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Simple intensity modulation of radiation therapy reduces acute toxicity compared with 2-dimensional techniques in adjuvant breast cancer treatment, but it remains unknown whether more complex or inverse-planned intensity modulated radiation therapy (IMRT) offers an advantage over forward-planned, 3-dimensional conformal radiation therapy (3DCRT).Using prospective data regarding patients receiving adjuvant whole breast radiation therapy without nodal irradiation at 23 institutions from 2011 to 2018, we compared the incidence of acute toxicity (moderate-severe pain or moist desquamation) in patients receiving 3DCRT versus IMRT (either inverse planned or, if forward-planned, using ≥5 segments per gantry angle). We evaluated associations between technique and toxicity using multivariable models with inverse-probability-of-treatment weighting, adjusting for treatment facility as a random effect.Of 1185 patients treated with 3DCRT and conventional fractionation, 650 (54.9%) experienced acute toxicity; of 774 treated with highly segmented forward-planned IMRT, 458 (59.2%) did; and of 580 treated with inverse-planned IMRT, 245 (42.2%) did. Of 1296 patients treated with hypofractionation and 3DCRT, 432 (33.3%) experienced acute toxicity; of 709 treated with highly segmented forward-planned IMRT, 227 (32.0%) did; and of 623 treated with inverse-planned IMRT, 164 (26.3%) did. On multivariable analysis with inverse-probability-of-treatment weighting, the odds ratio for acute toxicity after inverse-planned IMRT versus 3DCRT was 0.64 (95% confidence interval, 0.45-0.91) with conventional fractionation and 0.41 (95% confidence interval, 0.26-0.65) with hypofractionation.This large, prospective, multicenter comparative effectiveness study found a significant benefit from inverse-planned IMRT compared with 3DCRT in reducing acute toxicity of breast radiation therapy. Future research should identify the dosimetric differences that mediate this association and evaluate cost-effectiveness.

Purpose Questions remain about whether moderately hypofractionated whole-breast irradiation is appropriate for patients with triple-negative breast cancer. Methods and Materials Using the prospective database of a multicenter, collaborative quality improvement consortium, we identified patients with node-negative, triple-negative breast cancer who received whole-breast irradiation with either moderate hypofractionation or conventional fractionation. Using inverse probability of treatment weighting (IPTW), we compared outcomes using the Kaplan-Meier product-limit estimation method with Cox regression models estimating the hazard ratio for time-to-event endpoints between groups. Results The sample included 538 patients treated at 18 centers in 1 state in the United States, of whom 307 received conventionally fractionated whole-breast irradiation and 231 received moderately hypofractionated whole-breast irradiation. The median follow-up time was 5.0 years (95% confidence interval [CI], 4.77-5.15 years). The 5-year IPTW estimates for freedom from local recurrence were 93.6% (95% CI, 87.8%-96.7%) in the moderate hypofractionation group and 94.4% (95% CI, 90.3%-96.8%) in the conventional fractionation group. The hazard ratio was 1.05 (95% CI, 0.51-2.17; P = .89). The 5-year IPTW estimates for recurrence-free survival were 87.8% (95% CI, 81.0%-92.4%) in the moderate hypofractionation group and 88.4% (95% CI 83.2%-92.1%) in the conventional fractionation group. The hazard ratio was 1.02 (95% CI, 0.62-1.67; P = .95). The 5-year IPTW estimates for overall survival were 96.6% (95% CI, 92.0%-98.5%) in the moderate hypofractionation group and 93.4% (95% CI, 88.7%-96.1%) in the conventional fractionation group. The hazard ratio was 0.65 (95% CI, 0.30-1.42; P = .28). Conclusions Analysis of outcomes in this large observational cohort of patients with triple-negative, node-negative breast cancer treated with whole-breast irradiation revealed no differences by dose fractionation. This adds evidence to support the use of moderate hypofractionation in patients with triple-negative disease.

Functional or secondary tricuspid regurgitation (FTR) is a progressive disease with a significant negative impact on patient morbidity and mortality. Recently, atrial fibrillation (AF) has been recognized as a cause of FTR (with/without coexisting functional mitral regurgitation) by promoting right atrial (RA) remodeling and secondary tricuspid valve (TV) annulus dilation, even in the absence of right ventricular (RV) dilation or dysfunction. This distinct form of FTR has been called “atriogenic” or “atrial”. Recent evidence suggests that the RA is an important player in FTR pathophysiology not only for patients with AF, but also for those in sinus rhythm. Preliminary reports on atrial FTR show that cardioversion with documented maintenance of sinus rhythm promotes TV annulus and RA reverse remodeling and may significantly reduce FTR severity at follow-up. Large-scale studies on the prognostic benefits of rhythm vs rate-control strategy in atrial FTR patients are needed to substantiate specific guidelines indications for this subset of patients.

Purpose Brachytherapy is an essential technique to deliver radiation therapy and is involved in the treatment of multiple disease sites as monotherapy or as an adjunct to external beam radiation therapy. With a growing focus on the cost and value of cancer treatments as well new payment models, it is essential that standardized quality measures and metrics exist to allow for straightforward assessment of brachytherapy quality and for the development of clinically significant and relevant clinical data elements. We present the American Brachytherapy Society consensus statement on quality measures and metrics for brachytherapy as well as suggested clinical data elements. Methods and Materials Members of the American Brachytherapy Society with expertise in disease site specific brachytherapy created a consensus statement based on a literature review and clinical experience. Results Key quality measures (ex. workup, clinical indications), dosimetric metrics, and clinical data elements for brachytherapy were evaluated for each modality including breast cancer, cervical cancer, endometrial cancer, prostate cancer, keratinocyte carcinoma, soft tissue sarcoma, and uveal melanoma. Conclusions This consensus statement provides standardized quality measures and dosimetric quality metrics as well as clinical data elements for each disease site to allow for standardized assessments of brachytherapy quality. Moving forward, a similar paradigm can be considered for external beam radiation therapy as well, providing comprehensive radiation therapy quality measures, metrics, and clinical data elements that can be incorporated into new payment models.

Radiation therapy (RT) is an essential component in the management of breast cancer. Following breast-conserving surgery (BCS), adjuvant RT is the standard of care for most patients. Traditionally, RT was delivered with standard whole breast irradiation (WBI) over 5-7 weeks following BCS. However, WBI regimens have evolved; hypofractionated WBI now represents the standard approach, reducing the duration of treatment to 3-4 weeks. Over the past year, five-fraction WBI regimens have also emerged as standard of care for some patients based on data from the FAST and FAST-Forward trials. An alternative to WBI that is also available for patients with early-stage breast cancer following BCS is partial breast irradiation, which can reduce the duration of treatment and the volume of breast tissue irradiated. Outcomes from multiple randomized trials with over a 10-year follow-up have demonstrated the safety and efficacy of partial breast irradiation approaches. Single-fraction intraoperative RT has also been evaluated in two prospective trials although the outcomes available, as well as current guidelines, do not support its utilization outside of prospective studies. For patients requiring RT to the regional lymph nodes, data have demonstrated the safety of hypofractionated approaches for those undergoing BCS or mastectomy without reconstruction. Future directions for early-stage breast cancer radiotherapy include the study of even shorter regimens and studies evaluating the omission of RT versus omission of endocrine therapy for favorable-risk patients. Furthermore, studies are also underway evaluating shorter courses of radiation in patients undergoing breast reconstruction and the use of tumor genomics to identify appropriate patients for omission of radiation with limited nodal involvement.

Purpose To describe features of uveitis-glaucoma-hyphema (UGH) syndrome, using Anterior Segment-Optical Coherence Tomography (AS-OCT) and Ultrasound Biomicroscopy (UBM) and to evaluate the diagnostic role of AS-OCT as an imaging technique alternative to UBM. Design Retrospective case series. Methods Four eyes of 4 patients with UGH syndrome were analyzed. All patients reported previous uncomplicated cataract surgery with in-the-bag implantation of single-piece-intraocular lens (IOL). They underwent at presentation complete ophthalmological examination and imaging with slit-lamp anterior segment photographs, UBM and AS-OCT. Results Although AS-OCT did not allow to visualize the structures behind the iris, it displayed a contact between IOL (plate and/or haptics) and iris and IOL tilting in 3 out of 4 eyes. AS-OCT directly detected the cause of UGH syndrome in one eye, 2 eyes required some expedients to display the iris chafing, like scans in mydriasis and/or patient's gaze direction change. AS-OCT did not allow to appreciate the IOL-iris contact (showed by UBM technique) only in one eye, probably due to the change of patient position from supine to sitting, and consequent anteriorization of iris diaphragm. Furthermore AS-OCT showed fine details, as capsular bag collapse and indirect signs of haptic malposition in 3 out of 4 eyes. Conclusion AS-OCT is a non-invasive technique that allows to determine IOL position and IOL-uveal contact in selected cases of UGH syndrome. Considering AS-OCT and UBM advantages and limitations, AS-OCT should be used as first imaging modality when clinical diagnosis is uncertain. When UGH diagnosis cannot be verified using AS-OCT, UBM should be performed.

