B3 Breast Lesions: Positive Predictive Value and Follow-Up on a Large Single-Institution Series.

INTRODUCTION: Lesions of uncertain malignant potential (B3) represent 10% of core needle biopsies (CNBs) or vacuum-assisted breast biopsies (VABBs). Traditionally, B3 lesions are operated on. This study investigated the association between B3 subtypes and malignancy to determine the best management. METHODS: Pre- and postoperative histological reports from 226 patients, who had undergone excisional surgery for B3 lesions, following CNB or VABB, were retrospectively analyzed. The correlation between the CNB/VABB diagnosis and the final pathology was investigated, along with the correlation between malignancy upgrade and the type of mammographic lesion. The positive predictive value (PPV) of malignancy of B3 lesions was calculated by simple logistic regression. Patients without cancer diagnosis underwent a 7-y follow-up. RESULTS: Pathology showed 171 (75.6%) benign and 55 (24.3%) malignant lesions. The PPV was 24.3% (P = 0.043), including 31 (13.7%) ductal carcinomas in situ and 24 (10.6%) invasive carcinomas. The most frequently upgraded lesions were atypical ductal hyperplasia, 34.2% (P = 0.004), followed by lobular intraepithelial neoplasia, 27.5% (P = 0.025). The median diameter of mammographic lesions was 1.5 [0.9-2.5] cm, while for surgical specimens, it was 5 [4-7] cm (P < 0.0001). Mammographic findings and histology showed a significant correlation (P = 0.038). After a 7-y follow-up, 15 (8.9%) patients developed carcinoma, and 7 patients (4%) developed a new B3 lesion. CONCLUSIONS: We can conclude that atypical ductal hyperplasia and lobular intraepithelial neoplasia still require surgery for a significant PPV. Other types that lacked significance or confidence intervals were too wide to draw any conclusion.

Anatomical assessment of local recurrence site in breast cancer patients after breast reconstruction and post-mastectomy radiotherapy: implications for radiation volumes and techniques.

INTRODUCTION: Post-mastectomy radiotherapy (PMRT) improves local control rates and survival in patients with adverse prognostic features. The dose coverage to target volumes is critical to yield maximum benefit to treated patients, increasing local control and reducing risk of toxicity. This study aims to assess patterns of breast cancer relapse in patients treated with mastectomy, breast reconstruction and PMRT. METHODS: Breast cancer patients treated with PMRT between 1992 and 2017 were retrospectively reviewed. Clinical and pathological characteristics of patients were collected. Recurrences were defined as "in field," "marginal" or "out of field." Survival analyses were performed in relation to progression-free survival (PFS) and overall survival (OS). Correlation between baseline features was explored. RESULTS: Data of 140 patients are collected. After a median follow-up time of 72 months, median PFS and OS of 63 and 74 months were detected, respectively. Neoadjuvant chemotherapy, lympho-vascular space invasion (LVI) and size of primary tumor were all significantly associated with worst PFS and OS. Ten patients developed local recurrence: 30% "in field," 30% marginal recurrences, 20% "out of field" and 20% both "in field" and "out of field." No recurrence was detected under the expander, 80% above the device and 20% patients relapsed on IMN chain. The mean distant relapse-free survival was 39 months. Overall, 39 of 140 patients developed distant metastases. CONCLUSIONS: The onset of local-regional relapses occurred mainly above the expander/prosthesis, underlying the importance of inclusion of the subcutaneous tissues within the target volume. In order to refine new contouring recommendations for PMRT and breast reconstruction, future prospective studies are needed.

Processing Speech and Thoughts during Silent Reading: Direct Reference Effects for Speech by Fictional Characters in Voice-Selective Auditory Cortex and a Theory-of-Mind Network.

