| 1. |
- Appelgren, M., et al.
(författare)
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Patient-reported outcomes one year after positive sentinel lymph node biopsy with or without axillary lymph node dissection in the randomized SENOMAC trial
- 2022
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Ingår i: Breast. - : Elsevier BV. - 0960-9776 .- 1532-3080. ; 63, s. 16-23
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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.
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| 2. |
- Bergkvist, Charlotte, et al.
(författare)
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Exposure to dioxin-like pollutants via different food commodities in Swedish children and young adults.
- 2008
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Ingår i: Food and Chemical Toxicology. - : Elsevier BV. - 0278-6915 .- 1873-6351. ; 46:11, s. 3360-3367
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Tidskriftsartikel (refereegranskat)abstract
- The dietary intake of polychlorinated dibenzo-p-dioxins (PCDDs), dibenzofurans (PCDFs) and biphenyls (PCBs) in terms of toxic equivalents (TEQs) was investigated in Swedish children and young adults. Exposure was estimated from concentration data of six groups of individual food commodities (meat, fish, dairy products, egg, edible fats and other foodstuff) combined with food intake data from a 7-day record book obtained from 670 individuals aged 1-24 years. The results showed that Swedish boys and girls, up to the age of ten, had a median TEQ intake that exceeded the tolerable daily intake (TDI) of 2 pg TEQ/kg body weight. Children exceeding the TDI varied from almost all individuals among the youngest children to about 20% among young men and women. Dairy and fish products were the main sources of exposure for the average child, accounting for 59% of the total TEQ intake. The individuals most highly exposed were, on the other hand, characterized by a high consumption of fish. Since children constitute a vulnerable group, results obtained from the present study show that it is essential to perform age specific dietary intake assessments of pollutants and more carefully consider sensitive and/or highly exposed groups in the population in the risk management processes.
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| 3. |
- de Boniface, J., et al.
(författare)
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Omitting axillary dissection in breast cancer with sentinel-node metastases
- 2024
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Ingår i: New England Journal of Medicine. - 0028-4793 .- 1533-4406. ; 390:13, s. 1163-1175
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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.).
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| 4. |
- Hanberg, Annika, et al.
(författare)
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Phthalates and their metabolites in human breast milk, blood and urine as measures for monitoring exposure in human risk groups
- 2005
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Rapport (övrigt vetenskapligt/konstnärligt)abstract
- För att undersöka halter av ftalater i svenskar och vilken matris som bäst lämpar sig för hälsorelaterad miljöövervakning har ftalater och ftalatmetaboliter analyserats i en grupp kvinnor som nyligen fött barn. I samband med förlossning på Universitetssjukhuset i Lund tillfrågades förstföderskor om medverkan och 42 kvinnor kom att ingå i studien. När barnet var 2-3 veckor gammalt pumpade mamman ut 50 mL bröstmjölk. Blod- och urinprov togs en vecka senare. Omfattande förändringar av standardmetoder för provtagning av mjölk och blod gjordes för att minimera risken för kontaminering av proverna. För mjölkprovtagningen användes en specialkonstruerad manuell pump av polykarbonat med ftalatfri packning. Blodprov togs med hjälp av endast kanyl och provrör (eftersom propparna i vaccutainrör innehåller ftalater). Proverna förvarades i värmebehandlade glasbehållare och fosforsyra tillsattes för att motverka metabolism av ftalater i mjölk- och blodprover. Analyserna av bröstmjölk visade värden nära eller under detektionsgränsen (LOD) för flertalet ftalater eller deras metaboliter. Även i blod och serum var nivåerna vanligtvis nära eller under LOD. I urin analyserades endast metaboliter och dessa kunde kvantifieras i 53-100 % av proverna. Nivåerna av ftalatmetaboliter i urin hos de svenska kvinnorna var i paritet med nivåerna hos en allmänbefolkning i USA och Tyskland. Några klara korrelationer mellan nivåer i t ex urin och bröstmjölk respektive blod påvisades inte. Resultaten av studien anger att för närvarande är analys av ftalatmetaboliter i urin den mest framkomliga vägen för skattning av ftalatexponering hos människa. Provtagning och analys av mjölk och blod innebar betydligt större svårigheter. Framför allt framstår risken för kontaminering vid provtagning som betydande och en stor del av ftalaterna och dess metaboliter uppvisade låga halter, vid eller under LOD. Dessutom kan ftalater brytas ned i blod och mjölk. I flertalet internationella publicerade studier av ftalatexponering används urinmetabolit-analyser som ett mått på exponering för ftalater. I en nyligen publicerad amerikansk studie av ett 80-tal nyfödda pojkar sågs ett samband mellan kort ano-genitalt avstånd och nivåer av ftalatmetaboliter i urin hos deras mammor under graviditeten. Den amerikanska studien behöver bekräftas, men metaboliterna var desamma som i vår studie och en jämförelse visar att mediannivåerna var lägre för vissa men högre för andra metaboliter. Vår studie indikerar att svenska kvinnor i fertil ålder inte sällan exponeras för ftalater i nivåer som satts i samband med fosterpåverkan.
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| 5. |
- Hogberg, Johan, et al.
(författare)
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Phthalate diesters and their metabolites in human breast milk, blood or serum, and urine as biomarkers of exposure in vulnerable populations
- 2008
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Ingår i: Journal of Environmental Health Perspectives. - : Environmental Health Perspectives. - 0091-6765 .- 1552-9924. ; 116:3, s. 334-339
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Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND: Phthalates may pose a risk for perinatal developmental effects. An important question relates to the choice of suitable biological matrices for assessing exposure during this period. OBJECTIVES: This study was designed to measure the concentrations of phthalate diesters or their metabolites in breast milk, blood or serum, and urine and to evaluate their suitability for assessing perinatal exposure to phthalates. METHODS: In 2001, 2-3 weeks after delivery, 42 Swedish primipara provided breast milk, blood, and urine samples at home. Special care was taken to minimize contamination with phthalates (e.g., use of a special breast milk pump, heat treatment of glassware and needles, addition of phosphoric acid). RESULTS: Phthalate diesters and metabolites in milk and blood or serum, if detected, were present at concentrations close to the limit of detection. By contrast, most phthalate metabolites were detectable in urine at concentrations comparable to those from the general population in the United States and in Germany. No correlations existed between urine concentrations and those found in milk or blood/serum for single phthalate metabolites. Our data are at odds with a previous study documenting frequent detection and comparatively high concentrations of phthalate metabolites in Finnish and Danish mothers' milk. CONCLUSIONS: Concentrations of phthalate metabolites in urine are more informative than those in milk or serum. Furthermore, collection of milk or blood may be associated with discomfort and potential technical problems such as contamination (unless oxidative metabolites are measured). Although urine is a suitable matrix for health-related phthalate monitoring, urinary concentrations in nursing mothers cannot be used to estimate exposure to phthalates through milk ingestion by breast-fed infants.
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