Sentinel lymph node biopsy before and after neoadjuvant chemotherapy in cN0 breast cancer patients: impact on axillary morbidity and survival-a propensity score cohort study.

PURPOSE: In patients with clinically lymph node-negative (cN0) breast cancer, performing sentinel lymph node biopsy (SLNB) after neoadjuvant chemotherapy (NACT) has been preferentially embraced in comparison to before NACT. However, survival outcomes associated with both strategies remain understudied. We aimed to compare the axillary lymphadenectomy (ALND) rate, disease-free survival (DFS), and overall survival (OS), between two strategies. METHODS: We included 310 patients in a retrospective observational study. SNLB was performed before NACT from December 2006 to April 2014 (107 cases) and after NACT from May 2014 to May 2020 (203 patients). An inverse probability of treatment weighting (IPTW) method was applied to homogenize both groups. Hazard ratios (HR) and odd ratios (OR) are reported with 95% confidence intervals (95%CI). RESULTS: The lymphadenectomy rate was 29.9% before NACT and 7.4% after NACT (p < 0.001), with an OR of 5.35 95%CI (2.7-10.4); p = .002. After 4 years of follow-up, SLNB after NACT was associated with lower risk for DFS, HR 0.42 95%CI (0.17-1.06); p = 0.066 and better OS, HR 0.21 CI 95% (0.07-0.67); p = 0.009 than SLNB before NACT. After multivariate analysis, independent adverse prognostic factors for OS included SLNB before NACT, HR 3.095 95%CI (2.323-4.123), clinical nonresponse to NACT, HR 1.702 95% CI (1.012-2.861), and small tumors (cT1) with high proliferation index, HR 1.889 95% (1.195-2.985). CONCLUSION: Performing SLNB before NACT results in more ALND and has no benefit for patient survival. These findings support discontinuing the practice of SLNB before NACT in patients with cN0 breast cancer.

Management of the axilla in postmenopausal patients with cN0 hormone receptor-positive/HER2-negative breast cancer treated with neoadjuvant endocrine therapy and its prognostic impact.

PURPOSE: To evaluate the differences in nodal positivity if the sentinel lymph node biopsy (SLNB) is performed before or after neoadjuvant endocrine therapy (NET) in breast cancer patients, and its impact on prognosis. METHODS: A retrospective cohort study was performed in a single center including 91 postmenopausal cases with clinically node-negative and hormone receptor-positive/HER2-negative (HR + /HER2-) breast cancer, treated with NET and SLNB. SLNB was done pre-NET until 2014, and post-NET thereafter. Axillary lymph node dissection (ALND) was indicated only in SLNB macrometastasis, although in selected elderly patients, it was omitted. Kaplan-Meier survival curves were estimated in relation to the status of the axilla, and the differences assessed using the log-rank test. RESULTS: Between December 2006 and March 2022, SLNB was performed pre-NET in 14 cases and post-NET in 77. Both groups were similar in baseline tumor and patient characteristics. SLNB positivity was similar regardless of whether SLNB was performed before (5/14, 35.7%) or after NET (27/77, 37%), with 2/14 SLN macrometastases in the pre-NET cohort and 17/77 in the post-NET cohort. Only three patients (18.7%) with SLN macrometastasis had > 3 positive nodes following ALND. The 5-year overall survival and distant disease-free survival were 92.4% and 94.8%, respectively, with no significant differences according to SLNB status (p 0.5 and 0.8, respectively). CONCLUSION: SLN positivity did not differ according to its timing (before or after NET). Therefore, NET has no effect on lymph node clearance. Furthermore, the prognosis is good regardless of the axillary involvement. Therefore, factors other than axillary involvement may affect the prognosis in these patients.

Recurrence Rate and Morbidity after Ultrasound-guided Transvaginal Aspiration of Ultrasound Benign-appearing Adnexal Cystic Masses with and without Sclerotherapy: A Systematic Review and Meta-analysis.

