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1.
  • Andersson, Y., et al. (författare)
  • Axillary recurrence rate 5 years after negative sentinel node biopsy for breast cancer
  • 2012
  • Ingår i: British Journal of Surgery. - : Oxford University Press. - 1365-2168 .- 0007-1323. ; 99:2, s. 226-231
  • Tidskriftsartikel (refereegranskat)abstract
    • Background: Sentinel lymph node (SLN) biopsy has replaced axillary lymph node dissection (ALND) as the standard axillary staging procedure in breast cancer. Follow-up studies in SLN-negative women treated without ALND report low rates of axillary recurrence, but most studies have short follow-up, and few are multicentre studies. Methods: Between September 2000 and January 2004, patients who were SLN-negative and did not have ALND were included in a prospective cohort. Kaplan-Meier estimates were used to analyse the rates of axillary recurrence and survival. The risk of axillary recurrence was also compared in centres with high and low experience with the SLN biopsy (SLNB) technique. Results: A total of 2195 patients with 2216 breast tumours were followed for a median of 65 months. Isolated axillary recurrence was diagnosed in 1.0 per cent of patients. The event-free 5-year survival rate was 88.8 per cent and the overall 5-year survival rate 93.1 per cent. There was no difference in recurrence rates between centres contributing fewer than 150 SLNB procedures to the cohort and centres contributing 150 or more procedures. Conclusion: This study confirmed the low risk of axillary recurrence 5 years after SLNB for breast cancer without ALND.
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2.
  • de Boniface, J., et al. (författare)
  • Survival and axillary recurrence following sentinel node-positive breast cancer without completion axillary lymph node dissection: the randomized controlled SENOMAC trial
  • 2017
  • Ingår i: BMC Cancer. - : BIOMED CENTRAL LTD. - 1471-2407. ; 17
  • Tidskriftsartikel (refereegranskat)abstract
    • Background: The role of axillary lymph node dissection (ALND) has increasingly been called into question among patients with positive sentinel lymph nodes. Two recent trials have failed to show a survival difference in sentinel node-positive breast cancer patients who were randomized either to undergo completion ALND or not. Neither of the trials, however, included breast cancer patients undergoing mastectomy or those with tumors larger than 5 cm, and power was debatable to show a small survival difference. Methods: The prospective randomized SENOMAC trial includes clinically node-negative breast cancer patients with up to two macrometastases in their sentinel lymph node biopsy. Patients with T1-T3 tumors are eligible as well as patients prior to systemic neoadjuvant therapy. Both breast-conserving surgery and mastectomy, with or without breast reconstruction, are eligible interventions. Patients are randomized 1: 1 to either undergo completion ALND or not by a web-based randomization tool. This trial is designed as a non-inferiority study with breast cancer-specific survival at 5 years as the primary endpoint. Target accrual is 3500 patients to achieve 80% power in being able to detect a potential 2.5% deterioration of the breast cancer-specific 5-year survival rate. Follow-up is by annual clinical examination and mammography during 5 years, and additional controls after 10 and 15 years. Secondary endpoints such as arm morbidity and health-related quality of life are measured by questionnaires at 1, 3 and 5 years. Discussion: Several large subgroups of breast cancer patients, such as patients undergoing mastectomy or those with larger tumors, have not been included in key trials; however, the use of ALND is being questioned even in these groups without the support of high-quality evidence. Therefore, the SENOMAC Trial will investigate the need of completion ALND in case of limited spread to the sentinel lymph nodes not only in patients undergoing any breast surgery, but also in neoadjuvantly treated patients and patients with larger tumors.
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3.
