion). Shortly after the implementation of COVID-19 measures, an extra survey was sent to 1595 participants, including the validated European Organization for Research and Treatment of Cancer (EORTC) core (C30) and breast cancer-specific (BR23) Quality of Life Questionnaire (EORTC QLQ-C30/BR23) and Hospital Anxiety and Depression Scale (HADS) questionnaire. Patient-reported outcomes (PROs) were compared with the most recent PROs collected within UMBRELLA pre-COVID-19. The impact of COVID-19 on PROs was assessed using mixed model analysis, adjusting for potential confounders. RESULTS: 1051 patients and survivors (65.9%) completed the survey; 31.1% (n = 327) reported a higher threshold to contact their general practitioner amid the COVID-19 pandemic. A statistically significant deterioration in emotional functioning was observed (mean = 82.6 [SD = 18.7] to 77.9 [SD = 17.3]; P < .001), and 505 (48.0%, 95% confidence interval [CI] = 45.0% to 51.1%) patients and survivors reported moderate to severe loneliness. Small improvements were observed in quality of life and physical, social, and role functioning. In the subgroup of 51 patients under active treatment, social functioning strongly deteriorated (77.3 [95% CI = 69.4 to 85.2] to 61.3 [95% CI = 52.6 to 70.1]; P = .002). CONCLUSION: During the COVID-19 pandemic, breast cancer patients and survivors were less likely to contact physicians and experienced a deterioration in their emotional functioning. Patients undergoing active treatment reported a substantial drop in social functioning. One in 2 reported loneliness that was moderate or severe. Online interventions supporting mental health and social interaction are needed during times of social distancing and lockdowns.

Effects of a time out consultation with the general practitioner on cancer treatment decision-making: a randomised controlled trial: Time out with the general practitioner and cancer treatment decision.

OBJECTIVE: Improving shared decision-making (SDM) enables more tailored cancer treatment decisions. We evaluated a Time Out consultation (TOC) with the general practitioner (GP), between cancer diagnosis and treatment decision, which aims at supporting SDM and improving continuity of primary care. This study aims to evaluate the effects of a TOC on perceived SDM, information provision and self-efficacy. METHODS: This randomised controlled trial included newly diagnosed patients with curable cancer (breast, lung, colorectal, gynaecologic and melanoma) from four Dutch hospitals. Primary outcome is perceived SDM and secondary outcomes are information provision and self-efficacy. RESULTS: One hundred fifty-four patients (control n = 77, intervention n = 77) - female: 75%, mean age: 61 (SD ± 11.9). In the intervention group, 80.5% (n = 62) had a TOC, of which 82.3% (n = 51) took place after treatment decision. Perceived SDM was lower in the intervention group (-8.9 [95% CI: 0.6-17.1]). Among those with a TOC before treatment decision (n = 11), perceived SDM was comparable to the control group (66.5 ± 27.2 vs. 67.9 ± 26.1). CONCLUSION: Even though patients are motivated to have a TOC, implementing a TOC between diagnosis and treatment decision is challenging. Effects of a timely TOC could not be established. Non-timely TOC decreased perceived SDM. Planning of the TOC should be optimised, and future research should establish if adequately timed TOC results in improved SDM in cancer patients.

Impact of modern-day axillary treatment on patient reported arm morbidity and physical functioning in breast cancer patients.

PURPOSE: To reduce arm morbidity, routine axillary lymph node dissection (ALND) is often omitted or replaced by axillary radiotherapy (AxRT) in patients with limited nodal involvement. We evaluated patient-reported arm morbidity and physical functioning in breast cancer patients undergoing modern-day axillary treatment. METHODS: All patients within the UMBRELLA cohort undergoing local radiotherapy with sentinel lymph node biopsy (SLNB), ALND and/or AxRT were selected. Patient-reported arm morbidity and physical functioning were assessed with EORTC QLQ C30/BR23 questionnaires up to eighteen months after initiation of radiotherapy. Patient-reported outcomes were compared between patients with SLNB only, ALND only, AxRT (level I-II), AxRT (level I-IV) or AxRT plus ALND by means of mixed model analysis. RESULTS: In total, 949 patients were identified; 641 (68%) SLNB only, 57 (6%) ALND only, 94 (10%) AxRT level I-II, 72 (8%) AxRT level I-IV and 85 (9%) ALND + AxRT. SLNB only resulted in the least arm morbidity scores. ALND + AxRT resulted in most arm morbidity, with clinically relevant differences at 18 months. AxRT (level I-II or level I-IV) resulted in significantly less arm symptoms in the first 3 months compared to ALND. Arm symptom scores between those receiving AxRT on levels I-II and I-IV were similar. CONCLUSION: Of all axillary management strategies, ALND plus AxRT is associated with worst patient-reported outcomes. AxRT resulted in less arm morbidity compared to ALND. Selective radiotherapy treatment of the axilla, i.e. radiotherapy of levels I-II only instead of levels I-IV, did not lead to clinically relevant reduced arm morbidity.

