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A study was conducted to assess the fraction of female breast cancer (BC) deaths attributable to alcohol consumption in Italy. National mortality data for the period 2015-2019 were used along with national estimates of women from the general population exposed to moderate (11-20 gr/day) or heavy (>20 gr/day) alcohol consumption. From 2015 to 2019, 2918 (4.6%) out of 63,428 BC| deaths were attributable to alcohol consumption, including 1269 deaths (2.0%) caused by moderate consumption. Study findings could help stakeholders to prioritize programs aimed at reducing alcohol consumption, and to improve ways to effectively communicate alcohol-related health risks, including moderate consumption., Competing Interests: Declaration of competing interest All Authors declare that they have no conflicts of interest., (Copyright © 2023 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Background: The age-standardized rate of breast cancer (BC) increased nearly nine-fold in the last 30 years in Setif, Algeria. A case-control study was carried out to investigate the role of sociodemographic characteristics and reproductive factors in the etiology of BC in this young Arab/Berber population of Setif., Methods: Cases were 612 women with incident BC admitted to major teaching and general hospitals of Setif during 2012-2017. Controls were 615 women admitted for acute, non-neoplastic conditions to the same hospital network of cases. Information was elicited using a standardized questionnaire. Odds ratios (ORs) and 95% confidence intervals (CIs) were computed after allowance for age and education., Results: Significant associations with BC risk emerged for family history of BC (OR= 4.15 for yes vs. no; 95%CI: 2.22-7.77), for the generation of oral contraceptive used (OR=1.57 for II-generation vs. III-generation; 95%CI:1.01-2.44), and education (OR=0.63 for >11 years vs. no schooling; 95%CI: 0.46-0.86). Conversely, parity and body mass index were not associated with BC risk, whereas a late age at menarche was linked with a non statistically significant BC risk (OR=1.20 for >15 vs.

A higher frequency of early onset female breast cancers (BC) has been observed in low/middle income countries than in high income countries. We quantified the role of population ageing to this pattern using data from all population-based cancer registries (CRs) worldwide. Patients' median age at BC onset and that of the general population were extracted for CRs listed in volumes VI (1983-1987 years) through XI (2008-2012 years) of Cancer Incidence in Five Continents. Their association was assessed at cross-sectional level by linear regression model and longitudinally considering 25-year ageing of the population in long-standing CRs listed at the beginning and at the end of the study. During 2008-2012, each one-year increase of population ageing was associated with a nearly ½ year increase of age at BC diagnosis. Population demographics explained forty-two percent of the age variance for BC. In 1983-1987, long-standing CRs with a median age at BC below age 61.8 years showed an increase of age at BC after 25-years. Worldwide, age at BC diagnosis essentially reflected the median age of the population. Changes in BC detection methodology likely lessened this association. Nevertheless, the elevated absolute number of BCs in young populations deserves strategies of BC prevention.