OBJECTIVE: To determine the pooled recurrence rate of benign adnexal masses/cysts (namely simple cyst, endometrioma, hydrosalpinx, peritoneal cyst) after transvaginal ultrasound-guided aspiration, with or without sclerotherapy. DATA SOURCES: Search of studies published in PubMed and Web of Science databases between January 1990 and December 2020. METHODS OF STUDY SELECTION: A systematic search strategy was done using Medical Subject Heading terms. Only randomized trials and prospective studies published in English language were included. TABULATION, INTEGRATION, AND RESULTS: A total of 395 articles were screened. After applying inclusion and exclusion criteria, 20 studies were included in this review comprising data from 1386 patients with a mean follow-up of 11.4 months (range 0.5-26.5 months). The overall pooled rate of recurrence of adnexal masses was 27%, (95% confidence interval [CI], 18%-39%). Recurrence rate was significantly higher after only aspiration than after sclerotherapy (53%; 95% CI, 46%-60% vs 14%; 95% CI, 8%-22%; p <.001). However, a high heterogeneity across the studies was found. A total of 10 major complications were recorded in the different publications. CONCLUSION: In a selected population, aspiration with sclerotherapy had a lower recurrence rate than aspiration without sclerotherapy. However, these results should be interpreted with caution given the heterogeneity of the studies and the paucity of randomized controlled trials. Regarding the adoption of this procedure in routine clinical practice, we believe that aspiration should be considered an experimental procedure as there are few studies addressing long-term recurrence rate, and data comparing this technique with surgical cystectomy are lacking.

The effect of omitting axillary dissection and the impact of radiotherapy on patients with breast cancer sentinel node macrometastases: a cohort study following the ACOSOG Z0011 and AMAROS trials.

PURPOSE: To report the outcomes of implementing the ACOSOG Z0011 and AMAROS trials relevant to clinical practice, and to define target groups in whom to avoid or recommend axillary radiotherapy (ART). We also aimed to analyse the reduction in morbidity when axillary lymph node dissection (ALND) was omitted. METHODS: A retrospective cohort study of T1-T2 patients with macrometastases at sentinel lymph node (SLN) who were treated between 2011 and 2020. Breast surgery included either lumpectomy or mastectomy. Patients with ≤ 2 positive SLN were divided into two cohorts by whether they received ART or not. Survival outcomes and morbidity were analysed by Kaplan-Meyer curves and Cox-regression, respectively. RESULTS: 260 pN1a patients were included and ALND was avoided in 167 (64.2%). According the Z0011 results, 72 (43.1%) received no further ART; and based on AMAROS criteria 95 (56.9%) received ART. Median follow-up was 54 months. The 5-year overall survival was 96.8% in the non-RT cohort and 93.4% in the RT cohort (p = 0.19), while the respective 5-year disease-free survivals were 100% and 92.3% (p = 1.06). Lymphedema developed in 3.6% of patients after SLNB versus 43% after ALND (OR 20.25; 95%CI 8.13-50.43). Decreased upper-extremity range of motion appeared in 8.4% of patients after SLNB versus 31.2% after ALND (OR 4.95; 95%CI 2.45-9.98%). CONCLUSIONS: Our study confirms that omitting ALND is safe and has high survival rates in patients with T1-T2 tumours and ≤ 2 positive SLNs. Adding ART could be a treatment option for patients who present other risk factors. Avoiding ALND with or without ART was associated with significantly less arm morbidity.

Can we avoid axillary lymph node dissection in N2 breast cancer patients with chemo-sensitive tumours such as HER2 and TNBC?

