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BackgroundOncoplastic surgery is a well-established approach that combines breast-conserving treatment for breast cancer and plastic surgery techniques. Although this approach already has been described for multicentric and multifocal tumors, no long-term oncologic follow-up evaluation and no comparison with patients undergoing mastectomy have been published. This study aimed to evaluate whether oncoplastic surgery is a safe and reliable treatment for managing invasive primary multicentric and multifocal breast cancer.MethodsThe study compared a consecutive series of 100 patients with multicentric or multifocal tumors who had undergone oncoplastic surgery (study group) with 100 patients who had multicentric or multifocal tumors and had undergone mastectomy (control group) during a prolonged period. The end points evaluated were disease-free survival (DFS), overall survival (OS), cumulative incidence of local recurrence (CI-L), regional recurrence (CI-R), and distant recurrence (CI-D), all measured from the date of surgery.ResultsThe OS and DFS were similar between the two groups. The incidence of local events was higher in the oncoplastic group, whereas the incidence of regional events was slightly higher in the mastectomy group. These differences were not statistically significant. The cumulative incidence of distant events was similar between the two groups.ConclusionsTo the authors’ knowledge, the current study provides the best available evidence suggesting that the oncoplastic approach is a safe and reliable treatment for managing invasive multifocal and multicentric breast cancers.

BackgroundThe latest National Comprehensive Cancer Network Breast Cancer Guidelines still discourage repeat sentinel node biopsy (SNB) after mastectomy, and the largest multicentric study available reports only 35 cases in the absence of previous axillary dissection (AD).MethodsFrom January 2003 to November 2018, 89 patients of the European Institute of Oncology with local recurrence of breast cancer after mastectomy, free of distant metastases, with a clinically negative axilla and a negative axillary ultrasound, in absence of AD, underwent lymphatic mapping before wide local excision.ResultsDuring surgery, SNB was successful for 99% of the patients, with 14% being metastatic. Additional metastatic nodes removed by AD after a positive sentinel node occurred in 82% of cases. After a medium follow-up period of 3.7 years, the overall survival rate was 96.7%, and the disease-free survival rate was 84.4%. No axillary relapse after AD was recorded. One patient who refused human epidermal growth factor receptor 2 (HER2)-targeted treatment experienced ipsilateral axillary recurrence after a negative repeat SNB. The first axillary level was never directly irradiated because all the patients with positive repeat SNB underwent AD. For invasive luminal-like HER2-negative recurrences, the metastatic sentinel node was significantly associated with the choice to prescribe adjuvant chemotherapy (p = 0.003).ConclusionsIn specialized centers, repeat axillary SNB for patients with local recurrence after mastectomy in the absence of previous AD can represent a safe option for detection and removal of occult axillary disease that would otherwise not be excised/irradiated to achieve better local control and could possibly influence the choice of adjuvant treatments.

Purpose Metastatic triple negative breast cancer (mTNBC) is associated with poor prognosis and limited treatment options. It is known to be high immunogenic, with a high level of programmed cell death-ligand 1 (PD-L1) expression. PD-L1 expression in TNBC does not have a clear prognostic relevance. In this study, we aimed to assess survival outcomes according to PD-L1 expression in the real world. Methods We retrospectively analyzed mTNBC patients treated with first-line chemotherapy at European Institute of Oncology with evaluable PD-L1 expression. Primary endpoints were Progression-Free Survival (PFS) and Overall Survival (OS) according to PD-L1 expression. Results From January 2000 to December 2018, 190 patients fulfilled the inclusion criteria for final analysis. PD-L1 positive (≥ 1%) subgroup showed a median PFS of 6.8 vs 5.6 months in PD-L1 negative subgroup (PFS-HR 1.25, 95% CI 0.89–1.74, p -value = 0.191), while at data cutoff we had 120 deaths in the PD-L1 < 1% population with a median OS of 22.1 months and 42 deaths in PD-L1 positive patients with a median OS of 20.8 months (OS-HR 1.09, 95% CI 0.76–1.55, p -value = 0.64). No difference in PFS and OS was related to the choice of chemotherapy ( p -value for PFS: 0.19, p -value for OS: 0.53). Conclusion No differences in clinical outcome were found according to PD-L1 status or chemotherapy regimen chosen. In “unselected” patients, single agent or combination chemotherapy could be appropriate, although in the immunotherapy era patients with newly diagnosed mTNBC should be routinely tested for PD-L1 status. The variability in PD-L1 expression by metastatic site warrants further investigation.