To observe the effectiveness of preoperative drug-induced sleep endoscopy in improving surgical results of patients undergoing single-level barbed pharyngoplasty surgery for OSA, using a prospective randomized model. A single-center randomized controlled trial with two prospective arms was carried out to compare functional results in patients treated with barbed reposition pharyngoplasty (BRP) surgery without a preoperative drug-induced sleep endoscopy (DISE) evaluation vs patients treated with BRP surgery performed after DISE evaluation of sites/patterns of collapse. We compared 50 patients who underwent BRP without a preoperative DISE evaluation (Group A) and 42 patients (Group B) treated with BRP surgery but preoperatively selected by means of a preoperative DISE. In this second group of patients, after DISE evaluation, 70% of patients were selected for single-level BRP surgery because they showed an isolated velopharyngeal collapse at the DISE evaluation, without obstruction at other upper airway levels evaluated. Both groups of patients showed a statistically significant difference between preoperative and postoperative values of AHI, ODI, and LOS (p

Obstructive sleep apnea (OSA) is the most common sleep disorder due mainly to peripheral causes, characterized by repeated episodes of obstruction of the upper airways, associated with arousals and snoring. Sleep bruxism (SB) is a masticatory muscle activity during sleep that is characterized as rhythmic (phasic) or nonrhythmic (tonic) and is not a movement disorder or a sleep disorder in otherwise healthy individuals. Given the potentially severe consequences and complications of apnea, the concurrent high prevalence of SB in daily dental practice, getting deeper into the correlation between these phenomena is worthy of interest..The aim of this study was to investigate the correlation between SB-related masseter muscle activity (MMA) and apnea-hypopnea events as well as to assess their temporal sequence.Thirty (N = 30) patients with sleep respiratory disorders and clinical suspicion of sleep bruxism (SB) were recruited. Ambulatory polygraphic recording was performed to detect apnea-hypopnea events (AHEs) and sleep bruxism episodes (SBEs). Pearson test was used to assess the correlation between apnea-hypopnea index (AHI) and SB index (SBI). A 5-s time window with respect to the respiratory events was considered to describe the temporal distribution of SBEs. Furthermore, SBI was compared between groups of patients with different AHI severity (i.e., mild, moderate and severe) using ANOVA.On average, AHI was 27.1 ± 21.8 and SBI 9.1 ± 7.5. No correlation was shown between AHI and SBI. Most of SBEs (66.8%) occurred without a temporal relationship with respiratory events. Considering OSA, 65.7% of SBEs occurred within 5 s after AHEs, while in the case of central apnea (CA) 83.8% of SBEs occurred before the respiratory event. The participants with severe apnea (N = 9) show a tendency to have higher bruxism indexes when compared to patients with mild (N = 11) and moderate apnea (N = 10).Findings suggest that: 1. At the study population level, there is no correlation between AHI and SBI, as well as any temporal relationship between SBEs and respiratory events. 2. Specific patterns of temporal relationship might be identified with future studies focusing on the different types of apnea-hypopnea events and bruxism activities.

PURPOSE: No study to date has described the overall landscape of sleep disorders management and training in otolaryngology departments of different countries. The aim of our study was to investigate and compare settings, diagnostic and therapeutic approaches and training programmes. METHODS: An international online survey was developed with the collaboration of the YO-IFOS (Young Otolaryngologists-International Federation of Otorhinolaryngological Societies) to assess the current practice of otolaryngologists in the management of sleep disorders. The survey also included a session dedicated to training. RESULTS: A total of 126 otolaryngologists completed the survey. The larger part of responses was collected from Central/South America and Europe. The majority of responders from South/Central America (97%) declared to be certified as sleep specialist while 49% of Europeans stated the opposite. Of responders 83% perform a drug-induced sleep endoscopy (DISE) before planning a possible surgical intervention. Soft palate and base of tongue interventions were the most common procedure, respectively performed in 94% and 79% of the cases. Residents were allowed to perform soft palate surgery in 77% of the cases. Upper airway stimulation (26% vs 10%), trans-oral robotic surgery (36% vs 11%) and radiofrequency of the base of the tongue (58% vs 25%) were preferred more frequently by European responders. The highest caseloads of soft palate surgery and bi-maxillary advancement were registered in the academic institutions. CONCLUSION: Significant concordance and few interesting divergences in diagnosis and treatment of sleep disorders were observed between nationalities and types of institution. Economic resources might have played a significant role in the therapeutic choice. Trainees' lack of exposure to certain interventions and to a sufficient caseload appeared to be the main burden to overcome.

Fitz-Hugh-Curtis Syndrome is a rare disorder manifesting as a complication associated with Pelvic Inflammatory Disease. The initial presentation generally consists of concomitant right upper quadrant and lower abdominal pain. This syndrome is characterized by inflammation of the peritoneum with the involvement of hepatic capsule and the tissues surrounding the liver. Intrahepatic involvement is rare and not yet well investigated. An accurate interpretation of Computed Tomography and Magnetic Resonance Imaging findings is missing in the literature. This report presents a case of Fitz-Hugh-Curtis Syndrome in which Computed Tomography and Magnetic Resonance Imaging showed a region of heterogeneously decreased enhancement and abnormal signal intensity within the liver mimicking a lesion.

PURPOSE: Adjuvant therapy in patients with ductal carcinoma in situ who undergo partial mastectomy remains controversial, particularly for low-risk patients (60 years or older, estrogen-positive, tumor extent < 2.5 cm, grade 1 or 2, and margins ≥ 3 mm). We performed a cost-effectiveness analysis comparing three strategies: no adjuvant treatment after surgery, a five-fraction course of accelerated partial breast irradiation using intensity-modulated radiation therapy (accelerated partial breast irradiation [APBI]–alone), or APBI plus an aromatase inhibitor for 5 years. MATERIALS AND METHODS: Outcomes including local recurrence, distant metastases, and survival as well as toxicity data were modeled by a patient-level Markov microsimulation model, which were validated against trial data. Costs of treatment and possible adverse events were included from the societal perspective over a lifetime horizon, adjusted to 2019 US dollars and extracted from Medicare reimbursement data. Quality-adjusted life-years (QALYs) were calculated based on utilities extracted from the literature. RESULTS: No adjuvant therapy was the least costly approach ($5,744), followed by APBI-alone ($11,070); combined therapy was costliest ($16,052). Adjuvant therapy resulted in slightly higher QALYs (no adjuvant, 11.320; APBI-alone, 11.343; and combination, 11.381). In the base case, no treatment was the cost-effective strategy, with an incremental cost-effectiveness ratio of $239,109/QALY for APBI-alone and $171,718/QALY for combined therapy. The incremental cost-effectiveness ratio for combined therapy compared with APBI-alone was $131,949. Probabilistic sensitivity analyses found that no therapy was cost effective (defined as $100,000/QALY of lower) in 63% of trials, APBI-alone in 19%, and the combination in 18%. CONCLUSION: No adjuvant therapy represents the most cost-effective approach for postmenopausal women 60 years or older who receive partial mastectomy for low-risk ductal carcinoma in situ.

Background The 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). Methods From 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. Results During 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). Conclusions In 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.

To determine whether the quality of a low-volume reduced bowel preparation (LV-RBP) for CT Colonography (CTC) is noninferior to full-volume reduced bowel preparation (FV-RBP) regimen. In this randomized controlled trial, consecutive participants referred for CTC were randomly assigned to receive LV-RBP (52.5 g of PMF104 in 500 mL of water) or FV-RBP (105 g of PMF104 in 1000 mL of water). Images were independently reviewed by five blinded readers who rated the quality of bowel preparation from 0 (best score) to 3 (worst score). The primary outcome was the noninferiority of LV-RBP to FV-RBP in the proportion of colonic segments scored 0 for cleansing quality, with noninferiority margin of 10%. Volume of residual fluids, colonic distension, lesions and polyps detection rates and patient tolerability were secondary outcomes. From March 2019 to January 2020, 110 participants (mean age 65 years ± 14 [standard deviation]; 74 women) were allocated to LV-RBP (n = 55) or FV-RBP (n = 55) arms. There were 92% segment scored 0 in colon cleansing quality in LV-RBP and 94% in FV-RBP for prone scans, and 94% vs 92% for supine scans. Risk difference was – 2.1 (95% CI −5.9 to 1.7) and 1.5 (95% CI −2.4 to 5.4) for prone and supine positions, respectively. Residual fluids and colonic distension were also noninferior in LV-RBP. LV-RBP was associated with a lower number of evacuations during preparation (7 ± 5 vs 10 ± 6, p = 0.002). The LV-RBP for CTC demonstrated noninferior quality of colon cleansing with improved gastrointestinal tolerability compared to FV-RBP regimen.

Purpose: To describe the findings of four patients (four eyes) with optic disc melanocytoma (ODM), using multimodal imaging. Methods: Retrospective case series. Results: On ocular ultrasonography ODMs appeared as hyperechogenic lesions with moderate-to-high internal reflectivity. On blue-light fundus autofluorescence, ODMs showed total hypoautofluorescence, while, on infrared reflectance images appeared as bright and well-marginated lesions. MultiColor composite images showed reddish-brown lesions with well-defined margins. Swept-source optical coherence tomography revealed elevated lesions covering the optic disc with an irregular hyperreflective surface, dishomogeneous internal structure with hyperreflective dots, and posterior shadowing. In all cases optical coherence tomography angiography detected intratumoral blood vessels which were not detectable with fluorescein angiography. Conclusion: Multimodal imaging in ODM might be useful both at presentation, increasing the diagnostic accuracy, and at follow-up, providing helpful details, that can help to rule out the possibility of malignant transformation and other ocular complications.