Cyclic and non-cyclic breast-pain: A systematic review on pain reduction, side effects, and quality of life for various treatments.

CYCLIC AND NON-CYCLIC BREAST-PAIN: A systematic review on pain reduction, side effects, and quality of life for various treatments. BACKGROUND: No clear systematic-review on all the various treatment regimen for (Non-) cyclical-breast-pain currently exists. OBJECTIVES: The aim of this study was to assess the various forms of therapy for treatment of breast-pain and the evidence for their effectiveness. SEARCH STRATEGY: Search-terms included 'mastalgia' and 'therapy' or 'hormones' or 'nsaid' or 'psychotherapy' or 'analgesia' or 'surgery', and synonyms. SELECTION CRITERIA: The review was conducted according to the Preferred Reporting Items for Systematic-reviews and Meta-Analysis guidelines. RCT's and pro-/retrospective studies reporting on treatment of breast-pain were considered eligible. Minimal follow-up and sample-size criteria were 6 months and 10 patients respectively. DATA COLLECTION AND ANALYSIS: Data was extracted using standardized tables and encompassed number of subjects, type of breast-pain and treatment, efficacy of treatment and clinical complications/side-effects. No pooling of data could be achieved due to heterogeneity amongst studies. MAIN RESULTS: Twenty-three studies were included, that reported on 2100 patients in total. Topical-Diclofenac was found to reduce pain by 58.7 and 63.3 on a Visual-Analogue-Scale (VAS) in cyclical and non-cyclical-breast-pain respectively. Persistent cyclical-breast-pain can be treated with short courses (2-6 months) of either Bromocryptine (VAS↓=25.4) or Danazol (VAS↓=33.6) as long as benefits outweigh the side-effects. Last-resort options for unresponsive and severe debilitating breast-pain include surgery in the form of bilateral mastectomy with reconstruction. CONCLUSIONS: Pain reduction in patients with breast-pain can be achieved with analgesics, hormonal-regimen and possibly surgery as a last resort. Additional studies are needed with well-described patient-characteristics, robust study set-up, and longer follow-up times.

Impact of the transition from screen-film to digital screening mammography on interval cancer characteristics and treatment - a population based study from the Netherlands.

INTRODUCTION: In most breast screening programmes screen-film mammography (SFM) has been replaced by full-field digital mammography (FFDM). We compared interval cancer characteristics at SFM and FFDM screening mammography. PATIENTS AND METHODS: We included all 297 screen-detected and 104 interval cancers in 60,770 SFM examinations and 427 screen-detected and 124 interval cancers in 63,182 FFDM examinations, in women screened in the period 2008-2010. Breast imaging reports, biopsy results and surgical reports of all cancers were collected. Two radiologists reviewed prior and diagnostic mammograms of all interval cancers. They determined breast density, described mammographic abnormalities and classified interval cancers as missed, showing a minimal sign abnormality or true negative. RESULTS: The referral rate and cancer detection at SFM were 1.5% and 4.9‰ respectively, compared to 3.0% (p<0.001) and 6.6‰ (p<0.001) at FFDM. Screening sensitivity was 74.1% at SFM (297/401, 95% confidence interval (CI)=69.8-78.4%) and 77.5% at FFDM (427/551, 95% CI=74.0-81.0%). Significantly more interval cancers were true negative at prior FFDM than at prior SFM screening mammography (65.3% (81/124) versus 47.1% (49/104), p=0.02). For interval cancers following SFM or FFDM screening mammography, no significant differences were observed in breast density or mammographic abnormalities at the prior screen, tumour size, lymph node status, receptor status, Nottingham tumour grade or surgical treatment (mastectomy versus breast conserving therapy). CONCLUSION: FFDM resulted in a significantly higher cancer detection rate, but sensitivity was similar for SFM and FFDM. Interval cancers are more likely to be true negative at prior FFDM than at prior SFM screening mammography, whereas their tumour characteristics and type of surgical treatment are comparable.