The surrogacy value of distant disease-free survival for overall survival has not been validated in neoadjuvant randomised controlled trials (RCTs) for early breast cancer. Here, we assess the trial-level surrogacy value of distant disease-free survival for overall survival. In this pooled analysis, we included individual patient data from RCTs of neoadjuvant therapy for early breast cancer conducted by the German Breast Group (GBG) and the German Gynecological Oncology Breast Study Group (AGO-B) with available data on distant disease-free survival and overall survival. We used the trial-level measure of surrogacy R2trial from two-stage meta-analytical copula methods to quantify the association between treatment effects on overall survival and distant disease-free survival, overall and in prespecified clinical and pathological subgroups. According to ReSEEM guidelines, R2trial values of 0·7 or higher represent strong correlations, values between 0·69 and 0·5 represent moderate correlations, and values of less than 0·5 represent weak correlations. 11 RCTs, with a total of 15 neoadjuvant treatment comparisons and 12 247 patients, were included in the analysis. Overall, there was a strong association between copula model-based hazard ratios (HRs) for overall survival and copula model-based HRs for distant disease-free survival (R2trial=0·91 [95% CI 0·82–1·00]). No significant heterogeneity of results was observed across the majority of subgroups analysed (pheterogeneity>0·05 in all subgroups), with the exception of subgroups defined by tumour molecular features, such as tumour progesterone receptor status, HER2 status, and molecular subtypes. For molecular subtypes, the R2trial for the association between distant disease-free survival and overall survival was higher than 0·7, indicating strong surrogacy in hormone receptor-negative and HER2-negative tumours (R2trial=0·89 [95% CI 0·75–1·00]) and hormone receptor-negative and HER2-positive tumours (0·73 [0·36–1·00]), and below the 0·5 threshold for weak surrogacy in hormone receptor-positive and HER2-negative tumours (0·33 [0·00–0·83]) and hormone receptor-positive and HER2-positive tumours (0·11 [0·00–0·55]; pheterogeneity=0·021). With adequate follow-up, distant disease-free survival is a robust surrogate endpoint for predicting final overall survival outcomes in neoadjuvant RCTs for early breast cancer in most contexts. However, the distant disease-free survival surrogacy appears to be weak for the hormone receptor-positive and HER2-negative and for the hormone receptor-positive and HER2-positive molecular subtypes. These latter findings warrant further investigation in more recent RCTs enrolling higher-risk patient populations. None.

There is debate on which are the best surrogate endpoint and metric to capture treatment effect on overall survival (OS) in RCTs testing immune-checkpoint inhibitors (ICIs). We systematically searched for RCTs testing ICIs in patients with advanced solid tumors. Inclusion criteria were: RCTs i) assessing PD-(L)1 and CTLA-4 inhibitors either as monotherapy or in combination with another ICI, and/or targeted therapy, and/or chemotherapy, in patients with advanced solid tumors; ii) randomizing at least 100 patients. We performed a meta-analysis of RCTs to compare the surrogacy value of PFS and modified-PFS (mPFS) for OS in RCTs testing ICIs, when the treatment effect is measured by the hazard ratio (HR) for OS, and by the HR and the ratio of restricted mean survival time (rRMST) for PFS and mPFS. 61 RCTs (67 treatment comparisons and 36,034 patients) were included in the analysis. In comparisons testing ICI plus chemotherapy, HR and HR both had a strong surrogacy value (R = 0.74 and R = 0.81, respectively). In comparisons testing ICI as monotherapy, HR was the best surrogate, although having a moderate correlation (R = 0.58). In comparisons testing ICI plus other treatment(s), the associations were very weak for all the surrogate endpoints and treatment effect measures, with R ranging from 0.01 to 0.22. In RCTs testing ICIs, the value of potential surrogates for HR was strongly affected by the type of treatment(s) tested. The evidence available supports HR as the best surrogate, and disproves the use of alternative endpoints, such as the mPFS, or treatment effect measures, such as the RMST.

