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1.
Clin Cancer Res ; 30(5): 965-974, 2024 03 01.
Article in English | MEDLINE | ID: mdl-37847493

ABSTRACT

PURPOSE: The DIANA-5 randomized controlled trial assessed the effectiveness of a diet based on Mediterranean and macrobiotic traditions (macro-Mediterranean diet) in reducing breast cancer recurrence. PATIENTS AND METHODS: The DIANA-5 study involved 1,542 patients with breast cancer at high risk of recurrence because of estrogen receptor-negative cancer, or metabolic syndrome, or high plasma levels of insulin or testosterone. Women were randomly assigned to an active dietary intervention (IG) or a control group (CG). Both groups received the 2007 American Institute for Cancer Research/World Cancer Research Fund recommendations for cancer prevention. The intervention consisted of meetings with kitchen classes, community meals, and dietary recommendations. Recommended foods included whole grain cereals, legumes, soy products, vegetables, fruit, nuts, olive oil, and fish. Foods to be avoided were refined products, potatoes, sugar and desserts, red and processed meat, dairy products, and alcoholic drinks. A compliance Dietary Index was defined by the difference between recommended and discouraged foods. RESULTS: Over the 5 years of follow-up, 95 patients of the IG and 98 of the CG developed breast cancer recurrence [HR = 0.99; 95% confidence interval (CI): 0.69-1.40]. The analysis by compliance to the dietary recommendations (IG and CG together) showed that the women in the upper tertile of Dietary Index change had an HR of recurrence of 0.59 (95% CI: 0.36-0.92) compared with women in the lower tertile. CONCLUSIONS: The DIANA-5 dietary intervention trial failed to show a reduction in breast cancer recurrence, although self-reported diet at year 1 in IG and CG combined showed a protective association with the higher Dietary Index change. See related commentary by McTiernan, p. 931.


Subject(s)
Breast Neoplasms , Diet , Female , Humans , Breast Neoplasms/epidemiology , Breast Neoplasms/etiology , Breast Neoplasms/prevention & control , Neoplasm Recurrence, Local/epidemiology , Neoplasm Recurrence, Local/prevention & control , Testosterone
2.
J Pers Med ; 13(12)2023 Dec 08.
Article in English | MEDLINE | ID: mdl-38138920

ABSTRACT

Background: The management of early breast cancer (BC) needs supervision and skill maintenance, and should be performed by specialists working as a team in multidisciplinary breast units. This approach aims to improve the long-term survival and quality of life of patients with BC. Methods: This was a prospective observational study including patients newly diagnosed with operable BC. The study encompassed the pre-surgical phase, throughout the diagnostic and surgical workout, and included post-therapeutic master multidisciplinary team meetings (MTMs) sessions, between 2019 and 2022. Results: We enrolled 280 patients with BC from eight breast units. The Senonetwork indicators regarding diagnosis, waiting time, loco-regional treatment, and adjuvant therapy were collected for each patient discussed. Conclusions: Overall, the majority of quality indicators were respected among breast units. The most critical issue referred to timing indicators: more than 30 days from MTM to surgery, more than 42 days from diagnosis to surgery, and more than 60 days from the first screening mammogram to surgery for many patients. Some aspects of the histopathological diagnosis of intraductal BC also need to be improved. Furthermore, other critical issues in our study regarded some aesthetical indicators, demonstrating low interest in these essential quality indicators.

3.
Nutrients ; 13(9)2021 Aug 27.
Article in English | MEDLINE | ID: mdl-34578868

ABSTRACT

The Diet and Androgen-5 (DIANA-5) trial aimed at testing whether a dietary change based on the Mediterranean diet and on macrobiotic principles can reduce the incidence of breast cancer (BC)-related events. We analyzed the adherence to the DIANA-5 dietary recommendations by randomization group after 1 year of intervention. We evaluated the association between dietary adherence and changes in body weight and metabolic syndrome (MS) parameters. BC women aged 35-70 years were eligible. After the baseline examinations, women were randomized into an intervention group (IG) or a control group (CG). A total of 1344 BC women (689 IG and 655 CG) concluded the first year of dietary intervention. IG showed greater anthropometric and metabolic improvements compared to CG. These changes were significantly associated with increased adherence to the dietary recommendations. Women who increased recommended foods consumption or reduced discouraged foods consumption showed an Odds Ratio (OR) of 1.37 (0.70-2.67) and 2.02 (1.03-3.98) to improve three or more MS parameters. Moreover, women in the higher category of dietary change showed a four times higher OR of reducing body weight compared to the lower category (p < 0.001). The DIANA-5 dietary intervention is effective in reducing body weight and MS parameters.


