One-year nutrition counselling in the context of a Mediterranean diet reduced the dietary inflammatory index in women with breast cancer: a role for the dietary glycemic index.

Background: the Mediterranean diet, the low dietary glycemic index (GI) and the dietary inflammation index (DII®) have been associated with lower risk of breast cancer (BC) incidence and mortality. Objective: to investigate whether one-year nutrition counselling in the context of a Mediterranean diet, with or without low-GI carbohydrates counselling, may influence the DII in women with BC. Methods: data were obtained from participants of DEDiCa trial randomized to a Mediterranean diet (MD, n = 112) or a Mediterranean diet with low-GI carbohydrates (MDLGI, n = 111). The diet-derived DII and GI were calculated from 7-day food records while Mediterranean diet adherence from PREDIMED questionnaire. Differences between study arms were evaluated through Fisher's exact test or Mann-Whitney test and associations with multivariable regression analyses. Results: Mediterranean diet adherence significantly increased by 15% in MD and 20% in MDLGI with no difference between arms (p < 0.326). Dietary GI significantly decreased from 55.5 to 52.4 in MD and 55.1 to 47.6 in MDLGI with significant difference between arms (p < 0.001). DII significantly decreased by 28% in MD and 49% in MDLGI with no difference between arms (p < 0.360). Adjusting for energy intake (E-DII) did not change the results. Higher Mediterranean diet adherence and lower dietary GI independently contributed to DII lowering (ß-coefficient -0.203, p < 0.001; 0.046, p = 0.003, respectively). Conclusions: DII and E-DII scores decreased significantly after one-year with 4 nutrition counselling sessions on the Mediterranean diet and low GI. Increased adherence to the Mediterranean diet and low GI independently contributed to the DII changes. These results are relevant given that lowering the inflammatory potential of the diet may have implications in cancer prognosis and overall survival.

Identification of Immune Cell Components in Breast Tissues by a Multiparametric Flow Cytometry Approach.

Immune cell components are able to infiltrate tumor tissues, and different reports described the presence of infiltrating immune cells (TILs) in several types of solid tumors, including breast cancer. The primary immune cell component cells are reported as a lymphocyte population mainly comprising the cytotoxic (CD8+) T cells, with varying proportions of helper (CD4+) T cells and CD19+ B cells, and rarely NK cells. In clinical practice, an expert pathologist commonly detects TILs areas in hematoxylin and eosin (H&E)-stained histological slides via light microscopy. Moreover, other more in-depth approaches could be used to better define the immunological component associated with tumor tissues. Using a multiparametric flow cytometry approach, we have studied the immune cells obtained from breast tumor tissues compared to benign breast pathologies. A detailed evaluation of immune cell components was performed on 15 and 14 biopsies obtained from breast cancer and fibroadenoma subjects, respectively. The percentage of tumor-infiltrating T lymphocytes was significantly higher in breast cancer patients compared to patients with fibroadenoma. Infiltrating helper T lymphocytes were increased in the case of malignant breast lesions, while cytotoxic T lymphocytes disclosed an opposite trend. In addition, our data suggest that the synergistic effect of the presence/activation of NK cells and NKT cells, in line with the data in the literature, determines the dampening of the immune response. Moreover, the lymphocyte-to-monocyte ratio was calculated and was completely altered in patients with breast cancer. Our approach could be a potent prognostic factor to be used in diagnostic/therapeutic purposes for the improvement of breast cancer patients' management.

Preoperative localisation of nonpalpable breast lesions using magnetic markers in a tertiary cancer centre.

BACKGROUND: We retrospectively evaluated safety and performance of magnetic seed localisation of nonpalpable breast lesions. METHODS: We reviewed records of patients with nonpalpable breast lesions preoperative localised by placing magnetic Magseed® marker between February 2019 and December 2020. During surgery, Sentimag® magnetic probe was used to localise the marker and guide surgery. Safety, lesion identification and excision with tumour with free margins and re-excision rate were assessed. RESULTS: A total of 77 Magseed® devices were placed into the breasts of 73 patients, 44 under ultrasound and 33 under stereotactic guidance (4 bilateral). All devices were retrieved as were the target lesions. Magnetic marker placement was successful in all cases without any adverse event. Intraoperative identification and excision of the localised lesion were successful in 77 of 77 of cases (100%). In three cases (all of them calcifications with the seed placed under stereotactic guidance), the seed did not reach the exact target position of the biopsy clip; thus, larger excision was needed, with localisation failure attributed to incorrect clip insertion (n = 1) or to clip dislocation (n = 2). Migration of the marker was negligible in all patients. Complete excision after the initial procedure with at least 1-mm disease-free margins was obtained in 74 out of 77 (96.1%) lesions. The re-excision rate was 3 out of 77 (4%). CONCLUSIONS: Magnetic marker localisation for nonpalpable breast lesions was safe, reliable, and effective in terms of lesion identification, excision with tumour-free margins and re-excision rate.