  • de Boniface, J., et al. (författare)
  • The generalisability of randomised clinical trials: an interim external validity analysis of the ongoing SENOMAC trial in sentinel lymph node-positive breast cancer
  • 2020
  • Ingår i: Breast Cancer Research and Treatment. - : Springer. - 0167-6806 .- 1573-7217. ; 180:1, s. 167-176
  • Tidskriftsartikel (refereegranskat)abstract
    • Purpose None of the key randomised trials on the omission of axillary lymph node dissection (ALND) in sentinel lymph-positive breast cancer have reported external validity, even though results indicate selection bias. Our aim was to assess the external validity of the ongoing randomised SENOMAC trial by comparing characteristics of Swedish SENOMAC trial participants with non-included eligible patients registered in the Swedish National Breast Cancer Register (NKBC). Methods In the ongoing non-inferiority European SENOMAC trial, clinically node-negative cT1-T3 breast cancer patients with up to two sentinel lymph node macrometastases are randomised to undergo completion ALND or not. Both breast-conserving surgery and mastectomy are eligible interventions. Data from NKBC were extracted for the years 2016 and 2017, and patient and tumour characteristics compared with Swedish trial participants from the same years. Results Overall, 306 NKBC cases from non-participating and 847 NKBC cases from participating sites (excluding SENOMAC participants) were compared with 463 SENOMAC trial participants. Patients belonging to the middle age groups (p = 0.015), with smaller tumours (p = 0.013) treated by breast-conserving therapy (50.3 versus 47.1 versus 65.2%, p < 0.001) and less nodal tumour burden (only 1 macrometastasis in 78.8 versus 79.9 versus 87.3%, p = 0.001) were over-represented in the trial population. Time trends indicated, however, that differences may be mitigated over time. Conclusions This interim external validity analysis specifically addresses selection mechanisms during an ongoing trial, potentially increasing generalisability by the time full accrual is reached. Similar validity checks should be an integral part of prospective clinical trials. Trial registration: NCT 02240472, retrospective registration date September 14, 2015 after trial initiation on January 31, 2015
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4.
  • Johansson, Ann-Christin, et al. (författare)
  • Psychosocial stress factors among patients with lumbar disc herniation, scheduled for disc surgery in comparison with patients scheduled for arthroscopic knee surgery
  • 2007
  • Ingår i: European spine journal. - 0940-6719 .- 1432-0932. ; 16:7, s. 961-970
  • Tidskriftsartikel (refereegranskat)abstract
    • Returning to work after disc surgery appears to be more heavily influenced by psychological aspects of work than by MR-identified morphological alterations. It is still not known whether psychosocial factors of importance for outcome after disc surgery are present preoperatively or develop in the postoperative phase. The aim of this study was to investigate the presence of work-related stress, life satisfaction and demanding life events, among patients undergoing first-time surgery for lumbar disc herniation in comparison with patients scheduled for arthroscopic knee surgery. Sixty-nine patients with disc herniation and 162 patients awaiting arthroscopy were included in the study, during the time period March 2003 to May 2005. Sixty-two percent of the disc patients had been on sick leave for an average of 7.8 months and 14 percent of the knee patients had been on sick leave for an average of 4.2 months. The psychosocial factors were investigated preoperatively using a questionnaire, which was a combination of the questionnaire of quality of work competence (QWC), life satisfaction (LiSat9) and life events as a modification of the social readjustment scale. There were no significant differences between the two groups in terms of work-related stress or the occurrence of demanding life events. The disc patients were significantly less satisfied with functions highly inter-related to pain and discomfort, such as present work situation, leisure-time, activities of daily living (ADL) function and sleep. Patients with disc herniation on sick leave were significantly less satisfied with their present work situation than knee patients on sick leave; this sub-group of patients with disc herniation also reported significantly higher expectations in relation to future job satisfaction than knee patients. The results indicate that psychosocial stress is not more pronounced preoperatively in this selected group of disc patients, without co-morbidity waiting for first-time disc surgery, than among knee patients awaiting arthroscopy. It was notable that the disc patients had high expectations in terms of improved job satisfaction after treatment by surgery.
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5.
  • Sackey, H., et al. (författare)
  • Arm lymphoedema after axillary surgery in women with invasive breast cancer
  • 2014
  • Ingår i: British Journal of Surgery. - : Wiley-Blackwell. - 0007-1323 .- 1365-2168. ; 101:4, s. 390-397
  • Tidskriftsartikel (refereegranskat)abstract
    • BackgroundThe primary aim was to compare arm lymphoedema after sentinel lymph node biopsy (SLNB) alone versus axillary lymph node dissection (ALND) in women with node-negative and node-positive breast cancer. The secondary aim was to examine the potential association between self-reported and objectively measured arm lymphoedema. MethodsWomen who had surgery during 1999-2004 for invasive breast cancer in four centres in Sweden were included. The study groups were defined by the axillary procedure performed and the presence of axillary metastases: SLNB alone, ALND without axillary metastases, and ALND with axillary metastases. Before surgery, and 1, 2 and 3years after operation, arm volume was measured and a questionnaire regarding symptoms of arm lymphoedema was completed. A mixed model was used to determine the adjusted mean difference in arm volume between the study groups, and generalized estimating equations were employed to determine differences in self-reported arm lymphoedema. ResultsOne hundred and forty women had SLNB alone, 125 had node-negative ALND and 155 node-positive ALND. Women who underwent SLNB had no increase in postoperative arm volume over time, whereas both ALND groups showed a significant increase. The risk of self-reported arm lymphoedema 1, 2 and 3years after surgery was significantly lower in the SLNB group compared with that in both ALND groups. Three years after surgery there was a significant association between increased arm volume and self-reported symptoms of arm lymphoedema. ConclusionSLNB is associated with a minimal risk of increased arm volume and few symptoms of arm lymphoedema, significantly less than after ALND, regardless of lymph node status. Minimal after sentinel node biopsy
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6.