Stories transport readers into vivid imaginative worlds, but understanding how readers create such worlds-populating them with characters, objects, and events-presents serious challenges across disciplines. Auditory imagery is thought to play a prominent role in this process, especially when representing characters' voices. Previous research has shown that direct reference to speech in stories (e.g., He said, "I'm over here") may prompt spontaneous activation of voice-selective auditory cortex more than indirect speech [Yao, B., Belin, P., & Scheepers, C. Silent reading of direct versus indirect speech activates voice-selective areas in the auditory cortex. Journal of Cognitive Neuroscience, 23, 3146-3152, 2011]. However, it is unclear whether this effect reflects differential processing of speech or differences in linguistic content, source memory, or grammar. One way to test this is to compare direct reference effects for characters speaking and thinking in a story. Here, we present a multidisciplinary fMRI study of 21 readers' responses to characters' speech and thoughts during silent reading of short fictional stories. Activations relating to direct and indirect references were compared for both speaking and thinking. Eye-tracking and independent localizer tasks (auditory cortex and theory of mind [ToM]) established ROIs in which responses to stories could be tracked for individuals. Evidence of elevated auditory cortex responses to direct speech over indirect speech was observed, replicating previously reported effects; no reference effect was observed for thoughts. Moreover, a direct reference effect specific to speech was also evident in regions previously associated with inferring intentions from communication. Implications are discussed for the spontaneous representation of fictional characters and the potential roles of inner speech and ToM in this process.

Six-year prospective evaluation of second-look US with volume navigation for MRI-detected additional breast lesions.

OBJECTIVE: The aim of this study is to present a 6-year prospective evaluation of second-look ultrasound (US) using volume navigation (V Nav) for MRI-detected additional breast lesions. METHODS: After IRB approvals in both institutions, 1930 consecutive prone MRI breast examinations in 1437 patients were prospectively evaluated. All patients with an MRI-detected additional lesion underwent second-look US, and if occult, contrast-enhanced MRI in supine position was performed for US and MRI co-registration. For patients with breast hypertrophy, MRI-guided biopsy was performed directly. Pathologic examination was the standard of reference. One-way ANOVA and chi-square tests were used. RESULTS: In 490 MRI examinations (25.4%, 490/1930), at least one additional breast lesion was detected for a total of 722 only MRI-detected lesions. Second-look US identified 549 additional lesions (23 ± 8 mm); 362 (65.9%, 362/549) proved benign at pathology and 187 (34.1%, 187/549) malignant. Second-look US with V Nav identified 151 additional lesions (17 ± 9 mm, p = n.s.); 67 (44.4%, 67/151) proved benign at pathology and 84 (55.6%, 84/151) malignant. MRI-guided biopsy was performed on 22 additional breast lesions (22 ± 8 mm, p = n.s.); pathology revealed 20 (90.9%, 20/22) benign lesions and 2 (9.1%, 2/22) malignant ones. Mass lesions were significantly higher in the second-look US group (p < 0.001). No significant difference in lesion dimension was found between the three groups (p = 0.729). CONCLUSIONS: Second-look US with V Nav can be effective in detecting a large number of additional breast lesions occult at second-look US and to biopsy a significant number of malignant lesions safely and irrespective of distance from skin or lesion position. KEY POINTS: • Second-look US with volume navigation is effective in detecting occult additional lesions. • Permits safe biopsies irrespective of position and depth • Reduces the need for MRI-guided biopsy.

Robotic enucleations of pancreatic benign or low-grade malignant tumors: preliminary results and comparison with robotic demolitive resections.

BACKGROUND: The incidental detection of benign to low-grade malignant small pancreatic neoplasms increased in the last decades. The surgical management of these patients is still under debate. The aim of this paper is to evaluate the safety and feasibility of robotic enucleations and to compare the outcomes with non-parenchymal sparing robotic resections. METHODS: The study included a total of 25 patients. Nine of them underwent a robotic enucleation (EN Group) and 16 patients received a robotic demolitive resection (DR Group). Perioperative and medium-term outcomes were compared between the two groups. RESULTS: Patients' baseline characteristics were similar in the two groups except for presence of symptoms and tumor size, due to the inclusion criteria. Operative time was significantly shorter and postoperative results were better for EN group, including a significant shorter hospitalization (5 vs. 8 days, p = 0.027), reduced pancreatic leaks (22% vs. 50%, p = 0.287) and a better preservation of glandular function (100% vs. 62.5%, p = 0.066). Mortality rate was zero in both groups, with all patients free from disease at a median follow-up of 18 months. CONCLUSIONS: The risks of under/overtreatment remain still unavoidable for benign to low-grade malignant small pancreatic neoplasms. Simple enucleation should be performed whenever oncological appropriate, to achieve the best postoperative outcomes. The adoption of robotic technique might widen the indications for parenchymal sparing, minimally invasive surgery.

hERG1 channel expression associates with molecular subtypes and prognosis in breast cancer.