Background The role of radiation therapy (RT) following breast-conserving surgery (BCS) in ductal carcinoma in situ (DCIS) remains controversial. Trials have not identified a low-risk cohort, based on clinicopathologic features, who do not benefit from RT. A biosignature (DCISionRT®) that evaluates recurrence risk has been developed and validated. We evaluated the impact of DCISionRT on clinicians’ recommendations for adjuvant RT. Methods The PREDICT study is a prospective, multi-institutional, observational registry in which patients underwent DCISionRT testing. The primary endpoint was to identify the percentage of patients where testing led to a change in RT recommendations. Results Overall, 539 women were included in this study. Pre DCISionRT testing, RT was recommended to 69% of patients; however, post-testing, a change in the RT recommendation was made for 42% of patients compared with the pre-testing recommendation; the percentage of women who were recommended RT decreased by 20%. For women initially recommended not to receive an RT pre-test, 35% had their recommendation changed to add RT following testing, while post-test, 46% of patients had their recommendation changed to omit RT after an initial recommendation for RT. When considered in conjunction with other clinicopathologic factors, the elevated DCISionRT score risk group (DS > 3) had the strongest association with an RT recommendation (odds ratio 43.4) compared with age, grade, size, margin status, and other factors. Conclusions DCISionRT provided information that significantly changed the recommendations to add or omit RT. Compared with traditional clinicopathologic features used to determine recommendations for or against RT, the factor most strongly associated with RT recommendations was the DCISionRT result, with other factors of importance being patient preference, tumor size, and grade.

Purpose This meta-analysis study was designed to analyze endoscopic surgery’s role in treating rhinogenic contact point headache. Methods We performed a comprehensive review of the last 20 years’ English language regarding Rhinogenic contact point headache and endoscopic surgery. We included the analysis papers reporting post-operative outcomes through the Visual Analogue Scale or the Migraine Disability Assessment scale. Results We provided 18 articles for a total of 978 RCPH patients. While 777 (81.1%) subjects underwent functional nasal surgery for RCPH, 201 patients (20.9%) were medically treated. A significant decrease from the VAS score of 7.3 ± 1.5 to 2.7 ± 1.8 was recorded (p p Conclusion At comparison, surgical treatment in patients with rhinogenic contact points exhibited significantly better values at short-term, medium-term, and long term follow up. Endoscopic surgery should be proposed as the choice method in approaching the symptomatic patient.

BACKGROUND: Current national guidelines encourage consideration for treating the at-risk regional nodes (axillary, supraclavicular, and/or internal mammary) with directed regional nodal irradiation (RNI) during post-lumpectomy radiotherapy for high risk N0 (node negative) and N1 (1-3 nodes positive) breast cancer patients. This recommendation is based on the results of several randomized trials published over the last decade. Evidence regarding translation of these trials into clinical practice in the United States has been limited to date. In this study, we sought to characterize the temporal changes in and clinical factors associated with the utilization of RNI during post-lumpectomy radiotherapy for N0-N1 breast cancer across a contemporary, statewide consortium of radiation oncology practices. METHODS: Within a statewide radiation oncology quality consortium, 12,170 breast cancer patients were consecutively enrolled between 1/1/2013 and 10/31/2019 in both academic (teaching) and community (non-teaching) facilities. Data on receptor status, adjuvant systemic therapy, age, TNM stage, extent of axillary surgery, race, body mass index (BMI), type of treating facility, and year completing radiotherapy (RT) were collected. Eligibility for the present analysis was limited to patients with N0 and N1 disease not receiving neoadjuvant systemic therapy and receiving adjuvant radiotherapy after lumpectomy for non-metastatic breast cancer. Multiple variable logistic regression models were separately fit to explain the use of directed RNI (to the axilla, supraclavicular region, and/or internal mammary region) for the N0 and N1 populations separately and described using odds ratios (OR), with significant ORs (p RESULTS: A total of 8,468 patients from 29 treating facilities met the inclusion criteria: 6,929 (81.8%) with N0 and 1,539 (18.2%) N1 disease. RNI was performed in addition to whole breast radiation in 95 (1.4%) and 908 (59%) patients in the N0 and N1 cohorts respectively. For the N0 cohort, significant correlates of RNI on multivariable analysis (MVA) were receipt of adjuvant chemotherapy (OR 2.7), higher T-stage (OR 1.9 for T2 vs T1 and 27.3 for T3/T4 vs T1), axillary surgery [compared to sentinel node biopsy (SLN) alone : no axillary surgery (OR 14.5), axillary lymph node dissection (ALND) with 10+ nodes removed (OR 15.1) ALND after SLN (OR 2.7)], and underweight BMI (OR 4.9 compared to overweight, which was the reference as the largest BMI category). For the N1 cohort, MVA suggested adjuvant chemotherapy (OR 1.8) and larger tumors (OR 1.6 [T2 vs T1]) were significantly associated with use of RNI. The year completing RT was also significantly associated with RNI use, with 22% and 15% increases per year from 2013 to 2019 in the N0 and N1 cohorts, respectively. Lastly, receiving treatment in an academic facility compared to a community facility was significantly associated with receipt of RNI in both the N0 (OR 1.8) and N1 (OR 2.2) cohorts. CONCLUSION: In this large cohort, selective use of RNI added to post-lumpectomy whole breast radiotherapy is estimated to have increased over time, suggesting growing implementation of recent trial data and current clinical practice guidelines. Patient, treatment, and tumor characteristics appear to factor into the decision to treat with RNI, but differences in use between academic and community practices suggest opportunities for improving the consistency of care across care delivery settings. Ongoing trials seeking to identify subgroups of N1 patients in whom RNI can safely be omitted may be especially important to inform decisions, given the almost even split (59% receiving, 41% not) in practice observed in this large American cohort. Citation Format: Derek Bergsma, Kent Griffith, Reshma Jagsi, Michael Dominello, Thomas Boike, Joshua Dilworth, Amit Bhatt, Frank Vicini, Maggie Grubb, Jean Moran, James Hayman, Lori Pierce, on behalf of MROQC, the Michigan Radiation Oncology Quality Consortium. Contemporary practice patterns for the use of regional nodal irradiation during post-lumpectomy radiotherapy for patients with N0/N1 breast cancer [abstract]. In: Proceedings of the 2020 San Antonio Breast Cancer Virtual Symposium; 2020 Dec 8-11; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2021;81(4 Suppl):Abstract nr PD4-07.

BACKGROUND: Evaluating whether physicians (MDs) accurately detect symptoms in patients (pts) is important because recognition of symptoms facilitates supportive care and because clinical trials often rely on MD assessments using the Common Toxicity Criteria for Adverse Events (CTCAE). METHODS: Breast cancer pts who received radiotherapy (RT) after lumpectomy at 29 practices were enrolled in a quality initiative, MROQC. Of 13,725 pts who completed RT between 1/1/2012 and 3/31/2020, 9,941 completed at least one pt-reported outcomes (PRO) questionnaire during RT. Where MD CTCAE assessments were available within 3 days of PRO evaluation, pt and MD ratings of 4 symptoms were compared. Pts reported breast pain via an approved modification of the Brief Pain Inventory, asking for ratings in the last 24 hours of pain at its worst, least, average, and “right now.” MDs were deemed to under-recognize pain when pts reported moderate pain (score 4-6) but MDs graded pain as 0 (absent) on the CTCAE, or when pts reported severe pain (score 7-10) but MDs’ CTCAE grade was ≤1. Bother from pruritis and edema were measured by modified scaled measures adapted from the Skindex. MDs were deemed to under-recognize pruritus and edema if they graded these as absent (grade 0) when pts reported bother often or all of the time from itching or swelling, respectively. MDs were deemed to under-recognize fatigue if they graded fatigue as absent (grade 0) when pts reported having significant fatigue most of the time or always.We describe the proportion of pts for whom under-recognition of at least 1 of these 4 symptoms occurred at least once during the treatment course and use multivariable logistic regression to evaluate predictors of this under-recognition, hypothesizing that it would be more common in racial minorities. RESULTS: 3,434/9,940 pts (34.5%) reported substantial breast pain, 3,039/9,923 (30.6%) frequent bother from pruritus, 2,363/9,906 (23.9%) frequent bother from edema, and 2,209/8,860 (24.9%) severe fatigue. We could evaluate under-recognition in 9,868 pts, with 37,593 independent paired observations of pt and MD reports (35,797 on the same date and 1,796 within 3 days). Under-recognition existed in 2,094/6,781 (30.9%) observations of pt-reported moderate/severe pain, 748/2,039 (36.7%) of pt-reported frequent pruritis, 2,309/4,492 (51.4%) of pt-reported frequent edema, and 390/2,079 (18.8%) of pt-reported severe fatigue. Under-recognition of at least 1 of these 4 symptoms occurred at least once during the pt’s treatment course for 2,933/5,510 (53.2%) of the pts who reported at least 1 substantial symptom during RT.Factors independently associated with under-recognition were (Table): younger age (OR=1.4 and 1.2 for CONCLUSIONS: PRO collection appears essential for trials because relying on the CTCAE to detect adverse events may miss important symptoms. Moreover, since MDs systematically miss substantial symptoms in certain patients, including pts who are younger or of black or other race, improving symptom detection may be a targetable mechanism to reduce disparities in RT experiences and outcomes. Multivariable model of symptom under-recognitionOR95% CIpAge--0.001 Citation Format: Reshma Jagsi, Kent A. Griffith, Frank Vicini, Thomas Boike, Michael Dominello, Gregory Gustafson, James A. Hayman, Jean M. Moran, Jeffrey Radawski, Eleanor Walker, Lori J. Pierce, on behalf of MROQC, the Michigan Radiation Oncology Quality Consortium. Identifying patients whose symptoms are under-recognized during breast radiotherapy: Comparison of patient and physician reports of toxicity in a multicenter cohort [abstract]. In: Proceedings of the 2020 San Antonio Breast Cancer Virtual Symposium; 2020 Dec 8-11; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2021;81(4 Suppl):Abstract nr GS3-07.