  • Schüle, Jana, et al. (författare)
  • Sentinel node biopsy for breast cancer larger than 3 cm in diameter
  • 2007
  • Ingår i: British Journal of Surgery. - : Oxford University Press. - 0007-1323 .- 1365-2168. ; 94:8, s. 948-951
  • Tidskriftsartikel (refereegranskat)abstract
    • Background:Sentinel node biopsy (SNB) is a standard staging procedure in early breast cancer. Its suitability for larger tumours has been questioned. This study evaluated the reliability of SNB in women with invasive breast cancer larger than 3 cm in diameter who were clinically axillary node negative.Methods:Some 109 women with a tumour larger than 3 cm on pathological analysis were identified from the Swedish prospective SNB database. They were included if a completion axillary clearance was planned, regardless of SNB results.Results:The sentinel node detection rate was 103 (94·5 per cent) of 109. The overall false-negative rate was eight (13 per cent) of 64. Although a preoperative diagnosis of multifocal tumour was an exclusion criterion, 16 such cases were revealed on postoperative pathological examination. The false-negative rate in this subgroup was higher than that in women with a unifocal tumour (four (31 per cent) of 13 versus four (8 per cent) of 51; P = 0·012). No other significant predictors of a false-negative sentinel node biopsy were identified.Conclusion:SNB is feasible in patients with unifocal breast tumours larger than 3 cm. When large tumour size coincides with multifocality, however, the false-negative rate seems to be increased and a completion axillary clearance should be considered even if the SNB is negative.
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7.
  • Andersson, Yvette, et al. (författare)
  • Breast Cancer Survival in Relation to the Metastatic Tumor Burden in Axillary Lymph Nodes
  • 2010
  • Ingår i: Journal of Clinical Oncology. - 0732-183X .- 1527-7755. ; 28:17, s. 2868-2873
  • Tidskriftsartikel (refereegranskat)abstract
    • Purpose The aim of this study was to determine the prognostic significance of lymph node micrometastases in patients with breast cancer. Patients and Methods Between September 2000 and January 2004, 3,369 patients with breast cancer were included in a prospective cohort. According to their lymph node status, they were classified in the following four groups: 2,383 were node negative, 107 had isolated tumor cells, 123 had micrometastases, and 756 had macrometastases. Median follow-up time was 52 months. Kaplan-Meier estimates and the multivariate Cox proportional hazard regression model were used to analyze survival. Results Five-year cause-specific and event-free survival rates were lower for patients with micrometastases (pN1mi) than for node-negative (pN0) patients (94.1% v 96.9% and 79.6% v 87.1%, respectively; P = .020 and P = .032, respectively). There was no significant survival difference between node-negative patients and those with isolated tumor cells. The overall survival of pN1mi and pN0 patients did not differ. Conclusion This study demonstrates a worse prognosis for patients with micrometastases than for node-negative patients.
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8.
  • Andersson, Y., et al. (författare)
  • Causes of false-negative sentinel node biopsy in patients with breast cancer
  • 2013
  • Ingår i: British Journal of Surgery. - 0007-1323 .- 1365-2168. ; 100:6, s. 775-783
  • Tidskriftsartikel (refereegranskat)abstract
    • Background: Sentinel lymph node (SLN) biopsy has replaced axillary lymph node dissection as the routine staging procedure in clinically node-negative breast cancer. False-negative SLN biopsy results in misclassification and may cause undertreatment of the disease. The aim of this study was to investigate whether serial sectioning of SLNs reveals metastases more frequently in patients with false-negative SLNs than in patients with true-negative SLNs. Methods: This was a case-control study. Tissue blocks from patients with false-negative SLNs, defined as tumour-positive lymph nodes excised at completion axillary dissection or a subsequent axillary tumour recurrence, were reassessed by serial sectioning and immunohistochemical staining. For each false-negative node, two true-negative SLN biopsies were analysed. Tumour and node characteristics in patients with false-negative SLNs were compared with those in patients with a positive SLN by univariable and multivariable regression analysis. Results: Undiagnosed SLN metastases were discovered in nine (18 per cent) of 50 patients in the false-negative group and in 12 (11.2 per cent) of 107 patients in the true-negative group (P = 0.245). The metastases were represented by isolated tumour cells in 14 of these 21 patients. The risk of a false-negative SLN was higher in patients with hormone receptor-negative (odds ratio (OR) 2.50, 95 per cent confidence interval 1.17 to 5.33) or multifocal tumours (OR 3.39, 1.71 to 6.71), or if only one SLN was identified (OR 3.57, 1.98 to 6.45). Conclusion: SLN serial sectioning contributes to a higher rate of detection of SLN metastasis. The rate of upstaging of the tumour is similar in false-and true-negative groups of patients.