A simple risk score to predict the presence of non-sentinel lymph node metastases in breast cancer patients with a positive sentinel node.

BACKGROUND: Historically, completion axillary lymph node dissection (cALND) is recommended in sentinel lymph node (SLN)-positive patients. However, the high rate of negative non-sentinel nodes (NSNs) in cALND and the reported low axillary recurrence rates have led to a more conservative approach. A risk score was developed to identify a patient's individual risk for NSN metastases. METHODS: Data of 182 SLN-positive patients who underwent cALND were used for risk score development. The risk score, consisting of pathological tumor size (≤ 20/>20 mm), lymphovascular invasion (no/yes), extracapsular extension (no/yes), size of metastases (≤ 2/>2 mm), and number of positive SLNs (1/>1), was subsequently validated on an external population (n = 180). RESULTS: The area under the receiver operating characteristic curve was 0.78 (95 % CI 0.71-0.85) in the original population and 0.78 (95 % CI 0.70-0.85) in the validation population. Based on the predicted risk for positive NSNs, three groups were defined: low risk (≤ 20 %), intermediate risk (21-50 %), and high risk (>50 %). In total, 88 patients met the Z0011 inclusion criteria and none of them had a high predicted risk. Of the 199 non-Z0011 patients, 67 (33.7 %) had low risk, 96 (48.2 %) had intermediate risk, and 36 (18.1 %) had high risk. CONCLUSION: A simple risk score, integrating just five clinicopathological variables, was developed that may assist in individual decision making regarding ALND in SLN-positive patients outside of the Z0011 trial.

SUBMIT: Systemic therapy with or without up front surgery of the primary tumor in breast cancer patients with distant metastases at initial presentation.

BACKGROUND: Five percent of all patients with breast cancer have distant metastatic disease at initial presentation. Because metastatic breast cancer is considered to be an incurable disease, it is generally treated with a palliative intent. Recent non-randomized studies have demonstrated that (complete) resection of the primary tumor is associated with a significant improvement of the survival of patients with primary metastatic breast cancer. However, other studies have suggested that the claimed survival benefit by surgery may be caused by selection bias. Therefore, a randomized controlled trial will be performed to assess whether breast surgery in patients with primary distant metastatic breast cancer will improve the prognosis. DESIGN: Randomization will take place after the diagnosis of primary distant metastatic breast cancer. Patients will either be randomized to up front surgery of the breast tumor followed by systemic therapy or to systemic therapy, followed by delayed local treatment of the breast tumor if clinically indicated.Patients with primary distant metastatic breast cancer, with no prior treatment of the breast cancer, who are 18 years or older and fit enough to undergo surgery and systemic therapy are eligible. Important exclusion criteria are: prior invasive breast cancer, surgical treatment or radiotherapy of this breast tumor before randomization, irresectable T4 tumor and synchronous bilateral breast cancer. The primary endpoint is 2-year survival. Quality of life and local tumor control are among the secondary endpoints.Based on the results of prior research it was calculated that 258 patients are needed in each treatment arm, assuming a power of 80%. Total accrual time is expected to take 60 months. An interim analysis will be performed to assess any clinically significant safety concerns and to determine whether there is evidence that up front surgery is clinically or statistically inferior to systemic therapy with respect to the primary endpoint. DISCUSSION: The SUBMIT study is a randomized controlled trial that will provide evidence on whether or not surgery of the primary tumor in breast cancer patients with metastatic disease at initial presentation results in an improved survival. TRIAL REGISTRATION: NCT01392586.

Combined anxiety and depressive symptoms before diagnosis of breast cancer.

PURPOSE: To determine the relationship between pre-diagnosis state anxiety, depressive symptoms, and combined state anxiety and depressive symptoms (CADS) with quality of life (QOL), fatigue, state anxiety and depressive symptoms one and two years after surgery in women with breast cancer. METHODS: Women with breast problems referred to a Dutch outpatient clinic were recruited for the study. Participants (N=428) completed a set of questionnaires before diagnosis (Time0) and the women with breast cancer subsequently received questionnaires at 12 (Time1) and 24 months (Time2) after surgical treatment. The questionnaire set consisted of questionnaires on demographics, state anxiety, depressive symptoms, fatigue, QOL, neuroticism, and trait anxiety. Chi-square tests, independent samples T-tests, and multivariate linear regression analyses were used to do the analyses. RESULTS: Before their diagnosis of breast cancer, 111 women (28%) had CADS. Of the CADS-group, a higher percentage had elevated levels of anxiety, depressive symptoms, and CADS at all follow-up moments than of the non-CADS-group. CADS-score at before diagnosis and neuroticism were the most important predictors of outcome measures at Time1 and Time2. CONCLUSIONS: More than one in four women, who later received the diagnosis breast cancer, had elevated levels of both state anxiety and depressive symptoms (CADS) just before diagnosis. This factor was also a major predictor of QOL, state anxiety, depressive symptoms, and fatigue 12 and 24 months after surgery. This implies that women with a higher score on both state anxiety and depressive symptoms should be identified as soon as possible in the process of diagnosis and treatment of breast cancer using validated questionnaires or screening instruments. Only by identifying this group of patients, tailored psychological care can be accomplished.