PURPOSE: To find a group of cN2 patients or patients with high axillary burden who become ypN0 after neoadjuvant chemotherapy (NACT) and who may benefit from avoiding a lymphadenectomy. METHODS: A retrospective observational cohort study was conducted with 221 clinically staged N2 patients or patients with at least 3 suspicious lymph nodes found by ultrasound at diagnosis. The predictive factors for ypN0 analysed were age, MRI-determined tumour size, histological subtype, the Nottingham histologic grade, surrogate molecular subtype, ki-67 and vascular invasion when present. Clinical and radiological responses after NACT were also evaluated. Univariate and multivariate analyses by logistic regression were performed. Distant disease-free survival (DDFS) was calculated in relation to the status of the axillary lymph nodes after NACT. RESULTS: After NACT, 89 patients (40.3%) had axillary pathologic complete response (pCR) (ypN0) and 132 (59.7%) had residual axillary disease (ypN+). Molecular surrogate subtype, Ki-67 expression, and the clinical and radiological responses to NACT were the only independent factors associated with ypN0. Axillary pCR was observed more often in HER2-positive and triple-negative tumours than in luminal ones (OR 7.5 and 3.6, respectively). DDFS was 88.7% (95% CI 80.7-96.7%) for ypN0 and 56.2% (95% CI 32.1-80.3%) for ypN+ (p = 0.09). CONCLUSIONS: In HER2-positive and triple-negative breast cancer patients staged as cN2 or with high axillary burden before NACT, a sentinel lymph node biopsy after NACT could be recommended if there is a clinical and radiological response.

Predictive factors for omitting lymphadenectomy in patients with node-positive breast cancer treated with neo-adjuvant systemic therapy.

A pathologic complete response (pCR) in the axilla occurs in 30%-40% of patients with initially node-positive breast cancer after neo-adjuvant chemotherapy (NACT). Debate persists about whether to perform systematic axillary lymphadenectomy (ALND) in patients with initial node-positive disease and clinical complete response after NACT. We aimed to identify predictive factors of axillary pCR (ypN0) after NACT. This retrospective study analyzed data for all patients with initial biopsy-proven node-positive disease who underwent ALND after NACT between June 2008 and December 2016 at our institution. Clinical and pathologic features, recurrence and specific mortality rates were compared between patients who achieved an axillary pCR and those who did not (ypN0 vs ypN+, respectively). A total of 331 patients were included, of whom 128 (38.7%) became ypN0 after NACT. Among patients with >2 suspicious axillary lymph nodes before treatment, 54 (38%) achieved ypN0 status. The independent predictors of ypN0 were Ki-67 > 30 (OR 1.98; 95% CI, 1.146-3.381), HER2 positivity (OR 2.6; 95% CI, 1.354-5.108), nonluminal molecular-like subtype (OR 4.15; 95% CI, 2.068-5.108), and clinical complete response, defined as negative clinical and ultrasonographic findings (OR 2.8; 95% CI, 1.110-7.081). After a mean follow-up of 61 months, distant disease-free and overall survival rates were higher in patients with ypN0 disease (HR 4.14; 95% CI, 2.03-8.43) than ypN+ patients. Complete clinical response and the presence of nonluminal molecular-like subtypes independently predicted ypN0. Patients meeting these criteria might be suitable form omitting ALND and just performing targeted axillary procedures to patients meeting these criteria.

Ethanol Sclerotherapy versus Laparoscopic Surgery for Endometrioma Treatment: A Prospective, Multicenter, Cohort Pilot Study.

STUDY OBJECTIVE: To compare the cost-effectiveness of ultrasound (US)-guided aspiration and ethanol sclerotherapy versus laparoscopic surgery for benign-appearing ovarian endometrioma. DESIGN: Prospective, cohort pilot study. SETTING: Multiple centers, Spain. PATIENTS: Forty patients with suspected ovarian endometrioma identified by US, with a maximum diameter of 35 to 100 mm, of whom 33 met inclusion criteria. INTERVENTIONS: The study group (n = 17) underwent US-guided aspiration plus sclerotherapy with ethanol, and the control group (n = 14) underwent laparoscopic cystectomy. MEASUREMENTS AND MAIN RESULTS: Recurrence, complications, and direct costs were compared. One of 17 sclerotherapy patients recurred (5.9%) compared with 4 of 14 laparoscopic surgery patients (28.6%) (odds ratio 0.18, 0.01-1.53). No serious adverse effects (Clavien-Dindo ≥ III) were observed in the sclerotherapy group; 1 patient in the surgery group had a Clavien-Dindo IIIb complication. Median hospital direct costs were significantly lower in the sclerotherapy group than those in the surgery group-266 euros versus 2189 euros. CONCLUSION: Ethanol sclerotherapy seems to be cost-effective for endometrioma and also appears to reduce complications. In this pilot study, recurrence was not higher than with conventional surgery.