Subject(s)
Breast Neoplasms/complications , Diet, Mediterranean/statistics & numerical data , Metabolic Syndrome/complications , Metabolic Syndrome/diet therapy , Patient Compliance/statistics & numerical data , Weight Reduction Programs/methods , Adult , Aged , Body Weight , Female , Follow-Up Studies , Humans , Middle Aged , Weight Loss
4.
Article in English | MEDLINE | ID: mdl-32745814

ABSTRACT

OBJECTIVE: Intraoperative specimen mammography (ISM) is a diffuse technique that allows surgeons to check specimens immediately after lumpectomy. Although the specimen is slightly compressed, the radiological image can be distorted by tissue overlap, and this may affect the evaluation of tumour borders, resulting in extension of the lumpectomy. As ISM may be less precise due to inadequate compression, a vacuum effect was applied to the specimen to increase the precision of margin detection. STUDY DESIGN: This study was conducted at St. Anna Hospital Breast Unit, Turin, Italy. Women who underwent lumpectomy for cancer were eligible for inclusion. Both standard ISM (sISM) and vacuum ISM (vISM) were performed. Eighteen specimens obtained after lumpectomy from 1 April 2018 to 31 April 2018 were scanned. sISM (two orthogonal projections) was performed. Next, the specimen was placed in a vacuum, and vISM was performed. The examination was completed with a second orthogonal projection after removal of the vacuum, replacement of the specimen and repositioning of the vacuum. Additional tissue was removed if the surgeon considered that excision was inadequate. Finally, the specimen was sent for definitive histopathological analysis, which is the gold standard for the assessment of surgical margins. Intraoperative histological margin assessment was not performed. The sISM and vISM images and final histopathology reports were compared. RESULTS: For sISM, specificity was 47 % [95 % confidence interval (CI) 25-70], sensitivity was 67 % (95 % CI 21-94), positive predictive value (PPV) was 20 % (95 % CI 6-51) and negative predictive value (NPV) was 88 % (95 % CI 53-98). For vISM, specificity was 100 % (95 % CI 80-100), sensitivity was 67 % (95 % CI 21-94), PPV was 100 % (95 % CI 34-100) and NPV was 94 % (95 % CI 72-99). CONCLUSION: These data suggest that the vacuum technique is feasible, cost-saving and yields results that are similar to those from frozen sections but without the limitations, such as prolonged operating time, high variability in sensitivity due to pathologists' abilities, risk of compromising the histological report, and unreliability for small lumps and ductal carcinoma in situ.


Subject(s)
Breast Neoplasms , Mastectomy, Segmental , Breast Neoplasms/diagnostic imaging , Breast Neoplasms/surgery , Female , Humans , Italy , Mammography , Vacuum
5.
In Vivo ; 34(2): 909-915, 2020.
Article in English | MEDLINE | ID: mdl-32111803

ABSTRACT

BACKGROUND/AIM: The aim of the study was to evaluate whether residual tumor assessment by magnetic resonance imaging (MRI) after neoadjuvant chemotherapy (NACT) is fundamental for a successive surgical strategy. PATIENTS AND METHODS: We collected 55 MRIs performed after NACT. RESULTS: Pathological response rate was 20%. MRI's sensitivity, specificity, PPV and NPV were 50%, 88%, 54% and 86%, respectively. We observed a high variability between the different subgroups, with high number of false positives in luminal A/B tumors. Triple negative and HER2+ tumors had almost the same specificity and sensitivity (81% and 50%). Nevertheless, in the HER2+ group, PPV was greater than that in the triple negative group (71% and 33% respectively) and the NPV of the triple negative group was greater than that of the HER2+ one (90% and 64%, respectively). Statistical analysis showed a weak but significant correlation between MRI and pathological assessment of residual tumor dimension. CONCLUSION: The present study, confirms literature data about MRI accuracy in diagnosing HER2+ and triple negative tumors, but suggests caution in case of luminal tumors' evaluation.


Subject(s)
Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Breast Neoplasms/diagnostic imaging , Breast Neoplasms/drug therapy , Magnetic Resonance Imaging , Antineoplastic Combined Chemotherapy Protocols/adverse effects , Biomarkers, Tumor , Breast Neoplasms/mortality , Breast Neoplasms/pathology , Clinical Decision-Making , Disease Management , Female , Humans , Magnetic Resonance Imaging/methods , Magnetic Resonance Imaging/standards , Neoadjuvant Therapy , Neoplasm Staging , Sensitivity and Specificity , Treatment Outcome
6.
Breast ; 42: 15-22, 2018 Dec.
Article in English | MEDLINE | ID: mdl-30138762