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9.
  • Andersson, Yvette, et al. (författare)
  • Long-term breast cancer survival in relation to the metastatic tumor burden in axillary lymph nodes
  • 2018
  • Ingår i: Breast Cancer Research and Treatment. - 0167-6806 .- 1573-7217. ; 171:2, s. 359-369
  • Tidskriftsartikel (refereegranskat)abstract
    • Purpose: The clinical significance of lymph node micrometastases and isolated tumor cells (ITCs) in breast cancer is still controversial. After a median follow-up of 52 months, a report from the Swedish Multicenter Cohort Study presented a worse cancer-specific and event-free survival for patients with micrometastases than node-negative individuals, but could not demonstrate a significant difference in overall survival (OS). Due to the tendency of breast cancer to relapse after more than 5-10 years, we now report the long-term survival of the cohort.Methods: Between September 2000 and January 2004, 3355 breast cancer patients were included in a prospective cohort. Sentinel lymph node biopsy was always performed. Patients were classified in four groups according to their overall nodal stage: node negative (N0, 2372), ITCs (113), micrometastases (123), and macrometastases (747). Kaplan-Meier survival estimates and Cox proportional hazard regression models were applied.Results: Median follow-up was 156 months. Ten-year cancer-specific survival and OS were significantly lower in case of micrometastases than in N0 (84.7 vs. 93.5%, p = 0.001, and 75.5 vs. 84.2%, p = 0.046, respectively). In case of macrometastases, corresponding survival rates were 82.8 and 74.3%. Only for those aged less than 50 years, cancer-specific survival and OS were significantly worse in case of ITCs than N0. Patients with micrometastases received less often chemotherapy than those with macrometastases (24.4 vs. 53.9%).Conclusions: Lymph node micrometastases in breast cancer have a prognostic significance. This study demonstrates a similar survival for patients with micrometastases and those with macrometastases, possibly due to systemic undertreatment.
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10.
  • Andersson, Yvette, et al. (författare)
  • Prediction of non-sentinel lymph node status in breast cancer patients with sentinel lymph node metastases : evaluation of the tenon score
  • 2012
  • Ingår i: Breast Cancer. - 1178-2234 .- 1178-2234. ; 6, s. 31-38
  • Tidskriftsartikel (refereegranskat)abstract
    • INTRODUCTION:Current guidelines recommend completion axillary lymph node dissection (cALND) in case of a sentinel lymph node (SLN) metastasis larger than 0.2 mm. However, in 50%-65% of these patients, the non-SLNs contain no further metastases and cALND provides no benefit. Several nomograms and scoring systems have been suggested to predict the risk of metastases in non-SLNs. We have evaluated the Tenon score.PATIENTS AND METHODS:In a retrospective review of the Swedish Sentinel Node Multicentre Cohort Study, risk factors for additional metastases were analysed in 869 SLN-positive patients who underwent cALND, using uni- and multivariate logistic regression models. A receiver operating characteristic (ROC) curve was drawn on the basis of the sensitivity and specificity of the Tenon score, and the area under the curve (AUC) was calculated.RESULTS:Non-SLN metastases were identified in 270/869 (31.1%) patients. Tumour size and grade, SLN status and ratio between number of positive SLNs and total number of SLNs were significantly associated with non-SLN status in multivariate analyses. The area under the curve for the Tenon score was 0.65 (95% CI 0.61-0.69). In 102 patients with a primary tumour <2 cm, Elston grade 1-2 and SLN metastases ≤2 mm, the risk of non SLN metastasis was less than 10%.CONCLUSION:The Tenon score performed inadequately in our material and we could, based on tumour and SLN characteristics, only define a very small group of patients in which negative non-sentinel nodes could be predicted.
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