Objectives: To assess the accuracy of International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) codes in identifying patients diagnosed with incident carcinoma in situ and invasive breast cancer in three Italian administrative databases., Design: A diagnostic accuracy study comparing ICD-9-CM codes for carcinoma in situ (233.0) and for invasive breast cancer (174.x) with medical chart (as a reference standard). Case definition: (1) presence of a primary nodular lesion in the breast and (2) cytological or histological documentation of cancer from a primary or metastatic site., Setting: Administrative databases from Umbria Region, Azienda Sanitaria Locale (ASL) Napoli 3 Sud (NA) and Friuli VeneziaGiulia (FVG) Region., Participants: Women with breast carcinoma in situ (n=246) or invasive breast cancer (n=384) diagnosed (in primary position) between 2012 and 2014., Outcome Measures: Sensitivity and specificity for codes 233.0 and 174.x., Results: For invasive breast cancer the sensitivities were 98% (95% CI 93% to 99%) for Umbria, 96% (95% CI 91% to 99%) for NA and 100% (95% CI 97% to 100%) for FVG. Specificities were 90% (95% CI 82% to 95%) for Umbria, 91% (95% CI 83% to 96%) for NA and 91% (95% CI 84% to 96%) for FVG.For carcinoma in situ the sensitivities were 100% (95% CI 93% to 100%) for Umbria, 100% (95% CI 95% to 100%) for NA and 100% (95% CI 96% to 100%) for FVG. Specificities were 98% (95% CI 93% to 100%) for Umbria, 86% (95% CI 78% to 92%) for NA and 90% (95% CI 82% to 95%) for FVG., Conclusions: Administrative healthcare databases from Umbria, NA and FVG are accurate in identifying hospitalised news cases of carcinoma of the breast. The proposed case definition is a powerful tool to perform research on large populations of newly diagnosed patients with breast cancer., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2018. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objective: To define the accuracy of administrative datasets to identify primary diagnoses of breast cancer based on the International Classification of Diseases (ICD) 9th or 10th revision codes., Design: Systematic review., Data Sources: MEDLINE, EMBASE, Web of Science and the Cochrane Library (April 2017)., Eligibility Criteria: The inclusion criteria were: (a) the presence of a reference standard; (b) the presence of at least one accuracy test measure (eg, sensitivity) and (c) the use of an administrative database., Data Extraction: Eligible studies were selected and data extracted independently by two reviewers; quality was assessed using the Standards for Reporting of Diagnostic accuracy criteria., Data Analysis: Extracted data were synthesised using a narrative approach., Results: From 2929 records screened 21 studies were included (data collection period between 1977 and 2011). Eighteen studies evaluated ICD-9 codes (11 of which assessed both invasive breast cancer (code 174.x) and carcinoma in situ (ICD-9 233.0)); three studies evaluated invasive breast cancer-related ICD-10 codes. All studies except one considered incident cases.The initial algorithm results were: sensitivity ≥80% in 11 of 17 studies (range 57%-99%); positive predictive value was ≥83% in 14 of 19 studies (range 15%-98%) and specificity ≥98% in 8 studies. The combination of the breast cancer diagnosis with surgical procedures, chemoradiation or radiation therapy, outpatient data or physician claim may enhance the accuracy of the algorithms in some but not all circumstances. Accuracy for breast cancer based on outpatient or physician's data only or breast cancer diagnosis in secondary position diagnosis resulted low., Conclusion: Based on the retrieved evidence, administrative databases can be employed to identify primary breast cancer. The best algorithm suggested is ICD-9 or ICD-10 codes located in primary position., Trial Registration Number: CRD42015026881., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2018. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Within a dramatic socio-political context, cancer represents a growing health burden in the Gaza Strip. We investigated the survival experience of people diagnosed with breast (BC) or colorectal (CRC) cancer from 2005 to 2014., Methods: Data included 1360 BC cases (median age 55.1 years) and 722 CRC cases (median age: 59.5 years; 52.5% men) recorded by the Gaza Cancer Registry according to a standard protocol. Clinical information was available for cases diagnosed in 2005-2006 only. Survival probabilities were estimated by Kaplan-Meyer method, while hazard ratios (HRs) and 95% confidence intervals (CI), adjusted for age and sex, were computed to assess factors associated with the risk of death., Results: Five-year survival was 65.1% for women with BC and 50.2% for patients with CRC. Advanced age (> 65 years), stage, and grade increased the death risk. Full access to therapies was associated with a reduced risk of death as compared with patients who had limited access (HR = 0.26, 95% CI:0.13-0.51 for BC; and HR = 0.11, 95% CI:0.04-0.31 for CRC)., Conclusion(s): The 5-year survival after BC or CRC in the Gaza Strip was in line with estimates from surrounding Arab countries, but it was much lower than in developed Mediterranean countries (e.g., in Italy or in Jewish people in Israel).

Background: Mechanisms influencing breast cancer (BC) development and recurrence include hyperglycemia, hyperinsulinemia, high insulin-like growth factor-1, high circulating estrogen, inflammation and impaired cellular differentiation/apoptosis. A lifestyle program that targets all the above mechanisms may be warranted. Low glycemic index (GI) foods produce lower post-prandial glucose and insulin responses and have been associated with lower BC risk. Moderate physical activity post-diagnosis reduces BC recurrence and mortality, partly explained by reduced insulin and estrogen levels. Vitamin D increases cell differentiation/apoptosis and high serum vitamin D levels improve BC survival. Yet no trial has evaluated the combined effect of a low GI diet, moderate physical activity and vitamin D supplementation on BC recurrence in the context of a Mediterranean lifestyle setting., Methods: Women (30-74 yr) who had undergone surgery for primary histologically confirmed BC (stages I-III) within the previous 12 months, in cancer centres in Italy, will be randomized to follow, for a maximum of 33 months, either a high intensity treatment (HIT) composed of low GI diet + exercise + vitamin D (60 ng/mL serum concentration) or a lower intensity treatment (LITE) with general advice to follow a healthy diet and exercise pattern + vitamin D to avoid insufficiency. Both interventions are on a background of a Mediterranean diet. Considering a 20% recurrence rate within 3 years for BC cases and a predicted rate of 10% in the HIT group, with power of 80% and two-sided alpha of 0.05, the subject number required will be 506 (n = 253 in each arm). Clinic visits will be scheduled every 3 months. Dietary and exercise counselling and vitamin D supplements will be given at each clinic visit when blood samples, anthropometric measures and 7-day food records will be collected., Discussion: DEDiCa study aims to reduce BC recurrence in women with BC using a lifestyle approach with additional vitamin D and to investigate possible cardio-metabolic benefits as well as epigenetic modifications according to lifestyle changes. Given the supporting evidence and safety of the components of our intervention we believe it is feasible and urgent to test it in cancer patients., Trial Registration: May 11, 2016; NCT02786875 ., Eudract Number: 2015-005147-14.

