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.
Female breast cancer patients carrying a BRCA1/2 mutation have an increased risk of second primary breast cancer. Rapid genetic counseling and testing (RGCT) before surgery may influence choice of ...primary surgical treatment. In this article, we report on the psychosocial impact of RGCT.
Newly diagnosed breast cancer patients at risk for carrying a BRCA1/2 mutation were randomized to an intervention group (offer of RGCT) or a usual care control group (ratio 2:1). Psychosocial impact and quality of life were assessed with the Impact of Events Scale, Hospital Anxiety and Depression Scale, Cancer Worry Scale, and the EORTC QLQ-C30 and QLQ-BR23. Assessments took place at study entry and at 6- and 12-month follow-up visits.
Between 2008 and 2010, 265 patients were recruited into the study. Completeness of follow-up data was more than 90%. Of the 178 women in the intervention group, 177 had genetic counseling, of whom 71 (40%) had rapid DNA testing and 59 (33%) received test results before surgery. Intention-to-treat and per-protocol analyses showed no statistically significant differences between groups over time in any of the psychosocial outcomes.
In this study, RGCT in newly diagnosed breast cancer patients did not have any measurable adverse psychosocial effects.
Background
Rapid genetic counseling and testing (RGCT) in newly diagnosed high‐risk breast cancer (BC) patients may influence surgical treatment decisions. To successfully integrate RGCT in practice, ...knowledge of professionals’, and patients’ attitudes toward RGCT is essential.
Methods
Between 2008 and 2010, we performed a randomized clinical trial evaluating the impact of RGCT. Attitudes toward and experience with RGCT were assessed in 265 patients (at diagnosis, 6‐ and 12‐month follow‐up) and 29 medical professionals (before and after the recruitment period).
Results
At 6‐month follow‐up, more patients who had been offered RGCT felt they had been actively involved in treatment decision‐making than patients who had been offered usual care (67% vs 48%, P = 0.06). Patients who received DNA‐test results before primary surgery reported more often that RGCT influenced treatment decisions than those who received results afterwards (P < 0.01). Eighty‐seven percent felt that genetic counseling and testing (GCT) should preferably take place between diagnosis and surgery. Most professionals (72%) agreed that RGCT should be routinely offered to eligible patients. Most patients (74%) and professionals (85%) considered surgeons the most appropriate source for referral.
Conclusions
RGCT is viewed as helpful for newly diagnosed high‐risk BC patients in choosing their primary surgery and should be offered routinely by surgeons.
OBJECTIVE:To describe the distribution of femoral neck shortening after internal fixation and to determine whether shortening is associated with inferior hip function at 24 months after a hip ...fracture in patients 50 years of age or older.
DESIGN:Retrospective cohort study.
SETTING:A secondary analysis of data from 81 clinical centers included in the Fixation using Alternative Implants for the Treatment of Hip Fractures (FAITH) trial.
PARTICIPANTS:Three hundred fifty patients, 50 years of age or older, who had an isolated femoral neck fracture and underwent timely operative fixation of the fracture.
INTERVENTION:Femoral neck shortening was measured as a categorical variable and classified into one of the following groups, as determined by the Central Adjudication Committeeno shortening, mild shortening (≤5 mm), moderate shortening (6–10 mm), or severe shortening (>10 mm).
MAIN OUTCOME MEASUREMENT:The primary outcome for the current analysis was hip function, as measured by the Western Ontario & McMaster Universities Osteoarthritis Index questionnaire, at 24 months after injury.
RESULTS:Two-thirds of patients had no or mild shortening (≤5 mm), whereas one-third of patients had moderate or severe shortening (>5 mm). After adjusting for surgical treatment, a greater amount of femoral neck shortening was found to be associated with poorer hip function (P < 0.01).
CONCLUSIONS:We found that increasing femoral neck shortening was associated with inferior hip function. Although internal fixation often results in successful union, patients who heal in a shortened position report poorer functional outcomes.
LEVEL OF EVIDENCE:Prognostic Level II. See Instructions for Authors for a complete description of levels of evidence.
OBJECTIVES:The FAITH trial evaluated effects of sliding hip screws versus cancellous screws in femoral neck fracture patients. Using FAITH trial data, we quantified changes in living status, use of ...aids, and investigated factors associated with living and walking independently 12 months after fracture.
METHODS:We conducted a descriptive analysis to quantify patientsʼ changes in living status, use of aids, and used multivariable Cox regression analyses to determine factors associated with living and walking independently after fracture.