Anxiety after an abnormal screening mammogram is a serious problem.

PURPOSE: The aim of this study was to analyze the possible negative psychological consequences of a false positive screening mammogram (FPSM). We compared anxiety evoked by first (FSM) versus repeat screening mammogram (RSM). Questionnaires were completed prior to the diagnosis and during follow up. RESULTS: No differences in anxiety, depressive symptoms, and Quality of Life (QoL) were found between FSM (N = 186) or RSM (N = 296) groups. All women experienced high anxiety before diagnosis was known. High trait anxiety was predictive for more anxiety, depressive symptoms, and lower QoL. Women with low score on trait anxiety were more momentary anxious in FSM group compared with RSM group (p = 0.048). CONCLUSION: Negative psychological consequences after an FPSM are seen in all women. These effects are strengthened by personality and timing of the screening mammogram. All women should receive correct information concerning the negative psychological effects and should be offered psychosocial support if needed.

The role of surgery in metastatic breast cancer.

Some of the patients who present with breast cancer already have distant metastatic disease. According to recent literature, these patients may benefit from resection of the breast tumour. One explanation for the effect of this resection is that reducing the tumour load influences metastatic growth. Results of future randomised controlled trials should indicate whether surgery of the breast tumour truly improves survival. Selected patients could even benefit from metastasectomy of liver and lung metastases; survival seems to improve and these procedures seldom lead to major complications. When metastasectomy is not possible, minimally invasive techniques can be used in selected patients for the treatment of breast cancer liver metastases, radiofrequency ablation (RFA) being discussed most in the literature. Patients with locally advanced breast cancer are treated multidisciplinarily and with curative intent. Part of the treatment is surgery to reduce tumour load. Regarding treatment of the axilla, in a clinically negative axilla sentinel node biopsy is advised before neoadjuvant treatment; an axillary lymph node dissection is not warranted. In local recurrence, surgery is the primary treatment. Axillary staging can be done in patients with a previous negative sentinel node biopsy. Regional recurrence after breast-conserving surgery or mastectomy is treated with surgery followed by radiotherapy.

A brachialis muscle rupture diagnosed by ultrasound; case report.

Trauma to the elbow caused by lifting heavy objects frequently involves rupture of the tendon of the biceps brachii muscle. Less frequently a rupture of the brachialis muscle occurs. To our knowledge, only five cases involving traumatic rupture of the brachialis muscle were described in the past 20 years. We will briefly report these cases.To demonstrate and evaluate muscle injuries, magnetic resonance imaging (MRI) is considered the most sensitive and specific method of choice. We report an isolated brachialis muscle rupture caused by resisted flexion and pronation of the lower arm. Physical examination combined with ultrasound evaluation confirmed the diagnosis of ruptured brachialis muscle. Treatment was non-operative with full restoration of function.

Are breast conservation and mastectomy equally effective in the treatment of young women with early breast cancer? Long-term results of a population-based cohort of 1,451 patients aged ≤ 40 years.

To compare the effectiveness of breast-conserving therapy (BCT) and mastectomy, all women aged ≤ 40 years, treated for early-stage breast cancer in the southern part of the Netherlands between 1988 and 2005, were identified. A total of 562 patients underwent mastectomy and 889 patients received BCT. During follow-up, 23 patients treated with mastectomy and 135 patients treated with BCT developed a local relapse without previous or simultaneous evidence of distant disease. The local relapse risk for patients treated with mastectomy was 4.4% (95% confidence interval (CI) 2.4-6.4) at 5 years and reached a plateau after 6 years at 6.0% (95% CI 3.5-8.5). After BCT, the 5-, 10- and 15-year risks were 8.3% (95% CI 6.3-10.5), 18.4% (95% CI 15.0-21.8) and 28.2% (95% CI 23.0-33.4), respectively (P < 0.0001). Adjuvant systemic therapy following BCT reduced the 15-year local relapse risk from 32.9% (95% CI 26.7-39.1) to 16.1% (95% CI 9.1-23.1), (P = 0.0007). In conclusion, local tumor control in young patients with early-stage breast cancer is worse after BCT than after mastectomy. Adjuvant systemic therapy significantly improves local control following BCT and also for that reason it should be considered for most patients ≤ 40 years. Long-term follow-up is highly recommended for young patients after BCT, because even with systemic treatment an annual risk of local relapse of 1% remains up to 15 years after treatment.