Correction: Mediterranean diet and quality of life in women treated for breast cancer: A baseline analysis of DEDiCa multicentre trial.

[This corrects the article DOI: 10.1371/journal.pone.0239803.].

Mediterranean diet and quality of life in women treated for breast cancer: A baseline analysis of DEDiCa multicentre trial.

Evidence suggests a beneficial role of the Mediterranean Diet (MedDiet) on health-related quality of life (HRQoL) in healthy subjects. HRQoL is relevant in cancer therapy and disease outcomes, therefore we investigated the association between adherence to the MedDiet and HRQoL in breast cancer survivors participating in the multicentre trial DEDiCa. Diet and HRQoL were assessed at baseline in a subgroup of 309 women enrolled within 12 months of breast cancer diagnosis without metastasis (stages I-III, mean age 52±1 yrs, BMI 27±7 kg/m2). The 14-item PREDIMED questionnaire was used to analyse adherence to the MedDiet. HRQoL was assessed with three validated questionnaires measuring physical, mental, emotional and social factors: EQ-5D-3L, EORTC QLQ-C30 and EORTC QLQ-BR23. Analysis of variance (ANOVA) and multivariate analyses were performed to assess the possible role of the MedDiet on HRQoL. Patients with higher adherence to MedDiet (PREDIMED score >7) showed significantly higher scores for physical functioning (p = 0.02) and lower scores on the symptomatic pain scale (p = 0.04) assessed by the EORTC QLQ-C30 questionnaire compared to patients with a lower adherence to MedDiet (PREDIMED score ≤7). Higher scores from the EQ-5D-3L indicating higher well-being were observed mainly in participants with higher MedDiet adherence (p = 0.05). In adjusted multivariate analyses significant positive associations were found between MedDiet, physical functioning (p = 0.001) and EQ 5D-3L score (p = 0.003) while inverse associations were found with pain and insomnia symptoms (p = 0.005 and p = 0.029, respectively). These results suggest that higher adherence to the MedDiet in breast cancer survivors is associated with better aspects of quality of life, specifically higher physical functioning, better sleep, lower pain and generally higher well-being confirming findings in healthy subjects.

Quality of Life in Women Diagnosed with Breast Cancer after a 12-Month Treatment of Lifestyle Modifications.

Healthy lifestyles are associated with better health-related quality of life (HRQoL), favorable prognosis and lower mortality in breast cancer (BC) survivors. We investigated changes in HRQoL after a 12-month lifestyle modification program in 227 BC survivors participating in DEDiCa trial (Mediterranean diet, exercise, vitamin D). HRQoL was evaluated through validated questionnaires: EQ-5D-3L, EORTC-QLQ-C30 and EORTC QLQ-BR23. Baseline changes were tested using analysis of variance. Multiple regression analyses were performed to assess treatment effects on HRQoL. Increases were observed in global health status (p < 0.001), physical (p = 0.003), role (p = 0.002) and social functioning (p < 0.001), body image (p < 0.001), future perspective (p < 0.001), well-being (p = 0.001), and reductions in fatigue (p < 0.001), nausea and vomiting (p = 0.015), dyspnea (p = 0.001), constipation (p = 0.049), financial problems (p = 0.012), sexual functioning (p = 0.025), systematic therapy side effects (p < 0.001) and breast symptoms (p = 0.004). Multiple regression analyses found inverse associations between changes in BMI and global health status (p = 0.048) and between serum 25(OH)D levels and breast symptoms (p = 0.002). A healthy lifestyle treatment of traditional Mediterranean diet and exercise may impact positively on HRQoL in BC survivors possibly through reductions in body weight while vitamin D sufficiency may improve BC-related symptoms. These findings are relevant to BC survivors whose lower HRQoL negatively affects treatment compliance and disease outcomes.