BACKGROUND: When considering health-related, quality-of-life and monetary costs associated with post-surgical treatments for women diagnosed with Ductal Carcinoma In Situ (DCIS), there remains a need for prognostic and predictive tools to help design individual treatment planning. DCISionRT (PreludeDx, Laguna Hills, CA) is a validated biologic signature to assess the 10-year event risk for DCIS patients managed with breast conserving surgery (BCS). The 10-year risks are provided separately for patients treated with and without adjuvant radiation therapy (RT) after BCS. The study was designed to measure the change in adjuvant RT recommendation. This is a planned interim analysis of the study, which will eventually comprise up to 2,500 patients and 100 sites. METHODS: The registry includes females over the age of 25 who are candidates for breast conserving surgery and eligible for RT. Survey forms are completed pre- and post-DCISionRT test to capture treatment recommendations and patient preferences. This interim analysis was performed to assess changes in RT recommendation for patients treated with BCS in different clinicopathologic subgroups. Specifically, ‘good risk’ profiles were based on the RTOG 9804 and ECOG 5194 study designs. RTOG 9804 like criteria was screening detected tumors with nuclear grade of 1 or 2, size of ≤ 2.5 cm, and clear (≥ 2 mm) surgical margins. ECOG 5194 like criteria was tumors with nuclear grade of 1 or 2, size of ≤ 2.5 cm, and clear surgical margins, or nuclear grade of 3, size of ≤ 1 cm, and clear surgical margins. Statistics were provided as percentages and counts, and McNemar’s test was used to assess change in RT with a p-value of RESULTS: There were 513 patients from 32 sites with testing completed after treatment with BCS. Of these patients, 16% were ≤ 50 years of age, 60% were ≥ 60 years of age, and 26% were ≥ 70 years of age. The DCIS tumor nuclear grade was high in 32% of patients, and the size of the tumor was ≤ 1 cm for 68% of patients. There were 49% of patients who met RTOG 9804 like criteria, 51% who met the ECOG 5194 (grade 1 or 2) criteria, and 45% of patients who met the ECOG 5194 (grade 3) criteria. RT was recommended to 52% and 53% patients for RTOG 9804/ECOG 5194 (grade 1 or 2) criteria pre-testing, and 42% post-testing. For ECOG 5194 (grade 3) like criteria, 64% of patients were recommended RT pre-test, and 40% were recommended RT post-test. In all criteria groups, for patients whom were initially recommended RT pre-test, 51% to 54% were not recommended RT post-test, while patients initially not recommended RT pre-test, 25% to 37% were recommended RT post-test. Overall, the post-test RT recommendation was significantly changed from between 42% and 46% for patients with ‘good-risk’ clinicopathologic criteria. CONCLUSIONS: The PREDICT study interim analysis demonstrates a significant absolute overall change post DCISionRT testing for RT recommendation in patients with ‘good-risk’ clinicopathology. RT recommendations were changed post-test for 42% to 46% of patients meeting RTOG 9804/ECOG 5194 like criteria. Integration of DCISionRT testing had a significant impact on the RT recommendations aimed at reducing overtreatment and minimizing undertreatment. Table 1. Pre-Post DCISionRT Impact by ‘good-risk’ criteria.n% RTPre-testYes% RTPost-test Yes% RTPre-Yes, Post-No% RTPre-No, Post-Yes% Total Decision Change95% CIp-valueRTOG 9804 criteriaGrade 1 or 2, Size ≤ 2.5 cm, screen detected, wide margins2525242543746%40 - 52%1.2E-02ECOG E5194 criteriaGrade 1 and 2, Size ≤ 2.5 cm, wide margins2625342533645%39 - 51%0.010Grade 3, Size ≤ 1 cm, wide margins2316440512542%36 - 48%2.4E-08 Citation Format: Chirag Shah, Frank Vicini, Steven C Shivers, Pat W Whitworth, Rakesh Patel, Charles E Cox, Troy Bremer. Clinical utility of a biologic signature to assess DCIS recurrence risk in patients meeting ‘good-risk’ criteria (RTOG 9804, ECOG 5194): Interim analysis of the DCISionRT PREDICT study [abstract]. In: Proceedings of the 2020 San Antonio Breast Cancer Virtual Symposium; 2020 Dec 8-11; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2021;81(4 Suppl):Abstract nr PS6-17.

Recurrent respiratory infections (RRIs) are a common clinical condition in children, in fact about 25% of children under 1 year and 6% of children during the first 6 years of life have RRIs. In most cases, infections occur with mild clinical manifestations and the frequency of episodes tends to decrease over time with a complete resolution by 12 years of age. However, RRIs significantly reduce child and family quality of life and lead to significant medical and social costs. Despite the importance of this condition, there is currently no agreed definition of the term RRIs in the literature, especially concerning the frequency and type of infectious episodes to be considered. The aim of this consensus document is to propose an updated definition and provide recommendations with the intent of guiding the physician in the complex process of diagnosis, management and prevention of RRIs. Supplementary Information The online version contains supplementary material available at 10.1186/s13052-021-01150-0.

Background Interstitial lung disease (ILD) is a severe systemic manifestation of rheumatoid arthritis (RA). High-resolution computed tomography (HRCT) represents the gold standard for the diagnosis of ILD, but its routine use for screening programs is not advisable because of both high cost and X-ray exposure. Velcro crackles at lung auscultation occur very early in the course of interstitial pneumonia, and their detection is an indication for HRCT. Recently, we developed an algorithm (VECTOR) to detect the presence of Velcro crackles in pulmonary sounds and showed good results in a small sample of RA patients. The aim of the present investigation was to validate the diagnostic accuracy of VECTOR in a larger population of RA patients, compared with that of the reference standard of HRCT, from a multicentre study. Methods To avoid X-ray exposure, we enrolled 137 consecutive RA patients who had recently undergone HRCT. Lung sounds of all patients were recorded in 4 pulmonary fields bilaterally with a commercial electronic stethoscope (ES); subsequently, all HRCT images were blindly evaluated by a radiologist, and audio data were analysed by means of VECTOR. Results Fifty-nine of 137 patients showed ILD (43.1%). VECTOR correctly classified 115/137 patients, showing a diagnostic accuracy of 83.9% and a sensitivity and specificity of 93.2 and 76.9%, respectively. Conclusions VECTOR may represent the first validated tool for the screening of RA patients who are suspected for ILD and who should be directed to HRCT for the diagnosis. Moreover, early identification of RA-ILD could contribute to the design of prospective studies aimed at elucidating unclear aspects of the disease.

Adjuvant radiation therapy (RT) following breast-conserving surgery (BCS) represents a standard approach for most patients treated with breast-conserving therapy (BCT) for early-stage breast cancer. The first-generation of adjuvant RT schedules delivered daily treatment to the whole breast over 5–7 weeks. Although efficacious, this presented patients with a protracted course of treatment, reducing compliance and quality of life. While hypofractionated whole-breast irradiation (WBI) has become the standard, and part of the second-generation of RT regimens, it still requires 3–4 weeks. Concurrently, partial-breast irradiation (PBI) has also been explored as a technique to complete RT in a much shorter time period (1–3 weeks). There are now seven trials confirming the efficacy of this shorter treatment approach compared with standard WBI. In an effort to further reduce treatment duration, ultra-short WBI and PBI regimens have recently emerged as the third-generation of breast radiation schedules, allowing for the completion of treatment in 5 days or less. With respect to WBI, recent data from the FAST-Forward trial (which evaluated five fractions of WBI delivered in 1 week) demonstrated no difference in clinical outcomes at 5 years, with limited difference in toxicity, compared with hypofractionated 3-week WBI. Regarding PBI, published data on five-fraction regimens delivered in 2 weeks have also demonstrated comparable outcomes at 10 years, with reduced toxicities with long-term follow-up. This report will review additional ongoing studies evaluating even shorter courses of adjuvant RT treatment (one to five fractions), including single-fraction PBI or WBI.

We sought to evaluate time trends and correlates of the use of a radiation tumor bed boost (TBB) after breast-conserving surgery and either conventional or hypofractionated whole-breast irradiation (CWBI or HWBI) for patients with early stage breast cancer.The National Cancer Database was queried for patients diagnosed between 2012 and 2016. We evaluated the utilization of TBB before and after publication of the Society of Surgical Oncology-American Society for Radiation Oncology margin guidelines in relation to sociodemographic variables, treatment facility, tumor characteristics, and whole-breast fractionation.The population included 380,387 patients, of whom 76.7% received a TBB. Utilization of TBB decreased over time (2012-2013: 79.2%; 2014: 76.6%; 2015-2016: 74.7%; P.001); this was seen for most subgroups evaluated. Rates of TBB differed by facility type and region. There was a decrease in TBB use in patients treated with CWBI over time (2012-2013: 84.9%; 2014: 83.5%; 2015-2016: 82.3%; P.001) but an increase among patients treated with HWBI (2012-2013: 55.5%; 2014: 60.7%; 2015-2016: 65.1%; P.001); this was also seen for low-risk patients (age70 years, negative margins). Among patients undergoing HWBI, TBB was more frequently used when 15 fractions were used compared with 16 fractions (76.8% vs 59.1%; P.001).The use of TBB decreased over time, coinciding with the publication of new margin guidelines, for patients receiving CWBI and those with negative margins, but TBB use increased for patients treated with HWBI. Hence, fractionation regimen is a critical variable in analyzing changes over time in the practice patterns of TBB.