ABSTRACT

OBJECTIVES: Available evidence on axillary surgery has accumulated dramatically in the last two decades in favor of less invasive care. The aim of this paper is to study 16-years trends in the surgical management of the axilla in a large population-based data set of screen-detected breast cancers in Italy and to document at what extent recommendations have been adopted in actual clinical care. MATERIAL AND METHODS: This is a retrospective cohort study documenting the surgical management of the axilla in primary breast cancer patients over time. We retrieved from the Italian database of screen-detected cancers 41213 cases diagnosed in women aged 50-69 between years 2000 and 2015 in twelve Italian Regions. RESULTS: In pN0 cases, an increasing trend (p < 0.001) in the number of patients who received sentinel lymph node biopsy (SLNB) as the only axillary staging procedure was observed. In pN + cases SLNB was the only staging procedure in an increasing number of patients (p < 0.001) especially since the publication of the ACOSOG-Z0011 paper. In ductal carcinoma in situ (DCIS) SLNB was more frequent in mastectomies and in high grade and large lesions. However, 45% of low grade, small DCIS over the whole time period had some form of axillary surgery. CONCLUSION: This large series of screen-detected cases documents a strong time trend in the direction of reducing axillary surgery and hence potential harms from treatment. The continuing practice of SLNB in low risk DCIS is of concern in an era of increasing awareness towards overdiagnosis and overtreatment.


Subject(s)
Axilla/surgery , Breast Neoplasms/pathology , Breast Neoplasms/surgery , Lymph Node Excision/statistics & numerical data , Aged , Axilla/pathology , Carcinoma, Ductal, Breast/pathology , Carcinoma, Ductal, Breast/surgery , Carcinoma, Intraductal, Noninfiltrating/pathology , Carcinoma, Intraductal, Noninfiltrating/surgery , Cohort Studies , Female , Harm Reduction , Humans , Italy , Mastectomy, Segmental/statistics & numerical data , Middle Aged , Retrospective Studies
7.
Endocr Relat Cancer ; 25(3): 163-172, 2018 03.
Article in English | MEDLINE | ID: mdl-29386247

ABSTRACT

The significance of androgen receptor (AR) in breast cancer (BC) management is not fully defined, and it is still ambiguous how the level of AR expression influences oestrogen receptor-positive (ER+) tumours. The aim of the present study was to analyse the prognostic impact of AR/ER ratio, evaluated by immunohistochemistry (IHC), correlating this value with clinical, pathological and molecular characteristics. We retrospectively selected a cohort of 402 ER+BC patients. On each tumour, IHC analyses for AR, ER, PgR, HER2 and Ki67 were performed and AR+ cases were used to calculate the AR/ER value. A cut-off of ≥2 was selected using receiver-operating characteristic (ROC) curve analyses. RNA from 19 cases with AR/ER≥2 was extracted and used for Prosigna-PAM50 assays. Tumours with AR/ER≥2 (6%) showed more frequent metastatic lymph nodes, larger size, higher histological grade and lower PgR levels than cases with AR/ER<2. Multivariate analysis confirmed that patients with AR/ER≥2 had worse disease-free interval (DFI) and disease-specific survival (DSS) (hazard ratios (HR) = 4.96 for DFI and HR = 8.69 for DSS, both P ≤ 0.004). According to the Prosigna-PAM50 assay, 63% (12/19) of these cases resulted in intermediate or high risk of recurrence categories. Additionally, although all samples were positive for ER assessed by IHC, the molecular test assigned 47.4% (9/19) of BCs to intrinsic non-luminal subtypes. In conclusion, the AR/ER ratio ≥2 identifies a subgroup of patients with aggressive biological features and may represent an additional independent marker of worse BC prognosis. Moreover, the Prosigna-PAM50 results indicate that a significant number of cases with AR/ER≥2 could be non-luminal tumours.


Subject(s)
Breast Neoplasms/metabolism , Receptors, Androgen/metabolism , Receptors, Estrogen/metabolism , Adult , Aged , Aged, 80 and over , Breast Neoplasms/pathology , Female , Humans , Middle Aged , Prognosis
8.
Int J Cancer ; 138(1): 237-44, 2016 Jan 01.
Article in English | MEDLINE | ID: mdl-26175188

ABSTRACT

Metabolic syndrome (MetS), conventionally defined by the presence of at least three out of five dismetabolic traits (abdominal obesity, hypertension, low plasma HDL-cholesterol and high plasma glucose and triglycerides), has been associated with both breast cancer (BC) incidence and prognosis. We investigated the association between the prevalence of MetS and a score of adherence to the World Cancer Research Fund (WCRF) and American Institute for Cancer Research (AICR) recommendations for the prevention of cancer in a cross-sectional study of BC patients. The DIet and ANdrogen-5 study (DIANA-5) for the prevention of BC recurrences recruited 2092 early stage BC survivors aged 35-70. At recruitment, all women completed a 24-hour food frequency and physical activity diary on their consumption and activity of the previous day. Using these diaries we created a score of adherence to five relevant WCRF/AICR recommendations. The prevalence ratios (PRs) and 95% confidence intervals (CIs) of MetS associated with the number of recommendations met were estimated using a binomial regression model. The adjusted PRs of MetS decreased with increasing number of recommendations met (p < 0.001). Meeting all the five recommendations versus meeting none or only one was significantly associated with a 57% lower MetS prevalence (95% CI 0.35-0.73). Our results suggest that adherence to WCRF/AICR recommendations is a major determinant of MetS and may have a clinical impact.


