| 1. |
- de Boniface, J., et al.
(författare)
-
Omitting axillary dissection in breast cancer with sentinel-node metastases
- 2024
-
Ingår i: New England Journal of Medicine. - 0028-4793 .- 1533-4406. ; 390:13, s. 1163-1175
-
Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND Trials evaluating the omission of completion axillary-lymph-node dissection in patients with clinically node-negative breast cancer and sentinel-lymph-node metastases have been compromised by limited statistical power, uncertain nodal radiotherapy target volumes, and a scarcity of data on relevant clinical subgroups.METHODS We conducted a noninferiority trial in which patients with clinically node-negative primary T1 to T3 breast cancer (tumor size, T1, ≤20 mm; T2, 21 to 50 mm; and T3, >50 mm in the largest dimension) with one or two sentinel-node macrometastases (metastasis size, >2 mm in the largest dimension) were randomly assigned in a 1:1 ratio to completion axillary-lymph-node dissection or its omission (sentinel-node biopsy only). Adjuvant treatment and radiation therapy were used in accordance with national guidelines. The primary end point was overall survival. We report here the per-protocol and modified intention-to-treat analyses of the prespecified secondary end point of recurrence-free survival. To show noninferiority of sentinel-node biopsy only, the upper boundary of the confidence interval for the hazard ratio for recurrence or death had to be below 1.44.RESULTS Between January 2015 and December 2021, a total of 2766 patients were enrolled across five countries. The per-protocol population included 2540 patients, of whom 1335 were assigned to undergo sentinel-node biopsy only and 1205 to undergo completion axillary-lymph-node dissection (dissection group). Radiation therapy including nodal target volumes was administered to 1192 of 1326 patients (89.9%) in the sentinel-node biopsy–only group and to 1058 of 1197 (88.4%) in the dissection group. The median follow-up was 46.8 months (range, 1.5 to 94.5). Overall, 191 patients had recurrence or died. The estimated 5-year recurrence-free survival was 89.7% (95% confidence interval [CI], 87.5 to 91.9) in the sentinel-node biopsy–only group and 88.7% (95% CI, 86.3 to 91.1) in the dissection group, with a country-adjusted hazard ratio for recurrence or death of 0.89 (95% CI, 0.66 to 1.19), which was significantly (P<0.001) below the prespecified noninferiority margin.CONCLUSIONS The omission of completion axillary-lymph-node dissection was noninferior to the more extensive surgery in patients with clinically node-negative breast cancer who had sentinel-node macrometastases, most of whom received nodal radiation therapy. (Funded by the Swedish Research Council and others; SENOMAC ClinicalTrials.gov number, NCT02240472.).
|
|
| 2. |
- 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 Science and Business Media LLC. - 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
|
|
| 3. |
- Olsson, J., et al.
(författare)
-
Detection and quantification of ochratoxin A and deoxynivalenol in barley grains by GC-MS and electronic nose
- 2002
-
Ingår i: International Journal of Food Microbiology. - : Elsevier. - 0168-1605 .- 1879-3460. ; 72:3, s. 203-214
-
Tidskriftsartikel (refereegranskat)abstract
- Mycotoxin contamination of cereal grains can be detected and quantified using complex extraction procedures and analytical techniques. Normally, the grain odour, i.e. the presence of non-grain volatile metabolites, is used for quality classification of grain. We have investigated the possibility of using fungal volatile metabolites as indicators of mycotoxins in grain. Ten barley samples with normal odour, and 30 with some kind of off-odour were selected from Swedish granaries. The samples were evaluated with regard to moisture content, fungal contamination, ergosterol content, and levels of ochratoxin A (OA) and deoxynivalenol (DON). Volatile compounds were also analysed using both an electronic nose and gas chromatography combined with mass spectrometry (GC-MS). Samples with normal odour had no detectable ochratoxin A and average DON contents of 16 mug kg(-1) (range 0-80), while samples with off-odour had average OA contents of 76 mug kg(-1) (range 0-934) and DON contents of 69 mug kg(-1) (range 0-857). Data were evaluated by multivariate data analysis using projection methods such as principal component analysis (PCA) and partial least squares (PLS). The results show that it was possible to classify the OA level as below or above the maximum limit of 5 mug kg(-1) cereal grain established by the Swedish National Food Administration, and that the DON level could be estimated using PLS. Samples with OA levels below 5 mug kg(-1) had higher concentration of aldehydes (nonanal, 2-hexenal) and alcohols (1-penten-3-ol, 1-octanol). Samples with OA levels above 5 mug kg(-1) had higher concentrations of ketones (2-hexanone, 3-octanone). The GC-MS system predicted OA concentrations with a higher accuracy than the electronic nose, since the GC-MS misclassified only 3 of 37 samples and the electronic nose 7 of 37 samples. No correlation was found between odour and OA level, as samples with pronounced or strong off-odours had OA levels both below and above 5 mug kg(-1). We were able to predict DON levels in the naturally contaminated barley samples using the volatile compounds detected and quantified by either GC-MS or the electronic nose. Pentane, methylpyrazine, 3-pentanone, 3-octene-2-ol and isooctylacetate showed a positive correlation with DON, while ethylhexanol, pentadecane, toluene, 1-octanol, 1-nonanol, and 1-heptanol showed a negative correlation with DON. The root mean square error of estimation values for prediction of DON based on GC-MS and electronic nose data were 16 and 25 mug kg(-1) respectively.
|
|
| 4. |
- Olsson, J., et al.