Prognostic value of lymph node micrometastases in breast cancer: a multicenter cohort study.

BACKGROUND: To evaluate the prognostic meaning of lymph node micrometastases in breast cancer patients. METHODS: Between January 2000 and January 2003, 1411 patients with a cT(1-2)N(0) invasive breast carcinoma underwent surgery in 7 hospitals in the Netherlands. Sentinel lymph node biopsy was done in all patients. Based on lymph node status, patients were divided into 4 groups: (p)N(0) (n = 922), (p)N(1micro) (n = 103), (p)N(1a) (n = 285), and (p)N(≥1b) (n = 101). Median follow-up was 6.4 years. RESULTS: At the end of follow-up, 1121 women were still alive (79.4%), 184 had died (13.0%), and 106 were lost to follow-up (7.5%). Breast cancer recurred in 244 patients: distant metastasis (n = 165), locoregional relapse (n = 83), and contralateral breast cancer (n = 44). Following adjustment for possible confounding characteristics and for adjuvant systemic treatment, overall survival (OS) remained comparable for (p)N(0) and (p)N(1micro) and was significantly worse for (p)N(1a) and (p)N(≥1b) (hazard ratio [HR] 1.18; 95% confidence interval [95% CI] 0.58-2.39, HR 2.47; 95% CI 1.69-3.63, HR 4.36; 95% CI 2.70-7.04, respectively). Disease-free survival (DFS) was similar too in the (p)N(0) and (p)N(1micro) group, and worse for (p)N(1a) and (p)N(≥1b) (HR 0.96; 95% CI 0.56-1.67 vs HR 1.64; 95% CI 1.19-2.27, HR 2.95; CI 1.98-4.42). The distant metastases rate also did not differ significantly between the (p)N(0) and (p)N(1micro) group and was worse for (p)N(1a) and (p)N(≥1b) (HR 1.22; 95% CI 0.60-2.49, HR 2.26; 95% CI 1.49-3.40, HR 3.49; CI 2.12-5.77). CONCLUSIONS: In breast cancer patients survival is not affected by the presence of micrometastatic lymph node involvement.

Factors contributing to improved local control after mastectomy in patients with breast cancer aged 40 years or younger.

Long-term local control rates were studied in a series of 659 patients with invasive breast cancer aged 40 years or younger, who underwent mastectomy in general hospitals in the southern part of the Netherlands between 1988 and 2005. During a median follow-up time of 6.0 years, 34 patients developed a local recurrence in the chest wall without previous or simultaneous evidence of distant disease. The 5- and 10-year actuarial local recurrence rates for the total group were 5.6% (95% confidence interval [95% CI], 3.5-7.7%) and 7.3% (95% CI, 4.7-9.9%), respectively. A multivariate analysis showed that patients receiving radiotherapy (hazards ratio [HR], 0.29; 95% CI, 0.10-0.96) or adjuvant systemic treatment (HR 0.23; 95% CI, 0.08-0.65) had a significantly lower risk of local recurrence. It is concluded that excellent local control rates can be obtained with mastectomy in young women with breast cancer, especially in those who receive adjuvant systemic treatment and/or radiotherapy.

Impact of breast surgery on survival in patients with distant metastases at initial presentation: a systematic review of the literature.