Subject(s)
Advance Directive Adherence , Breast Neoplasms/complications , Breast Neoplasms/epidemiology , Metabolic Syndrome/complications , Metabolic Syndrome/epidemiology , Adult , Aged , Breast Neoplasms/diagnosis , Breast Neoplasms/prevention & control , Diet , Feeding Behavior , Female , Humans , Life Style , Metabolic Syndrome/diagnosis , Metabolic Syndrome/prevention & control , Middle Aged , Motor Activity , Neoplasm Staging , Prevalence , Risk Factors
9.
Epidemiol Prev ; 39(5-6): 360-5, 2015.
Article in Italian | MEDLINE | ID: mdl-26554687

ABSTRACT

Cancer screening may represent an ideal setting for promoting healthy lifestyle. We conducted a literature review of intervention studies of primary prevention interventions implemented in the context of established screening programmes. We identified 11 trials, 3 of which conducted in Italy. A positive impact of these interventions in favouring the adoption of cancer protective dietary behaviours was observed in all studies. A limited impact was reported for physical activity, while no effect could be observed for interventions aimed to promote smoking cessation. Long term maintenance of the observed behavioural changes and the sustainability overtime of these interventions within population-based programmes should be assessed. To enhance their effectiveness, these health education programmes should include multiple strategies, integrating and combining models of individual, social, and environmental change.


Subject(s)
Diet , Neoplasms/diagnosis , Primary Prevention , Clinical Trials as Topic , Early Detection of Cancer/methods , Health Education , Humans , Italy/epidemiology , Neoplasms/epidemiology , Primary Prevention/methods
10.
Epidemiol Prev ; 39(3 Suppl 1): 40-7, 2015.
Article in English | MEDLINE | ID: mdl-26405775

ABSTRACT

This annual survey, conducted by the Italian group for mammography screening (GISMa), collects individual data on diagnosis and treatment of about 50% of screen-detected, operated lesions in Italy. The 2011-2012 results show good overall quality and an improving trend over time. A number of critical issues have been identified, including waiting times (which have had a worsening trend over the years) and compliance with the recommendation of not performing frozen section examination on small lesions. Pre-operative diagnosis improved constantly over time, but there is still a large variation between Regions and programmes. For almost 90% of screen-detected invasive cancers a sentinel lymph node (SLN) biopsy was performed on the axilla, avoiding a large number of potentially harmful dissections. On the other hand, potential overuse of SLN dissection for ductal carcinoma in situ, although apparently starting to decline, deserves further investigation. The detailed results have been distributed, among other ways by means of a web-based data-warehouse, to regional and local screening programmes, in order to allow multidisciplinary discussion and identification of the appropriate solutions to any issues documented by the data. The problem of waiting times should be assigned priority. Specialist Breast Units with adequate case volume and enough resources would provide the best setting for making monitoring effective in producing quality improvements with shorter waiting times.


Subject(s)
Breast Neoplasms/diagnosis , Breast Neoplasms/therapy , Carcinoma in Situ/diagnosis , Carcinoma in Situ/therapy , Mammography , Medical Audit , Axilla/surgery , Early Detection of Cancer , Female , Health Surveys , Humans , Italy , Mass Screening , Middle Aged , Risk Factors , Sentinel Lymph Node Biopsy , Time Factors
11.
Breast Cancer Res Treat ; 147(1): 159-65, 2014 Aug.
Article in English | MEDLINE | ID: mdl-25104441

ABSTRACT

Metabolic syndrome (MS), conventionally defined by the presence of at least three out of five dysmetabolic traits (abdominal obesity, hypertension, low plasma HDL-cholesterol, high plasma glucose and high triglycerides), has been associated with an increased risk of several age-related chronic diseases, including breast cancer (BC). This may have prognostic implications for BC survivors. 2,092 early stage BC survivors aged 35-70, recruited in eleven Italian centres 0-5 years after surgical treatment (1.74 years on average), were followed-up over 2.8 years on average for additional BC-related events, including BC-specific mortality, distant metastasis, local recurrences and contralateral BC. At recruitment, 20 % of the patients had MS. Logistic regression models were carried out to generate OR and 95 % confidence intervals (CI) for new BC events associated with MS, adjusting for baseline pathological prognostic factors. New BC events occurred in 164 patients, including 89 distant metastases. The adjusted ORs for women with MS versus women without any MS traits were 2.17 (CI 1.31-3.60) overall, and 2.45 (CI 1.24-4.82) for distant metastasis. The OR of new BC events for women with only one or two MS traits was 1.40 (CI 0.91-2.16). All MS traits were positively associated with new BC events, and significantly so for low HDL and high triglycerides. MS is an important prognostic factor in BC. As MS is reversible through lifestyle changes, interventions to decrease MS traits in BC patients should be implemented in BC clinics.