BACKGROUND: Breast cancer (BC) is the most frequent malignancy among females worldwide. Despite several efforts and improvements in early diagnosis and treatment, there are still tumors characterized by an aggressive behavior due to unfavorable biology, thus quite difficult to treat. In this view, searching for novel potential biomarkers is mandatory. Among them, in the recent years data have been gathered addressing ion channel as important players in oncology. METHODS: A retrospective pilot study was performed on 40 BC samples by means of immunohistochemistry in order to evaluate hERG1 potassium channels expression in BC. RESULTS: We provide evidence that hERG1 is expressed in all the BC samples analyzed. hERG1 expression was significantly associated with molecular subtype with the highest expression in Luminal A and the lowest in basal-like tumors (p = 0.001), tumor grading (the highest hERG1 expression in well-moderate differentiated tumors, p = 0.020), estrogen receptors (high hERG1 expression in ER-positive samples, p = 0.008) and Ki67 proliferative index (high hERG1 scoring in samples with low proliferative index, p = 0.038). Also, a p value close to significance was noticed for the association between hERG1 and HER2 expression (p = 0.079). At the survival analysis, patients with high hERG1 expression turned out to have a longer progression-free survival, although statistical significance was not reached (p = 0.195). The same trend was observed analyzing local relapse free-survival (LRFS) and metastases-free survival (MFS): patients with higher hERG1 scoring had longer LRFS and MFS (p = 0.124 and p = 0.071, respectively). CONCLUSIONS: The results of this pilot study provide the first evidence that the hERG1 protein is expressed in primary BC, and its expression associates with molecular subtype. hERG1 apparently behaves as a protective factor, since it contributes to identify a subset of patients with better outcome. Overall, these data suggest that hERG1 might be an additional tool for the management of BC, nevertheless further investigations are warranted to better clarify hERG1 role and clinical usefulness in BC.

Uncharted features and dynamics of reading: Voices, characters, and crossing of experiences.

Readers often describe vivid experiences of voices and characters in a manner that has been likened to hallucination. Little is known, however, of how common such experiences are, nor the individual differences they may reflect. Here we present the results of a 2014 survey conducted in collaboration with a national UK newspaper and an international book festival. Participants (n=1566) completed measures of reading imagery, inner speech, and hallucination-proneness, including 413 participants who provided detailed free-text descriptions of their reading experiences. Hierarchical regression analysis indicated that reading imagery was related to phenomenological characteristics of inner speech and proneness to hallucination-like experiences. However, qualitative analysis of reader's accounts suggested that vivid reading experiences were marked not just by auditory phenomenology, but also their tendency to cross over into non-reading contexts. This supports social-cognitive accounts of reading while highlighting a role for involuntary and uncontrolled personality models in the experience of fictional characters.

Impact of age on cytotoxic-induced ovarian failure in breast cancer treated with adjuvant chemotherapy and triptorelin.

AIM: This study analyzes our single-center, retrospective experience on 63 premenopausal breast cancer patients treated with monthly triptorelin and concomitant chemotherapy. PATIENTS & METHODS: Concomitant chemotherapy and triptorelin were adopted as part of premature ovarian failure prevention strategy. RESULTS: Age at diagnosis was the main factor influencing fertility preservation (p = 0.002). Compared with patients aged 41-45 years, the probability of menses resumption was almost threefold than for women aged 35-40 years, and significantly higher for women aged <35 years (hazard ratio: 9.0; p = 0.0001). The cumulative proportion among patients who resumed menses was 33.3% at 6 months, 75% at 12 months and 87.5% at 24 months. Seven patients attempted pregnancy, and five (71%) obtained healthy deliveries. CONCLUSION: We observed an acceptable rate of fertility preservation. Age at diagnosis influences fertility preservation.

Safety of eribulin mesylate and concomitant radiotherapy for metastatic breast cancer: a single-center experience.

AIM: This study evaluates, for the first time, the safety of eribulin in metastatic breast cancer patients concomitantly treated with palliative radiotherapy (RT). Patients & materials: A total of 17 patients were pretreated for metastatic breast cancer. Patients received eribulin mesylate and bone RT. RESULTS: The most frequent grade 3 hematologic adverse events were neutropenia (56%) and anemia (20%). Mean pain score decreased from 2 (baseline) to 0.7 (end of observation). Analgesic score remained stable (1.8 vs 1.6). Bone pain scores dropped within a few weeks and remained below baseline values throughout the analysis. The overall response rate was 29%, and the clinical benefit rate was 59%. CONCLUSION: Eribulin is characterized by a manageable safety profile also when combined with palliative RT.