Introduction: Administrative healthcare databases are useful tools to study healthcare outcomes and to monitor the health status of a population. Patients with cancer can be identified through disease-specific codes, prescriptions and physician claims, but prior validation is required to achieve an accurate case definition. The objective of this protocol is to assess the accuracy of International Classification of Diseases Ninth Revision-Clinical Modification (ICD-9-CM) codes for breast, lung and colorectal cancers in identifying patients diagnosed with the relative disease in three Italian administrative databases., Methods and Analysis: Data from the administrative databases of Umbria Region (910,000 residents), Local Health Unit 3 of Napoli (1,170,000 residents) and Friuli--Venezia Giulia Region (1,227,000 residents) will be considered. In each administrative database, patients with the first occurrence of diagnosis of breast, lung or colorectal cancer between 2012 and 2014 will be identified using the following groups of ICD-9-CM codes in primary position: (1) 233.0 and (2) 174.x for breast cancer; (3) 162.x for lung cancer; (4) 153.x for colon cancer and (5) 154.0-154.1 and 154.8 for rectal cancer. Only incident cases will be considered, that is, excluding cases that have the same diagnosis in the 5 years (2007-2011) before the period of interest. A random sample of cases and non-cases will be selected from each administrative database and the corresponding medical charts will be assessed for validation by pairs of trained, independent reviewers. Case ascertainment within the medical charts will be based on (1) the presence of a primary nodular lesion in the breast, lung or colon-rectum, documented with imaging or endoscopy and (2) a cytological or histological documentation of cancer from a primary or metastatic site. Sensitivity and specificity with 95% CIs will be calculated., Dissemination: Study results will be disseminated widely through peer-reviewed publications and presentations at national and international conferences., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/)

Background: Neoadjuvant Chemotherapy (NC) including trastuzumab induces a high rate of pathological Complete Responses (pCR) in patients with locally advanced HER2-overexpressing Breast Cancer (BC), but is penalized by a severe cardiotoxicity when combined with anthracyclines. A phase II study was designed to assess whether an anthracycline-free NC regimen based on the early addition of trastuzumab to paclitaxel may increase the pCR rate without inducing severe cardiotoxicity in patients with locally advanced HER2-overexpressing BC. Immunomonitoring was performed to assess the contribution of patients' immunological background to the induction of clinical responses., Methods: Stage II-III HER2-positive BC patients received 24 weeks paclitaxel and trastuzumab NC, followed by 1 year adjuvant trastuzumab ± hormonal and/or radio-therapy. Assessment of pCR rate was the primary endpoint. A group of HER2-negative BC patients treated with neoadjuvant taxanes and anthracyclines was included. Serum levels of 10 cytokines and the efficiency of trastuzumab-mediated antibody-dependent cell cytotoxicity (ADCC) were monitored in vitro every 3 months., Results: From July 2006 to February 2013, we enrolled 109 patients including 46 evaluable HER2-positive cases. A pCR rate of 50% was reached and no severe cardiotoxicity occurred. Serum cytokine profiling revealed only an IL-10 decrease (P = 0.02) in patients achieving a partial response, while HER2-negative patients disclosed marked cytokines changes. Compared to the unfavourable F/F genotype, patients carrying the V allele in the FcγRIIIa-158 polymorphism showed a higher efficacy of trastuzumab-ADCC throughout treatment (P ≤0.05)., Conclusions: In the absence of anthracyclines, trastuzumab and paclitaxel induced a high rate of pCR, exploiting the synergy between the immunomodulating properties of these drugs and the retained immunological proficiency of patients with HER2-overexpressing BC., Trial Registration: Trial registration number: NCT02307227, registered on ClinicalTrials.gov (http://www.clinicaltrials.gov, November 26, 2014).