Radiofrequency Ablation Followed by Surgical Excision versus Lumpectomy for Early Stage Breast Cancer: A Randomized Phase II Clinical Trial.

Purpose To compare the safety and efficacy of US-guided percutaneous radiofrequency ablation (RFA) as a local treatment for breast cancer with that of lumpectomy. Materials and Methods A prospective, randomized open-label phase II clinical trial (clinicaltrials.gov identification number NCT02281812) was conducted in a single institution from 2013 to 2017. Women with invasive ductal carcinoma of the breast measuring 2 cm or smaller were randomly assigned to receive RFA or lumpectomy alone (control group). Margin status at surgery, tumor cell viability after RFA (with nicotinamide adenine dinucleotide [NADH] and cytokeratin 18 [CK18] staining), cosmetic results, adverse events, and local recurrences were evaluated with univariable and multivariable analyses. Results Forty subjects (20 in the RFA group and 20 in the lumpectomy group) were evaluated. The mean participant age was 64 years (range, 46-86 years). NADH and CK18 staining demonstrated absence of tumor cell viability after RFA with at least one of the two techniques. The surgical margins were positive in 11 of the 20 participants in the lumpectomy group (55%) and four of the 20 in the RFA group (20%) (P = .02). Median follow-up was 25 months (range, 1-83 months). Local breast inflammation after surgery was higher in the RFA group than in the lumpectomy group (40% [eight of 20 participants] vs 5% [one of 20 participants], respectively; P = .01). Local infection occurred in three participants who underwent RFA (two of whom had undergone partial irradiation of the breast). None of the participants in the control group developed local infection. No participants had recurrence or the need for a second surgery during the study period. Conclusion This preliminary study showed that radiofrequency ablation was effective for local tumor control and that tumor-free margins were obtained more often with radiofrequency ablation than with lumpectomy. Surgical excision after radiofrequency ablation was infrequently associated with local infection. © RSNA, 2018 Online supplemental material is available for this article.

Ultrasound-Guided Aspiration With and Without Ethanol Sclerotherapy in the Management of Simple Adnexal Cysts: A Single-Center Experience.

STUDY OBJECTIVES: To compare the efficacy of ultrasound-guided aspiration versus aspiration with ethanol sclerotherapy in the management of simple adnexal cysts measuring 3 to 10 cm, and to explore the risk factors for recurrence associated with each approach. DESIGN: A prospective follow-up of patients after cyst aspiration with and without ethanol sclerotherapy in simple adnexal cysts in a single-center trial (Canadian Task Force classification II-1). SETTING: Bellvitge Teaching Hospital, Barcelona, Spain. PATIENTS: Cyst aspiration and ethanol sclerotherapy were performed in 66 and 75 patients, respectively, between 2002 and 2014. Women enrolled before March 2009 underwent simple aspiration (group 1), and those enrolled after March 2009 underwent ethanol sclerotherapy (group 2). INTERVENTIONS: Ultrasound-guided fine-needle aspiration with and without ethanol sclerotherapy. MEASUREMENTS AND MAIN RESULTS: Potential risk factors for recurrence-age, menopausal status, symptoms, cyst diameter, laterality, aspirated volume, simple US-guided aspiration or alcohol sclerotherapy, and complications-were analyzed by logistic regression. The recurrence rates were analyzed by the Kaplan-Meier and Mantel-Haenszel methods. The overall recurrence rates were 72.7% (48 of 66) in group 1 and 22.7% (17 of 75) in group 2 (p < .0001). Risk factors significantly associated with recurrence were simple aspiration without ethanol sclerotherapy (odds ratio [OR], 19.7; 95% confidence interval [CI], 6.756-57.714), postmenopausal status (OR, 9.3; 95% CI, 1.720-50.956), and cyst size (OR, 1.04; 95% CI, 1.005-1.093). CONCLUSION: Based on the lower recurrence rate, ethanol sclerotherapy was more efficacious than simple aspiration in the management of simple adnexal cysts measuring <10 cm.