Accelerated partial breast irradiation using intensity-modulated radiotherapy technique compared to whole breast irradiation for patients aged 70 years or older: subgroup analysis from a randomized phase 3 trial.

The purpose of this study was to report the efficacy and the safety profile on the subset of selected early breast cancer (BC) patients aged 70 years or older from a single-center phase 3 trial comparing whole breast irradiation (WBI) to accelerated partial breast irradiation (APBI) using intensity-modulated radiation therapy technique. Between 2005 and 2013, 520 patients aged more than 40 years old were enrolled and randomly assigned to receive either WBI or APBI in a 1:1 ratio. Eligible patients were women with early BC (maximum diameter 2.5 cm) suitable for breast conserving surgery. This study is registered with ClinicalTrials.gov, NCT02104895. A total of 117 patients aged 70 years or more were analyzed (58 in the WBI arm, 59 in the APBI arm). At a median follow-up of 5-years (range 3.4-7.0), the ipsilateral breast tumor recurrence (IBTR) rate was 1.9 % in both groups. No significant difference between the two groups was identified (log-rank test p = 0.96). The 5-year disease-free survival (DFS) rates in the WBI group and APBI group were 6.1 and 1.9 %, respectively (p = 0.33). The APBI group presented significantly better results in terms of acute skin toxicity, considering both any grade (p = 0.0001) and grade 2 or higher (p = 0.0001). Our subgroup analyses showed a very low rate and no significant difference in terms of IBTR, using both WBI and APBI. A significant impact on patients compliance in terms of acute and early late toxicity was shown, which could translate in a consistent improvement of overall quality of life.

Pre-pectoral breast reconstruction with tissue expander entirely covered by acellular dermal matrix: feasibility, safety and histological features resulting from the first 64 procedures.

Background: Reconstructive options that can be used following conservative mastectomy, skin-, nipple-sparing and skin-reducing mastectomies, allow a remarkable variety of safe methods to restore the natural shape and aesthetics of the breast mound. In case of two-stage breast reconstruction, tissue expanders (TEs) are usually placed in a subpectoral position. The purpose of this retrospective cohort study is to evaluate the feasibility and safety of two-step reconstruction with TE in pre-pectoral position covered by acellular dermal matrix (ADM). Methods: Between March 2021 and May 2023, at the Azienda Ospedaliero Universitaria Careggi, University of Florence, 55 patients with BRCA 1/2 mutations or early breast cancer underwent conservative mastectomy with immediate pre-pectoral reconstruction using TE covered with ADM, followed by a second surgery with replacement of the expander with definitive prosthesis. Demographic, oncological, and histological data along with surgical complications were recorded. Results: A total of 64 conservative mastectomies were performed. In 2 patients (3.1%) complications were found that required reintervention and, in both cases, the TE had to be removed. Two patients developed hematoma and one patient developed seroma. Two patients showed wound dehiscence, both healed after conservative treatment and without implant exposure. No case of necrosis of the skin or nipple-areola complex has been observed, neither of capsular contracture. Capsule formed around TE was populated with cells and blood vessels and showed a thin area of synovial metaplasia. Conclusions: In selected cases it may be more cautious to perform a two-stage breast reconstruction after radical breast surgery by means of TEs. The placement of TEs in pre-pectoral position combines the excellent aesthetic and functional results of the pre-pectoral philosophy with a quite safer and more prudent two-step approach. Our experience reports optimistic results: the ADM covering the TE is seen successfully integrating during tissue expansion and becoming a vascularised new self-tissue. Complications rates are low and such ADM-assisted two-stage pre-pectoral reconstructive technique is a safe, practical, and reproducible method.

The Cholegas Study: safety of prophylactic cholecystectomy during gastrectomy for cancer: preliminary results of a multicentric randomized clinical trial.