Until the past century, mortality trends from coronary heart disease (CHD) and cerebrovascular disease (CVD) were less favorable in Latin than in North America. We calculated age-standardized mortality rates using data from the World Health Organization database over the period 1980 to 2013. To identify significant changes in trends, we performed joinpoint analysis. Since the early 2000's, CHD mortality rates decreased by about 35% in the USA and Canada in both genders; similar decreases were observed in some Latin American countries (i.e., Ecuador, Puerto Rico, and Chile), whereas the decreases were smaller in the other countries. In 2011 to 2013, the highest rates were in Venezuela (114.4/100,000 men) and Colombia (86.1/100,000 men) and the lowest ones (apart from Ecuador) in Panama, Chile, and Argentina (from 41 to 46/100,000 men and 18 to 19/100,000 women). For CVD mortality, a decrease by about 30% was observed in Argentina, Panama, and Uruguay plus Colombia for women, in addition to the USA and Canada. Smaller declines were observed in the other Latin American countries (from 23% in Colombian men to 5% in Venezuelan men). Throughout the period, rates in Latin America remained appreciably higher than those in North America. The highest CVD rates were observed in Brazil (51.6/100,000 men) and the lowest ones in Canada (12.9/100,000 women). In conclusion, trends in CHD and CVD mortality continue to be less favorable in Latin America than in Canada and the USA. The marked excess of CVD mortality is partly or largely attributable to inadequate control of dyslipidemia and hypertension.

Background Invasive lobular carcinomas (ILCs) account for 10–15% of all breast cancers. They are characterized by an elevated endocrine responsiveness and by a long lasting risk of relapse over time. Here we report for the first time an analysis of clinical and pathological features associated with the risk of late distant recurrence in ILCs. Patients and methods We retrospectively analyzed all consecutive patients with hormone receptor–positive ILC operated at the European Institute of Oncology (EIO) between June 1994 and December 2010 and scheduled to receive at least 5 years of endocrine treatment. The aim was to identify clinical and pathological variables that provide prognostic information in the period beginning 5 years after definitive surgery. The cumulative incidence of distant metastases (CI-DM) from 5 years after surgery was the prospectively defined primary endpoint. Results One thousand eight hundred seventy-two patients fulfilled the inclusion criteria. The median follow-up was 8.7 years. Increased tumor size and positive nodal status were significantly associated with higher risk of late distant recurrence, but nodal status had a significant lower prognostic value in late follow-up period (DM-HR, 3.21; 95% CI, 2.06–5.01) as compared with the first 5 years of follow-up (DM-HR, 9.55; 95% CI, 5.64–16.2; heterogeneity p value 0.002). Elevated Ki-67 labeling index (LI) retained a significant and independent prognostic value even after the first 5 years from surgery (DM-HR, 1.81; 95% CI 1.19–2.75), and it also stratified the prognosis of ILC patients subgrouped according to lymph node status. A combined score, obtained integrating the previously validated Clinical Treatment Score post 5 years (CTS5) and Ki-67 LI, had a strong association with the risk of late distant recurrence of ILCs. Conclusion We identified factors associated with the risk of late distant recurrence in ER-positive ILCs and developed a simple prognostic score, based on data that are readily available, which warrants further validation.

Purpose The careful evaluation of MDCT is an essential step for the treatment planning in pre-treatment imaging work-up for Trans-Arterial Radio Embolization (TARE). It may provide unique volumetric data (CTVs), which are information useful for an effective and safe TARE. The purpose of this study is to demonstrate that the radiographer is able to calculate CTVs of TARE simulation with the same precision as the interventional radiologist. Methods This study retrospectively considers 17 consecutive patients (8 males, 9 females; mean age 66.3 ± 13.2 years) who underwent pre-treatment work-up for TARE, between May 2019 and February 2020 (trial ID:2234 - protocol). For each patient, four specific parameters are evaluated from MDCT achieved during treatment simulation: healthy liver volume (HLV), the whole hepatic parenchyma (THV = healthy liver and TTV = tumour) involved by TARE, and whole liver volume (WLV). Four independent observers—R1 (expert interventional radiologist), T1, T2, and T3 (radiographers, with different experiences in the field of interventional radiology)—are involved in the imaging analysed. Results All the 4 observers detected the same number of hepatic lesion(s) per patient. Regarding the three radiographers, the intra-observer reliability for CTVs is very high 0.997 to 1.000 (95%CI). Also inter-observer reproducibility between radiographers is excellent regarding CTVs, 0.965 to 0.999 (95%CI). The accuracy of radiographer evaluation is very high 0.964 to 0.999 (95%CI). Conclusions and implications for practice The high intra- and inter-observer reproducibility shows that a properly trained radiographers might have the same accuracy as interventional radiologists, in assessing liver CTV data for planning TARE.