We describe a case of spontaneous rupture of the splenic vein in a pregnant patient at 33 weeks gestation. For the first time in literature, we report follow-up investigations aimed at understanding the cause of the event. The woman was admitted to the emergency ward for hypovolemic shock. Maternal and fetal distress prompted an immediate cesarean section. The fetus was delivered stillborn, hemoperitoneum was present and two spontaneous splenic vein’s lacerations were found to be the source of the bleeding. The immediate splenectomy and aggressive correction of anemia and coagulopathy determined maternal survival. During the follow-up, no evidence of neither congenital nor acquired causative factors for a splenic vein rupture was found. The aim of reporting this case is to increase the awareness between clinicians of this condition since it is both rare and with an aspecific clinical picture. It presents itself in apparently low-risk patients and a good maternal-fetal outcome can only be achieved by early diagnosis and prompt treatment.

PURPOSE Understanding acute toxicities after whole-breast radiotherapy is important to inform patients, guide treatment decisions, and target supportive care. We evaluated patient-reported outcomes prospectively collected from a cohort of patients with breast cancer. METHODS We describe the maximal toxicity reported by 8,711 patients treated between 2012 and 2019 at 27 practices. Multivariable models identified characteristics associated with (1) breast pain, (2) bother from itching, stinging/burning, swelling, or hurting of the treated breast, and (3) fatigue within 7 days of completing whole-breast radiotherapy. RESULTS Moderate or severe breast pain was reported by 3,233 (37.1%): 1,282 (28.9%) of those receiving hypofractionation and 1,951 (45.7%) of those receiving conventional fractionation. Frequent bother from at least one breast symptom was reported by 4,424 (50.8%): 1,833 (41.3%) after hypofractionation and 2,591 (60.7%) after conventional fractionation. Severe fatigue was reported by 2,008 (23.1%): 843 (19.0%) after hypofractionation and 1,165 (27.3%) after conventional fractionation. Among patients receiving hypofractionated radiotherapy, younger age ( P < .001), higher body mass index (BMI; P < .001), Black ( P < .001) or other race ( P = .002), smoking status ( P < .001), larger breast volume ( P = .002), lack of chemotherapy receipt ( P = .004), receipt of boost treatment ( P < .001), and treatment at a nonteaching center predicted breast pain. Among patients receiving conventionally fractionated radiotherapy, younger age ( P < .001), higher BMI ( P = .003), Black ( P < .001) or other race ( P = .002), diabetes ( P = .001), smoking status ( P < .001), and larger breast volume ( P < .001) predicted breast pain. CONCLUSION In this large observational data set, substantial differences existed according to radiotherapy dose fractionation. Race-related differences in pain existed despite controlling for multiple other factors; additional research is needed to understand what drives these differences to target potentially modifiable factors. Intensifying supportive care may be appropriate for subgroups identified as being vulnerable to greater toxicity.

The Coronavirus disease 2019 (COVID-19) outbreak has imposed the adoption of strategies to limit the risk of contagion for cancer patients without compromising their healthcare. As well as cancers of other sites, the treatment of certain ocular and periocular malignancies is considered non-deferrable and should proceed despite the pandemic. Delays in treatment of these patients may result in negative outcomes. Herein, we provide some practical considerations deriving from our experience at the Ocular Oncology Unit of Careggi University Hospital (Florence, Italy).

The American Brachytherapy Society brachytherapy schools have been pivotal in teaching and evolving the art of brachytherapy over the past decades. Founded in 1995, the schools have consistently provided content for the major disease sites including gynecologic, prostate, and breast with ocular, vascular, head and neck, pediatric, intraluminal, systemic, and intraoperative approaches more selectively addressed. In addition, Physics schools, either coupled with clinical schools or as stand-alone venues, have provided an essential educational component for practicing physicists, a pivotal part of the brachytherapy team. Celebrating 25 years in existence, this historical overview of the American Brachytherapy Society brachytherapy schools is a tribute to the many teachers who have shared their expertise, to the many students who have been enthusiastic and interactive participants, and the staff who have made it all possible, with the reward of perpetuating the important and timely art of brachytherapy.

Objectives To evaluate the incidence of facial canal dehiscence (FCD) and other intraoperative findings over the last 20 years as well as correlation with the Japanese Otological Society/European Academy of Otology and Neurotology classification in patients with cholesteatoma. Materials and methods A total of 469 patients operated from 1998 to 2018 were selected and divided into 2 groups of 10 years each. Results Dehiscence was significantly higher in patients with a history of pathology longer than 5 years (22.7%). Higher values were observed in revision surgery, 44.4% in the first period and 41.7% in the second. The tympanic segment was the one most frequently involved, affecting 92% of patients in the first period and 97% of patients in the second. Dehiscence occurred significantly more often in patients with a semicircular canal fistula, 14.8% in the first decade and 8.8% in the second. The incidence of FCD was significantly higher in patients with primary cholesteatoma (especially in those with combined pars tensa-flaccida) than in those with a secondary acquired one, 31.5% vs 7.4% in the first period, 21.1% vs 7.4% in the second, and in those with a stage III disease, 42% in the first period, 33.3% in the second. Conclusion Patients with a shorter history of cholesteatoma as well as those not previously operated had a lower incidence of FCD. The tympanic tract of the facial nerve remains the most frequent site of dehiscence, while the association between dehiscence and fistula of the semicircular canal remains strong. Patients with combined pars tensa-pars flaccida and stage III cholesteatoma have a higher incidence of FCD.

Objective Does nasal surgery affect multilevel surgical success outcome. Methods Prospective eight country nonrandomized trial of 735 obstructive sleep apnea (OSA) patients, who had multilevel palate and/or tongue surgery, divided into two groups, with or without nose surgery. Results There were 575 patients in nose group, 160 patients in no nose group. The mean age for nose group 44.6 ± 11.4, no nose group 44.2 ± 11.8. Mean preoperative BMI for nose group 27.5 ± 3.6, no nose group 27.5 ± 4.1, mean postoperative BMI nose group 26.3 ± 3.7, no nose group 27.1 ± 3.8 (P = .006). Mean preoperative AHI nose group 32.7 ± 19.4, no nose group 34.3 ± 25.0 (P = .377); and mean postoperative AHI nose group 13.5 ± 10.2, no nose group 17.1 ± 16.0 (P = .001). Mean preoperative ESS nose group was 11.3 ± 4.7, no nose group was 10.4 ± 5.4 (P = .051); and mean postoperative ESS nose group was 5.3 ± 3.2, no nose group was 6.7 ± 2.8 (P = .001). The nose group had higher percentage change (adjusted for age, gender, BMI) in AHI (33.7%, 95% CI 14% to 53.5%) compared to the no nose group (P = .001); the nose group also had more percentage change in ESS (37%, 95% CI 23.6% to 50.3%) compared to the no nose group (P

Background Myelin oligodendrocyte glycoprotein immunoglobulin G associated optic neuritis (MOG-ON) is a recently described entity. Recent studies have shown that MOG-ON has a more severe clinical presentation than classic optic neuritis (ON). Objective This study aimed to define morphological characteristics of MOG-ON, correlate these with clinical characteristics and compare them with multiple sclerosis associated ON (MS-ON) and healthy controls (CTRL). Methods In a retrospective study, we included MOG-ON and MS-ON patients seen between 2011 and 2018 at the University Hospital Bern. Data from clinical examination, perimetry, and optical coherence tomography (OCT) were analyzed. Results A total of 66 eyes of 43 patients were included; 22 MS-ON and 33 CTRL eyes were sex- and age-matched to 11 MOG-ON eyes. We found significantly worse visual acuity at nadir, but better recovery and thinner global peripapillary retinal nerve fiber layer thickness in MOG-ON patients compared to MS-ON patients. Both groups exhibited irregular thinning of the macular ganglion cell layer. Furthermore, the visual acuity and visual field parameters correlated to retinal layer thickness only in MOG-ON eyes. Conclusion In comparison to MS-ON, MOG-ON is associated with more prominent acute vision loss and more pronounced global thinning of the pRNFL. Both entities result in similar final visual acuity and atrophy of the macular ganglion cell layer.