Subject(s)
Body Mass Index , Breast Neoplasms/etiology , Metabolic Syndrome/complications , Adult , Aged , Breast Neoplasms/mortality , Female , Follow-Up Studies , Humans , Logistic Models , Metabolic Syndrome/diagnosis , Middle Aged , Neoplasm Grading , Neoplasm Staging , Prognosis , Risk Factors , Survival Rate
12.
Eur J Cancer ; 50(15): 2695-704, 2014 Oct.
Article in English | MEDLINE | ID: mdl-25149183

ABSTRACT

BACKGROUND: Ductal carcinoma in situ (DCIS) incidence has grown with the implementation of screening and its detection varies across International Cancer Screening Network (ICSN) countries. The aim of this survey is to describe the management of screen-detected DCIS in ICSN countries and to evaluate the potential for treatment related morbidity. METHODS: We sought screen-detected DCIS data from the ICSN countries identified during 2004-2008. We adopted standardised data collection forms and analysis and explored DCIS diagnosis and treatment processes ranging from pre-operative diagnosis to type of surgery and radiotherapy. RESULTS: Twelve countries contributed data from a total of 15 screening programmes, all from Europe except the United States of America and Japan. Among women aged 50-69 years, 7,176,050 screening tests and 5324 screen-detected DCIS were reported. From 21% to 93% of DCIS had a pre-operative diagnosis (PO); 67-90% of DCIS received breast conservation surgery (BCS), and in 41-100% of the cases this was followed by radiotherapy; 6.4-59% received sentinel lymph node biopsy (SLNB) only and 0.8-49% axillary dissection (ALND) with 0.6% (range by programmes 0-8.1%) being node positive. Among BCS patients 35% received SLNB only and 4.8% received ALND. Starting in 2006, PO and SLNB use increased while ALND remained stable. SLNB and ALND were associated with larger size and higher grade DCIS lesions. CONCLUSIONS: Variation in DCIS management among screened women is wide and includes lymph node surgery beyond what is currently recommended. This indicates the presence of varying levels of overtreatment and the potential for its reduction.


Subject(s)
Breast Neoplasms/therapy , Carcinoma, Intraductal, Noninfiltrating/therapy , Lymph Node Excision/statistics & numerical data , Mastectomy, Segmental/statistics & numerical data , Radiotherapy/statistics & numerical data , Aged , Breast Neoplasms/diagnosis , Carcinoma, Intraductal, Noninfiltrating/diagnosis , Early Detection of Cancer , Europe , Female , Humans , International Agencies , Japan , Lymph Node Excision/methods , Mastectomy, Segmental/methods , Middle Aged , Outcome Assessment, Health Care/methods , Outcome Assessment, Health Care/statistics & numerical data , Radiotherapy/methods , United States
13.
BMC Health Serv Res ; 13: 28, 2013 Jan 25.
Article in English | MEDLINE | ID: mdl-23351327

ABSTRACT

BACKGROUND: It has been documented that variations exist in breast cancer treatment despite wide dissemination of clinical practice guidelines. The aim of this population-based study was to evaluate the impact of regional guidelines (Piedmont guidelines, PGL) for breast cancer diagnosis and treatment on quality-of-care indicators in the Northwestern Italian region of Piedmont. METHODS: We included two samples of women aged 50-69 years with incident breast cancer treated in Piedmont before and after the introduction of PGL: 600 in 2002 (pre-PGL) and 621 in 2004 (post-PGL). Patients were randomly selected among all incident breast cancer cases identified through the hospital discharge records database. We extracted clinical data on breast cancer cases from medical charts and ascertained vital status through linkage with town offices. We assessed compliance with 14 quality-of-care indicators from PGL recommendations, before and after their introduction in clinical practice. RESULTS: Among patients with invasive lesions, 77.1% (N = 368) and 77.5% (N = 383) in the pre-PGL and post-PGL groups, respectively, received breast conservative surgery (BCS) as a first-line treatment. Following BCS, 87.7% received radiotherapy in 2002, compared to 87.9% in 2004. Of all patients at medium-to-high risk of distant metastasis, 65.5% (N = 268) and 63.6% (N = 252) received chemotherapy in 2002 and in 2004, respectively. Among the 117 patients with invasive lesions and negative estrogen receptor status in 2002, hormonal therapy was prescribed in 23 of them (19.6%). The incorrect prescription of hormonal therapy decreased to 10.8% (N = 10) among the 92 estrogen receptor-negative patients in 2004 (p < 0.01).Compliance with PGL recommendations was already high in the pre-PGL group, although some quality-of-care indicators did not reach the standard. In the pre/post analysis, 8 out of 14 quality-of-care indicators showed an improvement from 2002 to 2004, but only 4 out of 14 reached statistical significance. We did not find any change in the risk of mortality in the post-PGL versus the pre-PGL group (adjusted hazard ratio 0.94, 95%CI 0.56-1.56). CONCLUSIONS: These results highlight the need to continue to improve breast cancer care and to measure adherence to PGL.