Intracystic papillary breast carcinoma with DCIS in a man: a case report.

Here we report a case of 50-mm lump within the left breast in a 56-year-old man. The patient underwent left total mastectomy and sentinel node biopsy. The pathology report showed low-grade intracystic papillary breast carcinoma surrounded by ductal carcinoma in situ. Sentinel node biopsy was negative. The patient was prescribed five years tamoxifen.

Angiosarcoma of the breast, the unknown-a review of the current literature.

Angiosarcoma of the breast is one of the rarest malignancies. Breast angiosarcoma can be classified into primary when arising de novo and secondary to chronic lymphoedema or breast irradiation. Molecular pathways involved in angiosarcoma development have not been described clearly, yet some gene point mutations and protein altered expression levels have been detected. So far, their management is based above all on surgery. Hence, further studies starting from the few known key points may help to develop more effective strategies based both on target therapies, together with surgery.

Low glycemic index diet, exercise and vitamin D to reduce breast cancer recurrence (DEDiCa): design of a clinical trial.

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.

Added Value of Breast MRI for Preoperative Diagnosis of Ductal Carcinoma In Situ: Diagnostic Performance on 362 Patients.

INTRODUCTION: The purpose of this study was to evaluate the added value of breast magnetic resonance imaging (MRI) in preoperative diagnosis of ductal carcinoma in situ (DCIS). We reviewed our institution database of 3499 consecutive patients treated for breast cancer. PATIENTS AND METHODS: A total of 362 patients with histologically proven DCIS were selected from the institutional database. Of these, 245 (67.7%) preoperatively underwent conventional imaging (CI) (mammography/ultrasonography) (CI group), and 117 (32.3%) underwent CI and dynamic MRI (CI + MRI group). The pathology of surgical specimens served as a reference standard. The Mann-Whitney U, χ2 test, and Spearman correlation coefficient were performed. RESULTS: The CI + MRI group showed a sensitivity of 98.5% with an increase of 10.1% compared with the CI group to detect pure DCIS. Dynamic MRI identified 19.7% (n = 13) additional pure DCIS compared with CI. In the CI + MRI group, a single (1.5%) false negative was reported, whereas in the CI group, 11 (11.6%) false negatives were reported. Moreover, the CI + MRI group showed a sensitivity of 98.0% to detect DCIS + small invasive component. In this group, dynamic MRI identified 21.6% (n = 11) additional DCIS and a single (2.0%) false negative compared with the CI group, whereas in the CI group, 7 (4.7%) false negatives were reported. MRI and histopathologically measured lesion sizes, Breast Imaging Reporting and Data System MRI assessment categories, and enhancement signal intensity curve types showed a significant correlation. The MRI detection rate of DCIS increased significantly with increasing nuclear grade. CONCLUSIONS: Preoperative breast MRI showed a better accuracy then CI in preoperative diagnosis for both pure DCIS and DCIS + small invasive component with a precise assessment of lesion size. This can provide a more appropriate management of DCIS patients.

Breast Contrast Enhanced MR Imaging: Semi-Automatic Detection of Vascular Map and Predominant Feeding Vessel.