Background: A population of breast cancer patients exists who, for various reasons, never received adjuvant post-operative tamoxifen (TAM). This study was aimed to evaluate the role of late TAM in these patients., Methods: From 1997 to 2003, patients aged 35 to 75 years, operated more than 2 years previously for monolateral breast cancer without adjuvant TAM, with no signs of metastases and no contraindication to TAM were randomized to TAM 20 mg/day orally for 2 years or follow-up alone. Events were categorized as locoregional relapse, distant metastases, metachronous breast cancer, tumours other than breast cancer and death from any causes, whichever occurred first. The sample size (197 patients per arm, plus 10% allowance) was based on the assumption of a 30% decrease in the number of events occurring at a rate of 5% annually in the 10 years following randomization. Four hundred and thirty-three patients were randomized in the study (TAM 217, follow-up 216). Patients characteristics (TAM/follow-up) included: median age 55/55 years, median time from surgery 25/25 months (range, 25-288/25-294), in situ carcinoma 18/24, oestrogen receptor (ER) positive in 75/68, negative in 70/57, unknown in 72/91 patients. Previous adjuvant treatment included chemotherapy in 131/120 and an LHRH analogue in 11/13 patients., Results: Thirty-six patients prematurely discontinued TAM after a median of 1 month, mostly because of subjective intolerance. Eighty-three events (TAM 39, follow-up 44) occurred: locoregional relapse in 10/8, distant metastases in 14/16, metachronous breast cancer in 4/10, other tumours in 11/10 patients. Less ER-positive secondary breast cancers occurred in the TAM treated patients than in follow-up patients (1 vs 10, p = 0.005). Event-free survival was similar in both groups of patients., Conclusions: This 5-year analysis revealed significantly less metachronous ER-positive breast cancers in the TAM treated patients. No other statistically significant differences have emerged thus far.

Aims and Background: Trastuzumab-based therapy has improved survival of women with human epidermal growth factor receptor 2 (HER2)-overexpressing metastatic breast cancer., Study Design: From September 2002 to July 2006, 45 women with metastatic breast cancer HER2 3+, or 2+ and positive for HER2 gene amplification, were enrolled in the study and received a combination therapy with vinorelbine, 25 mg/m2 weeks 1 and 2, plus trastuzumab, 4 mg/kg loading dose and then 2 mg/kg weekly, in a three weeks cycle. Eligibility criteria included measurable disease and a baseline ejection fraction > or = 50%. Forty-two percent of the patients were not pretreated, whereas 58% had received a previous chemotherapy regimen for metastatic disease, including anthracyclines and/or taxanes (47%), and trastuzumab plus taxol (11%)., Results: We observed 14 (31%) complete responses and 21 (47%) partial responses, with an overall response rate of 78%. Stable disease > 6 months was assessed for 5 (11%) patients with a clinical benefit of 89%. Five (11%) patients progressed. With a median follow-up of 11 months, median time to progression was 9 months and median duration of response was 7.6 months for complete remissions and 4 months for partial remissions. Median survival was 29 months., Conclusions: In spite of a smaller dose intensity of vinorelbine than previously reported, the regimen evaluated was notably effective in terms of response rate, time to progression and survival, with very mild toxicity.

Background: The clinical and pathological characteristics and the clinical course of patients with breast cancer and BRCA 1-2 mutation are poorly known., Methods: From 1997, patients with breast cancer and a family history of breast or ovarian cancer were offered BRCA testing. The clinical and pathological features of patients with known BRCA status were retrospectively assessed and comparisons were made between cancers arising in BRCA positive and BRCA wild type (WT) patients respectively. Type of treatment, pattern of relapse, event (local relapse, contralateral breast cancer, metastases) free and overall survival were also compared in the two groups. Out of the 210 patients tested, 125 had been treated and followed-up at our Institution and were evaluated in this study., Results: BRCA positive patients tended to be more often premenopausal (79% vs 65%) and to have positive lymphnodes (63% vs 49%), poorly differentiated tumours (76% vs 40%--p = 0.002 at univariate analysis, not significant at multivariate analysis) and negative estrogen receptors (43% vs 29%). Treatment was not different in the two groups. In the 86 BRCA-WT patients, the first event was a local relapse in 3 (3%), metachronous contralateral breast cancer in 7 (8%) and distant metastases in 16 (19%). In the 39 BRCA positive patients, the corresponding figures were 3 (8%), 8 (21%) and 3 (8%). There was no difference in event free survival, with a median of 180 months in both groups of patients. At 20 years, projected survival was 85% for BRCA positive patients and 55% for BRCA-WT, but this difference was not statistically significant., Conclusion: Although BRCA positive patients have more frequently negative prognostic factors, their prognosis appears to be equal to or better than in patients with BRCA-WT.