Subject(s)
Breast Neoplasms/therapy , Guideline Adherence/trends , Practice Guidelines as Topic , Quality Indicators, Health Care , Aged , Breast Neoplasms/physiopathology , Evidence-Based Medicine , Female , Humans , Italy , Medical Audit , Middle Aged
14.
Tumori ; 98(1): 1-18, 2012.
Article in English | MEDLINE | ID: mdl-22495696

ABSTRACT

AIMS AND BACKGROUND: The DIANA (Diet and Androgens)-5 study is a multi-institutional randomized controlled trial of the effectiveness of a diet based on Mediterranean and macrobiotic recipes and principles, associated with moderate physical activity, in reducing additional breast cancer events in women with early stage invasive breast cancer at high risk of recurrence because of metabolic or endocrine milieu. The intervention is expected to reduce serum insulin and sex hormones, which were associated with breast prognosis in previous studies. METHODS: Between 2008 and 2010, the study randomly assigned 1208 patients to an intensive diet and exercise intervention or to a comparison group, to be followed-up through 2015. General lifestyle recommendations for the prevention of cancer are given to both groups, and the intervention group is being offered a comprehensive lifestyle intervention, including cooking classes, conferences, common meals and exercise sessions. Adherence assessments occurred at baseline and at 12 months and are planned at 36 and 60 months. They include food frequency diaries, anthropometric measures, body fat distribution assessed with impedance scale, one week registration of physical activity with a multisensor arm-band monitor, metabolic and endocrine blood parameters. Outcome breast cancer events are assessed through self report at semi annual meetings or telephone interview and are validated through medical record verification. RESULTS: The randomized groups were comparable for age (51.8 years), proportion of ER-negative tumors (22%), axillary node metastasis (42%), reproductive variables, tobacco smoking, blood pressure, anthropometric measurements and hormonal and metabolic parameters. CONCLUSIONS: DIANA-5 has the potential to establish whether a Mediterranean-macrobiotic lifestyle may reduce breast cancer recurrences. We will assess evidence of effectiveness, first by comparing the incidence of additional breast cancer events (local or distant recurrence, second ipsilateral or contralateral cancer) in the intervention and in the control group, by an intention-to-treat analysis, and second by analyzing the incidence of breast cancer events in the total study population by compliance assessment score.


Subject(s)
Breast Neoplasms/epidemiology , Breast Neoplasms/prevention & control , Diet, Mediterranean , Exercise , Life Style , Risk Reduction Behavior , Secondary Prevention/methods , Adult , Aged , Biomarkers/blood , Body Fat Distribution , Breast Neoplasms/blood , Breast Neoplasms/etiology , Breast Neoplasms/pathology , Caloric Restriction , Diet Records , Energy Metabolism , Female , Gonadal Steroid Hormones/blood , Humans , Insulin/blood , Insulin-Like Growth Factor I/metabolism , Italy/epidemiology , Lymphatic Metastasis , Middle Aged , Neoplasm Recurrence, Local/epidemiology , Neoplasm Recurrence, Local/prevention & control , Patient Compliance , Prognosis , Research Design , Risk Assessment , Risk Factors
15.
Epidemiol Prev ; 36(6 Suppl 1): 87-95, 2012.
Article in Italian | MEDLINE | ID: mdl-23293273

ABSTRACT

This survey, conducted by the Italian breast screening network (GISMa), collects yearly individual data on diagnosis and treatment on about 50% of all screen-detected, operated lesions in Italy. The 2010 results show good overall quality and an improving trend over time. Critical issues were identified, including waiting times and compliance with the recommendations on not performing frozen section examination on small lesions. Preoperative diagnosis improved constantly over the years, but there is still a large variation between regions and programmes. For almost 90% of screen-detected invasive cancers the sentinel lymph node technique (SLN) was performed on the axilla, avoiding a large number of potentially harmful dissections. On the other hand, potential overuse of SLN for ductal carcinoma in situ deserves further investigation. The detailed results have been distributed, also by means of a web data warehouse, to regional and local screening programmes in order to allow multidisciplinary discussion and identification of the appropriate solutions to any issues documented by the data. It should be assigned priority to the problem of waiting times. Specialist Breast Units with adequate case volume and enough resources would provide the best setting for making monitoring effective in producing quality improvements with shorter waiting times.