PURPOSE: To obtain breast vascular map and to assess correlation between predominant feeding vessel and tumor location with a semi-automatic method compared to conventional radiologic reading. METHODS: 148 malignant and 75 benign breast lesions were included. All patients underwent bilateral MR imaging. Written informed consent was obtained from the patients before MRI. The local ethics committee granted approval for this study. Semi-automatic breast vascular map and predominant vessel detection was performed on MRI, for each patient. Semi-automatic detection (depending on grey levels threshold manually chosen by radiologist) was compared with results of two expert radiologists; inter-observer variability and reliability of semi-automatic approach were assessed. RESULTS: Anatomic analysis of breast lesions revealed that 20% of patients had masses in internal half, 50% in external half and the 30% in subareolar/central area. As regards the 44 tumors in internal half, based on radiologic consensus, 40 demonstrated a predominant feeding vessel (61% were supplied by internal thoracic vessels, 14% by lateral thoracic vessels, 16% by both thoracic vessels and 9% had no predominant feeding vessel-p<0.01), based on semi-automatic detection, 38 tumors demonstrated a predominant feeding vessel (66% were supplied by internal thoracic vessels, 11% by lateral thoracic vessels, 9% by both thoracic vessels and 14% had no predominant feeding vessel-p<0.01). As regards the 111 tumors in external half, based on radiologic consensus, 91 demonstrated a predominant feeding vessel (25% were supplied by internal thoracic vessels, 39% by lateral thoracic vessels, 18% by both thoracic vessels and 18% had no predominant feeding vessel-p<0.01), based on semi-automatic detection, 94 demonstrated a predominant feeding vessel (27% were supplied by internal thoracic vessels, 45% by lateral thoracic vessels, 4% by both thoracic vessels and 24% had no predominant feeding vessel-p<0.01). An excellent agreement between two radiologic assessments (k = 0.81) and between radiologic consensus and semi-automatic assessment (k = 0.80) was found to identify origin of predominant feeding vessel. An excellent reliability for semi-automatic assessment (Cronbach's alpha = 0.96) was reported. CONCLUSIONS: Predominant feeding vessel location was correlated with breast lesion location: internal thoracic artery supplied the highest proportion of breasts with tumor in internal half and lateral thoracic artery supplied the highest proportion of breasts with lateral tumor.

Intraoperative radiotherapy in elderly patients with breast cancer: Is there a clinical applicability? Review of the current evidence.

INTRODUCTION: Screening and adjuvant postoperative therapies have increased survival amongst women with breast cancer, but these tools are seldom applied in elderly patients. Higher rates of local recurrence occur in those elderly patients who avoid radiotherapy. TARGIT-A and ELIOT trials has been reported to not to be inferior to external beam RT in suitable subgroups of patients. The TARGIT-Elderly trial has been launched in order to confirm the efficacy of intraoperative radiotherapy (IORT) in a well selected group of elderly patients who are more likely to decline radiation treatment. OBJECTIVES: Current evidence of the medical literature on the clinical reliability and applicability of intraoperative radiotherapy amongst older women diagnosed with early breast cancer is after summarized. MATERIALS AND METHODS: Literature databases were searched up to June 2015. Terms used to retrieve articles were 'breast cancer', 'elderly', 'intraoperative radiotherapy', 'IORT' and 'IOERT'. RESULTS: Elderly patients with pT1N0 tumours are regarded to be suitable for IORT according to ASTRO and GEC-ESTRO recommendations, respectively. DISCUSSION: In the light of the medical literature we can assume that patients benefit from postoperative radiation therapy, but we still do not know who can be spared from it. These issues emphasize the urgent need to develop and support clinical trials for this older population of breast cancer patients. CONCLUSIONS: Whether radiotherapy is beneficial in elderly still remains a matter of debate. IORT along with BCS in a selected subgroup of patients (>70years, pT1N0 tumours) could represent a valid option for a better local control.

Integration of DCE-MRI and DW-MRI Quantitative Parameters for Breast Lesion Classification.

OBJECTIVE: The purpose of our study was to evaluate the diagnostic value of an imaging protocol combining dynamic contrast-enhanced MRI (DCE-MRI) and diffusion-weighted MRI (DW-MRI) in patients with suspicious breast lesions. MATERIALS AND METHODS: A total of 31 breast lesions (15 malignant and 16 benign proved by histological examination) in 26 female patients were included in this study. For both DCE-MRI and DW-MRI model free and model based parameters were computed pixel by pixel on manually segmented ROIs. Statistical procedures included conventional linear analysis and more advanced techniques for classification of lesions in benign and malignant. RESULTS: Our findings indicated no strong correlation between DCE-MRI and DW-MRI parameters. Results of classification analysis show that combining of DCE parameters or DW-MRI parameter, in comparison of single feature, does not yield a dramatic improvement of sensitivity and specificity of the two techniques alone. The best performance was obtained considering a full combination of all features. Moreover, the classification results combining all features are dominated by DCE-MRI features alone. CONCLUSION: The combination of DWI and DCE-MRI does not show a potential to dramatically increase the sensitivity and specificity of breast MRI. DCE-MRI alone gave the same performance as in combination with DW-MRI.

BMI and breast cancer prognosis benefit: mammography screening reveals differences between normal weight and overweight women.

