| 1. |
- Alkner, Sara, et al.
(author)
-
Protocol for the T-REX-trial: tailored regional external beam radiotherapy in clinically node-negative breast cancer patients with 1-2 sentinel node macrometastases - an open, multicentre, randomised non-inferiority phase 3 trial.
- 2023
-
In: BMJ open. - 2044-6055. ; 13:9
-
Journal article (peer-reviewed)abstract
- Modern systemic treatment has reduced incidence of regional recurrences and improved survival in breast cancer (BC). It is thus questionable whether regional radiotherapy (RT) is still beneficial in patients with sentinel lymph node (SLN) macrometastasis. Postoperative regional RT is associated with an increased risk of arm morbidity, pneumonitis, cardiac disease and secondary cancer. Therefore, there is a need to individualise regional RT in relation to the risk of recurrence.In this multicentre, prospective randomised trial, clinically node-negative patients with oestrogen receptor-positive, HER2-negative BC and 1-2 SLN macrometastases are eligible. Participants are randomly assigned to receive regional RT (standard arm) or not (intervention arm). Regional RT includes the axilla level I-III, the supraclavicular fossa and in selected patients the internal mammary nodes. Both groups receive RT to the remaining breast. Chest-wall RT after mastectomy is given in the standard arm, but in the intervention arm only in cases of widespread multifocality according to national guidelines. RT quality assurance is an integral part of the trial.The trial aims to include 1350 patients between March 2023 and December 2028 in Sweden and Norway. Primary outcome is recurrence-free survival (RFS) at 5years. Non-inferiority will be declared if outcome in the de-escalation arm is not >4.5percentage units below that with regional RT, corresponding to an HR of 1.41 assuming 88% 5-year RFS with standard treatment. Secondary outcomes include locoregional recurrence, overall survival, patient-reported arm morbidity and health-related quality of life. Gene expression analysis and tumour tissue-based studies to identify prognostic and predictive markers for benefit of regional RT are included.The trial protocol is approved by the Swedish Ethics Authority (Dnr-2022-02178-01, 2022-05093-02, 2023-00826-02, 2023-03035-02). Results will be presented at scientific conferences and in peer-reviewed journals.NCT05634889.
|
|
| 2. |
- Hedström, Karin, et al.
(author)
-
Complications after breast augmentation with dermal fillers containing copolyamide : A systematic review
- 2024
-
In: JPRAS Open. - : Elsevier. - 2352-5878. ; 40, s. 19-31
-
Research review (peer-reviewed)abstract
- BackgroundDermal fillers containing copolyamide are used for breast augmentation and are marketed under different labels, such as Aquafilling, Los Deline, Aqualift, and Activegel. In recent years, the number of publications reporting complications after use of these fillers has increased.MethodsThrough a computerized search following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, a systematic review of published studies on complications, treatment options, and radiological findings related to breast augmentation with dermal fillers containing copolyamide was performed. Publications between January 1, 2007, and January 23, 2023, were included. Retrieved studies were screened for inclusion and quality assessment. The Joanna Briggs checklist for case reports and the Strengthening the Reporting of Observational Studies in Epidemiology checklist for cross-sectional studies were used.ResultsSixteen studies met the inclusion criteria: 14 case reports and 2 retrospective cohort studies, including 196 women and 333 complications. Long-term complications (≥30 days after surgery) were described in 15 studies. The most commonly reported complications were nodules in the breast (130 patients), pain (92 patients), inflammation and/or infection (43 patients), breast deformities (35 patients), and migration of the filler to the pectoralis muscle, abdominal wall, thoracic wall, pubic area, back, or upper extremity (27 patients). The median time between injection of the dermal filler and any complication was 18 months, and the majority of patients with complications required surgical intervention.ConclusionGiven the reports of severe complications months to years after injection of dermal fillers containing copolyamide and the lack of studies evaluating long-term safety, our interpretation is that dermal fillers containing copolyamide should not be used for breast augmentation.
|
|
| 3. |
- Sackey, Helena
(author)
-
Long-term follow-up after treatment of invasive and in situ breast cancer : aspects on second breast cancers HRQOL and lymphoedema
- 2014
-
Doctoral thesis (other academic/artistic)abstract
- Breast cancer is the most frequent cancer among Swedish women and in 2012, 8490 new inva- sive breast cancers were diagnosed. The incidence of in situ breast cancer has markedly in- creased since nationwide mammography screening was introduced in the late 1980s. The in- creasing figures of in situ breast cancer are predominantly attributable to an increased frequency of ductal carcinoma in situ (DCIS). In 2012, 1443 in situ breast cancers were diagnosed in Swe- den, which is approximately 15% of all diagnosed breast cancers. The main aims of the first two papers were to study the long-term HRQOL after different types of surgical treatment in women with DCIS (paper I) and to study the risk of developing a new in situ or invasive breast cancer after a first in situ cancer in women with and without a family his- tory for breast cancer (paper II). Since the 1980s, breast-conserving surgery for DCIS has been recommended whenever feasible. Several randomised trials have shown a decreased rate of ipsi- lateral DCIS or invasive breast cancer recurrence through the addition of adjuvant radiotherapy. Mastectomy is still recommended for women with either multifocal DCIS, and/or unfavourable proportion between tumour size and breast volume. For these women an immediate breast re- construction (IBR) is an alternative to maintain a breast contour. As surgery is the primary treatment for this disease, it is essential to increase current understanding of its long-term con- sequences. In paper I, 162 women treated for DCIS with breast-conserving surgery with or without postoperative radiotherapy, or with mastectomy and IBR, had a satisfactory long-term HRQOL. However, body image appeared to be affected in women after mastectomy and IBR. Using the population-based Swedish Multi-Generation and Cancer Registers we identified 8,111 women (paper II) diagnosed with in situ breast cancer between 1980 and 2004. The risk of a subsequent invasive breast cancer was increased more than fourfold [SIR 4.55 (95% CI 4.23- 4.88)] among women with in situ breast cancer as compared to women in the general population and the risk for a contralateral in situ breast cancer was almost sixteenfold increased [SIR 15.98(95% CI, 13.23-19.14)]. Having a family history for breast cancer increased the risk for contralateral invasive breast cancer by almost 50 % [incidence rate ratio 1.47 (95% CI 1.05- 2.05)]. The risk for a subsequent invasive breast cancer, as well as mortality was substantially higher in younger women, which should be taken into account when planning their treatment and follow-up. The main aims of paper III and IV were to evaluate the impact of axillary surgery on arm lym- phoedema and long-term HRQOL. Axillary lymph node dissection (ALND) was the standard surgical procedure for staging well into the 1990s, when it was replaced by the sentinel lymph node biopsy (SLNB), in patients with preoperatively no signs of axillary metastases. In a multi- centre study, including 557 women, we showed that SLNB alone is associated with a minimal risk of increased arm volume and few self-perceived symptoms of arm lymphoedema, signifi- cantly less than after ALND, regardless of lymph node status. Yet, 20% of the women who un- derwent SLNB, reported symptoms of arm lymphoedema, which emphasizes the importance of performing SLNB strictly on patients who can benefit from the staging results. Three years after surgery women in all three study groups appeared to have a satisfactory HRQOL. Women reporting self-perceived arm lymphoedema, regardless of objective lymphoedema or not, re- ported poorer HRQOL than those women who did not, indicating that more attention should be given to the subjective reports of symptoms, in order to better help these women.
|
|