Subject(s)
Breast Neoplasms/diagnosis , Carcinoma, Ductal, Breast/diagnosis , Carcinoma, Intraductal, Noninfiltrating/diagnosis , Early Detection of Cancer/standards , Mammography , Mass Screening/standards , Medical Audit , Quality Indicators, Health Care , Aged , Breast Neoplasms/diagnostic imaging , Breast Neoplasms/epidemiology , Breast Neoplasms/pathology , Breast Neoplasms/therapy , Carcinoma, Ductal, Breast/diagnostic imaging , Carcinoma, Ductal, Breast/epidemiology , Carcinoma, Ductal, Breast/pathology , Carcinoma, Ductal, Breast/therapy , Carcinoma, Intraductal, Noninfiltrating/diagnostic imaging , Carcinoma, Intraductal, Noninfiltrating/epidemiology , Carcinoma, Intraductal, Noninfiltrating/pathology , Carcinoma, Intraductal, Noninfiltrating/therapy , Female , Humans , Italy/epidemiology , Middle Aged , Neoplasm Grading , Neoplasm Staging , Sentinel Lymph Node Biopsy
16.
Epidemiol Prev ; 35(5-6 Suppl 5): 87-95, 2011.
Article in English, Italian | MEDLINE | ID: mdl-22166352

ABSTRACT

This survey, conducted by the Italian breast screening network (GISMa), collects individual data yearly on about 50% of all screen-detected, operated lesions in Italy. The 2008-2009 results show good overall quality of diagnosis and treatment and an improving trend over time. Critical issues were identified, including waiting times and compliance with the recommendations on not performing frozen section examination on small lesions. Pre-operative diagnosis reached the acceptable target, but there is a large variation between regions and programmes. For almost 90% of screen-detected invasive cancers the sentinel lymph node technique (SLN) was performed on the axilla, avoiding a large number of potentially harmful dissections. On the other hand, potential overuse of SLN deserves further investigation. The detailed results have been distributed, also by means of a web-based data warehouse, to regional and local screening programmes in order to allow multidisciplinary discussion and identification of the appropriate solutions to any problem documented by the data. Specialist breast units with adequate case volume and enough resources would provide the best setting for making audits effective in producing quality improvements with shorter waiting times.


Subject(s)
Axilla/surgery , Breast Neoplasms/pathology , Breast Neoplasms/surgery , Early Detection of Cancer/standards , Medical Audit , Sentinel Lymph Node Biopsy , Breast Neoplasms/epidemiology , Female , Frozen Sections , Guideline Adherence , Health Surveys , Humans , Italy/epidemiology , Treatment Outcome
17.
Epidemiol Prev ; 34(5-6 Suppl 4): 81-8, 2010.
Article in English | MEDLINE | ID: mdl-21220839

ABSTRACT

This survey, conducted by the Italian Breast Screening Network (GISMa), collects individual data yearly on about 50% of all screen-detected, operated lesions in Italy. The 2007 results show good overall quality of diagnosis and treatment and an improving trend over time. Critical issues were identified concerning waiting times, compliance with the recommendations on not performing frozen section examination on small lesions and on performing specimen X-rays. Preoperative diagnosis reached the acceptable target, but there is a large variation between Regions and programmes. For more than 80%of screen-detected invasive cancers the sentinel lymph node technique (SLN) was performed on the axilla, avoiding a large number of potentially harmful dissections. On the other hand, potential overuse of SLN deserves further investigation. The detailed results have been distributed, also by means of a web data-warehouse, to regional and local screening programmes in order to allow multidisciplinary discussion and identification of the appropriate solutions to any problem documented by the data. Specialist Breast Units with adequate case volume and enough resources would provide the best setting for making audits effective in producing quality improvements with a shorter waiting times.


Subject(s)
Breast Neoplasms/diagnosis , Breast Neoplasms/surgery , Mass Screening/standards , Quality Indicators, Health Care/statistics & numerical data , Aged , Female , Humans , Italy , Middle Aged
18.
Mod Pathol ; 23(2): 260-9, 2010 Feb.
Article in English | MEDLINE | ID: mdl-19915523