OBJECTIVES: Few studies are available on the potential impact of body weight on breast cancer prognosis in screen-detected patients. Moreover, it is not known whether body mass index (BMI) could have a different prognostic impact in screen-detected versus symptomatic breast cancer patients. To investigate these unsolved issues, we carried out a retrospective study evaluating the effect of BMI on breast cancer prognosis in screen-detected vs symptomatic breast cancer patients. MATERIALS AND METHODS: We conducted a follow-up study on 448 women diagnosed with incident, histologically-confirmed breast cancer. Patients were categorized according to their BMI as normal weight, overweight and obese. Disease free survival (DFS), overall survival (OS), and BMI curves were compared according to mode of cancer detection. RESULTS: Among screen-detected patients, higher BMI was associated with a significant lower DFS, whereas no significant difference was observed among symptomatic patients. OS showed similar results. In the multivariate analysis adjusting for age, education, tumor size, nodal status, estrogen receptor (ER), progesterone receptor (PR) and menopausal status, the risk for high level of BMI among screen-detected patients did not reach the statistical significance for either recurrence or survival. CONCLUSION: Our study highlights the potential impact of high bodyweight in breast cancer prognosis, the findings confirm that obesity plays a role in women breast cancer prognosis independently from diagnosis mode.

The role of CD44+/CD24-/low biomarker for screening, diagnosis and monitoring of breast cancer.

Cancer stem cells (CSCs) have been defined as 'a cell within a tumor that possesses the capacity to self-renew and to cause the heterogeneous lineages of cancer cells that comprise the tumor'. The CSC hypothesis postulates that a small subpopulation of cancer cells drives tumor initiation, growth and metastasis. CSCs have been isolated from breast cancer using CD44+/CD24-/low phenotype. The purpose of the present study was to evaluate the expression of CD44+/CD24-/low in two diverse breast carcinomas (ductal and lobular), and to determine the correlation between expression of CD44+/CD24-/low, and clinicopathological characteristics starting from human fresh breast cancer specimens. We analyzed specimens from 57 patients using CD44 and CD24 markers by flow cytometry and immunohistochemistry and correlated the CD44+/CD24-/low phenotype with clinicopathological characteristics. Moreover, mammosphere formation was tested. In all specimens tested, CD44+/CD24-/low phenotype was detectable with mean percentage of 4.73% as confirmed also by immunohistochemical analyses. A significant statistical association was found among these phenotypic groups and age, grade G3, estrogen and progesterone receptor, Ki-67 as well as lymph node metastasis. No correlation was found for histological type. In conclusion, our data showed that CD44+/CD24-/low phenotype was found at a high frequency in tumors pT2, G3, pN3, positive for Ki-67, and negative for estrogen and progesterone receptors highlighting the hypothesis that CD44+/CD24-/low profile correlates with the more aggressive clinical-pathological features of the disease.

Nuclear localization of cancer stem cell marker CD133 in triple-negative breast cancer: a case report.

AIM AND BACKGROUND: It has been recently demonstrated that the detection of stem cell niches in triple-negative (TN) breast cancer may provide good prognostic clues for this tumor. METHODS AND STUDY DESIGN: We investigated the subcellular expression and localization of the cancer stem cell marker CD133 in a TN breast cancer biopsy from a 42-year-old Caucasian woman with a histological diagnosis of high-grade invasive ductal breast carcinoma by immunohistochemistry, flow cytometry and quantitative real-time PCR (qRT-PCR). RESULTS: We describe for the first time in a TN breast cancer the nuclear mislocalization of CD133, which normally shows membrane localization and more sporadically cytoplasmic localization. We also found this aberrant expression with qRT-PCR analysis but not flow cytometry. CONCLUSIONS: Nuclear localization of CD133 may be an indicator of poor prognosis in TN breast cancer, as it is known that surface molecules, when moving into the nucleus, can act as transcriptional regulators by interfering with molecular pathways directly connected to the proliferation and differentiation of tumor cells.

Molecular profiles of screen detected vs. symptomatic breast cancer and their impact on survival: results from a clinical series.