Robotic Transperitoneal Infrarenal Para-Aortic Lymphadenectomy With Double Docking: Technique, Learning Curve, and Perioperative Outcomes.

Para-aortic lymphadenectomy (PAL) is a challenging procedure performed by minimally invasive surgery in very few centers, owing to its intrinsic technical complexity. We describe and assess the feasibility and learning curve of robotic double-docking transperitoneal infrarenal PAL combined with oncological pelvic surgery. Fifty patients who underwent this procedure using the Da Vinci S surgical system between March 2010 and May 2013 were included. The mean operating time for PAL surgery was 76 minutes (range, 32-150 minutes), and the mean number of lymph nodes per patient was 11.8 (range, 1-44). There were no conversions to laparotomy or laparoscopy. The mean length of hospital stay was 2 days (range, 1-25 days). Statistically significant decreases were noted for mean table rotation time (17 ± 6.8 minutes vs 13 ± 3.6 minutes; p = .02) and mean PAL operating time (85.4 ± 25.8 minutes vs 69.8 ± 24.6 minutes; p = .04) when comparing the first 20 patients and the last 30 patients. The number of nodes was similar in the first 20 patients and last 30 patients. The double-docking transperitoneal infrarenal PAL technique combined with oncological pelvic surgery is feasible, with minimal morbidity and a short learning curve.

Preliminary results: ethanol sclerotherapy after ultrasound-guided fine needle aspiration without anesthesia in the management of simple ovarian cysts.

STUDY OBJECTIVE: To investigate the feasibility of ultrasound-guided, fine-needle aspiration and ethanol sclerotherapy of simple ovarian cysts in an office setting without anesthesia. We also describe the rate of cyst recurrence in patients treated with this technique and explore the associated risk factors. DESIGN: Prospective follow-up of patients after ethanol sclerotherapy of simple adnexal cysts in a single center trial (Canadian Task Force classification II-1). SETTING: The study was conducted at Bellvitge Teaching Hospital in Barcelona, Spain. PATIENTS: Ethanol sclerotherapy was performed on 60 simple adnexal cysts between 2009 and 2012. INTERVENTIONS: Ultrasound-guided fine-needle aspiration and ethanol sclerotherapy. MEASUREMENTS AND MAIN RESULTS: Patient demographics and cyst characteristics were collected for all patients. Potential risk factors for recurrence were analyzed by univariate and multivariate analyses. All the procedures, except 1, were performed without anesthesia. The only major complication was a case of self-limiting hem peritoneum that was managed expectantly. Moderate abdominal pain occurred in 26.7% of patients during the procedure. Fifty-five patients completed at least 6 months of follow-up and were included in the statistical recurrence analyses. Cyst recurrence was recorded in 9.1% of the patients and was managed in the usual manner in all the cases. Univariate analyses indicated that a larger cyst diameter and a higher estimated cyst volume were significantly associated with recurrence. In the multivariate analysis, recurrence was only significantly associated with estimated cyst volume. CONCLUSION: Ethanol sclerotherapy of simple ovarian cysts in an office setting without anesthesia is a feasible technique associated with a low rate of complications and recurrence, although larger randomized studies are necessary to assess the predictive factors for cyst recurrence.

Ultrasound-guided aspiration of adnexal cysts with a low risk of malignancy: is it a recommendable option?