According to current treatment standards, patients with metastatic breast cancer at diagnosis receive palliative therapy. Local treatment of the breast is only recommended if the primary tumor is symptomatic. Recent studies suggest that surgical removal of the primary tumor has a favorable impact on the prognosis of patients with primary metastatic breast cancer. We performed a systematic review of the literature to weigh the evidence for and against breast surgery in this patient group. Ten retrospective studies were found in which the use of breast surgery in primary metastatic breast cancer and its impact on survival was examined. The hazard ratios of the studies were pooled to provide an estimate of the overall effect of surgery, and the results and conclusions of the studies were analyzed. A crude analysis, without adjustment for potential confounders, showed that surgical removal of the breast lesion in stage-IV disease was associated with a significantly higher overall survival rate in seven of the ten studies, and a trend toward a better survival in the three remaining studies. Surgery of the primary tumor appeared to be an independent factor for an improved survival in the multivariate analyses from the individual studies, with hazard ratios ranging from 0.47 to 0.71. The pooled hazard ratio for overall mortality was 0.65 (95% CI 0.59-0.72) in favor of the patients undergoing surgery. This systematic review of the literature suggests that surgery of the primary breast tumor in patients with stage-IV disease at initial presentation does have a positive impact on survival. In order to provide a definite answer on whether local tumor control in patients with primary metastatic disease improves survival, a randomized controlled trial comparing systemic therapy with and without breast surgery is needed.

Transanal endoscopic microsurgery versus endoscopic mucosal resection for large rectal adenomas (TREND-study).

BACKGROUND: Recent non-randomized studies suggest that extended endoscopic mucosal resection (EMR) is equally effective in removing large rectal adenomas as transanal endoscopic microsurgery (TEM). If equally effective, EMR might be a more cost-effective approach as this strategy does not require expensive equipment, general anesthesia and hospital admission. Furthermore, EMR appears to be associated with fewer complications.The aim of this study is to compare the cost-effectiveness and cost-utility of TEM and EMR for the resection of large rectal adenomas. METHODS/DESIGN: Multicenter randomized trial among 15 hospitals in the Netherlands. Patients with a rectal adenoma > or = 3 cm, located between 1-15 cm ab ano, will be randomized to a TEM- or EMR-treatment strategy. For TEM, patients will be treated under general anesthesia, adenomas will be dissected en-bloc by a full-thickness excision, and patients will be admitted to the hospital. For EMR, no or conscious sedation is used, lesions will be resected through the submucosal plane in a piecemeal fashion, and patients will be discharged from the hospital. Residual adenoma that is visible during the first surveillance endoscopy at 3 months will be removed endoscopically in both treatment strategies and is considered as part of the primary treatment. Primary outcome measure is the proportion of patients with recurrence after 3 months. Secondary outcome measures are: 2) number of days not spent in hospital from initial treatment until 2 years afterwards; 3) major and minor morbidity; 4) disease specific and general quality of life; 5) anorectal function; 6) health care utilization and costs. A cost-effectiveness and cost-utility analysis of EMR against TEM for large rectal adenomas will be performed from a societal perspective with respectively the costs per recurrence free patient and the cost per quality adjusted life year as outcome measures. Based on comparable recurrence rates for TEM and EMR of 3.3% and considering an upper-limit of 10% for EMR to be non-inferior (beta-error 0.2 and one-sided alpha-error 0.05), 89 patients are needed per group. DISCUSSION: The TREND study is the first randomized trial evaluating whether TEM or EMR is more cost-effective for the treatment of large rectal adenomas. TRIAL REGISTRATION NUMBER: (trialregister.nl) NTR1422.

Laparoscopic fenestration of liver cysts in polycystic liver disease results in a median volume reduction of 12.5%.

INTRODUCTION: Patients with polycystic liver disease (PCLD) may develop symptoms due to increased liver volume. Laparoscopic fenestration is one of the options to reduce liver volume and to relieve symptoms. This study was performed to evaluate the safety and efficacy of laparoscopic liver cyst fenestration. PATIENTS AND METHODS: Twelve patients (all female, median age 45 years, range 35-58) with symptomatic PCLD were included between August 2005 and April 2007. Surgical data were recorded, liver volumes were measured on pre- and postoperative computed tomography (CT) scans, and patients completed a validated symptom-based questionnaire pre- and postoperatively. RESULTS: Median preoperative liver volume was 4,854 ml (range 1,606-8,201) and decreased to 4,153 ml postoperatively (range 1,556-8,232) resulting in median liver volume reduction of 12.5% (range +9.5 to -24.7%). Median procedural time was 123.5 min (range 50-318), and median hospitalization period was 3.5 days (range 1-8). Postoperative complications occurred in three patients including biliary leakage, obstruction of inferior vena cava and sepsis, all recovering with conservative management. Patients reported decreased symptoms of postprandial fullness and abdominal distension. CONCLUSION: Laparoscopic fenestration in PCLD patients results in volume reduction of 12.5% and decrease of symptoms.