The role of radiation therapy in the management of breast cancer continues to evolve. For patients with early stage breast cancer, hypofractionated whole breast irradiation following breast conserving surgery now represents the standard of care based on randomized data with long-term efficacy and toxicity outcomes. Partial breast irradiation has been found, in several randomized trials, to be effective and appropriate in selected patients with the potential to reduce toxicities as compared to whole breast irradiation. The study of tumor biology and genetics and its role in radiation therapy decision making continues to grow and the advances may help identify patients where radiation therapy can be safely omitted, with future studies looking at de-intensification approaches. Recent randomized data has demonstrated a growing role for regional nodal irradiation in patients with more advanced disease, with future studies looking to identify whether nodal radiation is indicated following neoadjuvant chemotherapy or with certain favorable tumor biologies. While postmastectomy radiation therapy represents a standard approach for patients with locally advanced breast cancer, new data supports the role of hypofractionated regimens as well as its use in patients previously considered lower risk with unfavorable tumor biology. Oligometastatic disease represents a new area of study in breast cancer with prospective trials underway and current data supporting consideration of techniques such as stereotactic body radiation therapy in appropriately selected patients.

Purpose: To report a case of a large conjunctival melanoma (CM) successfully treated with surgical resection and pre- and postoperative topical mitomycin C (MMC). Methods: This is a single observational case report. Results: A 58-year-old man was referred to us for a large pigmented conjunctival lesion of the right eye. Slit lamp examination revealed an extensive pigmented lesion diffusely involving the temporal bulbar conjunctiva, with multifocal intensely dark areas and an elevated limbal component extending on the corneal surface. The remaining bulbar and forniceal conjunctiva was not involved. The lesion was clinically diagnosed as CM. Clinical examination and head and neck ultrasonography did not show regional lymphadenopathy. The patient was treated with neoadjuvant topical MMC 0.04% four times a day for 3 weeks. At the end of MMC therapy we observed a reduction in pigmentation and thickness of the lesion. Subsequently, the patient underwent surgical excision of the lesion with “no touch technique,” double freeze-thaw cryotherapy of the margins and reconstruction of the tissue defect with amniotic membrane graft. Histopathologic examination of the specimen confirmed the presence of CM, surrounded by primary acquired melanosis with atypia. The excision margins were positive for tumor involvement, so we decided to perform an adjuvant treatment with other four cycles of topical MMC. Conclusions: The patient was closely followed-up after the treatment, without any local or distant recurrence at 32 months.

Previous studies have shown discrepancies among countries in terms of treatment indications and patients' management due to different health care policies. Penile prosthesis implantation (PPI) is a highly effective treatment for erectile dysfunction (ED), which may have different accessibility according to the type of health system. We compared clinical characteristics of patients included in two national registries on PPI to investigate the influence of different health care systems on treatment indication and accessibility. The multicenter Italian Nationwide Systematic Inventarization of Surgical Treatment for ED (INSIST-ED) Registry and the multicenter Prospective Registry of Outcomes with Penile Prosthesis for Erectile Restoration (PROPPER), respectively for Italy and North America were considered. Clinical characteristics of patients included in both registries were compared using Wilcoxon Rank Sum test and the Pearson's Chi square test. Patients submitted to PPI in Italy are significantly younger (age: 61.2 vs. 63.8 years; p ≤ 0.001) compared with North America. The majority of patients are treated for post-radical prostatectomy ED in both registries (Italy: 31%; North America: 27%), although diabetes and cardiovascular diseases are more frequent reasons for PPI in the PROPPER registry (p ≤ 0.001), reflecting differences in disease prevalence among countries. In North America a non-hydraulic implant is considered only in 1% of cases as compared with 3% in Italy (p ≤ 0.001). In terms of postoperative management, a compressive surgical dressing (98% vs. 24%; p ≤ 0.001) is a more common strategy in North America. Finally, in Italy most surgeries are performed in a public hospital (82%), while the private setting (70.8%) is more common in North America (p ≤ 0.001). These findings suggest differences in health care systems between Italy and North America. A system like the American one would guarantee easier access to PPI in countries where the National Health System is mainly based on reimbursement to public hospital settings and where patients choosing private settings have to pay by themselves.

Purpose: To describe a case of retinopathy as onset manifestation of chronic myeloid leukemia (CML), successfully treated with leukapheresis and medical therapy. Methods: A 28-year-old male patient presented complaining painless acute visual impairment in his right eye (RE). He reported moderate asthenia and episodes of night sweats during the previous month. His past medical history was unremarkable. BCVA at presentation was 20/80 in RE and 20/32 in left eye (LE). Fundus examination revealed venous congestion, diffuse Roth spots, and whitish macular infiltrates in both eyes. OCT showed hyperreflective foveal infiltrates, in both eyes. Blood test showed markedly elevated white blood cells (WBCs) count (430 × 103/mm3). Clinical-instrumental examination revealed hepatosplenomegaly. These features were consistent with CML. The patient was treated with leukapheresis and nilotinib. Results: After 2 weeks of treatment, the WBCs count dropped (71 × 103/mm3), and the patient reported subjective improvement of symptoms. At 1-month follow-up, BCVA and retinopathy signs were improved in both eyes. OCT showed the almost complete resolution of foveal infiltrates with ellipsoid zone focal defects. At 4-months follow-up, we observed complete resolution of retinopathy. BCVA was 20/32 in RE and 20/25 in LE. OCT showed the persistence of ellipsoid zone focal defects in RE and complete anatomical restoration in LE. At 6-months follow-up, the patient was clinically well and his WBCs count was normal. Conclusion: In our case, the CML-related retinopathy represented the onset sign of the underlying systemic pathology, leading to proper management and treatment, with hematological normalization and resolution of the retinopathy.

The use of vinorelbine as a single agent or in combination regimens in non-small cell lung cancer (NSCLC) is associated with satisfactory clinical activity. However, the role of vinorelbine-based chemotherapy in chemonaive locally advanced unresectable or metastatic NSCLC patients, according to real-world treatment patterns, has still not been widely explored. Eighty-one patients treated at a single institution were retrospectively analyzed. Thirty-seven received standard first-line single-agent vinorelbine, and 44 received vinorelbine plus platinum drugs, based on physician’s choice; 61.7% were older than 70 years, and 60.5% were affected by ≥2 comorbidities. Sixty-three patients were evaluable for objective response: 22% achieved partial response and 41% stable disease. Median progression-free survival (PFS) was 5.4 months. A benefit in PFS was observed in patients treated with combinations vs. single-agent vinorelbine (6.7 vs. 3.5 months, p = 0.043). Median overall survival (OS) was 10.4 months without a statistically significant difference between treatments (12.4 vs. 7.5 months). In 55 stage IV patients, OS was positively correlated with combination regimens, M1a stage, or ≤2 metastatic lesions. Grade 3‐4 toxicity occurred in 33% of patients, and dose reduction in 11%. A statistically significant higher incidence of toxicity was observed in patients receiving combinations, in women, in patients younger than 75 years, or patients with metastases. In this real-word analysis, we confirmed the efficacy and tolerability of vinorelbine as a single agent or combined with platinums in patients usually underrepresented in controlled clinical trials. Single-agent vinorelbine may represent a suitable option in elderly or unfit NSCLC patients and warrants investigation as a potential drug candidate for immunochemotherapy combination regimens.

Purpose: An interim analysis of 508 patients who completed 12 months of prospective surveillance in the lymphedema PREVENT study found a significant difference in the time to preventive intervention trigger between those measured with Bioelectrical Impedance Spectroscopy (BIS) (9.5 months) vs. Tape Measure (TM) (2.8 months). However, questions emerged as to the reason for the difference and associated factors. Therefore, a study was performed to determine the factors that influenced the time to intervention trigger in patients randomized to either BIS or TM during the first 2 years post-operatively. Methods: Post-randomization to BIS or TM groups patients were assessed with the assigned measurement method at intervals of at least 3, 6, 12, 18, and 24 months post-operatively. A lymphedema prevention intervention consisting of wearing a compression sleeve and a gauntlet for 12 hours a day for 28 days was triggered when subclinical lymphedema was indicated. A change from baseline measures in the BIS group ≥ 6.5 L-DEX units and in TM ≥ 5% but Citation Format: Sheila Hedden Ridner, Mary S Dietrich, Chirag Shah, Frank Vicini. Factors associated with triggering events on the PREVENT trial at 2 years post-operatively [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr P2-13-15.