OBJECTIVES: The purpose of this study was to establish the viability of ultrasound (US)-guided adnexal cyst aspiration and identify a target group in which this procedure would be advisable. METHODS: A prospective cohort of 96 women with a low risk of malignant adnexal cysts was studied between 2002 and 2009, using recurrence after the procedure as the primary outcome measure. All procedures were performed on an outpatient basis without anesthesia. Patients were followed by US imaging at 6, 12, 24, 48, and 72 months. Potential risk factors for recurrence (menopausal status, previous hysterectomy, symptoms, US pattern, cyst diameter, and aspirated fluid volume and color) were analyzed by multivariate logistic regression. The association between recurrence and cyst size was calculated by Kaplan-Meier curves. RESULTS: The median diameter of the cysts was 61 (range, 30-150) mm. Multivariate logistic regression analysis showed that an increased risk of recurrence was associated with a cyst diameter of greater than 70 mm (odds ratio, 4.2; 95% confidence interval, 1.2-14.1) and the presence of symptoms (odds ratio, 5.03; 95% confidence interval, 1.02-24.6). The median follow-up time was 24 (range, 2-78) months. Surgery was avoided in 64 patients (73.6%). Full cyst recurrence was observed in 34 patients (39.0%). CONCLUSIONS: Ultrasound-guided aspiration is a viable alternative to surgery for treatment of adnexal cysts with a low risk of malignancy, especially when the cyst diameter is less than 70 mm.

Ecto-nucleotidases activities in the contents of ovarian endometriomas: potential biomarkers of endometriosis.

Endometriosis, defined as the growth of endometrial tissue outside the uterus, is a common gynecologic condition affecting millions of women worldwide. It is an inflammatory, estrogen-dependent complex disorder, with broad symptomatic variability, pelvic pain, and infertility being the main characteristics. Ovarian endometriomas are frequently developed in women with endometriosis. Late diagnosis is one of the main problems of endometriosis; thus, it is important to identify biomarkers for early diagnosis. The aim of the present work is to evaluate the ecto-nucleotidases activities in the contents of endometriomas. These enzymes, through the regulation of extracellular ATP and adenosine levels, are key enzymes in inflammatory processes, and their expression has been previously characterized in human endometrium. To achieve our objective, the echo-guided aspirated fluids of endometriomas were analyzed by evaluating the ecto-nucleotidases activities and compared with simple cysts. Our results show that enzyme activities are quantifiable in the ovarian cysts aspirates and that endometriomas show significantly higher ecto-nucleotidases activities than simple cysts (5.5-fold increase for ATPase and 20-fold for ADPase), thus being possible candidates for new endometriosis biomarkers. Moreover, we demonstrate the presence of ecto-nucleotidases bearing exosomes in these fluids. These results add up to the knowledge of the physiopathologic mechanisms underlying endometriosis and, open up a promising new field of study.

Ten-year experience of bone SBRT in breast cancer: analysis of predictive factors of effectiveness.

PURPOSE: Data on the benefit of stereotactic body radiation therapy (SBRT) in patients with breast cancer (BC) and bone metastases remain limited. The purpose of this study is to report our 10-year experience of bone SBRT, analyzing toxicity and prognostic factors for local control (LC); progression-free survival, and overall survival (OS). METHODS/PATIENTS: We analyzed all spine and non-spine bone SBRT performed in patients with BC during the 2012-2022 period at our institution. Treatments carried out with ablative intent in stereotactic conditions with dose/fraction ≥ 5 Gy in 5 or fewer sessions were considered. Demographic, treatment, and toxicity data were recorded according to CTCAEv4. Risk factors were assessed through univariate and multivariate analysis by Cox regression. RESULTS: 60 bone SBRT treatments were performed during the study period. 75% were spine SBRT and 25% were non-spine SBRT (median BED4Gy was 80 Gy4). The median age was 52.5 years (34-79). The median tumor volume was 2.9 cm3 (0.5-39.4). The median follow-up was 32.4 months (1.2-101.7). 1 and 2 years LC were 92.9 and 86.6%, respectively. 1 and 2 years OS were 100 and 90.6%, respectively. Multivariate analysis (MVA) associated volume of the treated lesion ≥ 13 cm3 with worse LC (p = 0.046; HR 12.1, 95%CI = 1.1-140.3). In addition, deferring SBRT > 3 months after lesion diagnosis to prioritize systemic treatment showed a significant benefit, improving the 2 years LC up to 96.8% vs. 67.5% for SBRT performed before this period (p = 0.031; HR 0.1, 95%CI = 0.01-0.8). Hormonal receptors, the total number of metastases, and CA15-3 value were significantly associated with OS in MVA. During follow-up, three non-spine fractures (5%) were observed. CONCLUSIONS: According to our data, bone SBRT is a safe and effective technique for BC. Upfront systemic treatment before SBRT offers a benefit in LC. Therefore, SBRT should be considered after prior systemic treatment in this population.