Aims and Background: Anthracyclines are among the most active agents for the treatment of patients with locally advanced breast cancer. The aim of our study was to evaluate the feasibility and activity of a relatively high-dose regimen with 4-epirubicin plus normal doses of cyclophosphamide over a short period of time without the use of hematologic growth factors as adjuvant in resected locally advanced breast cancer., Methods: Between January 1990 and June 1992, 43 consecutive patients, premenopausal or postmenopausal < 60 yrs, were surgically resected and then treated with epirubicin plus cyclophosphamide for at least 4 cycles (maximum 6). Electron beam (6-10 MeV energy) radiotherapy was delivered on the chest wall in patients with pathological skin infiltration (pT4b)., Results: Median age was 46 years (range, 27-59); 37 were premenopausal and 6 postmenopausal. The total number of administered cycles was 202 (6 in 15 patients and 4 in 28 patients); 195/202 (96.5%) were administered at full dose, and 7 (3.5%) were reduced to 75% of the planned dosage. The three-year disease-free survival was 67% for stage IIIa and 61% for stage IIIb patients. The three-year overall survival was 88% and 79%, respectively. Local relapse only was reported in one patient (2%), distant relapse in 11 patients (25%), and local and distant relapse in four patients (9%). Toxicity was acceptable and mainly hematologic., Conclusions: Our trial showed that the regimen is feasible without the use of hematologic growth factors. In this era of cost containment, the use of this short-term, high-dose induction course instead of repetitive courses of conventional dose regimens merits further evaluation, possibly in a large randomized trial.

In order to obtain prognostic clinicopathological information, 49 cases of pure ductal carcinoma in situ of the breast (DCIS), were evaluated for the immunohistochemical expression of potential predictor markers including c-erbB-2 oncogene product, p53 protein, oestrogen (ER) and progesterone (PR) receptors, oestrogen-regulated proteins pS2 and cathepsin-D (cath-D), CD44 protein and 67-kDa laminin receptor (MLuC5). Immunohistochemical findings were compared with conventional pathological parameters, clinical findings, and the clinical outcome of the patients. When markers were matched to each other, statistical analyses provided a significant positive correlation between c-erbB-2 overexpression and p53 positivity (P < 0.01) and between ER and PR (P < 0.01), ER, PR and pS2 (P < 0.01), pS2 and MLuC5 (P < 0.05). Significant negative correlations between c-erbB-2 overexpression and ER (P < 0.05), PR (P < 0.01) and pS2 (P < 0.01) positivity was also observed. Data on the relationship between marker status and pathological findings revealed a significant positive trend between c-erbB-2, p53, and increased grade values (P < 0.05) and opposite results with PR receptor expression (P < 0.01). c-erbB-2 overexpression was further significantly associated with comedotype carcinoma (P < 0.05) and distribution of disease in confluent neoplastic ducts (P < 0.01). Although no statistically significant correlation among biological markers expression, clinical findings and outcome was demonstrated, overall this study indicates that tumour cells from a subset of DCIS, which includes comedotype carcinoma, express significantly unfavourable prognostic factors.

The association between alcohol drinking and breast cancer risk was investigated in 132 breast cancer cases and 499 controls with acute conditions unrelated to alcohol or any of the suspected risk factors for breast cancer, in an area which shows among the highest levels of alcohol consumption and prevalence of alcohol-related diseases in Europe (i.e. Pordenone Province, Northeastern part of Italy). Compared with non-drinkers, the multivariate odds ratio (OR) for ever drinkers was 1.5 (95% confidence interval, CI: 0.8-2.6). The risks for wine (the almost exclusive source of alcohol in the present investigation) were 1.2 for up to 1 drink, 1.4 for up to two drinks, 1.9 for up to 3 and 1.6 for over 3 drinks per day. Time-related factors (i.e. drinking habit duration and age at start of drinking) did not seem to be risk indicators.