ABSTRACT

The clinical significance of micropapillary growth pattern in ductal carcinoma in situ is controversial and the impact of nuclear grading in terms of recurrence of this lesion is yet to be clarified. Our aim was to evaluate, on a series of micropapillary in situ carcinomas, the histological features correlated with recurrence and whether the micropapillary subtype had a different behavior from other non-micropapillary ductal carcinoma in situ. We collected 55 cases of micropapillary in situ carcinomas from four institutions. All cases were reviewed for nuclear grade, extent, necrosis, microinvasion and tested for estrogen and progesterone receptors, Ki67, HER2, EGFR and p53 expression. Clinical data, type of surgery and follow up were obtained for all patients. Our results showed that the nuclear grade is crucial in determining the biology of micropapillary carcinoma in situ, so that the high nuclear grade micropapillary ductal carcinoma in situ more frequently overexpressed HER2, showed higher proliferation index, displayed necrosis and microinvasion and was more extensive than low/intermediate nuclear grade. Logistic regression analysis confirmed the high nuclear grade (Odds ratio: 6.86; CI: 1.40-33.57) as the only parameter associated with elevated risk of local recurrence after breast-conserving surgery. However, the recurrence rate of 19 micropapillary carcinoma in situ, which were part of a cohort of 338 consecutive ductal carcinoma in situ, was significantly higher (log-rank test, P-value=0.019) than that of non-micropapillary, independently of the nuclear grade. In conclusion, although nuclear grade may significantly influence the biological behavior of micropapillary ductal carcinoma in situ, micropapillary growth pattern per se represents a risk factor for local recurrence after breast-conserving surgery.


Subject(s)
Breast Neoplasms/pathology , Carcinoma in Situ/pathology , Carcinoma, Ductal, Breast/pathology , Carcinoma, Papillary/pathology , Adult , Aged , Biomarkers, Tumor/analysis , Breast Neoplasms/metabolism , Breast Neoplasms/surgery , Carcinoma in Situ/metabolism , Carcinoma in Situ/surgery , Carcinoma, Ductal, Breast/metabolism , Carcinoma, Ductal, Breast/surgery , Carcinoma, Papillary/metabolism , Carcinoma, Papillary/surgery , ErbB Receptors/biosynthesis , Female , Humans , Immunohistochemistry , In Situ Hybridization, Fluorescence , Kaplan-Meier Estimate , Ki-67 Antigen/biosynthesis , Middle Aged , Neoplasm Recurrence, Local/epidemiology , Neoplasm Recurrence, Local/metabolism , Neoplasm Recurrence, Local/pathology , Receptor, ErbB-2/biosynthesis , Risk Factors , Tumor Suppressor Protein p53/biosynthesis
19.
Epidemiol Prev ; 33(3 Suppl 2): 83-90, 2009.
Article in English | MEDLINE | ID: mdl-19776489

ABSTRACT

Within this survey, conducted by the Italian Breast Screening Network (Gruppo Italiano per lo Screening Mammografico, GISMa), individual data are collected yearly on more than 50% of all screen-detected operated lesions in Italy. In 2006, results showed overall good diagnosis and treatment quality and an improving trend over time. Critical issues were identified in waiting times, compliance with recommendations on not performing frozen section examination on small lesions and on performing specimen X-ray. Pre-operative diagnosis reached the acceptable target, but there is a large variation between Regions and programmes. The sentinel lymph node technique (SLN) was performed on the axilla in more than 70% of screen-detected invasive cancers, avoiding a large number of potentially harmful dissections. On the other hand, potential overuse of SLN in ductal carcinoma in situ deserves further investigation. The detailed results have been distributed to regional and local screening programmes, also by means of an online database, in order to allow multidisciplinary discussion and the identification of appropriate solutions to any problems documented by the data. Specialist Breast Units with adequate case volume and enough resources would provide the best setting for making audit effective in producing quality improvement with a shortening of waiting times.


Subject(s)
Breast Neoplasms/diagnosis , Breast Neoplasms/surgery , Mass Screening/statistics & numerical data , Medical Audit/statistics & numerical data , Quality Indicators, Health Care , Aged , Female , Humans , Italy , Lymph Node Excision , Middle Aged
20.
Epidemiol Prev ; 32(2 Suppl 1): 77-84, 2008.
Article in English | MEDLINE | ID: mdl-18770996

ABSTRACT

Within this survey, conducted by the Italian Group of Mammography Screening (GISMa), individual data are collected yearly on more than 50% of all screen-detected operated lesions in Italy. In 2005, results showed overall good diagnosis and treatment quality, and an improving trend over time. Critical issues were identified in waiting times, compliance with the recommendations on not performing frozen section examination on small lesions and on performing specimen X-ray. Pre-operative diagnosis has reached the acceptable target, but room for improvement still exists. The sentinel lymph node technique (SLN) was performed on the axilla in more than 70% of screen-detected invasive cancers, avoiding a large number of potentially harmful dissections. On the other hand, potential overuse of SLN deserves further investigation. The detailed results have been distributed to local and regional screening programmes in order to allow multidisciplinary discussion and the identification of appropriate solutions to any problems documented by the data. Specialist Breast Units with adequate case volume would provide the best setting for making audit effective in producing quality improvement.


Subject(s)
Breast Neoplasms , Commission on Professional and Hospital Activities , Quality of Health Care/standards , Breast Neoplasms/diagnosis , Breast Neoplasms/epidemiology , Breast Neoplasms/therapy , Catchment Area, Health , Female , Humans , Incidence , Italy/epidemiology
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