Axillary lymph node dissection versus radiotherapy in breast cancer with positive sentinel nodes after neoadjuvant therapy (ADARNAT trial).

Introduction: Breast cancer surgery currently focuses on de-escalating treatment without compromising patient survival. Axillary radiotherapy (ART) now replaces axillary lymph node dissection (ALND) in patients with limited sentinel lymph node (SLN) involvement during the primary surgery, and this has significantly reduced the incidence of lymphedema without worsening the prognosis. However, patients treated with neoadjuvant systemic treatment (NST) cannot benefit from this option despite the low incidence of residual disease in the armpit in most cases. Data regarding the use of radiotherapy instead of ALND in this population are lacking. This study will assess whether ART is non-inferior to ALND in terms of recurrence and overall survival in patients with positive SLN after NST, including whether it reduces surgery-related adverse effects. Methods and analyses: This multicenter, randomized, open-label, phase 3 trial will enroll 1660 patients with breast cancer and positive SLNs following NST in approximately 50 Spanish centers over 3 years. Patients will be stratified by NST regimen and nodal involvement (isolated tumoral cells or micrometastasis versus macrometastasis) and randomly assigned 1:1 to ART without ALND (study arm) or ALND alone (control arm). Level 3 and supraclavicular radiotherapy will be added in both arms. The primary outcome is the 5-year axillary recurrence determined by clinical and radiological examination. The secondary outcomes include lymphedema or arm dysfunction, quality of life based (EORTC QLQ-C30 and QLQ-BR23 questionnaires), disease-free survival, and overall survival. Discussion: This study aims to provide data to confirm the efficacy and safety of ART over ALND in patients with a positive SLN after NST, together with the impact on morbidity. Ethics and dissemination: The Research Ethics Committee of Bellvitge University Hospital approved this trial (Protocol Record PR148/21, version 3, 1/2/2022) and all patients must provide written informed consent. The involvement of around 50 centers across Spain will facilitate the dissemination of our results. Trial registration: ClinicalTrials.gov, identifier number NCT04889924.

Efficacy and safety of concurrent trastuzumab plus weekly paclitaxel-FEC as primary therapy for HER2-positive breast cancer in everyday clinical practice.

One of the most efficacious primary therapies in HER2-positive breast cancer was published by the M.D. Anderson group in 2005. This randomized trial evaluated the addition of trastuzumab to a taxane-anthracycline based chemotherapy. Despite largely significant differences in pathological complete response (pCR) in the trastuzumab group (65 vs. 26 %) this regimen did not become a common standard due to toxicity concerns and its premature closure with a small sample size. In order to evaluate the efficacy and safety of this regimen in an off-trial setting we conducted a prospectively monitorized series of consecutive patients with early or locally advanced Her-2 positive breast cancer following the same treatment strategy. Stage II-IIIC HER2-positive breast cancer patients, including inflammatory disease, were treated with weekly-trastuzumab for 24 weeks administered concurrently with all primary chemotherapy containing paclitaxel (80 mg/m(2)) for 12 weeks and 4 cycles of FEC-75 (fluorouracil 500 mg/m(2), epirubicine 75 mg/m(2), and cyclophosphamide 500 mg/m(2)) followed by surgery. The objectives were efficacy, in terms of pCR in both the breast and lymph nodes, and safety, with close cardiac monitoring during and after treatment. From August 2004 to February 2009, 83 patients were included. Most patients (73.5 %) had node involvement and 13.2 % had inflammatory disease. Fifty-one patients (61.4 %) achieved a pCR in breast and axilla (95 % CI 50-72 %). HR-negative tumors were associated with higher pCR rate than HR-positive tumors (77 vs. 48 %, P = 0.006). At a median follow-up of 50.2 months no patient developed symptomatic cardiac failure, and 9 patients (10.8 %) presented a transient asymptomatic decrease in left ventricular ejection fraction. Primary therapy with concurrent trastuzumab plus paclitaxel-FEC for HER2-positive breast cancer in everyday practice is highly effective and safe confirming the results observed in a randomized trial stopped prematurely.