Descrizione della relazione tra classificazione NOHL definita durante la drug-induced sleep endoscopy e AHI iniziale in pazienti con OSAS da moderato a grave, e valutazione dei risultati ottenuti con dispositivi orali.La drug-induced sleep endoscopy (DISE) è ampiamente riconosciuta come un valido strumento per la diagnosi e la pianificazione del trattamento della sindrome delle apnee ostruttive (OSAS), in quanto consente una visualizzazione diretta dei siti e pattern di collasso delle vie aeree superiori (VAS). In letteratura sono state proposte molteplici classificazioni per descrivere gli eventi osservati duranti la DISE, fra cui la NOHL (Nasopharynx cavity and walls, Oropharynx, Hypopharynx, Larynx) classification (Vicini 2012). Lo studio si prefigge gli obiettivi di identificare quali strutture anatomiche, definite secondo la classificazione NOHL, sono più rappresentate nel collasso delle VAS in pazienti con OSAS da moderato (15 ≤ AHI ≤ 30) a grave (AHI30), e valutare il risultato del trattamento con dispositivi orali (OA), in termini di riduzione dell’AHI. Il gruppo studio è composto da 35 pazienti (29 M, 6 F, età media 50,6, BMI medio 26) con diagnosi polisonnografica di OSAS da moderato a severo, sottoposti a DISE e classificati secondo la classificazione NOHL per individuare le sedi anatomiche e i pattern di collasso più frequentemente riportati. I pazienti sono stati successivamente indirizzati a terapia con Mandibular Advancing Devices (MAD), ed è stato valutato il risultato del trattamento in termini di riduzione dell’AHI. Nel campione esaminato, le strutture anatomiche più frequentemente coinvolte nel collasso delle VAS risultano essere il nasofaringe (N) e la base lingua (H), con indice di correlazione 0,35 (p0,04), mentre non è stata evidenziata significatività per l’area retropalatale (O) e la laringe (L). L’analisi descrittiva ha evidenziato inoltre un collasso multisede in tutti i pazienti, con coinvolgimento di più strutture nella meccanica ostruttiva. In tutti i pazienti è stata osservata una riduzione dell’AHI dopo terapia con MAD (p0,00), sebbene in alcuni casi non completamente risolutiva della patologia.Nowadays, drug-induced sleep endoscopy is widely recognised as a valid tool for diagnosis and treatment planning of obstructive sleep apnoea syndrome (OSAS), as it allows a direct visualisation of sites and patterns of collapse of the upper airways (UA). Various classifications have been proposed in the literature to describe the events observed during DISE, including the NOHL (Nasopharynx cavity and walls, Oropharynx, Hypopharynx, Larynx) classification. This study was aimed at assessing which anatomical structures, according to the NOHL Classification, were most frequently involved in UA collapse in patients with moderate to severe OSAS, and evaluating treatment results with oral appliances (OA), in terms of AHI reduction. The study group consisted of 35 patients (29 M, 6 F, mean age 50.6, average BMI 26) with polysomnographic diagnosis of moderate to severe OSAS, subjected to DISE and classified according to the NOHL classification to identify the anatomical sites and patterns of UA collapse most frequently reported. Patients were subsequently addressed to mandibular advancing device (MAD) therapy and treatment results in terms of AHI reduction were evaluated. In the sample examined, the anatomical structures most frequently involved in the collapse of the UA were the nasopharynx cavity and walls and tongue base, with a correlation index of 0.35 (p0.04), while no significance was found for the retro-palatal area or larynx. Descriptive analysis revealed multilevel collapse in all patients, involving multiple anatomical structures in obstructive mechanics. In all patients, AHI reduction was observed after treatment with MAD (p0.00).

The correct surgical approach to benign parotid gland tumors is still matter of debate, it should be chosen considering the possibility of local recurrence or facial nerve complications in case of "not necessary" facial nerve dissection. In the era of minimally invasive surgery, more sparing approaches such as extracapsular dissection or partial superficial parotidectomy (PSP) are gaining popularity. The aim of the study is to present surgical results and long-term outcomes of PSP (level I or II) in a large group of patients. Six hundred fifty-one patients who underwent parotid surgery between 2004 and 2020 were initially considered. Five hundred forty patients with benign lesions treated with PSP, enucleation, ECD were enrolled. Clinical features, surgical data, postoperative scarring, seroma, dehiscence, neuroma, outcomes as Frey syndrome, and delayed facial nerve dysfunction have been evaluated. 65.5% PSP, 25.2% enucleation, and 9.2% extracapsular dissection. No statistical difference in surgical time has been found (P 0.16). P > 0.05 for seroma, neuroma, Frey syndrome, and facial palsy between different type of surgery. Frey syndrome in PSP: 6/135 (4.4%) in 2004 to 2012 and 2/219 (0.9%) in 2013 to 2020. The reduction between periods is significant (P

Objective Trans Oral Robotic Surgery (TORS) is a modality in the management of oropharyngeal squamous cell carcinoma(OPSCC). This study was planned to determine whether Selective Neck Dissection (SND) is oncological safe procedure even in patients with lymph node metastases. Methods OPSCC patients were divided into Modified Radical Neck Dissection (MRND) and SND groups. The outcome measures were overall survival (OS), disease-free survival (DFS) and regional recurrence free survival (RRFS). Results Thirty-seven SNDs and 18 MRNDs were performed. Regional relapse rate was 6.1% in SND group whilst 18.8% in MRND group(p=0.19). The 5-year OS, DFS and RRFS rates’ differences were not statistically significant between SND and MRND groups (p=0.40, p=0.42 and p=0.18, respectively). At multivariate analysis, advanced stage impacted the 5-year OS and DFS(HR=9.39, p Conclusions The SND seems to be effective in a TORS framework. The indication should be accurately discussed by the multidisciplinary tumor board.

It is unusual for a child or adolescent patient to complain of vertigo. However, in adults it is more commonly seen. Research conducted using a survey methodology has found a yearly incidence of 23% for dizziness in general and 5% for vestibular vertigo, in particular [1]. A study which recently assessed the frequency of diagnoses coded using ICD-9 and relating to problems with balance and the vestibular apparatus considered records from more than 560,000 consultations with paediatricians stretching over 4 years. These showed that unspecified dizziness occurred in a mere 0.4%, peripheral symptoms in 0.03% and central vestibulopathy in 0.02% of encounters [2, 3].

Introduction In patients with positive lymph nodes (cN+) prior to neoadjuvant treatment (NAT), which convert to a clinically negative axilla (cN0) after treatment, the use of sentinel node biopsy (SNB) is still debatable, since the false-negative rate (FNR) is significantly high (12.6–14.2%). The objective of this retrospective mono-institutional study, with a long follow-up, aimed to evaluate the outcome in patients undergoing NAT who remained or converted to cN0 and received SNB independent of target axillary dissection (TAD) or the removal of at least 3 sentinel nodes (SNs). Methods This study analyzed 688 consecutive cT1-3, cN0/1/2 patients, operated at the European Institute of Oncology, Milan, from 2000 to 2015 who became or remained cN0 after NAT and underwent SNB with a least one SN found. Axillary dissection (AD) was not performed if the SN was negative. Nodal radiotherapy (RT) was not mandatory. Results Axillary failure occurred in 1.8% of the initially cN1/2 patients and in 1.5% of the initially cN0 patients. After a median follow-up of 9.2 years (IQR 5.3–12.3), the 5- and 10-year overall survival (OS) were 91.3% (95% CI, 88.8–93.2) and 81.0% (95% CI, 77.2–84.2) in the whole cohort, 92.0% (95% CI, 89.0–94.2) and 81.5% (95% CI, 76.9–85.2) in those initially cN0, 89.8% (95% CI, 85.0–93.2) and 80.1% (95% CI, 72.8–85.7) in those initially cN1/2. Conclusion The 10-year follow-up confirmed our preliminary data that the use of standard SNB is acceptable in cN1/2 patients who become cN0 after NAT and will not translate into a worse outcome.

Purpose: To evaluate associations between CD4/CD8 ratio and pregnancy outcomes in women with HIV. Methods: We evaluated, in a national study of pregnant women with HIV receiving antiretroviral treatment (ART), values of CD4/CD8 ratio at entry in pregnancy, changes between first and third trimester, and possible associations with preterm delivery, low birthweight, and HIV-RNA < 50 copies/ml at third trimester in univariate and multivariate analyses. Results: Among 934 women, 536 (57.4%) were already on ART at conception. CD4/CD8 ratio (baseline value 0.570) increased significantly between the first and third trimesters, particularly in women who started ART in pregnancy (+ 0.163, vs. + 0.036 in women already on treatment). The rate of CD4/CD8 ratio normalization, defined by achieving a ratio ≥ 1 at the third trimester, was 13.2%. In multivariable analyses, women who entered pregnancy with a CD4/CD8 ratio < 0.3, compared to women with ratio ≥ 1, were almost four-times less likely to have third-trimester HIV-RNA < 50 copies/ml (AOR 0.258, 95%CI 0.111–0.601), and more than twice as likely to have preterm delivery (AOR 2.379, 95%CI 1.082–5.232). For preterm delivery, also a baseline CD4/CD8 ratio between 0.3 and 0.45 was significantly associated with an increased risk (AOR: 3.415, 95%CI 1.690–6.900). Conclusion: We described for the first time independent associations of low CD4/CD8 ratio with preterm delivery and HIV-RNA suppression.

To illustrate a new technological advance in the standard drug-induced sleep endoscopy (DISE) model, a new machine was used, the Experimental 5 Video Stream System (5VsEs), which is capable of simultaneously visualizing all the decisional parameters on a single monitor, and recording and storing them in a single uneditable video. The DISE procedure was performed on 48 obstructive sleep apnea (OSA) or snoring patients. The parameters simultaneously recorded on a single monitor are (1) the pharmacokinetics and pharmacodynamics of propofol (through the target controlled infusion (TCI) pump monitor), (2) the endoscopic upper airway view, (3) the polygraphic pattern, and (4) the level of sedation (through the bispectral index (BIS) value). In parallel to the BIS recording, the middle latency auditory evoked potential (MLAEP) was also recorded and provided. Recorded videos from the 5VsEs machine were re-evaluated six months later by the same clinician and a second clinician to evaluate the concordance of the therapeutic indications between the two. After the six-month period, the same operator confirmed all their clinical decisions for 45 out of 48 videos. Three videos were no longer evaluable for technical reasons, so were excluded from further analysis. The comparison between the two operators showed a complete adherence in 98% of cases. The 5VsEs machine provides a multiparametric evaluation setting, defined as an &ldquo, all in one glance&rdquo, strategy, which allows a faster and more effective interpretation of all the simultaneous parameters during the DISE procedure, improving the diagnostic accuracy, and providing a more accurate post-analysis, as well as legal and research advantages.