(författare)
-
Volatiles for mycological quality grading of barley grains : determinations using gas chromatography-mass spectrometry and electronic nose
- 2000
-
Ingår i: International Journal of Food Microbiology. - : Elsevier. - 0168-1605 .- 1879-3460. ; 59:3, s. 167-178
-
Tidskriftsartikel (refereegranskat)abstract
- The possibility of using an electronic nose or gas chromatography combined with mass spectrometry (GC-MS) to quantify ergosterol and colony forming units (CFU) of naturally contaminated barley samples was investigated. Each sample was split into three parts for (i) ergosterol and CFU analysis, (ii) measurements with the electronic nose and (iii) identification of volatiles collected on an adsorbent with a GC-MS system. Forty samples were selected after sensory analysis to obtain 10 samples with normal odour and 30 with some degree of off-odour. The data set of volatile compounds and the data collected from the electronic nose were evaluated by multivariate analyse techniques. SIMCA classification (soft independent modelling of class analogy) was used for objective evaluation of the usefulness of the data from the GC-MS or electronic nose measurements for classification of grain samples as normal or with off-odour. The main volatile compounds of grain with normal odour were 2-hexenal, benzaldehyde and nonanal, while 3-octanone, methylheptanone and trimethylbenzene were the main volatile compounds of grain with off-odours. Using data from the electronic nose three samples of 40 were misclassified, while data analysis of the volatile compounds detected with the GC-MS, led to six misclassified samples. Regression models (partial least-squares, PLS) were built to predict ergosterol- and CFU-levels with data from the GC-MS or electronic nose measurements. PLS models based on both GC-MS and electronic nose data could be used to predict the ergosterol levels with high accuracy and with low root mean square error of prediction (RMSEP). CFU values from naturally infected grain could not be predicted with the same degree of confidence.
|
|
| 5. |
|
|
| 6. |
|
|
| 7. |
|
|
| 8. |
- Appelgren, M., et al.
(författare)
-
Patient-reported outcomes one year after positive sentinel lymph node biopsy with or without axillary lymph node dissection in the randomized SENOMAC trial
- 2022
-
Ingår i: Breast. - : Elsevier BV. - 0960-9776 .- 1532-3080. ; 63, s. 16-23
-
Tidskriftsartikel (refereegranskat)abstract
- Introduction: This report evaluates whether health related quality of life (HRQoL) and patient-reported arm morbidity one year after axillary surgery are affected by the omission of axillary lymph node dissection (ALND). Methods: The ongoing international non-inferiority SENOMAC trial randomizes clinically node-negative breast cancer patients (T1-T3) with 1-2 sentinel lymph node (SLN) macrometastases to completion ALND or no further axillary surgery. For this analysis, the first 1181 patients enrolled in Sweden and Denmark between March 2015, and June 2019, were eligible. Data extraction from the trial database was on November 2020. This report covers the secondary outcomes of the SENOMAC trial: HRQoL and patient-reported arm morbidity. The EORTC QLQC30, EORTC QLQ-BR23 and Lymph-ICF questionnaires were completed in the early postoperative phase and at one-year follow-up. Adjusted one-year mean scores and mean differences between the groups are presented corrected for multiple testing.
|
|
| 9. |
- Boberg, Fredrik, et al.
(författare)
-
Solar mean magnetic field variability: A wavelet approach to Wilcox Solar Observatory and SOHO/Michelson Doppler Imager observations
- 2002
-
Ingår i: Journal of Geophysical Research. - 2156-2202. ; 107:A10: 1318
-
Tidskriftsartikel (övrigt vetenskapligt/konstnärligt)abstract
- Solar mean magnetic field (SMMF) measurements from the Wilcox Solar Observatory and with the SOHO/MDI instrument are described and analyzed. Even though two completely different methods of observation are used, the two data sets obtained show a strong similarity. Using continuous wavelet transforms, SMMF variability is found at a number of temporal scales. Detected SMMF signals with a 1–2 year period are considered to be linked to variations in the internal rotation of the Sun. Intermediate SMMF oscillations with a period of 80–200 days are probably connected to the evolution of large active regions. We also find evidence for 90 min variations with coronal mass ejections as a suggested origin.
|
|
| 10. |
|
|