BACKGROUND: Cholelithiasis is more frequent in patients after gastrectomy, due to dissection of vagal branches and gastrointestinal reconstruction. METHODS: A randomized controlled trial was conducted from November 2008 to March 2012. Patients were randomized into two groups: prophylactic cholecystectomy (PC) and standard gastric surgery only (SS) for curable cancers. We planned three end points: evaluation of the number of patients who developed symptoms and needed further surgery for cholelithiasis after standard gastric cancer surgery, evaluation of the incidence of cholelithiasis overall after standard gastric cancer surgery and perioperative complications or costs of prophylactic cholecystectomy. The present study answers to the last end point only. RESULTS: After 40 months from the beginning of study, 172 patients were eligible from 9 Centers. Ten patients refused consent and 32 were excluded due to flawing of inclusion criteria (not confirmed adenocarcinomas and no R0 surgery). Therefore, final analysis included 130 patients: 65 in PC group and 65 in SS. Among PC group, 12 patients had surgical complications during the perioperative period; only 1 biliary leakage, conservatively treated, might have been caused by prophylactic cholecystectomy. 6 patients had surgical complications in SS group. One postoperative death occurred in PC group due to pulmonary embolism. Differences were not statistically significant. Similarly, no differences were significant in duration of surgery, blood loss, hospital stay. CONCLUSIONS: Concomitant cholecystectomy during standard surgery for gastric malignancies seemed to add no extra perioperative morbidity, mortality and costs to the sample included in the study.

Routine use of simultaneous laparoendoscopic approach in patients with confirmed gallbladder and bile duct stones: fit for laparoscopy fit for "rendezvous".

BACKGROUND: The aim of the present work was to determine the feasibility and efficacy, in terms of equipment coordination and timing, of the laparoendoscopic intraoperative rendezvous technique (RVT) for the treatment of gallbladder and common bile duct stones (CBDS). METHODS: The procedure was considered in 269 unselected patients with a suspicion or preoperative imaging demonstration of CBDS who were fit for laparoscopic cholecystectomy (LC). Common bile duct stones were confirmed by intraoperative laparoscopic cholangiography (IOC) in only 113 of these patients (42 %). In 17 (15 %) patients the planned procedure was aborted because of organizational problems, mainly the unavailability of endoscopists in the urgent setting. The remaining 96 patients (84 %) underwent a formal attempt at RVT. Intraoperative endoscopic retrograde cholangiography (ERC) was performed, during LC, by means of a guidewire that reached the duodenum through the cystic duct. RESULTS: In 18 patients (19 %) the complete procedure failed, either because of difficulty in passing the guidewire through the papilla or because of other technical difficulties that required conversion to laparotomy. An intraoperative ERC was completed in six patients in the classical way (no guidewire) without conversion. No mortality and few complications were recorded (3 % overall: 1 perforation and 2 cholangitis). Retained stones were successively detected in 6 patients (6 %) and successfully retreated by a further ERC. Globally, the one-stage procedure (with and without the guidewire) was possible in 84 of 96 patients (87 %). CONCLUSIONS: The RVT appears to be effective and safe as it was performed at our institution, with an overall percentage of definitive success (passed guide wire and no further ERC) of 81 %. The RVT should be considered as a good option for the treatment of simultaneous gallstones and CBDS.

Selective Denervation of Pectoralis Major Muscle Improves Cosmetic Outcome and Quality of Life in Retro-Pectoral Implant Based Breast Reconstruction.

BACKGROUND: Selective pectoralis major muscle (PMM) denervation has been described in retro-pectoral reconstructions to obtain the advantages of the pre-pectoral approach. Present study compared subjective evaluations between retro-pectoral implant based breast reconstructions (IBBRs) with denervation to traditional techniques without denervation. METHODS: In 2020, two 2 groups of patients submitted to retro-pectoral IBBR, minimum 12-month follow-up, were compared through BREAST-Q post-operative questionnaire. Group-1 included direct-to-implant or two2-stage tissue expanderTE cases with selective PMM denervation, while Group-2 similar procedures, in the same time span 2017-2019, without denervation. BREAST-Q was divided into five 5 independent scales and for each scale item responses were summed up and transformed into a score, ranging from 0 to 100, to analyze and compare the results. RESULTS: 50 patients were included both in Group1 and Group-2. Group-1 patients reported significantly higher scores in "satisfaction with the reconstructed breast" scale compared to Group-2, means-medians of 56-58 and 47-50, respectively. A trend in favor of Group-1 was recorded in the scales of "psycho-social well-being", 64-65 vs. 58-53, and "sexual well-being", 53-47 vs. 48-47, albeit not significant. Substantial equivalence was found in "satisfaction with the result overall" and "physical well-being". CONCLUSION: PMM denervation can improve cosmetic results in retro-pec IBBRs, thus leading to better QoL. Possible pain and physical discomfort weren't caused by denervation with scores similar to non-denervated controls.