Effectiveness and safety of intraoperative radiotherapy (IORT) with low-energy X-rays (INTRABEAM®) for accelerated partial breast irradiation (APBI).

PURPOSE: To evaluate treatment outcomes in patients with early-stage breast cancer (ESBC) treated with targeted intraoperative radiation therapy (IORT) administered as accelerated partial breast irradiation (APBI). METHODS: Between December 2014 and May 2019, 50 patients diagnosed with ESBC were treated with a 50 kilovoltage (kV) X-ray source with a single dose of 20 Gy using the Intrabeam® radiotherapy delivery system. All patients were followed prospectively to assess local control (LC), disease-free survival (DFS), cancer-specific survival (CSS), overall survival (OS), radiation-induced toxicity, and cosmetic outcomes. We also evaluated the prognostic implications of the neutrophil-to-lymphocyte ratio (NLR) and platelet-to-lymphocyte ratio (PLR). RESULTS: Median follow-up was 53 months. Mean patient age was 70 years. The mean duration of radiation delivery was 22.25 min. Two patients developed a recurrence. One death was recorded. Elevated pretreatment NLR levels were a significant risk factor for mortality (p = 0.0026). The most common treatment-related toxicities were breast induration (30%) and seroma (18%). Five-year LC, DFS, CSS, and OS rates were 97.1%, 93.9%, 100%, and 94.4%, respectively. Cosmesis was excellent or good in most cases (94%). CONCLUSION: These findings confirm the effectiveness of a single dose of 20 Gy of IORT with the Intrabeam device as APBI. The toxicity profile was good with excellent cosmesis. These results provide further support for the clinical use of APBI in well-selected patients.

Pigmented paget disease of the breast nipple with underlying infiltrating carcinoma: a case report and review of the literature.

Paget disease of the breast represents a cutaneous manifestation of an underlying breast malignancy. The rare finding of a pigmented Paget disease mimicking melanoma represents a diagnostic problem. We report a case of a pigmented lesion involving the breast nipple with an underlying infiltrating breast carcinoma, and we describe the clinical presentation, histological findings, and immunohistochemical features with a review of reported cases.

Comparing the effects of alcohol sclerotherapy with those of surgery on anti-Müllerian hormone and ovarian reserve after endometrioma treatment. A prospective multicenter pilot cohort study.

STUDY OBJECTIVE: To compare the effects of ultrasound-guided aspiration and ethanol sclerotherapy with those of laparoscopic surgery on anti-Müllerian hormone (AMH) levels and ovarian reserve in benign-appearing ovarian endometrioma. DESIGN: A prospective, cohort pilot study. SETTING: Multiple centers, Spain. PATIENTS: Forty patients with a suspected ovarian endometrioma with a maximum diameter of 35-100 mm. Serum hormonal concentrations were analyzed in 26 of these women. INTERVENTIONS: Two groups: one that received US-guided aspiration plus alcohol sclerotherapy (n = 16) and the other that underwent laparoscopic cystectomy (n = 10). MEASUREMENTS AND MAIN RESULTS: We studied serum hormonal concentrations (AMH, FSH and 17-ß-estradiol) and antral follicle counts (AFC) in each patient at baseline, and after the procedures and pregnancies. No differences were found when comparing AMH and FSH concentrations before and after each procedure. 17-ß-estradiol concentrations were significantly increased after alcohol sclerotherapy (p < 0.001). AFC recovery after 6 months seemed to be higher after sclerotherapy than after surgery. Three patients became pregnant in the sclerotherapy group. CONCLUSION: This pilot study indicated that alcohol sclerotherapy preserves fertility in patients with endometriomas better than surgery, with significant increases in serum estradiol concentrations, possible AFC recovery and spontaneous pregnancies observed in the patients after sclerotherapy.