BACKGROUND: Stage shift is widely considered a major determinant of the survival benefit conferred by breast cancer screening. However, factors and mechanisms underlying such a prognostic advantage need further clarification. We sought to compare the molecular characteristics of screen detected vs. symptomatic breast cancers and assess whether differences in tumour biology might translate into survival benefit. METHODS: In a clinical series of 448 women with operable breast cancer, the Kaplan-Meier method and the log-rank test were used to estimate the likelihood of cancer recurrence and death. The Cox proportional hazard model was used for the multivariate analyses including mode of detection, age at diagnosis, tumour size, and lymph node status. These same models were applied to subgroups defined by molecular subtypes. RESULTS: Screen detected breast cancers tended to show more favourable clinicopathological features and survival outcomes compared to symptomatic cancers. The luminal A subtype was more common in women with mammography detected tumours than in symptomatic patients (68.5 vs. 59.0%, p=0.04). Data analysis across categories of molecular subtypes revealed significantly longer disease free and overall survival for screen detected cancers with a luminal A subtype only (p=0.01 and 0.02, respectively). For women with a luminal A subtype, the independent prognostic role of mode of detection on recurrence was confirmed in Cox proportional hazard models (p=0.03). An independent role of modality of detection on survival was also suggested (p=0.05). CONCLUSIONS: Molecular subtypes did not substantially explain the differences in survival outcomes between screened and symptomatic patients. However, our results suggest that molecular profiles might play a role in interpreting such differences at least partially.Further studies are warranted to reinterpret the efficacy of screening programmes in the light of tumour biology.

Effects on quality of life of weekly docetaxel-based chemotherapy in patients with locally advanced or metastatic breast cancer: results of a single-centre randomized phase 3 trial.

BACKGROUND: To evaluate whether weekly schedules of docetaxel-based chemotherapy were superior to 3-weekly ones in terms of quality of life in locally advanced or metastatic breast cancer. METHODS: Patients with locally advanced or metastatic breast cancer, aged ≤ 70 years, performance status 0-2, chemotherapy-naive for metastatic disease, were eligible. They were randomized to weekly or 3-weekly combination of docetaxel and epirubicin, if they were not treated with adjuvant anthracyclines, or docetaxel and capecitabine, if treated with adjuvant anthracyclines. Primary end-point was global quality of life change at 6-weeks, measured by EORTC QLQ-C30. With two-sided alpha 0.05 and 80% power for 35% effect size, 130 patients per arm were needed. RESULTS: From February 2004 to March 2008, 139 patients were randomized, 70 to weekly and 69 to 3-weekly arm; 129 and 89 patients filled baseline and 6-week questionnaires, respectively. Global quality of life was better in the 3-weekly arm (p = 0.03); patients treated with weekly schedules presented a significantly worsening in role functioning and financial scores (p = 0.02 and p < 0.001). Neutropenia and stomatitis were worse in the 3-weekly arm, where two toxic deaths were observed. Overall response rate was 39.1% and 33.3% in 3-weekly and weekly arms; hazard ratio of progression was 1.29 (95% CI: 0.84-1.97) and hazard ratio of death was 1.38 (95% CI: 0.82-2.30) in the weekly arm. CONCLUSIONS: In this trial, the weekly schedules of docetaxel-based chemotherapy appear to be inferior to the 3-weekly one in terms of quality of life in patients with locally advanced or metastatic breast cancer. TRIAL REGISTRATION: ClinicalTrials.gov NCT00540800.

Gail model risk factors: impact of adding an extended family history for breast cancer.

An approach commonly used in estimating breast cancer risk is the Gail model. The objective of this study was to evaluate the feasibility and impact of adding extended family history as a new breast cancer risk factor into the Gail model. The data of the present study include cases with breast cancer and hospitalized controls recruited in the National Cancer Institute of Naples (southern Italy) between 1997 and 2000. We compared the first-degree relative (FDR) risk factor (standard Gail model) with the second-degree relative (SDR) information; and the FDR risk factor (standard Gail model) with the combination of FDR and SDR. We computed the c-statistic by comparing the risks found in our population to those in Gail-US population. The concordance for the model with FDR was 0.55 (95% CI 0.53-0.58), the model with SDR shows a modest but significant discriminatory accuracy (0.56, 95% CI 0.53-0.59), and the combination of FDR+SDR gave the concordance statistic of 0.57 (95% CI 0.54-0.60), indicating a good comparison between the two models. The results of our study show that extended family history information could be useful to improve the discriminatory power of the Gail model risk factors.