Safety of CDK4/6 inhibitors and concomitant radiation therapy in patients affected by metastatic breast cancer.

PURPOSE: Cyclin-dependent kinase 4/6 inhibitors (CDK4/6i) currently represent the standard of care for the initial treatment of patients with metastatic hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) breast cancer. The aim of our study is to evaluate the safety of the use of concomitant radiation therapy (RT) in a consecutive series of HR+/HER2- patients treated in two academic institutions with CDK4/6i in the metastatic setting. METHODS AND MATERIALS: From September 2017 to February 2020, we retrospectively collected and analysed data on a sequential series of patients treated with CDK4/6i, receiving RT or not, at two European institutions. Primary outcome of the study was the association between RT and any adverse events (AEs) ≥ G3. Secondary outcomes were the association between RT and any AEs (any grade), CDK4/6i dose reduction rate, and CDK4/6i treatment discontinuation rate. RESULTS: We analysed a total of 132 consecutive women; RT was prescribed in 57 (43.2%) patients (70 irradiated lesions). The median age of the series was 52.1 years (range 32.3-78.2). Concomitant RT administration was not significantly related to higher AEs ≥ G3 (p = 0.19) and any grade AEs (p = 1.0); there was no association with RT and CDK4/6i dose reduction (p = 0.49) and discontinuation rates (p = 0.14). At a median follow-up of 18.8 months, the progression-free survival (PFS) rate was 35% and the overall survival (OS) rate was 38.7% in the whole group. The use of concomitant RT did not affect both PFS (p = 0.71) and OS rates (p = 0.55). CONCLUSIONS: Our data are encouraging regarding the safety of this combination, showing that concurrent RT did not increase severe toxicity and did not have an impact on systemic treatment conduction.

Pre-pectoral breast reconstruction: early and long-term safety evaluation of 146 unselected cases of the early pre-pectoral era of a single-institution, including cases with previous breast irradiation and post-mastectomy radiation therapy.

We re-evaluated acute and early-late toxicity-related factors among pre-pectoral immediate tissue expander/implant (TE/I) breast reconstruction (BR) unselected, first-era, cases, including previous breast radiation treatment and post-mastectomy radiation therapy (PMRT). A retrospective analysis of 146 (117 therapeutic and 29 prophylactic) pre-pectoral reconstructions, between 2012 and 2016, considered patient-related (age, body mass index [BMI], smoke-history, comorbidity, BRCA mutation), and treatment-related characteristics (previous irradiation, axillary surgery, PMRT, pre- and postoperative chemotherapy, endocrine therapy, and target-therapy). Safety was evaluated as acute and early-late complications, and TE/I failures. At multivariate analysis of the 146 cases (117 patients submitted to BR) a significant factor related to acute toxicity was: BMI ≥ 25 (31.3% [≥ 25] vs 8.8% [< 25]; OR 4.44, 95% CI 1.56-12.6; p = 0.003), while previous breast surgery on ipsilateral side presented a borderline significance (31.6% [previous surgery] vs 7.4% [no previous surgery]; OR 3.74, 95% CI 0.97-14.40; p = 0.055). Factors significantly related to TE/I failure were: current or previous smoking exposition (13.8% [smokers] vs 2.6% [non-smokers]; OR 7.32, 95% CI 1.37-39.08; p = 0.02) and preoperative chemotherapy (18.8% [yes] vs 3.5% [no]; OR 8.16, 95% CI 1.29-51.63; p = 0.026). At 4-year median follow-up, 3 deaths, 5 locoregional recurrences, and 14 distant metastases occurred. Immediate pre-pectoral BR is safe and effective, with low rates of acute and early-late complications. BMI and previous breast surgery were related to higher complications but not failure; smoking and preoperative chemotherapy were related to TE/I explant. Previous RT and PMRT were related neither to early-late toxicity nor failure.

Preoperative robotic radiosurgery for early breast cancer: Results of the phase II ROCK trial (NCT03520894).

