The combined efficacy analysis of the TEXT and SOFT trials showed a significant disease-free survival benefit with exemestane plus ovarian function suppression (OFS) compared with tamoxifen plus OFS. Altogether 4717 premenopausal women with hormone-receptor positive breast cancer were enrolled in TEXT or SOFT to receive unmasked adjuvant treatment with 5 years of exemestane plus OFS or tamoxifen plus OFS. Chemotherapy use was optional. At the time of analysis, the median follow-up was 5.7 years. Patients on tamoxifen plus OFS were more affected by hot flushes and sweats over 5 years than were those on exemestane plus OFS, although these symptoms improved. Patients on exemestane plus OFS reported more vaginal dryness, greater loss of sexual interest, and difficulties becoming aroused than did patients on tamoxifen plus OFS; these differences persisted over time. An increase in bone or joint pain was more pronounced, particularly in the short term, in patients on exemestane plus OFS than patients on tamoxifen plus OFS. Changes in global QoL indicators from baseline were small and similar between treatments over the 5 years. Overall, from a QoL perspective, there is no strong indication to favour either exemestane plus OFS or tamoxifen plus OFS. The distinct effects of the two treatments on the burden of endocrine symptoms need to be addressed with patients individually.
COBISS.SI-ID: 2063483
There is a paradigm that chemotherapy is ineffective in thyroid carcinoma. The aim of our study was to find out whether neoadjuvant chemotherapy before thyroid surgery had an effect on the size of primary tumour in patients with poorly differentiated thyroid carcinoma (PDTC) based on Turin proposal. Altogether, 13 patients (8 women, 5 men; median age 61 years) with PDTC based on Turin proposal were treated with neoadjuvant chemotherapy between 1986 and 2005. Tumour diameter was from 4.5 to 18 cm (median 9 cm). Regional and distant metastases were detected in 6 and 9 patients, respectively. Eight patients had pT4 tumour. Altogether, 29 (range 1%5) cycles of chemotherapy were given. Tumour diameter decreased in all the patients and by more than 30% in 5 patients (= 38%). Two of these five patients had also preoperative external beam irradiation (EBRT). Total thyroidectomy, lobectomy and neck dissection were performed in 10, 3 and 5 cases, respectively. R0 and R1 resection was done in 5 and 8 cases, respectively. Eight patients had postoperative EBRT of the neck and upper mediastinum. The 5-year and 10-year cause-specific survival rates of patients were 66% and 20%, respectively. Conclusions. After neoadjuvant chemotherapy a partial tumour regression was observed in 38% of patients with PDTC based on Turin proposal.
COBISS.SI-ID: 2077051
Serial quantification of BCR–ABL1 mRNA is an important therapeutic indicator in chronic myeloid leukaemia, but there is a substantial variation in results reported by different laboratories. To improve comparability, an internationally accepted plasmid certified reference material (CRM) was developed according to ISO Guide 34:2009. Fragments of BCR–ABL1 (e14a2 mRNA fusion), BCR and GUSB transcripts were amplified and cloned into pUC18 to yield plasmid pIRMM0099. Six different linearised plasmid solutions were produced with the following copy number concentrations, assigned by digital PCR, and expanded uncertainties: 1.08±0.13 × 106, 1.08±0.11 × 105, 1.03±0.10 × 104, 1.02±0.09 × 103, 1.04±0.10 × 102 and 10.0±1.5 copies/μl. Two suitability studies performed by 63 BCR–ABL1 testing laboratories demonstrated that this set of 6 plasmid CRMs can help to standardise a number of measured transcripts of e14a2 BCR–ABL1 and three control genes (ABL1, BCR and GUSB). The set of six plasmid CRMs is distributed worldwide by the Institute for Reference Materials and Measurements (Belgium) and its authorised distributors (https://ec.europa.eu/jrc/en/reference-materials/catalogue/; CRM code ERM-AD623a-f).
COBISS.SI-ID: 31742169
Flow cytometric immunophenotyping (FCI), is widely used in cytology for distinguishing between B-cell lymphoma (BCL) and reactive lymphocytic proliferations (RLP), mainly by identifying monotypic B-cell populations. Since this cannot always be determined by ratios of surface immunoglobulin light chains (sIg LCs) we wanted to assess if cytoplasmic immunoglobulin (cIg) LCs, Bcl-2 and polymerase chain reaction (PCR) based clonality analysis can improve accuracy of cytological diagnoses of BCL. Our study included 98 fine needle aspiration biopsies from lymph nodes suspicious for BCL with inconclusive sIg LCs. In all cases PCR clonality analysis was performed in order to determine immunoglobulin heavy chain (IGH) gene and T-cell receptor (TRC) gene rearrangement. In selected cases expression of Bcl-2 and cIg LC were determined by FC. Thirty patients had lymphoma and 68 had reactive lymphocytic proliferations. Three patterns of sIg LCs staining were found: negative, dual positive and difficult to interpret. Percentage of lymphomas was highest in the dual positive group (75 %). Morphology coupled with cIg LCs determination and/or Bcl-2 expression was able to give a correct diagnosis in 83 % of cases. Molecular tests would have been misleading in 15 % of cases because 7/30 BCL were polyclonal and 8/68 RLP were monoclonal. Determination of cIg LCs, Bcl-2 expression and PCR clonality analysis of B cells improved accuracy of cytological diagnoses in BCL with inconclusive sIg LC. However, clonality determined by PCR was misleading in some cases.
COBISS.SI-ID: 2232955
The association of systemic mastocytosis (SM) with a non-mast cell haematological neoplasm represents a specific subtype of mastocytosis termed systemic mastocytosis with associated haematological non-mast cell disease (SM-AHNMD). The overwhelming majority of the associated neoplasms are of myeloid origin, while lymphoid neoplasms associated with SM have been reported rarely. Association of SM with Hodgkin's lymphoma (HL) is exceedingly rare; so far, only two cases of HL as associated hematological non-mast cell disease in systemic mastocytosis have been published in the recent English literature. CASE: We present a case of a 37-year-old otherwise healthy male who was referred to our institution because of a one-month lasting dysphagia of both hard and liquid food. Physical examination showed tumour in the left jugular area measuring 2 cm in the largest diameter while computer tomography of the thorax revealed a 5.2 cm large, hypodense, soft tissue tumour between the trachea and left arteria carotis communis. On the basis of FNAB findings, the diagnosis of a "neutrophil-rich" Hodgkin's lymphoma was established. Excisional biopsy of mediastinal tumor showed lymphoid neoplasm with morphology and immunophenotype consistent with nodular sclerosis classical Hodgkin's lymphoma (NScHL). Bone marrow trephine biopsy and the MGG-stained smear of the bone marrow aspirate performed for lymphoma staging revealed an existence of systemic mastocytosis which was unexpected and incidental finding. Mast cells were highlighted by CD117 and tryptase immunostainings while CD25 positivity of mast cells was consistent with their neoplastic phenotype.There were no HL infiltrates present in the bone marrow. CONCLUSION: We report a very rare combination of systemic mastocytosis with Hodgkin's lymphoma as associated clonal haematological non-mast cell lineage disease. Systemic mastocytosis was an unexpected finding. The diagnosis of SM in bone marrow in our case was straight-forward, but it can be difficult in the case of reactive lymphoid aggregates or a difficult distinction between SM and HL infiltration. In particular, distinction can be challenging from the immunohistochemical point of view in the case of high-grade mast cell disease which can be CD30 positive.
COBISS.SI-ID: 2033531