RESULTS:Of patients who lived independently before hip fracture, 3.07% (50–80 years old) and 19.81% (>80 years old) were institutionalized 12 months after injury. Of patients who were walking independently before injury, 33.62% (50–80 years old) and 69.34% (>80 years old) required a walking aid 12 months after injury. Factors associated with higher chances of living independently included the followingbeing between 50 and 80 years, having a class I American Society of Anesthesiologists classification, not using a walking aid before fracture, being a nonsmoker or former smoker, and having an acceptable quality of implant placement. Factors associated with higher chances of walking without an aid included the followingbeing between 50 and 80 years, having a class I American Society of Anesthesiologists classification, living independently before fracture, being a nonsmoker or former smoker, having an undisplaced fracture, and not requiring revision surgery.
CONCLUSIONS:Femoral neck fracture patients suffer great losses of independence. Identifying factors associated with living and walking independently after hip fracture may help surgeons better identify which patients are at risk and optimize care of patients with this injury.
LEVEL OF EVIDENCE:Prognostic Level II. See Instructions for Authors for a complete description of levels of evidence.
Hip fractures are a common type of fragility fracture that afflict 293,000 Americans (over 5,000 per week) and 35,000 Canadians (over 670 per week) annually. Despite the large population impact the ...optimal fixation technique for low energy femoral neck fractures remains controversial. The primary objective of the FAITH study is to assess the impact of cancellous screw fixation versus sliding hip screws on rates of revision surgery at 24 months in individuals with femoral neck fractures. The secondary objective is to determine the impact on health-related quality of life, functional outcomes, health state utilities, fracture healing, mortality and fracture-related adverse events.
FAITH is a multi-centre, multi-national randomized controlled trial utilizing minimization to determine patient allocation. Surgeons in North America, Europe, Australia, and Asia will recruit a total of at least 1,000 patients with low-energy femoral neck fractures. Using central randomization, patients will be allocated to receive surgical treatment with cancellous screws or a sliding hip screw. Patient outcomes will be assessed at one week (baseline), 10 weeks, 6, 12, 18, and 24 months post initial fixation. We will independently adjudicate revision surgery and complications within 24 months of the initial fixation. Outcome analysis will be performed using a Cox proportional hazards model and likelihood ratio test.
This study represents major international efforts to definitively resolve the treatment of low-energy femoral neck fractures. This trial will not only change current Orthopaedic practice, but will also set a benchmark for the conduct of future Orthopaedic trials.
The FAITH trial is registered at ClinicalTrials.gov (Identifier NCT00761813).
Celotno besedilo
Dostopno za:
DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
Sixty-seven of 87 patients with soft tissue sarcoma underwent complete resection of the metastases in the lung. In this retrospective study, follow-up was for a median of 24 months. The 5-year ...overall, crude and disease-free survival was 38%, 45%, and 41%, respectively. Twenty-seven (40%) patients developed a recurrence in the lung. Of the six prognostic variables, the only factor significantly related to disease-free survival was grade. It is concluded that surgery for lung metastases of soft tissue sarcoma should be considered as standard therapy when preoperative evaluation predicts a complete resection. By adding chemotherapy to surgery, an improvement of prognosis probably can be achieved.
The predictive capability of time-lapse monitoring (TLM) selection algorithms is influenced by patient characteristics, type and quality of data included in the analysis and the used statistical ...methods. Previous studies excluded DET cycles of which only one embryo implanted, introducing bias into the data. Therefore, we wanted to develop a TLM prediction model that is able to predict pregnancy chances after both single- and double embryo transfer (SET and DET).
This is a retrospective study of couples (n = 1770) undergoing an in vitro fertilization cycle at the Erasmus MC, University Medical Centre Rotterdam (clinic A) or the Reinier de Graaf Hospital (clinic B). This resulted in 2058 transferred embryos with time-lapse and pregnancy outcome information. For each dataset a prediction model was established by using the Embryo-Uterus statistical model with the number of gestational sacs as the outcome variable. This process was followed by cross-validation.
Prediction model A (based on data of clinic A) included female age, t3-t2 and t5-t4, and model B (clinic B) included female age, t2, t3-t2 and t5-t4. Internal validation showed overfitting of model A (calibration slope 0.765 and area under the curve (AUC) 0.60), and minor overfitting of model B (slope 0.915 and AUC 0.65). External validation showed that model A was capable of predicting pregnancy in the dataset of clinic B with an AUC of 0.65 (95% CI: 0.61-0.69; slope 1.223, 95% CI: 0.903-1.561). Model B was less accurate in predicting pregnancy in the dataset of clinic A (AUC 0.60, 95% CI: 0.56-0.65; slope 0.671, 95% CI: 0.422-0.939).
Our study demonstrates a novel approach to the development of a TLM prediction model by applying the EU statistical model. With further development and validation in clinical practice, our prediction model approach can aid in embryo selection and decision making for SET or DET.
Celotno besedilo
Dostopno za:
DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
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