Background: Chemotherapy plus 1-year trastuzumab is the standard adjuvant treatment of HER2-positive breast cancer. The efficacy of less extended trastuzumab exposure is under investigation. The short-HER study was aimed to assess the non-inferiority of 9 weeks versus 1 year of adjuvant trastuzumab combined with chemotherapy. Patients and methods: HER2-positive breast cancer patients with node-positive or, if node negative, with at least one risk factor (pT>2 cm, G3, lympho-vascular invasion, Ki-67 > 20%, age 35 years, or hormone receptor negativity) were randomly assigned to receive sequential anthracycline-taxane combinations plus 1-year trastuzumab (arm A, long) or plus 9 weeks trastuzumab (arm B, short). This study was designed as a non-inferiority trial with disease-free survival (DFS) as primary end point. A DFS hazard ratio (HR)

Background: Nipple-sparing mastectomy (NSM) is increasingly used in women with breast cancer who are not eligible for conservative surgery, but extensive outcome data are lacking and indications have not been established. Objective: The aim of this study was to assess the oncological outcomes of NSM in a large series of patients with invasive or in situ breast cancer treated at a single center. Methods: We analyzed 1989 consecutive women who had an NSM in 2003–2011, for invasive (1711 patients) or in situ cancer (278 patients) at the European Institute of Oncology, Italy, and followed-up to December 2016. Endpoints were local recurrences, recurrences in the nipple-areola complex (NAC), NAC necrosis, and overall survival (OS). Results: After a median follow-up of 94 months (interquartile range 70–117), 91/1711 (5.3%) patients with invasive cancer had local recurrence (4.8% invasive disease, 0.5% in situ disease), and 11/278 (4.0%) patients with in situ disease had local recurrence (1.8% invasive disease, 2.2% in situ disease). Thirty-six (1.8%) patients had NAC recurrence, 9 with in situ disease (4 invasive and 5 in situ recurrences), and 27 with invasive disease (18 invasive and 9 in situ recurrences). NAC loss for necrosis occurred in 66 (3.3%) patients. There were 131 (6.6%) deaths, 109 (5.5%) as a result of breast cancer. OS at 5 years was 96.1% in women with invasive cancer and 99.2% in women with in situ disease. Conclusions: The findings in this large series, with a median follow-up of nearly 8 years, indicate that NSM is oncologically safe for selected patients. The rate of NAC loss was acceptably low.

(1) Background: This systematic review was designed to analyze adenotonsillectomy’s role in treating behavioural disorders and sleep-related quality of life in pediatric OSAS. (2) Methods: Papers that report pre-operative and post-operative outcomes by using the Epworth sleepiness scale, OSA-18, NEPSY, Conners’ rating scale, BRIEF, PSQ-SRBD, PedsQL and CBCL. We performed a comprehensive review of English papers published during the last 20 years regarding behavioural disorders in OSAS patients and adenotonsillectomy. (3) Results: We included 11 studies reporting behavioral outcomes and sleep related quality of life after surgery. We investigated changes in behavior and cognitive outcomes after AT, and we found significant improvements of the scores post-AT in almost all studies. After comparing the AT group and control group, only one study had no difference that reached significance at one year post-AT. In another study, it did not show any significant improvement in terms of all behavioural and cognitive outcomes. The questionnaires on sleep-related quality of life after AT (PSQ-SRBD or ESS or OSA-18 or KOSA) may improve with positive changes in sleep parameters (AHI, ODI and SpO2). Furthermore, there is a significantly higher decrease in OSAS symptoms than the pre-AT baseline score. (4) Conclusion: Future studies should pay more attention to characterizing patient populations as well as rapid surgical treatments through existing criteria.

Lower urinary tract or voiding disorders are prevalent across all ages and affect >40% of adults over 40 years old, leading to decreased quality of life and high health care costs. The pontine micturition center (PMC; i.e., Barrington9s nucleus) contains a large population of neurons that localize the stress-related neuropeptide, corticotropin-releasing hormone (CRH) and project to neurons in the spinal cord to regulate micturition. How the PMC and CRH-expressing neurons in the PMC control volitional micturition is of critical importance for human voiding disorders. To investigate the specific role of CRH in the PMC, neurons in the PMC-expressing CRH were optogenetically activated during in vivo cystometry in unanesthetized mice of either sex. Optogenetic activation of CRH-PMC neurons led to increased intermicturition interval and voided volume, similar to the altered voiding phenotype produced by social stress. Female mice showed a significantly more pronounced phenotype change compared with male mice. These effects were eliminated by CRH-receptor 1 antagonist pretreatment. Optogenetic inhibition of CRH-PMC neurons led to an altered voiding phenotype characterized by more frequent voids and smaller voided volumes. Last, in a cyclophosphamide cystitis model of bladder overactivity, optogenetic activation of CRH-PMC neurons returned the voiding pattern to normal. Collectively, our findings demonstrate that CRH from PMC spinal-projecting neurons has an inhibitory function on micturition and is a potential therapeutic target for human disease states, such as voiding postponement, urinary retention, and underactive or overactive bladder. SIGNIFICANCE STATEMENT The pontine micturition center (PMC), which is a major regulator of volitional micturition, is neurochemically heterogeneous, and excitatory neurotransmission derived from PMC neurons is thought to mediate the micturition reflex. In the present study, using optogenetic manipulation of CRH-containing neurons in double-transgenic mice, we demonstrate that CRH, which is prominent in PMC-spinal projections, has an inhibitory function on volitional micturition. Moreover, engaging this inhibitory function of CRH can ameliorate bladder hyperexcitability induced by cyclophosphamide in a model of cystitis. The data underscore CRH as a novel target for the treatment of voiding dysfunctions, which are highly prevalent disease processes in children and adults.

Introduction: Piggyback IntraOcular Lenses (IOLs), or supplementary secondary implant lenses, have been developed to provide a sufficient dioptric power in eyes with high refractive defects, which are not fully correctable after cataract surgery with single IOL in the range of powers available. These lenses can also be used for the correction of refractive errors that occurred for a wrong choice of the IOL power after cataract surgery. Case description: We report the case of a complete refractive success obtained in a patient with an abnormal cornea, with a central stable ectasia, with thinning, high myopic astigmatism and cataract, obtained with the implant of a primary posterior chamber IOL at the time of cataract surgery and a subsequent implant of a secondary piggyback, sulcus-based customized toric IOL (Camellens FIL 622-2 Toric Monofocal IOL, Soleko, Rome, Italy). Conclusions: This brief report demonstrates the utility of combining primary and piggyback IOLs implant for the correction of a complex spherical-cylindrical refractive defect in a case of abnormal cornea and cataract.

PurposeSecondary lung cancer (SLC) can offset the benefit of adjuvant breast radiotherapy (RT), and risks compound sharply after 25 to 30 years. We hypothesized that SLC risk is mainly an issue for early-stage breast cancer, and that lives could be saved using different RT techniques.Patients and MethodsThe SEER database was used to extract breast patient age, stage survival, and radiotherapy utilization over time and per stage and to assess the factors associated with increased SLC risk with a multivariable competing risk Cox model. The number of SLC was calculated using the BEIR model modified with patient survival, age, and use of RT from the SEER database. Stage distribution and number of new breast cancer cases were obtained from the NAACCR. Mean lung dose for various irradiation techniques was obtained from measurement or literature.ResultsOut of the 765,697 non-metastatic breast cancers in the SEER database from 1988 to 2012, 49.8% received RT. RT significantly increased the SLC risk for longer follow-up (HR=1.58), early stage including DCIS, stage I and IIA (HR = 1.11), and younger age (HR=1.061) (all pConclusionsSLC after breast RT remains a clinically significant issue for early-stage breast cancers. This mortality could be significantly reduced using a prone technique or APBI.

Breast cancer is the most common malignancy occurring during gestation. In early-stage breast cancer during pregnancy (PrBC), breast-conserving surgery (BCS) with delayed RT is a rational alternative to mastectomy, for long considered the standard-of-care. Regrettably, no specific guidelines on the surgical management of these patients are available. In this study, we investigated the feasibility and safety of BCS during the first trimester of pregnancy in women with early-stage PrBC. All patients with a diagnosis of PrBC during the first trimester of pregnancy jointly managed in two PrBC-specialized Centers were included in this study. All patients underwent BCS followed by adjuvant radiotherapy to the ipsilateral breast after delivery. Histopathological features and biomarkers were first profiled on pre-surgical biopsies. The primary outcome was the isolated local recurrence (ILR). Among 168 PrBC patients, 67 (39.9%) were diagnosed during the first trimester of gestation. Of these, 30 patients (age range, 23-43 years; median=36 years; gestational age, 2-12 weeks; median=7 weeks; median follow-up time=6.5 years) met the inclusion criteria. The patients that were subjected to radical surgery (n=14) served as controls. None of the patients experienced perioperative surgical complications. No ILR were observed within three months (n=30), 1 year (n=27), and 5 years (n=18) after surgery. Among the study group, 4 (12.3%) patients experienced ILR or new carcinomas after 6-13 years, the same number (n=4) had metastatic dissemination after 3-7 years. These patients are still alive and disease-free after 14-17 years of follow-up. The rate of recurrences and metastasis in the controls were not significantly different. The findings provide evidence that BCS in the first trimester PrBC is feasible and reasonably safe for both the mother and the baby.