Background and purpose: Preoperative partial breast irradiation (PBI) has got the advantage of treating a well-defined target. We report the results of the phase II ROCK trial (NCT03520894), enrolling early breast cancer (BC) patients treated with preoperative robotic radiosurgery (prRS), in terms of acute and early late toxicity, disease control, and cosmesis. Material and methods: The study recruited between 2018 and 2021 at our Radiation Oncology Unit. Eligible patients were 50 + years old BC, hormonal receptors positive/human epidermal growth factor receptor 2 negative (HR+/HER2-), sized up to 25 mm. The study aimed to prospectively assess the toxicity and feasibility of a robotic single 21 Gy-fraction prRS in preoperative setting. Results: A total of 70 patients were recruited and 22 patients were successfully treated with pRS. Overall, three G1 adverse events (13.6 %) were recorded within 7 days from prRS. Three events (13.6 %) were recorded between 7 and 30 days, one G2 breast oedema and two G1 breast pain. No acute toxicity greater than G2 was recorded. Five patients experienced early late G1 toxicity. One patient reported G2 breast induration. No early late toxicity greater than G2 was observed. At a median follow up of 18 months (range 6-29.8), cosmetic results were scored excellent/good and fair in 14 and 5 patients, respectively, while 3 patients experienced a poor cosmetic outcome. Conclusions: ROCK trial showed that a single 21 Gy dose prRS represents a feasible technique for selected patients affected by early BC, showing an acceptable preliminary toxicity profile.

Treatment With Oxygen-Enriched Olive Oil Improves Healing Parameters Following Augmentation-Mastopexy.

BACKGROUND: Breast augmentation-mastopexy can yield an aesthetically attractive breast, but the 1-stage procedure is prone to unsatisfactory outcomes, including poor wound healing. OBJECTIVES: The authors evaluated whether postsurgical application of a polyurethane bra cup coated with oxygen-enriched olive oil (NovoX Cup; Moss SpA, Lesa, Novara, Italy) would decrease pain associated with augmentation-mastopexy and improve the quality of the surgical scar. METHODS: This retrospective study was conducted at a single center from January 2016 to June 2019. All patients underwent 1-stage augmentation-mastopexy with the inverted T incision. For 2 weeks postsurgically, wounds were dressed either with the oxygen-enriched olive oil bra or with Fitostimoline (Farmaceutici Damor SpA, Naples, Italy). Patients indicated their pain intensity on postoperative days 2, 3, and 10, and patients and independent observers scored scar quality on the Patient and Observer Scar Assessment Scale (POSAS) 6 and 12 months after the procedure. RESULTS: A total of 240 women (120 per study arm) completed the study. All the patients had satisfactory aesthetic results, and there were no tolerability concerns with either postoperative dressing. Compared with patients in the Fitostimoline group, patients who received the oxygen-enriched olive oil bra cup had significantly lower pain levels, and their surgical scars were given better scores on the POSAS. CONCLUSIONS: The results suggest that maintenance of the surgical wound in a film of oxygen-enriched olive oil for 2 weeks is a safe, effective modality for suppressing pain and promoting healing following augmentation-mastopexy.

Titanium-coated polypropylene mesh as innovative bioactive material in conservatives mastectomies and pre-pectoral breast reconstruction.

Breast reconstruction is rapidly evolving, thanks to the growing acceptance of synthetic meshes as innovative biomaterials. 276 patients undergoing mastectomy (total of 328 mastectomies) were analyzed in a retrospective observational study to evaluate the pre-pectoral immediate breast reconstruction (IBR) using an implant wrapped with Titanium-Coated Polypropylene Mesh (TCPM) vs. patients treated with tissue expander (TE), equally placed pre-pectorally (and wrapped with the same TCPM in 74.3% of the control group' breasts). 163 patients, of the study group (SG), underwent mastectomy and pre-pectoral IBR with implant wrapped with TCPM, in a one-step surgery, called direct-to-implant technique (DTI), while 113 patients control group (CG) underwent mastectomy and TE. DTI technique has been performed in 192 breasts of the SG while TE procedure in 136 breasts of the CG. The BREAST-Q questionnaire has been provided before the treatment and 2 years later. Baker scale has been used to evaluate capsular contracture. Oncologic, surgical, and aesthetic outcomes along with BREAST-Q scores were analyzed. Additionally, a histologic evaluation was conducted in 11 capsules' samples randomly chosen (6 derived from SG patients and 5 derived from CG). Complications were recorded in 43 cases (29SG-14CG): 8 skin-nipple necrosis (5SG-3CG), 8 wound dehiscence (6SG-2CG), 3 hematomas (1SG-2CG), and 24 infections (8SG-16CG). Grade IV capsular contracture was detected in 9 breasts (1SG-8CG), whereas 254 breasts were grade I (110SG-144CG), 33 (10SG-23CG) grade II, and 32 (4SG-28CG) grade III. Implant wrinkling was detected in 18 cases (10SG-8CG) after 30 months. The local tumor recurrence rate was 5.8%. Three recurrences were on the nipple-areola complex (1.9%). SG patients showed significantly higher rates in the BREAST-Q overall Satisfaction with Outcome (74.1), overall Satisfaction with Breasts (69.1), Psychosocial Well-being (81.9), and Sexual Well-being (63.1), versus CG's patients (p < 0.05). Histological analysis showed a process of normal tissue repair with a complete mesh integration and normal healing. Conservative mastectomies with pre-pectoral IBR assisted by TCPM proved themselves oncologically safe, biologically integrated into native tissues, and highly accepted in terms of quality of life guaranteeing a more natural and aesthetic breast appearance. CORE TIP: This retrospective observational study provided clinical and histological outcomes of the pre-pectoral IBR using an implant wrapped with TCPM vs. patients treated with TE, equally placed pre-pectorally. The efficacy of IBR using an implant wrapped with TCPM was confirmed by the cosmetic results obtained and by a rate of side effects comparable to TE. All the histological analyses performed confirmed the TCPM mesh complete integration with the physiological aspects of healing: The Collagen 1 and 3 expressions did not differ, between TCPM and NO TCPM samples to confirm a process of healing overlapping to perfect device incorporation and normal healing.

Loco-regional adjuvant radiation therapy in breast cancer patients with positive axillary lymph-nodes at diagnosis (CN2) undergoing preoperative chemotherapy and with complete pathological lymph-nodes response. Development of GRADE (Grades of recommendation, assessment, Development and Evaluation) recommendation by the Italian Association of radiation therapy and Clinical Oncology (AIRO).

OBJECTIVE: To perform a meta-analysis to determine the effect of loco-regional radiation therapy (RT) compared to no loco-regional RT for operated patients in clinical stage cN2 breast cancer at diagnosis and ypN0 after preoperative chemotherapy (PST). MATERIAL AND METHODS: Eligible studies were identified through a systematic search of the medical literature performed independently by two researchers using a validated search strategy. An electronic search of Medline via PubMed and Embase (Breast cancer AND preoperative chemotherapy AND radiation therapy) was conducted with no language or publication status restrictions. The effect of loco-regional RT on overall (OS), disease free (DFS), loco-regional recurrence-free (LRRFS) survival and local recurrence was evaluated. An electronic search of Medline via PubMed and Embase (Toxicity AND radiation therapy breast cancer AND preoperative therapy; toxicity AND breast surgery AND preoperative chemotherapy) was conducted for outcomes of harm: major acute and late skin toxicity, lymphedema and cardiac events. RESULTS: Of 333 studies identified, 4 retrospective studies reporting on a total of 1107 patients were included in the meta-analysis. Six and 3 reported data of acute and late skin toxicity, while 2 studies provided information on cardiac events. Pooled results showed no difference in terms of hazard ratio for loco-regional RT versus no loco-regional RT [hazard ratio (HR) = 0.82, 95% confidence interval (CI) 0.63-1.68]. Loco-regional RT was associated with an OS benefit in the subgroup analysis: IIIB-C (loco-regional RT 79.3% vs no loco-regional RT 71.2%, p = 0.027) and T3-T4 (loco-regional RT 82.6% vs no loco-regional RT 76.6%, p = 0.025). No difference was shown in terms of 5-year DFS (loco-regional RT 91.2% vs no loco-regional RT 83%, p = 0.441) and LRRFS (loco-regional RT 98.1% vs no loco-regional RT 92.3%, p = 0.148). There was no significant difference between the groups in terms of acute and late skin toxicities, lymphedema and cardiac events. CONCLUSIONS: Because of the limitations due to the small number of studies and heterogeneity in the analysis, the present study does not allow to draw any definitive conclusion, highlighting the need for well-controlled trials to determine the effect of loco-regional RT in patients with cN2 having a pathological complete response in the axillary nodes after preoperative chemotherapy.